[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1082 Engrossed in Senate (ES)]

  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
110th CONGRESS
  1st Session
                                S. 1082

_______________________________________________________________________

                                 AN ACT


 
To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to reauthorize drug and device user fees and ensure the 
          safety of medical products, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Food and Drug Administration 
Revitalization Act''.

                  TITLE I--PRESCRIPTION DRUG USER FEES

SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

    (a) Short Title.--This title may be cited as the ``Prescription 
Drug User Fee Amendments of 2007''.
    (b) References in Title.--Except as otherwise specified, whenever 
in this title an amendment is expressed in terms of an amendment to a 
section or other provision, the reference shall be considered to be 
made to a section or other provision of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 102. DRUG FEES.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) by striking the section designation and all that 
        follows through ``For purposes of this subchapter:'' and 
        inserting the following:

``SEC. 735. DRUG FEES.

    ``(a) Purpose.--It is the purpose of this part that the fees 
authorized under this part be dedicated toward expediting the drug 
development process, the process for the review of human drug 
applications, and postmarket drug safety, as set forth in the goals 
identified for purposes of this part in the letters from the Secretary 
to the Chairman of the Committee on Health, Education, Labor, and 
Pensions of the Senate and the Chairman of the Committee on Energy and 
Commerce of the House of Representatives, as set forth in the 
Congressional Record.
    ``(b) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        subsection (a) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals. The 
        report for a fiscal year shall include information on all 
        previous cohorts for which the Secretary has not given a 
        complete response on all human drug applications and 
        supplements in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such 
        fiscal year and the use, by the Food and Drug Administration, 
        of the fees collected during such fiscal year for which the 
        report is made.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet website of the Food and Drug 
        Administration.
    ``(c) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of human drug 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
    ``(d) Definitions.--For purposes of this part:'';
            (2) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A), by striking 
                        ``505(b)(1),'' and inserting ``505(b), or'';
                            (ii) by striking subparagraph (B);
                            (iii) by redesignating subparagraph (C) as 
                        subparagraph (B); and
                            (iv) in the matter following subparagraph 
                        (B), as so redesignated, by striking 
                        ``subparagraph (C)'' and inserting 
                        ``subparagraph (B)'';
                    (B) in paragraph (3)(C), by--
                            (i) striking ``the list'' and inserting 
                        ``the list (not including the discontinued 
                        section of such list)''; and
                            (ii) striking ``a list'' and inserting ``a 
                        list (not including the discontinued section of 
                        such a list)'';
                    (C) in paragraph (4), by inserting before the 
                period at the end the following: ``(such as capsules, 
                tablets, and lyophilized products before 
                reconstitution)'';
                    (D) by amending paragraph (6)(F) to read as 
                follows:
                    ``(F) In the case of drugs approved under human 
                drug applications or supplements, postmarket safety 
                activities, including--
                            ``(i) collecting, developing, and reviewing 
                        safety information on approved drugs (including 
                        adverse event reports);
                            ``(ii) developing and using improved 
                        adverse event data collection systems 
                        (including information technology systems); and
                            ``(iii) developing and using improved 
                        analytical tools to assess potential safety 
                        problems (including by accessing external data 
                        bases).'';
                    (E) in paragraph (8)--
                            (i) by striking ``April of the preceding 
                        fiscal year'' and inserting ``October of the 
                        preceding fiscal year''; and
                            (ii) by striking ``April 1997'' and 
                        inserting ``October 1996'';
                    (F) by redesignating paragraph (9) as paragraph 
                (10); and
                    (G) by inserting after paragraph (8) the following:
            ``(9) The term `person' includes an affiliate of such 
        person.''.

SEC. 103. AUTHORITY TO ASSESS AND USE DRUG FEES.

    (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``2003'' and inserting ``2008'';
            (2) in paragraph (1)--
                    (A) in subparagraph (D)--
                            (i) in the heading, by inserting ``or 
                        withdrawn before filing'' after ``refund of fee 
                        if application refused for filing''; and
                            (ii) by inserting before the period at the 
                        end the following: ``or withdrawn without a 
                        waiver before filing'';
                    (B) by redesignating subparagraphs (E) and (F) as 
                subparagraphs (F) and (G), respectively; and
                    (C) by inserting after subparagraph (D) the 
                following:
                    ``(E) Fee for application previously refused for 
                filing or withdrawn before filing.--An application or 
                supplement that has been refused for filing or that was 
                withdrawn before filing, if filed under protest or 
                resubmitted, shall be subject to the fee under 
                subparagraph (A) (unless an exception under 
                subparagraph (C) or (F) applies or the fee is waived or 
                reduced under subsection (d)), without regard to 
                previous payment of such a fee and the refund of 75 
                percent of that fee under subparagraph (D).''; and
            (3) in paragraph (2)--
                    (A) in subparagraph (A), by striking ``subparagraph 
                (B)'' and inserting ``subparagraphs (B) and (C)''; and
                    (B) by adding at the end the following:
                    ``(C) Special rules for compounded positron 
                emission tomography drugs.--
                            ``(i) In general.--Except as provided in 
                        clause (ii), each person who is named as the 
                        applicant in an approved human drug application 
                        for a compounded positron emission tomography 
                        drug shall be subject under subparagraph (A) to 
                        one-fifth of an annual establishment fee with 
                        respect to each such establishment identified 
                        in the application as producing compounded 
                        positron emission tomography drugs under the 
                        approved application.
                            ``(ii) Exception from annual establishment 
                        fee.--Each person who is named as the applicant 
                        in an application described in clause (i) shall 
                        not be assessed an annual establishment fee for 
                        a fiscal year if the person certifies to the 
                        Secretary, at a time specified by the Secretary 
                        and using procedures specified by the 
                        Secretary, that--
                                    ``(I) the person is a not-for-
                                profit medical center that has only 1 
                                establishment for the production of 
                                compounded positron emission tomography 
                                drugs; and
                                    ``(II) at least 95 percent of the 
                                total number of doses of each 
                                compounded positron emission tomography 
                                drug produced by such establishment 
                                during such fiscal year will be used 
                                within the medical center.''.
    (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
amended to read as follows:
    ``(b) Fee Revenue Amounts.--Except as provided in subsections (c), 
(d), (f), and (g), fees under subsection (a) shall be established to 
generate the following revenue amounts, in each fiscal year beginning 
with fiscal year 2008 and continuing through fiscal year 2012: 
$392,783,000, plus an adjustment for workload on $354,893,000 of this 
amount. Such adjustment shall be made in accordance with the workload 
adjustment provisions in effect for fiscal year 2007, except that 
instead of commercial investigational new drug applications submitted 
to the Secretary, all commercial investigational new drug applications 
with a submission during the previous 12-month period shall be used in 
the determination. One-third of the revenue amount shall be derived 
from application fees, one-third from establishment fees, and one-third 
from product fees.''.
    (c) Adjustments to Fees.--
            (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
        379h(c)(1)) is amended--
                    (A) in the matter preceding subparagraph (A) by 
                striking ``The revenues established in subsection (b)'' 
                and inserting ``Beginning with fiscal year 2009, the 
                revenues established in subsection (b)'';
                    (B) in subparagraph (A) by striking ``or'' at the 
                end;
                    (C) in subparagraph (B) by striking the period at 
                the end and inserting ``, or,'';
                    (D) by inserting after subparagraph (B) the 
                following:
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.''; 
                and
                    (E) in the matter following subparagraph (C) (as 
                added by this paragraph), by striking ``fiscal year 
                2003'' and inserting ``fiscal year 2008''.
            (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
        379h(c)(2)) is amended--
                    (A) in the matter preceding subparagraph (A,) by 
                striking ``2004'' and inserting ``2009'';
                    (B) in the first sentence of subparagraph (A)--
                            (i) by striking ``, commercial 
                        investigational new drug applications'' and 
                        inserting ``(adjusted for changes in review 
                        activities)''; and
                            (ii) by inserting before the period at the 
                        end ``, and the change in the number of 
                        commercial investigational new drug 
                        applications with a submission during the 
                        previous 12-month period (adjusted for changes 
                        in review activities)'';
                    (C) in subparagraph (B), by adding at the end the 
                following new sentence: ``Further, any adjustment for 
                changes in review activities made in setting fees and 
                fee revenue amounts for fiscal year 2009 may not result 
                in the total workload adjustment being more than 2 
                percentage points higher than it would be absent the 
                adjustment for changes in review activities.''; and
                    (D) by adding at the end the following:
                    ``(C) The Secretary shall contract with an 
                independent accounting firm to study the adjustment for 
                changes in review activities applied in setting fees 
                for fiscal year 2009 and to make recommendations, if 
                warranted, on future changes in the methodology for 
                calculating the adjustment for changes in review 
                activity. After review of the recommendations by the 
                independent accounting firm, the Secretary shall make 
                appropriate changes to the workload adjustment 
                methodology in setting fees for fiscal years 2010 
                through 2012. If the study is not conducted, no 
                adjustment for changes in review activities shall be 
                made after fiscal year 2009.''.
            (3) Rent and rent-related cost adjustment.--Section 736(c) 
        (21 U.S.C. 379h(c)) is amended--
                    (A) by redesignating paragraphs (3), (4), and (5) 
                as paragraphs (4), (5), and (6), respectively; and
                    (B) by inserting after paragraph (2) the following:
            ``(3) Rent and rent-related cost adjustment.--Beginning 
        with fiscal year 2010, the Secretary shall, before making the 
        adjustments under paragraphs (1) and (2), reduce the fee 
        amounts established in subsection (b), if actual costs paid for 
        rent and rent-related expenses are less than $11,721,000. The 
        reductions made under this paragraph, if any, shall not exceed 
        the amounts by which costs fell below $11,721,000, and shall 
        not exceed $11,721,000 in any fiscal year.''.
            (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
        379h(c)) is amended--
                    (A) in paragraph (4), as redesignated by this 
                subsection--
                            (i) by striking ``2007'' each place it 
                        appears and inserting ``2012''; and
                            (ii) by striking ``2008'' and inserting 
                        ``2013''; and
                    (B) in paragraph (5), as redesignated by this 
                subsection, by striking ``2002'' and inserting 
                ``2007''.
    (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 379h(d)) is 
amended--
            (1) in paragraph (1), in the matter preceding subparagraph 
        (A), by--
                    (A) inserting ``to a person who is named as the 
                applicant'' after ``The Secretary shall grant'';
                    (B) inserting ``to that person'' after ``a waiver 
                from or a reduction of one or more fees assessed''; and
                    (C) striking ``finds'' and inserting 
                ``determines'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Evaluation.--For the purpose of determining whether 
        to grant a waiver or reduction of a fee under paragraph (1), 
        the Secretary shall consider only the circumstances and assets 
        of the applicant and any affiliate of the applicant.''; and
            (4) in paragraph (4), as redesignated by this subsection, 
        in subparagraph (A), by inserting before the period at the end 
        ``, and that does not have a drug product that has been 
        approved under a human drug application and introduced or 
        delivered for introduction into interstate commerce''.
    (e) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 736(g)(3) (21 
        U.S.C. 379h(g)(3)) is amended to read as follows:
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section such 
        sums as are authorized to be assessed and collected under this 
        section in each of fiscal years 2008 through 2012.''.
            (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
        amended to read as follows:
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, plus the amount 
        estimated to be collected for fiscal year 2011, exceeds the 
        amount of fees specified in aggregate in appropriation Acts for 
        such fiscal years, the aggregate amount in excess shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        authorized to be collected under this section pursuant to 
        appropriation Acts for fiscal year 2012.''.
    (f) Conforming Amendments.--
            (1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this 
        section, is amended--
                    (A) in paragraph (1)(A), by striking ``subsection 
                (c)(4)'' each place it appears and inserting 
                ``subsection (c)(5)'';
                    (B) in paragraph (2), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''; and
                    (C) in paragraph (3), by striking ``subsection 
                (c)(4)'' and inserting ``subsection (c)(5)''.
            (2) Section 736A(h)(3), as added by section 104 of this 
        title, is amended by striking ``735(3)'' and inserting 
        ``735(d)(3)''.

SEC. 104. AUTHORITY TO ASSESS AND USE PRESCRIPTION DRUG ADVERTISING 
              FEES.

    Chapter VII, subchapter C, part 2 (21 U.S.C. 379g et seq.) is 
amended by adding after section 736 the following new section:

``SEC. 736A. PROGRAM TO ASSESS AND USE FEES FOR THE ADVISORY REVIEW OF 
              PRESCRIPTION DRUG ADVERTISING.

    ``(a) Types of Direct-to-Consumer Television Advertisement Review 
Fees.--Beginning with fiscal year 2008, the Secretary shall assess and 
collect fees in accordance with this section as follows:
            ``(1) Advisory review fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each person that on or after October 
                1, 2007, submits a proposed direct-to-consumer 
                television advertisement for advisory review by the 
                Secretary prior to its initial public dissemination 
                shall be subject to a fee established under subsection 
                (c)(3).
                    ``(B) Exception for required submissions.--A 
                direct-to-consumer television advertisement that is 
                required to be submitted to the Secretary prior to 
                initial public dissemination shall not be assessed a 
                fee unless the sponsor designates it as a submission 
                for advisory review.
                    ``(C) Payment.--The fee required by subparagraph 
                (A) shall be due not later than October 1 of the fiscal 
                year in which the direct-to-consumer television 
                advertisement shall be submitted to the Secretary for 
                advisory review.
                    ``(D) Modification of advisory review fee.--
                            ``(i) Late payment.--If, on or before 
                        November 1 of the fiscal year in which the fees 
                        are due, a person has not paid all fees that 
                        were due and payable for advisory reviews 
                        identified in response to the Federal Register 
                        notice described in subsection (c)(3)(A), the 
                        fees shall be regarded as late. Such fees shall 
                        be due and payable 20 days before any direct-
                        to-consumer television advertisement is 
                        submitted by such person to the Secretary for 
                        advisory review. Notwithstanding any other 
                        provision of this section, such fees shall be 
                        due and payable for each of those advisory 
                        reviews in the amount of 150 percent of the 
                        advisory review fee established for that fiscal 
                        year pursuant to subsection (c)(3).
                            ``(ii) Late notice of submission.--If any 
                        person submits any direct-to-consumer 
                        television advertisements for advisory review 
                        that are in excess of the number identified by 
                        that person in response to the Federal Register 
                        notice described in subsection (c)(3)(A), that 
                        person must pay a fee for each of those 
                        advisory reviews in the amount of 150 percent 
                        of the advisory review fee established for that 
                        fiscal year pursuant to subsection (c)(3). Fees 
                        under this subparagraph shall be due 20 days 
                        before the direct-to-consumer television 
                        advertisement is submitted by such person to 
                        the Secretary for advisory review.
                    ``(E) Limits.--
                            ``(i) In general.--The payment of a fee 
                        under this paragraph for a fiscal year entitles 
                        the person that pays the fee to acceptance for 
                        advisory review by the Secretary of 1 direct-
                        to-consumer television advertisement and 
                        acceptance of 1 resubmission for advisory 
                        review of the same advertisement. The 
                        advertisement shall be submitted for review in 
                        the fiscal year for which the fee was assessed, 
                        except that a person may carry over no more 
                        than 1 paid advisory review submission to the 
                        next fiscal year. Resubmissions may be 
                        submitted without regard to the fiscal year of 
                        the initial advisory review submission.
                            ``(ii) No refund.--Except as provided by 
                        subsection (f), fees paid under this paragraph 
                        shall not be refunded.
                            ``(iii) No waiver, exemption, or 
                        reduction.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any fees due 
                        or payable under this section.
                            ``(iv) Non-transferability.--The right to 
                        an advisory review is not transferable, except 
                        to a successor in interest.
            ``(2) Operating reserve fee.--
                    ``(A) In general.--Each person that, on or after 
                October 1, 2007, is assessed an advisory review fee 
                under paragraph (1) shall be subject to an operating 
                reserve fee established under subsection (d)(2) only in 
                the first fiscal year in which an advisory review fee 
                is assessed.
                    ``(B) Payment.--Except as provided in subparagraph 
                (C), the fee required by subparagraph (A) shall be due 
                not later than October 1 of the first fiscal year in 
                which the person is required to pay an advisory review 
                fee under paragraph (1).
                    ``(C) Late notice of submission.--If, in the first 
                fiscal year of a person's participation in the Program, 
                that person submits any direct-to-consumer television 
                advertisements for advisory review that are in excess 
                of the number identified by that person in response to 
                the Federal Register notice described in subsection 
                (c)(3)(A), that person must pay an operating reserve 
                fee for each of those advisory reviews equal to the 
                advisory review fee for each submission established 
                under paragraph (1)(D)(ii). Fees required by this 
                subparagraph shall be in addition to the fees required 
                under subparagraph (B), if any. Fees under this 
                subparagraph shall be due 20 days before any direct-to-
                consumer television advertisement is submitted by such 
                person to the Secretary for advisory review.
    ``(b) Advisory Review Fee Revenue Amounts.--Fees under subsection 
(a)(1) shall be established to generate revenue amounts of $6,250,000 
for each of fiscal years 2008 through 2012, as adjusted pursuant to 
subsection (c).
    ``(c) Adjustments.--
            ``(1) Inflation adjustment.--Beginning with fiscal year 
        2009, the revenues established in subsection (b) shall be 
        adjusted by the Secretary by notice, published in the Federal 
        Register, for a fiscal year to reflect the greater of--
                    ``(A) the total percentage change that occurred in 
                the Consumer Price Index for all urban consumers (all 
                items; United States city average), for the 12-month 
                period ending June 30 preceding the fiscal year for 
                which fees are being established;
                    ``(B) the total percentage change for the previous 
                fiscal year in basic pay under the General Schedule in 
                accordance with section 5332 of title 5, as adjusted by 
                any locality-based comparability payment pursuant to 
                section 5304 of such title for Federal employees 
                stationed in the District of Columbia; or
                    ``(C) the average annual change in the cost, per 
                full-time equivalent position of the Food and Drug 
                Administration, of all personnel compensation and 
                benefits paid with respect to such positions, for the 
                first 5 fiscal years of the previous 6 fiscal years.
        The adjustment made each fiscal year by this paragraph shall be 
        added on a compounded basis to the sum of all adjustments made 
        each fiscal year after fiscal year 2008 under this subsection.
            ``(2) Workload adjustment.--
                    ``(A) In general.--Beginning with fiscal year 2009, 
                after the fee revenues established in subsection (b) of 
                this section are adjusted for a fiscal year for 
                inflation in accordance with paragraph (1), the fee 
                revenues shall be adjusted further for such fiscal year 
                to reflect changes in the workload of the Secretary 
                with respect to the submission of proposed direct-to-
                consumer television advertisements for advisory review 
                prior to initial broadcast.
                    ``(B) Determination of workload adjustment.--
                            ``(i) In general.--The workload adjustment 
                        under this paragraph for a fiscal year shall be 
                        determined by the Secretary--
                                    ``(I) based upon the number of 
                                direct-to-consumer television 
                                advertisements identified pursuant to 
                                paragraph (3)(A) for that fiscal year, 
                                excluding allowable previously paid 
                                carry over submissions; and
                                    ``(II) by multiplying the number of 
                                such advertisements projected for that 
                                fiscal year that exceeds 150 by $27,600 
                                (adjusted each year beginning with 
                                fiscal year 2009 for inflation in 
                                accordance with paragraph (1)).
                            ``(ii) Publication in federal register.--
                        The Secretary shall publish in the Federal 
                        Register, as part of the notice described in 
                        paragraph (1), the fee revenues and fees 
                        resulting from the adjustment made under this 
                        paragraph and the supporting methodologies.
                    ``(C) Limitation.--Under no circumstances shall the 
                adjustment made under this paragraph result in fee 
                revenues for a fiscal year that are less than the fee 
                revenues established for the prior fiscal year.
            ``(3) Annual fee setting.--
                    ``(A) Number of advertisements.--The Secretary 
                shall, 120 days before the start of each fiscal year, 
                publish a notice in the Federal Register requesting any 
                person to notify the Secretary within 30 days of the 
                number of direct-to-consumer television advertisements 
                the person intends to submit for advisory review by the 
                Secretary in the next fiscal year. Notification to the 
                Secretary of the number of advertisements a person 
                intends to submit for advisory review prior to initial 
                broadcast shall be a legally binding commitment by that 
                person to pay the annual advisory review fee for that 
                number of submissions on or before October 1 of the 
                fiscal year in which the advertisement is intended to 
                be submitted. A person shall at the same time also 
                notify the Secretary if such person intends to use a 
                paid submission from the previous fiscal year under 
                subsection (a)(1)(E)(i). If such person does not so 
                notify the Secretary, all submissions for advisory 
                review shall be subject to advisory review fees.
                    ``(B) Annual fee.--The Secretary shall, 60 days 
                before the start of each fiscal year, establish, for 
                the next fiscal year, the direct-to-consumer television 
                advertisement advisory review fee under subsection 
                (a)(1), based on the revenue amounts established under 
                subsection (b), the adjustments provided under this 
                subsection and the number of direct-to-consumer 
                television advertisements identified pursuant to 
                subparagraph (A), excluding allowable previously paid 
                carry over submissions. The annual advisory review fee 
                shall be established by dividing the fee revenue for a 
                fiscal year (as adjusted pursuant to this subsection) 
                by the number of direct-to-consumer television 
                advertisements identified pursuant to subparagraph (A), 
                excluding allowable previously paid carry over 
                submissions.
                    ``(C) Fiscal year 2008 fee limit.--Notwithstanding 
                subsection (b), the fee established under subparagraph 
                (B) for fiscal year 2008 may not be more than $83,000 
                per submission for advisory review.
                    ``(D) Annual fee limit.--Notwithstanding subsection 
                (b), the fee established under subparagraph (B) for a 
                fiscal year after fiscal year 2008 may not be more than 
                50 percent more than the fee established for the prior 
                fiscal year.
                    ``(E) Limit.--The total amount of fees obligated 
                for a fiscal year may not exceed the total costs for 
                such fiscal year for the resources allocated for the 
                process for the advisory review of prescription drug 
                advertising.
    ``(d) Operating Reserves.--
            ``(1) In general.--The Secretary shall establish in the 
        Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation a Direct-
        to-Consumer Advisory Review Operating Reserve, of at least 
        $6,250,000 in fiscal year 2008, to continue the Program in the 
        event the fees collected in any subsequent fiscal year pursuant 
        to subsection (c)(3) do not generate the fee revenue amount 
        established for that fiscal year.
            ``(2) Fee setting.--The Secretary shall establish the 
        operating reserve fee under subsection (a)(2)(A) for each 
        person required to pay the fee by multiplying the number of 
        direct-to-consumer television advertisements identified by that 
        person pursuant to subsection (c)(3)(A) by the advisory review 
        fee established pursuant to subsection (c)(3) for that fiscal 
        year. In no case shall the operating reserve fee assessed be 
        less than the operating reserve fee assessed if the person had 
        first participated in the Program in fiscal year 2008.
            ``(3) Use of operating reserve.--The Secretary may use 
        funds from the reserves under this subsection only to the 
        extent necessary in any fiscal year to make up the difference 
        between the fee revenue amount established for that fiscal year 
        under subsection (b) and the amount of fees collected for that 
        fiscal year pursuant to subsection (a), or to pay costs of 
        ending the Program if it is terminated pursuant to subsection 
        (f) or if it is not reauthorized after fiscal year 2012.
            ``(4) Refund of operating reserves.--Within 120 days of the 
        end of fiscal year 2012, or if the Program is terminated 
        pursuant to subsection (f), the Secretary, after setting aside 
        sufficient operating reserve amounts to terminate the Program, 
        shall refund all amounts remaining in the operating reserve on 
        a pro rata basis to each person that paid an operating reserve 
        fee assessment. In no event shall the refund to any person 
        exceed the total amount of operating reserve fees paid by such 
        person pursuant to subsection (a)(2).
    ``(e) Effect of Failure To Pay Fees.--Notwithstanding any other law 
or regulation of the Secretary, a submission for advisory review of a 
direct-to-consumer television advertisement submitted by a person 
subject to fees under subsection (a) shall be considered incomplete and 
shall not be accepted for review by the Secretary until all fees owed 
by such person under this section have been paid.
    ``(f) Effect of Inadequate Funding of Program.--
            ``(1) First fiscal year.--If on November 1, 2007, or 120 
        days after enactment of the Prescription Drug User Fee 
        Amendments of 2007, whichever is later, the Secretary has 
        received less than $11,250,000 in advisory review fees and 
        operating reserve fees combined, the Program shall be 
        terminated and all collected fees shall be refunded.
            ``(2) Subsequent fiscal years.--Beginning in fiscal year 
        2009, if, on November 1 of a fiscal year, the combination of 
        the operating reserves, annual fee revenues from that fiscal 
        year, and unobligated fee revenues from prior fiscal years is 
        less than $9,000,000, adjusted for inflation (in accordance 
        with subsection (c)(1)), the Program shall be terminated, and 
        the Secretary shall notify all participants, retain any money 
        from the unused advisory review fees and the operating reserves 
        needed to terminate the Program, and refund the remainder of 
        the unused fees and operating reserves. To the extent required 
        to terminate the Program, the Secretary shall first use 
        unobligated advisory review fee revenues from prior fiscal 
        years, then the operating reserves, and then unused advisory 
        review fees from the relevant fiscal year.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) 
        shall be collected and available for obligation only to the 
        extent and in the amount provided in advance in appropriations 
        Acts. Such fees are authorized to remain available until 
        expended. Such sums as may be necessary may be transferred from 
        the Food and Drug Administration salaries and expenses 
        appropriation account without fiscal year limitation to such 
        appropriation account for salaries and expenses with such 
        fiscal year limitation. The sums transferred shall be available 
        solely for the process for the advisory review of prescription 
        drug advertising.
            ``(2) Collections and appropriation acts.--The fees 
        authorized by this section--
                    ``(A) shall be retained in each fiscal year in an 
                amount not to exceed the amount specified in 
                appropriation Acts, or otherwise made available for 
                obligation for such fiscal year; and
                    ``(B) shall be available for obligation only if 
                appropriated budget authority continues to support at 
                least the total combined number of full-time equivalent 
                employees in the Food and Drug Administration, Center 
                for Drug Evaluation and Research, Division of Drug 
                Marketing, Advertising, and Communications, and the 
                Center for Biologics Evaluation and Research, 
                Advertising and Promotional Labeling Branch supported 
                in fiscal year 2007.
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section not 
        less than $6,250,000 for each of fiscal years 2008, 2009, 2010, 
        2011, and 2012, as adjusted to reflect adjustments in the total 
        fee revenues made under this section, plus amounts collected 
        for the reserve fund under subsection (d).
            ``(4) Offset.--Any amount of fees collected for a fiscal 
        year under this section that exceeds the amount of fees 
        specified in appropriation Acts for such fiscal year shall be 
        credited to the appropriation account of the Food and Drug 
        Administration as provided in paragraph (1), and shall be 
        subtracted from the amount of fees that would otherwise be 
        collected under this section pursuant to appropriation Acts for 
        a subsequent fiscal year.
    ``(h) Definitions.--For purposes of this section:
            ``(1) The term `advisory review' means reviewing and 
        providing advisory comments regarding compliance of a proposed 
        advertisement with the requirements of this Act prior to its 
        initial public dissemination.
            ``(2) The term `carry over submission' means a submission 
        for an advisory review for which a fee was paid in a fiscal 
        year that is submitted for review in the following fiscal year.
            ``(3) The term `direct-to-consumer television 
        advertisement' means an advertisement for a prescription drug 
        product as defined in section 735(3) intended to be displayed 
        on any television channel for less than 2 minutes.
            ``(4) The term `person' includes an individual, a 
        partnership, a corporation, and an association, and any 
        affiliate thereof or successor in interest.
            ``(5) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary 
        to review and provide advisory comments on proposed direct-to-
        consumer television advertisements prior to public 
        dissemination and, to the extent the Secretary has additional 
        staff resources available under the Program that are not 
        necessary for the advisory review of direct-to-consumer 
        television advertisements, the activities necessary to review 
        and provide advisory comments on other proposed advertisements 
        and promotional material prior to public dissemination.
            ``(6) The term `Program' means the Program to assess, 
        collect, and use fees for the advisory review of prescription 
        drug advertising established by this section.
            ``(7) The term `resources allocated for the process for the 
        advisory review of prescription drug advertising' means the 
        expenses incurred in connection with the process for the 
        advisory review of prescription drug advertising for--
                    ``(A) officers and employees of the Food and Drug 
                Administration, contractors of the Food and Drug 
                Administration, advisory committees, and costs related 
                to such officers, employees, and committees, and to 
                contracts with such contractors;
                    ``(B) management of information, and the 
                acquisition, maintenance, and repair of computer 
                resources;
                    ``(C) leasing, maintenance, renovation, and repair 
                of facilities and acquisition, maintenance, and repair 
                of fixtures, furniture, scientific equipment, and other 
                necessary materials and supplies;
                    ``(D) collection of fees under this section and 
                accounting for resources allocated for the advisory 
                review of prescription drug advertising; and
                    ``(E) terminating the Program under subsection 
                (f)(2), if necessary.
            ``(8) The term `resubmission' means a subsequent submission 
        for advisory review of a direct-to-consumer television 
        advertisement that has been revised in response to the 
        Secretary's comments on an original submission. A resubmission 
        may not introduce significant new concepts or creative themes 
        into the television advertisement.
            ``(9) The term `submission for advisory review' means an 
        original submission of a direct-to-consumer television 
        advertisement for which the sponsor voluntarily requests 
        advisory comments before the advertisement is publicly 
        disseminated.

``SEC. 736B. SUNSET.

    ``This part shall cease to be effective on October 1, 2012, except 
that subsection (b) of section 736 with respect to reports shall cease 
to be effective on January 31, 2013.''.

SEC. 105. SAVINGS CLAUSE.

    Notwithstanding section 509 of the Prescription Drug User Fee 
Amendments of 2002 (21 U.S.C. 379g note), and notwithstanding the 
amendments made by this title, part 2 of subchapter C of chapter VII of 
the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of enactment of this title, shall continue to be in 
effect with respect to human drug applications and supplements (as 
defined in such part as of such day) that on or after October 1, 2002, 
but before October 1, 2007, were accepted by the Food and Drug 
Administration for filing with respect to assessing and collecting any 
fee required by such part for a fiscal year prior to fiscal year 2008.

SEC. 106. TECHNICAL AMENDMENT.

    Section 739 (21 U.S.C. 379j-11) is amended in the matter preceding 
paragraph (1), by striking ``subchapter'' and inserting ``part''.

SEC. 107. EFFECTIVE DATES.

    (a) In General.--Except as provided in subsection (b), the 
amendments made by this title shall take effect October 1, 2007.
    (b) Exception.--The amendment made by section 104 of this title 
shall take effect on the date of enactment of this title.

                         TITLE II--DRUG SAFETY

SEC. 200. SHORT TITLE.

    This title may be cited as the ``Enhancing Drug Safety and 
Innovation Act of 2007''.

         Subtitle A--Risk Evaluation and Mitigation Strategies

SEC. 201. ROUTINE ACTIVE SURVEILLANCE AND ASSESSMENT.

    (a) In General.--Subsection (k) of section 505 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
the following:
            ``(3) Routine active surveillance and assessment.--
                    ``(A) Development of the postmarket risk 
                identification and analysis system.--The Secretary 
                shall, not later than 2 years after the date of 
                enactment of the Enhancing Drug Safety and Innovation 
                Act of 2007, act in collaboration with academic 
                institutions and private entities to--
                            ``(i) establish minimum standards for 
                        collection and transmission of postmarketing 
                        data elements from electronic health data 
                        systems; and
                            ``(ii) establish, through partnerships, a 
                        validated and integrated postmarket risk 
                        identification and analysis system to integrate 
                        and analyze safety data from multiple sources, 
                        with the goals of including, in aggregate--
                                    ``(I) at least 25,000,000 patients 
                                by July 1, 2010; and
                                    ``(II) at least 100,000,000 
                                patients by July 1, 2012.
                    ``(B) Data collection activities.--
                            ``(i) In general.--The Secretary shall, not 
                        later than 1 year after the establishment of 
                        the minimum standards and the identification 
                        and analysis system under subparagraph (A), 
                        establish and maintain an active surveillance 
                        infrastructure--
                                    ``(I) to collect and report data 
                                for pharmaceutical postmarket risk 
                                identification and analysis, in 
                                compliance with the regulations 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996; and
                                    ``(II) that includes, in addition 
                                to the collection and monitoring (in a 
                                standardized form) of data on all 
                                serious adverse drug experiences (as 
                                defined in subsection (o)(2)(C)) 
                                required to be submitted to the 
                                Secretary under paragraph (1), and 
                                those events voluntarily submitted from 
                                patients, providers, and drug, when 
                                appropriate, procedures to--
                                            ``(aa) provide for adverse 
                                        event surveillance by 
                                        collecting and monitoring 
                                        Federal health-related 
                                        electronic data (such as data 
                                        from the Medicare program and 
                                        the health systems of the 
                                        Department of Veterans 
                                        Affairs);
                                            ``(bb) provide for adverse 
                                        event surveillance by 
                                        collecting and monitoring 
                                        private sector health-related 
                                        electronic data (such as 
                                        pharmaceutical purchase data 
                                        and health insurance claims 
                                        data);
                                            ``(cc) provide for adverse 
                                        event surveillance by 
                                        monitoring standardized 
                                        electronic health records, as 
                                        available;
                                            ``(dd) provide for adverse 
                                        event surveillance by 
                                        collecting and monitoring other 
                                        information as the Secretary 
                                        deems necessary to create a 
                                        robust system to identify 
                                        adverse events and potential 
                                        drug safety signals;
                                            ``(ee) enable the program 
                                        to identify certain trends and 
                                        patterns with respect to data 
                                        reported to the program;
                                            ``(ff) enable the program 
                                        to provide regular reports to 
                                        the Secretary concerning 
                                        adverse event trends, adverse 
                                        event patterns, incidence and 
                                        prevalence of adverse events, 
                                        laboratory data, and other 
                                        information determined 
                                        appropriate, which may include 
                                        data on comparative national 
                                        adverse event trends; and
                                            ``(gg) enable the program 
                                        to export data in a form 
                                        appropriate for further 
                                        aggregation, statistical 
                                        analysis, and reporting.
                            ``(ii) Timeliness of reporting.--The 
                        procedures developed under clause (i) shall 
                        ensure that such data are collected, monitored, 
                        and reported in a timely, routine, and 
                        automatic manner, taking into consideration the 
                        need for data completeness, coding, cleansing, 
                        and transmission.
                            ``(iii) Private sector resources.--To 
                        ensure the establishment of the active 
                        surveillance infrastructure by the date 
                        described under clause (i), the Secretary may, 
                        on a temporary or permanent basis, implement 
                        systems or products developed by private 
                        entities.
                            ``(iv) Complementary approaches.--To the 
                        extent the active surveillance infrastructure 
                        established under clause (i) is not sufficient 
                        to gather data and information relevant to 
                        priority drug safety questions, the Secretary 
                        shall develop, support, and participate in 
                        complementary approaches to gather and analyze 
                        such data and information, including--
                                    ``(I) approaches that are 
                                complementary with respect to assessing 
                                the safety of use of a drug in domestic 
                                populations not included in the trials 
                                used to approve the drug (such as older 
                                people, people with comorbidities, 
                                pregnant women, or children); and
                                    ``(II) existing approaches such as 
                                the Vaccine Adverse Event Reporting 
                                System and the Vaccine Safety Datalink 
                                or successor databases.
                            ``(v) Authority for contracts.--The 
                        Secretary may enter into contracts with public 
                        and private entities to fulfill the 
                        requirements of this subparagraph.
                    ``(C) Risk identification and analysis.--
                            ``(i) Purpose.--To carry out this 
                        paragraph, the Secretary shall establish 
                        collaborations with other Government, academic, 
                        and private entities, including the Centers for 
                        Education and Research on Therapeutics under 
                        section 912 of the Public Health Service Act, 
                        to provide for the risk identification and 
                        analysis of the data collected under 
                        subparagraph (B) and data that is publicly 
                        available or is provided by the Secretary, in 
                        order to--
                                    ``(I) improve the quality and 
                                efficiency of postmarket drug safety 
                                risk-benefit analysis;
                                    ``(II) provide the Secretary with 
                                routine access to expertise to study 
                                advanced drug safety data; and
                                    ``(III) enhance the ability of the 
                                Secretary to make timely assessments 
                                based on drug safety data.
                            ``(ii) Public process for priority 
                        questions.--At least biannually, the Secretary 
                        shall seek recommendations from the Drug Safety 
                        and Risk Management Advisory Committee (or 
                        successor committee) and from other advisory 
                        committees, as appropriate, to the Food and 
                        Drug Administration on--
                                    ``(I) priority drug safety 
                                questions; and
                                    ``(II) mechanisms for answering 
                                such questions, including through--
                                            ``(aa) routine active 
                                        surveillance under subparagraph 
                                        (B); and
                                            ``(bb) when such 
                                        surveillance is not sufficient, 
                                        postmarket studies under 
                                        subsection (o)(4)(B) and 
                                        postapproval clinical trials 
                                        under subsection (o)(4)(C).
                            ``(iii) Procedures for the development of 
                        drug safety collaborations.--
                                    ``(I) In general.--Not later than 
                                180 days after the date of the 
                                establishment of the active 
                                surveillance infrastructure under 
                                subparagraph (B), the Secretary shall 
                                establish and implement procedures 
                                under which the Secretary may routinely 
                                collaborate with a qualified entity 
                                to--
                                            ``(aa) clean, classify, or 
                                        aggregate data collected under 
                                        subparagraph (B) and data that 
                                        is publicly available or is 
                                        provided by the Secretary;
                                            ``(bb) allow for prompt 
                                        investigation of priority drug 
                                        safety questions, including--

                                                    ``(AA) unresolved 
                                                safety questions for 
                                                drugs or classes of 
                                                drugs; and

                                                    ``(BB) for a newly-
                                                approved drug: safety 
                                                signals from clinical 
                                                trials used to approve 
                                                the drug and other 
                                                preapproval trials; 
                                                rare, serious drug side 
                                                effects; and the safety 
                                                of use in domestic 
                                                populations not 
                                                included in the trials 
                                                used to approve the 
                                                drug (such as older 
                                                people, people with 
                                                comorbidities, pregnant 
                                                women, or children);

                                            ``(cc) perform advanced 
                                        research and analysis on 
                                        identified drug safety risks;
                                            ``(dd) convene an expert 
                                        advisory committee to oversee 
                                        the establishment of standards 
                                        for the ethical and scientific 
                                        uses for, and communication of, 
                                        postmarketing data collected 
                                        under subparagraph (B), 
                                        including advising on the 
                                        development of effective 
                                        research methods for the study 
                                        of drug safety questions;
                                            ``(ee) focus postmarket 
                                        studies under subsection 
                                        (o)(4)(B) and postapproval 
                                        clinical trials under 
                                        subsection (o)(4)(C) more 
                                        effectively on cases for which 
                                        reports under paragraph (1) and 
                                        other safety signal detection 
                                        is not sufficient to resolve 
                                        whether there is an elevated 
                                        risk of a serious adverse event 
                                        associated with the use of a 
                                        drug; and
                                            ``(ff) carry out other 
                                        activities as the Secretary 
                                        deems necessary to carry out 
                                        the purposes of this paragraph.
                                    ``(II) Request for specific 
                                methodology.--The procedures described 
                                in subclause (I) shall permit the 
                                Secretary to request that a specific 
                                methodology be used by the qualified 
                                entity. The qualified entity shall work 
                                with the Secretary to finalize the 
                                methodology to be used.
                            ``(iv) Use of analyses.--The Secretary 
                        shall provide the analyses described under this 
                        subparagraph, including the methods and results 
                        of such analyses, about a drug to the sponsor 
                        or sponsors of such drug.
                            ``(v) Qualified entities.--
                                    ``(I) In general.--The Secretary 
                                shall enter into contracts with a 
                                sufficient number of qualified entities 
                                to develop and provide information to 
                                the Secretary in a timely manner.
                                    ``(II) Qualification.--The 
                                Secretary shall enter into a contract 
                                with an entity under subclause (I) only 
                                if the Secretary determines that the 
                                entity--
                                            ``(aa) has the research 
                                        capability and expertise to 
                                        conduct and complete the 
                                        activities under this 
                                        paragraph;
                                            ``(bb) has in place an 
                                        information technology 
                                        infrastructure to support 
                                        adverse event surveillance data 
                                        and operational standards to 
                                        provide security for such data;
                                            ``(cc) has experience with, 
                                        and expertise on, the 
                                        development of drug safety and 
                                        effectiveness research using 
                                        electronic population data;
                                            ``(dd) has an understanding 
                                        of drug development and risk/
                                        benefit balancing in a clinical 
                                        setting; and
                                            ``(ee) has a significant 
                                        business presence in the United 
                                        States.
                            ``(vi) Contract requirements.--Each 
                        contract with a qualified entity shall contain 
                        the following requirements:
                                    ``(I) Ensuring privacy.--The 
                                qualified entity shall provide 
                                assurances that the entity will not use 
                                the data provided by the Secretary in a 
                                manner that violates--
                                            ``(aa) the regulations 
                                        promulgated under section 
                                        264(c) of the Health Insurance 
                                        Portability and Accountability 
                                        Act of 1996; or
                                            ``(bb) sections 552 or 552a 
                                        of title 5, United States Code, 
                                        with regard to the privacy of 
                                        individually-identifiable 
                                        beneficiary health information.
                                    ``(II) Component of another 
                                organization.--If a qualified entity is 
                                a component of another organization--
                                            ``(aa) the qualified entity 
                                        shall maintain the data related 
                                        to the activities carried out 
                                        under this paragraph separate 
                                        from the other components of 
                                        the organization and establish 
                                        appropriate security measures 
                                        to maintain the confidentiality 
                                        and privacy of such data; and
                                            ``(bb) the entity shall not 
                                        make an unauthorized disclosure 
                                        of such data to the other 
                                        components of the organization 
                                        in breach of such 
                                        confidentiality and privacy 
                                        requirement.
                                    ``(III) Termination or 
                                nonrenewal.--If a contract with a 
                                qualified entity under this 
                                subparagraph is terminated or not 
                                renewed, the following requirements 
                                shall apply:
                                            ``(aa) Confidentiality and 
                                        privacy protections.--The 
                                        entity shall continue to comply 
                                        with the confidentiality and 
                                        privacy requirements under this 
                                        paragraph with respect to all 
                                        data disclosed to the entity.
                                            ``(bb) Disposition of 
                                        data.--The entity shall return 
                                        to the Secretary all data 
                                        disclosed to the entity or, if 
                                        returning the data is not 
                                        practicable, destroy the data.
                            ``(vii) Competitive procedures.--The 
                        Secretary shall use competitive procedures (as 
                        defined in section 4(5) of the Federal 
                        Procurement Policy Act) to enter into contracts 
                        under clause (v).
                            ``(viii) Review of contract in the even of 
                        a merger or acquisition.--The Secretary shall 
                        review the contract with a qualified entity 
                        under this paragraph in the event of a merger 
                        or acquisition of the entity in order to ensure 
                        that the requirements under this subparagraph 
                        will continue to be met.
                    ``(D) Coordination.--In carrying out this 
                paragraph, the Secretary shall provide for appropriate 
                communications to the public, scientific, public 
                health, and medical communities, and other key 
                stakeholders, and provide for the coordination of the 
                activities of private entities, professional 
                associations, or other entities that may have sources 
                of surveillance data.''.
    (b) Authorization of Appropriations.--To carry out activities under 
the amendment made by this section for which funds are made available 
under section 736 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 379h), there are authorized to be appropriated to carry out the 
amendment made by this section, in addition to such funds, $25,000,000 
for each of fiscal years 2008 through 2012.

SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355) is amended by adding at the end the following:
    ``(o) Risk Evaluation and Mitigation Strategy.--
            ``(1) In general.--In the case of any drug subject to 
        subsection (b) or to section 351 of the Public Health Service 
        Act for which a risk evaluation and mitigation strategy is 
        approved as provided for in this subsection, the applicant 
        shall comply with the requirements of such strategy.
            ``(2) Definitions.--In this subsection:
                    ``(A) Adverse drug experience.--The term `adverse 
                drug experience' means any adverse event associated 
                with the use of a drug in humans, whether or not 
                considered drug related, including--
                            ``(i) an adverse event occurring in the 
                        course of the use of the drug in professional 
                        practice;
                            ``(ii) an adverse event occurring from an 
                        overdose of the drug, whether accidental or 
                        intentional;
                            ``(iii) an adverse event occurring from 
                        abuse of the drug;
                            ``(iv) an adverse event occurring from 
                        withdrawal of the drug; and
                            ``(v) any failure of expected 
                        pharmacological action of the drug.
                    ``(B) New safety information.--The term `new safety 
                information' with respect to a drug means information 
                about--
                            ``(i) a serious risk or an unexpected 
                        serious risk with use of the drug that the 
                        Secretary has become aware of since the later 
                        of--
                                    ``(I) the date of initial approval 
                                of the drug under this section or 
                                initial licensure of the drug under 
                                section 351 of the Public Health 
                                Service Act; or
                                    ``(II) if applicable, the last 
                                assessment of the approved risk 
                                evaluation and mitigation strategy for 
                                the drug; or
                            ``(ii) the effectiveness of the approved 
                        risk evaluation and mitigation strategy for the 
                        drug obtained since the later of--
                                    ``(I) the approval of such 
                                strategy; or
                                    ``(II) the last assessment of such 
                                strategy.
                    ``(C) Serious adverse drug experience.--The term 
                `serious adverse drug experience' is an adverse drug 
                experience that--
                            ``(i) results in--
                                    ``(I) death;
                                    ``(II) the placement of the patient 
                                at immediate risk of death from the 
                                adverse drug experience as it occurred 
                                (not including an adverse drug 
                                experience that might have caused death 
                                had it occurred in a more severe form);
                                    ``(III) inpatient hospitalization 
                                or prolongation of existing 
                                hospitalization;
                                    ``(IV) a persistent or significant 
                                incapacity or substantial disruption of 
                                the ability to conduct normal life 
                                functions; or
                                    ``(V) a congenital anomaly or birth 
                                defect; or
                            ``(ii) based on appropriate medical 
                        judgment, may jeopardize the patient and may 
                        require a medical or surgical intervention to 
                        prevent an outcome described under clause (i).
                    ``(D) Serious risk.--The term `serious risk' means 
                a risk of a serious adverse drug experience.
                    ``(E) Signal of a serious risk.--The term `signal 
                of a serious risk' means information related to a 
                serious adverse drug experience derived from--
                            ``(i) a clinical trial;
                            ``(ii) adverse event reports under 
                        subsection (k)(1);
                            ``(iii) routine active surveillance under 
                        subsection (k)(3);
                            ``(iv) a postapproval study, including a 
                        study under paragraph (4)(B); or
                            ``(v) peer-reviewed biomedical literature.
                    ``(F) Unexpected serious risk.--The term 
                `unexpected serious risk' means a serious adverse drug 
                experience that--
                            ``(i) is not listed in the labeling of a 
                        drug; or
                            ``(ii) is symptomatically and 
                        pathophysiologically related to an adverse drug 
                        experience listed in the labeling of the drug, 
                        but differs from such adverse drug experience 
                        because of greater severity, specificity, or 
                        prevalence.
            ``(3) Required elements of a risk evaluation and mitigation 
        strategy.--If a risk evaluation and mitigation strategy for a 
        drug is required, such strategy shall include--
                    ``(A) the labeling for the drug for use by health 
                care providers as approved under subsection (c);
                    ``(B) a timetable for submission of assessments of 
                the strategy, that--
                            ``(i) for a drug no active ingredient 
                        (including any ester or salt of the active 
                        ingredient) of which has been approved in any 
                        other application under this section or section 
                        351 of the Public Health Service Act--
                                    ``(I) shall be no less frequently 
                                than 18 months and 3 years after the 
                                drug is initially approved and at a 
                                frequency specified in the strategy for 
                                subsequent years; and
                                    ``(II) may be eliminated after the 
                                first 3 years if the Secretary 
                                determines that serious risks of the 
                                drug have been adequately identified 
                                and assessed and are being adequately 
                                managed;
                            ``(ii) for a drug other than a drug 
                        described under clause (i), shall occur at a 
                        frequency determined by the Secretary; and
                            ``(iii) may be increased or reduced in 
                        frequency as necessary as provided for in 
                        paragraph (7)(B)(v)(VI).
            ``(4) Additional potential evaluation elements of a risk 
        evaluation and mitigation strategy.--
                    ``(A) Risk evaluation.--If a risk evaluation and 
                mitigation strategy for a drug is required, such 
                strategy may include 1 or more of the additional 
                evaluation elements described in this paragraph, so 
                long as the Secretary makes the determination required 
                with respect to each additional included element.
                    ``(B) Postapproval studies.--If the Secretary 
                determines that the reports under subsection (k)(1) and 
                routine active surveillance as available under 
                subsection (k)(3) (including available complementary 
                approaches under subsection (k)(3)(B)(iv)) will not be 
                sufficient to--
                            ``(i) assess a signal of a serious risk 
                        with use of a drug; or
                            ``(ii) identify, based on a review of a 
                        demonstrated pattern of use of the drug, 
                        unexpected serious risks in a domestic 
                        population, including older people, people with 
                        comorbidities, pregnant women, or children,
                the risk evaluation and mitigation strategy for the 
                drug may require that the applicant conduct an 
                appropriate postapproval study, such as a prospective 
                or retrospective observational study, of the drug 
                (which shall include a timeframe specified by the 
                Secretary for completing the study and reporting the 
                results to the Secretary).
                    ``(C) Postapproval clinical trials.--If the 
                Secretary determines that the reports under subsection 
                (k)(1), routine active surveillance as available under 
                subsection (k)(3) (including available complementary 
                approaches under subsection (k)(3)(B)(iv)), and a study 
                or studies under subparagraph (B) will likely be 
                inadequate to assess a signal of a serious risk with 
                use of a drug, and there is no effective approved 
                application for the drug under subsection (j) as of the 
                date that the requirement is first imposed, the risk 
                evaluation and mitigation strategy for the drug may 
                require that the applicant conduct an appropriate 
                postapproval clinical trial of the drug (which shall 
                include a timeframe specified by the Secretary for 
                completing the clinical trial and reporting the results 
                to the Secretary) to be included in the clinical trial 
                registry data bank provided for under subsections (i) 
                and (j) of section 402 of the Public Health Service 
                Act.
            ``(5) Additional potential communication elements of a risk 
        evaluation and mitigation strategy.--
                    ``(A) Risk communication.--If a risk evaluation and 
                mitigation strategy for a drug is required, such 
                strategy may include 1 or more of the additional 
                communication elements described in this paragraph, so 
                long as the Secretary makes the determination required 
                with respect to each additional included element.
                    ``(B) Medguide; patient package insert.--The risk 
                evaluation and mitigation strategy for a drug may 
                require that the applicant develop for distribution to 
                each patient when the drug is dispensed either or both 
                of the following:
                            ``(i) A Medication Guide, as provided for 
                        under part 208 of title 21, Code of Federal 
                        Regulations (or any successor regulations).
                            ``(ii) A patient package insert, if the 
                        Secretary determines that such insert may help 
                        mitigate a serious risk listed in the labeling 
                        of the drug.
                    ``(C) Communication plan.--If the Secretary 
                determines that a communication plan to health care 
                providers may support implementation of an element of 
                the risk evaluation and mitigation strategy for a drug, 
                such as a labeling change, the strategy may require 
                that the applicant conduct such a plan, which may 
                include--
                            ``(i) sending letters to health care 
                        providers;
                            ``(ii) disseminating information about the 
                        elements of the strategy to encourage 
                        implementation by health care providers of 
                        components that apply to such health care 
                        providers, or to explain certain safety 
                        protocols (such as medical monitoring by 
                        periodic laboratory tests); or
                            ``(iii) disseminating information to health 
                        care providers through professional societies 
                        about any serious risks of the drug and any 
                        protocol to assure safe use.
                    ``(D) Prereview.--
                            ``(i) In general.--If the Secretary 
                        determines that prereview of advertisements is 
                        necessary to ensure the inclusion of a true 
                        statement in such advertisements of information 
                        in brief summary relating to a serious risk 
                        listed in the labeling of a drug, or relating 
                        to a protocol to ensure the safe use described 
                        in the labeling of the drug, the risk 
                        evaluation and mitigation strategy for the drug 
                        may require that the applicant submit to the 
                        Secretary advertisements of the drug for 
                        prereview not later than 45 days before 
                        dissemination of the advertisement
                            ``(ii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to be submitted under clause (i).
                    ``(E) Specific disclosures.--
                            ``(i) Serious risk; safety protocol.--If 
                        the Secretary determines that advertisements 
                        lacking a specific disclosure about a serious 
                        risk listed in the labeling of a drug or about 
                        a protocol to ensure safe use described in the 
                        labeling of the drug would be false or 
                        misleading, the risk evaluation and mitigation 
                        strategy for the drug may require that the 
                        applicant include in advertisements of the drug 
                        such disclosure.
                            ``(ii) Date of approval.--If the Secretary 
                        determines that advertisements lacking a 
                        specific disclosure of the date a drug was 
                        approved and disclosure of a serious risk would 
                        be false or misleading, the risk evaluation and 
                        mitigation strategy for the drug may require 
                        that the applicant include in advertisements of 
                        the drug such disclosure.
                            ``(iii) Specification of advertisements.--
                        The Secretary may specify the advertisements 
                        required to include a specific disclosure under 
                        clause (i) or (ii).
                            ``(iv) Required safety surveillance.--If 
                        the approved risk evaluation and mitigation 
                        strategy for a drug requires the specific 
                        disclosure under clause (ii), the Secretary 
                        shall--
                                    ``(I) consider identifying and 
                                assessing all serious risks of using 
                                the drug to be a priority safety 
                                question under subsection (k)(3)(B);
                                    ``(II) not less frequently than 
                                every 3 months, evaluate the reports 
                                under subsection (k)(1) and the routine 
                                active surveillance as available under 
                                subsection (k)(3) with respect to such 
                                priority drug safety question to 
                                determine whether serious risks that 
                                might occur among patients expected to 
                                be treated with the drug have been 
                                adequately identified and assessed;
                                    ``(III) remove such specific 
                                disclosure requirement as an element of 
                                such strategy if such serious risks 
                                have been adequately identified and 
                                assessed; and
                                    ``(IV) consider whether a specific 
                                disclosure under clause (i) should be 
                                required.
            ``(6) Providing safe access for patients to drugs with 
        known serious risks that would otherwise be unavailable.--
                    ``(A) Allowing safe access to drugs with known 
                serious risks.--The Secretary may require that the risk 
                evaluation and mitigation strategy for a drug include 
                such elements as are necessary to assure safe use of 
                the drug, because of its inherent toxicity or potential 
                harmfulness, if the Secretary determines that--
                            ``(i) the drug, which has been shown to be 
                        effective, but is associated with a serious 
                        adverse drug experience, can be approved only 
                        if, or would be withdrawn unless, such elements 
                        are required as part of such strategy to 
                        mitigate a specific serious risk listed in the 
                        labeling of the drug; and
                            ``(ii) for a drug initially approved 
                        without elements to assure safe use, other 
                        elements under paragraphs (3), (4), and (5) are 
                        not sufficient to mitigate such serious risk.
                    ``(B) Assuring access and minimizing burden.--Such 
                elements to assure safe use under subparagraph (A) 
                shall--
                            ``(i) be commensurate with the specific 
                        serious risk listed in the labeling of the 
                        drug;
                            ``(ii) within 30 days of the date on which 
                        any element under subparagraph (A) is imposed, 
                        be posted publicly by the Secretary with an 
                        explanation of how such elements will mitigate 
                        the observed safety risk;
                            ``(iii) considering such risk, not be 
                        unduly burdensome on patient access to the 
                        drug, considering in particular--
                                    ``(I) patients with serious or 
                                life-threatening diseases or 
                                conditions; and
                                    ``(II) patients who have difficulty 
                                accessing health care (such as patients 
                                in rural or medically underserved 
                                areas); and
                            ``(iv) to the extent practicable, so as to 
                        minimize the burden on the health care delivery 
                        system--
                                    ``(I) conform with elements to 
                                assure safe use for other drugs with 
                                similar, serious risks; and
                                    ``(II) be designed to be compatible 
                                with established distribution, 
                                procurement, and dispensing systems for 
                                drugs.
                    ``(C) Elements to assure safe use.--The elements to 
                assure safe use under subparagraph (A) shall include 1 
                or more goals to mitigate a specific serious risk 
                listed in the labeling of the drug and, to mitigate 
                such risk, may require that--
                            ``(i) health care providers who prescribe 
                        the drug have particular training or 
                        experience, or are specially certified (which 
                        training or certification with respect to the 
                        drug shall be available to any willing provider 
                        from a frontier area in a widely available 
                        training or certification method (including an 
                        on-line course or via mail) as approved by the 
                        Secretary at minimal cost to the provider);
                            ``(ii) pharmacies, practitioners, or health 
                        care settings that dispense the drug are 
                        specially certified (which certification shall 
                        be available to any willing provider from a 
                        frontier area);
                            ``(iii) the drug be dispensed to patients 
                        only in certain health care settings, such as 
                        hospitals;
                            ``(iv) the drug be dispensed to patients 
                        with evidence or other documentation of safe-
                        use conditions, such as laboratory test 
                        results;
                            ``(v) each patient using the drug be 
                        subject to certain monitoring; or
                            ``(vi) each patient using the drug be 
                        enrolled in a registry.
                    ``(D) Implementation system.--The elements to 
                assure safe use under subparagraph (A) that are 
                described in clauses (ii), (iii), or (iv) of 
                subparagraph (C) may include a system through which the 
                applicant is able to take reasonable steps to--
                            ``(i) monitor and evaluate implementation 
                        of such elements by health care providers, 
                        pharmacists, and other parties in the health 
                        care system who are responsible for 
                        implementing such elements; and
                            ``(ii) work to improve implementation of 
                        such elements by such persons.
                    ``(E) Evaluation of elements to assure safe use.--
                The Secretary, through the Drug Safety and Risk 
                Management Advisory Committee (or successor committee) 
                of the Food and Drug Administration, shall--
                            ``(i) seek input from patients, physicians, 
                        pharmacists, and other health care providers 
                        about how elements to assure safe use under 
                        this paragraph for 1 or more drugs may be 
                        standardized so as not to be--
                                    ``(I) unduly burdensome on patient 
                                access to the drug; and
                                    ``(II) to the extent practicable, 
                                minimize the burden on the health care 
                                delivery system;
                            ``(ii) at least annually, evaluate, for 1 
                        or more drugs, the elements to assure safe use 
                        of such drug to assess whether the elements--
                                    ``(I) assure safe use of the drug;
                                    ``(II) are not unduly burdensome on 
                                patient access to the drug; and
                                    ``(III) to the extent practicable, 
                                minimize the burden on the health care 
                                delivery system; and
                            ``(iii) considering such input and 
                        evaluations--
                                    ``(I) issue or modify agency 
                                guidance about how to implement the 
                                requirements of this paragraph; and
                                    ``(II) modify elements under this 
                                paragraph for 1 or more drugs as 
                                appropriate.
                    ``(F) Additional mechanisms to assure access.--The 
                mechanisms under section 561 to provide for expanded 
                access for patients with serious or life-threatening 
                diseases or conditions may be used to provide access 
                for patients with a serious or life-threatening disease 
                or condition, the treatment of which is not an approved 
                use for the drug, to a drug that is subject to elements 
                to assure safe use under this paragraph. The Secretary 
                shall promulgate regulations for how a physician may 
                provide the drug under the mechanisms of section 561.
                    ``(G) Waiver in public health emergencies.--The 
                Secretary may waive any requirement of this paragraph 
                during the period described in section 319(a) of the 
                Public Health Service Act with respect to a qualified 
                countermeasure described under section 319F-1(a)(2) of 
                such Act, to which a requirement under this paragraph 
                has been applied, if the Secretary has--
                            ``(i) declared a public health emergency 
                        under such section 319; and
                            ``(ii) determined that such waiver is 
                        required to mitigate the effects of, or reduce 
                        the severity of, such public health emergency.
            ``(7) Submission and review of risk evaluation and 
        mitigation strategy.--
                    ``(A) Proposed risk evaluation and mitigation 
                strategy.--
                            ``(i) Voluntary proposal.--If there is a 
                        signal of a serious risk with a drug, an 
                        applicant may include a proposed risk 
                        evaluation and mitigation strategy for the drug 
                        in an application, including in a supplemental 
                        application, for the drug under subsection (b) 
                        or section 351 of the Public Health Service 
                        Act.
                            ``(ii) Required proposal.--
                                    ``(I) Determination necessary to 
                                require a proposal.--
                                            ``(aa) In general.--The 
                                        Secretary may require that the 
                                        applicant for a drug submit a 
                                        proposed risk evaluation and 
                                        mitigation strategy for a drug 
                                        if the Secretary (acting 
                                        through the office responsible 
                                        for reviewing the drug and the 
                                        office responsible for 
                                        postapproval safety with 
                                        respect to the drug) determines 
                                        that, based on a signal of a 
                                        serious risk with the drug, a 
                                        risk evaluation and mitigation 
                                        strategy is necessary to assess 
                                        such signal or mitigate such 
                                        serious risk.
                                            ``(bb) Non-delegation.--A 
                                        determination under item (aa) 
                                        for a drug shall be made by 
                                        individuals at or above the 
                                        level of individuals empowered 
                                        to approve a drug (such as 
                                        division directors within the 
                                        Center for Drug Evaluation and 
                                        Research).
                                    ``(II) Circumstances in which a 
                                proposal may be required.--The 
                                applicant shall submit a proposed risk 
                                evaluation and mitigation strategy for 
                                a drug--
                                            ``(aa) in response to a 
                                        letter from the Secretary 
                                        (acting through the office 
                                        responsible for reviewing the 
                                        drug and the office responsible 
                                        for postapproval safety with 
                                        respect to the drug) sent 
                                        regarding an application, 
                                        including a supplemental 
                                        application, for the drug, if 
                                        the Secretary determines that 
                                        data or information in the 
                                        application indicates that an 
                                        element under paragraph (4), 
                                        (5), or (6) should be included 
                                        in a strategy for the drug;
                                            ``(bb) within a timeframe 
                                        specified by the Secretary, not 
                                        to be less than 45 days, when 
                                        ordered by the Secretary 
                                        (acting through such offices), 
                                        if the Secretary determines 
                                        that new safety information 
                                        indicates that--

                                                    ``(AA) the labeling 
                                                of the drug should be 
                                                changed; or

                                                    ``(BB) an element 
                                                under paragraph (4) or 
                                                (5) should be included 
                                                in a strategy for the 
                                                drug; or

                                            ``(cc) within 90 days when 
                                        ordered by the Secretary 
                                        (acting through such offices), 
                                        if the Secretary determines 
                                        that new safety information 
                                        indicates that an element under 
                                        paragraph (6) should be 
                                        included in a strategy for the 
                                        drug.
                            ``(iii) Content of letter.--A letter under 
                        clause (ii)(II)(aa) shall describe--
                                    ``(I) the data or information in 
                                the application that warrants the 
                                proposal of a risk evaluation and 
                                mitigation strategy for the drug; and
                                    ``(II) what elements under 
                                paragraphs (4), (5), or (6) should be 
                                included in a strategy for the drug.
                            ``(iv) Content of order.--An order under 
                        item (aa) or (bb) of clause (ii)(II) shall 
                        describe--
                                    ``(I) the new safety information 
                                with respect to the drug that warrants 
                                the proposal of a risk evaluation and 
                                mitigation strategy for the drug; and
                                    ``(II) whether and how the labeling 
                                of the drug should be changed and what 
                                elements under paragraphs (4), (5), or 
                                (6) should be included in a strategy 
                                for the drug.
                            ``(v) Content of proposal.--A proposed risk 
                        evaluation and mitigation strategy--
                                    ``(I) shall include a timetable as 
                                described under paragraph (3)(B); and
                                    ``(II) may also include additional 
                                elements as provided for under 
                                paragraphs (4), (5), and (6).
                    ``(B) Assessment and modification of a risk 
                evaluation and mitigation strategy.--
                            ``(i) Voluntary assessments.--If a risk 
                        evaluation and mitigation strategy for a drug 
                        is required, the applicant may submit to the 
                        Secretary an assessment of, and propose a 
                        modification to, such approved strategy for the 
                        drug at any time.
                            ``(ii) Required assessments.--If a risk 
                        evaluation and mitigation strategy for a drug 
                        is required, the applicant shall submit an 
                        assessment of, and may propose a modification 
                        to, such approved strategy for the drug--
                                    ``(I) when submitting an 
                                application, including a supplemental 
                                application, for a new indication under 
                                subsection (b) or section 351 of the 
                                Public Health Service Act;
                                    ``(II) when required by the 
                                strategy, as provided for in the 
                                timetable under paragraph (3)(B);
                                    ``(III) within a timeframe 
                                specified by the Secretary, not to be 
                                less than 45 days, when ordered by the 
                                Secretary (acting through the offices 
                                described in subparagraph (A)(ii)(I)), 
                                if the Secretary determines that new 
                                safety information indicates that an 
                                element under paragraph (3) or (4) 
                                should be modified or added to the 
                                strategy;
                                    ``(IV) within 90 days when ordered 
                                by the Secretary (acting through such 
                                offices), if the Secretary determines 
                                that new safety information indicates 
                                that an element under paragraph (6) 
                                should be modified or added to the 
                                strategy; or
                                    ``(V) within 15 days when ordered 
                                by the Secretary (acting through such 
                                offices), if the Secretary determines 
                                that there may be a cause for action by 
                                the Secretary under subsection (e).
                            ``(iii) Content of order.--An order under 
                        subclauses (III), (IV), or (V) of clause (ii) 
                        shall describe--
                                    ``(I) the new safety information 
                                with respect to the drug that warrants 
                                an assessment of the approved risk 
                                evaluation and mitigation strategy for 
                                the drug; and
                                    ``(II) whether and how such 
                                strategy should be modified because of 
                                such information.
                            ``(iv) Assessment.--An assessment of the 
                        approved risk evaluation and mitigation 
                        strategy for a drug shall include--
                                    ``(I) a description of new safety 
                                information, if any, with respect to 
                                the drug;
                                    ``(II) whether and how to modify 
                                such strategy because of such 
                                information;
                                    ``(III) with respect to any 
                                postapproval study required under 
                                paragraph (4)(B) or otherwise 
                                undertaken by the applicant to 
                                investigate a safety issue, the status 
                                of such study, including whether any 
                                difficulties completing the study have 
                                been encountered;
                                    ``(IV) with respect to any 
                                postapproval clinical trial required 
                                under paragraph (4)(C) or otherwise 
                                undertaken by the applicant to 
                                investigate a safety issue, the status 
                                of such clinical trial, including 
                                whether enrollment has begun, the 
                                number of participants enrolled, the 
                                expected completion date, whether any 
                                difficulties completing the clinical 
                                trial have been encountered, and 
                                registration information with respect 
                                to requirements under subsections (i) 
                                and (j) of section 402 of the Public 
                                Health Service Act; and
                                    ``(V) with respect to any goal 
                                under paragraph (6) and considering 
                                input and evaluations, if applicable, 
                                under paragraph (6)(E), an assessment 
                                of how well the elements to assure safe 
                                use are meeting the goal of increasing 
                                safe access to drugs with known serious 
                                risks or whether the goal or such 
                                elements should be modified.
                            ``(v) Modification.--A modification 
                        (whether an enhancement or a reduction) to the 
                        approved risk evaluation and mitigation 
                        strategy for a drug may include the addition or 
                        modification of any element under subparagraph 
                        (A) or (B) of paragraph (3) or the addition, 
                        modification, or removal of any element under 
                        paragraph (4), (5), or (6), such as--
                                    ``(I) a labeling change, including 
                                the addition of a boxed warning;
                                    ``(II) adding a postapproval study 
                                or clinical trial requirement;
                                    ``(III) modifying a postapproval 
                                study or clinical trial requirement 
                                (such as a change in trial design due 
                                to legitimate difficulties recruiting 
                                participants);
                                    ``(IV) adding, modifying, or 
                                removing an element on advertising 
                                under subparagraph (D), (E), or (F) of 
                                paragraph (5);
                                    ``(V) adding, modifying, or 
                                removing an element to assure safe use 
                                under paragraph (6); or
                                    ``(VI) modifying the timetable for 
                                assessments of the strategy under 
                                paragraph (3)(B), including to 
                                eliminate assessments.
                    ``(C) Review.--The Secretary (acting through the 
                offices described in subparagraph (A)(ii)(I)) shall 
                promptly review the proposed risk evaluation and 
                mitigation strategy for a drug submitted under 
                subparagraph (A), or an assessment of the approved risk 
                evaluation and mitigation strategy for a drug submitted 
                under subparagraph (B).
                    ``(D) Discussion.--The Secretary (acting through 
                the offices described in subparagraph (A)(ii)(I)) shall 
                initiate discussions of the proposed risk evaluation 
                and mitigation strategy for a drug submitted under 
                subparagraph (A), or of an assessment of the approved 
                risk evaluation and mitigation strategy for a drug 
                submitted under subparagraph (B), with the applicant to 
                determine a strategy--
                            ``(i) if the proposed strategy or 
                        assessment is submitted as part of an 
                        application (including a supplemental 
                        application) under subparagraph (A)(i), 
                        (A)(ii)(II)(aa), or (B)(ii)(I), by the target 
                        date for communication of feedback from the 
                        review team to the applicant regarding proposed 
                        labeling and postmarketing study commitments, 
                        as set forth in the letters described in 
                        section 735(a);
                            ``(ii) if the proposed strategy is 
                        submitted under subparagraph (A)(ii)(II)(bb) or 
                        the assessment is submitted under subclause 
                        (II) or (III) of subparagraph (B)(ii), not 
                        later than 20 days after such submission;
                            ``(iii) if the proposed strategy is 
                        submitted under subparagraph (A)(ii)(II)(cc) or 
                        the assessment is submitted under subparagraph 
                        (B)(i) or under subparagraph (B)(ii)(IV), not 
                        later than 30 days after such submission; or
                            ``(iv) if the assessment is submitted under 
                        subparagraph (B)(ii)(V), not later than 10 days 
                        after such submission.
                    ``(E) Action.--
                            ``(i) In general.--Unless the applicant 
                        requests the dispute resolution process as 
                        described under subparagraph (F) or (G), the 
                        Secretary (acting through the offices described 
                        in subparagraph (A)(ii)(I)) shall approve and 
                        include the risk evaluation and mitigation 
                        strategy for a drug, or any modification to the 
                        strategy (including a timeframe for 
                        implementing such modification), with--
                                    ``(I) the action letter on the 
                                application, if a proposed strategy is 
                                submitted under subparagraph (A)(i) or 
                                (A)(ii)(II)(aa) or an assessment of the 
                                strategy is submitted under 
                                subparagraph (B)(ii)(I); or
                                    ``(II) an order, which shall be 
                                made public, issued not later than 50 
                                days after the date discussions of such 
                                proposed strategy or modification begin 
                                under subparagraph (D), if a proposed 
                                strategy is submitted under item (bb) 
                                or (cc) of subparagraph (A)(ii)(II) or 
                                an assessment of the strategy is 
                                submitted under subparagraph (B)(i) or 
                                under subclause (II), (III), (IV), or 
                                (V) of subparagraph (B)(ii).
                            ``(ii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided under clause 
                        (i).
                    ``(F) Dispute resolution at initial approval.--If a 
                proposed risk evaluation and mitigation strategy is 
                submitted under subparagraph (A)(i) or (A)(ii)(II)(aa) 
                in an application for initial approval of a drug and 
                there is a dispute about the strategy, the applicant 
                shall use the major dispute resolution procedures as 
                set forth in the letters described in section 735(a).
                    ``(G) Dispute resolution in all other cases.--
                            ``(i) Request for review.--In any case 
                        other than a submission under subparagraph 
                        (A)(i) or (A)(ii)(II)(aa) in an application for 
                        initial approval of a drug if there is a 
                        dispute about the strategy, not earlier than 15 
                        days, and not later than 35 days, after 
                        discussions under subparagraph (D) have begun, 
                        the applicant shall request in writing that the 
                        dispute be reviewed by the Drug Safety 
                        Oversight Board.
                            ``(ii) Scheduling review.--If the applicant 
                        requests review under clause (i), the 
                        Secretary--
                                    ``(I)(aa) shall schedule the 
                                dispute for review at 1 of the next 2 
                                regular meetings of the Drug Safety 
                                Oversight Board, whichever meeting date 
                                is more practicable; or
                                    ``(bb) may convene a special 
                                meeting of the Drug Safety Oversight 
                                Board to review the matter more 
                                promptly, including to meet an action 
                                deadline on an application (including a 
                                supplemental application);
                                    ``(II) shall give advance notice to 
                                the public through the Federal Register 
                                and on the Internet website of the Food 
                                and Drug Administration--
                                            ``(aa) that the drug is to 
                                        be discussed by the Drug Safety 
                                        Oversight Board; and
                                            ``(bb) of the date on which 
                                        the Drug Safety Oversight Board 
                                        shall discuss such drug; and
                                    ``(III) shall apply section 301(j), 
                                section 552 of title 5, and section 
                                1905 of title 18, United States Code, 
                                to any request for information about 
                                such review.
                            ``(iii) Agreement after discussion or 
                        administrative appeals.--
                                    ``(I) Further discussion or 
                                administrative appeals.--A request for 
                                review under clause (i) shall not 
                                preclude--
                                            ``(aa) further discussions 
                                        to reach agreement on the risk 
                                        evaluation and mitigation 
                                        strategy; or
                                            ``(bb) the use of 
                                        administrative appeals within 
                                        the Food and Drug 
                                        Administration to reach 
                                        agreement on the strategy, 
                                        including the major dispute 
                                        resolution procedures as set 
                                        forth in the letters described 
                                        in section 735(a).
                                    ``(II) Agreement terminates dispute 
                                resolution.--At any time before a 
                                decision and order is issued under 
                                clause (vi), the Secretary (acting 
                                through the offices described in 
                                subparagraph (A)(ii)(I)) and the 
                                applicant may reach an agreement on the 
                                risk evaluation and mitigation strategy 
                                through further discussion or 
                                administrative appeals, terminating the 
                                dispute resolution process, and the 
                                Secretary shall issue an action letter 
                                or order, as appropriate, that 
                                describes the strategy.
                            ``(iv) Meeting of the board.--At the 
                        meeting of the Drug Safety Oversight Board 
                        described in clause (ii), the Board shall--
                                    ``(I) hear from both parties; and
                                    ``(II) review the dispute.
                            ``(v) Recommendation of the board.--Not 
                        later than 5 days after such meeting of the 
                        Drug Safety Oversight Board, the Board shall 
                        provide a written recommendation on resolving 
                        the dispute to the Secretary.
                            ``(vi) Action by the secretary.--
                                    ``(I) Action letter.--With respect 
                                to a proposed risk evaluation and 
                                mitigation strategy submitted under 
                                subparagraph (A)(i) or (A)(ii)(II)(aa) 
                                or to an assessment of the strategy 
                                submitted under subparagraph 
                                (B)(ii)(I), the Secretary shall issue 
                                an action letter that resolves the 
                                dispute not later than the later of--
                                            ``(aa) the action deadline 
                                        for the action letter on the 
                                        application; or
                                            ``(bb) 7 days after 
                                        receiving the recommendation of 
                                        the Drug Safety Oversight 
                                        Board.
                                    ``(II) Order.--With respect to a 
                                proposed risk evaluation and mitigation 
                                strategy submitted under item (bb) or 
                                (cc) of subparagraph (A)(ii)(II) or an 
                                assessment of the risk evaluation and 
                                mitigation strategy under subparagraph 
                                (B)(i) or under subclause (II), (III), 
                                (IV), or (V) of subparagraph (B)(ii), 
                                the Secretary shall issue an order, 
                                which (with the recommendation of the 
                                Drug Safety Oversight Board) shall be 
                                made public, that resolves the dispute 
                                not later than 7 days after receiving 
                                the recommendation of the Drug Safety 
                                Oversight Board.
                            ``(vii) Inaction.--An approved risk 
                        evaluation and mitigation strategy shall remain 
                        in effect until the Secretary acts, if the 
                        Secretary fails to act as provided for under 
                        clause (vi).
                            ``(viii) Effect on action deadline.--With 
                        respect to the application or supplemental 
                        application in which a proposed risk evaluation 
                        and mitigation strategy is submitted under 
                        subparagraph (A)(i) or (A)(ii)(II)(aa) or in 
                        which an assessment of the strategy is 
                        submitted under subparagraph (B)(ii)(I), the 
                        Secretary shall be considered to have met the 
                        action deadline for the action letter on such 
                        application if the applicant requests the 
                        dispute resolution process described in this 
                        subparagraph and if the Secretary--
                                    ``(I) has initiated the discussions 
                                described under subparagraph (D) by the 
                                target date referred to in subparagraph 
                                (D)(i); and
                                    ``(II) has complied with the timing 
                                requirements of scheduling review by 
                                the Drug Safety Oversight Board, 
                                providing a written recommendation, and 
                                issuing an action letter under clauses 
                                (ii), (v), and (vi), respectively.
                            ``(ix) Disqualification.--No individual who 
                        is an employee of the Food and Drug 
                        Administration and who reviews a drug or who 
                        participated in an administrative appeal under 
                        clause (iii)(I) with respect to such drug may 
                        serve on the Drug Safety Oversight Board at a 
                        meeting under clause (iv) to review a dispute 
                        about the risk evaluation and mitigation 
                        strategy for such drug.
                            ``(x) Additional expertise.--The Drug 
                        Safety Oversight Board may add members with 
                        relevant expertise from the Food and Drug 
                        Administration, including the Office of 
                        Pediatrics, the Office of Women's Health, or 
                        the Office of Rare Diseases, or from other 
                        Federal public health or health care agencies, 
                        for a meeting under clause (iv) of the Drug 
                        Safety Oversight Board.
                    ``(H) Use of advisory committees.--The Secretary 
                (acting through the offices described in subparagraph 
                (A)(ii)(I)) may convene a meeting of 1 or more advisory 
                committees of the Food and Drug Administration to--
                            ``(i) review a concern about the safety of 
                        a drug or class of drugs, including before an 
                        assessment of the risk evaluation and 
                        mitigation strategy or strategies of such drug 
                        or drugs is required to be submitted under 
                        subclause (II), (III), (IV), or (V) of 
                        subparagraph (B)(ii);
                            ``(ii) review the risk evaluation and 
                        mitigation strategy or strategies of a drug or 
                        group of drugs; or
                            ``(iii) with the consent of the applicant, 
                        review a dispute under subparagraph (G).
                    ``(I) Process for addressing drug class effects.--
                            ``(i) In general.--When a concern about a 
                        serious risk of a drug may be related to the 
                        pharmacological class of the drug, the 
                        Secretary (acting through the offices described 
                        in subparagraph (A)(ii)(I)) may defer 
                        assessments of the approved risk evaluation and 
                        mitigation strategies for such drugs until the 
                        Secretary has--
                                    ``(I) convened, after appropriate 
                                public notice, 1 or more public 
                                meetings to consider possible responses 
                                to such concern; or
                                    ``(II) gathered additional 
                                information or data about such concern.
                            ``(ii) Public meetings.--Such public 
                        meetings may include--
                                    ``(I) 1 or more meetings of the 
                                applicants for such drugs;
                                    ``(II) 1 or more meetings of 1 or 
                                more advisory committees of the Food 
                                and Drug Administration, as provided 
                                for under subparagraph (H); or
                                    ``(III) 1 or more workshops of 
                                scientific experts and other 
                                stakeholders.
                            ``(iii) Action.--After considering the 
                        discussions from any meetings under clause 
                        (ii), the Secretary may--
                                    ``(I) announce in the Federal 
                                Register a planned regulatory action, 
                                including a modification to each risk 
                                evaluation and mitigation strategy, for 
                                drugs in the pharmacological class;
                                    ``(II) seek public comment about 
                                such action; and
                                    ``(III) after seeking such comment, 
                                issue an order addressing such 
                                regulatory action.
                    ``(J) International coordination.--The Secretary 
                (acting through the offices described in subparagraph 
                (A)(ii)(I)) may coordinate the timetable for submission 
                of assessments under paragraph (3)(B), a study under 
                paragraph (4)(B), or a clinical trial under paragraph 
                (4)(C), with efforts to identify and assess the serious 
                risks of such drug by the marketing authorities of 
                other countries whose drug approval and risk management 
                processes the Secretary deems comparable to the drug 
                approval and risk management processes of the United 
                States.
                    ``(K) Effect.--Use of the processes described in 
                subparagraphs (I) and (J) shall not delay action on an 
                application or a supplement to an application for a 
                drug.
                    ``(L) No effect on labeling changes that do not 
                require preapproval.--In the case of a labeling change 
                to which section 314.70 of title 21, Code of Federal 
                Regulations (or any successor regulation), applies for 
                which the submission of a supplemental application is 
                not required or for which distribution of the drug 
                involved may commence upon the receipt by the Secretary 
                of a supplemental application for the change, the 
                submission of an assessment of the approved risk 
                evaluation and mitigation strategy for the drug under 
                this subsection is not required.
            ``(8) Drug safety oversight board.--
                    ``(A) In general.--There is established a Drug 
                Safety Oversight Board.
                    ``(B) Composition; meetings.--The Drug Safety 
                Oversight Board shall--
                            ``(i) be composed of scientists and health 
                        care practitioners appointed by the Secretary, 
                        each of whom is an employee of the Federal 
                        Government;
                            ``(ii) include representatives from offices 
                        throughout the Food and Drug Administration 
                        (including the offices responsible for 
                        postapproval safety of drugs);
                            ``(iii) include at least 1 representative 
                        each from the National Institutes of Health, 
                        the Department of Health and Human Services 
                        (other than the Food and Drug Administration), 
                        and the Veterans Health Administration; and
                            ``(iv) meet at least monthly to provide 
                        oversight and advice to the Secretary on the 
                        management of important drug safety issues.
            ``(9) Civil monetary penalty.--Notwithstanding any other 
        provision of this Act, an applicant (as such term is defined 
        for purposes of this section) that knowingly fails to comply 
        with a requirement of an approved risk evaluation and 
        mitigation strategy under this subsection shall be subject to a 
        civil money penalty of $250,000 for the first 30-day period 
        that the applicant is in noncompliance, and such amount shall 
        double for every 30-day period thereafter that the requirement 
        is not complied with, not to exceed $2,000,000.''.

SEC. 203. ENFORCEMENT.

    (a) Misbranding.--Section 502 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 352) is amended by adding at the end the 
following:
    ``(x) If it is a drug subject to an approved risk evaluation and 
mitigation strategy under section 505(o) and the applicant for such 
drug fails to--
            ``(1) make a labeling change required by such strategy 
        after the Secretary has approved such strategy or completed 
        review of, and acted on, an assessment of such strategy under 
        paragraph (7) of such section; or
            ``(2) comply with a requirement of such strategy with 
        respect to advertising as provided for under subparagraph (D), 
        (E), or (F) of paragraph (5) of such section.''.
    (b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333(f)) is amended--
            (1) by redesignating paragraphs (3), (4), and (5) as 
        paragraphs (4), (5), and (6), respectively;
            (2) by inserting after paragraph (2) the following:
            ``(3) An applicant (as such term is used in section 505(o)) 
        who knowingly fails to comply with a requirement of an approved 
        risk evaluation and mitigation strategy under such section 
        505(o) shall be subject to a civil money penalty of not less 
        than $15,000 and not more than $250,000 per violation, and not 
        to exceed $1,000,000 for all such violations adjudicated in a 
        single proceeding.'';
            (3) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
        and inserting ``paragraph (4)(A)'';
            (4) in paragraph (4), as so redesignated, by striking 
        ``paragraph (1) or (2)'' each place it appears and inserting 
        ``paragraph (1), (2), or (3)''; and
            (5) in paragraph (6), as so redesignated, by striking 
        ``paragraph (4)'' each place it appears and inserting 
        ``paragraph (5)''.

SEC. 204. REGULATION OF DRUGS THAT ARE BIOLOGICAL PRODUCTS.

    Section 351 of the Public Health Service Act (42 U.S.C. 262) is 
amended--
            (1) in subsection (a)(2), by adding at the end the 
        following:
    ``(D) Risk Evaluation and Mitigation Strategy.--A person that 
submits an application for a license for a drug under this paragraph 
may submit to the Secretary as part of the application a proposed risk 
evaluation and mitigation strategy as described under section 505(o) of 
the Federal Food, Drug, and Cosmetic Act.''; and
            (2) in subsection (j), by inserting ``, including the 
        requirements under section 505(o) of such Act,'' after ``, and 
        Cosmetic Act''.

SEC. 205. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

    Section 505(e) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(e)) is amended by adding at the end the following: ``The 
Secretary may withdraw the approval of an application submitted under 
this section, or suspend the approval of such an application, as 
provided under this subsection, without first ordering the applicant to 
submit an assessment of the approved risk evaluation and mitigation 
strategy for the drug under subsection (o)(7)(B)(ii)(V).''.

SEC. 206. DRUGS SUBJECT TO AN ABBREVIATED NEW DRUG APPLICATION.

    Section 505(j)(2) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)(2)) is amended by adding at the end the following:
    ``(E) Risk Evaluation and Mitigation Strategy Requirement.--
            ``(i) In general.--A drug that is the subject of an 
        abbreviated new drug application under this subsection shall be 
        subject to only the following elements of the approved risk 
        evaluation and mitigation strategy if required under subsection 
        (o) for the applicable listed drug:
                    ``(I) Labeling, as required under subsection 
                (o)(3)(A) for the applicable listed drug.
                    ``(II) A Medication Guide or patient package 
                insert, if required under subsection (o)(5)(B) for the 
                applicable listed drug.
                    ``(III) Prereview of advertising, if required under 
                subsection (o)(5)(D) for the applicable listed drug.
                    ``(IV) Specific disclosures in advertising, if 
                required under subsection (o)(5)(E) for the applicable 
                listed drug.
                    ``(V) Elements to assure safe use, if required 
                under subsection (o)(6) for the applicable listed drug, 
                except that such drug may use a different, comparable 
                aspect of such elements as are necessary to assure safe 
                use of such drug if--
                            ``(aa) the corresponding aspect of the 
                        elements to assure safe use for the applicable 
                        listed drug is claimed by a patent that has not 
                        expired or is a method or process that as a 
                        trade secret is entitled to protection; and
                            ``(bb) the applicant certifies that it has 
                        sought a license for use of such aspect of the 
                        elements to assure safe use for the applicable 
                        listed drug.
            ``(ii) Action by secretary.--For an applicable listed drug 
        for which a drug is approved under this subsection, the 
        Secretary--
                    ``(I) shall undertake any communication plan to 
                health care providers required under section (o)(5)(C) 
                for the applicable listed drug;
                    ``(II) shall conduct, or contract for, any 
                postapproval study required under subsection (o)(4)(B) 
                for the applicable listed drug;
                    ``(III) shall inform the applicant for a drug 
                approved under this subsection if the approved risk 
                evaluation and mitigation strategy for the applicable 
                listed drug is modified; and
                    ``(IV) in order to minimize the burden on the 
                health care delivery system of different elements to 
                assure safe use for the drug approved under this 
                subsection and the applicable listed drug, may seek to 
                negotiate a voluntary agreement with the owner of the 
                patent, method, or process for a license under which 
                the applicant for such drug may use an aspect of the 
                elements to assure safe use, if required under 
                subsection (o)(6) for the applicable listed drug, that 
                is claimed by a patent that has not expired or is a 
                method or process that as a trade secret is entitled to 
                protection.''.

SEC. 207. RESOURCES.

    (a) User Fees.--Subparagraph (F) of section 735(d)(6) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379g(d)(6)), as amended 
by section 103, is amended--
            (1) in clause (ii), by striking ``systems); and'' and 
        inserting ``systems);''
            (2) in clause (iii), by striking ``bases).'' and inserting 
        ``bases); and''; and
            (3) by adding at the end the following:
                            ``(iv) reviewing, implementing, and 
                        ensuring compliance with risk evaluation and 
                        mitigation strategies.''.
    (b) Additional Fee Revenues for Drug Safety.--Section 736 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), as amended by 
section 103, is amended by--
            (1) striking the subsection designation and all that 
        follows through ``.--Except'' and inserting the following:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--Except''; and
            (2) adding at the end the following:
            ``(2) Additional fee revenues for drug safety.--
                    ``(A) In general.--Subject to subparagraph (C), in 
                each of fiscal years 2008 through 2012, paragraph (1) 
                shall be applied by substituting the amount determined 
                under subparagraph (B) for `$392,783,000'.
                    ``(B) Amount determined.--For any fiscal year 2008 
                through 2012, the amount determined under this 
                subparagraph is the sum of--
                            ``(i) $392,783,000; plus
                            ``(ii) the amount equal to--
                                    ``(I)(aa) for fiscal year 2008, 
                                $25,000,000;
                                    ``(bb) for fiscal year 2009, 
                                $35,000,000;
                                    ``(cc) for fiscal year 2010, 
                                $45,000,000;
                                    ``(dd) for fiscal year 2011, 
                                $55,000,000; and
                                    ``(ee) for fiscal year 2012, 
                                $65,000,000; minus
                            ``(II) the amount equal to one-fifth of the 
                        excess amount in item (bb), provided that--
                                    ``(aa) the amount of the total 
                                appropriation for the Food and Drug 
                                Administration for such fiscal year 
                                (excluding the amount of fees 
                                appropriated for such fiscal year) 
                                exceeds the amount of the total 
                                appropriation for the Food and Drug 
                                Administration for fiscal year 2007 
                                (excluding the amount of fees 
                                appropriated for such fiscal year), 
                                adjusted as provided under subsection 
                                (c)(1); and
                                    ``(bb) the amount of the total 
                                appropriations for the process of human 
                                drug review at the Food and Drug 
                                Administration for such fiscal year 
                                (excluding the amount of fees 
                                appropriated for such fiscal year) 
                                exceeds the amount of appropriations 
                                for the process of human drug review at 
                                the Food and Drug Administration for 
                                fiscal year 2007 (excluding the amount 
                                of fees appropriated for such fiscal 
                                year), adjusted as provided under 
                                subsection (c)(1).
                        In making the adjustment under subclause (II) 
                        for any fiscal year 2008 through 2012, 
                        subsection (c)(1) shall be applied by 
                        substituting `2007' for `2008.'
                    ``(C) Limitation.--This paragraph shall not apply 
                for any fiscal year if the amount described under 
                subparagraph (B)(ii) is less than 0.''.
    (c) Strategic Plan for Information Technology.--Not later than 1 
year after the date of enactment of this title, the Secretary of Health 
and Human Services (referred to in this title as the ``Secretary'') 
shall submit to the Committee on Health, Education, Labor, and Pensions 
and the Committee on Appropriations of the Senate and the Committee on 
Energy and Commerce and the Committee on Appropriations of the House of 
Representatives, a strategic plan on information technology that 
includes--
            (1) an assessment of the information technology 
        infrastructure, including systems for data collection, access 
        to data in external health care databases, data mining 
        capabilities, personnel, and personnel training programs, 
        needed by the Food and Drug Administration to--
                    (A) comply with the requirements of this subtitle 
                (and the amendments made by this subtitle);
                    (B) achieve interoperability within and among the 
                centers of the Food and Drug Administration and between 
                the Food and Drug Administration and product 
                application sponsors;
                    (C) utilize electronic health records;
                    (D) implement routine active surveillance under 
                section 505(k)(3) (including complementary approaches 
                under subsection (c) of such section) of the Federal 
                Food, Drug, and Cosmetic Act, as added by section 201 
                of this Act; and
                    (E) communicate drug safety information to 
                physicians and other health care providers;
            (2) an assessment of the extent to which the current 
        information technology assets of the Food and Drug 
        Administration are sufficient to meet the needs assessments 
        under paragraph (1);
            (3) a plan for enhancing the information technology assets 
        of the Food and Drug Administration toward meeting the needs 
        assessments under paragraph (1); and
            (4) an assessment of additional resources needed to so 
        enhance the information technology assets of the Food and Drug 
        Administration.

SEC. 208. SAFETY LABELING CHANGES.

    (a) In General.--Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting 
after section 506C the following:

``SEC. 506D. SAFETY LABELING CHANGES.

    ``(a) New Safety Information.--
            ``(1) Notification.--The holder of an approved application 
        under section 505 of this Act or a license under section 351 of 
        the Public Health Service Act (referred to in this section as a 
        `holder') shall promptly notify the Secretary if the holder 
        becomes aware of new safety information that the holder 
        believes should be included in the labeling of the drug. The 
        Secretary shall promptly notify the holder if the Secretary 
        becomes aware of new safety information that the Secretary 
        believes should be included in the labeling of the drug.
            ``(2) Discussion regarding labeling changes.--Following 
        notification pursuant to paragraph (1), the Secretary and 
        holder shall initiate discussions of the new safety information 
        in order to reach agreement on whether the labeling for the 
        drug should be modified to reflect the new safety information 
        and, if so, on the contents of such labeling changes.
            ``(3) Supplement.--If the Secretary determines that there 
        is reasonable scientific evidence that an adverse event is 
        associated with use of the drug, the Secretary may request the 
        holder to submit a supplement to an application under section 
        505 of this Act or to a license under section 351 of the Public 
        Health Service Act (referred to in this section as a 
        `supplement') proposing changes to the approved labeling to 
        reflect the new safety information, including changes to boxed 
        warnings, contraindications, warnings, precautions, or adverse 
        reactions (referred to in this section as a `safety labeling 
        change'). If the Secretary determines that no safety labeling 
        change is necessary or appropriate based upon the new safety 
        information, the Secretary shall notify the holder of this 
        determination in writing.
    ``(b) Labeling Supplements.--
            ``(1) In general.--The holder shall submit a supplement 
        whenever the holder seeks, either at the holder's own 
        initiative or at the request of the Secretary, to make a safety 
        labeling change.
            ``(2) Nonaccelerated process.--Unless the accelerated 
        labeling review process described in subsection (c) is 
        initiated, any supplement proposing a safety labeling change 
        shall be reviewed and acted upon by the Secretary not later 
        than 30 days after the date the Secretary receives the 
        supplement. Until the Secretary acts on such a supplement 
        proposing a safety labeling change, the existing approved 
        labeling shall remain in effect and be distributed by the 
        holder without change.
            ``(3) New safety information.--Nothing in this section 
        shall prohibit the Secretary from informing health care 
        professionals or the public about new safety information prior 
        to approval of a supplement proposing a safety labeling change.
    ``(c) Accelerated Labeling Review Process.--An accelerated labeling 
review process shall be available to resolve disagreements in a timely 
manner between the Secretary and a holder about the need for, or 
content of, a safety labeling change, as follows:
            ``(1) Request to initiate accelerated process.--The 
        accelerated labeling review process shall be initiated upon the 
        written request of either the Secretary or the holder. Such 
        request may be made at any time after the notification 
        described in subsection (a)(1), including during the 
        Secretary's review of a supplement proposing a safety labeling 
        change.
            ``(2) Scientific discussion and meetings.--
                    ``(A) In general.--Following initiation of the 
                accelerated labeling review process, the Secretary and 
                holder shall immediately initiate discussions to review 
                and assess the new safety information and to reach 
                agreement on whether safety labeling changes are 
                necessary and appropriate and, if so, the content of 
                such safety labeling changes.
                    ``(B) Time period.--The discussions under this 
                paragraph shall not extend for more than 45 calendar 
                days after the initiation of the accelerated labeling 
                review process.
                    ``(C) Dispute proceedings.--If the Secretary and 
                holder do not reach an agreement regarding the safety 
                labeling changes by not later than 25 calendar days 
                after the initiation of the accelerated labeling review 
                process, the dispute automatically shall be referred to 
                the director of the drug evaluation office responsible 
                for the drug under consideration, who shall be required 
                to take an active role in such discussions.
            ``(3) Request for safety labeling change and failure to 
        agree.--If the Secretary and holder fail to reach an agreement 
        on appropriate safety labeling changes by not later than 45 
        calendar days after the initiation of the accelerated labeling 
        review process--
                    ``(A) on the next calendar day (other than a 
                weekend or Federal holiday) after such period, the 
                Secretary shall--
                            ``(i) request in writing that the holder 
                        make any safety labeling change that the 
                        Secretary determines to be necessary and 
                        appropriate based upon the new safety 
                        information; or
                            ``(ii) notify the holder in writing that 
                        the Secretary has determined that no safety 
                        labeling change is necessary or appropriate; 
                        and
                    ``(B) if the Secretary fails to act within the 
                specified time, or if the holder does not agree to make 
                a safety labeling change requested by the Secretary or 
                does not agree with the Secretary's determination that 
                no labeling change is necessary or appropriate, the 
                Secretary (on his own initiative or upon request by the 
                holder) shall refer the matter for expedited review to 
                the Drug Safety Oversight Board.
            ``(4) Action by the drug safety oversight board.--Not later 
        than 45 days after receiving a referral under paragraph (3)(B), 
        the Drug Safety Oversight Board shall--
                    ``(A) review the new safety information;
                    ``(B) review all written material submitted by the 
                Secretary and the holder;
                    ``(C) convene a meeting to hear oral presentations 
                and arguments from the Secretary and holder; and
                    ``(D) make a written recommendation to the 
                Secretary--
                            ``(i) concerning appropriate safety 
                        labeling changes, if any; or
                            ``(ii) stating that no safety labeling 
                        changes are necessary or appropriate based upon 
                        the new safety information.
            ``(5) Consideration of recommendations.--
                    ``(A) Action by the secretary.--The Secretary shall 
                consider the recommendation of the Drug Safety 
                Oversight Board made under paragraph (4)(D) and, not 
                later than 20 days after receiving the recommendation--
                            ``(i) issue an order requiring the holder 
                        to make any safety labeling change that the 
                        Secretary determines to be necessary and 
                        appropriate; or
                            ``(ii) if the Secretary determines that no 
                        safety labeling change is necessary or 
                        appropriate, the Secretary shall notify the 
                        holder of this determination in writing.
                    ``(B) Failure to act.--If the Secretary fails to 
                act by not later than 20 days after receiving the 
                recommendation of the Drug Safety Oversight Board, the 
                written recommendation of the Drug Safety Oversight 
                Board shall be considered the order of the Secretary 
                under this paragraph.
                    ``(C) Nondelegation.--The Secretary's authority 
                under this paragraph shall not be redelegated to an 
                individual below the level of the Director of the 
                Center for Drug Evaluation and Research, or the 
                Director of the Center for Biologics Evaluation and 
                Research, of the Food and Drug Administration.
            ``(6) Misbranding.--If the holder, not later than 10 days 
        after receiving an order under subparagraph (A) or (B) of 
        paragraph (5), does not agree to make a safety labeling change 
        ordered by the Secretary, the Secretary may deem the drug that 
        is the subject of the request to be misbranded.
    ``(d) Rule of Construction.--Nothing in this section shall be 
construed to change the standards in existence on the date of enactment 
of this section for determining whether safety labeling changes are 
necessary or appropriate.''.
    (b) Conforming Amendment.--Section 502 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 352 et seq.), as amended by section 203, is 
further amended by adding at the end the following:
    ``(y) If it is a drug and the holder does not agree to make a 
safety labeling change ordered by the Secretary under section 506D(c) 
within 10 days after issuance of such an order.''.

SEC. 209. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND 
              PROVIDERS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by section 251, is amended by adding at the end the 
following:
    ``(r) Postmarket Drug Safety Information for Patients and 
Providers.--
            ``(1) Establishment.--Not later than 1 year after the date 
        of enactment of the Enhancing Drug Safety and Innovation Act of 
        2007, the Secretary shall improve the transparency of 
        pharmaceutical data and allow patients and health care 
        providers better access to pharmaceutical data by developing 
        and maintaining an Internet website that--
                    ``(A) provides comprehensive drug safety 
                information for prescription drugs that are approved by 
                the Secretary under this section or licensed under 
                section 351 of the Public Health Service Act; and
                    ``(B) improves communication of drug safety 
                information to patients and providers.
            ``(2) Internet website.--The Secretary shall carry out 
        paragraph (1) by--
                    ``(A) developing and maintaining an accessible, 
                consolidated Internet website with easily searchable 
                drug safety information, including the information 
                found on United States Government Internet websites, 
                such as the United States National Library of 
                Medicine's Daily Med and Medline Plus websites, in 
                addition to other such websites maintained by the 
                Secretary;
                    ``(B) ensuring that the information provided on the 
                Internet website is comprehensive and includes, when 
                available and appropriate--
                            ``(i) patient labeling and patient 
                        packaging inserts;
                            ``(ii) a link to a list of each drug, 
                        whether approved under this section or licensed 
                        under such section 351, for which a Medication 
                        Guide, as provided for under part 208 of title 
                        21, Code of Federal Regulations (or any 
                        successor regulations), is required;
                            ``(iii) a link to the clinical trial 
                        registry data bank provided for under 
                        subsections (i) and (j) of section 402 of the 
                        Public Health Service Act;
                            ``(iv) the most recent safety information 
                        and alerts issued by the Food and Drug 
                        Administration for drugs approved by the 
                        Secretary under this section, such as product 
                        recalls, warning letters, and import alerts;
                            ``(v) publicly available information about 
                        implemented RiskMAPs and risk evaluation and 
                        mitigation strategies under subsection (o);
                            ``(vi) guidance documents and regulations 
                        related to drug safety; and
                            ``(vii) other material determined 
                        appropriate by the Secretary;
                    ``(C) including links to non-Food and Drug 
                Administration Internet resources that provide access 
                to relevant drug safety information, such as medical 
                journals and studies;
                    ``(D) providing access to summaries of the assessed 
                and aggregated data collected from the active 
                surveillance infrastructure under subsection (k)(3) to 
                provide information of known and serious side-effects 
                for drugs approved by the Secretary under this section 
                or licensed under such section 351;
                    ``(E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports through the 
                Internet website;
                    ``(F) providing educational materials for patients 
                and providers about the appropriate means of disposing 
                of expired, damaged, or unusable medications; and
                    ``(G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes of the 
                Internet website.
            ``(3) Posting of drug labeling.--The Secretary shall post 
        on the Internet website established under paragraph (1) the 
        approved professional labeling and any required patient 
        labeling of a drug approved under this section or licensed 
        under such section 351 not later than 21 days after the date 
        the drug is approved or licensed, including in a supplemental 
        application with respect to a labeling change.
            ``(4) Private sector resources.--To ensure development of 
        the Internet website by the date described in paragraph (1), 
        the Secretary may, on a temporary or permanent basis, implement 
        systems or products developed by private entities.
            ``(5) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to fulfill the 
        requirements of this subsection.
            ``(6) Review.--The Advisory Committee on Risk Communication 
        under section 566 shall, on a regular basis, perform a 
        comprehensive review and evaluation of the types of risk 
        communication information provided on the Internet website 
        established under paragraph (1) and, through other means, shall 
        identify, clarify, and define the purposes and types of 
        information available to facilitate the efficient flow of 
        information to patients and providers, and shall recommend ways 
        for the Food and Drug Administration to work with outside 
        entities to help facilitate the dispensing of risk 
        communication information to patients and providers.''.

SEC. 210. ACTION PACKAGE FOR APPROVAL.

    Section 505(l) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(l)) is amended by--
            (1) redesignating paragraphs (1), (2), (3), (4), and (5) as 
        subparagraphs (A), (B), (C), (D), and (E), respectively;
            (2) striking ``(l) Safety and'' and inserting ``(l)(1) 
        Safety and''; and
            (3) adding at the end the following:
    ``(2) Action Package for Approval.--
            ``(A) Action package.--The Secretary shall publish the 
        action package for approval of an application under subsection 
        (b) or section 351 of the Public Health Service Act on the 
        Internet website of the Food and Drug Administration--
                    ``(i) not later than 30 days after the date of 
                approval of such application for a drug no active 
                ingredient (including any ester or salt of the active 
                ingredient) of which has been approved in any other 
                application under this section or section 351 of the 
                Public Health Service Act; and
                    ``(ii) not later than 30 days after the third 
                request for such action package for approval received 
                under section 552 of title 5, United States Code, for 
                any other drug.
            ``(B) Immediate publication of summary review.--
        Notwithstanding subparagraph (A), the Secretary shall publish, 
        on the Internet website of the Food and Drug Administration, 
        the materials described in subparagraph (C)(iv) not later than 
        48 hours after the date of approval of the drug, except where 
        such materials require redaction by the Secretary.
            ``(C) Contents.--An action package for approval of an 
        application under subparagraph (A) shall be dated and shall 
        include the following:
                    ``(i) Documents generated by the Food and Drug 
                Administration related to review of the application.
                    ``(ii) Documents pertaining to the format and 
                content of the application generated during drug 
                development.
                    ``(iii) Labeling submitted by the applicant.
                    ``(iv) A summary review that documents conclusions 
                from all reviewing disciplines about the drug, noting 
                any critical issues and disagreements with the 
                applicant and how they were resolved, recommendation 
                for action, and an explanation of any nonconcurrence 
                with review conclusions.
                    ``(v) If applicable, a separate review from a 
                supervisor who does not concur with the summary review.
                    ``(vi) Identification by name of each officer or 
                employee of the Food and Drug Administration who--
                            ``(I) participated in the decision to 
                        approve the application; and
                            ``(II) consents to have his or her name 
                        included in the package.
            ``(D) Disagreements.--A scientific review of an application 
        is considered the work of the reviewer and shall not be altered 
        by management or the reviewer once final. Disagreements by team 
        leaders, division directors, or office directors with any or 
        all of the major conclusions of a reviewer shall be document in 
        a separate review or in an addendum to the review.
            ``(E) Confidential information.--This paragraph does not 
        authorize the disclosure of any trade secret or confidential 
        commercial or financial information described in section 
        552(b)(4) of title 5, United States Code, unless the Secretary 
        declares an emergency under section 319 of the Public Health 
        Service Act and such disclosure is necessary to mitigate the 
        effects of such emergency.''.

SEC. 211. RISK COMMUNICATION.

    Subchapter E of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360bbb et seq.) is amended by adding at the end the 
following:

``SEC. 566. RISK COMMUNICATION.

    ``(a) Advisory Committee on Risk Communication.--
            ``(1) In general.--The Secretary shall establish an 
        advisory committee to be known as the `Advisory Committee on 
        Risk Communication' (referred to in this section as the 
        `Committee').
            ``(2) Duties of committee.--The Committee shall advise the 
        Commissioner on methods to effectively communicate risks 
        associated with the products regulated by the Food and Drug 
        Administration.
            ``(3) Members.--The Secretary shall ensure that the 
        Committee is composed of experts on risk communication, experts 
        on the risks described in subsection (b), and representatives 
        of patient, consumer, and health professional organizations.
            ``(4) Permanence of committee.--Section 14 of the Federal 
        Advisory Committee Act shall not apply to the Committee 
        established under this subsection.
    ``(b) Partnerships for Risk Communication.--
            ``(1) In general.--The Secretary shall partner with 
        professional medical societies, medical schools, academic 
        medical centers, and other stakeholders to develop robust and 
        multi-faceted systems for communication to health care 
        providers about emerging postmarket drug risks.
            ``(2) Partnerships.--The systems developed under paragraph 
        (1) shall--
                    ``(A) account for the diversity among physicians in 
                terms of practice, affinity for technology, and focus; 
                and
                    ``(B) include the use of existing communication 
                channels, including electronic communications, in place 
                at the Food and Drug Administration.''.

SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

    Section 505 of the Federal Food, Drug, and Cosmetic Act, as amended 
by section 202, is further amended by adding at the end the following:
    ``(p) Referral to Advisory Committee.--
            ``(1) In general.--Prior to the approval of a drug no 
        active ingredient (including any ester or salt of the active 
        ingredient) of which has been approved in any other application 
        under this section or section 351 of the Public Health Service 
        Act, the Secretary shall refer such drug to a Food and Drug 
        Administration advisory committee for review at a meeting of 
        such advisory committee.
            ``(2) Exception.--Notwithstanding paragraph (1), an 
        advisory committee review of a drug described under such 
        paragraph may occur within 1 year after approval of such a drug 
        if--
                    ``(A) the clinical trial that formed the primary 
                basis of the safety and efficacy determination was 
                halted by a drug safety monitoring board or an 
                Institutional Review Board before its scheduled 
                completion due to early unanticipated therapeutic 
                results; or
                    ``(B) the Secretary determines that it would be 
                beneficial to the public health.''.

SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

    (a) In General.--Not later than 1 year after the date of enactment 
of this title, the Secretary shall issue a report responding to the 
2006 report of the Institute of Medicine entitled ``The Future of Drug 
Safety--Promoting and Protecting the Health of the Public''.
    (b) Content of Report.--The report issued by the Secretary under 
subsection (a) shall include--
            (1) an update on the implementation by the Food and Drug 
        Administration of its plan to respond to the Institute of 
        Medicine report described under such subsection; and
            (2) an assessment of how the Food and Drug Administration 
        has implemented--
                    (A) the recommendations described in such Institute 
                of Medicine report; and
                    (B) the requirement under paragraph (7) of section 
                505(o) of the Federal Food, Drug, and Cosmetic Act (as 
                added by this title), that the appropriate office 
                responsible for reviewing a drug and the office 
                responsible for postapproval safety with respect to the 
                drug act together to assess, implement, and ensure 
                compliance with the requirements of such section 
                505(o).

SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

    (a) Effective Dates.--
            (1) In general.--Except as provided in paragraph (2), this 
        subtitle shall take effect 180 days after the date of enactment 
        of this title.
            (2) User fees.--The amendments made by subsections (a) 
        through (c) of section 207 shall take effect on October 1, 
        2007.
    (b) Drugs Deemed To Have Risk Evaluation and Mitigation 
Strategies.--
            (1) In general.--A drug that was approved before the 
        effective date of this subtitle shall be deemed to have an 
        approved risk evaluation and mitigation strategy under section 
        505(o) of the Federal Food, Drug, and Cosmetic Act (as added by 
        this subtitle) if there are in effect on the effective date of 
        this subtitle restrictions on distribution or use--
                    (A) required under section 314.520 or section 
                601.42 of title 21, Code of Federal Regulations; or
                    (B) otherwise agreed to by the applicant and the 
                Secretary for such drug.
            (2) Risk evaluation and mitigation strategy.--The approved 
        risk evaluation and mitigation strategy deemed in effect for a 
        drug under paragraph (1) shall consist of the elements 
        described in subparagraphs (A) and (B) of paragraph (3) of such 
        section 505(o) and any other additional elements under 
        paragraphs (4), (5), and (6) in effect for such drug on the 
        effective date of this subtitle.
            (3) Notification.--Not later than 30 days after the 
        effective date of this subtitle, the Secretary shall notify the 
        applicant for each drug described in paragraph (1)--
                    (A) that such drug is deemed to have an approved 
                risk evaluation and mitigation strategy pursuant to 
                such paragraph; and
                    (B) of the date, which, unless a safety issue with 
                the drug arises, shall be no earlier than 6 months 
                after the applicant is so notified, by which the 
                applicant shall submit to the Secretary an assessment 
                of such approved strategy under paragraph (7)(B) of 
                such section 505(o), except with respect to the drug 
                Mifeprex (mifepristone), such assessment shall be 
                submitted 6 months after the applicant is so notified.
            (4) Enforcement only after assessment and review.--Neither 
        the Secretary nor the Attorney General may seek to enforce a 
        requirement of a risk evaluation and mitigation strategy deemed 
        in effect under paragraph (1) before the Secretary has 
        completed review of, and acted on, the first assessment of such 
        strategy under such section 505(o).
    (c) No Effect on Veterinary Medicine.--This subtitle, and the 
amendments made by this subtitle, shall have no effect on the use of 
drugs approved under section 505 of the Federal Food, Drug, and 
Cosmetic Act by, or on the lawful written or oral order of, a licensed 
veterinarian within the context of a veterinarian-client-patient 
relationship, as provided for under section 512(a)(5) of such Act.

       Subtitle B--Reagan-Udall Foundation for the Food and Drug 
                             Administration

SEC. 221. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
              ADMINISTRATION.

    (a) In General.--Chapter VII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 371 et seq.) is amended by adding at the end 
the following:

     ``Subchapter I--Reagan-Udall Foundation for the Food and Drug 
                             Administration

``SEC. 770. ESTABLISHMENT AND FUNCTIONS OF THE FOUNDATION.

    ``(a) In General.--A nonprofit corporation to be known as the 
Reagan-Udall Foundation for the Food and Drug Administration (referred 
to in this subchapter as the `Foundation') shall be established in 
accordance with this section. The Foundation shall be headed by an 
Executive Director, appointed by the members of the Board of Directors 
under subsection (e). The Foundation shall not be an agency or 
instrumentality of the United States Government.
    ``(b) Purpose of Foundation.--The purpose of the Foundation is to 
advance the mission of the Food and Drug Administration to modernize 
medical, veterinary, food, food ingredient, and cosmetic product 
development, accelerate innovation, and enhance product safety.
    ``(c) Duties of the Foundation.--The Foundation shall--
            ``(1) taking into consideration the Critical Path reports 
        and priorities published by the Food and Drug Administration, 
        identify unmet needs in the development, manufacture, and 
        evaluation of the safety and effectiveness, including 
        postapproval, of devices, including diagnostics, biologics, and 
        drugs, and the safety of food, food ingredients, and cosmetics;
            ``(2) establish goals and priorities in order to meet the 
        unmet needs identified in paragraph (1);
            ``(3) in consultation with the Secretary, identify existing 
        and proposed Federal intramural and extramural research and 
        development programs relating to the goals and priorities 
        established under paragraph (2), coordinate Foundation 
        activities with such programs, and minimize Foundation 
        duplication of existing efforts;
            ``(4) award grants to, or enter into contracts, memoranda 
        of understanding, or cooperative agreements with, scientists 
        and entities, which may include the Food and Drug 
        Administration, university consortia, public-private 
        partnerships, institutions of higher education, entities 
        described in section 501(c)(3) of the Internal Revenue Code 
        (and exempt from tax under section 501(a) of such Code), and 
        industry, to efficiently and effectively advance the goals and 
        priorities established under paragraph (2);
            ``(5) recruit meeting participants and hold or sponsor (in 
        whole or in part) meetings as appropriate to further the goals 
        and priorities established under paragraph (2);
            ``(6) release and publish information and data and, to the 
        extent practicable, license, distribute, and release material, 
        reagents, and techniques to maximize, promote, and coordinate 
        the availability of such material, reagents, and techniques for 
        use by the Food and Drug Administration, nonprofit 
        organizations, and academic and industrial researchers to 
        further the goals and priorities established under paragraph 
        (2);
            ``(7) ensure that--
                    ``(A) action is taken as necessary to obtain 
                patents for inventions developed by the Foundation or 
                with funds from the Foundation;
                    ``(B) action is taken as necessary to enable the 
                licensing of inventions developed by the Foundation or 
                with funds from the Foundation; and
                    ``(C) executed licenses, memoranda of 
                understanding, material transfer agreements, contracts, 
                and other such instruments, promote, to the maximum 
                extent practicable, the broadest conversion to 
                commercial and noncommercial applications of licensed 
                and patented inventions of the Foundation to further 
                the goals and priorities established under paragraph 
                (2);
            ``(8) provide objective clinical and scientific information 
        to the Food and Drug Administration and, upon request, to other 
        Federal agencies to assist in agency determinations of how to 
        ensure that regulatory policy accommodates scientific advances 
        and meets the agency's public health mission;
            ``(9) conduct annual assessments of the unmet needs 
        identified in paragraph (1); and
            ``(10) carry out such other activities consistent with the 
        purposes of the Foundation as the Board determines appropriate.
    ``(d) Board of Directors.--
            ``(1) Establishment.--
                    ``(A) In general.--The Foundation shall have a 
                Board of Directors (referred to in this subchapter as 
                the `Board'), which shall be composed of ex officio and 
                appointed members in accordance with this subsection. 
                All appointed members of the Board shall be voting 
                members.
                    ``(B) Ex officio members.--The ex officio members 
                of the Board shall be the following individuals or 
                their designees:
                            ``(i) The Commissioner.
                            ``(ii) The Director of the National 
                        Institutes of Health.
                            ``(iii) The Director of the Centers for 
                        Disease Control and Prevention.
                            ``(iv) The Director of the Agency for 
                        Healthcare Research and Quality.
                    ``(C) Appointed members.--
                            ``(i) In general.--The ex officio members 
                        of the Board under subparagraph (B) shall, by 
                        majority vote, appoint to the Board 12 
                        individuals, from a list of candidates to be 
                        provided by the National Academy of Sciences. 
                        Of such appointed members--
                                    ``(I) 4 shall be representatives of 
                                the general pharmaceutical, device, 
                                food, cosmetic, and biotechnology 
                                industries;
                                    ``(II) 3 shall be representatives 
                                of academic research organizations;
                                    ``(III) 2 shall be representatives 
                                of Government agencies, including the 
                                Food and Drug Administration and the 
                                National Institutes of Health;
                                    ``(IV) 2 shall be representatives 
                                of patient or consumer advocacy 
                                organizations; and
                                    ``(V) 1 shall be a representative 
                                of health care providers.
                            ``(ii) Requirement.--The ex officio members 
                        shall ensure the Board membership includes 
                        individuals with expertise in areas including 
                        the sciences of developing, manufacturing, and 
                        evaluating the safety and effectiveness of 
                        devices, including diagnostics, biologics, and 
                        drugs, and the safety of food, food 
                        ingredients, and cosmetics.
                    ``(D) Initial meeting.--
                            ``(i) In general.--Not later than 30 days 
                        after the date of the enactment of the 
                        Enhancing Drug Safety and Innovation Act of 
                        2007, the Secretary shall convene a meeting of 
                        the ex officio members of the Board to--
                                    ``(I) incorporate the Foundation; 
                                and
                                    ``(II) appoint the members of the 
                                Board in accordance with subparagraph 
                                (C).
                            ``(ii) Service of ex officio members.--Upon 
                        the appointment of the members of the Board 
                        under clause (i)(II), the terms of service of 
                        the ex officio members of the Board as members 
                        of the Board shall terminate.
                            ``(iii) Chair.--The ex officio members of 
                        the Board under subparagraph (B) shall 
                        designate an appointed member of the Board to 
                        serve as the Chair of the Board.
            ``(2) Duties of board.--The Board shall--
                    ``(A) establish bylaws for the Foundation that--
                            ``(i) are published in the Federal Register 
                        and available for public comment;
                            ``(ii) establish policies for the selection 
                        of the officers, employees, agents, and 
                        contractors of the Foundation;
                            ``(iii) establish policies, including 
                        ethical standards, for the acceptance, 
                        solicitation, and disposition of donations and 
                        grants to the Foundation and for the 
                        disposition of the assets of the Foundation, 
                        including appropriate limits on the ability of 
                        donors to designate, by stipulation or 
                        restriction, the use or recipient of donated 
                        funds;
                            ``(iv) establish policies that would 
                        subject all employees, fellows, and trainees of 
                        the Foundation to the conflict of interest 
                        standards under section 208 of title 18, United 
                        States Code;
                            ``(v) establish licensing, distribution, 
                        and publication policies that support the 
                        widest and least restrictive use by the public 
                        of information and inventions developed by the 
                        Foundation or with Foundation funds to carry 
                        out the duties described in paragraphs (6) and 
                        (7) of subsection (c), and may include charging 
                        cost-based fees for published material produced 
                        by the Foundation;
                            ``(vi) specify principles for the review of 
                        proposals and awarding of grants and contracts 
                        that include peer review and that are 
                        consistent with those of the Foundation for the 
                        National Institutes of Health, to the extent 
                        determined practicable and appropriate by the 
                        Board;
                            ``(vii) specify a cap on administrative 
                        expenses for recipients of a grant, contract, 
                        or cooperative agreement from the Foundation;
                            ``(viii) establish policies for the 
                        execution of memoranda of understanding and 
                        cooperative agreements between the Foundation 
                        and other entities, including the Food and Drug 
                        Administration;
                            ``(ix) establish policies for funding 
                        training fellowships, whether at the 
                        Foundation, academic or scientific 
                        institutions, or the Food and Drug 
                        Administration, for scientists, doctors, and 
                        other professionals who are not employees of 
                        regulated industry, to foster greater 
                        understanding of and expertise in new 
                        scientific tools, diagnostics, manufacturing 
                        techniques, and potential barriers to 
                        translating basic research into clinical and 
                        regulatory practice;
                            ``(x) specify a process for annual Board 
                        review of the operations of the Foundation; and
                            ``(xi) establish specific duties of the 
                        Executive Director;
                    ``(B) prioritize and provide overall direction to 
                the activities of the Foundation;
                    ``(C) evaluate the performance of the Executive 
                Director; and
                    ``(D) carry out any other necessary activities 
                regarding the functioning of the Foundation.
            ``(3) Terms and vacancies.--
                    ``(A) Term.--The term of office of each member of 
                the Board appointed under paragraph (1)(C) shall be 4 
                years, except that the terms of offices for the initial 
                appointed members of the Board shall expire on a 
                staggered basis as determined by the ex officio 
                members.
                    ``(B) Vacancy.--Any vacancy in the membership of 
                the Board--
                            ``(i) shall not affect the power of the 
                        remaining members to execute the duties of the 
                        Board; and
                            ``(ii) shall be filled by appointment by 
                        the appointed members described in paragraph 
                        (1)(C) by majority vote.
                    ``(C) Partial term.--If a member of the Board does 
                not serve the full term applicable under subparagraph 
                (A), the individual appointed under subparagraph (B) to 
                fill the resulting vacancy shall be appointed for the 
                remainder of the term of the predecessor of the 
                individual.
                    ``(D) Serving past term.--A member of the Board may 
                continue to serve after the expiration of the term of 
                the member until a successor is appointed.
            ``(4) Compensation.--Members of the Board may not receive 
        compensation for service on the Board. Such members may be 
        reimbursed for travel, subsistence, and other necessary 
        expenses incurred in carrying out the duties of the Board, as 
        set forth in the bylaws issued by the Board.
    ``(e) Incorporation.--The ex officio members of the Board shall 
serve as incorporators and shall take whatever actions necessary to 
incorporate the Foundation.
    ``(f) Nonprofit Status.--The Foundation shall be considered to be a 
corporation under section 501(c) of the Internal Revenue Code of 1986, 
and shall be subject to the provisions of such section.
    ``(g) Executive Director.--
            ``(1) In general.--The Board shall appoint an Executive 
        Director who shall serve at the pleasure of the Board. The 
        Executive Director shall be responsible for the day-to-day 
        operations of the Foundation and shall have such specific 
        duties and responsibilities as the Board shall prescribe.
            ``(2) Compensation.--The compensation of the Executive 
        Director shall be fixed by the Board but shall not be greater 
        than the compensation of the Commissioner.
    ``(h) Administrative Powers.--In carrying out this subchapter, the 
Board, acting through the Executive Director, may--
            ``(1) adopt, alter, and use a corporate seal, which shall 
        be judicially noticed;
            ``(2) hire, promote, compensate, and discharge 1 or more 
        officers, employees, and agents, as may be necessary, and 
        define their duties;
            ``(3) prescribe the manner in which--
                    ``(A) real or personal property of the Foundation 
                is acquired, held, and transferred;
                    ``(B) general operations of the Foundation are to 
                be conducted; and
                    ``(C) the privileges granted to the Board by law 
                are exercised and enjoyed;
            ``(4) with the consent of the applicable executive 
        department or independent agency, use the information, 
        services, and facilities of such department or agencies in 
        carrying out this section;
            ``(5) enter into contracts with public and private 
        organizations for the writing, editing, printing, and 
        publishing of books and other material;
            ``(6) hold, administer, invest, and spend any gift, devise, 
        or bequest of real or personal property made to the Foundation 
        under subsection (i);
            ``(7) enter into such other contracts, leases, cooperative 
        agreements, and other transactions as the Board considers 
        appropriate to conduct the activities of the Foundation;
            ``(8) modify or consent to the modification of any contract 
        or agreement to which it is a party or in which it has an 
        interest under this subchapter;
            ``(9) take such action as may be necessary to obtain 
        patents and licenses for devices and procedures developed by 
        the Foundation and its employees;
            ``(10) sue and be sued in its corporate name, and complain 
        and defend in courts of competent jurisdiction;
            ``(11) appoint other groups of advisors as may be 
        determined necessary to carry out the functions of the 
        Foundation; and
            ``(12) exercise other powers as set forth in this section, 
        and such other incidental powers as are necessary to carry out 
        its powers, duties, and functions in accordance with this 
        subchapter.
    ``(i) Acceptance of Funds From Other Sources.--The Executive 
Director may solicit and accept on behalf of the Foundation, any funds, 
gifts, grants, devises, or bequests of real or personal property made 
to the Foundation, including from private entities, for the purposes of 
carrying out the duties of the Foundation.
    ``(j) Service of Federal Employees.--Federal Government employees 
may serve on committees advisory to the Foundation and otherwise 
cooperate with and assist the Foundation in carrying out its functions, 
so long as such employees do not direct or control Foundation 
activities.
    ``(k) Detail of Government Employees; Fellowships.--
            ``(1) Detail from federal agencies.--Federal Government 
        employees may be detailed from Federal agencies with or without 
        reimbursement to those agencies to the Foundation at any time, 
        and such detail shall be without interruption or loss of civil 
        service status or privilege. Each such employee shall abide by 
        the statutory, regulatory, ethical, and procedural standards 
        applicable to the employees of the agency from which such 
        employee is detailed and those of the Foundation.
            ``(2) Voluntary service; acceptance of federal employees.--
                    ``(A) Foundation.--The Executive Director of the 
                Foundation may accept the services of employees 
                detailed from Federal agencies with or without 
                reimbursement to those agencies.
                    ``(B) Food and drug administration.--The 
                Commissioner may accept the uncompensated services of 
                Foundation fellows or trainees. Such services shall be 
                considered to be undertaking an activity under contract 
                with the Secretary as described in section 708.
    ``(l) Annual Reports.--
            ``(1) Reports to foundation.--Any recipient of a grant, 
        contract, fellowship, memorandum of understanding, or 
        cooperative agreement from the Foundation under this section 
        shall submit to the Foundation a report on an annual basis for 
        the duration of such grant, contract, fellowship, memorandum of 
        understanding, or cooperative agreement, that describes the 
        activities carried out under such grant, contract, fellowship, 
        memorandum of understanding, or cooperative agreement.
            ``(2) Report to congress and the fda.--Beginning with 
        fiscal year 2009, the Executive Director shall submit to 
        Congress and the Commissioner an annual report that--
                    ``(A) describes the activities of the Foundation 
                and the progress of the Foundation in furthering the 
                goals and priorities established under subsection 
                (c)(2), including the practical impact of the 
                Foundation on regulated product development;
                    ``(B) provides a specific accounting of the source 
                and use of all funds used by the Foundation to carry 
                out such activities; and
                    ``(C) provides information on how the results of 
                Foundation activities could be incorporated into the 
                regulatory and product review activities of the Food 
                and Drug Administration.
    ``(m) Separation of Funds.--The Executive Director shall ensure 
that the funds received from the Treasury are held in separate accounts 
from funds received from entities under subsection (i).
    ``(n) Funding.--From amounts appropriated to the Food and Drug 
Administration for each fiscal year, the Commissioner shall transfer 
not less than $500,000 and not more than $1,250,000, to the Foundation 
to carry out subsections (a), (b), and (d) through (m).''.
    (b) Other Foundation Provisions.--Chapter VII (21 U.S.C. 371 et 
seq.) (as amended by subsection (a)) is amended by adding at the end 
the following:

``SEC. 771. LOCATION OF FOUNDATION.

    ``The Foundation shall, if practicable, be located not more than 20 
miles from the District of Columbia.

``SEC. 772. ACTIVITIES OF THE FOOD AND DRUG ADMINISTRATION.

    ``(a) In General.--The Commissioner shall receive and assess the 
report submitted to the Commissioner by the Executive Director of the 
Foundation under section 770(l)(2).
    ``(b) Report to Congress.--Beginning with fiscal year 2009, the 
Commissioner shall submit to Congress an annual report summarizing the 
incorporation of the information provided by the Foundation in the 
report described under section 770(l)(2) and by other recipients of 
grants, contracts, memoranda of understanding, or cooperative 
agreements into regulatory and product review activities of the Food 
and Drug Administration.
    ``(c) Extramural Grants.--The provisions of this subchapter shall 
have no effect on any grant, contract, memorandum of understanding, or 
cooperative agreement between the Food and Drug Administration and any 
other entity entered into before, on, or after the date of enactment of 
the Enhancing Drug Safety and Innovation Act of 2007.''.
    (c) Conforming Amendment.--Section 742(b) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379l(b)) is amended by adding at the 
end the following: ``Any such fellowships and training programs under 
this section or under section 770(d)(2)(A)(ix) may include provision by 
such scientists and physicians of services on a voluntary and 
uncompensated basis, as the Secretary determines appropriate. Such 
scientists and physicians shall be subject to all legal and ethical 
requirements otherwise applicable to officers or employees of the 
Department of Health and Human Services.''.

SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

    Chapter IX of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 910. OFFICE OF THE CHIEF SCIENTIST.

    ``(a) Establishment; Appointment.--The Secretary shall establish 
within the Office of the Commissioner an office to be known as the 
Office of the Chief Scientist. The Secretary shall appoint a Chief 
Scientist to lead such Office.
    ``(b) Duties of the Office.--The Office of the Chief Scientist 
shall--
            ``(1) oversee, coordinate, and ensure quality and 
        regulatory focus of the intramural research programs of the 
        Food and Drug Administration;
            ``(2) track and, to the extent necessary, coordinate 
        intramural research awards made by each center of the 
        Administration or science-based office within the Office of the 
        Commissioner, and ensure that there is no duplication of 
        research efforts supported by the Reagan-Udall Foundation for 
        the Food and Drug Administration;
            ``(3) develop and advocate for a budget to support 
        intramural research;
            ``(4) develop a peer review process by which intramural 
        research can be evaluated; and
            ``(5) identify and solicit intramural research proposals 
        from across the Food and Drug Administration through an 
        advisory board composed of employees of the Administration that 
        shall include--
                    ``(A) representatives of each of the centers and 
                the science-based offices within the Office of the 
                Commissioner; and
                    ``(B) experts on trial design, epidemiology, 
                demographics, pharmacovigilance, basic science, and 
                public health.''.

                      Subtitle C--Clinical Trials

SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

    (a) In General.--Section 402 of the Public Health Service Act (42 
U.S.C. 282) is amended by--
            (1) redesignating subsections (j) and (k) as subsections 
        (k) and (l), respectively; and
            (2) inserting after subsection (i) the following:
    ``(j) Expanded Clinical Trial Registry Data Bank.--
            ``(1) Definitions; requirement.--
                    ``(A) Definitions.--In this subsection:
                            ``(i) Applicable device clinical trial.--
                        The term `applicable device clinical trial' 
                        means--
                                    ``(I) a prospective study of health 
                                outcomes comparing an intervention 
                                against a control in human subjects 
                                intended to support an application 
                                under section 515 or 520(m), or a 
                                report under section 510(k), of the 
                                Federal Food, Drug, and Cosmetic Act 
                                (other than a limited study to gather 
                                essential information used to refine 
                                the device or design a pivotal trial 
                                and that is not intended to determine 
                                safety and effectiveness of a device); 
                                and
                                    ``(II) a pediatric postmarket 
                                surveillance as required under section 
                                522 of the Federal Food, Drug, and 
                                Cosmetic Act.
                            ``(ii) Applicable drug clinical trial.--
                                    ``(I) In general.--The term 
                                `applicable drug clinical trial' means 
                                a controlled clinical investigation, 
                                other than a phase I clinical 
                                investigation, of a product subject to 
                                section 505 of the Federal Food, Drug, 
                                and Cosmetic Act or to section 351 of 
                                this Act.
                                    ``(II) Clinical investigation.--For 
                                purposes of subclause (I), the term 
                                `clinical investigation' has the 
                                meaning given that term in section 
                                312.3 of title 21, Code of Federal 
                                Regulations.
                                    ``(III) Phase i.--The term `phase 
                                I' has the meaning given that term in 
                                section 312.21 of title 21, Code of 
                                Federal Regulations.
                            ``(iii) Clinical trial information.--The 
                        term `clinical trial information' means those 
                        data elements that are necessary to complete an 
                        entry in the clinical trial registry data bank 
                        under paragraph (2).
                            ``(iv) Completion date.--The term 
                        `completion date' means, with respect to an 
                        applicable drug clinical trial or an applicable 
                        device clinical trial, the date on which the 
                        last patient enrolled in the clinical trial has 
                        completed his or her last medical visit of the 
                        clinical trial, whether the clinical trial 
                        concluded according to the prespecified 
                        protocol plan or was terminated.
                            ``(v) Device.--The term `device' means a 
                        device as defined in section 201(h) of the 
                        Federal Food, Drug, and Cosmetic Act.
                            ``(vi) Drug.--The term `drug' means a drug 
                        as defined in section 201(g) of the Federal 
                        Food, Drug, and Cosmetic Act or a biological 
                        product as defined in section 351 of this Act.
                            ``(vii) Responsible party.--The term 
                        `responsible party', with respect to a clinical 
                        trial of a drug or device, means--
                                    ``(I) the sponsor of the clinical 
                                trial (as defined in section 50.3 of 
                                title 21, Code of Federal Regulations 
                                (or any successor regulations)) or the 
                                principal investigator of such clinical 
                                trial if so designated by such sponsor; 
                                or
                                    ``(II) if no sponsor exists, the 
                                grantee, contractor, or awardee for a 
                                trial funded by a Federal agency or the 
                                principal investigator of such clinical 
                                trial if so designated by such grantee, 
                                contractor, or awardee.
                    ``(B) Requirement.--The Secretary shall develop a 
                mechanism by which--
                            ``(i) the responsible party for each 
                        applicable drug clinical trial and applicable 
                        device clinical trial shall submit the identity 
                        and contact information of such responsible 
                        party to the Secretary at the time of 
                        submission of clinical trial information under 
                        paragraph (2); and
                            ``(ii) other Federal agencies may identify 
                        the responsible party for an applicable drug 
                        clinical trial or applicable device clinical 
                        trial.
            ``(2) Expansion of clinical trial registry data bank with 
        respect to clinical trial information.--
                    ``(A) In general.--
                            ``(i) Expansion of data bank.--To enhance 
                        patient enrollment and provide a mechanism to 
                        track subsequent progress of clinical trials, 
                        the Secretary, acting through the Director of 
                        NIH, shall expand, in accordance with this 
                        subsection, the clinical trials registry of the 
                        data bank described under subsection (i)(3)(A) 
                        (referred to in this subsection as the 
                        `registry data bank'). The Director of NIH 
                        shall ensure that the registry data bank is 
                        made publicly available through the Internet.
                            ``(ii) Content.--Not later than 18 months 
                        after the date of enactment of the Enhancing 
                        Drug Safety and Innovation Act of 2007, and 
                        after notice and comment, the Secretary shall 
                        promulgate regulations to expand the registry 
                        data bank to require the submission to the 
                        registry data bank of clinical trial 
                        information for applicable drug clinical trials 
                        and applicable device clinical trials that--
                                    ``(I) conforms to the International 
                                Clinical Trials Registry Platform trial 
                                registration data set of the World 
                                Health Organization;
                                    ``(II) includes the city, State, 
                                and zip code for each clinical trial 
                                location, or a toll-free number through 
                                which such location information may be 
                                accessed;
                                    ``(III) if the drug is not approved 
                                under section 505 of the Federal Food, 
                                Drug, and Cosmetic Act or licensed 
                                under section 351 of this Act, 
                                specifies whether or not there is 
                                expanded access to the drug under 
                                section 561 of the Federal Food, Drug, 
                                and Cosmetic Act for those who do not 
                                qualify for enrollment in the clinical 
                                trial and how to obtain information 
                                about such access;
                                    ``(IV) requires the inclusion of 
                                such other data elements to the 
                                registry data bank as appropriate; and
                                    ``(V) becomes effective 90 days 
                                after issuance of the final rule.
                    ``(B) Format and structure.--
                            ``(i) Searchable categories.--The Director 
                        of NIH shall ensure that the public may search 
                        the entries in the registry data bank by 1 or 
                        more of the following criteria:
                                    ``(I) The disease or condition 
                                being studied in the clinical trial, 
                                using Medical Subject Headers (MeSH) 
                                descriptors.
                                    ``(II) The treatment being studied 
                                in the clinical trial.
                                    ``(III) The location of the 
                                clinical trial.
                                    ``(IV) The age group studied in the 
                                clinical trial, including pediatric 
                                subpopulations.
                                    ``(V) The study phase of the 
                                clinical trial.
                                    ``(VI) The source of support for 
                                the clinical trial, which may be the 
                                National Institutes of Health or other 
                                Federal agency, a private industry 
                                source, or a university or other 
                                organization.
                                    ``(VII) The recruitment status of 
                                the clinical trial.
                                    ``(VIII) The National Clinical 
                                Trial number or other study 
                                identification for the clinical trial.
                            ``(ii) Format.--The Director of the NIH 
                        shall ensure that the registry data bank is 
                        easily used by the public, and that entries are 
                        easily compared.
                    ``(C) Data submission.--The responsible party for 
                an applicable drug clinical trial shall submit to the 
                Director of NIH for inclusion in the registry data bank 
                the clinical trial information described in 
                subparagraph (A)(ii).
                    ``(D) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable drug 
                        clinical trial or an applicable device clinical 
                        trial to include information from any source 
                        other than such clinical trial involved.
                    ``(E) Changes in clinical trial status.--
                            ``(i) Enrollment.--The responsible party 
                        for an applicable drug clinical trial or an 
                        applicable device clinical trial shall update 
                        the enrollment status not later than 30 days 
                        after the enrollment status of such clinical 
                        trial changes.
                            ``(ii) Completion.--The responsible party 
                        for an applicable drug clinical trial or 
                        applicable device clinical trial shall report 
                        to the Director of NIH that such clinical trial 
                        is complete not later than 30 days after the 
                        completion date of the clinical trial.
                    ``(F) Timing of submission.--The clinical trial 
                information for an applicable drug clinical trial or an 
                applicable device clinical trial required to be 
                submitted under this paragraph shall be submitted not 
                later than 21 days after the first patient is enrolled 
                in such clinical trial.
                    ``(G) Posting of data.--
                            ``(i) Applicable drug clinical trial.--The 
                        Director of NIH shall ensure that clinical 
                        trial information for an applicable drug 
                        clinical trial submitted in accordance with 
                        this paragraph is posted publicly within 30 
                        days of such submission.
                            ``(ii) Applicable device clinical trial.--
                        The Director of NIH shall ensure that clinical 
                        trial information for an applicable device 
                        clinical trial submitted in accordance with 
                        this paragraph is posted publicly within 30 
                        days of clearance under section 510(k) of the 
                        Federal Food, Drug, and Cosmetic Act, or 
                        approval under section 515 or section 520(m) of 
                        such Act, as applicable.
                    ``(H) Voluntary submissions.--A responsible party 
                for a clinical trial that is not an applicable drug 
                clinical trial or an applicable device clinical trial 
                may submit clinical trial information to the registry 
                data bank in accordance with this subsection.
            ``(3) Expansion of registry data bank to include results of 
        clinical trials.--
                    ``(A) Linking registry data bank to existing 
                results.--
                            ``(i) In general.--Beginning not later than 
                        90 days after the date of enactment of the 
                        Enhancing Drug Safety and Innovation Act of 
                        2007, for those clinical trials that form the 
                        primary basis of an efficacy claim or are 
                        conducted after the drug involved is approved 
                        or after the device involved is cleared or 
                        approved, the Secretary shall ensure that the 
                        registry data bank includes links to results 
                        information for such clinical trial--
                                    ``(I) not earlier than 30 days 
                                after the date of the approval of the 
                                drug involved or clearance or approval 
                                of the device involved; or
                                    ``(II) not later than 30 days after 
                                such information becomes publicly 
                                available, as applicable.
                            ``(ii) Required information.--
                                    ``(I) FDA information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) If an advisory 
                                        committee considered at a 
                                        meeting an applicable drug 
                                        clinical trial or an applicable 
                                        device clinical trial, any 
                                        posted Food and Drug 
                                        Administration summary document 
                                        regarding such applicable drug 
                                        clinical trial or applicable 
                                        clinical device trial.
                                            ``(bb) If an applicable 
                                        drug clinical trial was 
                                        conducted under section 505A or 
                                        505B of the Federal Food, Drug, 
                                        and Cosmetic Act, a link to the 
                                        posted Food and Drug 
                                        Administration assessment of 
                                        the results of such trial.
                                            ``(cc) Food and Drug 
                                        Administration public health 
                                        advisories regarding the drug 
                                        or device that is the subject 
                                        of the applicable drug clinical 
                                        trial or applicable device 
                                        clinical trial, respectively, 
                                        if any.
                                            ``(dd) For an applicable 
                                        drug clinical trial, the Food 
                                        and Drug Administration action 
                                        package for approval document 
                                        required under section 
                                        505(l)(2) of the Food Drug and 
                                        Cosmetic Act.
                                            ``(ee) For an applicable 
                                        device clinical trial, in the 
                                        case of a premarket 
                                        application, the detailed 
                                        summary of information 
                                        respecting the safety and 
                                        effectiveness of the device 
                                        required under section 
                                        520(h)(1) of the Federal Food, 
                                        Drug, and Cosmetic Act, or, in 
                                        the case of a report under 
                                        section 510(k) of such Act, the 
                                        section 510(k) summary of the 
                                        safety and effectiveness data 
                                        required under section 
                                        807.95(d) of title 21, Code of 
                                        Federal Regulations (or any 
                                        successor regulations).
                                    ``(II) NIH information.--The 
                                Secretary shall ensure that the 
                                registry data bank includes links to 
                                the following information:
                                            ``(aa) Medline citations to 
                                        any publications regarding each 
                                        applicable drug clinical trial 
                                        and applicable device clinical 
                                        trial.
                                            ``(bb) The entry for the 
                                        drug that is the subject of an 
                                        applicable drug clinical trial 
                                        in the National Library of 
                                        Medicine database of structured 
                                        product labels, if available.
                            ``(iii) Results for existing data bank 
                        entries.--The Secretary may include the links 
                        described in clause (ii) for data bank entries 
                        for clinical trials submitted to the data bank 
                        prior to enactment of the Enhancing Drug Safety 
                        and Innovation Act of 2007, as available.
                    ``(B) Feasibility study.--The Director of NIH 
                shall--
                            ``(i) conduct a study to determine the 
                        best, validated methods of making the results 
                        of clinical trials publicly available after the 
                        approval of the drug that is the subject of an 
                        applicable drug clinical trial; and
                            ``(ii) not later than 18 months after 
                        initiating such study, submit to the Secretary 
                        any findings and recommendations of such study.
                    ``(C) Negotiated rulemaking.--
                            ``(i) In general.--The Secretary shall 
                        establish a negotiated rulemaking process 
                        pursuant to subchapter IV of chapter 5 of title 
                        5, United States Code, to determine, for 
                        applicable drug clinical trials--
                                    ``(I) how to ensure quality and 
                                validate methods of expanding the 
                                registry data bank to include clinical 
                                trial results information for trials 
                                not within the scope of this Act;
                                    ``(II) the clinical trials of which 
                                the results information is appropriate 
                                for adding to the expanded registry 
                                data bank; and
                                    ``(III) the appropriate timing of 
                                the posting of such results 
                                information.
                            ``(ii) Time requirement.--The process 
                        described in paragraph (1) shall be conducted 
                        in a timely manner to ensure that--
                                    ``(I) any recommendation for a 
                                proposed rule--
                                            ``(aa) is provided to the 
                                        Secretary not later than 21 
                                        months after the date of the 
                                        enactment of the Enhancing Drug 
                                        Safety and Innovation Act of 
                                        2007; and
                                            ``(bb) includes an 
                                        assessment of the benefits and 
                                        costs of the recommendation; 
                                        and
                                    ``(II) a final rule is promulgated 
                                not later than 30 months after the date 
                                of the enactment of the Enhancing Drug 
                                Safety and Innovation Act of 2007, 
                                taking into account the recommendations 
                                under subclause (I) and the results of 
                                the feasibility study conducted under 
                                subparagraph (B).
                            ``(iii) Representation on negotiated 
                        rulemaking committee.--The negotiated 
                        rulemaking committee established by the 
                        Secretary pursuant to clause (i) shall include 
                        members representing--
                                    ``(I) the Food and Drug 
                                Administration;
                                    ``(II) the National Institutes of 
                                Health;
                                    ``(III) other Federal agencies as 
                                the Secretary determines appropriate;
                                    ``(IV) patient advocacy and health 
                                care provider groups;
                                    ``(V) the pharmaceutical industry;
                                    ``(VI) contract clinical research 
                                organizations;
                                    ``(VII) the International Committee 
                                of Medical Journal Editors; and
                                    ``(VIII) other interested parties, 
                                including experts in privacy 
                                protection, pediatrics, health 
                                information technology, health 
                                literacy, communication, clinical trial 
                                design and implementation, and health 
                                care ethics.
                            ``(iv) Content of regulations.--The 
                        regulations promulgated pursuant to clause (i) 
                        shall establish--
                                    ``(I) procedures to determine which 
                                clinical trials results information 
                                data elements shall be included in the 
                                registry data bank, taking into account 
                                the needs of different populations of 
                                users of the registry data bank;
                                    ``(II) a standard format for the 
                                submission of clinical trials results 
                                to the registry data bank;
                                    ``(III) a standard procedure for 
                                the submission of clinical trial 
                                results information, including the 
                                timing of submission and the timing of 
                                posting of results information, to the 
                                registry data bank, taking into account 
                                the possible impacts on publication of 
                                manuscripts based on the clinical 
                                trial;
                                    ``(IV) a standard procedure for the 
                                verification of clinical trial results 
                                information, including ensuring that 
                                free text data elements are non-
                                promotional; and
                                    ``(V) an implementation plan for 
                                the prompt inclusion of clinical trials 
                                results information in the registry 
                                data bank.
                    ``(D) Consideration of world health organization 
                data set.--The Secretary shall consider the status of 
                the consensus data elements set for reporting clinical 
                trial results of the World Health Organization when 
                promulgating the regulations under subparagraph (C).
                    ``(E) Truthful clinical trial information.--
                            ``(i) In general.--The clinical trial 
                        information submitted by a responsible party 
                        under this paragraph shall not be false or 
                        misleading in any particular.
                            ``(ii) Effect.--Clause (i) shall not have 
                        the effect of requiring clinical trial 
                        information with respect to an applicable drug 
                        clinical trial or an applicable device clinical 
                        trial to include information from any source 
                        other than such clinical trial involved.
                    ``(F) Waivers regarding certain clinical trial 
                results.--The Secretary may waive any applicable 
                requirements of this paragraph for an applicable drug 
                clinical trial or an applicable device clinical trial, 
                upon a written request from the responsible person, if 
                the Secretary determines that extraordinary 
                circumstances justify the waiver and that providing the 
                waiver is in the public interest, consistent with the 
                protection of public health, or in the interest of 
                national security. Not later than 30 days after any 
                part of a waiver is granted, the Secretary shall 
                notify, in writing, the appropriate committees of 
                Congress of the waiver and provide an explanation for 
                why the waiver was granted.
            ``(4) Coordination and compliance.--
                    ``(A) Clinical trials supported by grants from 
                federal agencies.--
                            ``(i) In general.--No Federal agency may 
                        release funds under a research grant to an 
                        awardee who has not complied with paragraph (2) 
                        for any applicable drug clinical trial or 
                        applicable device clinical trial for which such 
                        person is the responsible party.
                            ``(ii) Grants from certain federal 
                        agencies.--If an applicable drug clinical trial 
                        or applicable device clinical trial is funded 
                        in whole or in part by a grant from the Food 
                        and Drug Administration, National Institutes of 
                        Health, the Agency for Healthcare Research and 
                        Quality, or the Department of Veterans Affairs, 
                        any grant or progress report forms required 
                        under such grant shall include a certification 
                        that the responsible party has made all 
                        required submissions to the Director of NIH 
                        under paragraph (2).
                            ``(iii) Verification by federal agencies.--
                        The heads of the agencies referred to in clause 
                        (ii), as applicable, shall verify that the 
                        clinical trial information for each applicable 
                        drug clinical trial or applicable device 
                        clinical trial for which a grantee is the 
                        responsible party has been submitted under 
                        paragraph (2) before releasing any remaining 
                        funding for a grant or funding for a future 
                        grant to such grantee.
                            ``(iv) Notice and opportunity to remedy.--
                        If the head of an agency referred to in clause 
                        (ii), as applicable, verifies that a grantee 
                        has not submitted clinical trial information as 
                        described in clause (iii), such agency head 
                        shall provide notice to such grantee of such 
                        non-compliance and allow such grantee 30 days 
                        to correct such non-compliance and submit the 
                        required clinical trial information.
                            ``(v) Consultation with other federal 
                        agencies.--The Secretary shall--
                                    ``(I) consult with other agencies 
                                that conduct research involving human 
                                subjects in accordance with any section 
                                of part 46 of title 45, Code of Federal 
                                Regulations (or any successor 
                                regulations), to determine if any such 
                                research is an applicable drug clinical 
                                trial or an applicable device clinical 
                                trial under paragraph (1); and
                                    ``(II) develop with such agencies 
                                procedures comparable to those 
                                described in clauses (ii), (iii), and 
                                (iv) to ensure that clinical trial 
                                information for such applicable drug 
                                clinical trials and applicable device 
                                clinical trial is submitted under 
                                paragraph (2).
                    ``(B) Certification to accompany drug, biological 
                product, and device submissions.--At the time of 
                submission of an application under section 505 of the 
                Federal Food, Drug, and Cosmetic Act, section 515 of 
                such Act, section 520(m) of such Act, or section 351 of 
                this Act, or submission of a report under section 
                510(k) of such Act, such application or submission 
                shall be accompanied by a certification that all 
                applicable requirements of this subsection have been 
                met. Where available, such certification shall include 
                the appropriate National Clinical Trial control 
                numbers.
                    ``(C) Verification of submission prior to 
                posting.--In the case of clinical trial information 
                that is submitted under paragraph (2), but is not made 
                publicly available pending regulatory approval or 
                clearance, as applicable, the Director of NIH shall 
                respond to inquiries from other Federal agencies and 
                peer-reviewed scientific journals to confirm that such 
                clinical trial information has been submitted but has 
                not yet been posted.
            ``(5) Limitation on disclosure of clinical trial 
        information.--
                    ``(A) In general.--Nothing in this subsection (or 
                under section 552 of title 5, United States Code) shall 
                require the Secretary to publicly disclose, from any 
                record or source other than the registry data bank 
                expanded under this subsection, information described 
                in subparagraph (B).
                    ``(B) Information described.--Information described 
                in this subparagraph is--
                            ``(i) information submitted to the Director 
                        of NIH under this subsection, or information of 
                        the same general nature as (or integrally 
                        associated with) the information so submitted; 
                        and
                            ``(ii) not otherwise publicly available, 
                        including because it is protected from 
                        disclosure under section 552 of title 5, United 
                        States Code.
            ``(6) Authorization of appropriations.--There are 
        authorized to be appropriated to carry out this subsection 
        $10,000,000 for each fiscal year.''.
    (b) Conforming Amendments.--
            (1) Prohibited acts.--Section 301 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding at 
        the end the following:
    ``(jj)(1) The failure to submit the certification required by 
section 402(j)(4)(B) of the Public Health Service Act, or knowingly 
submitting a false certification under such section.
    ``(2) The submission of clinical trial information under subsection 
(i) or (j) of section 402 of the Public Health Service Act that is 
promotional or false or misleading in any particular under paragraph 
(2) or (3) of such subsection (j).''.
            (2) Civil money penalties.--Section 303(f) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended by 
        section 203, is further amended by--
                    (A) redesignating paragraphs (4), (5), and (6) as 
                paragraphs (5), (6), and (7), respectively;
                    (B) inserting after paragraph (3) the following:
    ``(4) Any person who violates section 301(jj) shall be subject to a 
civil monetary penalty of not more than $10,000 for the first 
violation, and not more than $20,000 for each subsequent violation.'';
                    (C) in paragraph (2)(C), by striking ``paragraph 
                (4)(A)'' and inserting ``paragraph (5)(A)'';
                    (D) in paragraph (5), as so redesignated, by 
                striking ``paragraph (1), (2), or (3)'' each place it 
                appears and inserting ``paragraph (1), (2), (3), or 
                (4)''; and
                    (E) in paragraph (7), as so redesignated, by 
                striking ``paragraph (5)'' each place it appears and 
                inserting ``paragraph (6)''.
            (3) New drugs and devices.--
                    (A) Investigational new drugs.--Section 505(i) of 
                the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(i)) is amended in paragraph (4), by adding at the 
                end the following: ``The Secretary shall update such 
                regulations to require inclusion in the informed 
                consent form a statement that clinical trial 
                information for such clinical investigation has been or 
                will be submitted for inclusion in the registry data 
                bank pursuant to subsections (i) and (j) of section 402 
                of the Public Health Service Act.''.
                    (B) New drug applications.--Section 505(b) of the 
                Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 
                355(b)) is amended by adding at the end the following:
            ``(6) An application submitted under this subsection shall 
        be accompanied by the certification required under section 
        402(j)(4)(B) of the Public Health Service Act. Such 
        certification shall not be considered an element of such 
        application.''.
                    (C) Device reports under section 510(k).--Section 
                510(k) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360(k)) is amended by adding at the end the 
                following:
``A notification submitted under this subsection that contains clinical 
trial data for an applicable device clinical trial (as defined in 
section 402(j)(1) of the Public Health Service Act) shall be 
accompanied by the certification required under section 402(j)(4)(B) of 
such Act. Such certification shall not be considered an element of such 
notification.''.
                    (D) Device premarket approval application.--Section 
                515(c) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 360e(c)) is amended--
                            (i) in subparagraph (F), by striking ``; 
                        and'' and inserting a semicolon;
                            (ii) by redesignating subparagraph (G) as 
                        subparagraph (H); and
                            (iii) by inserting after subparagraph (F) 
                        the following:
                    ``(G) the certification required under section 
                402(j)(4)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application); and''.
                    (E) Humanitarian device exemption.--Section 
                520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 360e(c)) is amended in the first sentence in 
                the matter following subparagraph (C), by inserting at 
                the end before the period ``and such application shall 
                include the certification required under section 
                402(j)(4)(B) of the Public Health Service Act (which 
                shall not be considered an element of such 
                application)''.
    (c) Preemption.--
            (1) In general.--No State or political subdivision of a 
        State may establish or continue in effect any requirement for 
        the registration of clinical trials or for the inclusion of 
        information relating to the results of clinical trials in a 
        database.
            (2) Rule of construction.--The fact of submission of 
        clinical trial information, if submitted in compliance with 
        subsection (i) and (j) of section 402 of the Public Health 
        Service Act (as amended by this section), that relates to a use 
        of a drug or device not included in the official labeling of 
        the approved drug or device shall not be construed by the 
        Secretary or in any administrative or judicial proceeding, as 
        evidence of a new intended use of the drug or device that is 
        different from the intended use of the drug or device set forth 
        in the official labeling of the drug or device. The 
        availability of clinical trial information through the data 
        bank under such subsections (i) and (j), if submitted in 
        compliance with such subsections, shall not be considered as 
        labeling, adulteration, or misbranding of the drug or device 
        under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
        et seq.).
    (d) Transition Rule; Effective Date of Funding Restrictions.--
            (1) Transition rule for clinical trials initiated prior to 
        expansion of registry data bank.--The responsible party (as 
        defined in paragraph (1) of section 402(j) of the Public Health 
        Service Act (as added by this section)) for an applicable drug 
        clinical trial or applicable device clinical trial (as defined 
        under such paragraph (1)) that is initiated after the date of 
        enactment of this subtitle and before the effective date of the 
        regulations promulgated under paragraph (2) of such section 
        402(j), shall submit required clinical trial information under 
        such section not later than 120 days after such effective date.
            (2) Funding restrictions.--Subparagraph (A) of paragraph 
        (4) of such section 402(j) shall take effect 210 days after the 
        effective date of the regulations promulgated under paragraph 
        (2) of such section 402(j).
    (e) Effective Date.--
            (1) In general.--Beginning 90 days after the date of 
        enactment of this title, the responsible party for an 
        applicable drug clinical trial or an applicable device clinical 
        trial (as that term is defined in such section 402(j)) that is 
        initiated after the date of enactment of this title and before 
        the effective date of the regulations issued under subparagraph 
        (A) of paragraph (2) of such subsection, shall submit clinical 
        trial information under such paragraph (2).
            (2) Rulemaking.--
                    (A) In general.--Except as provided in subparagraph 
                (B), subsection (c)(1) shall become effective on the 
                date on which the regulation promulgated pursuant to 
                section 402(j)(3)(C)(i) of the Public Health Service 
                Act, as added by this section, becomes effective.
                    (B) Exception.--Subsection (c)(1) shall apply with 
                respect to any clinical trial for which the registry 
                data bank includes links to results information, as 
                provided for under section 402(j)(3)(A) of such Act, as 
                added by this section.

                   Subtitle D--Conflicts of Interest

SEC. 241. CONFLICTS OF INTEREST.

    (a) In General.--Subchapter A of chapter VII of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) is amended by inserting 
at the end the following:

``SEC. 712. CONFLICTS OF INTEREST.

    ``(a) Definitions.--For purposes of this section:
            ``(1) Advisory committee.--The term `advisory committee' 
        means an advisory committee under the Federal Advisory 
        Committee Act that provides advice or recommendations to the 
        Secretary regarding activities of the Food and Drug 
        Administration.
            ``(2) Financial interest.--The term `financial interest' 
        means a financial interest under section 208(a) of title 18, 
        United States Code.
    ``(b) Appointments to Advisory Committees.--
            ``(1) Recruitment.--
                    ``(A) In general.--Given the importance of advisory 
                committees to the review process at the Food and Drug 
                Administration, the Secretary shall carry out 
                informational and recruitment activities for purposes 
                of recruiting individuals to serve as advisory 
                committee members. The Secretary shall seek input from 
                professional medical and scientific societies to 
                determine the most effective informational and 
                recruitment activities. The Secretary shall also take 
                into account the advisory committees with the greatest 
                number of vacancies.
                    ``(B) Recruitment activities.--The recruitment 
                activities under subparagraph (A) may include--
                            ``(i) advertising the process for becoming 
                        an advisory committee member at medical and 
                        scientific society conferences;
                            ``(ii) making widely available, including 
                        by using existing electronic communications 
                        channels, the contact information for the Food 
                        and Drug Administration point of contact 
                        regarding advisory committee nominations; and
                            ``(iii) developing a method through which 
                        an entity receiving National Institutes of 
                        Health funding can identify a person who the 
                        Food and Drug Administration can contact 
                        regarding the nomination of individuals to 
                        serve on advisory committees.
            ``(2) Evaluation and criteria.--When considering a term 
        appointment to an advisory committee, the Secretary shall 
        review the expertise of the individual and the financial 
        disclosure report filed by the individual pursuant to the 
        Ethics in Government Act of 1978 for each individual under 
        consideration for the appointment, so as to reduce the 
        likelihood that an appointed individual will later require a 
        written determination as referred to in section 208(b)(1) of 
        title 18, United States Code, a written certification as 
        referred to in section 208(b)(3) of title 18, United States 
        Code, or a waiver as referred to in subsection (c)(3) of this 
        section for service on the committee at a meeting of the 
        committee.
    ``(c) Granting and Disclosure of Waivers.--
            ``(1) In general.--Prior to a meeting of an advisory 
        committee regarding a `particular matter' (as that term is used 
        in section 208 of title 18, United States Code), each member of 
        the committee who is a full-time Government employee or special 
        Government employee shall disclose to the Secretary financial 
        interests in accordance with subsection (b) of such section 
        208.
            ``(2) Financial interest of advisory committee member or 
        family member.--No member of an advisory committee may vote 
        with respect to any matter considered by the advisory committee 
        if such member (or an immediate family member of such member) 
        has a financial interest that could be affected by the advice 
        given to the Secretary with respect to such matter, excluding 
        interests exempted in regulations issued by the Director of the 
        Office of Government Ethics as too remote or inconsequential to 
        affect the integrity of the services of the Government officers 
        or employees to which such regulations apply.
            ``(3) Waiver.--The Secretary may grant a waiver of the 
        prohibition in paragraph (2) if such waiver is necessary to 
        afford the advisory committee essential expertise.
            ``(4) Limitation.--The Secretary may not grant a waiver 
        under paragraph (3) for a member of an advisory committee when 
        the member's own scientific work is involved.
            ``(5) Disclosure of waiver.--Notwithstanding section 
        107(a)(2) of the Ethics in Government Act (5 U.S.C. App.), the 
        following shall apply:
                    ``(A) 15 or more days in advance.--As soon as 
                practicable, but in no case later than 15 days prior to 
                a meeting of an advisory committee to which a written 
                determination as referred to in section 208(b)(1) of 
                title 18, United States Code, a written certification 
                as referred to in section 208(b)(3) of title 18, United 
                States Code, or a waiver as referred to in paragraph 
                (3) applies, the Secretary shall disclose (other than 
                information exempted from disclosure under section 552 
                of title 5, United States Code, and section 552a of 
                title 5, United States Code (popularly known as the 
                Freedom of Information Act and the Privacy Act of 1974, 
                respectively)) on the Internet website of the Food and 
                Drug Administration--
                            ``(i) the type, nature, and magnitude of 
                        the financial interests of the advisory 
                        committee member to which such determination, 
                        certification, or waiver applies; and
                            ``(ii) the reasons of the Secretary for 
                        such determination, certification, or waiver.
                    ``(B) Less than 30 days in advance.--In the case of 
                a financial interest that becomes known to the 
                Secretary less than 30 days prior to a meeting of an 
                advisory committee to which a written determination as 
                referred to in section 208(b)(1) of title 18, United 
                States Code, a written certification as referred to in 
                section 208(b)(3) of title 18, United States Code, or a 
                waiver as referred to in paragraph (3) applies, the 
                Secretary shall disclose (other than information 
                exempted from disclosure under section 552 of title 5, 
                United States Code, and section 552a of title 5, United 
                States Code) on the Internet website of the Food and 
                Drug Administration, the information described in 
                clauses (i) and (ii) of subparagraph (A) as soon as 
                practicable after the Secretary makes such 
                determination, certification, or waiver, but in no case 
                later than the date of such meeting.
    ``(d) Public Record.--The Secretary shall ensure that the public 
record and transcript of each meeting of an advisory committee includes 
the disclosure required under subsection (c)(5) (other than information 
exempted from disclosure under section 552 of title 5, United States 
Code, and section 552a of title 5, United States Code).
    ``(e) Annual Report.--Not later than February 1 of each year, the 
Secretary shall submit to the Inspector General of the Department of 
Health and Human Services, the Committee on Appropriations and the 
Committee on Health, Education, Labor, and Pensions of the Senate, and 
the Committee on Appropriations and the Committee on Energy and 
Commerce of the House of Representatives, a report that describes--
            ``(1) with respect to the fiscal year that ended on 
        September 30 of the previous year, the number of vacancies on 
        each advisory committee, the number of nominees received for 
        each committee, and the number of such nominees willing to 
        serve;
            ``(2) with respect to such year, the aggregate number of 
        disclosures required under subsection (c)(5) for each meeting 
        of each advisory committee and the percentage of individuals to 
        whom such disclosures did not apply who served on such 
        committee for each such meeting;
            ``(3) with respect to such year, the number of times the 
        disclosures required under subsection (c)(5) occurred under 
        subparagraph (B) of such subsection; and
            ``(4) how the Secretary plans to reduce the number of 
        vacancies reported under paragraph (1) during the fiscal year 
        following such year, and mechanisms to encourage the nomination 
        of individuals for service on an advisory committee, including 
        those who are classified by the Food and Drug Administration as 
        academicians or practitioners.
    ``(f) Periodic Review of Guidance.--Not less than once every 5 
years, the Secretary shall review guidance of the Food and Drug 
Administration regarding conflict of interest waiver determinations 
with respect to advisory committees and update such guidance as 
necessary.''.
    (b) Conforming Amendment.--Section 505(n) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended by--
            (1) striking paragraph (4); and
            (2) redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (4), (5), (6), and (7), respectively.
    (c) Effective Date.--The amendments made by this section shall take 
effect on October 1, 2007.

                Subtitle E--Other Drug Safety Provisions

SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by this title, is further amended by adding at the end 
the following:
    ``(q) Database for Authorized Generic Drugs.--
            ``(1) In general.--
                    ``(A) Publication.--The Commissioner shall--
                            ``(i) not later than 9 months after the 
                        date of enactment of the Enhancing Drug Safety 
                        and Innovation Act of 2007, publish a complete 
                        list on the Internet website of the Food and 
                        Drug Administration of all authorized generic 
                        drugs (including drug trade name, brand company 
                        manufacturer, and the date the authorized 
                        generic drug entered the market); and
                            ``(ii) update the list quarterly to include 
                        each authorized generic drug included in an 
                        annual report submitted to the Secretary by the 
                        sponsor of a listed drug during the preceding 
                        3-month period.
                    ``(B) Notification.--The Commissioner shall notify 
                relevant Federal agencies, including the Centers for 
                Medicare & Medicaid Services and the Federal Trade 
                Commission, any time the Commissioner updates the 
                information described in subparagraph (A).
            ``(2) Inclusion.--The Commissioner shall include in the 
        list described in paragraph (1) each authorized generic drug 
        included in an annual report submitted to the Secretary by the 
        sponsor of a listed drug after January 1, 1999.
            ``(3) Authorized generic drug.--In this section, the term 
        `authorized generic drug' means a listed drug (as that term is 
        used in subsection (j)) that--
                    ``(A) has been approved under subsection (c); and
                    ``(B) is marketed, sold, or distributed directly or 
                indirectly to retail class of trade under a different 
                labeling, packaging (other than repackaging as the 
                listed drug in blister packs, unit doses, or similar 
                packaging for use in institutions), product code, 
                labeler code, trade name, or trade mark than the listed 
                drug.''.

SEC. 252. MEDICAL MARIJUANA.

    The Secretary shall require that State-legalized medical marijuana 
be subject to the full regulatory requirements of the Food and Drug 
Administration, including a risk evaluation and mitigation strategy and 
all other requirements and penalties of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 301 et seq.) regarding safe and effective 
reviews, approval, sale, marketing, and use of pharmaceuticals.

              Subtitle F--Antibiotic Access and Innovation

SEC. 261. INCENTIVES FOR THE DEVELOPMENT OF, AND ACCESS TO, CERTAIN 
              ANTIBIOTICS.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355), as amended by this Act, is further 
amended by adding at the end the following:
    ``(s) Antibiotic Drugs Submitted Before November 21, 1997.--
            ``(1) Antibiotic drugs approved before november 21, 1997.--
                    ``(A) In general.--Notwithstanding any provision of 
                the Food and Drug Administration Modernization Act of 
                1997 or any other provision of law, a sponsor of a drug 
                that is the subject of an application described in 
                subparagraph (B)(i) shall be eligible for, with respect 
                to the drug, the 3-year exclusivity period referred to 
                under clauses (iii) and (iv) of subsection (c)(3)(E) 
                and under clauses (iii) and (iv) of subsection 
                (j)(5)(F), subject to the requirements of such clauses, 
                as applicable.
                    ``(B) Application; antibiotic drug described.--
                            ``(i) Application.--An application 
                        described in this clause is an application for 
                        marketing submitted under this section after 
                        the date of enactment of this subsection in 
                        which the drug that is the subject of the 
                        application contains an antibiotic drug 
                        described in clause (ii).
                            ``(ii) Antibiotic drug.--An antibiotic drug 
                        described in this clause is an antibiotic drug 
                        that was the subject of an application approved 
                        by the Secretary under section 507 of this Act 
                        (as in effect before November 21, 1997).
            ``(2) Antibiotic drugs submitted before november 21, 1997, 
        but not approved.--
                    ``(A) In general.--Notwithstanding any provision of 
                the Food and Drug Administration Modernization Act of 
                1997 or any other provision of law, a sponsor of a drug 
                that is the subject of an application described in 
                subparagraph (B)(i) may elect to be eligible for, with 
                respect to the drug--
                            ``(i)(I) the 3-year exclusivity period 
                        referred to under clauses (iii) and (iv) of 
                        subsection (c)(3)(E) and under clauses (iii) 
                        and (iv) of subsection (j)(5)(F), subject to 
                        the requirements of such clauses, as 
                        applicable; and
                            ``(II) the 5-year exclusivity period 
                        referred to under clause (ii) of subsection 
                        (c)(3)(E) and under clause (ii) of subsection 
                        (j)(5)(F), subject to the requirements of such 
                        clauses, as applicable; or
                            ``(ii) a patent term extension under 
                        section 156 of title 35, United States Code, 
                        subject to the requirements of such section.
                    ``(B) Application; antibiotic drug described.--
                            ``(i) Application.--An application 
                        described in this clause is an application for 
                        marketing submitted under this section after 
                        the date of enactment of this subsection in 
                        which the drug that is the subject of the 
                        application contains an antibiotic drug 
                        described in clause (ii).
                            ``(ii) Antibiotic drug.--An antibiotic drug 
                        described in this clause is an antibiotic drug 
                        that was the subject of 1 or more applications 
                        received by the Secretary under section 507 of 
                        this Act (as in effect before November 21, 
                        1997), none of which was approved by the 
                        Secretary under such section.
            ``(3) Limitations.--
                    ``(A) Exclusivities and extensions.--Paragraphs 
                (1)(A) and (2)(A) shall not be construed to entitle a 
                drug that is the subject of an approved application 
                described in subparagraphs (1)(B)(i) or (2)(B)(i), as 
                applicable, to any market exclusivities or patent 
                extensions other than those exclusivities or extensions 
                described in paragraph (1)(A) or (2)(A).
                    ``(B) Conditions of use.--Paragraphs (1)(A) and 
                (2)(A)(i) shall not apply to any condition of use for 
                which the drug referred to in subparagraph (1)(B)(i) or 
                (2)(B)(i), as applicable, was approved before the date 
                of enactment of this subsection.
            ``(4) Application of certain provisions.--Notwithstanding 
        section 125, or any other provision, of the Food and Drug 
        Administration Modernization Act of 1997, or any other 
        provision of law, and subject to the limitations in paragraphs 
        (1), (2), and (3), the provisions of the Drug Price Competition 
        and Patent Term Restoration Act of 1984 shall apply to any drug 
        subject to paragraph (1) or any drug with respect to which an 
        election is made under paragraph (2)(A).''.
    (b) Transition Rule.--With respect to a patent issued on or before 
the date of enactment of this Act, any patent information required to 
be filed with the Secretary under subsection (b)(1) or (c)(2) of 
section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
to be listed on a drug to which subsection (s)(1) of such section 505 
(as added by this section) applies shall be filed with such Secretary 
not later than 60 days after the date of enactment of this Act.

SEC. 262. ANTIBIOTICS AS ORPHAN PRODUCTS.

    (a) Public Meeting.--The Commissioner of Food and Drugs shall 
convene a public meeting and, if appropriate, issue guidance, regarding 
which serious and life-threatening infectious diseases, such as 
diseases due to gram-negative bacteria and other diseases due to 
antibiotic-resistant bacteria, potentially qualify for available grants 
and contracts under subsection (a) of section 5 of the Orphan Drug Act 
(21 U.S.C. 360ee(a)) or other incentives for development.
    (b) Grants and Contracts for the Development of Orphan Drugs.--
Subsection (c) of section 5 of the Orphan Drug Act (21 U.S.C. 360ee(c)) 
is amended to read as follows:
    ``(c) For grants and contracts under subsection (a) there are 
authorized to be appropriated--
            ``(1) such sums as already have been appropriated for 
        fiscal year 2007; and
            ``(2) $35,000,000 for each of fiscal years 2008 through 
        2012.''.

SEC. 263. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE CONCENTRATIONS OF 
              ANTIMICROBIALS.

    (a) Definition.--In this section, the term ``clinically susceptible 
concentrations'' means specific values which characterize bacteria as 
clinically susceptible, intermediate, or resistant to the drug (or 
drugs) tested.
    (b) Identification.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), through the 
Commissioner of Food and Drugs, shall identify and periodically update 
clinically susceptible concentrations.
    (c) Public Availability.--The Secretary, through the Commissioner 
of Food and Drugs, shall make such clinically susceptible 
concentrations publicly available within 30 days of the date of 
identification and any update under this section.
    (d) Effect.--Nothing in this section shall be construed to 
restrict, in any manner, the prescribing of antibiotics by physicians, 
or to limit the practice of medicine, including for diseases such as 
Lyme and tick-borne diseases.

SEC. 264. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE ENANTIOMERS.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S. C. 
355), as amended by this subtitle, is amended by adding at the end the 
following:
    ``(t) Certain Drugs Containing Single Enantiomers.--
            ``(1) In general.--For purposes of subsections 
        (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is submitted 
        under subsection (b) for a non-racemic drug containing as an 
        active ingredient a single enantiomer that is contained in a 
        racemic drug approved in another application under subsection 
        (b), the applicant may, in the application for such non-racemic 
        drug, elect to have the single enantiomer not be considered the 
        same active ingredient as that contained in the approved 
        racemic drug, if--
                    ``(A)(i) the single enantiomer has not been 
                previously approved except in the approved racemic 
                drug; and
                    ``(ii) the application submitted under subsection 
                (b) for such non-racemic drug--
                            ``(I) includes full reports of new clinical 
                        investigations (other than bioavailability 
                        studies)--
                                    ``(aa) necessary for the approval 
                                of the application under subsections 
                                (c) and (d); and
                                    ``(bb) conducted or sponsored by 
                                the applicant; and
                            ``(II) does not rely on any investigations 
                        that are part of an application submitted under 
                        subsection (b) for approval of the approved 
                        racemic drug; and
                    ``(B) the application submitted under subsection 
                (b) for such non-racemic drug is not submitted for 
                approval of a condition of use--
                            ``(i) in a therapeutic category in which 
                        the approved racemic drug has been approved; or
                            ``(ii) for which any other enantiomer of 
                        the racemic drug has been approved.
            ``(2) Limitation.--
                    ``(A) No approval in certain therapeutic 
                categories.--Until the date that is 10 years after the 
                date of approval of a non-racemic drug described in 
                paragraph (1) and with respect to which the applicant 
                has made the election provided for by such paragraph, 
                the Secretary shall not approve such non-racemic drug 
                for any condition of use in the therapeutic category in 
                which the racemic drug has been approved.
                    ``(B) Labeling.--If applicable, the labeling of a 
                non-racemic drug described in paragraph (1) and with 
                respect to which the applicant has made the election 
                provided for by such paragraph shall include a 
                statement that the non-racemic drug is not approved, 
                and has not been shown to be safe and effective, for 
                any condition of use of the racemic drug.
            ``(3) Definition.--
                    ``(A) In general.--For purposes of this subsection, 
                the term `therapeutic category' means a therapeutic 
                category identified in the list developed by the United 
                States Pharmacopeia pursuant to section 1860D-
                4(b)(3)(C)(ii) of the Social Security Act and as in 
                effect on the date of enactment of this subsection.
                    ``(B) Publication by secretary.--The Secretary 
                shall publish the list described in subparagraph (A) 
                and may amend such list by regulation.
            ``(4) Availability.--The election referred to in paragraph 
        (1) may be made only in an application that is submitted to the 
        Secretary after the date of enactment of this subsection and 
        before October 1, 2012.''.

SEC. 265. REPORT.

    Not later than January 1, 2012, the Comptroller General of the 
United States shall submit a report to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives that examines 
whether and how this subtitle has--
            (1) encouraged the development of new antibiotics and other 
        drugs; and
            (2) prevented or delayed timely generic drug entry into the 
        market.

                       TITLE III--MEDICAL DEVICES

SEC. 300. REFERENCES.

    Except as otherwise specified, whenever in this title an amendment 
is expressed in terms of an amendment to a section or other provision, 
the reference shall be considered to be made to a section or other 
provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et 
seq.).

                      Subtitle A--Device User Fees

SEC. 301. SHORT TITLE.

    This subtitle may be cited as the ``Medical Device User Fee 
Amendments of 2007''.

SEC. 302. DEVICE FEES.

    Section 737 (21 U.S.C. 379i) is amended--
            (1) by striking the section designation and all that 
        follows through ``For purposes of this subchapter'' and 
        inserting the following:

``SEC. 737. DEVICE FEES.

    ``(a) Purpose.--It is the purpose of this part that the fees 
authorized under this part be dedicated toward expediting the process 
for the review of device applications and for assuring the safety and 
effectiveness of devices, as set forth in the goals identified for 
purposes of this part in the letters from the Secretary to the Chairman 
of the Committee on Health, Education, Labor, and Pensions of the 
Senate and the Chairman of the Committee on Energy and Commerce of the 
House of Representatives, as set forth in the Congressional Record.
    ``(b) Reports.--
            ``(1) Performance report.--For fiscal years 2008 through 
        2012, not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report 
        concerning the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters described in 
        subsection (a) during such fiscal year and the future plans of 
        the Food and Drug Administration for meeting the goals. The 
        report for a fiscal year shall include information on all 
        previous cohorts for which the Secretary has not given a 
        complete response on all device premarket applications, 
        supplements, and premarket notifications in the cohort.
            ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
        not later than 120 days after the end of each fiscal year 
        during which fees are collected under this part, the Secretary 
        shall prepare and submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives, a report on the 
        implementation of the authority for such fees during such 
        fiscal year and the use, by the Food and Drug Administration, 
        of the fees collected during such fiscal year for which the 
        report is made.
            ``(3) Public availability.--The Secretary shall make the 
        reports required under paragraphs (1) and (2) available to the 
        public on the Internet website of the Food and Drug 
        Administration.
    ``(c) Reauthorization.--
            ``(1) Consultation.--In developing recommendations to 
        present to Congress with respect to the goals, and plans for 
        meeting the goals, for the process for the review of device 
        applications for the first 5 fiscal years after fiscal year 
        2012, and for the reauthorization of this part for such fiscal 
        years, the Secretary shall consult with--
                    ``(A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    ``(B) the Committee on Health, Education, Labor, 
                and Pensions of the Senate;
                    ``(C) scientific and academic experts;
                    ``(D) health care professionals;
                    ``(E) representatives of patient and consumer 
                advocacy groups; and
                    ``(F) the regulated industry.
            ``(2) Public review of recommendations.--After negotiations 
        with the regulated industry, the Secretary shall--
                    ``(A) present the recommendations developed under 
                paragraph (1) to the Congressional committees specified 
                in such paragraph;
                    ``(B) publish such recommendations in the Federal 
                Register;
                    ``(C) provide for a period of 30 days for the 
                public to provide written comments on such 
                recommendations;
                    ``(D) hold a meeting at which the public may 
                present its views on such recommendations; and
                    ``(E) after consideration of such public views and 
                comments, revise such recommendations as necessary.
            ``(3) Transmittal of recommendations.--Not later than 
        January 15, 2012, the Secretary shall transmit to Congress the 
        revised recommendations under paragraph (2), a summary of the 
        views and comments received under such paragraph, and any 
        changes made to the recommendations in response to such views 
        and comments.
    ``(d) Definitions.--For purposes of this part:'';
            (2) by redesignating paragraphs (5), (6), (7), and (8), as 
        paragraphs (7), (8), (9), and (11), respectively;
            (3) in paragraph (4)--
                    (A) in subparagraph (A), by striking ``or an 
                efficacy supplement,'' and inserting ``an efficacy 
                supplement, or a 30-day notice,''; and
                    (B) by adding at the end the following:
            ``(F) The term `30-day notice' means a supplement to an 
        approved premarket application or premarket report under 
        section 515 that is limited to a request to make modifications 
        to manufacturing procedures or methods of manufacture affecting 
        the safety and effectiveness of the device.'';
            (4) by inserting after paragraph (4) the following:
            ``(5) The term `request for classification information' 
        means a request made under section 513(g) for information 
        respecting the class in which a device has been classified or 
        the requirements applicable to a device.
            ``(6) The term `annual fee for periodic reporting 
        concerning a class III device' means the fee associated with 
        reports imposed by a premarket application approval order (as 
        described in section 814.82(a)(7) of title 21, Code of Federal 
        Regulations), usually referred to as `annual reports.''';
            (5) in paragraph (9), as redesignated by paragraph (2)--
                    (A) by striking ``April of'' and inserting 
                ``October of''; and
                    (B) by striking ``April 2002'' and inserting 
                ``October 2001'';
            (6) by inserting after paragraph (9), as redesignated by 
        paragraph (2), the following:
            ``(10) The term `person' includes an affiliate of such 
        person.''; and
            (7) by adding at the end the following:
            ``(12) The term `establishment subject to a registration 
        fee' means an establishment required to register with the 
        Secretary under section 510 at which any of the following types 
        of activities are conducted:
                    ``(A) Manufacturer.--An establishment that makes by 
                any means any article that is a device including an 
                establishment that sterilizes or otherwise makes such 
                article for or on behalf of a specification developer 
                or any other person.
                    ``(B) Single-use device reprocessor.--An 
                establishment that performs manufacturing operations on 
                a single-use device that has previously been used on a 
                patient.
                    ``(C) Specification developer.--An establishment 
                that develops specifications for a device that is 
                distributed under the establishment's name but that 
                performs no manufacturing, including establishments 
                that, in addition to developing specifications, arrange 
                for the manufacturing of devices labeled with another 
                establishment's name by a contract manufacturer.
            ``(13) The term `establishment registration fee' means a 
        fee assessed under section 738(a)(3) for the registration of an 
        establishment subject to a registration fee.
    ``(e) Sunset.--This part shall cease to be effective on October 1, 
2012, except that subsection (b) with respect to reports shall cease to 
be effective January 31, 2013.''.

SEC. 303. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    Section 738 (21 U.S.C. 379j) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (2)--
                            (i) in the header, by inserting ``, and 
                        annual fee for periodic reporting concerning a 
                        class iii device'' after ``fee'';
                            (ii) in subparagraph (A)--
                                    (I) in clause (iii), by inserting 
                                ``75 percent of'' after ``a fee equal 
                                to'';
                                    (II) in clause (iv), by striking 
                                ``21.5'' and inserting ``15'';
                                    (III) in clause (v), by striking 
                                ``7.2'' and inserting ``7'';
                                    (IV) by redesignating clauses (vi) 
                                and (vii) as clauses (vii) and (viii), 
                                respectively;
                                    (V) by inserting after clause (v) 
                                the following:
                            ``(vi) For a 30-day notice, a fee equal to 
                        1.6 percent of the fee that applies under 
                        clause (i).'';
                                    (VI) in clause (viii), as 
                                redesignated by subclause (IV)--
                                            (aa) by striking ``1.42'' 
                                        and inserting ``1.84''; and
                                            (bb) by striking ``, 
                                        subject to any adjustment under 
                                        subsection (e)(2)(C)(ii)''; and
                                    (VII) by adding at the end the 
                                following:
                            ``(ix) For a request for classification 
                        information, a fee equal to 1.35 percent of the 
                        fee that applies under clause (i).
                            ``(x) For periodic reporting concerning a 
                        class III device, the annual fee shall be equal 
                        to 3.5 percent of the fee that applies under 
                        clause (i).'';
                            (iii) in subparagraph (C)--
                                    (I) in the first sentence--
                                            (aa) by striking ``or''; 
                                        and
                                            (bb) by striking ``except 
                                        that'' and all that follows 
                                        through the period and 
                                        inserting ``, 30-day notice, 
                                        request for classification 
                                        information, or periodic report 
                                        concerning a class III 
                                        device.''; and
                                    (II) by striking the third 
                                sentence; and
                            (iv) in subparagraph (D)--
                                    (I) in clause (iii), by striking 
                                the last two sentences; and
                                    (II) by adding at the end the 
                                following:
                            ``(iv) Modular application withdrawn before 
                        first action.--The Secretary shall refund 75 
                        percent of the application fee paid for a 
                        modular application submitted under section 
                        515(c)(4) that is withdrawn before a second 
                        module is submitted and before a first action 
                        on the first module. If the modular application 
                        is withdrawn after a second or subsequent 
                        module is submitted but before any first 
                        action, the Secretary may return a portion of 
                        the fee. The amount of refund, if any, shall be 
                        based on the level of effort already expended 
                        on the review of the modules submitted.
                            ``(v) Sole discretion to refund.--The 
                        Secretary shall have sole discretion to refund 
                        a fee or portion of the fee under this 
                        subparagraph. A determination by the Secretary 
                        concerning a refund under this paragraph shall 
                        not be reviewable.''; and
                    (B) by adding at the end the following:
            ``(3) Annual establishment registration fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to a 
                registration fee shall be subject to a fee for each 
                initial or annual registration beginning with its 
                registration for fiscal year 2008.
                    ``(B) Exception for federal or state government 
                establishment.--No fee shall be required under 
                subparagraph (A) for an establishment operated by a 
                Federal or State government entity unless a device 
                manufactured by the establishment is to be distributed 
                commercially.
                    ``(C) Payment.--The annual establishment 
                registration fee shall be due once each fiscal year, 
                upon the initial registration of the establishment or 
                upon the annual registration under section 510.'';
            (2) by striking subsection (b) and inserting the following:
    ``(b) Fee Amounts.--Except as provided in subsections (c), (d), and 
(e), the fees under subsection (a) shall be based on the following fee 
amounts:


----------------------------------------------------------------------------------------------------------------
                                                             Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                         Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011  Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application                                       $185,000   $200,725   $217,787   $236,298   $256,384
----------------------------------------------------------------------------------------------------------------
Establishment Registration Fee                                $1,706     $1,851     $2,008     $2,179  $2,364'';
----------------------------------------------------------------------------------------------------------------

            (3) in subsection (c)--
                    (A) in the heading, by striking ``Annual Fee 
                Setting.--'' and inserting ``Annual Fee Setting.--'';
                    (B) in paragraph (1), by striking the second 
                sentence;
                    (C) by redesignating paragraphs (2) and (3) as 
                paragraphs (3) and (4), respectively;
                    (D) by inserting after paragraph (1) the following:
            ``(2) Adjustment of annual establishment registration 
        fee.--
                    ``(A) In general.--When setting the fees for fiscal 
                year 2010, the Secretary may increase the establishment 
                registration fee specified in subsection (b) only if 
                the Secretary estimates that the number of 
                establishments submitting fees for fiscal year 2009 is 
                less than 12,250. The percent increase shall be the 
                percent by which the estimate of establishments 
                submitting fees in fiscal year 2009 is less than 
                12,750, but in no case shall the percent increase be 
                more than 8.5 percent over the amount for such fee 
                specified in subsection (b) for fiscal year 2010. If 
                the Secretary makes any adjustment to the establishment 
                registration fee for fiscal year 2010, then the 
                establishment registration fee for fiscal years 2011 
                and 2012 under subsection (b) shall be adjusted as 
                follows: the fee for fiscal year 2011 shall be equal to 
                the adjusted fee for fiscal year 2010, increased by 8.5 
                percent, and the fee for fiscal year 2012 shall be 
                equal to the adjusted fee for fiscal year 2011, 
                increased by 8.5 percent.
                    ``(B) Publication in the federal register.--The 
                Secretary shall publish any determination with respect 
                to any establishment registration fee adjustment made 
                under subparagraph (A), and the rationale for such 
                determination, in the Federal Register.''; and
                    (E) in paragraph (4)(A), as so redesignated--
                            (i) by striking ``For fiscal years 2006 and 
                        2007, the'' and inserting ``The''; and
                            (ii) by striking ``of fiscal year 2008'' 
                        and inserting ``of the next fiscal year'';
            (4) in subsection (d)--
                    (A) in paragraph (1), by striking ``, partners, and 
                parent firms'';
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``, 
                        partners, and parent firms'';
                            (ii) in subparagraph (B)--
                                    (I) by striking ``An applicant 
                                shall'' and inserting the following:
                            ``(i) In general.--An applicant shall'';
                                    (II) by striking ``The applicant 
                                shall support'' and inserting the 
                                following:
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support'';
                                    (III) by striking ``, partners, and 
                                parent firms'' both places the term 
                                appears;
                                    (IV) by striking ``partners, or 
                                parent firms, the'' and inserting 
                                ``the'';
                                    (V) by striking ``, partners, or 
                                parent firms, respectively''; and
                                    (VI) by adding at the end the 
                                following:
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--
                        The applicant shall support its claim that it 
                        meets the definition under subparagraph (A) by 
                        submission of the following:
                                    ``(I) A signed certification, in 
                                such form as the Secretary may direct 
                                through a notice published in the 
                                Federal Register, that the applicant 
                                meets the criteria for a small 
                                business.
                                    ``(II) A certification, in English, 
                                from the national taxing authority of 
                                the country in which it is 
                                headquartered. Such certification shall 
                                provide the applicant's gross receipts 
                                and sales for the most recent year, in 
                                both the local currency and in United 
                                States dollars, the exchange rate used 
                                in making this conversion to dollars, 
                                and the dates during which these 
                                receipts and sales were collected, and 
                                it shall bear the official seal of the 
                                national taxing authority.
                                    ``(III) Identical certifications 
                                shall be provided for each of the 
                                applicant's affiliates.
                                    ``(IV) A statement signed by the 
                                head of the applicant or its chief 
                                financial officer that it has submitted 
                                certifications for all of its 
                                affiliates, or that it had no 
                                affiliates, whichever is applicable.''; 
                                and
                            (iii) in subparagraph (C)--
                                    (I) by striking ``reduced rate of'' 
                                and inserting ``reduced rate of--''; 
                                and
                                    (II) by striking ``38 percent'' and 
                                all that follows through the period and 
                                inserting the following:
                            ``(i) 25 percent of the fee established 
                        under such subsection for a premarket 
                        application, a premarket report, a supplement, 
                        or a periodic report concerning a class III 
                        device; and
                            ``(ii) 50 percent of the fee established 
                        under such subsection for a 30-day notice or a 
                        request for classification information.'';
            (5) in subsection (e)--
                    (A) in paragraph (1), by striking ``2004'' and 
                inserting ``2008''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``, 
                        partners, and parent firms'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) Evidence of qualification.--
                            ``(i) In general.--An applicant shall pay 
                        the higher fees established by the Secretary 
                        each year unless the applicant submits evidence 
                        that it qualifies for the lower fee rate.
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support its claim that it meets 
                        the definition under subparagraph (A) by 
                        submission of a copy of its most recent Federal 
                        income tax return for a taxable year, and a 
                        copy of such returns of its affiliates, which 
                        show an amount of gross sales or receipts that 
                        is less than the maximum established in 
                        subparagraph (A). The applicant, and each of 
                        such affiliates, shall certify that the 
                        information provided is a true and accurate 
                        copy of the actual tax forms they submitted to 
                        the Internal Revenue Service. If no tax forms 
                        are submitted for affiliates, the applicant 
                        shall certify that the applicant has no 
                        affiliates.
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--
                        The applicant shall support its claim that it 
                        meets the definition under subparagraph (A) by 
                        submission of the following:
                                    ``(I) A signed certification, in 
                                such form as the Secretary may direct 
                                through a notice published in the 
                                Federal Register, that the applicant 
                                meets the criteria for a small 
                                business.
                                    ``(II) A certification, in English, 
                                from the national taxing authority of 
                                the country in which it is 
                                headquartered. Such certification shall 
                                provide the applicant's gross receipts 
                                and sales for the most recent year, in 
                                both the local currency and in United 
                                States dollars, and the exchange rate 
                                used in making such conversion to 
                                dollars, and the dates during which 
                                such receipts and sales were collected, 
                                and it shall bear the official seal of 
                                the national taxing authority.
                                    ``(III) Identical certifications 
                                shall be provided for each of the 
                                applicant's affiliates.
                                    ``(IV) A statement signed by the 
                                head of the applicant or its chief 
                                financial officer that it has submitted 
                                certifications for all of its 
                                affiliates, or that it had no 
                                affiliates, whichever is applicable.''; 
                                and
                            (iii) by striking subparagraph (C) and 
                        inserting the following:
                    ``(C) Reduced fees.--For fiscal year 2008 and each 
                subsequent fiscal year, where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fee for a premarket notification 
                submission may be paid at 50 percent of the fee that 
                applies under subsection (a)(2)(A)(viii) and as 
                established under subsection (c)(1).'';
            (6) by striking subsection (f) and inserting the following:
    ``(f) Effect of Failure To Pay Fees.--
            ``(1) In general.--A premarket application, premarket 
        report, supplement, or premarket notification submission, 30-
        day notice, request for classification information, or periodic 
        report concerning a class III device submitted by a person 
        subject to fees under paragraphs (2) and (3) of subsection (a) 
        shall be considered incomplete and shall not be accepted by the 
        Secretary until all fees owed by such person have been paid.
            ``(2) Registration information.--Registration information 
        submitted by an establishment subject to a registration fee 
        under subsection (a)(3) shall be considered incomplete and 
        shall not be accepted by the Secretary until the registration 
        fee owed for the establishment has been paid. Until the fee is 
        paid and the registration is complete, the establishment shall 
        be deemed to have failed to register in accordance with section 
        510.'';
            (7) in subsection (g)--
                    (A) by striking paragraph (1) and inserting the 
                following:
            ``(1) Performance goals; termination of program.--With 
        respect to the amount that, under the salaries and expenses 
        account of the Food and Drug Administration, is appropriated 
        for a fiscal year for devices and radiological products, fees 
        may not be assessed under subsection (a) for the fiscal year, 
        and the Secretary is not expected to meet any performance goals 
        identified for the fiscal year, if--
                    ``(A) the amount so appropriated for the fiscal 
                year, excluding the amount of fees appropriated for the 
                fiscal year, is more than 1 percent less than 
                $205,720,000 multiplied by the adjustment factor 
                applicable to such fiscal year; or
                    ``(B) fees were not assessed under subsection (a) 
                for the previous fiscal year.''; and
                    (B) in paragraph (2), by striking ``and premarket 
                notification submissions, and'' and inserting 
                ``premarket notification submissions, 30-day notices, 
                requests for classification information, periodic 
                reports concerning a class III device, and 
                establishment registrations''; and
            (8) in subsection (h), by striking paragraphs (3) and (4) 
        and inserting the following:
            ``(3) Authorization of appropriations.--There are 
        authorized to be appropriated for fees under this section--
                    ``(A) $48,431,000 for fiscal year 2008;
                    ``(B) $52,547,000 for fiscal year 2009;
                    ``(C) $57,014,000 for fiscal year 2010;
                    ``(D) $61,860,000 for fiscal year 2011; and
                    ``(E) $67,118,000 for fiscal year 2012.
            ``(4) Offset.--If the cumulative amount of fees collected 
        during fiscal years 2008, 2009, and 2010, added to the amount 
        estimated to be collected for fiscal year 2011 (which estimate 
        shall be based upon the amount of fees received by the 
        Secretary through June 30, 2011), exceeds the amount of fees 
        specified in aggregate in paragraph (3) for such 4 fiscal 
        years, the aggregate amount in excess shall be credited to the 
        appropriation account of the Food and Drug Administration as 
        provided in paragraph (1), and shall be subtracted from the 
        amount of fees that would otherwise be authorized to be 
        collected under this section pursuant to appropriation Acts for 
        fiscal year 2012.''.

SEC. 304. SAVINGS CLAUSE.

    Notwithstanding section 107 of the Medical Device User Fee and 
Modernization Act of 2002 (Public Law 107-250), and notwithstanding the 
amendments made by this subtitle, part 3 of subchapter C of chapter VII 
of the Federal Food, Drug, and Cosmetic Act, as in effect on the day 
before the date of enactment of this subtitle, shall continue to be in 
effect with respect to premarket applications, premarket reports, 
premarket notification submissions, and supplements (as defined in such 
part as of such day) that on or after October 1, 2002, but before 
October 1, 2007, were accepted by the Food and Drug Administration for 
filing with respect to assessing and collecting any fee required by 
such part for a fiscal year prior to fiscal year 2008.

SEC. 305. EFFECTIVE DATE.

    The amendments made by this subtitle shall take effect on October 
1, 2007.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.

    Section 704(g) (21 U.S.C. 374(g)) is amended--
            (1) in paragraph (1), by striking ``Not later than one year 
        after the date of enactment of this subsection, the Secretary'' 
        and inserting ``The Secretary'';
            (2) in paragraph (2), by--
                    (A) striking ``Not later than 180 days after the 
                date of enactment of this subsection, the'' and 
                inserting ``The Secretary''; and
                    (B) striking the fifth sentence;
            (3) in paragraph (3), by adding at the end the following:
                    ``(F) Such person shall notify the Secretary of any 
                withdrawal, suspension, restriction, or expiration of 
                certificate of conformance with the quality systems 
                standard referred to in paragraph (7) for any device 
                establishment that such person inspects under this 
                subsection not later than 30 days after such 
                withdrawal, suspension, restriction, or expiration.
                    ``(G) Such person may conduct audits to establish 
                conformance with the quality systems standard referred 
                to in paragraph (7).'';
            (4) by amending paragraph (6) to read as follows:
    ``(6)(A) Subject to subparagraphs (B) and (C), a device 
establishment is eligible for inspection by persons accredited under 
paragraph (2) if the following conditions are met:
            ``(i) The Secretary classified the results of the most 
        recent inspection of the establishment as `no action indicated' 
        or `voluntary action indicated'.
            ``(ii) With respect to inspections of the establishment to 
        be conducted by an accredited person, the owner or operator of 
        the establishment submits to the Secretary a notice that--
                    ``(I) provides the date of the last inspection of 
                the establishment by the Secretary and the 
                classification of that inspection;
                    ``(II) states the intention of the owner or 
                operator to use an accredited person to conduct 
                inspections of the establishment;
                    ``(III) identifies the particular accredited person 
                the owner or operator intends to select to conduct such 
                inspections; and
                    ``(IV) includes a certification that, with respect 
                to the devices that are manufactured, prepared, 
                propagated, compounded, or processed in the 
                establishment--
                            ``(aa) at least 1 of such devices is 
                        marketed in the United States; and
                            ``(bb) at least 1 of such devices is 
                        marketed, or is intended to be marketed, in 1 
                        or more foreign countries, 1 of which countries 
                        certifies, accredits, or otherwise recognizes 
                        the person accredited under paragraph (2) and 
                        identified under subclause (III) as a person 
                        authorized to conduct inspections of device 
                        establishments.
    ``(B)(i) Except with respect to the requirement of subparagraph 
(A)(i), a device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 30 days after 
receiving such notice, issues a response that--
            ``(I) denies clearance to participate as provided under 
        subparagraph (C); or
            ``(II) makes a request under clause (ii).
    ``(ii) The Secretary may request from the owner or operator of a 
device establishment in response to the notice under subparagraph 
(A)(ii) with respect to the establishment, or from the particular 
accredited person identified in such notice--
            ``(I) compliance data for the establishment in accordance 
        with clause (iii)(I); or
            ``(II) information concerning the relationship between the 
        owner or operator of the establishment and the accredited 
        person identified in such notice in accordance with clause 
        (iii)(II).
        The owner or operator of the establishment, or such accredited 
        person, as the case may be, shall respond to such a request not 
        later than 60 days after receiving such request.
    ``(iii)(I) The compliance data to be submitted by the owner or 
operation of a device establishment in response to a request under 
clause (ii)(I) are data describing whether the quality controls of the 
establishment have been sufficient for ensuring consistent compliance 
with current good manufacturing practice within the meaning of section 
501(h) and with other applicable provisions of this Act. Such data 
shall include complete reports of inspectional findings regarding good 
manufacturing practice or other quality control audits that, during the 
preceding 2-year period, were conducted at the establishment by persons 
other than the owner or operator of the establishment, together with 
all other compliance data the Secretary deems necessary. Data under the 
preceding sentence shall demonstrate to the Secretary whether the 
establishment has facilitated consistent compliance by promptly 
correcting any compliance problems identified in such inspections.
    ``(II) A request to an accredited person under clause (ii)(II) may 
not seek any information that is not required to be maintained by such 
person in records under subsection (f)(1).
    ``(iv) A device establishment is deemed to have clearance to 
participate in the program and to use the accredited person identified 
in the notice under subparagraph (A)(ii) for inspections of the 
establishment unless the Secretary, not later than 60 days after 
receiving the information requested under clause (ii), issues a 
response that denies clearance to participate as provided under 
subparagraph (C).
    ``(C)(i) The Secretary may deny clearance to a device establishment 
if the Secretary has evidence that the certification under subparagraph 
(A)(ii)(IV) is untrue and the Secretary provides to the owner or 
operator of the establishment a statement summarizing such evidence.
    ``(ii) The Secretary may deny clearance to a device establishment 
if the Secretary determines that the establishment has failed to 
demonstrate consistent compliance for purposes of subparagraph 
(B)(iii)(I) and the Secretary provides to the owner or operator of the 
establishment a statement of the reasons for such determination.
    ``(iii)(I) The Secretary may reject the selection of the accredited 
person identified in the notice under subparagraph (A)(ii) if the 
Secretary provides to the owner or operator of the establishment a 
statement of the reasons for such rejection. Reasons for the rejection 
may include that the establishment or the accredited person, as the 
case may be, has failed to fully respond to the request, or that the 
Secretary has concerns regarding the relationship between the 
establishment and such accredited person.
    ``(II) If the Secretary rejects the selection of an accredited 
person by the owner or operator of a device establishment, the owner or 
operator may make an additional selection of an accredited person by 
submitting to the Secretary a notice that identifies the additional 
selection. Clauses (i) and (ii) of subparagraph (B), and subclause (I) 
of this clause, apply to the selection of an accredited person through 
a notice under the preceding sentence in the same manner and to the 
same extent as such provisions apply to a selection of an accredited 
person through a notice under subparagraph (A)(ii).
    ``(iv) In the case of a device establishment that is denied 
clearance under clause (i) or (ii) or with respect to which the 
selection of the accredited person is rejected under clause (iii), the 
Secretary shall designate a person to review the statement of reasons, 
or statement summarizing such evidence, as the case may be, of the 
Secretary under such clause if, during the 30-day period beginning on 
the date on which the owner or operator of the establishment receives 
such statement, the owner or operator requests the review. The review 
shall commence not later than 30 days after the owner or operator 
requests the review, unless the Secretary and the owner or operator 
otherwise agree.'';
            (5) in paragraph (7)--
                    (A) by amending subparagraph (A) to read as 
                follows:
                    ``(A) Persons accredited under paragraph (2) to 
                conduct inspections shall record in writing their 
                inspection observations and shall present the 
                observations to the device establishment's designated 
                representative and describe each observation. 
                Additionally, such accredited person shall prepare an 
                inspection report in a form and manner designated by 
                the Secretary to conduct inspections, taking into 
                consideration the goals of international harmonization 
                of quality systems standards. Any official 
                classification of the inspection shall be determined by 
                the Secretary.''; and
                    (B) by adding at the end the following:
                    ``(F) For the purpose of setting risk-based 
                inspectional priorities, the Secretary shall accept 
                voluntary submissions of reports of audits assessing 
                conformance with appropriate quality systems standards 
                set by the International Organization for 
                Standardization (ISO) and identified by the Secretary 
                in public notice. If the owner or operator of an 
                establishment elects to submit audit reports under this 
                subparagraph, the owner or operator shall submit all 
                such audit reports with respect to the establishment 
                during the preceding 2-year periods.''; and
            (6) in paragraphs (10)(C)(iii), by striking ``based'' and 
        inserting ``base''.

SEC. 312. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF PREMARKET 
              NOTIFICATION.

    Section 523(c) (21 U.S.C. 360m(c)) is amended by striking ``2007'' 
and inserting ``2012''.

SEC. 313. REGISTRATION.

    (a) Annual Registration of Producers of Drugs and Devices.--Section 
510(b) (21 U.S.C. 359(b)) is amended--
            (1) by redesignating the existing text as paragraph (1), 
        and indenting and relocating it appropriately;
            (2) in paragraph (1), as so redesignated, by striking ``or 
        a device or devices''; and
            (3) by adding at the end the following new paragraph:
            ``(2) Between October 1 and December 31 of each year every 
        person who owns or operates any establishment in any State 
        engaged in the manufacture, preparation, propagation, 
        compounding, or processing of a device or devices shall 
        register with the Secretary his name, places of business, and 
        all such establishments.''.
    (b) Registration of Foreign Establishments.--Section 510(i)(1) (21 
U.S.C. 359(i)(1)) is amended--
            (1) by redesignating the existing text as subparagraph (A), 
        and indenting and relocating it appropriately;
            (2) in subparagraph (A), as so redesignated--
                    (A) by striking ``processing of a drug or a device 
                that is imported'' and inserting ``processing of a drug 
                that is imported''; and
                    (B) by striking ``or device'' each place it 
                appears; and
            (3) by adding after such subparagraph (A) the following new 
        subparagraph:
                    ``(B) Between October 1 and December 31 of each 
                year, any establishment within any foreign country 
                engaged in the manufacture, preparation, propagation, 
                compounding, or processing of a device that is imported 
                or offered for import into the United States shall, 
                through electronic means in accordance with the 
                criteria of the Secretary, register with the Secretary 
                the name and place of business of the establishment, 
                the name of the United States agent for the 
                establishment, the name of each importer of such device 
                in the United States that is known to the 
                establishment, and the name of each person who imports 
                or offers for import such device to the United States 
                for purposes of importation.''.

SEC. 314. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED PREPARED, 
              PROPAGATED AND COMPOUNDED BY REGISTRANTS; STATEMENTS; 
              ACCOMPANYING DISCLOSURES.

    Section 510(j)(2) (21 U.S.C. 360(j)(2) is amended, in the matter 
preceding subparagraph (A), to read as follows:
            ``(2) Each person who registers with the Secretary under 
        this section shall report to the Secretary (i) with regard to 
        drugs, once during the month of June of each year and once 
        during the month of December of each year, and (ii) with regard 
        to devices, once each year between October 1 and December 31, 
        the following information:''.

SEC. 315. ELECTRONIC REGISTRATION AND LISTING.

    Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:
    ``(p)(1) With regard to any establishment engaged in the 
manufacture, preparation, propagation, compounding, or processing of a 
drug, registrations under subsections (b), (c), (d), and (i) of this 
section (including the submission of updated information) shall be 
submitted to the Secretary by electronic means, upon a finding by the 
Secretary that the electronic receipt of such registrations is 
feasible, unless the Secretary grants a request for waiver of such 
requirement because use of electronic means is not reasonable for the 
person requesting such waiver.
    ``(2) With regard to any establishment engaged in the manufacture, 
preparation, propagation, compounding, or processing of a device, the 
registration and listing information required by this section shall be 
submitted to the Secretary by electronic means, unless the Secretary 
grants a waiver because electronic registration and listing is not 
reasonable for the person requesting such waiver.''.

                  TITLE IV--PEDIATRIC MEDICAL PRODUCTS

             Subtitle A--Best Pharmaceuticals for Children

SEC. 401. SHORT TITLE.

    This subtitle may be cited as the ``Best Pharmaceuticals for 
Children Amendments of 2007''.

SEC. 402. PEDIATRIC STUDIES OF DRUGS.

    (a) In General.--Section 505A of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a) is amended--
            (1) in subsection (a), by inserting before the period at 
        the end the following: ``, and, at the discretion of the 
        Secretary, may include preclinical studies'';
            (2) in subsection (b)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(1) In general.--Except as provided in paragraph (2), if, 
        prior to approval of an application that is submitted under 
        section 505(b)(1), the Secretary determines that information 
        relating to the use of a new drug in the pediatric population 
        may produce health benefits in that population, the Secretary 
        makes a written request for pediatric studies (which shall 
        include a timeframe for completing such studies), the applicant 
        agrees to the request, such studies are completed using 
        appropriate formulations for each age group for which the study 
        is requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3), and if the Secretary determines that labeling changes 
        are appropriate, such changes are made within the timeframe 
        requested by the Secretary--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend a period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) if the 
        determination made under subsection (d)(3) is made less than 9 
        months prior to the expiration of such period.'';
            (3) in subsection (c)--
                    (A) in paragraph (1)(A)(i), by striking ``(D)'' 
                both places it appears and inserting ``(E)'';
                    (B) in paragraph (1)(A)(ii), by striking ``(D)'' 
                and inserting ``(E)'';
                    (C) by striking ``(1)(A)(i)'' and inserting 
                ``(A)(i)(I)'';
                    (D) by striking ``(ii) the'' and inserting ``(II) 
                the'';
                    (E) by striking ``(B) if the drug is designated'' 
                and inserting ``(ii) if the drug is designated'';
                    (F) by striking ``(2)(A)'' and inserting 
                ``(B)(i)'';
                    (G) by striking ``(i) a listed patent'' and 
                inserting ``(I) a listed patent'';
                    (H) by striking ``(ii) a listed patent'' and 
                inserting ``(II) a listed patent'';
                    (I) by striking ``(B) if the drug is the subject'' 
                and inserting ``(ii) if the drug is the subject'';
                    (J) by striking ``If'' and all that follows through 
                ``subsection (d)(3)'' and inserting the following:
            ``(1) In general.--Except as provided in paragraph (2), if 
        the Secretary determines that information relating to the use 
        of an approved drug in the pediatric population may produce 
        health benefits in that population and makes a written request 
        to the holder of an approved application under section 
        505(b)(1) for pediatric studies (which shall include a 
        timeframe for completing such studies), the holder agrees to 
        the request, such studies are completed using appropriate 
        formulations for each age group for which the study is 
        requested within any such timeframe, and the reports thereof 
        are submitted and accepted in accordance with subsection 
        (d)(3), and if the Secretary determines that labeling changes 
        are appropriate, such changes are made within the timeframe 
        requested by the Secretary--''; and
                    (K) by adding at the end the following:
            ``(2) Exception.--The Secretary shall not extend a period 
        referred to in paragraph (1)(A) or in paragraph (1)(B) if the 
        determination made under subsection (d)(3) is made less than 9 
        months prior to the expiration of such period.'';
            (4) by striking subsection (d) and inserting the following:
    ``(d) Conduct of Pediatric Studies.--
            ``(1) Request for studies.--
                    ``(A) In general.--The Secretary may, after 
                consultation with the sponsor of an application for an 
                investigational new drug under section 505(i), the 
                sponsor of an application for a new drug under section 
                505(b)(1), or the holder of an approved application for 
                a drug under section 505(b)(1), issue to the sponsor or 
                holder a written request for the conduct of pediatric 
                studies for such drug. In issuing such request, the 
                Secretary shall take into account adequate 
                representation of children of ethnic and racial 
                minorities. Such request to conduct pediatric studies 
                shall be in writing and shall include a timeframe for 
                such studies and a request to the sponsor or holder to 
                propose pediatric labeling resulting from such studies.
                    ``(B) Single written request.--A single written 
                request--
                            ``(i) may relate to more than 1 use of a 
                        drug; and
                            ``(ii) may include uses that are both 
                        approved and unapproved.
            ``(2) Written request for pediatric studies.--
                    ``(A) Request and response.--
                            ``(i) In general.--If the Secretary makes a 
                        written request for pediatric studies 
                        (including neonates, as appropriate) under 
                        subsection (b) or (c), the applicant or holder, 
                        not later than 180 days after receiving the 
                        written request, shall respond to the Secretary 
                        as to the intention of the applicant or holder 
                        to act on the request by--
                                    ``(I) indicating when the pediatric 
                                studies will be initiated, if the 
                                applicant or holder agrees to the 
                                request; or
                                    ``(II) indicating that the 
                                applicant or holder does not agree to 
                                the request and the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of enactment of the Best 
                        Pharmaceuticals for Children Amendments of 
                        2007, the applicant or holder does not agree to 
                        the request on the grounds that it is not 
                        possible to develop the appropriate pediatric 
                        formulation, the applicant or holder shall 
                        submit to the Secretary the reasons such 
                        pediatric formulation cannot be developed.
                    ``(B) Adverse event reports.--An applicant or 
                holder that, on or after the date of enactment of the 
                Best Pharmaceuticals for Children Amendments of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as submission of the 
                reports of such studies, with all postmarket adverse 
                event reports regarding the drug that is the subject of 
                such studies and are available prior to submission of 
                such reports.
            ``(3) Meeting the studies requirement.--Not later than 180 
        days after the submission of the reports of the studies, the 
        Secretary shall accept or reject such reports and so notify the 
        sponsor or holder. The Secretary's only responsibility in 
        accepting or rejecting the reports shall be to determine, 
        within the 180 days, whether the studies fairly respond to the 
        written request, have been conducted in accordance with 
        commonly accepted scientific principles and protocols, and have 
        been reported in accordance with the requirements of the 
        Secretary for filing.
            ``(4) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.'';
            (5) by striking subsections (e) and (f) and inserting the 
        following:
    ``(e) Notice of Determinations on Studies Requirement.--
            ``(1) In general.--The Secretary shall publish a notice of 
        any determination, made on or after the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007, that 
        the requirements of subsection (d) have been met and that 
        submissions and approvals under subsection (b)(2) or (j) of 
        section 505 for a drug will be subject to the provisions of 
        this section. Such notice shall be published not later than 30 
        days after the date of the Secretary's determination regarding 
        market exclusivity and shall include a copy of the written 
        request made under subsection (b) or (c).
            ``(2) Identification of certain drugs.--The Secretary shall 
        publish a notice identifying any drug for which, on or after 
        the date of enactment of the Best Pharmaceuticals for Children 
        Amendments of 2007, a pediatric formulation was developed, 
        studied, and found to be safe and effective in the pediatric 
        population (or specified subpopulation) if the pediatric 
        formulation for such drug is not introduced onto the market 
        within 1 year of the date that the Secretary publishes the 
        notice described in paragraph (1). Such notice identifying such 
        drug shall be published not later than 30 days after the date 
        of the expiration of such 1 year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--
                    ``(A) In general.--The Secretary shall create an 
                internal review committee to review all written 
                requests issued and all reports submitted on or after 
                the date of enactment of the Best Pharmaceuticals for 
                Children Amendments of 2007, in accordance with 
                paragraphs (2) and (3).
                    ``(B) Members.--The committee under subparagraph 
                (A) shall include individuals, each of whom is an 
                employee of the Food and Drug Administration, with the 
                following expertise:
                            ``(i) Pediatrics.
                            ``(ii) Biopharmacology.
                            ``(iii) Statistics.
                            ``(iv) Drugs and drug formulations.
                            ``(v) Legal issues.
                            ``(vi) Appropriate expertise, such as 
                        expertise in child and adolescent psychiatry, 
                        pertaining to the pediatric product under 
                        review.
                            ``(vii) One or more experts from the Office 
                        of Pediatric Therapeutics, which may include an 
                        expert in pediatric ethics.
                            ``(viii) Other individuals as designated by 
                        the Secretary.
                    ``(C) Action by committee.--The committee 
                established under this paragraph may perform a function 
                under this section using appropriate members of the 
                committee under subparagraph (B) and need not convene 
                all members of the committee under subparagraph (B) in 
                order to perform a function under this section.
                    ``(D) Documentation of committee action.--The 
                committee established under this paragraph shall 
                document for each function under paragraphs (2) and 
                (3), which members of the committee participated in 
                such function.
            ``(2) Review of written requests.--All written requests 
        under this section shall be reviewed and approved by the 
        committee established under paragraph (1) prior to being 
        issued.
            ``(3) Review of pediatric studies.--The committee 
        established under paragraph (1) shall review all studies 
        conducted pursuant to this section to make a recommendation to 
        the Secretary whether to accept or reject such reports under 
        subsection (d)(3).
            ``(4) Tracking pediatric studies and labeling changes.--The 
        committee established under paragraph (1) shall be responsible 
        for tracking and making available to the public, in an easily 
        accessible manner, including through posting on the website of 
        the Food and Drug Administration--
                    ``(A) the number of studies conducted under this 
                section;
                    ``(B) the specific drugs and drug uses, including 
                labeled and off-labeled indications, studied under this 
                section;
                    ``(C) the types of studies conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons such formulations were not 
                developed;
                    ``(E) the labeling changes made as a result of 
                studies conducted under this section;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under this section for 
                distribution pursuant to subsection (k)(2);
                    ``(G) information regarding reports submitted on or 
                after the date of enactment of the Best Pharmaceuticals 
                for Children Amendments of 2007; and
                    ``(H) the number of times the committee established 
                under paragraph (1) made a recommendation to the 
                Secretary under paragraph (3), the number of times the 
                Secretary did not follow such a recommendation to 
                accept reports under subsection (d)(3), and the number 
                of times the Secretary did not follow such a 
                recommendation to reject such reports under section 
                (d)(3).
            ``(5) Committee.--The committee established under paragraph 
        (1) is the committee established under section 505B(f)(1).'';
            (6) in subsection (g)--
                    (A) in paragraph (1)--
                            (i) by striking ``(c)(1)(A)(ii)'' and 
                        inserting ``(c)(1)(A)(i)(II)''; and
                            (ii) by striking ``(c)(2)'' and inserting 
                        ``(c)(1)(B)'';
                    (B) in paragraph (2), by striking ``(c)(1)(B)'' and 
                inserting ``(c)(1)(A)(ii)'';
                    (C) by redesignating paragraphs (1) and (2) as 
                subparagraphs (A) and (B), respectively;
                    (D) by striking ``Limitations.--A drug'' and 
                inserting ``Limitations.--
            ``(1) In general.--Notwithstanding subsection (c)(2), a 
        drug''; and
                    (E) by adding at the end the following:
            ``(2) Exclusivity adjustment.--
                    ``(A) Adjustment.--
                            ``(i) In general.--With respect to any 
                        drug, if the organization designated under 
                        subparagraph (B) notifies the Secretary that 
                        the combined annual gross sales for all drugs 
                        with the same active moiety exceeded 
                        $1,000,000,000 in any calendar year prior to 
                        the time the sponsor or holder agrees to the 
                        initial written request pursuant to subsection 
                        (d)(2), then each period of market exclusivity 
                        deemed or extended under subsection (b) or (c) 
                        shall be reduced by 3 months for such drug.
                            ``(ii) Determination.--The determination 
                        under clause (i) of the combined annual gross 
                        sales shall be determined--
                                    ``(I) taking into account only 
                                those sales within the United States; 
                                and
                                    ``(II) taking into account only the 
                                sales of all drugs with the same active 
                                moiety of the sponsor or holder and its 
                                affiliates.
                    ``(B) Designation.--The Secretary shall designate 
                an organization other than the Food and Drug 
                Administration to evaluate whether the combined annual 
                gross sales for all drugs with the same active moiety 
                exceeded $1,000,000,000 in a calendar year as described 
                in subparagraph (A). Prior to designating such 
                organization, the Secretary shall determine that such 
                organization is independent and is qualified to 
                evaluate the sales of pharmaceutical products. The 
                Secretary shall re-evaluate the designation of such 
                organization once every 3 years.
                    ``(C) Notification.--Once a year at a time 
                designated by the Secretary, the organization 
                designated under subparagraph (B) shall notify the Food 
                and Drug Administration of all drugs with the same 
                active moiety with combined annual gross sales that 
                exceed $1,000,000,000 during the previous calendar 
                year.'';
            (7) in subsection (i)--
                    (A) in the heading, by striking ``Supplements'' and 
                inserting ``Changes'';
                    (B) in paragraph (1)--
                            (i) in the heading, by inserting 
                        ``applications and'' after ``pediatric'';
                            (ii) by inserting ``application or'' after 
                        ``Any'';
                            (iii) by striking ``change pursuant to a 
                        report on a pediatric study under'' and 
                        inserting ``change as a result of any pediatric 
                        study conducted pursuant to''; and
                            (iv) by inserting ``application or'' after 
                        ``to be a priority''; and
                    (C) in paragraph (2)(A), by--
                            (i) striking ``If the Commissioner'' and 
                        inserting ``If, on or after the date of 
                        enactment of the Best Pharmaceuticals for 
                        Children Amendments of 2007, the 
                        Commissioner''; and
                            (ii) striking ``an application with'' and 
                        all that follows through ``on appropriate'' and 
                        inserting ``the sponsor and the Commissioner 
                        have been unable to reach agreement on 
                        appropriate'';
            (8) by striking subsection (m);
            (9) by redesignating subsections (j), (k), (l), and (n), as 
        subsections (k), (m), (o), and (p), respectively;
            (10) by inserting after subsection (i) the following:
    ``(j) Other Labeling Changes.--If, on or after the date of 
enactment of the Best Pharmaceuticals for Children Amendments of 2007, 
the Secretary determines that a pediatric study conducted under this 
section does or does not demonstrate that the drug that is the subject 
of the study is safe and effective, including whether such study 
results are inconclusive, in pediatric populations or subpopulations, 
the Secretary shall order the labeling of such product to include 
information about the results of the study and a statement of the 
Secretary's determination.'';
            (11) in subsection (k), as redesignated by paragraph (9)--
                    (A) in paragraph (1)--
                            (i) by striking ``a summary of the medical 
                        and'' and inserting ``the medical, statistical, 
                        and''; and
                            (ii) by striking ``for the supplement'' and 
                        all that follows through the period and 
                        inserting ``under subsection (b) or (c).'';
                    (B) by redesignating paragraph (2) as paragraph 
                (3); and
                    (C) by inserting after paragraph (1) the following:
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of enactment of the Best 
        Pharmaceuticals for Children Amendments of 2007, the Secretary 
        shall require that the sponsors of the studies that result in 
        labeling changes that are reflected in the annual summary 
        developed pursuant to subsection (f)(4)(F) distribute, at least 
        annually (or more frequently if the Secretary determines that 
        it would be beneficial to the public health), such information 
        to physicians and other health care providers.'';
            (12) by inserting after subsection (k), as redesignated by 
        paragraph (9), the following:
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        of 2007, during the 1-year period beginning on the date a 
        labeling change is made pursuant to subsection (i), the 
        Secretary shall ensure that all adverse event reports that have 
        been received for such drug (regardless of when such report was 
        received) are referred to the Office of Pediatric Therapeutics 
        established under section 6 of the Best Pharmaceuticals for 
        Children Act (Public Law 107-109). In considering such reports, 
        the Director of such Office shall provide for the review of the 
        report by the Pediatric Advisory Committee, including obtaining 
        any recommendations of such Committee regarding whether the 
        Secretary should take action under this section in response to 
        such reports.
            ``(2) Reporting in subsequent years.--Following the 1-year 
        period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics all 
        pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such reports.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.'';
            (13) by inserting after subsection (m), as redesignated by 
        paragraph (9), the following:
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007, if 
        pediatric studies of a drug have not been completed under 
        subsection (d) and if the Secretary, through the committee 
        established under subsection (f), determines that there is a 
        continuing need for information relating to the use of the drug 
        in the pediatric population (including neonates, as 
        appropriate), the Secretary shall carry out the following:
                    ``(A) For a drug for which a listed patent has not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B. Prior to making such determination, the 
                Secretary may take not more than 60 days to certify 
                whether the Foundation for the National Institutes of 
                Health has sufficient funding at the time of such 
                certification to initiate 1 or more of the pediatric 
                studies of such drug referred to in the sentence 
                preceding this paragraph and fund 1 or more of such 
                studies in their entirety. Only if the Secretary makes 
                such certification in the affirmative, the Secretary 
                shall refer such pediatric study or studies to the 
                Foundation for the National Institutes of Health for 
                the conduct of such study or studies.
                    ``(B) For a drug that has no listed patents or has 
                1 or more listed patents that have expired, the 
                Secretary shall refer the drug for inclusion on the 
                list established under section 409I of the Public 
                Health Service Act for the conduct of studies.
            ``(2) Public notice.--The Secretary shall give the public 
        notice of--
                    ``(A) a decision under paragraph (1)(A) not to 
                require an assessment under section 505B and the basis 
                for such decision; and
                    ``(B) any referral under paragraph (1)(B) of a drug 
                for inclusion on the list established under section 
                409I of the Public Health Service Act.
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.''; and
            (14) in subsection (p), as redesignated by paragraph (9)--
                    (A) striking ``6-month period'' and inserting ``3-
                month or 6-month period'';
                    (B) by striking ``subsection (a)'' and inserting 
                ``subsection (b)''; and
                    (C) by striking ``2007'' both places it appears and 
                inserting ``2012''.
    (b) Effective Date.--Except as otherwise provided in the amendments 
made by subsection (a), such amendments shall apply to written requests 
under section 505A of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355a) made after the date of enactment of this subtitle.

SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    Section 409I of the Public Health Service Act (42 U.S.C. 284m) is 
amended--
            (1) by striking subsections (a) and (b) and inserting the 
        following:
    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than 1 year after the date of 
        enactment of the Best Pharmaceuticals for Children Amendments 
        of 2007, the Secretary, acting through the Director of the 
        National Institutes of Health and in consultation with the 
        Commissioner of Food and Drugs and experts in pediatric 
        research, shall develop and publish a priority list of needs in 
        pediatric therapeutics, including drugs or indications that 
        require study. The list shall be revised every 3 years.
            ``(2) Consideration of available information.--In 
        developing and prioritizing the list under paragraph (1), the 
        Secretary shall consider--
                    ``(A) therapeutic gaps in pediatrics that may 
                include developmental pharmacology, pharmacogenetic 
                determinants of drug response, metabolism of drugs and 
                biologics in children, and pediatric clinical trials;
                    ``(B) particular pediatric diseases, disorders or 
                conditions where more complete knowledge and testing of 
                therapeutics, including drugs and biologics, may be 
                beneficial in pediatric populations; and
                    ``(C) the adequacy of necessary infrastructure to 
                conduct pediatric pharmacological research, including 
                research networks and trained pediatric investigators.
    ``(b) Pediatric Studies and Research.--The Secretary, acting 
through the National Institutes of Health, shall award funds to 
entities that have the expertise to conduct pediatric clinical trials 
or other research (including qualified universities, hospitals, 
laboratories, contract research organizations, practice groups, 
federally funded programs such as pediatric pharmacology research 
units, other public or private institutions, or individuals) to enable 
the entities to conduct the drug studies or other research on the 
issues described in subsection (a). The Secretary may use contracts, 
grants, or other appropriate funding mechanisms to award funds under 
this subsection.'';
            (2) in subsection (c)--
                    (A) in the heading, by striking ``Contracts'' and 
                inserting ``Proposed Pediatric Study Requests'';
                    (B) by striking paragraphs (4) and (12);
                    (C) by redesignating paragraphs (1), (2), and (3), 
                as paragraphs (2), (3), and (4);
                    (D) by inserting before paragraph (2), as 
                redesignated by subparagraph (C), the following:
            ``(1) Submission of proposed pediatric study request.--The 
        Director of the National Institutes of Health shall, as 
        appropriate, submit proposed pediatric study requests for 
        consideration by the Commissioner of Food and Drugs for 
        pediatric studies of a specific pediatric indication identified 
        under subsection (a). Such a proposed pediatric study request 
        shall be made in a manner equivalent to a written request made 
        under subsection (b) or (c) of section 505A of the Federal 
        Food, Drug, and Cosmetic Act, including with respect to the 
        information provided on the pediatric studies to be conducted 
        pursuant to the request. The Director of the National 
        Institutes of Health may submit a proposed pediatric study 
        request for a drug for which--
                    ``(A)(i) there is an approved application under 
                section 505(j) of the Federal Food, Drug, and Cosmetic 
                Act; or
                    ``(ii) there is a submitted application that could 
                be approved under the criteria of section 505(j) of the 
                Federal Food, Drug, and Cosmetic Act;
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least 1 form of the drug 
                under the Federal Food, Drug, and Cosmetic Act; and
                    ``(C) additional studies are needed to assess the 
                safety and effectiveness of the use of the drug in the 
                pediatric population.'';
                    (E) in paragraph (2), as redesignated by 
                subparagraph (C)--
                            (i) by inserting ``based on the proposed 
                        pediatric study request for the indication or 
                        indications submitted pursuant to paragraph 
                        (1)'' after ``issue a written request'';
                            (ii) by striking ``in the list described in 
                        subsection (a)(1)(A) (except clause (iv))'' and 
                        inserting ``under subsection (a)''; and
                            (iii) by inserting ``and using appropriate 
                        formulations for each age group for which the 
                        study is requested'' before the period at the 
                        end;
                    (F) in paragraph (3), as redesignated by 
                subparagraph (C)--
                            (i) in the heading, by striking 
                        ``contract'';
                            (ii) by striking ``paragraph (1)'' and 
                        inserting ``paragraph (2)'';
                            (iii) by striking ``or if a referral 
                        described in subsection (a)(1)(A)(iv) is 
                        made,'';
                            (iv) by striking ``for contract proposals'' 
                        and inserting ``for proposals''; and
                            (v) by inserting ``in accordance with 
                        subsection (b)'' before the period at the end;
                    (G) in paragraph (4), as redesignated by 
                subparagraph (C)--
                            (i) by striking ``contract''; and
                            (ii) by striking ``paragraph (2)'' and 
                        inserting ``paragraph (3)'';
                    (H) in paragraph (5)--
                            (i) by striking the heading and inserting 
                        ``Contracts, grants, or other funding 
                        mechanisms''; and
                            (ii) by striking ``A contract'' and all 
                        that follows through ``is submitted'' and 
                        inserting ``A contract, grant, or other funding 
                        may be awarded under this section only if a 
                        proposal is submitted'';
                    (I) in paragraph (6)(A)--
                            (i) by striking ``a contract awarded'' and 
                        inserting ``an award''; and
                            (ii) by inserting ``, including a written 
                        request if issued'' after ``with the study''; 
                        and
            (3) by inserting after subsection (c) the following:
    ``(d) Dissemination of Pediatric Information.--Not later than 1 
year after the date of enactment of the Best Pharmaceuticals for 
Children Amendments of 2007, the Secretary, acting through the Director 
of the National Institutes of Health, shall study the feasibility of 
establishing a compilation of information on pediatric drug use and 
report the findings to Congress.''
    ``(e) Authorization of Appropriations.--
            ``(1) In general.--There are authorized to be appropriated 
        to carry out this section--
                    ``(A) $200,000,000 for fiscal year 2008; and
                    ``(B) such sums as are necessary for each of the 4 
                succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.

SEC. 404. REPORTS AND STUDIES.

    (a) GAO Report.--Not later than January 31, 2011, the Comptroller 
General of the United States, in consultation with the Secretary of 
Health and Human Services, shall submit to Congress a report that 
addresses the effectiveness of section 505A of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by 
children are tested and properly labeled, including--
            (1) the number and importance of drugs for children that 
        are being tested as a result of the amendments made by this 
        subtitle and the importance for children, health care 
        providers, parents, and others of labeling changes made as a 
        result of such testing;
            (2) the number and importance of drugs for children that 
        are not being tested for their use notwithstanding the 
        provisions of this subtitle and the amendments made by this 
        subtitle, and possible reasons for the lack of testing, 
        including whether the number of written requests declined by 
        sponsors or holders of drugs subject to section 505A(g)(2) of 
        the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355a(g)(2)), has increased or decreased as a result of the 
        amendments made by this subtitle;
            (3) the number of drugs for which testing is being done and 
        labeling changes required, including the date labeling changes 
        are made and which labeling changes required the use of the 
        dispute resolution process established pursuant to the 
        amendments made by this subtitle, together with a description 
        of the outcomes of such process, including a description of the 
        disputes and the recommendations of the Pediatric Advisory 
        Committee;
            (4) any recommendations for modifications to the programs 
        established under section 505A of the Federal Food, Drug and 
        Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public 
        Health Service Act (42 U.S.C. 284m) that the Secretary 
        determines to be appropriate, including a detailed rationale 
        for each recommendation; and
            (5)(A) the efforts made by the Secretary to increase the 
        number of studies conducted in the neonate population; and
            (B) the results of those efforts, including efforts made to 
        encourage the conduct of appropriate studies in neonates by 
        companies with products that have sufficient safety and other 
        information to make the conduct of the studies ethical and 
        safe.
    (b) IOM Study.--Not later than 3 years after the date of enactment 
of this subtitle, the Secretary of Health and Human Services shall 
enter into a contract with the Institute of Medicine to conduct a study 
and report to Congress regarding the written requests made and the 
studies conducted pursuant to section 505A of the Federal Food, Drug, 
and Cosmetic Act. The Institute of Medicine may devise an appropriate 
mechanism to review a representative sample of requests made and 
studies conducted pursuant to such section in order to conduct such 
study. Such study shall--
            (1) review such representative written requests issued by 
        the Secretary since 1997 under subsections (b) and (c) of such 
        section 505A;
            (2) review and assess such representative pediatric studies 
        conducted under such subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies; and
            (3) review the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, and ethical issues in 
        pediatric clinical trials.

SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

    (a) Investment in Tomorrow's Pediatric Researchers.--Section 
452G(2) of the Public Health Service Act (42 U.S.C. 285g-10(2)) is 
amended by adding before the period at the end the following: ``, 
including pediatric pharmacological research''.
    (b) Pediatric Research Loan Repayment Program.--Section 487F(a)(1) 
of the Public Health Service Act (42 U.S.C. 288-6(a)(1)) is amended by 
inserting ``including pediatric pharmacological research,'' after 
``pediatric research,''.

SEC. 406. FOUNDATION FOR THE NATIONAL INSTITUTES OF HEALTH.

    Section 499(c)(1)(C) of the Public Health Service Act (42 U.S.C. 
290b(c)(1)(C)) is amended by striking ``and studies listed by the 
Secretary pursuant to section 409I(a)(1)(A) of the is Act and referred 
under section 505A(d)(4)(C) of the Federal Food, Drug and Cosmetic Act 
(21 U.S.C. 355(a)(d)(4)(C)'' and inserting ``and studies for which the 
Secretary issues a certification under section 505A(n)(1)(A) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(n)(1)(A))''.

SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.

    Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended by adding at the end the following:
    ``(d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act (5 U.S.C. App.), the 
advisory committee shall continue to operate during the 5-year period 
beginning on the date of enactment of the Best Pharmaceuticals for 
Children Amendments of 2007.''.

SEC. 408. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS ADVISORY 
              COMMITTEE.

    Section 15 of the Best Pharmaceuticals for Children Act (42 U.S.C. 
284m note) is amended--
            (1) in subsection (a)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (B), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (C), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by adding at the end the following:
                    ``(D) provide recommendations to the internal 
                review committee created under section 505A(f) of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
                355a(f)) regarding the implementation of amendments to 
                sections 505A and 505B of the Federal Food, Drug, and 
                Cosmetic Act (21 U.S.C. 355a and 355c) with respect to 
                the treatment of pediatric cancers.''; and
                    (B) by adding at the end the following:
            ``(3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory Committee 
        Act (5 U.S.C. App.), the Subcommittee shall continue to operate 
        during the 5-year period beginning on the date of enactment of 
        the Best Pharmaceuticals for Children Amendments of 2007.''; 
        and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.

SEC. 409. EFFECTIVE DATE AND LIMITATION FOR RULE RELATING TO TOLL-FREE 
              NUMBER FOR ADVERSE EVENTS ON LABELING FOR HUMAN DRUG 
              PRODUCTS.

    (a) In General.--Notwithstanding subchapter II of chapter 5, and 
chapter 7, of title 5, United States Code (commonly known as the 
``Administrative Procedure Act'') and any other provision of law, the 
proposed rule issued by the Commissioner of Food and Drugs entitled 
``Toll-Free Number for Reporting Adverse Events on Labeling for Human 
Drug Products'', 69 Fed. Reg. 21778, (April 22, 2004) shall take effect 
on January 1, 2008, unless such Commissioner issues the final rule 
before such date.
    (b) Limitation.--The proposed rule that takes effect under 
subsection (a), or the final rule described under subsection (a), 
shall, notwithstanding section 17(a) of the Best Pharmaceuticals for 
Children Act (21 U.S.C. 355b(a)), not apply to a drug--
            (1) for which an application is approved under section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
            (2) that is not described under section 503(b)(1) of such 
        Act (21 U.S.C. 353(b)(1)); and
            (3) the packaging of which includes a toll-free number 
        through which consumers can report complaints to the 
        manufacturer or distributor of the drug.

               Subtitle B--Pediatric Research Improvement

SEC. 411. SHORT TITLE.

    This subtitle may be cited as the ``Pediatric Research Improvement 
Act''.

SEC. 412. PEDIATRIC FORMULATIONS, EXTRAPOLATIONS, AND DEFERRALS.

    Section 505B(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(a)) is amended--
            (1) in paragraph (4)(C), by adding at the end the 
        following: ``An applicant seeking either a partial or full 
        waiver on this ground shall submit to the Secretary 
        documentation detailing why a pediatric formulation cannot be 
        developed, and, if the waiver is granted, the applicant's 
        submission shall promptly be made available to the public in an 
        easily accessible manner, including through posting on the 
        website of the Food and Drug Administration'';
            (2) in paragraph (2)(B), by adding at the end the 
        following:
                            ``(iii) Information on extrapolation.--A 
                        brief documentation of the scientific data 
                        supporting the conclusion under clauses (i) and 
                        (ii) shall be included in any pertinent reviews 
                        for the application under section 505 or 
                        section 351 of the Public Health Service 
                        Act.''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Deferral.--
                    ``(A) In general.--On the initiative of the 
                Secretary or at the request of the applicant, the 
                Secretary may defer submission of some or all 
                assessments required under paragraph (1) until a 
                specified date after approval of the drug or issuance 
                of the license for a biological product if--
                            ``(i) the Secretary finds that--
                                    ``(I) the drug or biological 
                                product is ready for approval for use 
                                in adults before pediatric studies are 
                                complete;
                                    ``(II) pediatric studies should be 
                                delayed until additional safety or 
                                effectiveness data have been collected; 
                                or
                                    ``(III) there is another 
                                appropriate reason for deferral; and
                            ``(ii) the applicant submits to the 
                        Secretary--
                                    ``(I) certification of the grounds 
                                for deferring the assessments;
                                    ``(II) a description of the planned 
                                or ongoing studies;
                                    ``(III) evidence that the studies 
                                are being conducted or will be 
                                conducted with due diligence and at the 
                                earliest possible time; and
                                    ``(IV) a timeline for the 
                                completion of such studies.
                    ``(B) Annual review.--
                            ``(i) In general.--On an annual basis 
                        following the approval of a deferral under 
                        subparagraph (A), the applicant shall submit to 
                        the Secretary the following information:
                                    ``(I) Information detailing the 
                                progress made in conducting pediatric 
                                studies.
                                    ``(II) If no progress has been made 
                                in conducting such studies, evidence 
                                and documentation that such studies 
                                will be conducted with due diligence 
                                and at the earliest possible time.
                            ``(ii) Public availability.--The 
                        information submitted through the annual review 
                        under clause (i) shall promptly be made 
                        available to the public in an easily accessible 
                        manner, including through the website of the 
                        Food and Drug Administration.''.

SEC. 413. IMPROVING AVAILABILITY OF PEDIATRIC DATA FOR ALREADY MARKETED 
              PRODUCTS.

    Section 505B(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c(b)) is amended--
            (1) by striking paragraph (1) and inserting the following:
            ``(1) In general.--After providing notice in the form of a 
        written request under section 505A that was declined by the 
        sponsor or holder, or a letter referencing such declined 
        written request, and an opportunity for written response and a 
        meeting, which may include an advisory committee meeting, the 
        Secretary may (by order in the form of a letter) require the 
        sponsor or holder of an approved application for a drug under 
        section 505 or the holder of a license for a biological product 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262) to submit by a specified date the assessments described in 
        subsection (a)(2) and the written request, as appropriate, for 
        the labeled indication or indications, if the Secretary finds 
        that--
                    ``(A)(i) the drug or biological product is used for 
                a substantial number of pediatric patients for the 
                labeled indications; and
                    ``(ii) adequate pediatric labeling could confer a 
                benefit on pediatric patients;
                    ``(B) there is reason to believe that the drug or 
                biological product would represent a meaningful 
                therapeutic benefit over existing therapies for 
                pediatric patients for 1 or more of the claimed 
                indications; or
                    ``(C) the absence of adequate pediatric labeling 
                could pose a risk to pediatric patients.'';
            (2) in paragraph (2)(C), by adding at the end the 
        following: ``An applicant seeking either a partial or full 
        waiver shall submit to the Secretary documentation detailing 
        why a pediatric formulation cannot be developed, and, if the 
        waiver is granted, the applicant's submission shall promptly be 
        made available to the public in an easily accessible manner, 
        including through posting on the website of the Food and Drug 
        Administration.''; and
            (3) by striking paragraph (3) and inserting the following:
            ``(3) Effect of subsection.--Nothing in this subsection 
        alters or amends section 301(j) of this Act or section 552 of 
        title 5 or section 1905 of title 18, United States Code.''.

SEC. 414. SUNSET; REVIEW OF PEDIATRIC ASSESSMENTS; ADVERSE EVENT 
              REPORTING; LABELING CHANGES; AND PEDIATRIC ASSESSMENTS.

    Section 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355c) is amended--
            (1) redesignating subsection (h) as subsection (j);
            (2) in subsection (j), as so redesignated, by striking 
        ``505A(n)'' and inserting ``505A(p)'';
            (3) by redesignating subsection (f) as subsection (k);
            (4) by redesignating subsection (g) as subsection (l); and
            (5) by inserting after subsection (e) the following:
    ``(f) Review of Pediatric Assessment Requests, Pediatric 
Assessments, Deferrals, and Waivers.--
            ``(1) Review.--The Secretary shall create an internal 
        committee to review all pediatric assessment requests issued 
        under this section, all pediatric assessments conducted under 
        this section, and all deferral and waiver requests made 
        pursuant to this section. Such internal committee shall include 
        individuals, each of whom is an employee of the Food and Drug 
        Administration, with the following expertise:
                    ``(A) Pediatrics.
                    ``(B) Biopharmacology.
                    ``(C) Statistics.
                    ``(D) Drugs and drug formulations.
                    ``(E) Pediatric ethics.
                    ``(F) Legal issues.
                    ``(G) Appropriate expertise, such as expertise in 
                child and adolescent psychiatry, pertaining to the 
                pediatric product under review.
                    ``(H) 1 or more experts from the Office of 
                Pediatric Therapeutics.
                    ``(I) Other individuals as designated by the 
                Secretary.
            ``(2) Action by the committee.--The committee established 
        under paragraph (1) may perform a function under this section 
        using appropriate members of the committee under paragraph (1) 
        and need not convene all members of the committee under 
        paragraph (1) in order to perform a function under this 
        section.
            ``(3) Documentation of committee action.--For each drug or 
        biological product, the committee established under this 
        paragraph shall document for each function under paragraph (4) 
        or (5), which members of the committee participated in such 
        function.
            ``(4) Review of requests for pediatric assessments, 
        deferrals, and waivers.--All written requests for a pediatric 
        assessment issued pursuant to this section and all requests for 
        deferrals and waivers from the requirement to conduct a 
        pediatric assessment under this section shall be reviewed and 
        approved by the committee established under paragraph (1).
            ``(5) Review of assessments.--The committee established 
        under paragraph (1) shall review all assessments conducted 
        under this section to determine whether such assessments meet 
        the requirements of this section.
            ``(6) Tracking of assessments and labeling changes.--The 
        committee established under paragraph (1) is responsible for 
        tracking and making public in an easily accessible manner, 
        including through posting on the website of the Food and Drug 
        Administration--
                    ``(A) the number of assessments conducted under 
                this section;
                    ``(B) the specific drugs and drug uses assessed 
                under this section;
                    ``(C) the types of assessments conducted under this 
                section, including trial design, the number of 
                pediatric patients studied, and the number of centers 
                and countries involved;
                    ``(D) the total number of deferrals requested and 
                granted under this section, and, if granted, the 
                reasons for such deferrals, the timeline for 
                completion, and the number completed and pending by the 
                specified date, as outlined in subsection (a)(3);
                    ``(E) the number of waivers requested and granted 
                under this section, and, if granted, the reasons for 
                the waivers;
                    ``(F) the number of pediatric formulations 
                developed and the number of pediatric formulations not 
                developed and the reasons any such formulations were 
                not developed;
                    ``(G) the labeling changes made as a result of 
                assessments conducted under this section;
                    ``(H) an annual summary of labeling changes made as 
                a result of assessments conducted under this section 
                for distribution pursuant to subsection (i)(2); and
                    ``(I) an annual summary of the information 
                submitted pursuant to subsection (a)(3)(B).
            ``(7) Committee.--The committee established under paragraph 
        (1) is the committee established under section 505A(f)(1).
    ``(g) Labeling Changes.--
            ``(1) Priority status for pediatric supplement.--Any 
        supplement to an application under section 505 and section 351 
        of the Public Health Service Act proposing a labeling change as 
        a result of any pediatric assessments conducted pursuant to 
        this section--
                    ``(A) shall be considered a priority supplement; 
                and
                    ``(B) shall be subject to the performance goals 
                established by the Commissioner for priority drugs.
            ``(2) Dispute resolution.--
                    ``(A) Request for labeling change and failure to 
                agree.--If the Commissioner determines that a sponsor 
                and the Commissioner have been unable to reach 
                agreement on appropriate changes to the labeling for 
                the drug that is the subject of the application or 
                supplement, not later than 180 days after the date of 
                the submission of the application or supplement--
                            ``(i) the Commissioner shall request that 
                        the sponsor make any labeling change that the 
                        Commissioner determines to be appropriate; and
                            ``(ii) if the sponsor does not agree to 
                        make a labeling change requested by the 
                        Commissioner, the Commissioner shall refer the 
                        matter to the Pediatric Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A)(ii), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the pediatric study reports; 
                        and
                            ``(ii) make a recommendation to the 
                        Commissioner concerning appropriate labeling 
                        changes, if any.
                    ``(C) Consideration of recommendations.--The 
                Commissioner shall consider the recommendations of the 
                Pediatric Advisory Committee and, if appropriate, not 
                later than 30 days after receiving the recommendation, 
                make a request to the sponsor of the application or 
                supplement to make any labeling changes that the 
                Commissioner determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor, within 30 days 
                after receiving a request under subparagraph (C), does 
                not agree to make a labeling change requested by the 
                Commissioner, the Commissioner may deem the drug that 
                is the subject of the application or supplement to be 
                misbranded.
                    ``(E) No effect on authority.--Nothing in this 
                subsection limits the authority of the United States to 
                bring an enforcement action under this Act when a drug 
                lacks appropriate pediatric labeling. Neither course of 
                action (the Pediatric Advisory Committee process or an 
                enforcement action referred to in the preceding 
                sentence) shall preclude, delay, or serve as the basis 
                to stay the other course of action.
            ``(3) Other labeling changes.--If the Secretary makes a 
        determination that a pediatric assessment conducted under this 
        section does or does not demonstrate that the drug that is the 
        subject of such assessment is safe and effective, including 
        whether such assessment results are inconclusive, in pediatric 
        populations or subpopulations, the Secretary shall order the 
        labeling of such product to include information about the 
        results of the assessment and a statement of the Secretary's 
        determination.
    ``(h) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a pediatric assessment under this section, the 
        Secretary shall make available to the public in an easily 
        accessible manner the medical, statistical, and clinical 
        pharmacology reviews of such pediatric assessments and shall 
        post such assessments on the website of the Food and Drug 
        Administration.
            ``(2) Dissemination of information regarding labeling 
        changes.--The Secretary shall require that the sponsors of the 
        assessments that result in labeling changes that are reflected 
        in the annual summary developed pursuant to subsection 
        (f)(4)(H) distribute such information to physicians and other 
        health care providers.
            ``(3) Effect of subsection.--Nothing in this subsection 
        shall alter or amend section 301(j) of this Act or section 552 
        of title 5, United States Code, or section 1905 of title 18, 
        United States Code.
    ``(i) Adverse Event Reporting.--
            ``(1) Reporting in year 1.--During the 1-year period 
        beginning on the date a labeling change is made pursuant to 
        subsection (g), the Secretary shall ensure that all adverse 
        event reports that have been received for such drug (regardless 
        of when such report was received) are referred to the Office of 
        Pediatric Therapeutics. In considering such reports, the 
        Director of such Office shall provide for the review of the 
        report by the Pediatric Advisory Committee, including obtaining 
        any recommendations of such committee regarding whether the 
        Secretary should take action under this Act in response to such 
        report.
            ``(2) Reporting in subsequent years.--Following the 1-year 
        period described in paragraph (1), the Secretary shall, as 
        appropriate, refer to the Office of Pediatric Therapeutics with 
        all pediatric adverse event reports for a drug for which a 
        pediatric study was conducted under this section. In 
        considering such reports, the Director of such Office may 
        provide for the review of such reports by the Pediatric 
        Advisory Committee, including obtaining any recommendation of 
        such Committee regarding whether the Secretary should take 
        action in response to such report.
            ``(3) Effect.--The requirements of this subsection shall 
        supplement, not supplant, other review of such adverse event 
        reports by the Secretary.''.

SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.

    Section 505B(c) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355c) is amended--
            (1) by striking ``estimates'' and inserting ``determines''; 
        and
            (2) by striking ``would'' and inserting ``could''.

SEC. 416. REPORTS.

    (a) Institute of Medicine Study.--
            (1) In general.--Not later than 3 years after the date of 
        enactment of this subtitle, the Secretary shall contract with 
        the Institute of Medicine to conduct a study and report to 
        Congress regarding the pediatric studies conducted pursuant to 
        section 505B of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355c) since 1997.
            (2) Content of study.--The study under paragraph (1) shall 
        review and assess--
                    (A) pediatric studies conducted pursuant to section 
                505B of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355c) since 1997 and labeling changes made as a 
                result of such studies; and
                    (B) the use of extrapolation for pediatric 
                subpopulations, the use of alternative endpoints for 
                pediatric populations, neonatal assessment tools, 
                number and type of pediatric adverse events, and 
                ethical issues in pediatric clinical trials.
            (3) Representative sample.--The Institute of Medicine may 
        devise an appropriate mechanism to review a representative 
        sample of studies conducted pursuant to section 505B of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c) from each 
        review division within the Center for Drug Evaluation and 
        Research and the Center for Biologics Evaluation and Research 
        in order to make the required assessment.
    (b) GAO Report.--Not later than September 1, 2010, the Comptroller 
General of the United States, in consultation with the Secretary of 
Health and Human Services, shall submit to Congress a report that 
addresses the effectiveness of section 505B of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355a) in ensuring that medicines used by 
children are tested and properly labeled, including--
            (1) the number and importance of drugs for children that 
        are being tested as a result of this provision and the 
        importance for children, health care providers, parents, and 
        others of labeling changes made as a result of such testing;
            (2) the number and importance of drugs for children that 
        are not being tested for their use notwithstanding the 
        provisions of such section 505B, and possible reasons for the 
        lack of testing; and
            (3) the number of drugs for which testing is being done and 
        labeling changes required, including the date labeling changes 
        are made and which labeling changes required the use of the 
        dispute resolution process established under such section 505B, 
        together with a description of the outcomes of such process, 
        including a description of the disputes and the recommendations 
        of the Pediatric Advisory Committee.

SEC. 417. TECHNICAL CORRECTIONS.

    Section 505B(a)(2)(B)(ii) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355c(a)(2)(B)(ii)) is amended by striking ``one'' and 
inserting ``1''.

                 Subtitle C--Pediatric Medical Devices

SEC. 421. SHORT TITLE.

    This subtitle may be cited as the ``Pediatric Medical Device Safety 
and Improvement Act of 2007''.

SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 515 the following:

``SEC. 515A. PEDIATRIC USES OF DEVICES.

    ``(a) New Devices.--
            ``(1) In general.--A person that submits to the Secretary 
        an application under section 520(m), or an application (or 
        supplement to an application) or a product development protocol 
        under section 515, shall include in the application or protocol 
        the information described in paragraph (2).
            ``(2) Required information.--The application or protocol 
        described in paragraph (1) shall include, with respect to the 
        device for which approval is sought and if readily available--
                    ``(A) a description of any pediatric subpopulations 
                that suffer from the disease or condition that the 
                device is intended to treat, diagnose, or cure; and
                    ``(B) the number of affected pediatric patients.
            ``(3) Annual report.--Not later than 18 months after the 
        date of enactment of this section, and annually thereafter, the 
        Secretary shall submit to the Committee on Health, Education, 
        Labor, and Pensions of the Senate and the Committee on Energy 
        and Commerce of the House of Representatives a report that 
        includes--
                    ``(A) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                for which there is a pediatric subpopulation that 
                suffers from the disease or condition that the device 
                is intended to treat, diagnose, or cure;
                    ``(B) the number of devices approved in the year 
                preceding the year in which the report is submitted, 
                labeled for use in pediatric patients;
                    ``(C) the number of pediatric devices approved in 
                the year preceding the year in which the report is 
                submitted, exempted from a fee pursuant to section 
                738(a)(2)(B)(v); and
                    ``(D) the review time for each device described in 
                subparagraphs (A), (B), and (C).
    ``(b) Determination of Pediatric Effectiveness Based on Similar 
Course of Disease or Condition or Similar Effect of Device on Adults.--
            ``(1) In general.--If the course of the disease or 
        condition and the effects of the device are sufficiently 
        similar in adults and pediatric patients, the Secretary may 
        conclude that adult data may be used to support a determination 
        of a reasonable assurance of effectiveness in pediatric 
        populations, as appropriate.
            ``(2) Extrapolation between subpopulations.--A study may 
        not be needed in each pediatric subpopulation if data from one 
        subpopulation can be extrapolated to another subpopulation.
    ``(c) Pediatric Subpopulation.--In this section, the term 
`pediatric subpopulation' has the meaning given the term in section 
520(m)(6)(E)(ii).''.

SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

    (a) In General.--Section 520(m) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)) is amended--
            (1) in paragraph (3), by striking ``No'' and inserting 
        ``Except as provided in paragraph (6), no'';
            (2) in paragraph (5)--
                    (A) by inserting ``, if the Secretary has reason to 
                believe that the requirements of paragraph (6) are no 
                longer met,'' after ``public health''; and
                    (B) by adding at the end the following: ``If the 
                person granted an exemption under paragraph (2) fails 
                to demonstrate continued compliance with the 
                requirements of this subsection, the Secretary may 
                suspend or withdraw the exemption from the 
                effectiveness requirements of sections 514 and 515 for 
                a humanitarian device only after providing notice and 
                an opportunity for an informal hearing.'';
            (3) by striking paragraph (6) and inserting the following:
    ``(6)(A) Except as provided in subparagraph (D), the prohibition in 
paragraph (3) shall not apply with respect to a person granted an 
exemption under paragraph (2) if each of the following conditions 
apply:
            ``(i)(I) The device with respect to which the exemption is 
        granted is intended for the treatment or diagnosis of a disease 
        or condition that occurs in pediatric patients or in a 
        pediatric subpopulation, and such device is labeled for use in 
        pediatric patients or in a pediatric subpopulation in which the 
        disease or condition occurs.
            ``(II) The device was not previously approved under this 
        subsection for the pediatric patients or the pediatric 
        subpopulation described in subclause (I) prior to the date of 
        enactment of the Pediatric Medical Device Safety and 
        Improvement Act of 2007.
            ``(ii) During any calendar year, the number of such devices 
        distributed during that year does not exceed the annual 
        distribution number specified by the Secretary when the 
        Secretary grants such exemption. The annual distribution number 
        shall be based on the number of individuals affected by the 
        disease or condition that such device is intended to treat, 
        diagnose, or cure, and of that number, the number of 
        individuals likely to use the device, and the number of devices 
        reasonably necessary to treat such individuals. In no case 
        shall the annual distribution number exceed the number 
        identified in paragraph (2)(A).
            ``(iii) Such person immediately notifies the Secretary if 
        the number of such devices distributed during any calendar year 
        exceeds the annual distribution number referred to in clause 
        (ii).
            ``(iv) The request for such exemption is submitted on or 
        before October 1, 2012.
    ``(B) The Secretary may inspect the records relating to the number 
of devices distributed during any calendar year of a person granted an 
exemption under paragraph (2) for which the prohibition in paragraph 
(3) does not apply.
    ``(C) A person may petition the Secretary to modify the annual 
distribution number specified by the Secretary under subparagraph 
(A)(ii) with respect to a device if additional information on the 
number of individuals affected by the disease or condition arises, and 
the Secretary may modify such number but in no case shall the annual 
distribution number exceed the number identified in paragraph (2)(A).
    ``(D) If a person notifies the Secretary, or the Secretary 
determines through an inspection under subparagraph (B), that the 
number of devices distributed during any calendar year exceeds the 
annual distribution number, as required under subparagraph (A)(iii), 
and modified under subparagraph (C), if applicable, then the 
prohibition in paragraph (3) shall apply with respect to such person 
for such device for any sales of such device after such notification.
    ``(E)(i) In this subsection, the term `pediatric patients' means 
patients who are 21 years of age or younger at the time of the 
diagnosis or treatment.
    ``(ii) In this subsection, the term `pediatric subpopulation' means 
1 of the following populations:
            ``(I) Neonates.
            ``(II) Infants.
            ``(III) Children.
            ``(IV) Adolescents.''; and
            (4) by adding at the end the following:
    ``(7) The Secretary shall refer any report of an adverse event 
regarding a device for which the prohibition under paragraph (3) does 
not apply pursuant to paragraph (6)(A) that the Secretary receives to 
the Office of Pediatric Therapeutics, established under section 6 of 
the Best Pharmaceuticals for Children Act (Public Law 107-109)). In 
considering the report, the Director of the Office of Pediatric 
Therapeutics, in consultation with experts in the Center for Devices 
and Radiological Health, shall provide for periodic review of the 
report by the Pediatric Advisory Committee, including obtaining any 
recommendations of such committee regarding whether the Secretary 
should take action under this Act in response to the report.''.
    (b) Report.--Not later than January 1, 2012, the Comptroller 
General of the United States shall submit to the Committee on Health, 
Education, Labor, and Pensions of the Senate and the Committee on 
Energy and Commerce of the House of Representatives a report on the 
impact of allowing persons granted an exemption under section 520(m)(2) 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
respect to a device to profit from such device pursuant to section 
520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as amended by subsection 
(a)), including--
            (1) an assessment of whether such section 520(m)(6) (as 
        amended by subsection (a)) has increased the availability of 
        pediatric devices for conditions that occur in small numbers of 
        children, including any increase or decrease in the number of--
                    (A) exemptions granted under such section 520(m)(2) 
                for pediatric devices; and
                    (B) applications approved under section 515 of such 
                Act (21 U.S.C. 360e) for devices intended to treat, 
                diagnose, or cure conditions that occur in pediatric 
                patients or for devices labeled for use in a pediatric 
                population;
            (2) the conditions or diseases the pediatric devices were 
        intended to treat or diagnose and the estimated size of the 
        pediatric patient population for each condition or disease;
            (3) the costs of the pediatric devices, based on a survey 
        of children's hospitals;
            (4) the extent to which the costs of such devices are 
        covered by health insurance;
            (5) the impact, if any, of allowing profit on access to 
        such devices for patients;
            (6) the profits made by manufacturers for each device that 
        receives an exemption;
            (7) an estimate of the extent of the use of the pediatric 
        devices by both adults and pediatric populations for a 
        condition or disease other than the condition or disease on the 
        label of such devices;
            (8) recommendations of the Comptroller General of the 
        United States regarding the effectiveness of such section 
        520(m)(6) (as amended by subsection (a)) and whether any 
        modifications to such section 520(m)(6) (as amended by 
        subsection (a)) should be made;
            (9) existing obstacles to pediatric device development; and
            (10) an evaluation of the demonstration grants described in 
        section 425, which shall include an evaluation of the number of 
        pediatric medical devices--
                    (A) that have been or are being studied in 
                children; and
                    (B) that have been submitted to the Food and Drug 
                Administration for approval, clearance, or review under 
                such section 520(m) (as amended by this Act) and any 
                regulatory actions taken.
    (c) Guidance.--Not later than 180 days after the date of enactment 
of this subtitle, the Commissioner of Food and Drugs shall issue 
guidance for institutional review committees on how to evaluate 
requests for approval for devices for which a humanitarian device 
exemption under section 520(m)(2) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360j(m)(2)) has been granted.

SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.

    Section 402(b) of the Public Health Service Act (42 U.S.C. 282(b)) 
is amended--
            (1) in paragraph (21), by striking ``and'' after the 
        semicolon at the end;
            (2) in paragraph (22), by striking the period at the end 
        and inserting ``; and''; and
            (3) by inserting after paragraph (22) the following:
            ``(23) shall designate a contact point or office to help 
        innovators and physicians identify sources of funding available 
        for pediatric medical device development.''.

SEC. 425. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
              AVAILABILITY.

    (a) In General.--
            (1) Request for proposals.--Not later than 90 days after 
        the date of enactment of this subtitle, the Secretary of Health 
        and Human Services shall issue a request for proposals for 1 or 
        more grants or contracts to nonprofit consortia for 
        demonstration projects to promote pediatric device development.
            (2) Determination on grants or contracts.--Not later than 
        180 days after the date the Secretary of Health and Human 
        Services issues a request for proposals under paragraph (1), 
        the Secretary shall make a determination on the grants or 
        contracts under this section.
    (b) Application.--A nonprofit consortium that desires to receive a 
grant or contract under this section shall submit an application to the 
Secretary of Health and Human Services at such time, in such manner, 
and containing such information as the Secretary may require.
    (c) Use of Funds.--A nonprofit consortium that receives a grant or 
contract under this section shall facilitate the development, 
production, and distribution of pediatric medical devices by--
            (1) encouraging innovation and connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
            (2) mentoring and managing pediatric device projects 
        through the development process, including product 
        identification, prototype design, device development, and 
        marketing;
            (3) connecting innovators and physicians to existing 
        Federal and non-Federal resources, including resources from the 
        Food and Drug Administration, the National Institutes of 
        Health, the Small Business Administration, the Department of 
        Energy, the Department of Education, the National Science 
        Foundation, the Department of Veterans Affairs, the Agency for 
        Healthcare Research and Quality, and the National Institute of 
        Standards and Technology;
            (4) assessing the scientific and medical merit of proposed 
        pediatric device projects; and
            (5) providing assistance and advice as needed on business 
        development, personnel training, prototype development, 
        postmarket needs, and other activities consistent with the 
        purposes of this section.
    (d) Coordination.--
            (1) National institutes of health.--Each consortium that 
        receives a grant or contract under this section shall--
                    (A) coordinate with the National Institutes of 
                Health's pediatric device contact point or office, 
                designated under section 424; and
                    (B) provide to the National Institutes of Health 
                any identified pediatric device needs that the 
                consortium lacks sufficient capacity to address or 
                those needs in which the consortium has been unable to 
                stimulate manufacturer interest.
            (2) Food and drug administration.--Each consortium that 
        receives a grant or contract under this section shall 
        coordinate with the Commissioner of Food and Drugs and device 
        companies to facilitate the application for approval or 
        clearance of devices labeled for pediatric use.
            (3) Effectiveness and outcomes.--Each consortium that 
        receives a grant or contract under this section shall annually 
        report to the Secretary of Health and Human Services on--
                    (A) the effectiveness of activities conducted under 
                subsection (c);
                    (B) the impact of activities conducted under 
                subsection (c) on pediatric device development; and
                    (C) the status of pediatric device development that 
                has been facilitated by the consortium.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $6,000,000 for each of fiscal 
years 2008 through 2012.

SEC. 426. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC 
              ADVISORY COMMITTEE.

    (a) In General.--
            (1) Office of pediatric therapeutics.--Section 6(b) of the 
        Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
        amended by inserting ``, including increasing pediatric access 
        to medical devices'' after ``pediatric issues''.
            (2) Plan for pediatric medical device research.--
                    (A) In general.--Not later than 270 days after the 
                date of enactment of this subtitle, the Office of 
                Pediatric Therapeutics, in collaboration with the 
                Director of the National Institutes of Health and the 
                Director of the Agency for Healthcare Research and 
                Quality, shall submit to the Committee on Health, 
                Education, Labor, and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives a plan for expanding pediatric medical 
                device research and development. In developing such 
                plan, the Commissioner of Food and Drugs shall consult 
                with individuals and organizations with appropriate 
                expertise in pediatric medical devices.
                    (B) Contents.--The plan under subparagraph (A) 
                shall include--
                            (i) the current status of federally funded 
                        pediatric medical device research;
                            (ii) any gaps in such research, which may 
                        include a survey of pediatric medical providers 
                        regarding unmet pediatric medical device needs, 
                        as needed; and
                            (iii) a research agenda for improving 
                        pediatric medical device development and Food 
                        and Drug Administration clearance or approval 
                        of pediatric medical devices, and for 
                        evaluating the short- and long-term safety and 
                        effectiveness of pediatric medical devices.
    (b) Pediatric Advisory Committee.--Section 14 of the Best 
Pharmaceuticals for Children Act (42 U.S.C. 284m note) is amended--
            (1) in subsection (a), by inserting ``(including drugs and 
        biological products) and medical devices'' after 
        ``therapeutics''; and
            (2) in subsection (b)--
                    (A) in paragraph (1), by inserting ``(including 
                drugs and biological products) and medical devices'' 
                after ``therapeutics''; and
                    (B) in paragraph (2)--
                            (i) in subparagraph (A), by striking ``and 
                        505B'' and inserting ``505B, 510(k), 515, and 
                        520(m)'';
                            (ii) by striking subparagraph (B) and 
                        inserting the following:
                    ``(B) identification of research priorities related 
                to therapeutics (including drugs and biological 
                products) and medical devices for pediatric populations 
                and the need for additional diagnostics and treatments 
                for specific pediatric diseases or conditions; and''; 
                and
                            (iii) in subparagraph (C), by inserting 
                        ``(including drugs and biological products) and 
                        medical devices'' after ``therapeutics''.

SEC. 427. POSTMARKET SURVEILLANCE.

    (a) Postmarket Surveillance.--Section 522 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360l) is amended--
            (1) by striking subsection (a) and inserting the following:
    ``(a) Postmarket Surveillance.--
            ``(1) In general.--
                    ``(A) Conduct.--The Secretary may by order require 
                a manufacturer to conduct postmarket surveillance for 
                any device of the manufacturer that is a class II or 
                class III device--
                            ``(i) the failure of which would be 
                        reasonably likely to have serious adverse 
                        health consequences;
                            ``(ii) that is expected to have significant 
                        use in pediatric populations; or
                            ``(iii) that is intended to be--
                                    ``(I) implanted in the human body 
                                for more than 1 year; or
                                    ``(II) a life-sustaining or life-
                                supporting device used outside a device 
                                user facility.
                    ``(B) Condition.--The Secretary may order a 
                postmarket surveillance under subparagraph (A) as a 
                condition to approval or clearance of a device 
                described in subparagraph (A)(ii).
            ``(2) Rule of construction.--The provisions of paragraph 
        (1) shall have no effect on authorities otherwise provided 
        under the Act or regulations issued under this Act.''; and
            (2) in subsection (b)--
                    (A) by striking ``(b) Surveillance Approval.--
                Each'' and inserting the following:
    ``(b) Surveillance Approval.--
            ``(1) In general.--Each'';
                    (B) by striking ``The Secretary, in consultation'' 
                and inserting ``Except as provided in paragraph (2), 
                the Secretary, in consultation'';
                    (C) by striking ``Any determination'' and inserting 
                ``Except as provided in paragraph (2), any 
                determination''; and
                    (D) by adding at the end the following:
            ``(2) Longer surveillances for pediatric devices.--The 
        Secretary may by order require a prospective surveillance 
        period of more than 36 months with respect to a device that is 
        expected to have significant use in pediatric populations if 
        such period of more than 36 months is necessary in order to 
        assess the impact of the device on growth and development, or 
        the effects of growth, development, activity level, or other 
        factors on the safety of the device.''.

                       TITLE V--OTHER PROVISIONS

SEC. 501. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES 
              PUBLISHED BY FDA EMPLOYEES.

    Subchapter A of chapter VII of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371 et seq.), as amended by section 241, is further 
amended by adding at the end the following:

``SEC. 713. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC ARTICLES 
              PUBLISHED BY FDA EMPLOYEES.

    ``(a) Definition.--In this section, the term `article' means a 
paper, poster, abstract, book, book chapter, or other published 
writing.
    ``(b) Policies.--The Secretary, through the Commissioner of Food 
and Drugs, shall establish and make publicly available clear written 
policies to implement this section and govern the timely submission, 
review, clearance, and disclaimer requirements for articles.
    ``(c) Timing of Submission for Review.--If an officer or employee, 
including a Staff Fellow and a contractor who performs staff work, of 
the Food and Drug Administration is required by the policies 
established under subsection (b) to submit an article to the supervisor 
of such officer or employee, or to some other official of the Food and 
Drug Administration, for review and clearance before such officer or 
employee may seek to publish or present such an article at a 
conference, such officer or employee shall submit such article for such 
review and clearance not less than 30 days before submitting the 
article for publication or presentation.
    ``(d) Timing for Review and Clearance.--The supervisor or other 
reviewing official shall review such article and provide written 
clearance, or written clearance on the condition of specified changes 
being made, to such officer or employee not later than 30 days after 
such officer or employee submitted such article for review.
    ``(e) Non-Timely Review.--If, 31 days after such submission under 
subsection (c), the supervisor or other reviewing official has not 
cleared or has not reviewed such article and provided written 
clearance, such officer or employee may consider such article not to 
have been cleared and may submit the article for publication or 
presentation with an appropriate disclaimer as specified in the 
policies established under subsection (b).''.

SEC. 502. TECHNICAL AMENDMENTS.

    The Public Health Service Act (42 U.S.C. 201 et seq.) is amended--
            (1) in section 319C-2(j)(3)(B), by striking ``section 319C-
        1(h)'' and inserting ``section 319C-1(i)'';
            (2) in section 402(b)(4), by inserting ``minority and 
        other'' after ``reducing'';
            (3) in section 403(a)(4)(C)(iv)(III), by inserting ``and 
        post doctoral training funded through investigator-initiated 
        research grant awards'' before the semicolon; and
            (4) in section 403C(a)--
                    (A) in the matter preceding paragraph (1), by 
                inserting ``graduate students supported by NIH for'' 
                after ``with respect to'';
                    (B) in paragraph (1), by inserting ``such'' after 
                ``percentage of''; and
                    (C) in paragraph (2), by inserting ``(not including 
                any leaves of absence)'' after ``average time''.

SEC. 503. SEVERABILITY CLAUSE.

    If any provision of this Act, an amendment made this Act, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this Act, 
the amendments made by this Act, and the application of the provisions 
of such to any person or circumstances shall not be affected thereby.

SEC. 504. SENSE OF THE SENATE WITH RESPECT TO FOLLOW-ON BIOLOGICS.

    (a) Findings.--The Senate finds the following:
            (1) The Food and Drug Administration has stated that it 
        requires legislative authority to review follow-on biologics.
            (2) Business, consumer, and government purchasers require 
        competition and choice to ensure more affordable prescription 
        drug options.
            (3) Well-constructed policies that balance the needs of 
        innovation and affordability have broad bipartisan support.
    (b) Sense of the Senate.--It is the sense of the Senate that 
legislation should be enacted to--
            (1) provide the Food and Drug Administration with the 
        authority and flexibility to approve biopharmaceuticals subject 
        to an abbreviated approval pathway;
            (2) ensure that patient safety remains paramount in the 
        system;
            (3) establish a regulatory pathway that is efficient, 
        effective, and scientifically-grounded and that also includes 
        measures to ensure timely resolution of patent disputes; and
            (4) provide appropriate incentives to facilitate the 
        research and development of innovative biopharmaceuticals.

SEC. 505. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
              DISEASES.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR TROPICAL 
              DISEASES.

    ``(a) Definitions.--In this section:
            ``(1) AIDS.--The term `AIDS' means the acquired immune 
        deficiency syndrome.
            ``(2) AIDS drug.--The term `AIDS drug' means a drug 
        indicated for treating HIV.
            ``(3) HIV.--The term `HIV' means the human immunodeficiency 
        virus, the pathogen that causes AIDS.
            ``(4) Neglected or tropical disease.--The term `neglected 
        or tropical disease' means--
                    ``(A) HIV, malaria, tuberculosis, and related 
                diseases; or
                    ``(B) any other infectious disease that 
                disproportionately affects poor and marginalized 
                populations, including those diseases targeted by the 
                Special Programme for Research and Training in Tropical 
                Diseases cosponsored by the United Nations Development 
                Program, UNICEF, the World Bank, and the World Health 
                Organization.
            ``(5) Priority review.--The term `priority review', with 
        respect to a new drug application described in paragraph (6), 
        means review and action by the Secretary on such application 
        not later than 180 days after receipt by the Secretary of such 
        application, pursuant to the Manual of Policies and Procedures 
        of the Food and Drug Administration.
            ``(6) Priority review voucher.--The term `priority review 
        voucher' means a voucher issued by the Secretary to the sponsor 
        of a tropical disease product that entitles such sponsor, or a 
        person described under subsection (b)(2), to priority review of 
        a new drug application submitted under section 505(b)(1) after 
        the date of approval of the tropical disease product.
            ``(7) Tropical disease product.--The term `tropical disease 
        product' means a product that--
                    ``(A) is a new drug, antibiotic drug, biological 
                product, vaccine, device, diagnostic, or other tool for 
                treatment of a neglected or tropical disease; and
                    ``(B) is approved by the Secretary for use in the 
                treatment of a neglected or tropical disease.
    ``(b) Priority Review Voucher.--
            ``(1) In general.--The Secretary shall award a priority 
        review voucher to the sponsor of a tropical disease product 
        upon approval by the Secretary of such tropical disease 
        product.
            ``(2) Transferability.--The sponsor of a tropical disease 
        product that receives a priority review voucher under this 
        section may transfer (including by sale) the entitlement to 
        such voucher to a sponsor of a new drug for which an 
        application under section 505(b)(1) will be submitted after the 
        date of the approval of the tropical disease product.
            ``(3) Limitation.--A sponsor of a tropical disease product 
        may not receive a priority review voucher under this section if 
        the tropical disease product was approved by the Secretary 
        prior to the date of enactment of this section.
    ``(c) Priority Review User Fee.--
            ``(1) In general.--The Secretary shall establish a user fee 
        program under which a sponsor of a drug that is the subject of 
        a priority review voucher shall pay to the Secretary a fee 
        determined under paragraph (2). Such fee shall be in addition 
        to any fee required to be submitted by the sponsor under 
        chapter VII.
            ``(2) Fee amount.--The amount of the priority review user 
        fee shall be determined each fiscal year by the Secretary and 
        based on the anticipated costs to the Secretary of implementing 
        this section.
            ``(3) Annual fee setting.--The Secretary shall establish, 
        before the beginning of each fiscal year beginning after 
        September 30, 2007, for that fiscal year, the amount of the 
        priority review user fee.
            ``(4) Payment.--
                    ``(A) In general.--The fee required by this 
                subsection shall be due upon the filing of the new drug 
                application under section 505(b)(1) for which the 
                voucher is used.
                    ``(B) Complete application.--An application 
                described under subparagraph (A) for which the sponsor 
                requests the use of a priority review voucher shall be 
                considered incomplete if the fee required by this 
                subsection is not included in such application.
            ``(5) Offsetting collections.--Fees collected pursuant to 
        this subsection for any fiscal year--
                    ``(A) shall be deposited and credited as offsetting 
                collections to the account providing appropriations to 
                the Food and Drug Administration; and
                    ``(B) shall not be collected for any fiscal year 
                except to the extent provided in advance in 
                appropriation Acts.''.

SEC. 506. CITIZENS PETITIONS AND PETITIONS FOR STAY OF AGENCY ACTION.

    Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355), as amended by this Act, is amended by adding at the end the 
following:
    ``(s) Citizen Petitions and Petitions for Stay of Agency Action.--
            ``(1) In general.--
                    ``(A) No delay of consideration or approval.--
                            ``(i) In general.--With respect to a 
                        pending application submitted under subsection 
                        (b)(2) or (j), if a petition is submitted to 
                        the Secretary that seeks to have the Secretary 
                        take, or refrain from taking, any form of 
                        action relating to the approval of the 
                        application, including a delay in the effective 
                        date of the application, clauses (ii) and (iii) 
                        shall apply.
                            ``(ii) No delay of consideration or 
                        approval.--Except as provided in clause (iii), 
                        the receipt and consideration of a petition 
                        described in clause (i) shall not delay 
                        consideration or approval of an application 
                        submitted under subsection (b)(2) or (j).
                            ``(iii) No delay of approval without 
                        determination.--The Secretary shall not delay 
                        approval of an application submitted under 
                        subsection (b)(2) or (j) while a petition 
                        described in clause (i) is reviewed and 
                        considered unless the Secretary determines, not 
                        later than 25 business days after the 
                        submission of the petition, that a delay is 
                        necessary to protect the public health.
                    ``(B) Determination of delay.--With respect to a 
                determination by the Secretary under subparagraph 
                (A)(iii) that a delay is necessary to protect the 
                public health the following shall apply:
                            ``(i) Not later than 5 days after making 
                        such determination, the Secretary shall publish 
                        on the Internet website of the Food and Drug 
                        Administration a detailed statement providing 
                        the reasons underlying the determination. The 
                        detailed statement shall include a summary of 
                        the petition and comments and supplements, the 
                        specific substantive issues that the petition 
                        raises which need to be considered prior to 
                        approving a pending application submitted under 
                        subsection (b)(2) or (j), and any 
                        clarifications and additional data that is 
                        needed by the Secretary to promptly review the 
                        petition.
                            ``(ii) Not later than 10 days after making 
                        such determination, the Secretary shall provide 
                        notice to the sponsor of the pending 
                        application submitted under subsection (b)(2) 
                        or (j) and provide an opportunity for a meeting 
                        with appropriate staff as determined by the 
                        Commissioner to discuss the determination.
            ``(2) Timing of final agency action on petitions.--
                    ``(A) In general.--Notwithstanding a determination 
                made by the Secretary under paragraph (1)(A)(iii), the 
                Secretary shall take final agency action with respect 
                to a petition not later than 180 days of submission of 
                that petition unless the Secretary determines, prior to 
                the date that is 180 days after the date of submission 
                of the petition, that a delay is necessary to protect 
                the public health.
                    ``(B) Determination of delay.--With respect to a 
                determination by the Secretary under subparagraph (A) 
                that a delay is necessary to protect the public health 
                the following shall apply:
                            ``(i) Not later than 5 days after making 
                        the determination under subparagraph (A), the 
                        Secretary shall publish on the Internet website 
                        of the Food and Drug Administration a detailed 
                        statement providing the reasons underlying the 
                        determination. The detailed statement should 
                        include the state of the review of the 
                        petition, the specific outstanding issues that 
                        still need to be resolved, a proposed timeframe 
                        to resolve the issues, and any additional 
                        information that has been requested by the 
                        Secretary of the petitioner or needed by the 
                        Secretary in order to resolve the petition and 
                        not further delay an application filed under 
                        subsection (b)(2) or (j).
                            ``(ii) Not later than 10 days after making 
                        the determination under subparagraph (A), the 
                        Secretary shall provide notice to the sponsor 
                        of the pending application submitted under 
                        subsection (b)(2) or (j) and provide an 
                        opportunity for a meeting with appropriate 
                        staff as determined by the Commissioner to 
                        discuss the determination.
            ``(3) Verifications.--
                    ``(A) Petitions for review.--The Secretary shall 
                not accept a petition for review unless it is signed 
                and contains the following verification: `I certify 
                that, to my best knowledge and belief: (a) this 
                petition includes all information and views upon which 
                the petition relies; (b) this petition includes 
                representative data and/or information known to the 
                petitioner which are unfavorable to the petition; and 
                (c) information upon which I have based the action 
                requested herein first became known to the party on 
                whose behalf this petition is filed on or about 
                __________. I received or expect to receive payments, 
                including cash and other forms of consideration, from 
                the following persons or organizations to file this 
                petition: ________. I verify under penalty of perjury 
                that the foregoing is true and correct.', with the date 
                of the filing of such petition and the signature of the 
                petitioner inserted in the first and second blank 
                space, respectively.
                    ``(B) Supplemental information.--The Secretary 
                shall not accept for review any supplemental 
                information or comments on a petition unless the party 
                submitting such information or comments does so in 
                written form and that the subject document is signed 
                and contains the following verification: `I certify 
                that, to my best knowledge and belief: (a) I have not 
                intentionally delayed submission of this document or 
                its contents; and (b) the information upon which I have 
                based the action requested herein first became known to 
                me on or about __________. I received or expect to 
                receive payments, including cash and other forms of 
                consideration, from the following persons or 
                organizations to submit this information or its 
                contents: _____. I verify under penalty of perjury that 
                the foregoing is true and correct.', with the date of 
                the submission of such document and the signature of 
                the petitioner inserted in the first and second blank 
                space, respectively.
            ``(4) Annual report on delays in approvals per petition.--
        The Secretary shall annually submit to the Congress a report 
        that specifies--
                    ``(A) the number of applications under subsection 
                (b)(2) and (j) that were approved during the preceding 
                1-year period;
                    ``(B) the number of petitions that were submitted 
                during such period;
                    ``(C) the number of applications whose effective 
                dates were delayed by petitions during such period and 
                the number of days by which the applications were so 
                delayed; and
                    ``(D) the number of petitions that were filed under 
                this subsection that were deemed by the Secretary under 
                paragraph (1)(A)(iii) to require delaying an 
                application under subsection (b)(2) or (j) and the 
                number of days by which the applications were so 
                delayed.
            ``(5) Exception.--This subsection does not apply to a 
        petition that is made by the sponsor of the application under 
        subsection (b)(2) or (j) and that seeks only to have the 
        Secretary take or refrain from taking any form of action with 
        respect to that application.
            ``(6) Report by inspector general.--The Office of Inspector 
        General of the Department of Health and Human Services shall 
        issue a report not later than 2 years after the date of 
        enactment of this subsection evaluating evidence of the 
        compliance of the Food and Drug Administration with the 
        requirement that the consideration by the Secretary of 
        petitions that do not raise public health concerns remain 
        separate and apart from the review and approval of an 
        application submitted under subsection (b)(2) or (j).
            ``(7) Definition.--For purposes of this subsection, the 
        term `petition' includes any request for an action described in 
        paragraph (1)(A)(i) to the Secretary, without regard to whether 
        the request is characterized as a petition.''.

SEC. 507. PUBLICATION OF ANNUAL REPORTS.

    (a) In General.--The Commissioner on Food and Drugs shall annually 
submit to Congress and publish on the Internet website of the Food and 
Drug Administration, a report concerning the results of the 
Administration's pesticide residue monitoring program, that includes--
            (1) information and analysis similar to that contained in 
        the report entitled ``Food and Drug Administration Pesticide 
        Program Residue Monitoring 2003'' as released in June of 2005;
            (2) based on an analysis of previous samples, an 
        identification of products or countries (for imports) that 
        require special attention and additional study based on a 
        comparison with equivalent products manufactured, distributed, 
        or sold in the United States (including details on the plans 
        for such additional studies), including in the initial report 
        (and subsequent reports as determined necessary) the results 
        and analysis of the Ginseng Dietary Supplements Special Survey 
        as described on page 13 of the report entitled ``Food and Drug 
        Administration Pesticide Program Residue Monitoring 2003'';
            (3) information on the relative number of interstate and 
        imported shipments of each tested commodity that were sampled, 
        including recommendations on whether sampling is statistically 
        significant, provides confidence intervals or other related 
        statistical information, and whether the number of samples 
        should be increased and the details of any plans to provide for 
        such increase; and
            (4) a description of whether certain commodities are being 
        improperly imported as another commodity, including a 
        description of additional steps that are being planned to 
        prevent such smuggling.
    (b) Initial Reports.--Annual reports under subsection (a) for 
fiscal years 2004 through 2006 may be combined into a single report, by 
not later than June 1, 2008, for purposes of publication under 
subsection (a). Thereafter such reports shall be completed by June 1 of 
each year for the data collected for the year that was 2-years prior to 
the year in which the report is published.
    (c) Memorandum of Understanding.--The Commissioner of Food and 
Drugs, the Administrator of the Food Safety and Inspection Service, the 
Department of Commerce, and the head of the Agricultural Marketing 
Service shall enter into a memorandum of understanding to permit 
inclusion of data in the reports under subsection (a) relating to 
testing carried out by the Food Safety and Inspection Service and the 
Agricultural Marketing Service on meat, poultry, eggs, and certain raw 
agricultural products, respectively.

SEC. 508. HEAD START ACT AMENDMENT IMPOSING PARENTAL CONSENT 
              REQUIREMENT FOR NONEMERGENCY INTRUSIVE PHYSICAL 
              EXAMINATIONS.

    The Head Start Act (42 U.S.C. 9831 et seq.) is amended by adding at 
the end the following:

``SEC. 657A. PARENTAL CONSENT REQUIREMENT FOR NONEMERGENCY INTRUSIVE 
              PHYSICAL EXAMINATIONS.

    ``(a) In General.--A Head Start agency shall obtain written 
parental consent before administration of any nonemergency intrusive 
physical examination of a child in connection with participation in a 
program under this subchapter.
    ``(b) Definition.--The term `nonemergency intrusive physical 
examination' means, with respect to a child, a physical examination 
that--
            ``(1) is not immediately necessary to protect the health or 
        safety of the child involved or the health or safety of another 
        individual; and
            ``(2) requires incision or is otherwise invasive, or 
        involves exposure of private body parts.
    ``(c) Rule of Construction.--Nothing in this section shall be 
construed to prohibit agencies from using established methods, for 
handling cases of suspected or known child abuse and neglect, that are 
in compliance with applicable Federal, State, or tribal law.''.

SEC. 509. SAFETY OF FOOD ADDITIVES.

    Not later than 90 days after the date of enactment of this Act, the 
Food and Drug Administration shall issue a report on the question of 
whether substances used to preserve the appearance of fresh meat may 
create any health risks, or mislead consumers.

SEC. 510. IMPROVING GENETIC TEST SAFETY AND QUALITY.

    Not later than 30 days after the date of enactment of this Act, the 
Secretary shall enter into a contract with the Institute of Medicine to 
conduct a study to assess the overall safety and quality of genetic 
tests and prepare a report that includes recommendations to improve 
Federal oversight and regulation of genetic tests. Such study shall 
take into consideration relevant reports by the Secretary's Advisory 
Committee on Genetic Testing and other groups and shall be completed 
not later than 1 year after the date on which the Secretary entered 
into such contract.

SEC. 511. ORPHAN DISEASE TREATMENT IN CHILDREN.

    (a) Finding.--The Senate finds that parents of children suffering 
from rare genetic diseases known as orphan diseases face multiple 
obstacles in obtaining safe and effective treatment for their children 
due mainly to the fact that many Food and Drug Administration-approved 
drugs used in the treatment of orphan diseases in children may not be 
approved for pediatric indications.
    (b) Sense of the Senate.--It is the sense of the Senate that the 
Food and Drug Administration should enter into a contract with the 
Institute of Medicine for the conduct of a study concerning measures 
that may be taken to improve the likelihood that Food and Drug 
Administration-approved drugs that are safe and effective in treating 
children with orphan diseases are made available and affordable for 
pediatric indications.

SEC. 512. COLOR CERTIFICATION REPORTS.

    Section 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
379e) is amended by adding at the end the following:
    ``(g) Color Certification Reports.--Not later than--
            ``(1) 90 days after the close of a fiscal year in which 
        color certification fees are collected, the Secretary shall 
        submit to Congress a performance report for such fiscal year on 
        the number of batches of color additives approved, the average 
        turn around time for approval, and quantifiable goals for 
        improving laboratory efficiencies; and
            ``(2) 120 days after the close of a fiscal year in which 
        color certification fees are collected, the Secretary shall 
        submit to Congress a financial report for such fiscal year that 
        includes all fees and expenses of the color certification 
        program, the balance remaining in the fund at the end of the 
        fiscal year, and anticipated costs during the next fiscal year 
        for equipment needs and laboratory improvements of such 
        program.''.

SEC. 513. PROHIBITION ON IMPORTATION FROM A FOREIGN FOOD FACILITY THAT 
              DENIES ACCESS TO FOOD INSPECTORS.

    Notwithstanding any other provision of law, no food product may be 
imported into the United States that is the product of a foreign 
facility registered under section 415 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 350d) that refuses to permit United States 
inspectors, upon request, to inspect such facility or that unduly 
delays access to United States inspectors.

SEC. 514. COUNTERFEIT-RESISTANT TECHNOLOGIES.

    Notwithstanding any other provision of this Act, the requirement 
that the Secretary of Health and Human Services certify that the 
implementation of the title of this Act relating to the Importation of 
Prescription Drugs will pose no additional risk to the public's health 
and safety and will result in a significant reduction in the cost of 
covered products to the American consumer shall not apply to the 
requirement that the Secretary require that the packaging of any 
prescription drug incorporates--
            (1) not later than 18 months after the date of enactment of 
        this Act, a standardized numerical identifier (which, to the 
        extent practicable, shall be harmonized with international 
        consensus standards for such an identifier) unique to each 
        package of such drug, applied at the point of manufacturing and 
        repackaging (in which case the numerical identifier shall be 
        linked to the numerical identifier applied at the point of 
        manufacturing); and
            (2) not later than 24 months after the date of enactment of 
        this Act for the 50 prescription drugs with the highest dollar 
        volume of sales in the United States, based on the calendar 
        year that ends of December 31, 2007, and, not later than 30 
        months after the date of enactment of this Act for all other 
        prescription drugs--
                    (A) overt optically variable counterfeit-resistant 
                technologies that--
                            (i) are visible to the naked eye, providing 
                        for visual identification of product 
                        authenticity without the need for readers, 
                        microscopes, lighting devices, or scanners;
                            (ii) are similar to that used by the Bureau 
                        of Engraving and Printing to secure United 
                        States currency;
                            (iii) are manufactured and distributed in a 
                        highly secure, tightly controlled environment; 
                        and
                            (iv) incorporate additional layers of 
                        nonvisible convert security features up to and 
                        including forensic capability; or
                    (B) technologies that have a function of security 
                comparable to that described in subparagraph (A), as 
                determined by the Secretary.

SEC. 515. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

    (a) Findings.--Congress finds the following:
            (1) In 2007, there has been an overwhelming increase in the 
        volume of aquaculture and seafood that has been found to 
        contain substances that are not approved for use in food in the 
        United States.
            (2) As of May 2007, inspection programs are not able to 
        satisfactorily accomplish the goals of ensuring the food safety 
        of the United States.
            (3) To protect the health and safety of consumers in the 
        United States, the ability of the Secretary of Health and Human 
        Services to perform inspection functions must be enhanced.
    (b) Heightened Inspections.--The Secretary of Health and Human 
Services (referred to in this section as the ``Secretary'') is 
authorized to, by regulation, enhance, as necessary, the inspection 
regime of the Food and Drug Administration for aquaculture and seafood, 
consistent with obligations of the United States under international 
agreements and United States law.
    (c) Report to Congress.--Not later than 90 days after the date of 
enactment of this Act, the Secretary shall submit to Congress a report 
that--
            (1) describes the specifics of the aquaculture and seafood 
        inspection program;
            (2) describes the feasibility of developing a traceability 
        system for all catfish and seafood products, both domestic and 
        imported, for the purpose of identifying the processing plant 
        of origin of such products; and
            (3) provides for an assessment of the risks associated with 
        particular contaminants and banned substances.
    (d) Partnerships With States.--Upon the request by any State, the 
Secretary may enter into partnership agreements, as soon as practicable 
after the request is made, to implement inspection programs regarding 
the importation of aquaculture and seafood.
    (e) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as may be necessary to carry out this section.

SEC. 516. SENSE OF THE SENATE REGARDING CERTAIN PATENT INFRINGEMENTS.

    (a) Findings.--The Senate makes the following findings:
            (1) Innovation in developing life-saving prescription drugs 
        saves millions of lives around the world each year.
            (2) The responsible protection of intellectual property is 
        vital to the continued development of new and life-saving drugs 
        and future growth of the United States economy.
            (3) In order to maintain the global competitiveness of the 
        United States, the United States Trade Representative's Office 
        of Intellectual Property and Innovation develops and implements 
        trade policy in support of vital American innovations, 
        including innovation in the pharmaceutical and medical 
        technology industries.
            (4) The United States Trade Representative also provides 
        trade policy leadership and expertise across the full range of 
        interagency initiatives to enhance protection and enforcement 
        of intellectual property rights.
            (5) Strong and fair intellectual property protection, 
        including patent, copyright, trademark, and data protection 
        plays an integral role in fostering economic growth and 
        development and ensuring patient access to the most effective 
        medicines around the world.
            (6) There are concerns that certain countries have engaged 
        in unfair price manipulation and abuse of compulsory licensing. 
        Americans bear the majority of research and development costs 
        for the world, which could undermine the value of existing 
        United States pharmaceutical patents and could impede access to 
        important therapies.
            (7) There is a growing global threat of counterfeit 
        medicines and increased need for the United States Trade 
        Representative and other United States agencies to use 
        available trade policy measures to strengthen laws and 
        enforcement abroad to prevent harm to United States patients 
        and patients around the world.
    (b) Sense of the Senate.--It is the sense of the Senate that--
            (1) the United States Trade Representative should use all 
        the tools at the disposal of the Trade Representative to 
        address violations and other concerns with intellectual 
        property, including through--
                    (A) bilateral engagement with United States trading 
                partners;
                    (B) transparency and balance of the annual 
                ``Special 301'' review and reviews of compliance with 
                the intellectual property requirements of countries 
                with respect to which the United States grants trade 
                preferences;
                    (C) negotiation of responsible and fair 
                intellectual property provisions as part of bilateral 
                and regional trade agreements; and
                    (D) multilateral engagement through the World Trade 
                Organization (WTO); and
            (2) the United States Trade Representative should develop 
        and submit to Congress a strategic plan to address the problem 
        of countries that infringe upon American pharmaceutical 
        intellectual property rights and the problem of countries that 
        engage in price manipulation.

SEC. 517. CONSULTATION REGARDING GENETICALLY ENGINEERED SEAFOOD 
              PRODUCTS.

    The Commissioner of Food and Drugs shall consult with the Assistant 
Administrator of the National Marine Fisheries Service of the National 
Oceanic and Atmospheric Administration to produce a report on any 
environmental risks associated with genetically engineered seafood 
products, including the impact on wild fish stocks.

SEC. 518. REPORT ON THE MARKETING OF CERTAIN CRUSTACEANS.

    Not later than 30 days after the date of enactment of this Act, the 
Secretary of Health and Human Services, in consultation with the 
Secretary of Commerce, shall submit to the Health, Education, Labor, 
and Pensions Committee and the Committee on Commerce, Science, and 
Transportation of the Senate, a report on the differences between 
taxonomy of species of lobster in the subfamily Nephropinae, and 
species of langostino, specifically from the infraorder Caridea or 
Anomura. This report shall also describe the differences in consumer 
perception of such species, including such factors as taste, quality, 
and value of the species.

SEC. 519. CIVIL PENALTIES; DIRECT-TO-CONSUMER ADVERTISEMENT.

    (a) Civil Penalties.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following:
    ``(g)(1) Any applicant (as such term is used in section 505(o)) who 
disseminates a direct-to-consumer advertisement for a prescription drug 
that is false or misleading and a violation of section 502(n) shall be 
liable to the United States for a civil penalty in an amount not to 
exceed $150,000 for the first such violation in any 3-year period, and 
not to exceed $300,000 for each subsequent violation committed after 
the applicant has been penalized under this paragraph any time in the 
preceding 3-year period. For the purposes of this paragraph, repeated 
dissemination of the same or similar advertisement prior to the receipt 
of the written notice referred to in paragraph (2) for such 
advertisements shall be considered as 1 violation.
    ``(2) A civil penalty under paragraph (1) shall be assessed by the 
Secretary by an order made on the record after providing written notice 
to the applicant to be assessed a civil penalty and an opportunity for 
a hearing in accordance with this paragraph and section 554 of title 5, 
United States Code. If upon receipt of the written notice, the 
applicant to be assessed a civil penalty objects and requests a 
hearing, then in the course of any investigation related to such 
hearing, the Secretary may issue subpoenas requiring the attendance and 
testimony of witnesses and the production of evidence that relates to 
the matter under investigation, including information pertaining to the 
factors described in paragraph (3).
    ``(3) Upon the request of the applicant to be assessed a civil 
penalty, the Secretary, in determining the amount of a civil penalty, 
shall take into account the nature, circumstances, extent, and gravity 
of the violation or violations, including the following factors:
            ``(A) Whether the applicant submitted the advertisement or 
        a similar advertisement for review under section 736A.
            ``(B) Whether the applicant submitted the advertisement for 
        prereview if required under section 505(o)(5)(D).
            ``(C) Whether, after submission of the advertisement as 
        described in subparagraph (A) or (B), the applicant 
        disseminated the advertisement before the end of the 45-day 
        comment period.
            ``(D) Whether the applicant failed to incorporate any 
        comments made by the Secretary with regard to the advertisement 
        or a similar advertisement into the advertisement prior to its 
        dissemination.
            ``(E) Whether the applicant ceased distribution of the 
        advertisement upon receipt of the written notice referred to in 
        paragraph (2) for such advertisement.
            ``(F) Whether the applicant had the advertisement reviewed 
        by qualified medical, regulatory, and legal reviewers prior to 
        its dissemination.
            ``(G) Whether the violations were material.
            ``(H) Whether the applicant who created the advertisement 
        acted in good faith.
            ``(I) Whether the applicant who created the advertisement 
        has been assessed a civil penalty under this provision within 
        the previous 1-year period.
            ``(J) The scope and extent of any voluntary, subsequent 
        remedial action by the applicant.
            ``(K) Such other matters, as justice may require.
    ``(4)(A) Subject to subparagraph (B), no applicant shall be 
required to pay a civil penalty under paragraph (1) if the applicant 
submitted the advertisement to the Secretary and disseminated such 
advertisement after incorporating any comment received from the 
Secretary.
    ``(B) The Secretary may retract or modify any prior comments the 
Secretary has provided to an advertisement submitted to the Secretary 
based on new information or changed circumstances, so long as the 
Secretary provides written notice to the applicant of the new views of 
the Secretary on the advertisement and provides a reasonable time for 
modification or correction of the advertisement prior to seeking any 
civil penalty under paragraph (1).
    ``(5) The Secretary may compromise, modify, remit, with or without 
conditions, any civil penalty which may be assessed under paragraph 
(1). The amount of such penalty, when finally determined, or the amount 
charged upon in compromise, may be deducted from any sums owned by the 
United States to the applicant charged.
    ``(6) Any applicant who requested, in accordance with paragraph 
(2), a hearing with respect to the assessment of a civil penalty and 
who is aggrieved by an order assessing a civil penalty, may file a 
petition for de novo judicial review of such order with the United 
States Court of Appeals for the District of Columbia Circuit or for any 
other circuit in which such applicant resides or transacts business. 
Such a petition may only be filed within the 60-day period beginning on 
the date the order making such assessments was issued.
    ``(7) If any applicant fails to pay an assessment of a civil 
penalty--
            ``(A) after the order making the assessment becomes final, 
        and if such applicant does not file a petition for judicial 
        review of the order in accordance with paragraph (6); or
            ``(B) after a court in an action brought under paragraph 
        (6) has entered a final judgment in favor of the Secretary,
the Attorney General shall recover the amount assessed (plus interest 
at currently prevailing rates from the date of the expiration of the 
60-day period referred to in paragraph (6) or date of such final 
judgment, as the case may be) in an action brought in any appropriate 
district court of the United States. In such an action, the validity, 
amount, and appropriateness of such penalty shall not be subject to 
review.''.
    (b) Direct-to-Consumer Advertisement.--
            (1) In general.--Section 502(n) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(n)) is amended by inserting 
        after the first sentence the following: ``In the case of an 
        advertisement for a prescription drug presented directly to 
        consumers in television or radio format that states the name of 
        the drug and its conditions of use, the major statement 
        relating to side effects, contraindications, and effectiveness 
        referred to in the previous sentence shall be stated in a clear 
        and conspicuous (neutral) manner.''.
            (2) Regulations to determine neutral manner.--The Secretary 
        of Health and Human Services shall by regulation establish 
        standards for determining whether a major statement, relating 
        to side effects, contraindications, and effectiveness of a 
        drug, described in section 502(n) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 352(n)) (as amended by paragraph 
        (1)) is presented in the manner required under such section.

SEC. 520. REPORT BY THE FOOD AND DRUG ADMINISTRATION REGARDING LABELING 
              INFORMATION ON THE RELATIONSHIP BETWEEN THE USE OF INDOOR 
              TANNING DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER 
              SKIN DAMAGE.

    (a) In General.--The Secretary of Health and Human Services 
(referred to in this section as the ``Secretary''), acting through the 
Commissioner of Food and Drugs, shall determine--
            (1) whether the labeling requirements for indoor tanning 
        devices, including the positioning requirements, provide 
        sufficient information to consumers regarding the risks that 
        the use of such devices pose for the development of 
        irreversible damage to the eyes and skin, including skin 
        cancer; and
            (2)(A) whether modifying the warning label required on 
        tanning beds to read, ``Ultraviolet radiation can cause skin 
        cancer'', or any other additional warning, would communicate 
        the risks of indoor tanning more effectively; or
            (B) whether there is no warning that would be capable of 
        adequately communicating such risks.
    (b) Consumer Testing.--In making the determinations under 
subsection (a), the Secretary shall conduct appropriate consumer 
testing, using the best available methods for determining consumer 
understanding of label warnings.
    (c) Public Hearings; Public Comment.--The Secretary shall hold 
public hearings and solicit comments from the public in making the 
determinations under subsection (a).
    (d) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Secretary shall submit to the Congress a report that 
provides the determinations under subsection (a). In addition, the 
Secretary shall include in the report the measures being implemented by 
the Secretary to significantly reduce the risks associated with indoor 
tanning devices.

                         TITLE VI--FOOD SAFETY

SEC. 601. FINDINGS.

    (a) Findings.--Congress finds that--
            (1) the safety and integrity of the United States food 
        supply is vital to the public health, to public confidence in 
        the food supply, and to the success of the food sector of the 
        Nation's economy;
            (2) illnesses and deaths of individuals and companion 
        animals caused by contaminated food--
                    (A) have contributed to a loss of public confidence 
                in food safety; and
                    (B) have caused significant economic losses to 
                manufacturers and producers not responsible for 
                contaminated food items;
            (3) the task of preserving the safety of the food supply of 
        the United States faces tremendous pressures with regard to--
                    (A) emerging pathogens and other contaminants and 
                the ability to detect all forms of contamination; and
                    (B) an increasing volume of imported food from a 
                wide variety of countries; and
                    (C) a shortage of adequate resources for monitoring 
                and inspection;
            (4) the United States is increasing the amount of food that 
        it imports such that--
                    (A) from 2003 to the present, the value of food 
                imports has increased from $45,600,000,000 to 
                $64,000,000,000; and
                    (B) imported food accounts for 13 percent of the 
                average Americans diet including 31 percent of fruits, 
                juices, and nuts, 9.5 percent of red meat and 78.6 
                percent of fish and shellfish; and
            (5) the number of full time equivalent Food and Drug 
        Administration employees conducting inspections has decreased 
        from 2003 to 2007.

SEC. 602. ENSURING THE SAFETY OF PET FOOD.

    (a) Processing and Ingredient Standards.--Not later than 18 months 
after the date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this title as the ``Secretary''), in 
consultation with the Association of American Feed Control Officials, 
and other relevant stakeholder groups, including veterinary medical 
associations, animal health organizations, and pet food manufacturers, 
shall by regulation establish--
            (1) processing and ingredient standards with respect to pet 
        food, animal waste, and ingredient definitions; and
            (2) updated standards for the labeling of pet food that 
        includes nutritional information and ingredient information.
    (b) Early Warning Surveillance Systems and Notification During Pet 
Food Recalls.--Not later than 180 days after the date of enactment of 
this Act, the Secretary shall by regulation establish an early warning 
and surveillance system to identify adulteration of the pet food supply 
and outbreaks of illness associated with pet food. In establishing such 
system, the Secretary shall--
            (1) use surveillance and monitoring mechanisms similar to, 
        or in coordination with, those mechanisms used by the Centers 
        for Disease Control and Prevention to monitor human health, 
        such as the Foodborne Diseases Active Surveillance Network 
        (FoodNet) and PulseNet;
            (2) consult with relevant professional associations and 
        private sector veterinary hospitals; and
            (3) work with the Health Alert Network and other 
        notification networks to inform veterinarians and relevant 
        stakeholders during any recall of pet food.

SEC. 603. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS DURING A 
              RECALL.

    The Secretary shall, during an ongoing recall of human or pet 
food--
            (1) work with companies, relevant professional 
        associations, and other organizations to collect and aggregate 
        information pertaining to the recall;
            (2) use existing networks of communication including 
        electronic forms of information dissemination to enhance the 
        quality and speed of communication with the public; and
            (3) post information regarding recalled products on the 
        Internet website of the Food and Drug Administration in a 
        consolidated, searchable form that is easily accessed and 
        understood by the public.

SEC. 604. STATE AND FEDERAL COOPERATION.

    (a) In General.--The Secretary shall work with the States in 
undertaking activities and programs that assist in improving the safety 
of fresh and processed produce so that State food safety programs 
involving the safety of fresh and processed produce and activities 
conducted by the Secretaries function in a coordinated and cost-
effective manner. With the assistance provided under subsection (b), 
the Secretary shall encourage States to--
            (1) establish, continue, or strengthen State food safety 
        programs, especially with respect to the regulation of retail 
        commercial food establishments; and
            (2) establish procedures and requirements for ensuring that 
        processed produce under the jurisdiction of the State food 
        safety programs is not unsafe for human consumption.
    (b) Assistance.--The Secretary may provide to a State, for 
planning, developing, and implementing such a food safety program--
            (1) advisory assistance;
            (2) technical assistance, training, and laboratory 
        assistance (including necessary materials and equipment); and
            (3) financial and other assistance.
    (c) Service Agreements.--The Secretary may, under an agreement 
entered into with a Federal, State, or local agency, use, on a 
reimbursable basis or otherwise, the personnel, services, and 
facilities of the agency to carry out the responsibilities of the 
agency under this section. An agreement entered into with a State 
agency under this subsection may provide for training of State 
employees.

SEC. 605. ADULTERATED FOOD REGISTRY.

    (a) Findings.--Congress makes the following findings:
            (1) In 1994, Congress passed the Dietary Supplement Health 
        and Education Act (P.L. 103-417) to provide the Food and Drug 
        Administration with the legal framework to ensure that dietary 
        supplements are safe and properly labeled foods.
            (2) In 2006, Congress passed the Dietary Supplement and 
        Nonprescription Drug Consumer Protection Act (P.L. 109-462) to 
        establish a mandatory reporting system of serious adverse 
        events for non-prescription drugs and dietary supplements sold 
        and consumed in the United States.
            (3) The adverse event reporting system created under the 
        Dietary Supplement and Nonprescription Drug Consumer Protection 
        Act will serve as the early warning system for any potential 
        public health issues associated with the use of these food 
        products.
            (4) A reliable mechanism to track patterns of adulteration 
        in food would support efforts by the Food and Drug 
        Administration to effectively target limited inspection 
        resources to protect the public health.
    (b) In General.--Chapter IV of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 341 et seq.) is amended by adding at the end the 
following:

``SEC. 417. ADULTERATED FOOD REGISTRY.

    ``(a) Definitions.--In this section:
            ``(1) Importer.--The term `importer', with respect to an 
        article of food, means the person who submitted the notice with 
        respect to such article of food under section 801(m).
            ``(2) Responsible party.--The term `responsible party', 
        with respect to an article of food, means any registered food 
        facility under section 415(a), including those responsible for 
        the manufacturing, processing, packaging or holding of such 
        food for consumption in the United States.
            ``(3) Reportable adulterated food.--The term `reportable 
        adulterated food' for purposes of this section means a food 
        that is adulterated or--
                    ``(A) presents a situation in which there is a 
                reasonable probability that the use of, or exposure to, 
                a violative product will cause serious adverse health 
                consequences or death as defined in section 7.3(m)(1) 
                of title, Code of Federal Regulations (or any successor 
                regulations); or
                    ``(B) meets the threshold established in section 
                304(h).
    ``(b) Establishment.--
            ``(1) In general.--Not later than 180 days after the date 
        of enactment of this section, the Secretary shall establish 
        within the Food and Drug Administration an Adulterated Food 
        Registry to which instances of reportable adulterated food may 
        be submitted by the Food and Drug Administration after receipt 
        of reports of adulteration, via an electronic portal, from--
                    ``(A) Federal, State, and local public health 
                officials;
                    ``(B) an importer;
                    ``(C) a responsible party; or
                    ``(D) a consumer or other individual.
            ``(2) Review by secretary.--The Secretary shall review and 
        determine the validity of the information submitted under 
        paragraph (1) for the purposes of identifying adulterated food, 
        submitting entries to the Adulterated Food Registry, acting 
        under subsection (c), and exercising other existing food safety 
        authorities under the Act to protect the public health.
    ``(c) Issuance of an Alert by the Secretary.--
            ``(1) In general.--The Secretary shall issue an alert with 
        respect to an adulterated food if the Adulterated Food Registry 
        shows that the food--
                    ``(A) has been associated with repeated and 
                separate outbreaks of illness or has been repeatedly 
                determined to be adulterated; or
                    ``(B) is a reportable adulterated food.
            ``(2) Scope of alert.--An alert under paragraph (1) may 
        apply to a particular food or to food from a particular 
        producer, manufacturer, shipper, growing area, or country, to 
        the extent that elements in subparagraph (A) or (B) of 
        paragraph (1) are associated with the particular food, 
        producer, manufacturer, shipper, growing area, or country.
    ``(d) Submission by a Consumer or Other Individual.--A consumer or 
other individual may submit a report to the Food and Drug 
Administration using the electronic portal data elements described in 
subsection (e). Such reports shall be evaluated by the Secretary as 
specified in subsection (b)(2).
    ``(e) Notification and Reporting of Adulteration.--
            ``(1) Determination by responsible party or importer.--If a 
        responsible party or importer determines that an article of 
        food it produced, processed, manufactured, distributed, or 
        otherwise handled is a reportable adulterated food, the 
        responsible party shall provide the notifications described 
        under paragraph (2).
            ``(2) Notification of adulteration.--
                    ``(A) In general.--Not later than 5 days after a 
                responsible party or importer receives a notification, 
                the responsible party or importer, as applicable, shall 
                review whether the food referenced in the report 
                described in paragraph (1) is a reportable adulterated 
                food.
                    ``(B) Notification.--If a determination is made by 
                such responsible party or importer that the food is a 
                reportable adulterated food, such responsible party or 
                importer shall, no later than 2 days after such 
                determination is made, notify other responsible parties 
                directly linked in the supply chain to which and from 
                which the article of reportable adulterated food was 
                transferred.
            ``(3) Submission of reports to the food and drug 
        administration by a responsible party or importer.--The 
        responsible party or importer, as applicable, shall submit a 
        report to the Food and Drug Administration through the 
        electronic portal using the data elements described in 
        subsection (f) not later than 2 days after a responsible party 
        or importer--
                    ``(A) makes a notification under paragraph (2)(B); 
                or
                    ``(B) determines that an article of food it 
                produced, processed, manufactured, distributed, 
                imported, or otherwise handled is a reportable 
                adulterated food, except that if such adulteration was 
                initiated with such responsible party or importer, was 
                detected prior to any transfer of such article of food, 
                and was destroyed, no report is necessary.
    ``(f) Data Elements in the Registry.--A report submitted to the 
Food and Drug Administration electronic portal under subsection (e) 
shall include the following data elements:
            ``(1) Contact information for the individual or entity 
        submitting the report.
            ``(2) The date on which an article of food was determined 
        to be adulterated or suspected of being adulterated.
            ``(3) A description of the article of food including the 
        quantity or amount.
            ``(4) The extent and nature of the adulteration.
            ``(5) The disposition of the article.
            ``(6) Product information typically found on packaging 
        including product codes, use by dates, and names of 
        manufactures or distributors.
            ``(7) Information about the place of purchase or process by 
        which the consumer or other individual acquired the article of 
        adulterated food.
            ``(8) In the case of a responsible party or an importer, 
        the elements required for the registration of food facilities 
        under section 415(a).
            ``(9) The contact information for parties directly linked 
        in the supply chain and notified under subsection (e)(2).
            ``(10) In the case of an importer, the elements required 
        for the prior notice of imported food shipments under section 
        801(m).
    ``(g) Maintenance and Inspection of Records.--The responsible 
person or importer shall maintain records related to each report 
received, notification made, and report submitted to the Food and Drug 
Administration under this section and permit inspection of such records 
as provided for in section 414. Such records shall also be made 
available during an inspection under section 704.
    ``(h) Request for Information.--Section 552 of title 5, United 
States Code, shall apply to any request for information regarding a 
record in the Adulterated Food Registry.
    ``(i) Homeland Security Notification.--If, after receiving a report 
under subsection (e), the Secretary suspects such food may have been 
deliberately adulterated, the Secretary shall immediately notify the 
Secretary of Homeland Security. The Secretary shall make the data in 
the Adulterated Imported Food Registry available to the Secretary of 
Homeland Security.''.
    (c) Definition.--Section 201(ff) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking ``section 
201(g)'' and inserting ``sections 201(g) and 417''.
    (d) Prohibited Acts.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331), as amended by this Act, is further 
amended by adding at the end the following:
    ``(kk) The failure to provide a report as required under section 
417(e)(3).
    ``(ll) The falsification a report as required under section 
417(e)(3).''.
    (e) Suspected Food Adulteration Regulations.--The Secretary shall, 
within 180 days of enactment of this Act, promulgate regulations that 
establish standards and thresholds by which importers and responsible 
parties shall be required and consumers may be able to, under section 
417 of the Federal Food, Drug, and Cosmetic Act (as added by this 
section)--
            (1) report instances of suspected reportable adulteration 
        of food to the Food and Drug Administration for possible 
        inclusion in the Adulterated Food Registry after evaluation of 
        such report; and
            (2) notify, in keeping with subsection (e)(2) of such 
        section 417, other responsible parties directly linked in the 
        supply chain, including establishments as defined in section 
        415(b) of such Act.
    (f) Effective Date.--The requirements of section 417(e) of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall 
become effective 180 days after the date of enactment of this Act.

SEC. 606. SENSE OF THE SENATE.

    It is the sense of the Senate that--
            (1) it is vital for Congress to provide the Food and Drug 
        Administration with additional resources, authorities, and 
        direction with respect to ensuring the safety of the food 
        supply of the United States;
            (2) additional inspectors are required to improve the Food 
        and Drug Administration's ability to safeguard the food supply 
        of the United States;
            (3) because of the increasing volume of international trade 
        in food products the Secretary of Health and Human Services 
        should make it a priority to enter into agreements with the 
        trading partners of the United States with respect to food 
        safety; and
            (4) the Senate should work to develop a comprehensive 
        response to the issue of food safety.

SEC. 607. ANNUAL REPORT TO CONGRESS.

    The Secretary shall, on an annual basis, submit to the Committee on 
Health, Education, Labor, and Pensions and the Committee on 
Appropriations of the Senate and the Committee on Energy and Commerce 
and the Committee on Appropriations of the House of Representatives a 
report that includes, with respect to the preceding 1-year period--
            (1) the number and amount of food products regulated by the 
        Food and Drug Administration imported into the United States, 
        aggregated by country and type of food;
            (2) a listing of the number of Food and Drug Administration 
        inspectors of imported food products referenced in paragraph 
        (1) and the number of Food and Drug Administration inspections 
        performed on such products; and
            (3) aggregated data on the findings of such inspections, 
        including data related to violations of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 201 et seq.), and enforcement 
        actions used to follow-up on such findings and violations.

SEC. 608. RULE OF CONSTRUCTION.

    Nothing in this title (or an amendment made by this title) shall be 
construed to affect--
            (1) the regulation of dietary supplements under the Dietary 
        Supplement Health and Education Act; or
            (2) the adverse event reporting system for dietary 
        supplements created under the Dietary Supplement and 
        Nonprescription Drug Consumer Protection Act.

SEC. 609. AUTHORIZATION OF APPROPRIATIONS.

    There are authorized to be appropriated to carry out this title 
(and the amendments made by this title) such sums as may be necessary.

              TITLE VII--DOMESTIC PET TURTLE MARKET ACCESS

SEC. 701. SHORT TITLE.

    This title may be cited as the ``Domestic Pet Turtle Market Access 
Act of 2007''.

SEC. 702. FINDINGS.

    Congress makes the following findings:
            (1) Pet turtles less than 10.2 centimeters in diameter have 
        been banned for sale in the United States by the Food and Drug 
        Administration since 1975 due to health concerns.
            (2) The Food and Drug Administration does not ban the sale 
        of iguanas or other lizards, snakes, frogs, or other amphibians 
        or reptiles that are sold as pets in the United States that 
        also carry salmonella bacteria. The Food and Drug 
        Administration also does not require that these animals be 
        treated for salmonella bacteria before being sold as pets.
            (3) The technology to treat turtles for salmonella, and 
        make them safe for sale, has greatly advanced since 1975. 
        Treatments exist that can nearly eradicate salmonella from 
        turtles, and individuals are more aware of the causes of 
        salmonella, how to treat salmonella poisoning, and the 
        seriousness associated with salmonella poisoning.
            (4) University research has shown that these turtles can be 
        treated in such a way that they can be raised, shipped, and 
        distributed without having a recolonization of salmonella.
            (5) University research has also shown that pet owners can 
        be equipped with a treatment regiment that allows the turtle to 
        be maintained safe from salmonella.
            (6) The Food and Drug Administration should allow the sale 
        of turtles less than 10.2 centimeters in diameter as pets as 
        long as the sellers are required to use proven methods to treat 
        these turtles for salmonella.

SEC. 703. SALE OF BABY TURTLES.

    Notwithstanding any other provision of law, the Food and Drug 
Administration shall not restrict the sale by a turtle farmer, 
wholesaler, or commercial retail seller of a turtle that is less than 
10.2 centimeters in diameter as a pet if--
            (1) the State or territory in which such farmer is located 
        has developed a regulatory process by which pet turtle farmers 
        are required to have a State license to breed, hatch, 
        propagate, raise, grow, receive, ship, transport, export, or 
        sell pet turtles or pet turtle eggs;
            (2) such State or territory requires certification of 
        sanitization that is signed by a veterinarian who is licensed 
        in the State or territory, and approved by the State or 
        territory agency in charge of regulating the sale of pet 
        turtles;
            (3) the certification of sanitization requires each turtle 
        to be sanitized or treated for diseases, including salmonella, 
        and is dependant upon using the Siebeling method, or other such 
        proven non-antibiotic method, to make the turtle salmonella-
        free; and
            (4) the turtle farmer or commercial retail seller includes, 
        with the sale of such a turtle, a disclosure to the buyer that 
        includes--
                    (A) information regarding--
                            (i) the possibility that salmonella can re-
                        colonize in turtles;
                            (ii) the dangers, including possible severe 
                        illness or death, especially for at-risk people 
                        who may be susceptible to salmonella poisoning, 
                        such as children, pregnant women, and others 
                        who may have weak immune systems, that could 
                        result if the turtle is not properly handled 
                        and safely maintained;
                            (iii) the proper handling of the turtle, 
                        including an explanation of proper hygiene such 
                        as handwashing after handling a turtle; and
                            (iv) the proven methods of treatment that, 
                        if properly applied, keep the turtle safe from 
                        salmonella;
                    (B) a detailed explanation of how to properly treat 
                the turtle to keep it safe from salmonella, using the 
                proven methods of treatment referred to under 
                subparagraph (A), and how the buyer can continue to 
                purchase the tools, treatments, or any other required 
                item to continually treat the turtle; and
                    (C) a statement that buyers of pet turtles should 
                not abandon the turtle or abandon it outside, as the 
                turtle may become an invasive species to the local 
                community, but should instead return them to a 
                commercial retail pet seller or other organization that 
                would accept turtles no longer wanted as pets.

SEC. 704. FDA REVIEW OF STATE PROTECTIONS.

    The Commissioner of Food and Drugs may, after providing an 
opportunity for the affected State to respond, restrict the sale of a 
turtle only if the Secretary of Health and Human Services determines 
that the actual implementation of State health protections described in 
this title are insufficient to protect consumers against infectious 
diseases acquired from such turtle at the time of sale.

             TITLE VIII--IMPORTATION OF PRESCRIPTION DRUGS

SEC. 801. SHORT TITLE.

    This title may be cited as the ``Pharmaceutical Market Access and 
Drug Safety Act of 2007''.

SEC. 802. FINDINGS.

    Congress finds that--
            (1) Americans unjustly pay up to 5 times more to fill their 
        prescriptions than consumers in other countries;
            (2) the United States is the largest market for 
        pharmaceuticals in the world, yet American consumers pay the 
        highest prices for brand pharmaceuticals in the world;
            (3) a prescription drug is neither safe nor effective to an 
        individual who cannot afford it;
            (4) allowing and structuring the importation of 
        prescription drugs to ensure access to safe and affordable 
        drugs approved by the Food and Drug Administration will provide 
        a level of safety to American consumers that they do not 
        currently enjoy;
            (5) American spend more than $200,000,000,000 on 
        prescription drugs every year;
            (6) the Congressional Budget Office has found that the cost 
        of prescription drugs are between 35 to 55 percent less in 
        other highly-developed countries than in the United States; and
            (7) promoting competitive market pricing would both 
        contribute to health care savings and allow greater access to 
        therapy, improving health and saving lives.

SEC. 803. REPEAL OF CERTAIN SECTION REGARDING IMPORTATION OF 
              PRESCRIPTION DRUGS.

    Chapter VIII of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381 et seq.) is amended by striking section 804.

SEC. 804. IMPORTATION OF PRESCRIPTION DRUGS; WAIVER OF CERTAIN IMPORT 
              RESTRICTIONS.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 803, is 
further amended by inserting after section 803 the following:

``SEC. 804. COMMERCIAL AND PERSONAL IMPORTATION OF PRESCRIPTION DRUGS.

    ``(a) Importation of Prescription Drugs.--
            ``(1) In general.--In the case of qualifying drugs imported 
        or offered for import into the United States from registered 
        exporters or by registered importers--
                    ``(A) the limitation on importation that is 
                established in section 801(d)(1) is waived; and
                    ``(B) the standards referred to in section 801(a) 
                regarding admission of the drugs are subject to 
                subsection (g) of this section (including with respect 
                to qualifying drugs to which section 801(d)(1) does not 
                apply).
            ``(2) Importers.--A qualifying drug may not be imported 
        under paragraph (1) unless--
                    ``(A) the drug is imported by a pharmacy, group of 
                pharmacies, or a wholesaler that is a registered 
                importer; or
                    ``(B) the drug is imported by an individual for 
                personal use or for the use of a family member of the 
                individual (not for resale) from a registered exporter.
            ``(3) Rule of construction.--This section shall apply only 
        with respect to a drug that is imported or offered for import 
        into the United States--
                    ``(A) by a registered importer; or
                    ``(B) from a registered exporter to an individual.
            ``(4) Definitions.--
                    ``(A) Registered exporter; registered importer.--
                For purposes of this section:
                            ``(i) The term `registered exporter' means 
                        an exporter for which a registration under 
                        subsection (b) has been approved and is in 
                        effect.
                            ``(ii) The term `registered importer' means 
                        a pharmacy, group of pharmacies, or a 
                        wholesaler for which a registration under 
                        subsection (b) has been approved and is in 
                        effect.
                            ``(iii) The term `registration condition' 
                        means a condition that must exist for a 
                        registration under subsection (b) to be 
                        approved.
                    ``(B) Qualifying drug.--For purposes of this 
                section, the term `qualifying drug' means a drug for 
                which there is a corresponding U.S. label drug.
                    ``(C) U.S. label drug.--For purposes of this 
                section, the term `U.S. label drug' means a 
                prescription drug that--
                            ``(i) with respect to a qualifying drug, 
                        has the same active ingredient or ingredients, 
                        route of administration, dosage form, and 
                        strength as the qualifying drug;
                            ``(ii) with respect to the qualifying drug, 
                        is manufactured by or for the person that 
                        manufactures the qualifying drug;
                            ``(iii) is approved under section 505(c); 
                        and
                            ``(iv) is not--
                                    ``(I) a controlled substance, as 
                                defined in section 102 of the 
                                Controlled Substances Act (21 U.S.C. 
                                802);
                                    ``(II) a biological product, as 
                                defined in section 351 of the Public 
                                Health Service Act (42 U.S.C. 262), 
                                including--
                                            ``(aa) a therapeutic DNA 
                                        plasmid product;
                                            ``(bb) a therapeutic 
                                        synthetic peptide product;
                                            ``(cc) a monoclonal 
                                        antibody product for in vivo 
                                        use; and
                                            ``(dd) a therapeutic 
                                        recombinant DNA-derived 
                                        product;
                                    ``(III) an infused drug, including 
                                a peritoneal dialysis solution;
                                    ``(IV) an injected drug;
                                    ``(V) a drug that is inhaled during 
                                surgery;
                                    ``(VI) a drug that is the listed 
                                drug referred to in 2 or more 
                                abbreviated new drug applications under 
                                which the drug is commercially 
                                marketed; or
                                    ``(VII) a sterile opthlamic drug 
                                intended for topical use on or in the 
                                eye.
                    ``(D) Other definitions.--For purposes of this 
                section:
                            ``(i)(I) The term `exporter' means a person 
                        that is in the business of exporting a drug to 
                        individuals in the United States from Canada or 
                        from a permitted country designated by the 
                        Secretary under subclause (II), or that, 
                        pursuant to submitting a registration under 
                        subsection (b), seeks to be in such business.
                            ``(II) The Secretary shall designate a 
                        permitted country under subparagraph (E) (other 
                        than Canada) as a country from which an 
                        exporter may export a drug to individuals in 
                        the United States if the Secretary determines 
                        that--
                                    ``(aa) the country has statutory or 
                                regulatory standards that are 
                                equivalent to the standards in the 
                                United States and Canada with respect 
                                to--
                                            ``(AA) the training of 
                                        pharmacists;
                                            ``(BB) the practice of 
                                        pharmacy; and
                                            ``(CC) the protection of 
                                        the privacy of personal medical 
                                        information; and
                                    ``(bb) the importation of drugs to 
                                individuals in the United States from 
                                the country will not adversely affect 
                                public health.
                            ``(ii) The term `importer' means a 
                        pharmacy, a group of pharmacies, or a 
                        wholesaler that is in the business of importing 
                        a drug into the United States or that, pursuant 
                        to submitting a registration under subsection 
                        (b), seeks to be in such business.
                            ``(iii) The term `pharmacist' means a 
                        person licensed by a State to practice 
                        pharmacy, including the dispensing and selling 
                        of prescription drugs.
                            ``(iv) The term `pharmacy' means a person 
                        that--
                                    ``(I) is licensed by a State to 
                                engage in the business of selling 
                                prescription drugs at retail; and
                                    ``(II) employs 1 or more 
                                pharmacists.
                            ``(v) The term `prescription drug' means a 
                        drug that is described in section 503(b)(1).
                            ``(vi) The term `wholesaler'--
                                    ``(I) means a person licensed as a 
                                wholesaler or distributor of 
                                prescription drugs in the United States 
                                under section 503(e)(2)(A); and
                                    ``(II) does not include a person 
                                authorized to import drugs under 
                                section 801(d)(1).
                    ``(E) Permitted country.--The term `permitted 
                country' means--
                            ``(i) Australia;
                            ``(ii) Canada;
                            ``(iii) a member country of the European 
                        Union, but does not include a member country 
                        with respect to which--
                                    ``(I) the country's Annex to the 
                                Treaty of Accession to the European 
                                Union 2003 includes a transitional 
                                measure for the regulation of human 
                                pharmaceutical products that has not 
                                expired; or
                                    ``(II) the Secretary determines 
                                that the requirements described in 
                                subclauses (I) and (II) of clause (vii) 
                                will not be met by the date on which 
                                such transitional measure for the 
                                regulation of human pharmaceutical 
                                products expires;
                            ``(iv) Japan;
                            ``(v) New Zealand;
                            ``(vi) Switzerland; and
                            ``(vii) a country in which the Secretary 
                        determines the following requirements are met:
                                    ``(I) The country has statutory or 
                                regulatory requirements--
                                            ``(aa) that require the 
                                        review of drugs for safety and 
                                        effectiveness by an entity of 
                                        the government of the country;
                                            ``(bb) that authorize the 
                                        approval of only those drugs 
                                        that have been determined to be 
                                        safe and effective by experts 
                                        employed by or acting on behalf 
                                        of such entity and qualified by 
                                        scientific training and 
                                        experience to evaluate the 
                                        safety and effectiveness of 
                                        drugs on the basis of adequate 
                                        and well-controlled 
                                        investigations, including 
                                        clinical investigations, 
                                        conducted by experts qualified 
                                        by scientific training and 
                                        experience to evaluate the 
                                        safety and effectiveness of 
                                        drugs;
                                            ``(cc) that require the 
                                        methods used in, and the 
                                        facilities and controls used 
                                        for the manufacture, 
                                        processing, and packing of 
                                        drugs in the country to be 
                                        adequate to preserve their 
                                        identity, quality, purity, and 
                                        strength;
                                            ``(dd) for the reporting of 
                                        adverse reactions to drugs and 
                                        procedures to withdraw approval 
                                        and remove drugs found not to 
                                        be safe or effective; and
                                            ``(ee) that require the 
                                        labeling and promotion of drugs 
                                        to be in accordance with the 
                                        approval of the drug.
                                    ``(II) The valid marketing 
                                authorization system in the country is 
                                equivalent to the systems in the 
                                countries described in clauses (i) 
                                through (vi).
                                    ``(III) The importation of drugs to 
                                the United States from the country will 
                                not adversely affect public health.
    ``(b) Registration of Importers and Exporters.--
            ``(1) Registration of importers and exporters.--A 
        registration condition is that the importer or exporter 
        involved (referred to in this subsection as a `registrant') 
        submits to the Secretary a registration containing the 
        following:
                    ``(A)(i) In the case of an exporter, the name of 
                the exporter and an identification of all places of 
                business of the exporter that relate to qualifying 
                drugs, including each warehouse or other facility owned 
                or controlled by, or operated for, the exporter.
                    ``(ii) In the case of an importer, the name of the 
                importer and an identification of the places of 
                business of the importer at which the importer 
                initially receives a qualifying drug after importation 
                (which shall not exceed 3 places of business except by 
                permission of the Secretary).
                    ``(B) Such information as the Secretary determines 
                to be necessary to demonstrate that the registrant is 
                in compliance with registration conditions under--
                            ``(i) in the case of an importer, 
                        subsections (c), (d), (e), (g), and (j) 
                        (relating to the sources of imported qualifying 
                        drugs; the inspection of facilities of the 
                        importer; the payment of fees; compliance with 
                        the standards referred to in section 801(a); 
                        and maintenance of records and samples); or
                            ``(ii) in the case of an exporter, 
                        subsections (c), (d), (f), (g), (h), (i), and 
                        (j) (relating to the sources of exported 
                        qualifying drugs; the inspection of facilities 
                        of the exporter and the marking of compliant 
                        shipments; the payment of fees; and compliance 
                        with the standards referred to in section 
                        801(a); being licensed as a pharmacist; 
                        conditions for individual importation; and 
                        maintenance of records and samples).
                    ``(C) An agreement by the registrant that the 
                registrant will not under subsection (a) import or 
                export any drug that is not a qualifying drug.
                    ``(D) An agreement by the registrant to--
                            ``(i) notify the Secretary of a recall or 
                        withdrawal of a qualifying drug distributed in 
                        a permitted country that the registrant has 
                        exported or imported, or intends to export or 
                        import, to the United States under subsection 
                        (a);
                            ``(ii) provide for the return to the 
                        registrant of such drug; and
                            ``(iii) cease, or not begin, the 
                        exportation or importation of such drug unless 
                        the Secretary has notified the registrant that 
                        exportation or importation of such drug may 
                        proceed.
                    ``(E) An agreement by the registrant to ensure and 
                monitor compliance with each registration condition, to 
                promptly correct any noncompliance with such a 
                condition, and to promptly report to the Secretary any 
                such noncompliance.
                    ``(F) A plan describing the manner in which the 
                registrant will comply with the agreement under 
                subparagraph (E).
                    ``(G) An agreement by the registrant to enforce a 
                contract under subsection (c)(3)(B) against a party in 
                the chain of custody of a qualifying drug with respect 
                to the authority of the Secretary under clauses (ii) 
                and (iii) of that subsection.
                    ``(H) An agreement by the registrant to notify the 
                Secretary not more than 30 days before the registrant 
                intends to make the change, of--
                            ``(i) any change that the registrant 
                        intends to make regarding information provided 
                        under subparagraph (A) or (B); and
                            ``(ii) any change that the registrant 
                        intends to make in the compliance plan under 
                        subparagraph (F).
                    ``(I) In the case of an exporter--
                            ``(i) An agreement by the exporter that a 
                        qualifying drug will not under subsection (a) 
                        be exported to any individual not authorized 
                        pursuant to subsection (a)(2)(B) to be an 
                        importer of such drug.
                            ``(ii) An agreement to post a bond, payable 
                        to the Treasury of the United States that is 
                        equal in value to the lesser of--
                                    ``(I) the value of drugs exported 
                                by the exporter to the United States in 
                                a typical 4-week period over the course 
                                of a year under this section; or
                                    ``(II) $1,000,000;
                            ``(iii) An agreement by the exporter to 
                        comply with applicable provisions of Canadian 
                        law, or the law of the permitted country 
                        designated under subsection (a)(4)(D)(i)(II) in 
                        which the exporter is located, that protect the 
                        privacy of personal information with respect to 
                        each individual importing a prescription drug 
                        from the exporter under subsection (a)(2)(B).
                            ``(iv) An agreement by the exporter to 
                        report to the Secretary--
                                    ``(I) not later than August 1 of 
                                each fiscal year, the total price and 
                                the total volume of drugs exported to 
                                the United States by the exporter 
                                during the 6-month period from January 
                                1 through June 30 of that year; and
                                    ``(II) not later than January 1 of 
                                each fiscal year, the total price and 
                                the total volume of drugs exported to 
                                the United States by the exporter 
                                during the previous fiscal year.
                    ``(J) In the case of an importer, an agreement by 
                the importer to report to the Secretary--
                            ``(i) not later than August 1 of each 
                        fiscal year, the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the 6-month period from 
                        January 1 through June 30 of that fiscal year; 
                        and
                            ``(ii) not later than January 1 of each 
                        fiscal year, the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the previous fiscal 
                        year.
                    ``(K) Such other provisions as the Secretary may 
                require by regulation to protect the public health 
                while permitting--
                            ``(i) the importation by pharmacies, groups 
                        of pharmacies, and wholesalers as registered 
                        importers of qualifying drugs under subsection 
                        (a); and
                            ``(ii) importation by individuals of 
                        qualifying drugs under subsection (a).
            ``(2) Approval or disapproval of registration.--
                    ``(A) In general.--Not later than 90 days after the 
                date on which a registrant submits to the Secretary a 
                registration under paragraph (1), the Secretary shall 
                notify the registrant whether the registration is 
                approved or is disapproved. The Secretary shall 
                disapprove a registration if there is reason to believe 
                that the registrant is not in compliance with one or 
                more registration conditions, and shall notify the 
                registrant of such reason. In the case of a disapproved 
                registration, the Secretary shall subsequently notify 
                the registrant that the registration is approved if the 
                Secretary determines that the registrant is in 
                compliance with such conditions.
                    ``(B) Changes in registration information.--Not 
                later than 30 days after receiving a notice under 
                paragraph (1)(H) from a registrant, the Secretary shall 
                determine whether the change involved affects the 
                approval of the registration of the registrant under 
                paragraph (1), and shall inform the registrant of the 
                determination.
            ``(3) Publication of contact information for registered 
        exporters.--Through the Internet website of the Food and Drug 
        Administration and a toll-free telephone number, the Secretary 
        shall make readily available to the public a list of registered 
        exporters, including contact information for the exporters. 
        Promptly after the approval of a registration submitted under 
        paragraph (1), the Secretary shall update the Internet website 
        and the information provided through the toll-free telephone 
        number accordingly.
            ``(4) Suspension and termination.--
                    ``(A) Suspension.--With respect to the 
                effectiveness of a registration submitted under 
                paragraph (1):
                            ``(i) Subject to clause (ii), the Secretary 
                        may suspend the registration if the Secretary 
                        determines, after notice and opportunity for a 
                        hearing, that the registrant has failed to 
                        maintain substantial compliance with a 
                        registration condition.
                            ``(ii) If the Secretary determines that, 
                        under color of the registration, the exporter 
                        has exported a drug or the importer has 
                        imported a drug that is not a qualifying drug, 
                        or a drug that does not comply with subsection 
                        (g)(2)(A) or (g)(4), or has exported a 
                        qualifying drug to an individual in violation 
                        of subsection (i)(2)(F), the Secretary shall 
                        immediately suspend the registration. A 
                        suspension under the preceding sentence is not 
                        subject to the provision by the Secretary of 
                        prior notice, and the Secretary shall provide 
                        to the registrant an opportunity for a hearing 
                        not later than 10 days after the date on which 
                        the registration is suspended.
                            ``(iii) The Secretary may reinstate the 
                        registration, whether suspended under clause 
                        (i) or (ii), if the Secretary determines that 
                        the registrant has demonstrated that further 
                        violations of registration conditions will not 
                        occur.
                    ``(B) Termination.--The Secretary, after notice and 
                opportunity for a hearing, may terminate the 
                registration under paragraph (1) of a registrant if the 
                Secretary determines that the registrant has engaged in 
                a pattern or practice of violating 1 or more 
                registration conditions, or if on 1 or more occasions 
                the Secretary has under subparagraph (A)(ii) suspended 
                the registration of the registrant. The Secretary may 
                make the termination permanent, or for a fixed period 
                of not less than 1 year. During the period in which the 
                registration is terminated, any registration submitted 
                under paragraph (1) by the registrant, or a person that 
                is a partner in the export or import enterprise, or a 
                principal officer in such enterprise, and any 
                registration prepared with the assistance of the 
                registrant or such a person, has no legal effect under 
                this section.
            ``(5) Default of bond.--A bond required to be posted by an 
        exporter under paragraph (1)(I)(ii) shall be defaulted and paid 
        to the Treasury of the United States if, after opportunity for 
        an informal hearing, the Secretary determines that the exporter 
        has--
                    ``(A) exported a drug to the United States that is 
                not a qualifying drug or that is not in compliance with 
                subsection (g)(2)(A), (g)(4), or (i); or
                    ``(B) failed to permit the Secretary to conduct an 
                inspection described under subsection (d).
    ``(c) Sources of Qualifying Drugs.--A registration condition is 
that the exporter or importer involved agrees that a qualifying drug 
will under subsection (a) be exported or imported into the United 
States only if there is compliance with the following:
            ``(1) The drug was manufactured in an establishment--
                    ``(A) required to register under subsection (h) or 
                (i) of section 510; and
                    ``(B)(i) inspected by the Secretary; or
                    ``(ii) for which the Secretary has elected to rely 
                on a satisfactory report of a good manufacturing 
                practice inspection of the establishment from a 
                permitted country whose regulatory system the Secretary 
                recognizes as equivalent under a mutual recognition 
                agreement, as provided for under section 510(i)(3), 
                section 803, or part 26 of title 21, Code of Federal 
                Regulations (or any corresponding successor rule or 
                regulation).
            ``(2) The establishment is located in any country, and the 
        establishment manufactured the drug for distribution in the 
        United States or for distribution in 1 or more of the permitted 
        countries (without regard to whether in addition the drug is 
        manufactured for distribution in a foreign country that is not 
        a permitted country).
            ``(3) The exporter or importer obtained the drug--
                    ``(A) directly from the establishment; or
                    ``(B) directly from an entity that, by contract 
                with the exporter or importer--
                            ``(i) provides to the exporter or importer 
                        a statement (in such form and containing such 
                        information as the Secretary may require) that, 
                        for the chain of custody from the 
                        establishment, identifies each prior sale, 
                        purchase, or trade of the drug (including the 
                        date of the transaction and the names and 
                        addresses of all parties to the transaction);
                            ``(ii) agrees to permit the Secretary to 
                        inspect such statements and related records to 
                        determine their accuracy;
                            ``(iii) agrees, with respect to the 
                        qualifying drugs involved, to permit the 
                        Secretary to inspect warehouses and other 
                        facilities, including records, of the entity 
                        for purposes of determining whether the 
                        facilities are in compliance with any standards 
                        under this Act that are applicable to 
                        facilities of that type in the United States; 
                        and
                            ``(iv) has ensured, through such 
                        contractual relationships as may be necessary, 
                        that the Secretary has the same authority 
                        regarding other parties in the chain of custody 
                        from the establishment that the Secretary has 
                        under clauses (ii) and (iii) regarding such 
                        entity.
            ``(4)(A) The foreign country from which the importer will 
        import the drug is a permitted country; or
            ``(B) The foreign country from which the exporter will 
        export the drug is the permitted country in which the exporter 
        is located.
            ``(5) During any period in which the drug was not in the 
        control of the manufacturer of the drug, the drug did not enter 
        any country that is not a permitted country.
            ``(6) The exporter or importer retains a sample of each lot 
        of the drug for testing by the Secretary.
    ``(d) Inspection of Facilities; Marking of Shipments.--
            ``(1) Inspection of facilities.--A registration condition 
        is that, for the purpose of assisting the Secretary in 
        determining whether the exporter involved is in compliance with 
        all other registration conditions--
                    ``(A) the exporter agrees to permit the Secretary--
                            ``(i) to conduct onsite inspections, 
                        including monitoring on a day-to-day basis, of 
                        places of business of the exporter that relate 
                        to qualifying drugs, including each warehouse 
                        or other facility owned or controlled by, or 
                        operated for, the exporter;
                            ``(ii) to have access, including on a day-
                        to-day basis, to--
                                    ``(I) records of the exporter that 
                                relate to the export of such drugs, 
                                including financial records; and
                                    ``(II) samples of such drugs;
                            ``(iii) to carry out the duties described 
                        in paragraph (3); and
                            ``(iv) to carry out any other functions 
                        determined by the Secretary to be necessary 
                        regarding the compliance of the exporter; and
                    ``(B) the Secretary has assigned 1 or more 
                employees of the Secretary to carry out the functions 
                described in this subsection for the Secretary 
                randomly, but not less than 12 times annually, on the 
                premises of places of businesses referred to in 
                subparagraph (A)(i), and such an assignment remains in 
                effect on a continuous basis.
            ``(2) Marking of compliant shipments.--A registration 
        condition is that the exporter involved agrees to affix to each 
        shipping container of qualifying drugs exported under 
        subsection (a) such markings as the Secretary determines to be 
        necessary to identify the shipment as being in compliance with 
        all registration conditions. Markings under the preceding 
        sentence shall--
                    ``(A) be designed to prevent affixation of the 
                markings to any shipping container that is not 
                authorized to bear the markings; and
                    ``(B) include anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies.
            ``(3) Certain duties relating to exporters.--Duties of the 
        Secretary with respect to an exporter include the following:
                    ``(A) Inspecting, randomly, but not less than 12 
                times annually, the places of business of the exporter 
                at which qualifying drugs are stored and from which 
                qualifying drugs are shipped.
                    ``(B) During the inspections under subparagraph 
                (A), verifying the chain of custody of a statistically 
                significant sample of qualifying drugs from the 
                establishment in which the drug was manufactured to the 
                exporter, which shall be accomplished or supplemented 
                by the use of anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies, except 
                that a drug that lacks such technologies from the point 
                of manufacture shall not for that reason be excluded 
                from importation by an exporter.
                    ``(C) Randomly reviewing records of exports to 
                individuals for the purpose of determining whether the 
                drugs are being imported by the individuals in 
                accordance with the conditions under subsection (i). 
                Such reviews shall be conducted in a manner that will 
                result in a statistically significant determination of 
                compliance with all such conditions.
                    ``(D) Monitoring the affixing of markings under 
                paragraph (2).
                    ``(E) Inspecting as the Secretary determines is 
                necessary the warehouses and other facilities, 
                including records, of other parties in the chain of 
                custody of qualifying drugs.
                    ``(F) Determining whether the exporter is in 
                compliance with all other registration conditions.
            ``(4) Prior notice of shipments.--A registration condition 
        is that, not less than 8 hours and not more than 5 days in 
        advance of the time of the importation of a shipment of 
        qualifying drugs, the importer involved agrees to submit to the 
        Secretary a notice with respect to the shipment of drugs to be 
        imported or offered for import into the United States under 
        subsection (a). A notice under the preceding sentence shall 
        include--
                    ``(A) the name and complete contact information of 
                the person submitting the notice;
                    ``(B) the name and complete contact information of 
                the importer involved;
                    ``(C) the identity of the drug, including the 
                established name of the drug, the quantity of the drug, 
                and the lot number assigned by the manufacturer;
                    ``(D) the identity of the manufacturer of the drug, 
                including the identity of the establishment at which 
                the drug was manufactured;
                    ``(E) the country from which the drug is shipped;
                    ``(F) the name and complete contact information for 
                the shipper of the drug;
                    ``(G) anticipated arrival information, including 
                the port of arrival and crossing location within that 
                port, and the date and time;
                    ``(H) a summary of the chain of custody of the drug 
                from the establishment in which the drug was 
                manufactured to the importer;
                    ``(I) a declaration as to whether the Secretary has 
                ordered that importation of the drug from the permitted 
                country cease under subsection (g)(2)(C) or (D); and
                    ``(J) such other information as the Secretary may 
                require by regulation.
            ``(5) Marking of compliant shipments.--A registration 
        condition is that the importer involved agrees, before 
        wholesale distribution (as defined in section 503(e)) of a 
        qualifying drug that has been imported under subsection (a), to 
        affix to each container of such drug such markings or other 
        technology as the Secretary determines necessary to identify 
        the shipment as being in compliance with all registration 
        conditions, except that the markings or other technology shall 
        not be required on a drug that bears comparable, compatible 
        markings or technology from the manufacturer of the drug. 
        Markings or other technology under the preceding sentence 
        shall--
                    ``(A) be designed to prevent affixation of the 
                markings or other technology to any container that is 
                not authorized to bear the markings; and
                    ``(B) shall include anticounterfeiting or track-
                and-trace technologies, taking into account the 
                economic and technical feasibility of such 
                technologies.
            ``(6) Certain duties relating to importers.--Duties of the 
        Secretary with respect to an importer include the following:
                    ``(A) Inspecting, randomly, but not less than 12 
                times annually, the places of business of the importer 
                at which a qualifying drug is initially received after 
                importation.
                    ``(B) During the inspections under subparagraph 
                (A), verifying the chain of custody of a statistically 
                significant sample of qualifying drugs from the 
                establishment in which the drug was manufactured to the 
                importer, which shall be accomplished or supplemented 
                by the use of anticounterfeiting or track-and-trace 
                technologies, taking into account the economic and 
                technical feasibility of those technologies, except 
                that a drug that lacks such technologies from the point 
                of manufacture shall not for that reason be excluded 
                from importation by an importer.
                    ``(C) Reviewing notices under paragraph (4).
                    ``(D) Inspecting as the Secretary determines is 
                necessary the warehouses and other facilities, 
                including records of other parties in the chain of 
                custody of qualifying drugs.
                    ``(E) Determining whether the importer is in 
                compliance with all other registration conditions.
    ``(e) Importer Fees.--
            ``(1) Registration fee.--A registration condition is that 
        the importer involved pays to the Secretary a fee of $10,000 
        due on the date on which the importer first submits the 
        registration to the Secretary under subsection (b).
            ``(2) Inspection fee.--A registration condition is that the 
        importer involved pays a fee to the Secretary in accordance 
        with this subsection. Such fee shall be paid not later than 
        October 1 and April 1 of each fiscal year in the amount 
        provided for under paragraph (3).
            ``(3) Amount of inspection fee.--
                    ``(A) Aggregate total of fees.--Not later than 30 
                days before the start of each fiscal year, the 
                Secretary, in consultation with the Secretary of 
                Homeland Security and the Secretary of the Treasury, 
                shall establish an aggregate total of fees to be 
                collected under paragraph (2) for importers for that 
                fiscal year that is sufficient, and not more than 
                necessary, to pay the costs for that fiscal year of 
                administering this section with respect to registered 
                importers, including the costs associated with--
                            ``(i) inspecting the facilities of 
                        registered importers, and of other entities in 
                        the chain of custody of a qualifying drug as 
                        necessary, under subsection (d)(6);
                            ``(ii) developing, implementing, and 
                        operating under such subsection an electronic 
                        system for submission and review of the notices 
                        required under subsection (d)(4) with respect 
                        to shipments of qualifying drugs under 
                        subsection (a) to assess compliance with all 
                        registration conditions when such shipments are 
                        offered for import into the United States; and
                            ``(iii) inspecting such shipments as 
                        necessary, when offered for import into the 
                        United States to determine if such a shipment 
                        should be refused admission under subsection 
                        (g)(5).
                    ``(B) Limitation.--Subject to subparagraph (C), the 
                aggregate total of fees collected under paragraph (2) 
                for a fiscal year shall not exceed 2.5 percent of the 
                total price of qualifying drugs imported during that 
                fiscal year into the United States by registered 
                importers under subsection (a).
                    ``(C) Total price of drugs.--
                            ``(i) Estimate.--For the purposes of 
                        complying with the limitation described in 
                        subparagraph (B) when establishing under 
                        subparagraph (A) the aggregate total of fees to 
                        be collected under paragraph (2) for a fiscal 
                        year, the Secretary shall estimate the total 
                        price of qualifying drugs imported into the 
                        United States by registered importers during 
                        that fiscal year by adding the total price of 
                        qualifying drugs imported by each registered 
                        importer during the 6-month period from January 
                        1 through June 30 of the previous fiscal year, 
                        as reported to the Secretary by each registered 
                        importer under subsection (b)(1)(J).
                            ``(ii) Calculation.--Not later than March 1 
                        of the fiscal year that follows the fiscal year 
                        for which the estimate under clause (i) is 
                        made, the Secretary shall calculate the total 
                        price of qualifying drugs imported into the 
                        United States by registered importers during 
                        that fiscal year by adding the total price of 
                        qualifying drugs imported by each registered 
                        importer during that fiscal year, as reported 
                        to the Secretary by each registered importer 
                        under subsection (b)(1)(J).
                            ``(iii) Adjustment.--If the total price of 
                        qualifying drugs imported into the United 
                        States by registered importers during a fiscal 
                        year as calculated under clause (ii) is less 
                        than the aggregate total of fees collected 
                        under paragraph (2) for that fiscal year, the 
                        Secretary shall provide for a pro-rata 
                        reduction in the fee due from each registered 
                        importer on April 1 of the subsequent fiscal 
                        year so that the limitation described in 
                        subparagraph (B) is observed.
                    ``(D) Individual importer fee.--Subject to the 
                limitation described in subparagraph (B), the fee under 
                paragraph (2) to be paid on October 1 and April 1 by an 
                importer shall be an amount that is proportional to a 
                reasonable estimate by the Secretary of the semiannual 
                share of the importer of the volume of qualifying drugs 
                imported by importers under subsection (a).
            ``(4) Use of fees.--
                    ``(A) In general.--Subject to appropriations Acts, 
                fees collected by the Secretary under paragraphs (1) 
                and (2) shall be credited to the appropriation account 
                for salaries and expenses of the Food and Drug 
                Administration until expended (without fiscal year 
                limitation), and the Secretary may, in consultation 
                with the Secretary of Homeland Security and the 
                Secretary of the Treasury, transfer some proportion of 
                such fees to the appropriation account for salaries and 
                expenses of the Bureau of Customs and Border Protection 
                until expended (without fiscal year limitation).
                    ``(B) Sole purpose.--Fees collected by the 
                Secretary under paragraphs (1) and (2) are only 
                available to the Secretary and, if transferred, to the 
                Secretary of Homeland Security, and are for the sole 
                purpose of paying the costs referred to in paragraph 
                (3)(A).
            ``(5) Collection of fees.--In any case where the Secretary 
        does not receive payment of a fee assessed under paragraph (1) 
        or (2) within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        subchapter II of chapter 37 of title 31, United States Code.
    ``(f) Exporter Fees.--
            ``(1) Registration fee.--A registration condition is that 
        the exporter involved pays to the Secretary a fee of $10,000 
        due on the date on which the exporter first submits that 
        registration to the Secretary under subsection (b).
            ``(2) Inspection fee.--A registration condition is that the 
        exporter involved pays a fee to the Secretary in accordance 
        with this subsection. Such fee shall be paid not later than 
        October 1 and April 1 of each fiscal year in the amount 
        provided for under paragraph (3).
            ``(3) Amount of inspection fee.--
                    ``(A) Aggregate total of fees.--Not later than 30 
                days before the start of each fiscal year, the 
                Secretary, in consultation with the Secretary of 
                Homeland Security and the Secretary of the Treasury, 
                shall establish an aggregate total of fees to be 
                collected under paragraph (2) for exporters for that 
                fiscal year that is sufficient, and not more than 
                necessary, to pay the costs for that fiscal year of 
                administering this section with respect to registered 
                exporters, including the costs associated with--
                            ``(i) inspecting the facilities of 
                        registered exporters, and of other entities in 
                        the chain of custody of a qualifying drug as 
                        necessary, under subsection (d)(3);
                            ``(ii) developing, implementing, and 
                        operating under such subsection a system to 
                        screen marks on shipments of qualifying drugs 
                        under subsection (a) that indicate compliance 
                        with all registration conditions, when such 
                        shipments are offered for import into the 
                        United States; and
                            ``(iii) screening such markings, and 
                        inspecting such shipments as necessary, when 
                        offered for import into the United States to 
                        determine if such a shipment should be refused 
                        admission under subsection (g)(5).
                    ``(B) Limitation.--Subject to subparagraph (C), the 
                aggregate total of fees collected under paragraph (2) 
                for a fiscal year shall not exceed 2.5 percent of the 
                total price of qualifying drugs imported during that 
                fiscal year into the United States by registered 
                exporters under subsection (a).
                    ``(C) Total price of drugs.--
                            ``(i) Estimate.--For the purposes of 
                        complying with the limitation described in 
                        subparagraph (B) when establishing under 
                        subparagraph (A) the aggregate total of fees to 
                        be collected under paragraph (2) for a fiscal 
                        year, the Secretary shall estimate the total 
                        price of qualifying drugs imported into the 
                        United States by registered exporters during 
                        that fiscal year by adding the total price of 
                        qualifying drugs exported by each registered 
                        exporter during the 6-month period from January 
                        1 through June 30 of the previous fiscal year, 
                        as reported to the Secretary by each registered 
                        exporter under subsection (b)(1)(I)(iv).
                            ``(ii) Calculation.--Not later than March 1 
                        of the fiscal year that follows the fiscal year 
                        for which the estimate under clause (i) is 
                        made, the Secretary shall calculate the total 
                        price of qualifying drugs imported into the 
                        United States by registered exporters during 
                        that fiscal year by adding the total price of 
                        qualifying drugs exported by each registered 
                        exporter during that fiscal year, as reported 
                        to the Secretary by each registered exporter 
                        under subsection (b)(1)(I)(iv).
                            ``(iii) Adjustment.--If the total price of 
                        qualifying drugs imported into the United 
                        States by registered exporters during a fiscal 
                        year as calculated under clause (ii) is less 
                        than the aggregate total of fees collected 
                        under paragraph (2) for that fiscal year, the 
                        Secretary shall provide for a pro-rata 
                        reduction in the fee due from each registered 
                        exporter on April 1 of the subsequent fiscal 
                        year so that the limitation described in 
                        subparagraph (B) is observed.
                    ``(D) Individual exporter fee.--Subject to the 
                limitation described in subparagraph (B), the fee under 
                paragraph (2) to be paid on October 1 and April 1 by an 
                exporter shall be an amount that is proportional to a 
                reasonable estimate by the Secretary of the semiannual 
                share of the exporter of the volume of qualifying drugs 
                exported by exporters under subsection (a).
            ``(4) Use of fees.--
                    ``(A) In general.--Subject to appropriations Acts, 
                fees collected by the Secretary under paragraphs (1) 
                and (2) shall be credited to the appropriation account 
                for salaries and expenses of the Food and Drug 
                Administration until expended (without fiscal year 
                limitation), and the Secretary may, in consultation 
                with the Secretary of Homeland Security and the 
                Secretary of the Treasury, transfer some proportion of 
                such fees to the appropriation account for salaries and 
                expenses of the Bureau of Customs and Border Protection 
                until expended (without fiscal year limitation).
                    ``(B) Sole purpose.--Fees collected by the 
                Secretary under paragraphs (1) and (2) are only 
                available to the Secretary and, if transferred, to the 
                Secretary of Homeland Security, and are for the sole 
                purpose of paying the costs referred to in paragraph 
                (3)(A).
            ``(5) Collection of fees.--In any case where the Secretary 
        does not receive payment of a fee assessed under paragraph (1) 
        or (2) within 30 days after it is due, such fee shall be 
        treated as a claim of the United States Government subject to 
        subchapter II of chapter 37 of title 31, United States Code.
    ``(g) Compliance With Section 801(a).--
            ``(1) In general.--A registration condition is that each 
        qualifying drug exported under subsection (a) by the registered 
        exporter involved or imported under subsection (a) by the 
        registered importer involved is in compliance with the 
        standards referred to in section 801(a) regarding admission of 
        the drug into the United States, subject to paragraphs (2), 
        (3), and (4).
            ``(2) Section 505; approval status.--
                    ``(A) In general.--A qualifying drug that is 
                imported or offered for import under subsection (a) 
                shall comply with the conditions established in the 
                approved application under section 505(b) for the U.S. 
                label drug as described under this subsection.
                    ``(B) Notice by manufacturer; general provisions.--
                            ``(i) In general.--The person that 
                        manufactures a qualifying drug that is, or will 
                        be, introduced for commercial distribution in a 
                        permitted country shall in accordance with this 
                        paragraph submit to the Secretary a notice 
                        that--
                                    ``(I) includes each difference in 
                                the qualifying drug from a condition 
                                established in the approved application 
                                for the U.S. label drug beyond--
                                            ``(aa) the variations 
                                        provided for in the 
                                        application; and
                                            ``(bb) any difference in 
                                        labeling (except ingredient 
                                        labeling); or
                                    ``(II) states that there is no 
                                difference in the qualifying drug from 
                                a condition established in the approved 
                                application for the U.S. label drug 
                                beyond--
                                            ``(aa) the variations 
                                        provided for in the 
                                        application; and
                                            ``(bb) any difference in 
                                        labeling (except ingredient 
                                        labeling).
                            ``(ii) Information in notice.--A notice 
                        under clause (i)(I) shall include the 
                        information that the Secretary may require 
                        under section 506A, any additional information 
                        the Secretary may require (which may include 
                        data on bioequivalence if such data are not 
                        required under section 506A), and, with respect 
                        to the permitted country that approved the 
                        qualifying drug for commercial distribution, or 
                        with respect to which such approval is sought, 
                        include the following:
                                    ``(I) The date on which the 
                                qualifying drug with such difference 
                                was, or will be, introduced for 
                                commercial distribution in the 
                                permitted country.
                                    ``(II) Information demonstrating 
                                that the person submitting the notice 
                                has also notified the government of the 
                                permitted country in writing that the 
                                person is submitting to the Secretary a 
                                notice under clause (i)(I), which 
                                notice describes the difference in the 
                                qualifying drug from a condition 
                                established in the approved application 
                                for the U.S. label drug.
                                    ``(III) The information that the 
                                person submitted or will submit to the 
                                government of the permitted country for 
                                purposes of obtaining approval for 
                                commercial distribution of the drug in 
                                the country which, if in a language 
                                other than English, shall be 
                                accompanied by an English translation 
                                verified to be complete and accurate, 
                                with the name, address, and a brief 
                                statement of the qualifications of the 
                                person that made the translation.
                            ``(iii) Certifications.--The chief 
                        executive officer and the chief medical officer 
                        of the manufacturer involved shall each certify 
                        in the notice under clause (i) that--
                                    ``(I) the information provided in 
                                the notice is complete and true; and
                                    ``(II) a copy of the notice has 
                                been provided to the Federal Trade 
                                Commission and to the State attorneys 
                                general.
                            ``(iv) Fee.--If a notice submitted under 
                        clause (i) includes a difference that would, 
                        under section 506A, require the submission of a 
                        supplemental application if made as a change to 
                        the U.S. label drug, the person that submits 
                        the notice shall pay to the Secretary a fee in 
                        the same amount as would apply if the person 
                        were paying a fee pursuant to section 
                        736(a)(1)(A)(ii). Subject to appropriations 
                        Acts, fees collected by the Secretary under the 
                        preceding sentence are available only to the 
                        Secretary and are for the sole purpose of 
                        paying the costs of reviewing notices submitted 
                        under clause (i).
                            ``(v) Timing of submission of notices.--
                                    ``(I) Prior approval notices.--A 
                                notice under clause (i) to which 
                                subparagraph (C) applies shall be 
                                submitted to the Secretary not later 
                                than 120 days before the qualifying 
                                drug with the difference is introduced 
                                for commercial distribution in a 
                                permitted country, unless the country 
                                requires that distribution of the 
                                qualifying drug with the difference 
                                begin less than 120 days after the 
                                country requires the difference.
                                    ``(II) Other approval notices.--A 
                                notice under clause (i) to which 
                                subparagraph (D) applies shall be 
                                submitted to the Secretary not later 
                                than the day on which the qualifying 
                                drug with the difference is introduced 
                                for commercial distribution in a 
                                permitted country.
                                    ``(III) Other notices.--A notice 
                                under clause (i) to which subparagraph 
                                (E) applies shall be submitted to the 
                                Secretary on the date that the 
                                qualifying drug is first introduced for 
                                commercial distribution in a permitted 
                                country and annually thereafter.
                            ``(vi) Review by secretary.--
                                    ``(I) In general.--In this 
                                paragraph, the difference in a 
                                qualifying drug that is submitted in a 
                                notice under clause (i) from the U.S. 
                                label drug shall be treated by the 
                                Secretary as if it were a manufacturing 
                                change to the U.S. label drug under 
                                section 506A.
                                    ``(II) Standard of review.--Except 
                                as provided in subclause (III), the 
                                Secretary shall review and approve or 
                                disapprove the difference in a notice 
                                submitted under clause (i), if required 
                                under section 506A, using the safe and 
                                effective standard for approving or 
                                disapproving a manufacturing change 
                                under section 506A.
                                    ``(III) Bioequivalence.--If the 
                                Secretary would approve the difference 
                                in a notice submitted under clause (i) 
                                using the safe and effective standard 
                                under section 506A and if the Secretary 
                                determines that the qualifying drug is 
                                not bioequivalent to the U.S. label 
                                drug, the Secretary shall--
                                            ``(aa) include in the 
                                        labeling provided under 
                                        paragraph (3) a prominent 
                                        advisory that the qualifying 
                                        drug is safe and effective but 
                                        is not bioequivalent to the 
                                        U.S. label drug if the 
                                        Secretary determines that such 
                                        an advisory is necessary for 
                                        health care practitioners and 
                                        patients to use the qualifying 
                                        drug safely and effectively; or
                                            ``(bb) decline to approve 
                                        the difference if the Secretary 
                                        determines that the 
                                        availability of both the 
                                        qualifying drug and the U.S. 
                                        label drug would pose a threat 
                                        to the public health.
                                    ``(IV) Review by the secretary.--
                                The Secretary shall review and approve 
                                or disapprove the difference in a 
                                notice submitted under clause (i), if 
                                required under section 506A, not later 
                                than 120 days after the date on which 
                                the notice is submitted.
                                    ``(V) Establishment inspection.--If 
                                review of such difference would require 
                                an inspection of the establishment in 
                                which the qualifying drug is 
                                manufactured--
                                            ``(aa) such inspection by 
                                        the Secretary shall be 
                                        authorized; and
                                            ``(bb) the Secretary may 
                                        rely on a satisfactory report 
                                        of a good manufacturing 
                                        practice inspection of the 
                                        establishment from a permitted 
                                        country whose regulatory system 
                                        the Secretary recognizes as 
                                        equivalent under a mutual 
                                        recognition agreement, as 
                                        provided under section 
                                        510(i)(3), section 803, or part 
                                        26 of title 21, Code of Federal 
                                        Regulations (or any 
                                        corresponding successor rule or 
                                        regulation).
                            ``(vii) Publication of information on 
                        notices.--
                                    ``(I) In general.--Through the 
                                Internet website of the Food and Drug 
                                Administration and a toll-free 
                                telephone number, the Secretary shall 
                                readily make available to the public a 
                                list of notices submitted under clause 
                                (i).
                                    ``(II) Contents.--The list under 
                                subclause (I) shall include the date on 
                                which a notice is submitted and 
                                whether--
                                            ``(aa) a notice is under 
                                        review;
                                            ``(bb) the Secretary has 
                                        ordered that importation of the 
                                        qualifying drug from a 
                                        permitted country cease; or
                                            ``(cc) the importation of 
                                        the drug is permitted under 
                                        subsection (a).
                                    ``(III) Update.--The Secretary 
                                shall promptly update the Internet 
                                website with any changes to the list.
                    ``(C) Notice; drug difference requiring prior 
                approval.--In the case of a notice under subparagraph 
                (B)(i) that includes a difference that would, under 
                section 506A(c) or (d)(3)(B)(i), require the approval 
                of a supplemental application before the difference 
                could be made to the U.S. label drug the following 
                shall occur:
                            ``(i) Promptly after the notice is 
                        submitted, the Secretary shall notify 
                        registered exporters, registered importers, the 
                        Federal Trade Commission, and the State 
                        attorneys general that the notice has been 
                        submitted with respect to the qualifying drug 
                        involved.
                            ``(ii) If the Secretary has not made a 
                        determination whether such a supplemental 
                        application regarding the U.S. label drug would 
                        be approved or disapproved by the date on which 
                        the qualifying drug involved is to be 
                        introduced for commercial distribution in a 
                        permitted country, the Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country not begin until the 
                                Secretary completes review of the 
                                notice; and
                                    ``(II) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the order.
                            ``(iii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would not be approved, the 
                        Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country cease, or provide 
                                that an order under clause (ii), if 
                                any, remains in effect;
                                    ``(II) notify the permitted country 
                                that approved the qualifying drug for 
                                commercial distribution of the 
                                determination; and
                                    ``(III) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                            ``(iv) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would be approved, the 
                        Secretary shall--
                                    ``(I) vacate the order under clause 
                                (ii), if any;
                                    ``(II) consider the difference to 
                                be a variation provided for in the 
                                approved application for the U.S. label 
                                drug;
                                    ``(III) permit importation of the 
                                qualifying drug under subsection (a); 
                                and
                                    ``(IV) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                    ``(D) Notice; drug difference not requiring prior 
                approval.--In the case of a notice under subparagraph 
                (B)(i) that includes a difference that would, under 
                section 506A(d)(3)(B)(ii), not require the approval of 
                a supplemental application before the difference could 
                be made to the U.S. label drug the following shall 
                occur:
                            ``(i) During the period in which the notice 
                        is being reviewed by the Secretary, the 
                        authority under this subsection to import the 
                        qualifying drug involved continues in effect.
                            ``(ii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would not be approved, the 
                        Secretary shall--
                                    ``(I) order that the importation of 
                                the qualifying drug involved from the 
                                permitted country cease;
                                    ``(II) notify the permitted country 
                                that approved the qualifying drug for 
                                commercial distribution of the 
                                determination; and
                                    ``(III) promptly notify registered 
                                exporters, registered importers, the 
                                Federal Trade Commission, and the State 
                                attorneys general of the determination.
                            ``(iii) If the Secretary determines that 
                        such a supplemental application regarding the 
                        U.S. label drug would be approved, the 
                        difference shall be considered to be a 
                        variation provided for in the approved 
                        application for the U.S. label drug.
                    ``(E) Notice; drug difference not requiring 
                approval; no difference.--In the case of a notice under 
                subparagraph (B)(i) that includes a difference for 
                which, under section 506A(d)(1)(A), a supplemental 
                application would not be required for the difference to 
                be made to the U.S. label drug, or that states that 
                there is no difference, the Secretary--
                            ``(i) shall consider such difference to be 
                        a variation provided for in the approved 
                        application for the U.S. label drug;
                            ``(ii) may not order that the importation 
                        of the qualifying drug involved cease; and
                            ``(iii) shall promptly notify registered 
                        exporters and registered importers.
                    ``(F) Differences in active ingredient, route of 
                administration, dosage form, or strength.--
                            ``(i) In general.--A person who 
                        manufactures a drug approved under section 
                        505(b) shall submit an application under 
                        section 505(b) for approval of another drug 
                        that is manufactured for distribution in a 
                        permitted country by or for the person that 
                        manufactures the drug approved under section 
                        505(b) if--
                                    ``(I) there is no qualifying drug 
                                in commercial distribution in permitted 
                                countries whose combined population 
                                represents at least 50 percent of the 
                                total population of all permitted 
                                countries with the same active 
                                ingredient or ingredients, route of 
                                administration, dosage form, and 
                                strength as the drug approved under 
                                section 505(b); and
                                    ``(II) each active ingredient of 
                                the other drug is related to an active 
                                ingredient of the drug approved under 
                                section 505(b), as defined in clause 
                                (v).
                            ``(ii) Application under section 505(b).--
                        The application under section 505(b) required 
                        under clause (i) shall--
                                    ``(I) request approval of the other 
                                drug for the indication or indications 
                                for which the drug approved under 
                                section 505(b) is labeled;
                                    ``(II) include the information that 
                                the person submitted to the government 
                                of the permitted country for purposes 
                                of obtaining approval for commercial 
                                distribution of the other drug in that 
                                country, which if in a language other 
                                than English, shall be accompanied by 
                                an English translation verified to be 
                                complete and accurate, with the name, 
                                address, and a brief statement of the 
                                qualifications of the person that made 
                                the translation;
                                    ``(III) include a right of 
                                reference to the application for the 
                                drug approved under section 505(b); and
                                    ``(IV) include such additional 
                                information as the Secretary may 
                                require.
                            ``(iii) Timing of submission of 
                        application.--An application under section 
                        505(b) required under clause (i) shall be 
                        submitted to the Secretary not later than the 
                        day on which the information referred to in 
                        clause (ii)(II) is submitted to the government 
                        of the permitted country.
                            ``(iv) Notice of decision on application.--
                        The Secretary shall promptly notify registered 
                        exporters, registered importers, the Federal 
                        Trade Commission, and the State attorneys 
                        general of a determination to approve or to 
                        disapprove an application under section 505(b) 
                        required under clause (i).
                            ``(v) Related active ingredients.--For 
                        purposes of clause (i)(II), 2 active 
                        ingredients are related if they are--
                                    ``(I) the same; or
                                    ``(II) different salts, esters, or 
                                complexes of the same moiety.
            ``(3) Section 502; labeling.--
                    ``(A) Importation by registered importer.--
                            ``(i) In general.--In the case of a 
                        qualifying drug that is imported or offered for 
                        import by a registered importer, such drug 
                        shall be considered to be in compliance with 
                        section 502 and the labeling requirements under 
                        the approved application for the U.S. label 
                        drug if the qualifying drug bears--
                                    ``(I) a copy of the labeling 
                                approved for the U.S. label drug under 
                                section 505, without regard to whether 
                                the copy bears any trademark involved;
                                    ``(II) the name of the manufacturer 
                                and location of the manufacturer;
                                    ``(III) the lot number assigned by 
                                the manufacturer;
                                    ``(IV) the name, location, and 
                                registration number of the importer; 
                                and
                                    ``(V) the National Drug Code number 
                                assigned to the qualifying drug by the 
                                Secretary.
                            ``(ii) Request for copy of the labeling.--
                        The Secretary shall provide such copy to the 
                        registered importer involved, upon request of 
                        the importer.
                            ``(iii) Requested labeling.--The labeling 
                        provided by the Secretary under clause (ii) 
                        shall--
                                    ``(I) include the established name, 
                                as defined in section 502(e)(3), for 
                                each active ingredient in the 
                                qualifying drug;
                                    ``(II) not include the proprietary 
                                name of the U.S. label drug or any 
                                active ingredient thereof;
                                    ``(III) if required under paragraph 
                                (2)(B)(vi)(III), a prominent advisory 
                                that the qualifying drug is safe and 
                                effective but not bioequivalent to the 
                                U.S. label drug; and
                                    ``(IV) if the inactive ingredients 
                                of the qualifying drug are different 
                                from the inactive ingredients for the 
                                U.S. label drug, include--
                                            ``(aa) a prominent notice 
                                        that the ingredients of the 
                                        qualifying drug differ from the 
                                        ingredients of the U.S. label 
                                        drug and that the qualifying 
                                        drug must be dispensed with an 
                                        advisory to people with 
                                        allergies about this difference 
                                        and a list of ingredients; and
                                            ``(bb) a list of the 
                                        ingredients of the qualifying 
                                        drug as would be required under 
                                        section 502(e).
                    ``(B) Importation by individual.--
                            ``(i) In general.--In the case of a 
                        qualifying drug that is imported or offered for 
                        import by a registered exporter to an 
                        individual, such drug shall be considered to be 
                        in compliance with section 502 and the labeling 
                        requirements under the approved application for 
                        the U.S. label drug if the packaging and 
                        labeling of the qualifying drug complies with 
                        all applicable regulations promulgated under 
                        sections 3 and 4 of the Poison Prevention 
                        Packaging Act of 1970 (15 U.S.C. 1471 et seq.) 
                        and the labeling of the qualifying drug 
                        includes--
                                    ``(I) directions for use by the 
                                consumer;
                                    ``(II) the lot number assigned by 
                                the manufacturer;
                                    ``(III) the name and registration 
                                number of the exporter;
                                    ``(IV) if required under paragraph 
                                (2)(B)(vi)(III), a prominent advisory 
                                that the drug is safe and effective but 
                                not bioequivalent to the U.S. label 
                                drug;
                                    ``(V) if the inactive ingredients 
                                of the drug are different from the 
                                inactive ingredients for the U.S. label 
                                drug--
                                            ``(aa) a prominent advisory 
                                        that persons with an allergy 
                                        should check the ingredient 
                                        list of the drug because the 
                                        ingredients of the drug differ 
                                        from the ingredients of the 
                                        U.S. label drug; and
                                            ``(bb) a list of the 
                                        ingredients of the drug as 
                                        would be required under section 
                                        502(e); and
                                    ``(VI) a copy of any special 
                                labeling that would be required by the 
                                Secretary had the U.S. label drug been 
                                dispensed by a pharmacist in the United 
                                States, without regard to whether the 
                                special labeling bears any trademark 
                                involved.
                            ``(ii) Packaging.--A qualifying drug 
                        offered for import to an individual by an 
                        exporter under this section that is packaged in 
                        a unit-of-use container (as those items are 
                        defined in the United States Pharmacopeia and 
                        National Formulary) shall not be repackaged, 
                        provided that--
                                    ``(I) the packaging complies with 
                                all applicable regulations under 
                                sections 3 and 4 of the Poison 
                                Prevention Packaging Act of 1970 (15 
                                U.S.C. 1471 et seq.); or
                                    ``(II) the consumer consents to 
                                waive the requirements of such Act, 
                                after being informed that the packaging 
                                does not comply with such Act and that 
                                the exporter will provide the drug in 
                                packaging that is compliant at no 
                                additional cost.
                            ``(iii) Request for copy of special 
                        labeling and ingredient list.--The Secretary 
                        shall provide to the registered exporter 
                        involved a copy of the special labeling, the 
                        advisory, and the ingredient list described 
                        under clause (i), upon request of the exporter.
                            ``(iv) Requested labeling and ingredient 
                        list.--The labeling and ingredient list 
                        provided by the Secretary under clause (iii) 
                        shall--
                                    ``(I) include the established name, 
                                as defined in section 502(e)(3), for 
                                each active ingredient in the drug; and
                                    ``(II) not include the proprietary 
                                name of the U.S. label drug or any 
                                active ingredient thereof.
            ``(4) Section 501; adulteration.--A qualifying drug that is 
        imported or offered for import under subsection (a) shall be 
        considered to be in compliance with section 501 if the drug is 
        in compliance with subsection (c).
            ``(5) Standards for refusing admission.--A drug exported 
        under subsection (a) from a registered exporter or imported by 
        a registered importer may be refused admission into the United 
        States if 1 or more of the following applies:
                    ``(A) The drug is not a qualifying drug.
                    ``(B) A notice for the drug required under 
                paragraph (2)(B) has not been submitted to the 
                Secretary.
                    ``(C) The Secretary has ordered that importation of 
                the drug from the permitted country cease under 
                paragraph (2) (C) or (D).
                    ``(D) The drug does not comply with paragraph (3) 
                or (4).
                    ``(E) The shipping container appears damaged in a 
                way that may affect the strength, quality, or purity of 
                the drug.
                    ``(F) The Secretary becomes aware that--
                            ``(i) the drug may be counterfeit;
                            ``(ii) the drug may have been prepared, 
                        packed, or held under insanitary conditions; or
                            ``(iii) the methods used in, or the 
                        facilities or controls used for, the 
                        manufacturing, processing, packing, or holding 
                        of the drug do not conform to good 
                        manufacturing practice.
                    ``(G) The Secretary has obtained an injunction 
                under section 302 that prohibits the distribution of 
                the drug in interstate commerce.
                    ``(H) The Secretary has under section 505(e) 
                withdrawn approval of the drug.
                    ``(I) The manufacturer of the drug has instituted a 
                recall of the drug.
                    ``(J) If the drug is imported or offered for import 
                by a registered importer without submission of a notice 
                in accordance with subsection (d)(4).
                    ``(K) If the drug is imported or offered for import 
                from a registered exporter to an individual and 1 or 
                more of the following applies:
                            ``(i) The shipping container for such drug 
                        does not bear the markings required under 
                        subsection (d)(2).
                            ``(ii) The markings on the shipping 
                        container appear to be counterfeit.
                            ``(iii) The shipping container or markings 
                        appear to have been tampered with.
    ``(h) Exporter Licensure in Permitted Country.--A registration 
condition is that the exporter involved agrees that a qualifying drug 
will be exported to an individual only if the Secretary has verified 
that--
            ``(1) the exporter is authorized under the law of the 
        permitted country in which the exporter is located to dispense 
        prescription drugs; and
            ``(2) the exporter employs persons that are licensed under 
        the law of the permitted country in which the exporter is 
        located to dispense prescription drugs in sufficient number to 
        dispense safely the drugs exported by the exporter to 
        individuals, and the exporter assigns to those persons 
        responsibility for dispensing such drugs to individuals.
    ``(i) Individuals; Conditions for Importation.--
            ``(1) In general.--For purposes of subsection (a)(2)(B), 
        the importation of a qualifying drug by an individual is in 
        accordance with this subsection if the following conditions are 
        met:
                    ``(A) The drug is accompanied by a copy of a 
                prescription for the drug, which prescription--
                            ``(i) is valid under applicable Federal and 
                        State laws; and
                            ``(ii) was issued by a practitioner who, 
                        under the law of a State of which the 
                        individual is a resident, or in which the 
                        individual receives care from the practitioner 
                        who issues the prescription, is authorized to 
                        administer prescription drugs.
                    ``(B) The drug is accompanied by a copy of the 
                documentation that was required under the law or 
                regulations of the permitted country in which the 
                exporter is located, as a condition of dispensing the 
                drug to the individual.
                    ``(C) The copies referred to in subparagraphs 
                (A)(i) and (B) are marked in a manner sufficient--
                            ``(i) to indicate that the prescription, 
                        and the equivalent document in the permitted 
                        country in which the exporter is located, have 
                        been filled; and
                            ``(ii) to prevent a duplicative filling by 
                        another pharmacist.
                    ``(D) The individual has provided to the registered 
                exporter a complete list of all drugs used by the 
                individual for review by the individuals who dispense 
                the drug.
                    ``(E) The quantity of the drug does not exceed a 
                90-day supply.
                    ``(F) The drug is not an ineligible subpart H drug. 
                For purposes of this section, a prescription drug is an 
                `ineligible subpart H drug' if the drug was approved by 
                the Secretary under subpart H of part 314 of title 21, 
                Code of Federal Regulations (relating to accelerated 
                approval), with restrictions under section 520 of such 
                part to assure safe use, and the Secretary has 
                published in the Federal Register a notice that the 
                Secretary has determined that good cause exists to 
                prohibit the drug from being imported pursuant to this 
                subsection.
            ``(2) Notice regarding drug refused admission.--If a 
        registered exporter ships a drug to an individual pursuant to 
        subsection (a)(2)(B) and the drug is refused admission to the 
        United States, a written notice shall be sent to the individual 
        and to the exporter that informs the individual and the 
        exporter of such refusal and the reason for the refusal.
    ``(j) Maintenance of Records and Samples.--
            ``(1) In general.--A registration condition is that the 
        importer or exporter involved shall--
                    ``(A) maintain records required under this section 
                for not less than 2 years; and
                    ``(B) maintain samples of each lot of a qualifying 
                drug required under this section for not more than 2 
                years.
            ``(2) Place of record maintenance.--The records described 
        under paragraph (1) shall be maintained--
                    ``(A) in the case of an importer, at the place of 
                business of the importer at which the importer 
                initially receives the qualifying drug after 
                importation; or
                    ``(B) in the case of an exporter, at the facility 
                from which the exporter ships the qualifying drug to 
                the United States.
    ``(k) Drug Recalls.--
            ``(1) Manufacturers.--A person that manufactures a 
        qualifying drug imported from a permitted country under this 
        section shall promptly inform the Secretary--
                    ``(A) if the drug is recalled or withdrawn from the 
                market in a permitted country;
                    ``(B) how the drug may be identified, including lot 
                number; and
                    ``(C) the reason for the recall or withdrawal.
            ``(2) Secretary.--With respect to each permitted country, 
        the Secretary shall--
                    ``(A) enter into an agreement with the government 
                of the country to receive information about recalls and 
                withdrawals of qualifying drugs in the country; or
                    ``(B) monitor recalls and withdrawals of qualifying 
                drugs in the country using any information that is 
                available to the public in any media.
            ``(3) Notice.--The Secretary may notify, as appropriate, 
        registered exporters, registered importers, wholesalers, 
        pharmacies, or the public of a recall or withdrawal of a 
        qualifying drug in a permitted country.
    ``(l) Drug Labeling and Packaging.--
            ``(1) In general.--When a qualifying drug that is imported 
        into the United States by an importer under subsection (a) is 
        dispensed by a pharmacist to an individual, the pharmacist 
        shall provide that the packaging and labeling of the drug 
        complies with all applicable regulations promulgated under 
        sections 3 and 4 of the Poison Prevention Packaging Act of 1970 
        (15 U.S.C. 1471 et seq.) and shall include with any other 
        labeling provided to the individual the following:
                    ``(A) The lot number assigned by the manufacturer.
                    ``(B) The name and registration number of the 
                importer.
                    ``(C) If required under paragraph (2)(B)(vi)(III) 
                of subsection (g), a prominent advisory that the drug 
                is safe and effective but not bioequivalent to the U.S. 
                label drug.
                    ``(D) If the inactive ingredients of the drug are 
                different from the inactive ingredients for the U.S. 
                label drug--
                            ``(i) a prominent advisory that persons 
                        with allergies should check the ingredient list 
                        of the drug because the ingredients of the drug 
                        differ from the ingredients of the U.S. label 
                        drug; and
                            ``(ii) a list of the ingredients of the 
                        drug as would be required under section 502(e).
            ``(2) Packaging.--A qualifying drug that is packaged in a 
        unit-of-use container (as those terms are defined in the United 
        States Pharmacopeia and National Formulary) shall not be 
        repackaged, provided that--
                    ``(A) the packaging complies with all applicable 
                regulations under sections 3 and 4 of the Poison 
                Prevention Packaging Act of 1970 (15 U.S.C. 1471 et 
                seq.); or
                    ``(B) the consumer consents to waive the 
                requirements of such Act, after being informed that the 
                packaging does not comply with such Act and that the 
                pharmacist will provide the drug in packaging that is 
                compliant at no additional cost.
    ``(m) Charitable Contributions.--Notwithstanding any other 
provision of this section, this section does not authorize the 
importation into the United States of a qualifying drug donated or 
otherwise supplied for free or at nominal cost by the manufacturer of 
the drug to a charitable or humanitarian organization, including the 
United Nations and affiliates, or to a government of a foreign country.
    ``(n) Unfair and Discriminatory Acts and Practices.--
            ``(1) In general.--It is unlawful for a manufacturer, 
        directly or indirectly (including by being a party to a 
        licensing agreement or other agreement), to--
                    ``(A) discriminate by charging a higher price for a 
                prescription drug sold to a registered exporter or 
                other person in a permitted country that exports a 
                qualifying drug to the United States under this section 
                than the price that is charged, inclusive of rebates or 
                other incentives to the permitted country or other 
                person, to another person that is in the same country 
                and that does not export a qualifying drug into the 
                United States under this section;
                    ``(B) discriminate by charging a higher price for a 
                prescription drug sold to a registered importer or 
                other person that distributes, sells, or uses a 
                qualifying drug imported into the United States under 
                this section than the price that is charged to another 
                person in the United States that does not import a 
                qualifying drug under this section, or that does not 
                distribute, sell, or use such a drug;
                    ``(C) discriminate by denying, restricting, or 
                delaying supplies of a prescription drug to a 
                registered exporter or other person in a permitted 
                country that exports a qualifying drug to the United 
                States under this section or to a registered importer 
                or other person that distributes, sells, or uses a 
                qualifying drug imported into the United States under 
                this section;
                    ``(D) discriminate by publicly, privately, or 
                otherwise refusing to do business with a registered 
                exporter or other person in a permitted country that 
                exports a qualifying drug to the United States under 
                this section or with a registered importer or other 
                person that distributes, sells, or uses a qualifying 
                drug imported into the United States under this 
                section;
                    ``(E) knowingly fail to submit a notice under 
                subsection (g)(2)(B)(i), knowingly fail to submit such 
                a notice on or before the date specified in subsection 
                (g)(2)(B)(v) or as otherwise required under subsection 
                (e) (3), (4), and (5) of section 4 of the 
                Pharmaceutical Market Access and Drug Safety Act of 
                2007, knowingly submit such a notice that makes a 
                materially false, fictitious, or fraudulent statement, 
                or knowingly fail to provide promptly any information 
                requested by the Secretary to review such a notice;
                    ``(F) knowingly fail to submit an application 
                required under subsection (g)(2)(F), knowingly fail to 
                submit such an application on or before the date 
                specified in subsection (g)(2)(F)(ii), knowingly submit 
                such an application that makes a materially false, 
                fictitious, or fraudulent statement, or knowingly fail 
                to provide promptly any information requested by the 
                Secretary to review such an application;
                    ``(G) cause there to be a difference (including a 
                difference in active ingredient, route of 
                administration, dosage form, strength, formulation, 
                manufacturing establishment, manufacturing process, or 
                person that manufactures the drug) between a 
                prescription drug for distribution in the United States 
                and the drug for distribution in a permitted country;
                    ``(H) refuse to allow an inspection authorized 
                under this section of an establishment that 
                manufactures a qualifying drug that is, or will be, 
                introduced for commercial distribution in a permitted 
                country;
                    ``(I) fail to conform to the methods used in, or 
                the facilities used for, the manufacturing, processing, 
                packing, or holding of a qualifying drug that is, or 
                will be, introduced for commercial distribution in a 
                permitted country to good manufacturing practice under 
                this Act;
                    ``(J) become a party to a licensing agreement or 
                other agreement related to a qualifying drug that fails 
                to provide for compliance with all requirements of this 
                section with respect to such drug;
                    ``(K) enter into a contract that restricts, 
                prohibits, or delays the importation of a qualifying 
                drug under this section;
                    ``(L) engage in any other action to restrict, 
                prohibit, or delay the importation of a qualifying drug 
                under this section; or
                    ``(M) engage in any other action that the Federal 
                Trade Commission determines to discriminate against a 
                person that engages or attempts to engage in the 
                importation of a qualifying drug under this section.
            ``(2) Referral of potential violations.--The Secretary 
        shall promptly refer to the Federal Trade Commission each 
        potential violation of subparagraph (E), (F), (G), (H), or (I) 
        of paragraph (1) that becomes known to the Secretary.
            ``(3) Affirmative defense.--
                    ``(A) Discrimination.--It shall be an affirmative 
                defense to a charge that a manufacturer has 
                discriminated under subparagraph (A), (B), (C), (D), or 
                (M) of paragraph (1) that the higher price charged for 
                a prescription drug sold to a person, the denial, 
                restriction, or delay of supplies of a prescription 
                drug to a person, the refusal to do business with a 
                person, or other discriminatory activity against a 
                person, is not based, in whole or in part, on--
                            ``(i) the person exporting or importing a 
                        qualifying drug into the United States under 
                        this section; or
                            ``(ii) the person distributing, selling, or 
                        using a qualifying drug imported into the 
                        United States under this section.
                    ``(B) Drug differences.--It shall be an affirmative 
                defense to a charge that a manufacturer has caused 
                there to be a difference described in subparagraph (G) 
                of paragraph (1) that--
                            ``(i) the difference was required by the 
                        country in which the drug is distributed;
                            ``(ii) the Secretary has determined that 
                        the difference was necessary to improve the 
                        safety or effectiveness of the drug;
                            ``(iii) the person manufacturing the drug 
                        for distribution in the United States has given 
                        notice to the Secretary under subsection 
                        (g)(2)(B)(i) that the drug for distribution in 
                        the United States is not different from a drug 
                        for distribution in permitted countries whose 
                        combined population represents at least 50 
                        percent of the total population of all 
                        permitted countries; or
                            ``(iv) the difference was not caused, in 
                        whole or in part, for the purpose of 
                        restricting importation of the drug into the 
                        United States under this section.
            ``(4) Effect of subsection.--
                    ``(A) Sales in other countries.--This subsection 
                applies only to the sale or distribution of a 
                prescription drug in a country if the manufacturer of 
                the drug chooses to sell or distribute the drug in the 
                country. Nothing in this subsection shall be construed 
                to compel the manufacturer of a drug to distribute or 
                sell the drug in a country.
                    ``(B) Discounts to insurers, health plans, pharmacy 
                benefit managers, and covered entities.--Nothing in 
                this subsection shall be construed to--
                            ``(i) prevent or restrict a manufacturer of 
                        a prescription drug from providing discounts to 
                        an insurer, health plan, pharmacy benefit 
                        manager in the United States, or covered entity 
                        in the drug discount program under section 340B 
                        of the Public Health Service Act (42 U.S.C. 
                        256b) in return for inclusion of the drug on a 
                        formulary;
                            ``(ii) require that such discounts be made 
                        available to other purchasers of the 
                        prescription drug; or
                            ``(iii) prevent or restrict any other 
                        measures taken by an insurer, health plan, or 
                        pharmacy benefit manager to encourage 
                        consumption of such prescription drug.
                    ``(C) Charitable contributions.--Nothing in this 
                subsection shall be construed to--
                            ``(i) prevent a manufacturer from donating 
                        a prescription drug, or supplying a 
                        prescription drug at nominal cost, to a 
                        charitable or humanitarian organization, 
                        including the United Nations and affiliates, or 
                        to a government of a foreign country; or
                            ``(ii) apply to such donations or supplying 
                        of a prescription drug.
            ``(5) Enforcement.--
                    ``(A) Unfair or deceptive act or practice.--A 
                violation of this subsection shall be treated as a 
                violation of a rule defining an unfair or deceptive act 
                or practice prescribed under section 18(a)(1)(B) of the 
                Federal Trade Commission Act (15 U.S.C. 57a(a)(1)(B)).
                    ``(B) Actions by the commission.--The Federal Trade 
                Commission--
                            ``(i) shall enforce this subsection in the 
                        same manner, by the same means, and with the 
                        same jurisdiction, powers, and duties as though 
                        all applicable terms and provisions of the 
                        Federal Trade Commission Act (15 U.S.C. 41 et 
                        seq.) were incorporated into and made a part of 
                        this section; and
                            ``(ii) may seek monetary relief threefold 
                        the damages sustained, in addition to any other 
                        remedy available to the Federal Trade 
                        Commission under the Federal Trade Commission 
                        Act (15 U.S.C. 41 et seq.).
            ``(6) Actions by states.--
                    ``(A) In general.--
                            ``(i) Civil actions.--In any case in which 
                        the attorney general of a State has reason to 
                        believe that an interest of the residents of 
                        that State have been adversely affected by any 
                        manufacturer that violates paragraph (1), the 
                        attorney general of a State may bring a civil 
                        action on behalf of the residents of the State, 
                        and persons doing business in the State, in a 
                        district court of the United States of 
                        appropriate jurisdiction to--
                                    ``(I) enjoin that practice;
                                    ``(II) enforce compliance with this 
                                subsection;
                                    ``(III) obtain damages, 
                                restitution, or other compensation on 
                                behalf of residents of the State and 
                                persons doing business in the State, 
                                including threefold the damages; or
                                    ``(IV) obtain such other relief as 
                                the court may consider to be 
                                appropriate.
                            ``(ii) Notice.--
                                    ``(I) In general.--Before filing an 
                                action under clause (i), the attorney 
                                general of the State involved shall 
                                provide to the Federal Trade 
                                Commission--
                                            ``(aa) written notice of 
                                        that action; and
                                            ``(bb) a copy of the 
                                        complaint for that action.
                                    ``(II) Exemption.--Subclause (I) 
                                shall not apply with respect to the 
                                filing of an action by an attorney 
                                general of a State under this 
                                paragraph, if the attorney general 
                                determines that it is not feasible to 
                                provide the notice described in that 
                                subclause before filing of the action. 
                                In such case, the attorney general of a 
                                State shall provide notice and a copy 
                                of the complaint to the Federal Trade 
                                Commission at the same time as the 
                                attorney general files the action.
                    ``(B) Intervention.--
                            ``(i) In general.--On receiving notice 
                        under subparagraph (A)(ii), the Federal Trade 
                        Commission shall have the right to intervene in 
                        the action that is the subject of the notice.
                            ``(ii) Effect of intervention.--If the 
                        Federal Trade Commission intervenes in an 
                        action under subparagraph (A), it shall have 
                        the right--
                                    ``(I) to be heard with respect to 
                                any matter that arises in that action; 
                                and
                                    ``(II) to file a petition for 
                                appeal.
                    ``(C) Construction.--For purposes of bringing any 
                civil action under subparagraph (A), nothing in this 
                subsection shall be construed to prevent an attorney 
                general of a State from exercising the powers conferred 
                on the attorney general by the laws of that State to--
                            ``(i) conduct investigations;
                            ``(ii) administer oaths or affirmations; or
                            ``(iii) compel the attendance of witnesses 
                        or the production of documentary and other 
                        evidence.
                    ``(D) Actions by the commission.--In any case in 
                which an action is instituted by or on behalf of the 
                Federal Trade Commission for a violation of paragraph 
                (1), a State may not, during the pendency of that 
                action, institute an action under subparagraph (A) for 
                the same violation against any defendant named in the 
                complaint in that action.
                    ``(E) Venue.--Any action brought under subparagraph 
                (A) may be brought in the district court of the United 
                States that meets applicable requirements relating to 
                venue under section 1391 of title 28, United States 
                Code.
                    ``(F) Service of process.--In an action brought 
                under subparagraph (A), process may be served in any 
                district in which the defendant--
                            ``(i) is an inhabitant; or
                            ``(ii) may be found.
                    ``(G) Measurement of damages.--In any action under 
                this paragraph to enforce a cause of action under this 
                subsection in which there has been a determination that 
                a defendant has violated a provision of this 
                subsection, damages may be proved and assessed in the 
                aggregate by statistical or sampling methods, by the 
                computation of illegal overcharges or by such other 
                reasonable system of estimating aggregate damages as 
                the court in its discretion may permit without the 
                necessity of separately proving the individual claim 
                of, or amount of damage to, persons on whose behalf the 
                suit was brought.
                    ``(H) Exclusion on duplicative relief.--The 
                district court shall exclude from the amount of 
                monetary relief awarded in an action under this 
                paragraph brought by the attorney general of a State 
                any amount of monetary relief which duplicates amounts 
                which have been awarded for the same injury.
            ``(7) Effect on antitrust laws.--Nothing in this subsection 
        shall be construed to modify, impair, or supersede the 
        operation of the antitrust laws. For the purpose of this 
        subsection, the term `antitrust laws' has the meaning given it 
        in the first section of the Clayton Act, except that it 
        includes section 5 of the Federal Trade Commission Act to the 
        extent that such section 5 applies to unfair methods of 
        competition.
            ``(8) Manufacturer.--In this subsection, the term 
        `manufacturer' means any entity, including any affiliate or 
        licensee of that entity, that is engaged in--
                    ``(A) the production, preparation, propagation, 
                compounding, conversion, or processing of a 
                prescription drug, either directly or indirectly by 
                extraction from substances of natural origin, or 
                independently by means of chemical synthesis, or by a 
                combination of extraction and chemical synthesis; or
                    ``(B) the packaging, repackaging, labeling, 
                relabeling, or distribution of a prescription drug.''.
    (b) Prohibited Acts.--The Federal Food, Drug, and Cosmetic Act is 
amended--
            (1) in section 301 (21 U.S.C. 331), by striking paragraph 
        (aa) and inserting the following:
    ``(aa)(1) The sale or trade by a pharmacist, or by a business 
organization of which the pharmacist is a part, of a qualifying drug 
that under section 804(a)(2)(A) was imported by the pharmacist, other 
than--
            ``(A) a sale at retail made pursuant to dispensing the drug 
        to a customer of the pharmacist or organization; or
            ``(B) a sale or trade of the drug to a pharmacy or a 
        wholesaler registered to import drugs under section 804.
    ``(2) The sale or trade by an individual of a qualifying drug that 
under section 804(a)(2)(B) was imported by the individual.
    ``(3) The making of a materially false, fictitious, or fraudulent 
statement or representation, or a material omission, in a notice under 
clause (i) of section 804(g)(2)(B) or in an application required under 
section 804(g)(2)(F), or the failure to submit such a notice or 
application.
    ``(4) The importation of a drug in violation of a registration 
condition or other requirement under section 804, the falsification of 
any record required to be maintained, or provided to the Secretary, 
under such section, or the violation of any registration condition or 
other requirement under such section.''; and
            (2) in section 303(a) (21 U.S.C. 333(a)), by striking 
        paragraph (6) and inserting the following:
    ``(6) Notwithstanding subsection (a), any person that knowingly 
violates section 301(i) (2) or (3) or section 301(aa)(4) shall be 
imprisoned not more than 10 years, or fined in accordance with title 
18, United States Code, or both.''.
    (c) Amendment of Certain Provisions.--
            (1) In general.--Section 801 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 381) is amended by striking subsection 
        (g) and inserting the following:
    ``(g) With respect to a prescription drug that is imported or 
offered for import into the United States by an individual who is not 
in the business of such importation, that is not shipped by a 
registered exporter under section 804, and that is refused admission 
under subsection (a), the Secretary shall notify the individual that--
            ``(1) the drug has been refused admission because the drug 
        was not a lawful import under section 804;
            ``(2) the drug is not otherwise subject to a waiver of the 
        requirements of subsection (a);
            ``(3) the individual may under section 804 lawfully import 
        certain prescription drugs from exporters registered with the 
        Secretary under section 804; and
            ``(4) the individual can find information about such 
        importation, including a list of registered exporters, on the 
        Internet website of the Food and Drug Administration or through 
        a toll-free telephone number required under section 804.''.
            (2) Establishment registration.--Section 510(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(i)) is 
        amended in paragraph (1) by inserting after ``import into the 
        United States'' the following: ``, including a drug that is, or 
        may be, imported or offered for import into the United States 
        under section 804,''.
            (3) Effective date.--The amendments made by this subsection 
        shall take effect on the date that is 90 days after the date of 
        enactment of this title.
    (d) Exhaustion.--
            (1) In general.--Section 271 of title 35, United States 
        Code, is amended--
                    (A) by redesignating subsections (h) and (i) as (i) 
                and (j), respectively; and
                    (B) by inserting after subsection (g) the 
                following:
    ``(h) It shall not be an act of infringement to use, offer to sell, 
or sell within the United States or to import into the United States 
any patented invention under section 804 of the Federal Food, Drug, and 
Cosmetic Act that was first sold abroad by or under authority of the 
owner or licensee of such patent.''.
            (2) Rule of construction.--Nothing in the amendment made by 
        paragraph (1) shall be construed to affect the ability of a 
        patent owner or licensee to enforce their patent, subject to 
        such amendment.
    (e) Effect of Section 804.--
            (1) In general.--Section 804 of the Federal Food, Drug, and 
        Cosmetic Act, as added by subsection (a), shall permit the 
        importation of qualifying drugs (as defined in such section 
        804) into the United States without regard to the status of the 
        issuance of implementing regulations--
                    (A) from exporters registered under such section 
                804 on the date that is 90 days after the date of 
                enactment of this title; and
                    (B) from permitted countries, as defined in such 
                section 804, by importers registered under such section 
                804 on the date that is 1 year after the date of 
                enactment of this title.
            (2) Review of registration by certain exporters.--
                    (A) Review priority.--In the review of 
                registrations submitted under subsection (b) of such 
                section 804, registrations submitted by entities in 
                Canada that are significant exporters of prescription 
                drugs to individuals in the United States as of the 
                date of enactment of this title will have priority 
                during the 90 day period that begins on such date of 
                enactment.
                    (B) Period for review.--During such 90-day period, 
                the reference in subsection (b)(2)(A) of such section 
                804 to 90 days (relating to approval or disapproval of 
                registrations) is, as applied to such entities, deemed 
                to be 30 days.
                    (C) Limitation.--That an exporter in Canada 
                exports, or has exported, prescription drugs to 
                individuals in the United States on or before the date 
                that is 90 days after the date of enactment of this 
                title shall not serve as a basis, in whole or in part, 
                for disapproving a registration under such section 804 
                from the exporter.
                    (D) First year limit on number of exporters.--
                During the 1-year period beginning on the date of 
                enactment of this title, the Secretary of Health and 
                Human Services (referred to in this section as the 
                ``Secretary'') may limit the number of registered 
                exporters under such section 804 to not less than 50, 
                so long as the Secretary gives priority to those 
                exporters with demonstrated ability to process a high 
                volume of shipments of drugs to individuals in the 
                United States.
                    (E) Second year limit on number of exporters.--
                During the 1-year period beginning on the date that is 
                1 year after the date of enactment of this title, the 
                Secretary may limit the number of registered exporters 
                under such section 804 to not less than 100, so long as 
                the Secretary gives priority to those exporters with 
                demonstrated ability to process a high volume of 
                shipments of drugs to individuals in the United States.
                    (F) Further limit on number of exporters.--During 
                any 1-year period beginning on a date that is 2 or more 
                years after the date of enactment of this title, the 
                Secretary may limit the number of registered exporters 
                under such section 804 to not less than 25 more than 
                the number of such exporters during the previous 1-year 
                period, so long as the Secretary gives priority to 
                those exporters with demonstrated ability to process a 
                high volume of shipments of drugs to individuals in the 
                United States.
            (3) Limits on number of importers.--
                    (A) First year limit on number of importers.--
                During the 1-year period beginning on the date that is 
                1 year after the date of enactment of this title, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 100 (of which 
                at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups), so long as the 
                Secretary gives priority to those importers with 
                demonstrated ability to process a high volume of 
                shipments of drugs imported into the United States.
                    (B) Second year limit on number of importers.--
                During the 1-year period beginning on the date that is 
                2 years after the date of enactment of this title, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 200 (of which 
                at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups), so long as the 
                Secretary gives priority to those importers with 
                demonstrated ability to process a high volume of 
                shipments of drugs into the United States.
                    (C) Further limit on number of importers.--During 
                any 1-year period beginning on a date that is 3 or more 
                years after the date of enactment of this title, the 
                Secretary may limit the number of registered importers 
                under such section 804 to not less than 50 more (of 
                which at least a significant number shall be groups of 
                pharmacies, to the extent feasible given the 
                applications submitted by such groups) than the number 
                of such importers during the previous 1-year period, so 
                long as the Secretary gives priority to those importers 
                with demonstrated ability to process a high volume of 
                shipments of drugs to the United States.
            (4) Notices for drugs for import from canada.--The notice 
        with respect to a qualifying drug introduced for commercial 
        distribution in Canada as of the date of enactment of this 
        title that is required under subsection (g)(2)(B)(i) of such 
        section 804 shall be submitted to the Secretary not later than 
        30 days after the date of enactment of this title if--
                    (A) the U.S. label drug (as defined in such section 
                804) for the qualifying drug is 1 of the 100 
                prescription drugs with the highest dollar volume of 
                sales in the United States based on the 12 calendar 
                month period most recently completed before the date of 
                enactment of this Act; or
                    (B) the notice is a notice under subsection 
                (g)(2)(B)(i)(II) of such section 804.
            (5) Notice for drugs for import from other countries.--The 
        notice with respect to a qualifying drug introduced for 
        commercial distribution in a permitted country other than 
        Canada as of the date of enactment of this title that is 
        required under subsection (g)(2)(B)(i) of such section 804 
        shall be submitted to the Secretary not later than 180 days 
        after the date of enactment of this title if--
                    (A) the U.S. label drug for the qualifying drug is 
                1 of the 100 prescription drugs with the highest dollar 
                volume of sales in the United States based on the 12 
                calendar month period that is first completed on the 
                date that is 120 days after the date of enactment of 
                this title; or
                    (B) the notice is a notice under subsection 
                (g)(2)(B)(i)(II) of such section 804.
            (6) Notice for other drugs for import.--
                    (A) Guidance on submission dates.--The Secretary 
                shall by guidance establish a series of submission 
                dates for the notices under subsection (g)(2)(B)(i) of 
                such section 804 with respect to qualifying drugs 
                introduced for commercial distribution as of the date 
                of enactment of this title and that are not required to 
                be submitted under paragraph (4) or (5).
                    (B) Consistent and efficient use of resources.--The 
                Secretary shall establish the dates described under 
                subparagraph (A) so that such notices described under 
                subparagraph (A) are submitted and reviewed at a rate 
                that allows consistent and efficient use of the 
                resources and staff available to the Secretary for such 
                reviews. The Secretary may condition the requirement to 
                submit such a notice, and the review of such a notice, 
                on the submission by a registered exporter or a 
                registered importer to the Secretary of a notice that 
                such exporter or importer intends to import such 
                qualifying drug to the United States under such section 
                804.
                    (C) Priority for drugs with higher sales.--The 
                Secretary shall establish the dates described under 
                subparagraph (A) so that the Secretary reviews the 
                notices described under such subparagraph with respect 
                to qualifying drugs with higher dollar volume of sales 
                in the United States before the notices with respect to 
                drugs with lower sales in the United States.
            (7) Notices for drugs approved after effective date.--The 
        notice required under subsection (g)(2)(B)(i) of such section 
        804 for a qualifying drug first introduced for commercial 
        distribution in a permitted country (as defined in such section 
        804) after the date of enactment of this title shall be 
        submitted to and reviewed by the Secretary as provided under 
        subsection (g)(2)(B) of such section 804, without regard to 
        paragraph (4), (5), or (6).
            (8) Report.--Beginning with the first full fiscal year 
        after the date of enactment of this title, not later than 90 
        days after the end of each fiscal year during which the 
        Secretary reviews a notice referred to in paragraph (4), (5), 
        or (6), the Secretary shall submit a report to Congress 
        concerning the progress of the Food and Drug Administration in 
        reviewing the notices referred to in paragraphs (4), (5), and 
        (6).
            (9) User fees.--
                    (A) Exporters.--When establishing an aggregate 
                total of fees to be collected from exporters under 
                subsection (f)(2) of such section 804, the Secretary 
                shall, under subsection (f)(3)(C)(i) of such section 
                804, estimate the total price of drugs imported under 
                subsection (a) of such section 804 into the United 
                States by registered exporters during the first fiscal 
                year in which this title takes effect to be an amount 
                equal to the amount which bears the same ratio to 
                $1,000,000,000 as the number of days in such fiscal 
                year during which this title is effective bears to 365.
                    (B) Importers.--When establishing an aggregate 
                total of fees to be collected from importers under 
                subsection (e)(2) of such section 804, the Secretary 
                shall, under subsection (e)(3)(C)(i) of such section 
                804, estimate the total price of drugs imported under 
                subsection (a) of such section 804 into the United 
                States by registered importers during--
                            (i) the first fiscal year in which this 
                        title takes effect to be an amount equal to the 
                        amount which bears the same ratio to 
                        $1,000,000,000 as the number of days in such 
                        fiscal year during which this title is 
                        effective bears to 365; and
                            (ii) the second fiscal year in which this 
                        title is in effect to be $3,000,000,000.
                    (C) Second year adjustment.--
                            (i) Reports.--Not later than February 20 of 
                        the second fiscal year in which this title is 
                        in effect, registered importers shall report to 
                        the Secretary the total price and the total 
                        volume of drugs imported to the United States 
                        by the importer during the 4-month period from 
                        October 1 through January 31 of such fiscal 
                        year.
                            (ii) Reestimate.--Notwithstanding 
                        subsection (e)(3)(C)(ii) of such section 804 or 
                        subparagraph (B), the Secretary shall 
                        reestimate the total price of qualifying drugs 
                        imported under subsection (a) of such section 
                        804 into the United States by registered 
                        importers during the second fiscal year in 
                        which this title is in effect. Such reestimate 
                        shall be equal to--
                                    (I) the total price of qualifying 
                                drugs imported by each importer as 
                                reported under clause (i); multiplied 
                                by
                                    (II) 3.
                            (iii) Adjustment.--The Secretary shall 
                        adjust the fee due on April 1 of the second 
                        fiscal year in which this title is in effect, 
                        from each importer so that the aggregate total 
                        of fees collected under subsection (e)(2) for 
                        such fiscal year does not exceed the total 
                        price of qualifying drugs imported under 
                        subsection (a) of such section 804 into the 
                        United States by registered importers during 
                        such fiscal year as reestimated under clause 
                        (ii).
                    (D) Failure to pay fees.--Notwithstanding any other 
                provision of this section, the Secretary may prohibit a 
                registered importer or exporter that is required to pay 
                user fees under subsection (e) or (f) of such section 
                804 and that fails to pay such fees within 30 days 
                after the date on which it is due, from importing or 
                offering for importation a qualifying drug under such 
                section 804 until such fee is paid.
                    (E) Annual report.--
                            (i) Food and drug administration.--Not 
                        later than 180 days after the end of each 
                        fiscal year during which fees are collected 
                        under subsection (e), (f), or (g)(2)(B)(iv) of 
                        such section 804, the Secretary shall prepare 
                        and submit to the House of Representatives and 
                        the Senate a report on the implementation of 
                        the authority for such fees during such fiscal 
                        year and the use, by the Food and Drug 
                        Administration, of the fees collected for the 
                        fiscal year for which the report is made and 
                        credited to the Food and Drug Administration.
                            (ii) Customs and border control.--Not later 
                        than 180 days after the end of each fiscal year 
                        during which fees are collected under 
                        subsection (e) or (f) of such section 804, the 
                        Secretary of Homeland Security, in consultation 
                        with the Secretary of the Treasury, shall 
                        prepare and submit to the House of 
                        Representatives and the Senate a report on the 
                        use, by the Bureau of Customs and Border 
                        Protection, of the fees, if any, transferred by 
                        the Secretary to the Bureau of Customs and 
                        Border Protection for the fiscal year for which 
                        the report is made.
            (10) Special rule regarding importation by individuals.--
                    (A) In general.--Notwithstanding any provision of 
                this title (or an amendment made by this title), the 
                Secretary shall expedite the designation of any 
                additional countries from which an individual may 
                import a qualifying drug into the United States under 
                such section 804 if any action implemented by the 
                Government of Canada has the effect of limiting or 
                prohibiting the importation of qualifying drugs into 
                the United States from Canada.
                    (B) Timing and criteria.--The Secretary shall 
                designate such additional countries under subparagraph 
                (A)--
                            (i) not later than 6 months after the date 
                        of the action by the Government of Canada 
                        described under such subparagraph; and
                            (ii) using the criteria described under 
                        subsection (a)(4)(D)(i)(II) of such section 
                        804.
    (f) Implementation of Section 804.--
            (1) Interim rule.--The Secretary may promulgate an interim 
        rule for implementing section 804 of the Federal Food, Drug, 
        and Cosmetic Act, as added by subsection (a) of this section.
            (2) No notice of proposed rulemaking.--The interim rule 
        described under paragraph (1) may be developed and promulgated 
        by the Secretary without providing general notice of proposed 
        rulemaking.
            (3) Final rule.--Not later than 1 year after the date on 
        which the Secretary promulgates an interim rule under paragraph 
        (1), the Secretary shall, in accordance with procedures under 
        section 553 of title 5, United States Code, promulgate a final 
        rule for implementing such section 804, which may incorporate 
        by reference provisions of the interim rule provided for under 
        paragraph (1), to the extent that such provisions are not 
        modified.
    (g) Consumer Education.--The Secretary shall carry out activities 
that educate consumers--
            (1) with regard to the availability of qualifying drugs for 
        import for personal use from an exporter registered with and 
        approved by the Food and Drug Administration under section 804 
        of the Federal Food, Drug, and Cosmetic Act, as added by this 
        section, including information on how to verify whether an 
        exporter is registered and approved by use of the Internet 
        website of the Food and Drug Administration and the toll-free 
        telephone number required by this title;
            (2) that drugs that consumers attempt to import from an 
        exporter that is not registered with and approved by the Food 
        and Drug Administration can be seized by the United States 
        Customs Service and destroyed, and that such drugs may be 
        counterfeit, unapproved, unsafe, or ineffective;
            (3) with regard to the suspension and termination of any 
        registration of a registered importer or exporter under such 
        section 804; and
            (4) with regard to the availability at domestic retail 
        pharmacies of qualifying drugs imported under such section 804 
        by domestic wholesalers and pharmacies registered with and 
        approved by the Food and Drug Administration.
    (h) Effect on Administration Practices.--Notwithstanding any 
provision of this title (and the amendments made by this title), the 
practices and policies of the Food and Drug Administration and Bureau 
of Customs and Border Protection, in effect on January 1, 2004, with 
respect to the importation of prescription drugs into the United States 
by an individual, on the person of such individual, for personal use, 
shall remain in effect.
    (i) Report to Congress.--The Federal Trade Commission shall, on an 
annual basis, submit to Congress a report that describes any action 
taken during the period for which the report is being prepared to 
enforce the provisions of section 804(n) of the Federal Food, Drug, and 
Cosmetic Act (as added by this title), including any pending 
investigations or civil actions under such section.

SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION INTO UNITED 
              STATES.

    (a) In General.--Chapter VIII of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 381 et seq.), as amended by section 804, is 
further amended by adding at the end the following section:

``SEC. 805. DISPOSITION OF CERTAIN DRUGS DENIED ADMISSION.

    ``(a) In General.--The Secretary of Homeland Security shall deliver 
to the Secretary a shipment of drugs that is imported or offered for 
import into the United States if--
            ``(1) the shipment has a declared value of less than 
        $10,000; and
            ``(2)(A) the shipping container for such drugs does not 
        bear the markings required under section 804(d)(2); or
            ``(B) the Secretary has requested delivery of such shipment 
        of drugs.
    ``(b) No Bond or Export.--Section 801(b) does not authorize the 
delivery to the owner or consignee of drugs delivered to the Secretary 
under subsection (a) pursuant to the execution of a bond, and such 
drugs may not be exported.
    ``(c) Destruction of Violative Shipment.--The Secretary shall 
destroy a shipment of drugs delivered by the Secretary of Homeland 
Security to the Secretary under subsection (a) if--
            ``(1) in the case of drugs that are imported or offered for 
        import from a registered exporter under section 804, the drugs 
        are in violation of any standard described in section 
        804(g)(5); or
            ``(2) in the case of drugs that are not imported or offered 
        for import from a registered exporter under section 804, the 
        drugs are in violation of a standard referred to in section 
        801(a) or 801(d)(1).
    ``(d) Certain Procedures.--
            ``(1) In general.--The delivery and destruction of drugs 
        under this section may be carried out without notice to the 
        importer, owner, or consignee of the drugs except as required 
        by section 801(g) or section 804(i)(2). The issuance of 
        receipts for the drugs, and recordkeeping activities regarding 
        the drugs, may be carried out on a summary basis.
            ``(2) Objective of procedures.--Procedures promulgated 
        under paragraph (1) shall be designed toward the objective of 
        ensuring that, with respect to efficiently utilizing Federal 
        resources available for carrying out this section, a 
        substantial majority of shipments of drugs subject to described 
        in subsection (c) are identified and destroyed.
    ``(e) Evidence Exception.--Drugs may not be destroyed under 
subsection (c) to the extent that the Attorney General of the United 
States determines that the drugs should be preserved as evidence or 
potential evidence with respect to an offense against the United 
States.
    ``(f) Rule of Construction.--This section may not be construed as 
having any legal effect on applicable law with respect to a shipment of 
drugs that is imported or offered for import into the United States and 
has a declared value equal to or greater than $10,000.''.
    (b) Procedures.--Procedures for carrying out section 805 of the 
Federal Food, Drug, and Cosmetic Act, as added by subsection (a), shall 
be established not later than 90 days after the date of the enactment 
of this title.
    (c) Effective Date.--The amendments made by this section shall take 
effect on the date that is 90 days after the date of enactment of this 
title.

SEC. 806. WHOLESALE DISTRIBUTION OF DRUGS; STATEMENTS REGARDING PRIOR 
              SALE, PURCHASE, OR TRADE.

    (a) Striking of Exemptions; Applicability to Registered 
Exporters.--Section 503(e) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 353(e)) is amended--
            (1) in paragraph (1)--
                    (A) by striking ``and who is not the manufacturer 
                or an authorized distributor of record of such drug'';
                    (B) by striking ``to an authorized distributor of 
                record or''; and
                    (C) by striking subparagraph (B) and inserting the 
                following:
    ``(B) The fact that a drug subject to subsection (b) is exported 
from the United States does not with respect to such drug exempt any 
person that is engaged in the business of the wholesale distribution of 
the drug from providing the statement described in subparagraph (A) to 
the person that receives the drug pursuant to the export of the drug.
    ``(C)(i) The Secretary shall by regulation establish requirements 
that supersede subparagraph (A) (referred to in this subparagraph as 
`alternative requirements') to identify the chain of custody of a drug 
subject to subsection (b) from the manufacturer of the drug throughout 
the wholesale distribution of the drug to a pharmacist who intends to 
sell the drug at retail if the Secretary determines that the 
alternative requirements, which may include standardized anti-
counterfeiting or track-and-trace technologies, will identify such 
chain of custody or the identity of the discrete package of the drug 
from which the drug is dispensed with equal or greater certainty to the 
requirements of subparagraph (A), and that the alternative requirements 
are economically and technically feasible.
    ``(ii) When the Secretary promulgates a final rule to establish 
such alternative requirements, the final rule in addition shall, with 
respect to the registration condition established in clause (i) of 
section 804(c)(3)(B), establish a condition equivalent to the 
alternative requirements, and such equivalent condition may be met in 
lieu of the registration condition established in such clause (i).'';
            (2) in paragraph (2)(A), by adding at the end the 
        following: ``The preceding sentence may not be construed as 
        having any applicability with respect to a registered exporter 
        under section 804.''; and
            (3) in paragraph (3), by striking ``and subsection (d)--'' 
        in the matter preceding subparagraph (A) and all that follows 
        through ``the term `wholesale distribution' means'' in 
        subparagraph (B) and inserting the following: ``and subsection 
        (d), the term `wholesale distribution' means''.
    (b) Conforming Amendment.--Section 503(d) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 353(d)) is amended by adding at the 
end the following:
    ``(4) Each manufacturer of a drug subject to subsection (b) shall 
maintain at its corporate offices a current list of the authorized 
distributors of record of such drug.
    ``(5) For purposes of this subsection, the term `authorized 
distributors of record' means those distributors with whom a 
manufacturer has established an ongoing relationship to distribute such 
manufacturer's products.''.
    (c) Effective Date.--
            (1) In general.--The amendments made by paragraphs (1) and 
        (3) of subsection (a) and by subsection (b) shall take effect 
        on January 1, 2010.
            (2) Drugs imported by registered importers under section 
        804.--Notwithstanding paragraph (1), the amendments made by 
        paragraphs (1) and (3) of subsection (a) and by subsection (b) 
        shall take effect on the date that is 90 days after the date of 
        enactment of this title with respect to qualifying drugs 
        imported under section 804 of the Federal Food, Drug, and 
        Cosmetic Act, as added by section 804.
            (3) Effect with respect to registered exporters.--The 
        amendment made by subsection (a)(2) shall take effect on the 
        date that is 90 days after the date of enactment of this title.
            (4) Alternative requirements.--The Secretary shall issue 
        regulations to establish the alternative requirements, referred 
        to in the amendment made by subsection (a)(1), that take effect 
        not later than January 1, 2010.
            (5) Intermediate requirements.--The Secretary shall by 
        regulation require the use of standardized anti-counterfeiting 
        or track-and-trace technologies on prescription drugs at the 
        case and pallet level effective not later than 1 year after the 
        date of enactment of this title.
            (6) Additional requirements.--
                    (A) In general.--Notwithstanding any other 
                provision of this section, the Secretary shall, not 
                later than 18 months after the date of enactment of 
                this title, require that the packaging of any 
                prescription drug incorporates--
                            (i) a standardized numerical identifier 
                        unique to each package of such drug, applied at 
                        the point of manufacturing and repackaging (in 
                        which case the numerical identifier shall be 
                        linked to the numerical identifier applied at 
                        the point of manufacturing); and
                            (ii)(I) overt optically variable 
                        counterfeit-resistant technologies that--
                                    (aa) are visible to the naked eye, 
                                providing for visual identification of 
                                product authenticity without the need 
                                for readers, microscopes, lighting 
                                devices, or scanners;
                                    (bb) are similar to that used by 
                                the Bureau of Engraving and Printing to 
                                secure United States currency;
                                    (cc) are manufactured and 
                                distributed in a highly secure, tightly 
                                controlled environment; and
                                    (dd) incorporate additional layers 
                                of nonvisible convert security features 
                                up to and including forensic 
                                capability, as described in 
                                subparagraph (B); or
                            (II) technologies that have a function of 
                        security comparable to that described in 
                        subclause (I), as determined by the Secretary.
                    (B) Standards for packaging.--For the purpose of 
                making it more difficult to counterfeit the packaging 
                of drugs subject to this paragraph, the manufacturers 
                of such drugs shall incorporate the technologies 
                described in subparagraph (A) into at least 1 
                additional element of the physical packaging of the 
                drugs, including blister packs, shrink wrap, package 
                labels, package seals, bottles, and boxes.

SEC. 807. INTERNET SALES OF PRESCRIPTION DRUGS.

    (a) In General.--Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after section 503A 
the following:

``SEC. 503B. INTERNET SALES OF PRESCRIPTION DRUGS.

    ``(a) Requirements Regarding Information on Internet Site.--
            ``(1) In general.--A person may not dispense a prescription 
        drug pursuant to a sale of the drug by such person if--
                    ``(A) the purchaser of the drug submitted the 
                purchase order for the drug, or conducted any other 
                part of the sales transaction for the drug, through an 
                Internet site;
                    ``(B) the person dispenses the drug to the 
                purchaser by mailing or shipping the drug to the 
                purchaser; and
                    ``(C) such site, or any other Internet site used by 
                such person for purposes of sales of a prescription 
                drug, fails to meet each of the requirements specified 
                in paragraph (2), other than a site or pages on a site 
                that--
                            ``(i) are not intended to be accessed by 
                        purchasers or prospective purchasers; or
                            ``(ii) provide an Internet information 
                        location tool within the meaning of section 
                        231(e)(5) of the Communications Act of 1934 (47 
                        U.S.C. 231(e)(5)).
            ``(2) Requirements.--With respect to an Internet site, the 
        requirements referred to in subparagraph (C) of paragraph (1) 
        for a person to whom such paragraph applies are as follows:
                    ``(A) Each page of the site shall include either 
                the following information or a link to a page that 
                provides the following information:
                            ``(i) The name of such person.
                            ``(ii) Each State in which the person is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(iii) The address and telephone number of 
                        each place of business of the person with 
                        respect to sales of prescription drugs through 
                        the Internet, other than a place of business 
                        that does not mail or ship prescription drugs 
                        to purchasers.
                            ``(iv) The name of each individual who 
                        serves as a pharmacist for prescription drugs 
                        that are mailed or shipped pursuant to the 
                        site, and each State in which the individual is 
                        authorized by law to dispense prescription 
                        drugs.
                            ``(v) If the person provides for medical 
                        consultations through the site for purposes of 
                        providing prescriptions, the name of each 
                        individual who provides such consultations; 
                        each State in which the individual is licensed 
                        or otherwise authorized by law to provide such 
                        consultations or practice medicine; and the 
                        type or types of health professions for which 
                        the individual holds such licenses or other 
                        authorizations.
                    ``(B) A link to which paragraph (1) applies shall 
                be displayed in a clear and prominent place and manner, 
                and shall include in the caption for the link the words 
                `licensing and contact information'.
    ``(b) Internet Sales Without Appropriate Medical Relationships.--
            ``(1) In general.--Except as provided in paragraph (2), a 
        person may not dispense a prescription drug, or sell such a 
        drug, if--
                    ``(A) for purposes of such dispensing or sale, the 
                purchaser communicated with the person through the 
                Internet;
                    ``(B) the patient for whom the drug was dispensed 
                or purchased did not, when such communications began, 
                have a prescription for the drug that is valid in the 
                United States;
                    ``(C) pursuant to such communications, the person 
                provided for the involvement of a practitioner, or an 
                individual represented by the person as a practitioner, 
                and the practitioner or such individual issued a 
                prescription for the drug that was purchased;
                    ``(D) the person knew, or had reason to know, that 
                the practitioner or the individual referred to in 
                subparagraph (C) did not, when issuing the 
                prescription, have a qualifying medical relationship 
                with the patient; and
                    ``(E) the person received payment for the 
                dispensing or sale of the drug.
        For purposes of subparagraph (E), payment is received if money 
        or other valuable consideration is received.
            ``(2) Exceptions.--Paragraph (1) does not apply to--
                    ``(A) the dispensing or selling of a prescription 
                drug pursuant to telemedicine practices sponsored by--
                            ``(i) a hospital that has in effect a 
                        provider agreement under title XVIII of the 
                        Social Security Act (relating to the Medicare 
                        program); or
                            ``(ii) a group practice that has not fewer 
                        than 100 physicians who have in effect provider 
                        agreements under such title; or
                    ``(B) the dispensing or selling of a prescription 
                drug pursuant to practices that promote the public 
                health, as determined by the Secretary by regulation.
            ``(3) Qualifying medical relationship.--
                    ``(A) In general.--With respect to issuing a 
                prescription for a drug for a patient, a practitioner 
                has a qualifying medical relationship with the patient 
                for purposes of this section if--
                            ``(i) at least one in-person medical 
                        evaluation of the patient has been conducted by 
                        the practitioner; or
                            ``(ii) the practitioner conducts a medical 
                        evaluation of the patient as a covering 
                        practitioner.
                    ``(B) In-person medical evaluation.--A medical 
                evaluation by a practitioner is an in-person medical 
                evaluation for purposes of this section if the 
                practitioner is in the physical presence of the patient 
                as part of conducting the evaluation, without regard to 
                whether portions of the evaluation are conducted by 
                other health professionals.
                    ``(C) Covering practitioner.--With respect to a 
                patient, a practitioner is a covering practitioner for 
                purposes of this section if the practitioner conducts a 
                medical evaluation of the patient at the request of a 
                practitioner who has conducted at least one in-person 
                medical evaluation of the patient and is temporarily 
                unavailable to conduct the evaluation of the patient. A 
                practitioner is a covering practitioner without regard 
                to whether the practitioner has conducted any in-person 
                medical evaluation of the patient involved.
            ``(4) Rules of construction.--
                    ``(A) Individuals represented as practitioners.--A 
                person who is not a practitioner (as defined in 
                subsection (e)(1)) lacks legal capacity under this 
                section to have a qualifying medical relationship with 
                any patient.
                    ``(B) Standard practice of pharmacy.--Paragraph (1) 
                may not be construed as prohibiting any conduct that is 
                a standard practice in the practice of pharmacy.
                    ``(C) Applicability of requirements.--Paragraph (3) 
                may not be construed as having any applicability beyond 
                this section, and does not affect any State law, or 
                interpretation of State law, concerning the practice of 
                medicine.
    ``(c) Actions by States.--
            ``(1) In general.--Whenever an attorney general of any 
        State has reason to believe that the interests of the residents 
        of that State have been or are being threatened or adversely 
        affected because any person has engaged or is engaging in a 
        pattern or practice that violates section 301(l), the State may 
        bring a civil action on behalf of its residents in an 
        appropriate district court of the United States to enjoin such 
        practice, to enforce compliance with such section (including a 
        nationwide injunction), to obtain damages, restitution, or 
        other compensation on behalf of residents of such State, to 
        obtain reasonable attorneys fees and costs if the State 
        prevails in the civil action, or to obtain such further and 
        other relief as the court may deem appropriate.
            ``(2) Notice.--The State shall serve prior written notice 
        of any civil action under paragraph (1) or (5)(B) upon the 
        Secretary and provide the Secretary with a copy of its 
        complaint, except that if it is not feasible for the State to 
        provide such prior notice, the State shall serve such notice 
        immediately upon instituting such action. Upon receiving a 
        notice respecting a civil action, the Secretary shall have the 
        right--
                    ``(A) to intervene in such action;
                    ``(B) upon so intervening, to be heard on all 
                matters arising therein; and
                    ``(C) to file petitions for appeal.
            ``(3) Construction.--For purposes of bringing any civil 
        action under paragraph (1), nothing in this chapter shall 
        prevent an attorney general of a State from exercising the 
        powers conferred on the attorney general by the laws of such 
        State to conduct investigations or to administer oaths or 
        affirmations or to compel the attendance of witnesses or the 
        production of documentary and other evidence.
            ``(4) Venue; service of process.--Any civil action brought 
        under paragraph (1) in a district court of the United States 
        may be brought in the district in which the defendant is found, 
        is an inhabitant, or transacts business or wherever venue is 
        proper under section 1391 of title 28, United States Code. 
        Process in such an action may be served in any district in 
        which the defendant is an inhabitant or in which the defendant 
        may be found.
            ``(5) Actions by other state officials.--
                    ``(A) Nothing contained in this section shall 
                prohibit an authorized State official from proceeding 
                in State court on the basis of an alleged violation of 
                any civil or criminal statute of such State.
                    ``(B) In addition to actions brought by an attorney 
                general of a State under paragraph (1), such an action 
                may be brought by officers of such State who are 
                authorized by the State to bring actions in such State 
                on behalf of its residents.
    ``(d) Effect of Section.--This section shall not apply to a person 
that is a registered exporter under section 804.
    ``(e) General Definitions.--For purposes of this section:
            ``(1) The term `practitioner' means a practitioner referred 
        to in section 503(b)(1) with respect to issuing a written or 
        oral prescription.
            ``(2) The term `prescription drug' means a drug that is 
        described in section 503(b)(1).
            ``(3) The term `qualifying medical relationship', with 
        respect to a practitioner and a patient, has the meaning 
        indicated for such term in subsection (b).
    ``(f) Internet-Related Definitions.--
            ``(1) In general.--For purposes of this section:
                    ``(A) The term `Internet' means collectively the 
                myriad of computer and telecommunications facilities, 
                including equipment and operating software, which 
                comprise the interconnected world-wide network of 
                networks that employ the transmission control protocol/
                internet protocol, or any predecessor or successor 
                protocols to such protocol, to communicate information 
                of all kinds by wire or radio.
                    ``(B) The term `link', with respect to the 
                Internet, means one or more letters, words, numbers, 
                symbols, or graphic items that appear on a page of an 
                Internet site for the purpose of serving, when 
                activated, as a method for executing an electronic 
                command--
                            ``(i) to move from viewing one portion of a 
                        page on such site to another portion of the 
                        page;
                            ``(ii) to move from viewing one page on 
                        such site to another page on such site; or
                            ``(iii) to move from viewing a page on one 
                        Internet site to a page on another Internet 
                        site.
                    ``(C) The term `page', with respect to the 
                Internet, means a document or other file accessed at an 
                Internet site.
                    ``(D)(i) The terms `site' and `address', with 
                respect to the Internet, mean a specific location on 
                the Internet that is determined by Internet Protocol 
                numbers. Such term includes the domain name, if any.
                    ``(ii) The term `domain name' means a method of 
                representing an Internet address without direct 
                reference to the Internet Protocol numbers for the 
                address, including methods that use designations such 
                as `.com', `.edu', `.gov', `.net', or `.org'.
                    ``(iii) The term `Internet Protocol numbers' 
                includes any successor protocol for determining a 
                specific location on the Internet.
            ``(2) Authority of secretary.--The Secretary may by 
        regulation modify any definition under paragraph (1) to take 
        into account changes in technology.
    ``(g) Interactive Computer Service; Advertising.--No provider of an 
interactive computer service, as defined in section 230(f)(2) of the 
Communications Act of 1934 (47 U.S.C. 230(f)(2)), or of advertising 
services shall be liable under this section for dispensing or selling 
prescription drugs in violation of this section on account of another 
person's selling or dispensing such drugs, provided that the provider 
of the interactive computer service or of advertising services does not 
own or exercise corporate control over such person.''.
    (b) Inclusion as Prohibited Act.--Section 301 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 331) is amended by inserting after 
paragraph (k) the following:
    ``(l) The dispensing or selling of a prescription drug in violation 
of section 503B.''.
    (c) Internet Sales of Prescription Drugs; Consideration by 
Secretary of Practices and Procedures for Certification of Legitimate 
Businesses.--In carrying out section 503B of the Federal Food, Drug, 
and Cosmetic Act (as added by subsection (a) of this section), the 
Secretary of Health and Human Services shall take into consideration 
the practices and procedures of public or private entities that certify 
that businesses selling prescription drugs through Internet sites are 
legitimate businesses, including practices and procedures regarding 
disclosure formats and verification programs.
    (d) Reports Regarding Internet-Related Violations of Federal and 
State Laws on Dispensing of Drugs.--
            (1) In general.--The Secretary of Health and Human Services 
        (referred to in this subsection as the ``Secretary'') shall, 
        pursuant to the submission of an application meeting the 
        criteria of the Secretary, make an award of a grant or contract 
        to the National Clearinghouse on Internet Prescribing (operated 
        by the Federation of State Medical Boards) for the purpose of--
                    (A) identifying Internet sites that appear to be in 
                violation of Federal or State laws concerning the 
                dispensing of drugs;
                    (B) reporting such sites to State medical licensing 
                boards and State pharmacy licensing boards, and to the 
                Attorney General and the Secretary, for further 
                investigation; and
                    (C) submitting, for each fiscal year for which the 
                award under this subsection is made, a report to the 
                Secretary describing investigations undertaken with 
                respect to violations described in subparagraph (A).
            (2) Authorization of appropriations.--For the purpose of 
        carrying out paragraph (1), there is authorized to be 
        appropriated $100,000 for each of the first 3 fiscal years in 
        which this section is in effect.
    (e) Effective Date.--The amendments made by subsections (a) and (b) 
take effect 90 days after the date of enactment of this title, without 
regard to whether a final rule to implement such amendments has been 
promulgated by the Secretary of Health and Human Services under section 
701(a) of the Federal Food, Drug, and Cosmetic Act. The preceding 
sentence may not be construed as affecting the authority of such 
Secretary to promulgate such a final rule.

SEC. 808. PROHIBITING PAYMENTS TO UNREGISTERED FOREIGN PHARMACIES.

    (a) In General.--Section 303 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 333) is amended by adding at the end the 
following:
    ``(g) Restricted Transactions.--
            ``(1) In general.--The introduction of restricted 
        transactions into a payment system or the completion of 
        restricted transactions using a payment system is prohibited.
            ``(2) Payment system.--
                    ``(A) In general.--The term `payment system' means 
                a system used by a person described in subparagraph (B) 
                to effect a credit transaction, electronic fund 
                transfer, or money transmitting service that may be 
                used in connection with, or to facilitate, a restricted 
                transaction, and includes--
                            ``(i) a credit card system;
                            ``(ii) an international, national, 
                        regional, or local network used to effect a 
                        credit transaction, an electronic fund 
                        transfer, or a money transmitting service; and
                            ``(iii) any other system that is centrally 
                        managed and is primarily engaged in the 
                        transmission and settlement of credit 
                        transactions, electronic fund transfers, or 
                        money transmitting services.
                    ``(B) Persons described.--A person referred to in 
                subparagraph (A) is--
                            ``(i) a creditor;
                            ``(ii) a credit card issuer;
                            ``(iii) a financial institution;
                            ``(iv) an operator of a terminal at which 
                        an electronic fund transfer may be initiated;
                            ``(v) a money transmitting business; or
                            ``(vi) a participant in an international, 
                        national, regional, or local network used to 
                        effect a credit transaction, electronic fund 
                        transfer, or money transmitting service.
            ``(3) Restricted transaction.--The term `restricted 
        transaction' means a transaction or transmittal, on behalf of 
        an individual who places an unlawful drug importation request 
        to any person engaged in the operation of an unregistered 
        foreign pharmacy, of--
                    ``(A) credit, or the proceeds of credit, extended 
                to or on behalf of the individual for the purpose of 
                the unlawful drug importation request (including credit 
                extended through the use of a credit card);
                    ``(B) an electronic fund transfer or funds 
                transmitted by or through a money transmitting 
                business, or the proceeds of an electronic fund 
                transfer or money transmitting service, from or on 
                behalf of the individual for the purpose of the 
                unlawful drug importation request;
                    ``(C) a check, draft, or similar instrument which 
                is drawn by or on behalf of the individual for the 
                purpose of the unlawful drug importation request and is 
                drawn on or payable at or through any financial 
                institution; or
                    ``(D) the proceeds of any other form of financial 
                transaction (identified by the Board by regulation) 
                that involves a financial institution as a payor or 
                financial intermediary on behalf of or for the benefit 
                of the individual for the purpose of the unlawful drug 
                importation request.
            ``(4) Unlawful drug importation request.--The term 
        `unlawful drug importation request' means the request, or 
        transmittal of a request, made to an unregistered foreign 
        pharmacy for a prescription drug by mail (including a private 
        carrier), facsimile, phone, or electronic mail, or by a means 
        that involves the use, in whole or in part, of the Internet.
            ``(5) Unregistered foreign pharmacy.--The term 
        `unregistered foreign pharmacy' means a person in a country 
        other than the United States that is not a registered exporter 
        under section 804.
            ``(6) Other definitions.--
                    ``(A) Credit; creditor; credit card.--The terms 
                `credit', `creditor', and `credit card' have the 
                meanings given the terms in section 103 of the Truth in 
                Lending Act (15 U.S.C. 1602).
                    ``(B) Access device; electronic fund transfer.--The 
                terms `access device' and `electronic fund transfer'--
                            ``(i) have the meaning given the term in 
                        section 903 of the Electronic Fund Transfer Act 
                        (15 U.S.C. 1693a); and
                            ``(ii) the term `electronic fund transfer' 
                        also includes any fund transfer covered under 
                        Article 4A of the Uniform Commercial Code, as 
                        in effect in any State.
                    ``(C) Financial institution.--The term `financial 
                institution'--
                            ``(i) has the meaning given the term in 
                        section 903 of the Electronic Transfer Fund Act 
                        (15 U.S.C. 1693a); and
                            ``(ii) includes a financial institution (as 
                        defined in section 509 of the Gramm-Leach-
                        Bliley Act (15 U.S.C. 6809)).
                    ``(D) Money transmitting business; money 
                transmitting service.--The terms `money transmitting 
                business' and `money transmitting service' have the 
                meaning given the terms in section 5330(d) of title 31, 
                United States Code.
                    ``(E) Board.--The term `Board' means the Board of 
                Governors of the Federal Reserve System.
            ``(7) Policies and procedures required to prevent 
        restricted transactions.--
                    ``(A) Regulations.--The Board shall promulgate 
                regulations requiring--
                            ``(i) an operator of a credit card system;
                            ``(ii) an operator of an international, 
                        national, regional, or local network used to 
                        effect a credit transaction, an electronic fund 
                        transfer, or a money transmitting service;
                            ``(iii) an operator of any other payment 
                        system that is centrally managed and is 
                        primarily engaged in the transmission and 
                        settlement of credit transactions, electronic 
                        transfers or money transmitting services where 
                        at least one party to the transaction or 
                        transfer is an individual; and
                            ``(iv) any other person described in 
                        paragraph (2)(B) and specified by the Board in 
                        such regulations,
                to establish policies and procedures that are 
                reasonably designed to prevent the introduction of a 
                restricted transaction into a payment system or the 
                completion of a restricted transaction using a payment 
                system
                    ``(B) Requirements for policies and procedures.--In 
                promulgating regulations under subparagraph (A), the 
                Board shall--
                            ``(i) identify types of policies and 
                        procedures, including nonexclusive examples, 
                        that shall be considered to be reasonably 
                        designed to prevent the introduction of 
                        restricted transactions into a payment system 
                        or the completion of restricted transactions 
                        using a payment system; and
                            ``(ii) to the extent practicable, permit 
                        any payment system, or person described in 
                        paragraph (2)(B), as applicable, to choose 
                        among alternative means of preventing the 
                        introduction or completion of restricted 
                        transactions.
                    ``(C) No liability for blocking or refusing to 
                honor restricted transaction.--
                            ``(i) In general.--A payment system, or a 
                        person described in paragraph (2)(B) that is 
                        subject to a regulation issued under this 
                        subsection, and any participant in such payment 
                        system that prevents or otherwise refuses to 
                        honor transactions in an effort to implement 
                        the policies and procedures required under this 
                        subsection or to otherwise comply with this 
                        subsection shall not be liable to any party for 
                        such action.
                            ``(ii) Compliance.--A person described in 
                        paragraph (2)(B) meets the requirements of this 
                        subsection if the person relies on and complies 
                        with the policies and procedures of a payment 
                        system of which the person is a member or in 
                        which the person is a participant, and such 
                        policies and procedures of the payment system 
                        comply with the requirements of the regulations 
                        promulgated under subparagraph (A).
                    ``(D) Enforcement.--
                            ``(i) In general.--This section shall be 
                        enforced by the Federal functional regulators 
                        and the Federal Trade Commission under 
                        applicable law in the manner provided in 
                        section 505(a) of the Gramm-Leach-Bliley Act 
                        (15 U.S.C. 6805(a)).
                            ``(ii) Factors to be considered.--In 
                        considering any enforcement action under this 
                        subsection against a payment system or person 
                        described in paragraph (2)(B), the Federal 
                        functional regulators and the Federal Trade 
                        Commission shall consider the following 
                        factors:
                                    ``(I) The extent to which the 
                                payment system or person knowingly 
                                permits restricted transactions.
                                    ``(II) The history of the payment 
                                system or person in connection with 
                                permitting restricted transactions.
                                    ``(III) The extent to which the 
                                payment system or person has 
                                established and is maintaining policies 
                                and procedures in compliance with 
                                regulations prescribed under this 
                                subsection.
            ``(8) Transactions permitted.--A payment system, or a 
        person described in paragraph (2)(B) that is subject to a 
        regulation issued under this subsection, is authorized to 
        engage in transactions with foreign pharmacies in connection 
        with investigating violations or potential violations of any 
        rule or requirement adopted by the payment system or person in 
        connection with complying with paragraph (7). A payment system, 
        or such a person, and its agents and employees shall not be 
        found to be in violation of, or liable under, any Federal, 
        State or other law by virtue of engaging in any such 
        transaction.
            ``(9) Relation to state laws.--No requirement, prohibition, 
        or liability may be imposed on a payment system, or a person 
        described in paragraph (2)(B) that is subject to a regulation 
        issued under this subsection, under the laws of any state with 
        respect to any payment transaction by an individual because the 
        payment transaction involves a payment to a foreign pharmacy.
            ``(10) Timing of requirements.--A payment system, or a 
        person described in paragraph (2)(B) that is subject to a 
        regulation issued under this subsection, must adopt policies 
        and procedures reasonably designed to comply with any 
        regulations required under paragraph (7) within 60 days after 
        such regulations are issued in final form.''.
    (b) Effective Date.--The amendment made by this section shall take 
effect on the day that is 90 days after the date of enactment of this 
Act.
    (c) Implementation.--The Board of Governors of the Federal Reserve 
System shall promulgate regulations as required by subsection (g)(7) of 
section 303 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
333), as added by subsection (a), not later than 90 days after the date 
of enactment of this title.

SEC. 809. IMPORTATION EXEMPTION UNDER CONTROLLED SUBSTANCES IMPORT AND 
              EXPORT ACT.

    Section 1006(a)(2) of the Controlled Substances Import and Export 
Act (21 U.S.C. 956(a)(2)) is amended by striking ``not import the 
controlled substance into the United States in an amount that exceeds 
50 dosage units of the controlled substance.'' and inserting ``import 
into the United States not more than 10 dosage units combined of all 
such controlled substances.''.

SEC. 810. SEVERABILITY.

    If any provision of this title, an amendment by this title, or the 
application of such provision or amendment to any person or 
circumstance is held to be unconstitutional, the remainder of this 
title, the amendments made by this title, and the application of the 
provisions of such to any person or circumstance shall not affected 
thereby.

SEC. 811. PROTECTION OF HEALTH AND SAFETY.

    This title, and the amendments made by this title, shall become 
effective only if the Secretary of Health and Human Services certifies 
to Congress that the implementation of this title (and amendments) 
will--
            (1) pose no additional risk to the public's health and 
        safety; and
            (2) result in a significant reduction in the cost of 
        covered products to the American consumer.

            Passed the Senate May 9, 2007.

            Attest:

                                                             Secretary.
110th CONGRESS

  1st Session

                                S. 1082

_______________________________________________________________________

                                 AN ACT

To amend the Federal Food, Drug, and Cosmetic Act and the Public Health 
  Service Act to reauthorize drug and device user fees and ensure the 
          safety of medical products, and for other purposes.