[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2900 Introduced in House (IH)]







110th CONGRESS
  1st Session
                                H. R. 2900

To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs and for medical devices, 
      to enhance the postmarket authorities of the Food and Drug 
   Administration with respect to the safety of drugs, and for other 
                               purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             June 28, 2007

Mr. Dingell (for himself, Mr. Barton of Texas, Mr. Pallone, Mr. Deal of 
  Georgia, Mr. Waxman, Mr. Barrow, Mr. Butterfield, Mr. Gonzalez, Mr. 
Gene Green of Texas, Mr. Gordon of Tennessee, Ms. Solis, Mr. Matheson, 
   Mr. Inslee, Ms. Eshoo, Ms. Hooley, Ms. Baldwin, Mr. Ferguson, Mr. 
  Engel, Mr. Ross, Mr. Towns, Mr. Rogers of Michigan, Mr. Markey, Ms. 
DeGette, Ms. Schakowsky, Mr. Allen, Mr. Burgess, Mr. Terry, Mrs. Bono, 
    Mrs. Myrick, Mrs. Capps, Mr. Upton, Mr. Melancon, and Mr. Rush) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend 
 the user-fee programs for prescription drugs and for medical devices, 
      to enhance the postmarket authorities of the Food and Drug 
   Administration with respect to the safety of drugs, 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 
Amendments Act of 2007''.

SEC. 2. TABLE OF CONTENTS.

    The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug 
                            television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.
          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title.
              Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Annual reports.
Sec. 214. Consultation.
Sec. 215. Additional authorization of appropriations for postmarket 
                            safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.
     Subtitle B--Amendments Regarding Regulation of Medical Devices

Sec. 221. Extension of authority for third party review of premarket 
                            notification.
Sec. 222. Registration.
Sec. 223. Filing of lists of drugs and devices manufactured, prepared, 
                            propagated, and compounded by registrants; 
                            statements; accompanying disclosures.
Sec. 224. Electronic registration and listing.
Sec. 225. Report by Government Accountability Office.
Sec. 226. Unique device identification system.
Sec. 227. Frequency of reporting for certain devices.
Sec. 228. Inspections by accredited persons.
Sec. 229. Study of nosocomial infections relating to medical devices.
 TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

Sec. 301. Short title.
Sec. 302. Tracking pediatric device approvals.
Sec. 303. Modification to humanitarian device exemption.
Sec. 304. Encouraging pediatric medical device research.
Sec. 305. Demonstration grants for improving pediatric device 
                            availability.
Sec. 306. Amendments to office of pediatric therapeutics and pediatric 
                            advisory committee.
Sec. 307. Postmarket Studies.
            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Government Accountability Office report.
         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.
                   TITLE VI--REAGAN-UDALL FOUNDATION

Sec. 601. The Reagan-Udall Foundation for the Food and Drug 
                            Administration.
Sec. 602. Office of the Chief Scientist.
Sec. 603. Critical path public-private partnerships.
                    TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.
                  TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Clinical trial registry database and clinical trial results 
                            database.
Sec. 802. Study by Government Accountability Office.
  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

Sec. 901. Postmarket studies and clinical trials regarding human drugs; 
                            risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Postmarket risk identification and analysis system for active 
                            surveillance and assessment.
Sec. 907. Statement for inclusion in direct-to-consumer advertisements 
                            of drugs.
Sec. 908. Clinical trial guidance for antibiotic drugs.
Sec. 909. Prohibition against food to which drugs or biological 
                            products have been added.
Sec. 910. Assuring pharmaceutical safety.
Sec. 911. Orphan antibiotic drugs.
Sec. 912. Authorization of appropriations.
Sec. 913. Effective date and applicability.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

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 Act.--Except as otherwise specified, amendments 
made by this title to a section or other provision of law are 
amendments to such section or other provision of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

SEC. 102. DEFINITIONS.

    Section 735 (21 U.S.C. 379g) is amended--
            (1) in paragraph (1)--
                    (A) in subparagraph (A), by striking ``505(b)(1),'' 
                and inserting ``505(b), or'';
                    (B) by striking subparagraph (B); and
                    (C) by redesignating subparagraph (C) as 
                subparagraph (B);
            (2) in paragraph (3)(C)--
                    (A) by striking ``505(j)(7)(A)'' and inserting 
                ``505(j)(7)(A) (not including the discontinued section 
                of such list),''; and
                    (B) by inserting before the period ``(not including 
                the discontinued section of such list)'';
            (3) in paragraph (4), by inserting before the period at the 
        end the following: ``(such as capsules, tablets, or lyophilized 
        products before reconstitution)'';
            (4) by amending paragraph (6)(F) to read as follows:
                    ``(F) Postmarket safety activities with respect to 
                drugs approved under human drug applications or 
                supplements, including the following activities:
                            ``(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.
                            ``(iii) Developing and using improved 
                        analytical tools to assess potential safety 
                        problems, including access to external data 
                        bases.
                            ``(iv) Preparing and making publicly 
                        available (including on the website of the Food 
                        and Drug Administration) a summary analysis of 
                        the adverse drug reaction reports received for 
                        recently approved drugs, including 
                        identification of any new risks not previously 
                        identified, potential new risks, or known risks 
                        reported in unusual number not previously 
                        identified within 18 months of the drug's 
                        initial marketing or after exposure of 10,000 
                        individuals to the drug, whichever is later.
                            ``(v) Conducting regular, bi-weekly 
                        screening of the Adverse Event Reporting System 
                        database and developing a report every 15 days 
                        on any new safety concerns.
                            ``(vi) Ensuring that the reports available 
                        to the public under the Adverse Event Reporting 
                        System are updated at least every 6 months.
                            ``(vii) Reporting to the Congress on--
                                    ``(I) the recommendations received 
                                in consultations with, and reports 
                                from, the Office of Surveillance and 
                                Epidemiology within the Food and Drug 
                                Administration on postmarket safety 
                                activities;
                                    ``(II) a description of the actions 
                                taken on those recommendations; and
                                    ``(III) if no action is taken, or a 
                                different action is taken relative to 
                                the action recommended by the Office of 
                                Surveillance and Epidemiology, an 
                                explanation of why no action or a 
                                different action was taken.
                            ``(viii) On an annual basis, reviewing the 
                        entire backlog of postmarket safety commitments 
                        to determine which commitments require revision 
                        or should be eliminated, reporting to the 
                        Congress on these determinations, and assigning 
                        start dates and estimated completion dates for 
                        such commitments.
                            ``(ix) Developing postmarket safety 
                        performance measures, including those listed in 
                        clauses (iv) through (viii), that are as 
                        measurable and rigorous as the ones already 
                        developed for premarket review.'';
            (5) in paragraph (8)--
                    (A) by striking ``April of the preceding fiscal 
                year'' and inserting ``October of the preceding fiscal 
                year''; and
                    (B) by striking ``April 1997'' and inserting 
                ``October 1996'';
            (6) by redesignating paragraph (9) as paragraph (11); and
            (7) by inserting after paragraph (8) the following 
        paragraphs:
            ``(9) The term `person' includes an affiliate thereof.
            ``(10) The term `active', with respect to a commercial 
        investigational new drug application, means such an application 
        to which information was submitted during the relevant 
        period.''.  

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 ``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) Fees for applications previously refused for 
                filing or withdrawn before filing.--A human drug 
                application or supplement that was submitted but was 
                refused for filing, or was withdrawn before being 
                accepted or refused for filing, shall be subject to the 
                full fee under subparagraph (A) upon being resubmitted 
                or filed over protest, unless the fee is waived or 
                reduced under subsection (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 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 positron emission tomography drug shall 
                        be subject under subparagraph (A) to one-sixth 
                        of an annual establishment fee with respect to 
                        each such establishment identified in the 
                        application as producing 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 
                                positron emission tomography drugs; and
                                    ``(II) at least 95 percent of the 
                                total number of doses of each positron 
                                emission tomography drug produced by 
                                such establishment during such fiscal 
                                year will be used within the medical 
                                center.
                            ``(iii) Definition.--For purposes of this 
                        subparagraph, the term `positron emission 
                        tomography drug' has the meaning given to the 
                        term `compounded positron emission tomography 
                        drug' in section 201(ii), except that 
                        subparagraph (1)(B) of such section shall not 
                        apply.''.
    (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 379h(b)) is 
amended to read as follows:
    ``(b) Fee Revenue Amounts.--
            ``(1) In general.--For each of the fiscal years 2008 
        through 2012, fees under subsection (a) shall, except as 
        provided in subsections (c), (d), (f), and (g), be established 
        to generate a total revenue amount under such subsection that 
        is equal to the sum of--
                    ``(A) $392,783,000; and
                    ``(B) an amount equal to the modified workload 
                adjustment factor for fiscal year 2007 (as determined 
                under paragraph (3)).
            ``(2) Types of fees.--Of the total revenue amount 
        determined for a fiscal year under paragraph (1)--
                    ``(A) one-third shall be derived from fees under 
                subsection (a)(1) (relating to human drug applications 
                and supplements);
                    ``(B) one-third shall be derived from fees under 
                subsection (a)(2) (relating to prescription drug 
                establishments); and
                    ``(C) one-third shall be derived from fees under 
                subsection (a)(3) (relating to prescription drug 
                products).
            ``(3) Modified workload adjustment factor for fiscal year 
        2007.--For purposes of paragraph (1)(B), the Secretary shall 
        determine the modified workload adjustment factor by 
        determining the dollar amount that results from applying the 
        methodology that was in effect under subsection (c)(2) for 
        fiscal year 2007 to the amount $354,893,000, except that, with 
        respect to the portion of such determination that is based on 
        the change in the total number of commercial investigational 
        new drug applications, the Secretary shall count the number of 
        such applications that were active during the most recent 12-
        month period for which data on such submissions is available.
            ``(4) Additional fee revenues for drug safety.--
                    ``(A) In general.--For each of the fiscal years 
                2008 through 2012, paragraph (1)(A) shall, subject to 
                subparagraph (C), be applied by substituting the amount 
                determined under subparagraph (B) for `$392,783,000'.
                    ``(B) Amount determined.--For each of the fiscal 
                years 2008 through 2012, the amount determined under 
                this subparagraph is the sum of--
                            ``(i) $392,783,000; plus
                            ``(ii) an 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 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 of fiscal years 
                                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) 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 ``For fiscal year 2009 and subsequent 
                fiscal years, 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 years of the preceding 6 fiscal years.''; and
                    (E) in the matter following subparagraph (C) (as 
                added under 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 ``Beginning with fiscal year 2004,'' and 
                inserting ``For fiscal year 2009 and subsequent fiscal 
                years,'';
                    (B) in subparagraph (A), in the first sentence--
                            (i) by striking ``human drug 
                        applications,'' and inserting ``human drug 
                        applications (adjusted for changes in review 
                        activities, as described in the notice that the 
                        Secretary is required to publish in the Federal 
                        Register under this subparagraph),'';
                            (ii) by striking ``commercial 
                        investigational new drug applications,''; and
                            (iii) by inserting before the period the 
                        following: ``, and the change in the total 
                        number of active commercial investigational new 
                        drug applications (adjusted for changes in 
                        review activities, as so described) during the 
                        most recent 12-month period for which data on 
                        such submissions is available'';
                    (C) in subparagraph (B), by adding at the end the 
                following: ``Any adjustment for changes in review 
                activities made in setting fees and revenue amounts for 
                fiscal year 2009 may not result in the total workload 
                adjustment being more than 2 percentage points higher 
                than it would have been in the absence of 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 
                and revenue amounts for fiscal year 2009 and to make 
                recommendations, if warranted, for future changes in 
                the methodology for calculating the adjustment. After 
                review of the recommendations, the Secretary shall, if 
                warranted, make appropriate changes to the methodology, 
                and the changes shall be effective for each of the 
                fiscal years 2010 through 2012. The Secretary shall not 
                make any adjustment for changes in review activities 
                for any fiscal year after 2009 unless such study has 
                been completed.''.
            (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.--For fiscal 
        year 2010 and each subsequent fiscal year, the Secretary shall, 
        before making adjustments under paragraphs (1) and (2), 
        decrease the fee revenue amount established in subsection (b) 
        if actual costs paid for rent and rent-related expenses for the 
        preceding fiscal year are less than estimates made for such 
        year in fiscal year 2006. Any reduction made under this 
        paragraph shall not exceed the amount by which such costs fall 
        below the estimates made in fiscal year 2006 for such fiscal 
        year, and shall not exceed $11,721,000 for 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 paragraph 
                (3)(A))--
                            (i) by striking ``2007'' each place it 
                        appears and inserting ``2012'';
                            (ii) by striking ``paragraphs (1) and (2)'' 
                        and inserting ``paragraphs (1), (2), and (3)''; 
                        and
                            (iii) by striking ``2008'' and inserting 
                        ``2013''; and
                    (B) in paragraph (5) (as so redesignated), 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)--
                    (A) by inserting after ``The Secretary shall 
                grant'' the following: ``to a person who is named as 
                the applicant in a human drug application''; and
                    (B) by inserting ``to that person'' after ``one or 
                more fees assessed'';
            (2) by redesignating paragraphs (2) and (3) as paragraphs 
        (3) and (4), respectively;
            (3) by inserting after paragraph (1) the following:
            ``(2) Considerations.--In 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 involved and any affiliate of the applicant.''; and
            (4) in paragraph (4) (as redesignated by paragraph (2)), in 
        subparagraph (A), by inserting before the period the following: 
        ``, 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.--For each of the 
        fiscal years 2008 through 2012, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) for the 
        fiscal year, as adjusted or otherwise affected under subsection 
        (c) and paragraph (4) of this subsection.''.
            (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
        amended to read as follows:
            ``(4) Offset.--If the sum of the cumulative amount of fees 
        collected under this section for the fiscal years 2008 through 
        2010 and the amount of fees estimated to be collected under 
        this section for fiscal year 2011 exceeds the cumulative amount 
        appropriated under paragraph (3) for the fiscal years 2008 
        through 2011, the 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) Exemption for Orphan Drugs.--Section 736 (21 U.S.C. 379h) is 
further amended by adding at the end the following:
    ``(k) Orphan Drugs.--A drug designated under section 526 for a rare 
disease or condition and approved under section 505 or under section 
351 of the Public Health Service Act shall be exempt from product and 
facility fees under this section, provided that the drug meets all of 
the following:
            ``(1) The drug had United States sales in the previous year 
        of less than $25,000,000 for the active moiety, for all 
        indications, dosage forms, and strengths for which the drug is 
        approved and for any off-label uses.
            ``(2) The drug meets the public health requirements 
        contained in this Act as such requirements are applied to 
        requests for waivers for product and facility fees.
            ``(3) The drug is owned or licensed and marketed by a 
        company that had less than $100,000,000 in gross worldwide 
        revenue during the previous year.''.
    (g) Conforming Amendment.--Section 736(a) (21 U.S.C. 379h(a)) is 
amended in paragraphs (1)(A)(i), (1)(A)(ii), (2)(A), and (3)(A) by 
striking ``(c)(4)'' each place such term appears and inserting 
``(c)(5)''.

SEC. 104. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG 
              TELEVISION ADVERTISING.

    Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et seq.) is 
amended by adding after section 736 the following:

``SEC. 736A. FEES RELATING TO ADVISORY REVIEW OF PRESCRIPTION-DRUG 
              TELEVISION ADVERTISING.

    ``(a) Types of Direct-to-Consumer Television Advertisement Review 
Fees.--Beginning in fiscal year 2008, the Secretary shall assess and 
collect fees in accordance with this section as follows:
            ``(1) Advisory review fee.--
                    ``(A) In general.--With respect to a proposed 
                direct-to-consumer television advertisement (referred 
                to in this section as a `DTC advertisement'), each 
                person that on or after October 1, 2007, submits such 
                an advertisement for advisory review by the Secretary 
                prior to its initial public broadcast (referred to in 
                this section as `prebroadcast advisory review') shall, 
                except as provided in subparagraph (B), be subject to a 
                fee established under subsection (c)(3).
                    ``(B) Exception for required submissions.--A DTC 
                advertisement that is required under section 502(n) to 
                be submitted to the Secretary prior to initial public 
                broadcast is not subject to a fee under subparagraph 
                (A) unless the sponsor designates the submission as a 
                submission for prebroadcast advisory review.
                    ``(C) Notice to secretary of number of 
                advertisements.--Not later than June 1 of each fiscal 
                year, the Secretary shall publish a notice in the 
                Federal Register requesting any person to notify the 
                Secretary within 30 days of the number of DTC 
                advertisements the person intends to submit for 
                prebroadcast advisory review in the next fiscal year.
                    ``(D) Payment.--
                            ``(i) In general.--The fee required by 
                        subparagraph (A) (referred to in this section 
                        as `an advisory review fee') shall be due not 
                        later than October 1 of the fiscal year in 
                        which the DTC advertisement involved is 
                        intended be submitted for prebroadcast advisory 
                        review, subject to subparagraph (F)(i).
                            ``(ii) Effect of submission.--Notification 
                        of the Secretary under subparagraph (C) of the 
                        number of DTC advertisements a person intends 
                        to submit for prebroadcast advisory review is 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.
                            ``(iii) Notice regarding carryover 
                        submissions.--In making a notification under 
                        subparagraph (C), the person involved shall in 
                        addition notify the Secretary if under 
                        subparagraph (F)(i) the person intends to 
                        submit a DTC advertisement for which the 
                        advisory review fee has already been paid. If 
                        the person does not so notify the Secretary, 
                        each DTC advertisement submitted by the person 
                        for prebroadcast advisory review in the fiscal 
                        year involved shall be subject to the advisory 
                        review fee.
                    ``(E) Modification of advisory review fee.--
                            ``(i) Late payment.--If a person has 
                        submitted a notification under subparagraph (C) 
                        with respect to a fiscal year and has not paid 
                        all advisory review fees due under subparagraph 
                        (D) on or before November 1 of such fiscal 
                        year, the fees are regarded as late and a 
                        revised due date and an increase in the amount 
                        of fees applies in accordance with this clause, 
                        notwithstanding any other provision of this 
                        section. For such person, the advisory review 
                        fee for each DTC advertisement submitted in 
                        such fiscal year for prebroadcast advisory 
                        review shall be due and payable 20 days before 
                        the advertisement is submitted to the 
                        Secretary, and each such fee shall be revised 
                        to be equal to 150 percent of the fee that 
                        otherwise would have applied pursuant to 
                        subsection (c)(3).
                            ``(ii) Exceeding identified number of 
                        submissions.--If a person submits a number of 
                        DTC ads for prebroadcast advisory review in a 
                        fiscal year that exceeds the number identified 
                        by the person under subparagraph (C), a revised 
                        due date and an increase in the amount of fees 
                        applies under this clause for each submission 
                        in excess of such number, notwithstanding any 
                        other provision of this section. For each such 
                        DTC ad, the advisory review fee shall be due 
                        and payable 20 days before the advertisement is 
                        submitted to the Secretary, and the fee shall 
                        be revised to be equal to 150 percent of the 
                        fee that otherwise would have applied pursuant 
                        to subsection (c)(3).
                    ``(F) Limits.--
                            ``(i) Submissions.--For each advisory 
                        review fee paid by a person for a fiscal year, 
                        the person is entitled to acceptance for 
                        advisory review by the Secretary of one DTC 
                        advertisement and acceptance of one 
                        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 not more than one 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 refunds.--Except as provided by 
                        subsection (f), fees paid under subparagraph 
                        (A) shall not be refunded.
                            ``(iii) No waivers, exemptions, or 
                        reductions.--The Secretary shall not grant a 
                        waiver, exemption, or reduction of any fees due 
                        or payable under this section.
                            ``(iv) Right to advisory review not 
                        transferable.--The right to an advisory review 
                        under this paragraph 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 fee established 
                under subsection (d)(2) referred to in this section as 
                an `operating reserve fee' for the first fiscal year in 
                which an advisory review fee is assessed to such 
                person. The person is not subject to an operating 
                reserve fee for any other fiscal year.
                    ``(B) Payment.--Except as provided in subparagraph 
                (C), the operating reserve fee shall be due no 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 
                under this section, that person submits any DTC 
                advertisements for prebroadcast advisory review that 
                are in excess of the number identified by that person 
                in response to the Federal Register notice described in 
                subsection (a)(1)(C), that person shall 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 
                any fees required by subparagraph (A). Fees under this 
                subparagraph shall be due 20 days before any DTC 
                advertisement is submitted by such person to the 
                Secretary for prebroadcast 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 
subsections (c) and (g)(4).
    ``(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; U.S. 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, United States 
                Code, 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 subsection will 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.--Beginning with fiscal year 
        2009, after the fee revenues established in subsection (b) 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 DTC advertisements 
        for advisory review prior to initial broadcast. With respect to 
        such adjustment:
                    ``(A) The adjustment shall be determined by the 
                Secretary based upon the number of DTC advertisements 
                identified pursuant to subsection (a)(1)(C) for the 
                upcoming fiscal year, excluding allowable previously 
                paid carry over submissions. The adjustment shall be 
                determined 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)). The Secretary shall publish in the 
                Federal Register the fee revenues and fees resulting 
                from the adjustment and the supporting methodologies.
                    ``(B) Under no circumstances shall the adjustment 
                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 for advisory review.--
                    ``(A) In general.--Not later than August 1 of each 
                fiscal year, the Secretary shall establish for the next 
                fiscal year the DTC advertisement advisory review fee 
                under subsection (a)(1), based on the revenue amounts 
                established under subsection (b), the adjustments 
                provided under paragraphs (1) and (2), and the number 
                of DTC advertisements identified pursuant to subsection 
                (a)(1)(C), 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 DTC advertisements so identified, excluding 
                allowable previously-paid carry over submissions.
                    ``(B) Fiscal year 2008 fee limit.--Notwithstanding 
                subsection (b) and the adjustments pursuant to this 
                subsection, the fee established under subparagraph (A) 
                for fiscal year 2008 may not be more than $83,000 per 
                submission for advisory review.
                    ``(C) Annual fee limit.--Notwithstanding subsection 
                (b) and the adjustments pursuant to this subsection, 
                the fee established under subparagraph (A) 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.
                    ``(D) 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 under 
        this section in the event the fees collected in any subsequent 
        fiscal year pursuant to subsection (a)(1) 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 DTC 
        advertisements identified by that person pursuant to subsection 
        (a)(1)(C) by the advisory review fee established pursuant to 
        subsection (c)(3) for that fiscal year, except that 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 under this section in fiscal year 
        2008.
            ``(3) Use of operating reserve.--The Secretary may use 
        funds from the reserves 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 subsections (b) 
        and (c) and the amount of fees actually collected for that 
        fiscal year pursuant to subsection (a)(1), or to pay costs of 
        ending the program under this section if it is terminated 
        pursuant to subsection (f) or not reauthorized beyond fiscal 
        year 2012.
            ``(4) Refund of operating reserves.--Within 120 days of the 
        end of fiscal year 2012, or if the program under this section 
        ends early pursuant to subsection (f), the Secretary, after 
        setting aside sufficient operating reserve amounts to terminate 
        the program under this section, 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 
requirement, a submission for prebroadcast advisory review of a DTC 
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) Initial funding.--If on November 1, 2007, or 120 days 
        after enactment of this provision, whichever is later, the 
        Secretary has not received at least $11,250,000 in advisory 
        review fees and operating reserve fees combined, the program 
        under this section shall not commence and all collected fees 
        shall be refunded.
            ``(2) Later fiscal years.--Beginning in fiscal year 2009, 
        if, on November 1 of the fiscal year, the combination of the 
        operating reserves, annual fee revenues from that fiscal year, 
        and unobligated fee revenues from prior fiscal years falls 
        below $9,000,000, adjusted for inflation (as described in 
        subsection (c)(1)), the program under this section shall cease 
        to exist, and the Secretary shall notify all participants, 
        retain any money from the unused advisory review fees and the 
        operating reserves needed to close down the program under this 
        section, and refund the remainder of the unused fees and 
        operating reserves. To the extent required to close down the 
        program under this section, the Secretary shall first use 
        unobligated advisory review fee revenues from prior fiscal 
        years, then the operating reserves, and finally, unused 
        advisory review fees from the relevant fiscal year.
    ``(g) Crediting and Availability of Fees.--
            ``(1) In general.--Fees authorized under subsection (a) of 
        this section 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.--
                    ``(A) In general.--The fees authorized by this 
                section--
                            ``(i) 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
                            ``(ii) shall be available for obligation 
                        only if the amounts appropriated as budget 
                        authority for such fiscal year are sufficient 
                        to support a number of full-time equivalent 
                        review employees that is not fewer than the 
                        number of such employees supported in fiscal 
                        year 2007.
                    ``(B) Review employees.--For purposes of 
                subparagraph (A)(ii), the term `full-time equivalent 
                review employees' means the total combined number of 
                full-time equivalent employees in--
                            ``(i) the Center for Drug Evaluation and 
                        Research, Division of Drug Marketing, 
                        Advertising, and Communications, Food and Drug 
                        Administration; and
                            ``(ii) the Center for Biologics Evaluation 
                        and Research, Advertising and Promotional 
                        Labeling Branch, Food and Drug Administration.
            ``(3) Authorization of appropriations.--For each of the 
        fiscal years 2008 through 2012, there is authorized to be 
        appropriated for fees under this section an amount equal to the 
        total revenue amount determined under subsection (b) for the 
        fiscal year, as adjusted pursuant to subsection (c) and 
        paragraph (4) of this subsection, 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 subchapter:
            ``(1) The term `advisory review' means reviewing and 
        providing advisory comments on a proposed advertisement prior 
        to its initial public broadcast.
            ``(2) The term `advisory review fee' has the meaning 
        indicated for such term in subsection (a)(1)(D).
            ``(3) The term `carry over submission' means a submission 
        for an advisory review for which a fee was paid in one fiscal 
        year that is submitted for review in the following fiscal year.
            ``(4) 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 3 minutes.
            ``(5) The term `DTC advertisement' has the meaning 
        indicated for such term in subsection (a)(1)(A).
            ``(6) The term `operating reserve fee' has the meaning 
        indicated for such term in subsection (a)(2)(A).
            ``(7) The term `person' includes an individual, 
        partnership, corporation, and association, and any affiliate 
        thereof or successor in interest.
            ``(8) The term `prebroadcast advisory review' has the 
        meaning indicated for such term in subsection (a)(1)(A).
            ``(9) The term `process for the advisory review of 
        prescription drug advertising' means the activities necessary 
        to review and provide advisory comments on DTC advertisements 
        prior to public broadcast and, to the extent the Secretary has 
        additional staff resources available under the program under 
        this section that are not necessary for the advisory review of 
        DTC advertisements, the activities necessary to review and 
        provide advisory comments on other proposed advertisements and 
        promotional material prior to public broadcast.
            ``(10) 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) closing down the program under this section 
                pursuant to subsection (f)(2) if that becomes 
                necessary.
            ``(11) 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.
            ``(12) 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. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.

    (a) Performance Report.--Beginning with fiscal year 2008, not later 
than 120 days after the end of each fiscal year for which fees are 
collected under part 2 of subchapter C of chapter VII of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 379g et seq.), the Secretary of 
Health and Human Services (referred to in this section as the 
``Secretary'') shall prepare and submit to the Committee on Energy and 
Commerce of the House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report concerning the 
progress of the Food and Drug Administration in achieving the goals 
identified in the letters described in section 502(4) of the 
Prescription Drug User Fee Amendments of 2002 (Subtitle A of title V of 
Public Law 107-188) during such fiscal year and the future plans of the 
Food and Drug Administration for meeting the goals.
    (b) Fiscal Report.--Beginning with fiscal year 2008, not later than 
120 days after the end of each fiscal year for which fees are collected 
under the part described in subsection (a), the Secretary shall prepare 
and submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of 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 such fiscal year.
    (c) Reauthorization.--
            (1) Consultation.--In developing recommendations to present 
        to the 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 and representatives of patient and 
        consumer advocacy groups, 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.
            (4) Public availability of minutes.--Before presenting the 
        recommendations developed under paragraphs (1) and (2) to the 
        Congress, the Secretary shall make publicly available, on the 
        public website of the Food and Drug Administration, the minutes 
        of all negotiations conducted under paragraph (1) or (2), as 
        applicable, between the Food and Drug Administration and the 
        regulated industry and representatives of patient and consumer 
        advocacy groups.

SEC. 106. SUNSET DATES.

    The amendments made by sections 102, 103, and 104 cease to be 
effective October 1, 2012.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

SEC. 201. SHORT TITLE; REFERENCES IN TITLE.

    (a) Short Title.--This title may be cited as the ``Medical Device 
User Fee Amendments of 2007''.
    (b) References in Act.--Except as otherwise specified, amendments 
made by this title to a section or other provision of law are 
amendments to such section or other provision of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).

              Subtitle A--Fees Related to Medical Devices

SEC. 211. DEFINITIONS.

    Section 737 (21 U.S.C. 379i) is amended--
            (1) 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 after subparagraph (E) 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.'';
            (2) by redesignating paragraphs (5), (6), (7), and (8) as 
        paragraphs (7), (8), (9), and (11), respectively;
            (3) by inserting after paragraph (4), as amended by 
        paragraph (1) of this section, 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', with respect to periodic 
        reporting concerning a class III device, means the annual fee 
        associated with periodic reports required by a PMA approval 
        order (as described in section 814.82(a)(7) of title 21, Code 
        of Federal Regulations (or any successor regulation)).'';
            (4) in paragraph (9), as so redesignated--
                    (A) by striking ``April of the preceding fiscal 
                year'' and inserting ``October of the preceding fiscal 
                year''; and
                    (B) by striking ``April 2002'' and inserting 
                ``October 2001'';
            (5) by inserting after paragraph (9), as so amended, the 
        following:
            ``(10) The term `person' includes an affiliate thereof.''; 
        and
            (6) by inserting after paragraph (11), as redesignated by 
        paragraph (2) of this section, the following:
            ``(12) The term `establishment subject to registration' 
        means an establishment that is required to register with the 
        Secretary under section 510 and is one of the following types 
        of establishments:
                    ``(A) Manufacturer.--An establishment that makes by 
                any means any article that is a device, as defined in 
                section 201(h), 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.
                    ``(C) Specification developer.--An establishment 
                that develops specifications for a device that is 
                distributed under the establishment's name but which 
                performs no manufacturing, including an establishment 
                that, in addition to developing specifications, also 
                arranges for the manufacturing of devices labeled with 
                another establishment's name by a contract 
                manufacturer.''.

SEC. 212. AUTHORITY TO ASSESS AND USE DEVICE FEES.

    (a) Types of Fees.--
            (1) In general.--The designation and heading of paragraph 
        (2) of section 738(a) (21 U.S.C. 379j(a)(2)) are amended to 
        read as follows:
            ``(2) Premarket application, premarket report, supplement, 
        and submission fee, and annual fee for periodic reporting 
        concerning a class iii device.--''.
            (2) Fee amounts.--Section 738(a)(2)(A) (21 U.S.C. 
        379j(a)(2)(A)) is amended--
                    (A) in clause (iii), by striking ``a fee equal to 
                the fee that applies'' and inserting ``a fee equal to 
                75 percent of the fee that applies'';
                    (B) in clause (iv), by striking ``21.5 percent'' 
                and inserting ``15 percent'';
                    (C) in clause (v), by striking ``7.2 percent'' and 
                inserting ``7 percent'';
                    (D) by redesignating clauses (vi) and (vii) as 
                clauses (vii) and (viii), respectively;
                    (E) by inserting after clause (v), as amended by 
                this paragraph, the following:
                            ``(vi) For a 30-day notice, a fee equal to 
                        1.6 percent of the fee that applies under 
                        clause (i).'';
                    (F) in clause (viii), as so redesignated, by 
                striking ``1.42 percent'' and inserting ``1.84 
                percent''; and
                    (G) by inserting after such clause (viii) 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).''.
            (3) Payment.--Section 738(a)(2)(C) (21 U.S.C. 
        379j(a)(2)(C)) is amended to read as follows:
                    ``(C) Payment.--The fee required by subparagraph 
                (A) shall be due upon submission of the premarket 
                application, premarket report, supplement, premarket 
                notification submission, 30-day notice, request for 
                classification information, or periodic reporting 
                concerning a class III device. Applicants submitting 
                portions of applications pursuant to section 515(c)(3) 
                shall pay such fees upon submission of the first 
                portion of such applications.''.
            (4) Refunds.--Section 738(a)(2)(D) (21 U.S.C. 
        379j(a)(2)(D)) is amended by adding after clause (iii) the 
        following:
                            ``(iv) Modular applications 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.''.
            (5) Annual establishment registration fee.--Section 738(a) 
        (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) 
        the following:
            ``(3) Annual establishment registration fee.--
                    ``(A) In general.--Except as provided in 
                subparagraph (B), each establishment subject to 
                registration shall be subject to a fee for each initial 
                or annual registration under section 510 beginning with 
                its registration for fiscal year 2008.
                    ``(B) Exception.--No fee shall be required under 
                subparagraph (A) for an establishment operated by a 
                State or Federal governmental entity or an Indian tribe 
                (as defined in the Indian Self Determination and 
                Educational Assistance Act), unless a device 
                manufactured by the establishment is to be distributed 
                commercially.
                    ``(C) Payment.--The fee required under subparagraph 
                (A) shall be due once each fiscal year, upon the 
                initial registration of the establishment or upon the 
                annual registration under section 510.''.
    (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is amended to 
read as follows:
            ``(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...............................     $1,706     $1,851     $2,008     $2,179  $2,364.''
                                                                                                               .
----------------------------------------------------------------------------------------------------------------

    (c) Annual Fee Setting.--
            (1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is 
        amended--
                    (A) in the subsection heading, by striking ``Annual 
                Fee Setting'' and inserting ``Annual Fee Setting''; and
                    (B) in paragraph (1), by striking the last 
                sentence.
            (2) Adjustment of annual establishment fee.--Section 738(c) 
        (21 U.S.C. 379j(c)), as amended by paragraph (1), is further 
        amended--
                    (A) by redesignating paragraphs (2) and (3) as 
                paragraphs (3) and (4), respectively;
                    (B) by inserting after paragraph (1) the following:
            ``(2) Adjustment.--
                    ``(A) In general.--When setting fees for fiscal 
                year 2010, the Secretary may increase the fee under 
                subsection (a)(3)(A) (applicable to establishments 
                subject to registration) only if the Secretary 
                estimates that the number of establishments submitting 
                fees for fiscal year 2009 is less than 12,250. The 
                percentage increase shall be the percentage by which 
                the estimate of establishments submitting fees in 
                fiscal year 2009 is less than 12,750, but in no case 
                may the percentage increase be more than 8.5 percent 
                over that specified in subsection (b) for fiscal year 
                2010. If the Secretary makes any adjustment to the fee 
                under subsection (a)(3)(A) for fiscal year 2010, then 
                such fee for fiscal years 2011 and 2012 shall be 
                adjusted so that such fee for fiscal year 2011 is equal 
                to the adjusted fee for fiscal year 2010 increased by 
                8.5 percent, and such fee for fiscal year 2012 is equal 
                to the adjusted fee for fiscal year 2011 increased by 
                8.5 percent.
                    ``(B) Publication.--For any adjustment made under 
                subparagraph (A), the Secretary shall publish in the 
                Federal Register the Secretary's determination to make 
                the adjustment and the rationale for the 
                determination.''; and
                    (C) in paragraph (4), as redesignated by this 
                paragraph, in subparagraph (A)--
                            (i) by striking ``For fiscal years 2006 and 
                        2007, the Secretary'' and inserting ``The 
                        Secretary''; and
                            (ii) by striking ``for the first month of 
                        fiscal year 2008'' and inserting ``for the 
                        first month of the next fiscal year''.
    (d) Small Businesses; Fee Waiver and Fee Reduction Regarding 
Premarket Approval.--
            (1) In general.--Section 738(d)(1) (21 U.S.C. 379j(d)(1)) 
        is amended--
                    (A) by striking ``, partners, and parent firms''; 
                and
                    (B) by striking ``clauses (i) through (vi) of 
                subsection (a)(2)(A)'' and inserting ``clauses (i) 
                through (v) and clauses (vii), (ix), and (x) of 
                subsection (a)(2)(A)''.
            (2) Rules relating to premarket approval fees.--
                    (A) Definition.--Section 738(d)(2)(A) (21 U.S.C. 
                379j(d)(2)(A)) is amended by striking ``, partners, and 
                parent firms''.
                    (B) Evidence of qualification.--Section 
                738(d)(2)(B) (21 U.S.C. 379j(d)(2)(B)) is amended--
                            (i) by striking ``(B) Evidence of 
                        qualification.--An applicant'' and inserting 
                        the following:
                    ``(B) Evidence of qualification.--
                            ``(i) In general.--An applicant'';
                            (ii) by striking ``The applicant shall 
                        support its claim'' and inserting the 
                        following:
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support its claim'';
                            (iii) by striking ``, partners, and parent 
                        firms'' each place it appears;
                            (iv) by striking the last sentence and 
                        inserting ``If no tax forms are submitted for 
                        any affiliate, the applicant shall certify that 
                        the applicant has no affiliates.''; and
                            (v) by adding at the end the following:
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--In 
                        the case of an applicant that has not 
                        previously submitted a Federal income tax 
                        return, the applicant and each of its 
                        affiliates shall demonstrate that it meets the 
                        definition under subparagraph (A) by submission 
                        of a signed certification, in such form as the 
                        Secretary may direct through a notice published 
                        in the Federal Register, that the applicant or 
                        affiliate meets the criteria for a small 
                        business and a certification, in English, from 
                        the national taxing authority of the country in 
                        which the applicant or, if applicable, 
                        affiliate is headquartered. The certification 
                        from such taxing authority shall bear the 
                        official seal of such taxing authority and 
                        shall provide the applicant's or affiliate's 
                        gross receipts and sales for the most recent 
                        year in both the local currency of such country 
                        and in United States dollars, the exchange rate 
                        used in converting such local currency to 
                        dollars, and the dates during which these 
                        receipts and sales were collected. The 
                        applicant shall also submit a statement signed 
                        by the head of the applicant's firm or by its 
                        chief financial officer that the applicant has 
                        submitted certifications for all of its 
                        affiliates, or that the applicant has no 
                        affiliates.''.
            (3) Reduced fees.--Section 738(d)(2)(C) (21 U.S.C. 
        379j(d)(2)(C)) is amended to read as follows:
                    ``(C) Reduced fees.--Where the Secretary finds that 
                the applicant involved meets the definition under 
                subparagraph (A), the fees established under subsection 
                (c)(1) may be paid at a reduced rate of--
                            ``(i) 25 percent of the fee established 
                        under such subsection for a premarket 
                        application, a premarket report, a supplement 
                        (other than a 30-day notice), or periodic 
                        reporting 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.''.
    (e) Small Businesses; Fee Reduction Regarding Premarket 
Notification Submissions.--
            (1) In general.--Section 738(e)(1) (21 U.S.C. 379j(e)(1)) 
        is amended--
                    (A) by striking ``2004'' and inserting ``2008''; 
                and
                    (B) by striking ``(a)(2)(A)(vii)'' and inserting 
                ``(a)(2)(A)(viii)''.
            (2) Rules relating to premarket notification submissions.--
                    (A) Definition.--Section 738(e)(2)(A) (21 U.S.C. 
                379j(e)(2)(A)) is amended by striking ``, partners, and 
                parent firms''.
                    (B) Evidence of qualification.--Section 
                738(e)(2)(B) (21 U.S.C. 379j(e)(2)(A)) is amended--
                            (i) by striking ``(B) Evidence of 
                        qualification.--An applicant'' and inserting 
                        the following:
                    ``(B) Evidence of qualification.--
                            ``(i) In general.--An applicant'';
                            (ii) by striking ``The applicant shall 
                        support its claim'' and inserting the 
                        following:
                            ``(ii) Firms submitting tax returns to the 
                        united states internal revenue service.--The 
                        applicant shall support its claim'';
                            (iii) by striking ``, partners, and parent 
                        firms'' each place it appears;
                            (iv) by striking the last sentence and 
                        inserting ``If no tax forms are submitted for 
                        any affiliate, the applicant shall certify that 
                        the applicant has no affiliates.''; and
                            (v) by adding at the end the following:
                            ``(iii) Firms not submitting tax returns to 
                        the united states internal revenue service.--In 
                        the case of an applicant that has not 
                        previously submitted a Federal income tax 
                        return, the applicant and each of its 
                        affiliates shall demonstrate that it meets the 
                        definition under subparagraph (A) by submission 
                        of a signed certification, in such form as the 
                        Secretary may direct through a notice published 
                        in the Federal Register, that the applicant or 
                        affiliate meets the criteria for a small 
                        business and a certification, in English, from 
                        the national taxing authority of the country in 
                        which the applicant or, if applicable, 
                        affiliate is headquartered. The certification 
                        from such taxing authority shall bear the 
                        official seal of such taxing authority and 
                        shall provide the applicant's or affiliate's 
                        gross receipts and sales for the most recent 
                        year in both the local currency of such country 
                        and in United States dollars, the exchange rate 
                        used in converting such local currency to 
                        dollars, and the dates during which these 
                        receipts and sales were collected. The 
                        applicant shall also submit a statement signed 
                        by the head of the applicant's firm or by its 
                        chief financial officer that the applicant has 
                        submitted certifications for all of its 
                        affiliates, or that the applicant has no 
                        affiliates.''.
            (3) Reduced fees.--Section 738(e)(2)(C) (21 U.S.C. 
        379j(e)(2)(C)) is amended to read as follows:
                    ``(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).''.
    (f) Effect of Failure To Pay Fees.--Section 738(f) (21 U.S.C. 
379j(f)) is amended to read as follows:
    ``(f) Effect of Failure To Pay Fees.--
            ``(1) No acceptance of submissions.--A premarket 
        application, premarket report, supplement, premarket 
        notification submission, 30-day notice, request for 
        classification information, or periodic reporting concerning a 
        class III device submitted by a person subject to fees under 
        subsection (a)(2) and (a)(3) shall be considered incomplete and 
        shall not be accepted by the Secretary until all fees owed by 
        such person have been paid.
            ``(2) No registration.--Registration information submitted 
        under section 510 by an establishment subject to registration 
        shall be considered incomplete and shall not be accepted by the 
        Secretary until the registration fee under subsection (a)(3) 
        owed for the establishment has been paid. Until the fee is paid 
        and the registration is complete, the establishment is deemed 
        to have failed to register in accordance with section 510.''.
    (g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is amended--
            (1) in paragraph (1)(D)--
                    (A) in the matter preceding clause (i), by striking 
                ``For fiscal year 2007'' and inserting ``For fiscal 
                year 2007 and for each subsequent year'';
                    (B) in clause (i), by striking ``applicable to 
                fiscal year 2007'' and inserting ``applicable to such 
                fiscal year''; and
                    (C) in clause (ii)--
                            (i) by striking ``subparagraph (C)'' and 
                        inserting ``this subparagraph''; and
                            (ii) by striking ``for fiscal year 2006'' 
                        and inserting ``for the previous fiscal year''; 
                        and
            (2) by amending paragraph (2) to read as follows:
            ``(2) Authority.--If the Secretary does not assess fees 
        under subsection (a) during any portion of a fiscal year 
        because of subparagraph (C) or (D) of paragraph (1) and if at a 
        later date in such fiscal year the Secretary may assess such 
        fees, the Secretary may assess and collect such fees, without 
        any modification in the rate for premarket applications, 
        supplements, premarket reports, premarket notification 
        submissions, 30-day notices, requests for classification 
        information, periodic reporting concerning a class III device, 
        and establishment registrations at any time in such fiscal 
        year, notwithstanding the provisions of subsection (a) relating 
        to the date fees are to be paid.''.
    (h) Crediting and Availability of Fees.--
            (1) Authorization of appropriations.--Section 738(h)(3) (21 
        U.S.C. 379j(h)(3)) is amended to read as follows:
            ``(3) Authorizations 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.''.
            (2) Offset.--Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
        amended to read as follows:
            ``(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 these four 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. 213. ANNUAL REPORTS.

    Beginning with fiscal year 2008, the Secretary shall prepare and 
submit to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate a report concerning--
            (1) the progress of the Food and Drug Administration in 
        achieving the goals identified in the letters from the 
        Secretary of Health and Human Services to the Committee on 
        Energy and Commerce of the House of Representatives and the 
        Committee on Health, Education, Labor, and Pensions of the 
        Senate, as set forth in the Congressional Record during such 
        fiscal year, and the future plans of the Food and Drug 
        Administration for meeting the goals, not later than 60 days 
        after the end of each fiscal year during which fees are 
        collected under part 3 of chapter VII of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 379i et seq.); and
            (2) 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 
        (including a description of the use of such fees for postmarket 
        safety activities), not later than 120 days after the end of 
        each fiscal year during which fees are collected under the 
        medical device user-fee program reauthorized by this title.

SEC. 214. CONSULTATION.

    (a) In General.--In developing recommendations to the Congress for 
the goals and plans for meeting the goals for the process for the 
review of medical device applications for fiscal years after fiscal 
year 2012, and for the reauthorization of sections 737 and 738 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379i, 379j), the 
Secretary of Health and Human Services (referred to in this section as 
the ``Secretary'') shall consult with the Committee on Energy and 
Commerce of the House of Representatives, the Committee on Health, 
Education, Labor, and Pensions of the Senate, appropriate scientific 
and academic experts, health care professionals, representatives of 
patient and consumer advocacy groups, and the regulated industry.
    (b) Recommendations.--The Secretary shall publish in the Federal 
Register recommendations under subsection (a), after negotiations with 
the regulated industry and patient and consumer advocacy groups; shall 
present such recommendations to the congressional committees specified 
in such subsection; shall hold a meeting at which the public may 
present its views on such recommendations; and shall provide for a 
period of 30 days for the public to provide written comments on such 
recommendations.

SEC. 215. ADDITIONAL AUTHORIZATION OF APPROPRIATIONS FOR POSTMARKET 
              SAFETY INFORMATION.

    For the purpose of collecting, developing, reviewing, and 
evaluating postmarket safety information on medical devices, there are 
authorized to be appropriated to the Food and Drug Administration, in 
addition to the amounts authorized by other provisions of law for such 
purpose, $7,100,000 for fiscal year 2008, and for each of the fiscal 
years 2009 through 2012, $7,100,000 increased by the amount necessary 
to offset the effects of inflation occurring after October 1, 2007.

SEC. 216. EFFECTIVE DATE.

    The amendments made by this title shall take effect on the date of 
the enactment of this title, except that fees shall be assessed for all 
premarket applications, premarket reports, supplements, and premarket 
notification submissions received on or after October 1, 2007, 
regardless of the date of enactment.

SEC. 217. SUNSET CLAUSE.

    The amendments made by this title cease to be effective October 1, 
2012, except that section 213 (regarding annual reports) ceases to be 
effective January 31, 2013.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

SEC. 221. 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. 222. REGISTRATION.

    (a) Annual Registration of Producers of Drugs and Devices.--Section 
510(b) (21 U.S.C. 360(b)) is amended--
            (1) by striking ``On or before'' and inserting ``(1) On or 
        before'';
            (2) by striking ``or a device or devices''; and
            (3) by adding at the end the following:
    ``(2) During the period beginning on October 1 and ending on 
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. 360(i)(1)) is amended by striking ``On or before December 31'' 
and all that follows and inserting the following: ``Any establishment 
within any foreign country engaged in the manufacture, preparation, 
propagation, compounding, or processing of a drug or device that is 
imported or offered for import into the United States shall, through 
electronic means in accordance with the criteria of the Secretary--
            ``(A) upon first engaging in any such activity, immediately 
        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 drug or device 
        in the United States that is known to the establishment, and 
        the name of each person who imports or offers for import such 
        drug or device to the United States for purposes of 
        importation; and
            ``(B) each establishment subject to the requirements of 
        subparagraph (A) shall thereafter--
                    ``(i) with respect to drugs, register with the 
                Secretary on or before December 31 of each year; and
                    ``(ii) with respect to devices, register with the 
                Secretary during the period beginning on October 1 and 
                ending on December 31 of each year.''.

SEC. 223. 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), by striking ``Each person'' and all that 
follows through ``the following information:'' and inserting ``Each 
person who registers with the Secretary under this section shall report 
to the Secretary, with regard to drugs once during the month of June of 
each year and once during the month of December of each year, and with 
regard to devices once each year during the period beginning on October 
1 and ending on December 31, the following information:''.

SEC. 224. ELECTRONIC REGISTRATION AND LISTING.

    Section 510(p) (21 U.S.C. 360(p)) is amended to read as follows:
    ``(p)(1) Registrations and listings under this section (including 
the submission of updated information) shall be submitted to the 
Secretary by electronic means 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.''.

SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on the appropriate use of the process under section 
510(k) of the Federal Food, Drug, and Cosmetic Act as part of the 
device classification process to determine whether a new device is as 
safe and effective as a classified device.
    (b) Consideration.--In determining the effectiveness of the 
premarket notification and classification authority under section 
510(k) and subsections (f) and (i) of section 513, the study under 
subsection (a) shall consider the Secretary's evaluation of the 
respective intended uses and technologies of such devices, including 
the effectiveness of the Secretary's comparative assessment of 
technological characteristics such as device materials, principles of 
operations, and power sources.
    (c) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.

SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.

    Section 519 (21 U.S.C. 360i) is amended--
            (1) by redesignating subsection (f) as subsection (g); and
            (2) by inserting after subsection (e) the following:

                 ``Unique Device Identification System

    ``(f) The Secretary shall promulgate regulations establishing a 
unique device identification system for medical devices requiring the 
labeling of devices to bear a unique identifier.''.

SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.

    Subparagraph (B) of section 519(a)(1) (21 U.S.C. 360i(a)(1)) is 
amended by striking ``were to recur;'' and inserting the following: 
``were to recur, which report under this subparagraph--
                            ``(i) shall be submitted in accordance with 
                        part 803 of title 21, Code of Federal 
                        Regulations (or successor regulations), if the 
                        device involved is--
                                    ``(I) a class III device;
                                    ``(II) a class II device that is 
                                permanently implantable, is life 
                                supporting, or is life sustaining; or
                                    ``(III) a type of device that the 
                                Secretary has by regulation determined 
                                should be subject to such part 803 in 
                                order to protect the public health; or
                            ``(ii) shall, if the device is not subject 
                        to clause (i), be submitted in accordance with 
                        criteria established by the Secretary for 
                        reports made pursuant to this clause, which 
                        criteria shall require the reports to be in 
                        summary form and made on a quarterly basis;''.

SEC. 228. 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 the 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 Secretary'' 
                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) in subparagraph (A), by striking ``(A) 
                Persons'' and all that follows through the end and 
                inserting the following: ``(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 paragraph (10)(C)(iii), by striking ``based'' and 
        inserting ``base''.

SEC. 229. STUDY OF NOSOCOMIAL INFECTIONS RELATING TO MEDICAL DEVICES.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study on--
            (1) the number of nosocomial infections attributable to new 
        and reused medical devices; and
            (2) the causes of such nosocomial infections, including the 
        following:
                    (A) Reprocessed single use devices.
                    (B) Handling of sterilized medical devices.
                    (C) In-hospital sterilization of medical devices.
                    (D) Health care professionals' practices for 
                patient examination and treatment.
                    (E) Hospital-based policies and procedures for 
                infection control and prevention.
                    (F) Hospital-based practices for handling of 
                medical waste.
                    (G) Other causes.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General shall complete the study under 
subsection (a) and submit to the Congress a report on the results of 
such study.
    (c) Definition.--In this section, the term ``nosocomial infection'' 
means an infection that is acquired while an individual is a patient at 
a hospital and was neither present nor incubating in the patient prior 
to receiving services in the hospital.

 TITLE III--PEDIATRIC MEDICAL DEVICE SAFETY AND IMPROVEMENT ACT OF 2007

SEC. 301. SHORT TITLE.

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

SEC. 302. 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.--For purposes of this section, the 
term `pediatric subpopulation' has the meaning given the term in 
section 520(m)(6)(E)(ii).''.

SEC. 303. 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.''; and
            (3) by striking paragraph (6) and inserting after paragraph 
        (5) the following new paragraphs:
    ``(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, 2013.
    ``(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.
    ``(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.
    ``(8) In consultation with the Office of Pediatric Therapeutics and 
the Center for Devices and Radiological Health, the Secretary shall 
provide for an annual review by the Pediatric Advisory Committee of all 
devices described in paragraph (6) to ensure that the exemption under 
paragraph (2) remains appropriate for the pediatric populations for 
which it is granted.''.
    (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 305.
    (c) Guidance.--Not later than 180 days after the date of enactment 
of this Act, 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. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

    (a) Access to Funding.--The Director of the National Institutes of 
Health shall designate a contact point or office at the National 
Institutes of Health to help innovators and physicians access funding 
for pediatric medical device development.
    (b) Plan for Pediatric Medical Device Research.--
            (1) In general.--Not later than 180 days after the date of 
        enactment of this Act, the Commissioner of Food and Drugs, 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.
            (2) Contents.--The plan under paragraph (1) shall include--
                    (A) the current status of federally funded 
                pediatric medical device research;
                    (B) any gaps in such research, which may include a 
                survey of pediatric medical providers regarding unmet 
                pediatric medical device needs, as needed; and
                    (C) 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.

SEC. 305. 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 Act, 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--
            (1) encourage innovation by connecting qualified 
        individuals with pediatric device ideas with potential 
        manufacturers;
            (2) mentor and manage pediatric device projects through the 
        development process, including product identification, 
        prototype design, device development, and marketing;
            (3) connect innovators and physicians to existing 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) assess the scientific and medical merit of proposed 
        pediatric device projects;
            (5) assess business feasibility and provide business 
        advice;
            (6) provide assistance with prototype development; and
            (7) provide assistance with postmarket needs, including 
        training, logistics, and reporting.
    (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 304; 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.
    (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. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND PEDIATRIC 
              ADVISORY COMMITTEE.

    (a) 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''.
    (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
                            (iii) in subparagraph (C), by inserting 
                        ``(including drugs and biological products) and 
                        medical devices'' after ``therapeutics''.

SEC. 307. POSTMARKET STUDIES.

    Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360l) is amended--
            (1) in subsection (a)--
                    (A) by inserting ``, or as a condition to approval 
                of an application (or a supplement to an application) 
                or a product development protocol under section 515 or 
                as a condition to clearance of a premarket notification 
                under section 510(k), for a pediatric population or 
                pediatric subpopulation,'' after ``The Secretary may by 
                order''; and
                    (B) by inserting ``, or that is indicated for 
                pediatric populations or subpopulations or is expected 
                to have significant use in pediatric populations,'' 
                after ``health consequences''; 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 studies 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 or efficacy of the device.
    ``(c) Dispute Resolution.--A manufacturer may request review under 
section 562 of any order or condition requiring postmarket surveillance 
under this section. During the pendency of such review, the device 
subject to such a postmarket surveillance order or condition shall not 
be deemed misbranded under section 502(t) or otherwise in violation of 
such order or condition or a related requirement of this Act unless 
deemed necessary to protect the public health.''.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

SEC. 401. SHORT TITLE.

    This title may be cited as the ``Pediatric Research Equity Act of 
2007''.

SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

    (a) In General.--Section 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355c) is amended to read as follows:

``SEC. 505B. RESEARCH INTO PEDIATRIC USES FOR DRUGS AND BIOLOGICAL 
              PRODUCTS.

    ``(a) New Drugs and Biological Products.--
            ``(1) In general.--A person that submits, on or after the 
        date of enactment of the Pediatric Research Equity Act of 2007, 
        an application (or supplement to an application)--
                    ``(A) under section 505 for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration, or
                    ``(B) under section 351 of the Public Health 
                Service Act (42 U.S.C. 262) for a new active 
                ingredient, new indication, new dosage form, new dosing 
                regimen, or new route of administration,
        shall submit with the application the assessments described in 
        paragraph (2).
            ``(2) Assessments.--
                    ``(A) In general.--The assessments referred to in 
                paragraph (1) shall contain data, gathered using 
                appropriate formulations for each age group for which 
                the assessment is required, that are adequate--
                            ``(i) to assess the safety and 
                        effectiveness of the drug or the biological 
                        product for the claimed indications in all 
                        relevant pediatric subpopulations; and
                            ``(ii) to support dosing and administration 
                        for each pediatric subpopulation for which the 
                        drug or the biological product is safe and 
                        effective.
                    ``(B) Similar course of disease or similar effect 
                of drug or biological product.--
                            ``(i) In general.--If the course of the 
                        disease and the effects of the drug are 
                        sufficiently similar in adults and pediatric 
                        patients, the Secretary may conclude that 
                        pediatric effectiveness can be extrapolated 
                        from adequate and well-controlled studies in 
                        adults, usually supplemented with other 
                        information obtained in pediatric patients, 
                        such as pharmacokinetic studies.
                            ``(ii) Extrapolation between age groups.--A 
                        study may not be needed in each pediatric age 
                        group if data from one age group can be 
                        extrapolated to another age group.
                            ``(iii) Information on extrapolation.--A 
                        brief documentation of the scientific data 
                        supporting the conclusion under clauses (i) and 
                        (ii) shall be included in the medical review 
                        that is collected as part of the application 
                        under section 505 of this Act or section 351 of 
                        the Public Health Service Act (42 U.S.C. 262).
            ``(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.
            ``(4) Waivers.--
                    ``(A) Full waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a full waiver, as appropriate, of 
                the requirement to submit assessments for a drug or 
                biological product under this subsection if the 
                applicant certifies and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients is so small or the patients 
                        are geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups; or
                            ``(iii) The drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients; and
                                    ``(II) is not likely to be used in 
                                a substantial number of pediatric 
                                patients.
                    ``(B) Partial waiver.--On the initiative of the 
                Secretary or at the request of an applicant, the 
                Secretary shall grant a partial waiver, as appropriate, 
                of the requirement to submit assessments for a drug or 
                biological product under this subsection with respect 
                to a specific pediatric age group if the applicant 
                certifies and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii) the drug or biological product--
                                    ``(I) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(II) is not likely to be used by 
                                a substantial number of pediatric 
                                patients in that age group; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial 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.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(b) Marketed Drugs and Biological Products.--
            ``(1) In general.--Beginning on the date of enactment of 
        the Pediatric Research Equity Act of 2007, after providing 
        notice in the form of a letter 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 to submit by a specified date the assessments 
        described in subsection (a)(2), 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) Waivers.--
                    ``(A) Full waiver.--At the request of an applicant, 
                the Secretary shall grant a full waiver, as 
                appropriate, of the requirement to submit assessments 
                under this subsection if the applicant certifies and 
                the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed); or
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in all pediatric 
                        age groups.
                    ``(B) Partial waiver.--At the request of an 
                applicant, the Secretary shall grant a partial waiver, 
                as appropriate, of the requirement to submit 
                assessments under this subsection with respect to a 
                specific pediatric age group if the applicant certifies 
                and the Secretary finds that--
                            ``(i) necessary studies are impossible or 
                        highly impracticable (because, for example, the 
                        number of patients in that age group is so 
                        small or patients in that age group are 
                        geographically dispersed);
                            ``(ii) there is evidence strongly 
                        suggesting that the drug or biological product 
                        would be ineffective or unsafe in that age 
                        group;
                            ``(iii)(I) the drug or biological product--
                                    ``(aa) does not represent a 
                                meaningful therapeutic benefit over 
                                existing therapies for pediatric 
                                patients in that age group; and
                                    ``(bb) is not likely to be used in 
                                a substantial number of pediatric 
                                patients in that age group; and
                            ``(II) the absence of adequate labeling 
                        could not pose significant risks to pediatric 
                        patients; or
                            ``(iv) the applicant can demonstrate that 
                        reasonable attempts to produce a pediatric 
                        formulation necessary for that age group have 
                        failed.
                    ``(C) Pediatric formulation not possible.--If a 
                waiver is granted on the ground that it is not possible 
                to develop a pediatric formulation, the waiver shall 
                cover only the pediatric groups requiring that 
                formulation. An applicant seeking either a full or 
                partial 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.
                    ``(D) Labeling requirement.--If the Secretary 
                grants a full or partial waiver because there is 
                evidence that a drug or biological product would be 
                ineffective or unsafe in pediatric populations, the 
                information shall be included in the labeling for the 
                drug or biological product.
    ``(c) Meaningful Therapeutic Benefit.--For the purposes of 
paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) and 
paragraphs (1)(B)(I) and (2)(B)(iii)(I)(aa) of subsection (b), a drug 
or biological product shall be considered to represent a meaningful 
therapeutic benefit over existing therapies if the Secretary determines 
that--
            ``(1) if approved, the drug or biological product could 
        represent an improvement in the treatment, diagnosis, or 
        prevention of a disease, compared with marketed products 
        adequately labeled for that use in the relevant pediatric 
        population; or
            ``(2) the drug or biological product is in a class of 
        products or for an indication for which there is a need for 
        additional options.
    ``(d) Submission of Assessments.--If a person fails to submit an 
assessment described in subsection (a)(2), or a request for approval of 
a pediatric formulation described in subsection (a) or (b), in 
accordance with applicable provisions of subsections (a) and (b)--
            ``(1) the drug or biological product that is the subject of 
        the assessment or request may be considered misbranded solely 
        because of that failure and subject to relevant enforcement 
        action (except that the drug or biological product shall not be 
        subject to action under section 303); but
            ``(2) the failure to submit the assessment or request shall 
        not be the basis for a proceeding--
                    ``(A) to withdraw approval for a drug under section 
                505(e); or
                    ``(B) to revoke the license for a biological 
                product under section 351 of the Public Health Service 
                Act.
    ``(e) Meetings.--Before and during the investigational process for 
a new drug or biological product, the Secretary shall meet at 
appropriate times with the sponsor of the new drug or biological 
product to discuss--
            ``(1) information that the sponsor submits on plans and 
        timelines for pediatric studies; or
            ``(2) any planned request by the sponsor for waiver or 
        deferral of pediatric studies.
    ``(f) Review of Pediatric Plans, Deferrals, and Waivers.--
            ``(1) Review.--Beginning not later than 30 days after the 
        date of enactment of the Pediatric Research Equity Act of 2007, 
        the Secretary shall utilize an internal committee to provide 
        consultation to reviewing divisions on all pediatric plans and 
        assessments prior to approval of an application or supplement 
        for which a pediatric assessment is required under this section 
        and all deferral and waiver requests granted pursuant to this 
        section. Such internal committee shall include employees of the 
        Food and Drug Administration, with expertise in pediatrics 
        (including representation from the Office of Pediatric 
        Therapeutics), biopharmacology, statistics, chemistry, legal 
        issues, pediatric ethics, and the appropriate expertise 
        pertaining to the pediatric product under review, and other 
        individuals designated by the Secretary.
            ``(2) Activity by committee.--The committee referred to in 
        paragraph (1) may operate using appropriate members of such 
        committee and need not convene all members of the committee.
            ``(3) Documentation of committee action.--For each drug or 
        biological product, the committee referred to in paragraph (1) 
        shall document, for each activity described in paragraph (4), 
        which members of the committee participated in such activity.
            ``(4) Review of pediatric plans, deferrals and waivers.--
        Consultation on pediatric plans and assessments by the internal 
        committee pursuant to this section shall occur prior to 
        approval of an application or supplement for which a pediatric 
        assessment is required under this section. The internal 
        committee shall review all requests for deferrals and waivers 
        from the requirement to submit a pediatric assessment granted 
        under this section and shall provide recommendations as needed 
        to reviewing divisions.
            ``(5) Retrospective review of pediatric plans, deferrals 
        and waivers.--Within one year after enactment of the Pediatric 
        Research Equity Act of 2007, the committee shall conduct a 
        retrospective review and analysis of a representative sample of 
        assessments submitted and deferrals and waivers approved under 
        this section since enactment of the Pediatric Research Equity 
        Act of 2003. Such review shall include an analysis of the 
        quality and consistency of pediatric information in pediatric 
        assessments and the appropriateness of waivers and deferrals 
        granted. Based on such review, the Secretary shall issue 
        recommendations to the review divisions for improvements and 
        initiate guidance to industry related to the scope of pediatric 
        studies required under this section.
            ``(6) Tracking of assessments and labeling changes.--
        Beginning on the date of enactment of the Pediatric Research 
        Equity Act of 2007, the Secretary shall track and make 
        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 assessments conducted under 
                this section;
                    ``(B) the specific drugs and biological products 
                and their 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 formulation was 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 (h)(2); and
                    ``(I) an annual summary of information submitted 
                pursuant to subsection (a)(3)(B).
            ``(7) Committee.--The committee utilized under paragraph 
        (1) shall be the committee established under section 
        505A(f)(1).
    ``(g) Labeling Changes.--
            ``(1) Priority status for pediatric applications.--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 application or 
                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, on or after the date of enactment of the 
                Pediatric Research Equity Act of 2007, 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 of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor does not agree within 
                        30 days after the Commissioner's request 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 to 
                make any labeling changes that the Commissioner 
                determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application, 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 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, on or after the date of 
        enactment of the Pediatric Research Equity Act of 2007, 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 in pediatric populations or subpopulations, including 
        whether such assessment results are inconclusive, the Secretary 
        shall order the label 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.--Beginning on the date of enactment of the Pediatric 
        Research Equity Act of 2007, 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)(6)(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 or section 1905 of title 18, United States Code.
    ``(i) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of 
        enactment of the Pediatric Research Equity Act of 2007, during 
        the one-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 the 
        report, 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 one-
        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 the report, the Director of such Office may provide 
        for the review of the report 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.
    ``(j) Scope of Authority.--Nothing in this section provides to the 
Secretary any authority to require a pediatric assessment of any drug 
or biological product, or any assessment regarding other populations or 
uses of a drug or biological product, other than the pediatric 
assessments described in this section.
    ``(k) Orphan Drugs.--Unless the Secretary requires otherwise by 
regulation, this section does not apply to any drug for an indication 
for which orphan designation has been granted under section 526.
    ``(l) Institute of Medicine Study.--
            ``(1) In general.--Not later than three years after the 
        date of the enactment of the Pediatric Research Equity Act of 
        2007, the Secretary shall contract with the Institute of 
        Medicine to conduct a study and report to Congress regarding 
        the pediatric studies conducted pursuant to this section since 
        1997 and labeling changes made as a result of such studies.
            ``(2) Content of study.--The study under paragraph (1) 
        shall review and assess the use of extrapolation for pediatric 
        subpopulations, the use of alternative endpoints for pediatric 
        populations, neonatal assessment tools, the 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 this section from each 
        review division within the Center for Drug Evaluation and 
        Research in order to make the requested assessment.''.
    (b) Applicability.--The amendment made in subsection (a) applies to 
assessments required under section 505B on or after the date of 
enactment of this Act.

SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

    Not later than September 1, 2011, the Comptroller General of the 
United States, in consultation with the Secretary of Health and Human 
Services, shall submit to the Congress a report that addresses the 
effectiveness of sections 505A and 505B of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public 
Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by 
children are tested and properly labeled. Such report shall include--
            (1) the number and importance of drugs and biological 
        products for children that are being tested as a result of the 
        amendments made by this title and title V 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 and biological 
        products for children that are not being tested for their use 
        notwithstanding the provisions of this title and title V 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 title;
            (3) the number of drugs and biological products 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 title, 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 sections 505A and 505B 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.

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

SEC. 501. SHORT TITLE.

    This title may be cited as the ``Best Pharmaceuticals for Children 
Act of 2007''.

SEC. 502. REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT.

    (a) Pediatric Studies of Drugs.--
            (1) In general.--Section 505A of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 355a) is amended to read as 
        follows:

``SEC. 505A. PEDIATRIC STUDIES OF DRUGS.

    ``(a) Definitions.--As used in this section, the term `pediatric 
studies' or `studies' means at least one clinical investigation (that, 
at the Secretary's discretion, may include pharmacokinetic studies) in 
pediatric age groups (including neonates in appropriate cases) in which 
a drug is anticipated to be used, and at the discretion of the 
Secretary, may include preclinical studies.
    ``(b) Market Exclusivity for New Drugs.--
            ``(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 has determined that labeling 
        changes are appropriate, such changes are approved within the 
        timeframe requested by the Secretary--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(E) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsections (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions).
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        is made later than one year prior to the expiration of such 
        period.
    ``(c) Market Exclusivity for Already-Marketed Drugs.--
            ``(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 and such changes are approved within the timeframe 
        requested by the Secretary--
                    ``(A)(i)(I) the period referred to in subsection 
                (c)(3)(E)(ii) of section 505, and in subsection 
                (j)(5)(F)(ii) of such section, is deemed to be five 
                years and six months rather than five years, and the 
                references in subsections (c)(3)(E)(ii) and 
                (j)(5)(F)(ii) of such section to four years, to forty-
                eight months, and to seven and one-half years are 
                deemed to be four and one-half years, fifty-four 
                months, and eight years, respectively; or
                    ``(II) the period referred to in clauses (iii) and 
                (iv) of subsection (c)(3)(D) of such section, and in 
                clauses (iii) and (iv) of subsection (j)(5)(F) of such 
                section, is deemed to be three years and six months 
                rather than three years; and
                    ``(ii) if the drug is designated under section 526 
                for a rare disease or condition, the period referred to 
                in section 527(a) is deemed to be seven years and six 
                months rather than seven years; and
                    ``(B)(i) if the drug is the subject of--
                            ``(I) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(ii) or (j)(2)(A)(vii)(II) 
                        of section 505 and for which pediatric studies 
                        were submitted prior to the expiration of the 
                        patent (including any patent extensions); or
                            ``(II) a listed patent for which a 
                        certification has been submitted under 
                        subsection (b)(2)(A)(iii) or 
                        (j)(2)(A)(vii)(III) of section 505,
                the period during which an application may not be 
                approved under section 505(c)(3) or section 
                505(j)(5)(B)(ii) shall be extended by a period of six 
                months after the date the patent expires (including any 
                patent extensions); or
                    ``(ii) if the drug is the subject of a listed 
                patent for which a certification has been submitted 
                under subsection (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of 
                section 505, and in the patent infringement litigation 
                resulting from the certification the court determines 
                that the patent is valid and would be infringed, the 
                period during which an application may not be approved 
                under section 505(c)(3) or section 505(j)(5)(B) shall 
                be extended by a period of six months after the date 
                the patent expires (including any patent extensions)
            ``(2) Exception.--The Secretary shall not extend the period 
        referred to in paragraph (1)(A) or (1)(B) if the determination 
        is made later than one year prior to the expiration of such 
        period.
    ``(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 one 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 stating the reasons for 
                                declining the request.
                            ``(ii) Disagree with request.--If, on or 
                        after the date of the enactment of the Best 
                        Pharmaceuticals for Children Act 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 the enactment of 
                the Best Pharmaceuticals for Children Act of 2007, 
                agrees to the request for such studies shall provide 
                the Secretary, at the same time as the 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-day period, 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.
    ``(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 the enactment 
        of the Best Pharmaceuticals for Children Act 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 the enactment of the Best Pharmaceuticals for 
        Children Act 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 one year after 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 one year period.
    ``(f) Internal Review of Written Requests and Pediatric Studies.--
            ``(1) Internal review.--
                    ``(A) In general.--The Secretary shall establish an 
                internal review committee to review all written 
                requests issued on or after the date of the enactment 
                of the Best Pharmaceuticals for Children Act of 2007, 
                in accordance with paragraph (2).
                    ``(B) Members.--The committee established under 
                subparagraph (A) shall include individuals with 
                expertise in pediatrics, biopharmacology, statistics, 
                drugs and drug formulations, legal issues, pediatric 
                ethics, the appropriate expertise, such as expertise in 
                child and adolescent psychiatry, pertaining to the 
                pediatric product under review, one or more experts 
                from the Office of Pediatric Therapeutics, and other 
                individuals designated by the Secretary.
            ``(2) Review of written requests.--The committee 
        established under paragraph (1) shall review all written 
        requests issued pursuant to this section prior to being issued.
            ``(3) Tracking pediatric studies and labeling changes.--The 
        Secretary shall track and make 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 and under section 409I of the Public Health 
                Service Act;
                    ``(B) the specific drugs and biological products 
                and their uses, including labeled and off-labeled 
                indications, studied under such sections;
                    ``(C) the types of studies conducted under such 
                sections, 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 such sections;
                    ``(F) an annual summary of labeling changes made as 
                a result of studies conducted under such sections for 
                distribution pursuant to subsection (k)(2); and
                    ``(G) information regarding reports submitted on or 
                after the date of the enactment of the Best 
                Pharmaceuticals for Children Act of 2007.
            ``(4) Committee.--The committee established under paragraph 
        (1) shall be the committee utilized under section 505B(f)(1).
    ``(g) Limitations.--Notwithstanding subsection (c)(2), a drug to 
which the six-month period under subsection (b) or (c) has already been 
applied--
            ``(1) may receive an additional six-month period under 
        subsection (c)(1)(A)(i)(II) for a supplemental application if 
        all other requirements under this section are satisfied; and
            ``(2) may not receive any additional such period under 
        subsection (c)(1)(A)(ii).
    ``(h) Relationship to Pediatric Research Requirements.--
Notwithstanding any other provision of law, if any pediatric study is 
required by a provision of law (including a regulation) other than this 
section and such study meets the completeness, timeliness, and other 
requirements of this section, such study shall be deemed to satisfy the 
requirement for market exclusivity pursuant to this section.
    ``(i) Labeling Changes.--
            ``(1) Priority status for pediatric applications and 
        supplements.--Any application or supplement to an application 
        under section 505 proposing a labeling change as a result of 
        any pediatric study conducted pursuant to this section--
                    ``(A) shall be considered to be a priority 
                application or 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, on or after the date of the enactment of 
                the Best Pharmaceuticals for Children Act of 2007, the 
                Commissioner determines that the 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, not later than 180 
                days after the date of submission of the application--
                            ``(i) the Commissioner shall request that 
                        the sponsor of the application make any 
                        labeling change that the Commissioner 
                        determines to be appropriate; and
                            ``(ii) if the sponsor of the application 
                        does not agree within 30 days after the 
                        Commissioner's request 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 to 
                make any labeling change that the Commissioner 
                determines to be appropriate.
                    ``(D) Misbranding.--If the sponsor of the 
                application, 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 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.
    ``(j) Other Labeling Changes.--If, on or after the date of the 
enactment of the Best Pharmaceuticals for Children Act 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 in pediatric populations or 
subpopulations, including whether such study results are inconclusive, 
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.
    ``(k) Dissemination of Pediatric Information.--
            ``(1) In general.--Not later than 180 days after the date 
        of submission of a report on a pediatric study under this 
        section, the Secretary shall make available to the public the 
        medical, statistical, and clinical pharmacology reviews of 
        pediatric studies conducted under subsection (b) or (c).
            ``(2) Dissemination of information regarding labeling 
        changes.--Beginning on the date of the enactment of the Best 
        Pharmaceuticals for Children Act of 2007, the Secretary shall 
        include as a requirement of a written request that the sponsors 
        of the studies that result in labeling changes that are 
        reflected in the annual summary developed pursuant to 
        subsection (f)(3)(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.
            ``(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.
    ``(l) Adverse Event Reporting.--
            ``(1) Reporting in year one.--Beginning on the date of the 
        enactment of the Best Pharmaceuticals for Children Act of 2007, 
        during the one-year period beginning on the date a labeling 
        change is approved 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 the reports, 
        the Director of such Office shall provide for the review of the 
        reports 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 reports.
            ``(2) Reporting in subsequent years.--Following the one-
        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.
    ``(m) Clarification of Interaction of Market Exclusivity Under This 
Section and Market Exclusivity Awarded to An Applicant for Approval of 
A Drug Under Section 505(j).--If a 180-day period under section 
505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this 
section, so that the applicant for approval of a drug under section 
505(j) entitled to the 180-day period under that section loses a 
portion of the 180-day period to which the applicant is entitled for 
the drug, the 180-day period shall be extended from--
            ``(1) the date on which the 180-day period would have 
        expired by the number of days of the overlap, if the 180-day 
        period would, but for the application of this subsection, 
        expire after the 6-month exclusivity period; or
            ``(2) the date on which the 6-month exclusivity period 
        expires, by the number of days of the overlap if the 180-day 
        period would, but for the application of this subsection, 
        expire during the six-month exclusivity period.
    ``(n) Referral if Pediatric Studies Not Completed.--
            ``(1) In general.--Beginning on the date of the enactment 
        of the Best Pharmaceuticals for Children Act of 2007, if 
        pediatric studies 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--
                    ``(A) for a drug for which listed patents have not 
                expired, make a determination regarding whether an 
                assessment shall be required to be submitted under 
                section 505B; or
                    ``(B) for a drug that has no listed patents or has 
                1 or more listed patents that have expired, determine 
                whether there are funds available under section 736 to 
                award a grant to conduct the requested studies pursuant 
                to paragraph (2).
            ``(2) Funding of studies.--If, pursuant to paragraph (1), 
        the Secretary determines that there are funds available under 
        section 736 to award a grant to conduct the requested pediatric 
        studies, then the Secretary shall issue a proposal to award a 
        grant to conduct the requested studies. If the Secretary 
        determines that funds are not available under section 736, the 
        Secretary shall refer the drug for inclusion on the list 
        established under section 409I of the Public Health Service Act 
        or the conduct of studies.
            ``(3) 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;
                    ``(B) the name of any drug, its manufacturer, and 
                the indications to be studied pursuant to a grant made 
                under paragraph (2); and
                    ``(C) any decision under paragraph (2) to include a 
                drug on the list established under section 409I of the 
                Public Health Service Act.
            ``(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.
    ``(o) Prompt Approval of Drugs Under Section 505(j) When Pediatric 
Information Is Added to Labeling.--
            ``(1) General rule.--A drug for which an application has 
        been submitted or approved under section 505(j) shall not be 
        considered ineligible for approval under that section or 
        misbranded under section 502 on the basis that the labeling of 
        the drug omits a pediatric indication or any other aspect of 
        labeling pertaining to pediatric use when the omitted 
        indication or other aspect is protected by patent or by 
        exclusivity under clause (iii) or (iv) of section 505(j)(5)(F).
            ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
        section 505(j)(5)(F), the Secretary may require that the 
        labeling of a drug approved under section 505(j) that omits a 
        pediatric indication or other aspect of labeling as described 
        in paragraph (1) include--
                    ``(A) a statement that, because of marketing 
                exclusivity for a manufacturer--
                            ``(i) the drug is not labeled for pediatric 
                        use; or
                            ``(ii) in the case of a drug for which 
                        there is an additional pediatric use not 
                        referred to in paragraph (1), the drug is not 
                        labeled for the pediatric use under paragraph 
                        (1); and
                    ``(B) a statement of any appropriate pediatric 
                contraindications, warnings, or precautions that the 
                Secretary considers necessary.
            ``(3) Preservation of pediatric exclusivity and other 
        provisions.--This subsection does not affect--
                    ``(A) the availability or scope of exclusivity 
                under this section;
                    ``(B) the availability or scope of exclusivity 
                under section 505 for pediatric formulations;
                    ``(C) the question of the eligibility for approval 
                of any application under section 505(j) that omits any 
                other conditions of approval entitled to exclusivity 
                under clause (iii) or (iv) of section 505(j)(5)(F); or
                    ``(D) except as expressly provided in paragraphs 
                (1) and (2), the operation of section 505.
    ``(p) Institute of Medicine Study.--Not later than 3 years after 
the date of the enactment of the Best Pharmaceuticals for Children Act 
of 2007, the Secretary 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 this 
section. The Institute of Medicine may devise an appropriate mechanism 
to review a representative sample of requests made and studies 
conducted pursuant to this 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);
            ``(2) review and assess such representative pediatric 
        studies conducted under subsections (b) and (c) since 1997 and 
        labeling changes made as a result of such studies;
            ``(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; and
            ``(4) make recommendations regarding appropriate incentives 
        for encouraging pediatric studies of biologics.
    ``(q) Sunset.--A drug may not receive any 6-month period under 
subsection (b) or (c) unless--
            ``(1) on or before October 1, 2012, the Secretary makes a 
        written request for pediatric studies of the drug;
            ``(2) on or before October 1, 2012, an application for the 
        drug is accepted for filing under section 505(b); and
            ``(3) all requirements of this section are met.''.
            (2) Effective date.--The amendment made by this subsection 
        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 the enactment of this Act.
    (b) Program for Pediatric Studies of Drugs.--Section 409I of the 
Public Health Service Act (42 U.S.C. 284m) is amended to read as 
follows:

``SEC. 409I. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

    ``(a) List of Priority Issues in Pediatric Therapeutics.--
            ``(1) In general.--Not later than one year after the date 
        of the enactment of the Best Pharmaceuticals for Children Act 
        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 three 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.
    ``(c) Process for Proposed Pediatric Study Requests and Labeling 
Changes.--
            ``(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 such section; and
                    ``(B) there is no patent protection or market 
                exclusivity protection for at least one 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.
            ``(2) Written request to holders of approved applications 
        for drugs lacking exclusivity.--The Commissioner of Food and 
        Drugs, in consultation with the Director of the National 
        Institutes of Health, may issue a written request based on the 
        proposed pediatric study request for the indication or 
        indications submitted pursuant to paragraph (1) (which shall 
        include a timeframe for negotiations for an agreement) for 
        pediatric studies concerning a drug identified under subsection 
        (a) to all holders of an approved application for the drug 
        under section 505 of the Federal Food, Drug, and Cosmetic Act. 
        Such a written request shall be made in a manner equivalent to 
        the manner in which a written request is made under subsection 
        (b) or (c) of section 505A of such Act, including with respect 
        to information provided on the pediatric studies to be 
        conducted pursuant to the request and using appropriate 
        formulations for each age group for which the study is 
        requested.
            ``(3) Requests for proposals.--If the Commissioner of Food 
        and Drugs does not receive a response to a written request 
        issued under paragraph (2) not later than 30 days after the 
        date on which a request was issued, the Secretary, acting 
        through the Director of the National Institutes of Health and 
        in consultation with the Commissioner of Food and Drugs, shall 
        publish a request for proposals to conduct the pediatric 
        studies described in the written request in accordance with 
        subsection (b).
            ``(4) Disqualification.--A holder that receives a first 
        right of refusal shall not be entitled to respond to a request 
        for proposals under paragraph (3).
            ``(5) Contracts, grants, or other funding mechanisms.--A 
        contract, grant, or other funding may be awarded under this 
        section only if a proposal is submitted to the Secretary in 
        such form and manner, and containing such agreements, 
        assurances, and information as the Secretary determines to be 
        necessary to carry out this section.
            ``(6) Reporting of studies.--
                    ``(A) In general.--On completion of a pediatric 
                study in accordance with an award under this section, a 
                report concerning the study shall be submitted to the 
                Director of the National Institutes of Health and the 
                Commissioner of Food and Drugs. The report shall 
                include all data generated in connection with the 
                study, including a written request if issued.
                    ``(B) Availability of reports.--Each report 
                submitted under subparagraph (A) shall be considered to 
                be in the public domain (subject to section 505A(d)(4) 
                of the Federal Food, Drug, and Cosmetic Act) and shall 
                be assigned a docket number by the Commissioner of Food 
                and Drugs. An interested person may submit written 
                comments concerning such pediatric studies to the 
                Commissioner of Food and Drugs, and the written 
                comments shall become part of the docket file with 
                respect to each of the drugs.
                    ``(C) Action by commissioner.--The Commissioner of 
                Food and Drugs shall take appropriate action in 
                response to the reports submitted under subparagraph 
                (A) in accordance with paragraph (7).
            ``(7) Requests for labeling change.--During the 180-day 
        period after the date on which a report is submitted under 
        paragraph (6)(A), the Commissioner of Food and Drugs shall--
                    ``(A) review the report and such other data as are 
                available concerning the safe and effective use in the 
                pediatric population of the drug studied;
                    ``(B) negotiate with the holders of approved 
                applications for the drug studied for any labeling 
                changes that the Commissioner of Food and Drugs 
                determines to be appropriate and requests the holders 
                to make; and
                    ``(C)(i) place in the public docket file a copy of 
                the report and of any requested labeling changes; and
                    ``(ii) publish in the Federal Register and through 
                a posting on the website of the Food and Drug 
                Administration a summary of the report and a copy of 
                any requested labeling changes.
            ``(8) Dispute resolution.--
                    ``(A) Referral to pediatric advisory committee.--
                If, not later than the end of the 180-day period 
                specified in paragraph (7), the holder of an approved 
                application for the drug involved does not agree to any 
                labeling change requested by the Commissioner of Food 
                and Drugs under that paragraph, the Commissioner of 
                Food and Drugs shall refer the request to the Pediatric 
                Advisory Committee.
                    ``(B) Action by the pediatric advisory committee.--
                Not later than 90 days after receiving a referral under 
                subparagraph (A), the Pediatric Advisory Committee 
                shall--
                            ``(i) review the available information on 
                        the safe and effective use of the drug in the 
                        pediatric population, including study reports 
                        submitted under this section; and
                            ``(ii) make a recommendation to the 
                        Commissioner of Food and Drugs as to 
                        appropriate labeling changes, if any.
            ``(9) FDA determination.--Not later than 30 days after 
        receiving a recommendation from the Pediatric Advisory 
        Committee under paragraph (8)(B)(ii) with respect to a drug, 
        the Commissioner of Food and Drugs shall consider the 
        recommendation and, if appropriate, make a request to the 
        holders of approved applications for the drug to make any 
        labeling change that the Commissioner of Food and Drugs 
        determines to be appropriate.
            ``(10) Failure to agree.--If a holder of an approved 
        application for a drug, within 30 days after receiving a 
        request to make a labeling change under paragraph (9), does not 
        agree to make a requested labeling change, the Commissioner of 
        Food and Drugs may deem the drug to be misbranded under the 
        Federal Food, Drug, and Cosmetic Act.
            ``(11) No effect on authority.--Nothing in this subsection 
        limits the authority of the United States to bring an 
        enforcement action under the Federal Food, Drug, and Cosmetic 
        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.
    ``(d) Dissemination of Pediatric Information.--Not later than one 
year after the date of the enactment of the Best Pharmaceuticals for 
Children Act 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 
                four succeeding fiscal years.
            ``(2) Availability.--Any amount appropriated under 
        paragraph (1) shall remain available to carry out this section 
        until expended.''.
    (c) Fees Relating to Drugs.--Section 735(6) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 379(6)) is amended by adding at the 
end the following new subparagraph:
                    ``(G) Activities relating to the support of studies 
                of drugs on pediatric populations under section 
                505A(n)(1).''.
    (d) 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 this 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))''.
    (e) 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 new subsection:
    ``(d) Continuation of Operation of Committee.--Notwithstanding 
section 14 of the Federal Advisory Committee Act, the advisory 
committee shall continue to operate during the five-year period 
beginning on the date of the enactment of the Best Pharmaceuticals for 
Children Act of 2007.''.
    (f) 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 
                        new subparagraph:
                    ``(D) provide recommendations to the internal 
                review committee created under section 505A(f) of the 
                Federal Food, Drug, and Cosmetic Act regarding the 
                implementation of amendments to sections 505A and 505B 
                of the Federal Food, Drug, and Cosmetic Act with 
                respect to the treatment of pediatric cancers.''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(3) Continuation of operation of subcommittee.--
        Notwithstanding section 14 of the Federal Advisory Committee 
        Act, the Subcommittee shall continue to operate during the 
        five-year period beginning on the date of the enactment of the 
        Best Pharmaceuticals for Children Act of 2007.''; and
            (2) in subsection (d), by striking ``2003'' and inserting 
        ``2009''.
    (g) Effective Date and Limitation for Rule Relating to Toll-Free 
Number for Adverse Events on Labeling for Human Drug Products.--
            (1) 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.
            (2) 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--
                    (A) for which an application is approved under 
                section 505 of the Federal Food, Drug, and Cosmetic Act 
                (21 U.S.C. 355);
                    (B) that is not described under section 503(b)(1) 
                of such Act (21 U.S.C. 353(b)(1)); and
                    (C) the packaging of which includes a toll-free 
                number through which consumers can report complaints to 
                the manufacturer or distributor of the drug.

                   TITLE VI--REAGAN-UDALL FOUNDATION

SEC. 601. 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, 
        and including the incorporation of more sensitive and 
        predictive tools and devices to measure safety;
            ``(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 this Act, 
                        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 of the Federal Food, 
Drug, and Cosmetic Act (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 
this subchapter.''.
    (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. 602. 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.''.

SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    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. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

    ``(a) Establishment.--The Secretary, acting through the 
Commissioner of Food and Drugs, shall enter into collaborative 
agreements, to be known as Critical Path Public-Private Partnerships, 
with one or more eligible entities to implement the Critical Path 
Initiative of the Food and Drug Administration by developing 
innovative, collaborative projects in research, education, and outreach 
for the purpose of fostering medical product innovation, enabling the 
acceleration of medical product development, and enhancing medical 
product safety.
    ``(b) Eligible Entity.--In this section, the term `eligible entity' 
means an entity that meets each of the following:
            ``(1) The entity is--
                    ``(A) an institution of higher education (as such 
                term is defined in section 101 of the Higher Education 
                Act of 1965); or
                    ``(B) an organization described in section 
                501(c)(3) of the Internal Revenue Code of 1986 and 
                exempt from tax under section 501(a) of such Code.
            ``(2) The entity has experienced personnel and clinical and 
        other technical expertise in the biomedical sciences.
            ``(3) The entity demonstrates to the Secretary's 
        satisfaction that the entity is capable of--
                    ``(A) developing and critically evaluating tools, 
                methods, and processes--
                            ``(i) to increase efficiency, 
                        predictability, and productivity of medical 
                        product development; and
                            ``(ii) to more accurately identify the 
                        benefits and risks of new and existing medical 
                        products;
                    ``(B) establishing partnerships, consortia, and 
                collaborations with health care practitioners and other 
                providers of health care goods or services; 
                pharmacists; pharmacy benefit managers and purchasers; 
                health maintenance organizations and other managed 
                health care organizations; health care insurers; 
                government agencies; patients and consumers; 
                manufacturers of prescription drugs, biological 
                products, diagnostic technologies, and devices; and 
                academic scientists; and
                    ``(C) securing funding for the projects of a 
                Critical Path Public-Private Partnership from Federal 
                and nonfederal governmental sources, foundations, and 
                private individuals.
    ``(c) Funding.--The Secretary may not enter into a collaborative 
agreement under subsection (a) unless the eligible entity involved 
provides an assurance that the entity will not accept funding for a 
Critical Path Public-Private Partnership project from any organization 
that manufactures or distributes products regulated by the Food and 
Drug Administration unless--
            ``(1) the entity accepts such funding for such project from 
        2 or more such organizations; and
            ``(2) the entity provides assurances in its agreement with 
        the Food and Drug Administration that the results of the 
        Critical Path Public-Private Partnership project will not be 
        influenced by any source of funding.
    ``(d) Annual Report.--Not later than 18 months after the date of 
the enactment of this section, and annually thereafter, the Secretary, 
in collaboration with the parties to each Critical Path Public-Private 
Partnership, 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--
            ``(1) reviewing the operations and activities of the 
        Partnerships in the previous year; and
            ``(2) addressing such other issues relating to this section 
        as the Secretary determines to be appropriate.
    ``(e) Definition.--In this section, the term `medical product' 
includes a drug, a biological product, a device, and any combination of 
such products.
    ``(f) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $5,000,000 for fiscal year 2008 
and such sums as may be necessary for each of fiscal years 2009 through 
2012.''.

                    TITLE VII--CONFLICTS OF INTEREST

SEC. 701. 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, through the Office of 
                Women's Health, the Office of Orphan Product 
                Development, the Office of Pediatric Therapeutics, and 
                other offices within the Food and Drug Administration 
                with relevant expertise, shall develop and implement 
                strategies on effective outreach to potential members 
                of advisory committees at universities, colleges, other 
                academic research centers, professional and medical 
                societies, and patient and consumer groups. 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 funding from the National 
                        Institutes of Health, the Agency for Healthcare 
                        Research and Quality, the Centers for Disease 
                        Control and Prevention, or the Veterans Health 
                        Administration 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.
            ``(3) Participation of guest expert with financial 
        interest.--Notwithstanding any other provision of this section, 
        an individual with a financial interest with respect to any 
        matter considered by an advisory committee may be allowed to 
        participate in a meeting of an advisory committee as a guest 
        expert if the Secretary determines that the individual has 
        particular expertise required for the meeting. An individual 
        participating as a guest expert may provide information and 
        expert opinion, but shall not participate in the discussion or 
        voting by the members of the advisory 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) Limitations.--
                    ``(A) One waiver per committee meeting.--
                Notwithstanding any other provision of this section, 
                with respect to each advisory committee, the Secretary 
                shall not grant more than 1 waiver under paragraph (3) 
                per committee meeting.
                    ``(B) Scientific work.--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 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--
            (1) by striking paragraph (4); and
            (2) by 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.

                  TITLE VIII--CLINICAL TRIAL DATABASES

SEC. 801. CLINICAL TRIAL REGISTRY DATABASE AND CLINICAL TRIAL RESULTS 
              DATABASE.

    (a) In General.--Title IV of the Public Health Service Act (42 
U.S.C. 281 et seq.) is amended--
            (1) in section 402, by striking subsection (i); and
            (2) by inserting after section 492B the following new 
        section:

``SEC. 492C. CLINICAL TRIAL REGISTRY DATABASE; CLINICAL TRIAL RESULTS 
              DATABASE.

    ``(a) Definitions.--In this section:
            ``(1) Applicable clinical trial.--The term `applicable 
        clinical trial'--
                    ``(A) means a clinical trial that is conducted to 
                test the safety or effectiveness (including comparative 
                effectiveness) of a drug or device (irrespective of 
                whether the clinical trial is federally or privately 
                funded, and whether the clinical trial involves an 
                approved or unapproved drug or device);
                    ``(B) includes such a clinical trial that is 
                conducted outside of the United States if--
                            ``(i) there is an application or premarket 
                        notification pending before the Food and Drug 
                        Administration for approval or clearance of the 
                        drug or device involved under section 505, 
                        510(k), or 515 of the Federal Food, Drug, and 
                        Cosmetic Act or section 351 of this Act; or
                            ``(ii) the drug or device involved is so 
                        approved or cleared; and
                    ``(C) notwithstanding subparagraphs (A) and (B), 
                excludes--
                            ``(i) a clinical trial to determine the 
                        safety of a use of a drug that is designed 
                        solely to detect major toxicities in the drug 
                        or to investigate pharmacokinetics, unless the 
                        clinical trial is designed to investigate 
                        pharmacokinetics in a special population or 
                        populations; and
                            ``(ii) a small clinical trial to determine 
                        the feasibility of a device, or a clinical 
                        trial to test prototype devices where the 
                        primary focus is feasibility.
            ``(2) Clinical trial information.--The term `clinical trial 
        information' means those data elements that are necessary to 
        complete an entry in the clinical trial registry database under 
        subsection (b) or the clinical trial results database under 
        subsection (c), as applicable.
            ``(3) Completion date.--The term `completion date' means 
        the date of the final collection of data from subjects in the 
        clinical trial for the primary and secondary outcomes to be 
        examined in the trial.
            ``(4) Device.--The term `device' has the meaning given to 
        that term in section 201(h) of the Federal Food, Drug, and 
        Cosmetic Act.
            ``(5) 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.
            ``(6) Responsible party.--The term `responsible party', 
        with respect to an applicable clinical trial, means--
                    ``(A) the primary sponsor (as defined in the 
                International Clinical Trials Registry Platform trial 
                registration data set of the World Health Organization) 
                of the clinical trial; or
                    ``(B) the principal investigator of such clinical 
                trial if so designated by such sponsor, so long as the 
                principal investigator is responsible for conducting 
                the trial, has access to and control over the data, has 
                the right to publish the results of the trial, and has 
                the responsibility to meet all of the requirements 
                under this section that are applicable to responsible 
                parties.
    ``(b) Clinical Trials Registry Database.--
            ``(1) Establishment.--To enhance patient enrollment and 
        provide a mechanism to track subsequent progress of clinical 
        trials, the Secretary, acting through the Director of NIH, 
        shall establish and administer a clinical trial registry 
        database in accordance with this section (referred to in this 
        section as the `registry database'). The Director of NIH shall 
        ensure that the registry database is made publicly available 
        through the Internet.
            ``(2) Content.--The Secretary shall promulgate regulations 
        for the submission to the registry database of clinical trial 
        information that--
                    ``(A) conforms to the International Clinical Trials 
                Registry Platform trial registration data set of the 
                World Health Organization;
                    ``(B) 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;
                    ``(C) includes a statement of the estimated 
                completion date for the clinical trial;
                    ``(D) includes the identity and contact information 
                of the responsible party;
                    ``(E) 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, or the device is not 
                cleared under section 510(k) or approved under section 
                515 of the Federal Food, Drug, and Cosmetic Act, 
                specifies whether or not there is expanded access to 
                the drug or device 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;
                    ``(F) includes, with respect to any individual who 
                is not an employee of the responsible party for the 
                clinical trial or of the manufacturer of the drug or 
                device involved, information on whether the responsible 
                party or manufacturer has entered into any agreement 
                with such individual that restricts in any manner the 
                ability of the individual--
                            ``(i) to discuss the results of the trial 
                        at a scientific meeting or any other public or 
                        private forum; or
                            ``(ii) to publish the results of the trial, 
                        or a description or discussion of the results 
                        of the trial, in a scientific or academic 
                        journal; and
                    ``(G) requires the inclusion of such other data 
                elements to the registry database as appropriate.
            ``(3) Format and structure.--
                    ``(A) Searchable categories.--The Director of NIH 
                shall ensure that the public may search the entries in 
                the registry database by 1 or more of the following 
                criteria:
                            ``(i) The indication being studied in the 
                        clinical trial, using Medical Subject Headers 
                        (MeSH) descriptors.
                            ``(ii) The safety issue being studied in 
                        the clinical trial.
                            ``(iii) The enrollment status of the 
                        clinical trial.
                            ``(iv) The sponsor of the clinical trial.
                    ``(B) Format.--The Director of the NIH shall ensure 
                that the registry database is easily used by patients, 
                and that entries are easily compared.
            ``(4) Data submission.--The responsible party for an 
        applicable clinical trial shall submit to the Director of NIH 
        for inclusion in the registry database the clinical trial 
        information described in paragraph (2).
            ``(5) Truthful clinical trial information.--
                    ``(A) In general.--The clinical trial information 
                submitted by a responsible party under this subsection 
                shall not be false or misleading.
                    ``(B) Effect.--Subparagraph (A) shall not have the 
                effect of requiring clinical trial information to 
                include information from any source other than the 
                clinical trial involved.
            ``(6) Timing of submission.--Except as provided in 
        paragraph (7), the clinical trial information for a clinical 
        trial required to be submitted under this subsection shall be 
        submitted not later than 14 days after the first patient is 
        enrolled in such clinical trial.
            ``(7) Updates.--The responsible party for an applicable 
        clinical trial shall submit to the Director of NIH for 
        inclusion in the registry database periodic updates to reflect 
        changes to the clinical trial information submitted under this 
        subsection. Such updates--
                    ``(A) shall be provided not less than once every 6 
                months until information on the results of the trial is 
                submitted under subsection (c);
                    ``(B) shall include identification of the dates of 
                any such changes;
                    ``(C) not later than 30 days after the enrollment 
                status of such clinical trial changes, shall include an 
                update of the enrollment status; and
                    ``(D) not later than 30 days after the completion 
                date of the clinical trial, shall include a report to 
                the Director that such clinical trial is complete.
            ``(8) Applicability of device trials.--In the case of an 
        applicable clinical trial regarding a device, the responsible 
        person for the trial shall submit to the Director of NIH the 
        clinical trial information as required in paragraph (4), but 
        the Director may not make the information publicly available 
        through the registry database until the device is approved or 
        cleared (as the case may be).
    ``(c) Clinical Trials Results Database.--
            ``(1) Establishment.--To ensure that results of clinical 
        trials are made public and that patients and providers have 
        current information regarding the results of clinical trials, 
        the Secretary, acting through the Director of NIH, shall 
        establish and administer a clinical trial results database in 
        accordance with this section (referred to in this section as 
        the `results database'). The Director of NIH shall ensure that 
        the results database is made publicly available through the 
        Internet.
            ``(2) Searchable categories.--The Director of NIH shall 
        ensure that the public may search the entries in the results 
        database by 1 or more of the following:
                    ``(A) The indication studied in the clinical trial, 
                using Medical Subject Headers (MeSH) descriptors.
                    ``(B) The safety issue studied in the clinical 
                trial.
                    ``(C) Whether an application for the tested 
                indication is approved, pending approval, withdrawn, or 
                not submitted.
                    ``(D) The phase of the clinical trial.
                    ``(E) The name of the drug or device that is the 
                subject of the clinical trial.
                    ``(F) Within the documents described in clauses (i) 
                and (ii) of paragraph (3)(B), the following 
                information, as applicable:
                            ``(i) The sponsor of the clinical trial.
                            ``(ii) Each financial sponsor of the 
                        clinical trial.
            ``(3) Contents.--
                    ``(A) In general.--The responsible party for an 
                applicable clinical trial shall submit to the Director 
                of NIH for inclusion in the results database the 
                clinical trial information described in subparagraph 
                (B).
                    ``(B) Required elements.--In submitting clinical 
                trial information for a clinical trial to the Director 
                of NIH for inclusion in the results database, the 
                responsible party shall include, with respect to such 
                clinical trial, the following information:
                            ``(i) The information described in 
                        subparagraphs (A) through (E) of subsection 
                        (b)(2).
                            ``(ii) A summary that is written in non-
                        technical, understandable language for patients 
                        that includes the following:
                                    ``(I) The purpose of the clinical 
                                trial.
                                    ``(II) The sponsor of the clinical 
                                trial.
                                    ``(III) A point of contact for 
                                information about the clinical trial.
                                    ``(IV) A description of the patient 
                                population tested in the clinical 
                                trial.
                                    ``(V) A general description of the 
                                clinical trial and results, including a 
                                description of and the reasons for any 
                                changes in the clinical trial design 
                                that occurred since the date of 
                                submission of clinical trial 
                                information for inclusion in the 
                                registry database established under 
                                subsection (b) and a description of any 
                                significant safety information.
                            ``(iii) A summary that is technical in 
                        nature that includes the following:
                                    ``(I) The purpose of the clinical 
                                trial.
                                    ``(II) The sponsor of the clinical 
                                trial.
                                    ``(III) Each financial sponsor of 
                                the clinical trial.
                                    ``(IV) A point of contact for 
                                scientific information about the 
                                clinical trial.
                                    ``(V) A description of the patient 
                                population tested in the clinical 
                                trial.
                                    ``(VI) A general description of the 
                                clinical trial and results, including a 
                                description of and the reasons for any 
                                changes in the clinical trial design 
                                that occurred since the date of 
                                submission of clinical trial 
                                information for the clinical trial in 
                                the registry database established under 
                                subsection (b).
                                    ``(VII) Summary data describing the 
                                results, including--
                                            ``(aa) whether the primary 
                                        endpoint was achieved, 
                                        including relevant statistics;
                                            ``(bb) an assessment of any 
                                        secondary endpoints, if 
                                        applicable, including relevant 
                                        statistics; and
                                            ``(cc) any significant 
                                        safety information, including a 
                                        summary of the incidence of 
                                        serious adverse events observed 
                                        in the clinical trial and a 
                                        summary of the most common 
                                        adverse events observed in the 
                                        clinical trial and the 
                                        frequencies of such events.
                            ``(iv) With respect to the group of 
                        subjects receiving the drug or device involved, 
                        and each comparison group of subjects, the 
                        percentage of individuals who ceased 
                        participation as subjects and the reasons for 
                        ceasing participation.
                            ``(v) With respect to an individual who is 
                        not an employee of the responsible party for 
                        the clinical trial or of the manufacturer of 
                        the drug or device involved, information (to 
                        the extent not submitted under subsection 
                        (b)(2)(F)) on any agreement that the 
                        responsible party or manufacturer has entered 
                        into with such individual that restricts in any 
                        manner the ability of the individual--
                                    ``(I) to discuss the results of the 
                                trial at a scientific meeting or any 
                                other public or private forum; or
                                    ``(II) to publish the results of 
                                the trial, or a description or 
                                discussion of the results of the trial, 
                                in a scientific or academic journal.
                            ``(vi) The completion date of the clinical 
                        trial.
                            ``(vii) A link to the Internet web posting 
                        of any adverse regulatory actions taken by the 
                        Food and Drug Administration, such as a warning 
                        letter, that was substantively based on the 
                        clinical trial design, outcome, or 
                        representation made by the applicant about the 
                        design or outcome of the clinical trial.
                    ``(C) Links in database.--The Director of NIH shall 
                ensure that the results database includes the 
                following:
                            ``(i) Links to Medline citations to 
                        publications reporting results from each 
                        applicable drug clinical trial and applicable 
                        device clinical trial.
                            ``(ii) Links to the entry for the product 
                        that is the subject of an applicable drug 
                        clinical trial in the National Library of 
                        Medicine database of structured product labels, 
                        if available.
                            ``(iii) Links described in clauses (i) and 
                        (ii) for data bank entries for clinical trials 
                        submitted to the data bank prior to enactment 
                        of this section, as available.
            ``(4) Timing.--
                    ``(A) In general.--Except as provided in 
                subparagraphs (B) and (C), a responsible party shall 
                submit to the Director of NIH for inclusion in the 
                results database clinical trial information for an 
                applicable clinical trial not later than 1 year after 
                the earlier of--
                            ``(i) the estimated completion date of the 
                        trial, as submitted under subsection (b)(2); or
                            ``(ii) the actual date of the completion, 
                        or termination before completion, of the trial, 
                        as applicable.
                    ``(B) Extensions.--The Director of NIH may provide 
                an extension of the deadline for submission of clinical 
                trial information under subparagraph (A) if the 
                responsible party for the trial submits to the Director 
                a written request that demonstrates good cause for the 
                extension and provides an estimate of the date on which 
                the information will be submitted. The Director of NIH 
                may grant more than one such extension for the clinical 
                trial involved.
                    ``(C) Updates.--The responsible party for an 
                applicable clinical trial shall submit to the Director 
                of NIH for inclusion in the results database periodic 
                updates to reflect changes in the clinical trial 
                information submitted under this subsection. Such 
                updates--
                            ``(i) shall be provided not less frequently 
                        than once every 6 months during the 10-year 
                        period beginning on the date on which 
                        information is due under subparagraph (A);
                            ``(ii) shall identify the dates on which 
                        the changes were made; and
                            ``(iii) shall include, not later than 30 
                        days after any change in the regulatory status 
                        of the drug or device involved, an update 
                        informing the Director of NIH of such change.
            ``(5) Truthful clinical trial information.--
                    ``(A) In general.--The clinical trial information 
                submitted by a responsible party under this subsection 
                shall not be false or misleading in any particular.
                    ``(B) Effect.--Subparagraph (A) shall not have the 
                effect of requiring clinical trial information with 
                respect to a clinical trial to include information from 
                any source other than such clinical trial.
            ``(6) Public availability of results.--
                    ``(A) Pre-approval studies.--Except as provided in 
                subparagraph (E), with respect to an applicable 
                clinical trial that is completed before the drug is 
                initially approved under section 505 of the Federal 
                Food, Drug, and Cosmetic Act or initially licensed 
                under section 351 of this Act, or the device is 
                initially cleared under section 510(k) or approved 
                under section 515 of the Federal Food, Drug, and 
                Cosmetic Act, the Director of NIH shall make publicly 
                available on the results database the clinical trial 
                information submitted for such clinical trial not later 
                than 30 days after--
                            ``(i) the drug or device is approved under 
                        such section 505, licensed under such section 
                        351, cleared under such section 510(k), or 
                        approved under such section 515, as applicable; 
                        or
                            ``(ii) the Secretary issues a not 
                        approvable letter or a not substantially 
                        equivalent letter for the drug or device under 
                        such section 505, 351, 510(k), or 515, as 
                        applicable.
                    ``(B) Medical and clinical pharmacology reviews of 
                pre-approval studies.--Not later than 90 days after the 
                date applicable under clause (i) or (ii) of 
                subparagraph (A) with respect to an applicable clinical 
                trial, the Director of NIH shall make publicly 
                available on the results database a summary of the 
                available medical and clinical pharmacology reviews 
                conducted by the Food and Drug Administration for such 
                trial.
                    ``(C) Post-approval studies.--Except as provided in 
                subparagraphs (D) and (E), with respect to an 
                applicable clinical trial that is completed after the 
                drug is initially approved under such section 505 or 
                licensed under such section 351, or the device is 
                initially cleared under such section 510(k) or approved 
                under such section 515, the Director of NIH shall make 
                publicly available on the results database the clinical 
                trial information submitted for such clinical trial not 
                later than 30 days after the date of such submission.
                    ``(D) Seeking approval of a new use for the drug or 
                device.--
                            ``(i) In general.--If the manufacturer of 
                        the drug or device is the sponsor or a 
                        financial sponsor of an applicable clinical 
                        trial, and such manufacturer certifies to the 
                        Director of NIH that such manufacturer has 
                        filed, or will file within 1 year, an 
                        application seeking approval under such section 
                        505, licensing under such section 351, 
                        clearance under such section 510(k), or 
                        approval under such section 515 for the use 
                        studied in such clinical trial (which use is 
                        not included in the labeling of the approved 
                        drug or device), then the Director of NIH shall 
                        make publicly available on the results database 
                        the clinical trial information submitted for 
                        such clinical trial on the earlier of the date 
                        that is 30 days after the date--
                                    ``(I) the new use of the drug or 
                                device is approved under such section 
                                505, licensed under such section 351, 
                                cleared under such section 510(k), or 
                                approved under such section 515;
                                    ``(II) the Secretary issues a not 
                                approvable letter or a not 
                                substantially equivalent letter for the 
                                new use of the drug or device under 
                                such section 505, 351, 510(k), or 515; 
                                or
                                    ``(III) the application or 
                                premarket notification under such 
                                section 505, 351, 510(k), or 515 is 
                                withdrawn.
                            ``(ii) Limitation on certification.--If a 
                        manufacturer makes a certification under clause 
                        (i) with respect to a clinical trial, the 
                        manufacturer shall make such a certification 
                        with respect to each applicable clinical trial 
                        that is required to be submitted in an 
                        application for approval of the use studied in 
                        the clinical trial.
                            ``(iii) 2-year limitation.--The clinical 
                        trial information subject to clause (i) shall 
                        be made publicly available on the results 
                        database on the date that is 2 years after the 
                        date the certification referred to in clause 
                        (i) was made to the Director of NIH, if a 
                        regulatory action referred to in subclause (I), 
                        (II), or (III) of clause (i) has not occurred 
                        by such date.
                            ``(iv) Medical and clinical pharmacology 
                        reviews.--Not later than 90 days after the date 
                        applicable under subclause (I), (II), or (III) 
                        of clause (i) or clause (iii) with respect to 
                        an applicable clinical trial, the Director of 
                        NIH shall make publicly available on the 
                        results database a summary of the available 
                        medical and clinical pharmacology reviews 
                        conducted by the Food and Drug Administration 
                        for such trial.
                    ``(E) Seeking publication.--
                            ``(i) In general.--If the principal 
                        investigator of an applicable clinical trial is 
                        seeking publication in a peer-reviewed 
                        biomedical journal of a manuscript based on the 
                        results of the clinical trial and the 
                        responsible party so certifies to the Director 
                        of NIH--
                                    ``(I) the responsible party shall 
                                notify the Director of NIH of the 
                                publication date of such manuscript not 
                                later than 15 days after such date; and
                                    ``(II) the Director of NIH shall 
                                make publicly available on the results 
                                database the clinical trial information 
                                submitted for such clinical trial on 
                                the date that is 30 days after the 
                                publication date of such manuscript.
                            ``(ii) Limitations.--The clinical trial 
                        information subject to clause (i)--
                                    ``(I) shall be made publicly 
                                available on the results database on 
                                the date that is 2 years after the date 
                                that the clinical trial information was 
                                required to be submitted to the 
                                Director of NIH if the manuscript 
                                referred to in such clause has not been 
                                published by such date; and
                                    ``(II) shall not be required to be 
                                made publicly available under section 
                                552 of title 5, United States Code 
                                (commonly known as the `Freedom of 
                                Information Act'), prior to the date 
                                applicable to such clinical trial 
                                information under this subparagraph.
            ``(7) Verification of submission prior to public 
        availability.--In the case of clinical trial information that 
        is submitted under this subsection, but is not made publicly 
        available pending either regulatory action or publication under 
        subparagraph (D) or (E) of paragraph (6), as applicable, the 
        Director of NIH shall respond to inquiries from other Federal 
        agencies and peer-reviewed journals to confirm that such 
        clinical trial information has been submitted but has not yet 
        been made publicly available on the results database.
    ``(d) Updates; Tracking of Changes in Submitted Information.--The 
Director of NIH shall ensure that updates submitted to the Director 
under subsections (b)(7) and (c)(4) do not result in the removal from 
the registry database or the results database of the original 
submissions or of any preceding updates, and that information in such 
databases is presented in a manner that enables users to readily access 
each original submission and to track the changes made by the updates.
    ``(e) Coordination and Compliance.--
            ``(1) Consultation with other federal agencies.--The 
        Secretary shall--
                    ``(A) consult with other agencies that conduct 
                human studies in accordance with part 46 of title 45, 
                Code of Federal Regulations (or any successor 
                regulations), to determine if any such studies are 
                applicable clinical trials; and
                    ``(B) develop with such agencies appropriate 
                procedures to ensure that clinical trial information 
                for such applicable clinical trials is submitted under 
                subsection (b) and (c).
            ``(2) Coordination of registry database and results 
        database.--
                    ``(A) In general.--Each entry in the registry 
                database under subsection (b) or the results database 
                under subsection (c) shall include a link to the 
                corresponding entry in the results database or the 
                registry database, respectively.
                    ``(B) Missing entries.--
                            ``(i) In general.--If, based on a review of 
                        the entries in the registry database under 
                        subsection (b), the Director of NIH determines 
                        that a responsible party has failed to submit 
                        required clinical trial information to the 
                        results database under subsection (c), the 
                        Director of NIH shall inform the responsible 
                        party involved of such failure and permit the 
                        responsible party to correct the failure within 
                        30 days.
                            ``(ii) Failure to correct.--If the 
                        responsible party does not correct a failure to 
                        submit required clinical trial information 
                        within the 30-day period described under clause 
                        (i), the Director of NIH shall report such 
                        noncompliance to the scientific peer review 
                        committees of the Federal research agencies and 
                        to the Office of Human Research Protections.
                            ``(iii) Public notice of failure to 
                        correct.--The Director of NIH shall include in 
                        the clinical trial registry database entry and 
                        the clinical trial results database entry for 
                        each applicable clinical trial a notice of any 
                        uncorrected failure to submit required clinical 
                        trial information and shall provide that the 
                        public may easily search for such entries.
            ``(3) Action on applications.--
                    ``(A) Verification prior to filing.--The Secretary, 
                acting through the Commissioner of Food and Drugs, 
                shall verify that the clinical trial information 
                required under subsections (b) and (c) for an 
                applicable clinical trial is submitted pursuant to such 
                subsections, as applicable--
                            ``(i) when considering a drug or device for 
                        an exemption under section 505(i) or section 
                        520(g) of the Federal Food, Drug, and Cosmetic 
                        Act; and
                            ``(ii) prior to filing an application or 
                        premarket notification under section 505, 
                        510(k), or 515 of the Federal Food, Drug, and 
                        Cosmetic Act or section 351 of this Act, that 
                        includes information from such clinical trial.
                    ``(B) Notification.--If the Secretary determines 
                under subparagraph (A) that clinical trial information 
                has not been submitted as required by subsection (b) or 
                (c), the Secretary shall notify the applicant and the 
                responsible party of such noncompliance and require 
                submission of such information within 30 days.
                    ``(C) Refusal to file.--If the responsible party 
                does not remedy such noncompliance within 30 days of 
                receipt of notification under subparagraph (B), the 
                Secretary shall refuse to file, approve, or clear such 
                application or premarket notification.
            ``(4) Content review.--
                    ``(A) In general.--To ensure that the summary 
                documents described in subsection (c)(3) are non-
                promotional, and are not false or misleading in any 
                particular under subsection (c)(5), the Secretary shall 
                compare such documents to the results data of the 
                clinical trial for a representative sample of 
                applicable clinical trials by--
                            ``(i) acting through the Commissioner of 
                        Food and Drugs to examine the results data for 
                        such clinical trials submitted to Secretary 
                        when such data are submitted--
                                    ``(I) for review as part of an 
                                application under section 505 or 515 of 
                                the Federal Food, Drug, and Cosmetic 
                                Act or under section 351 of this Act or 
                                a premarket notification under section 
                                510(k) of the Federal Food, Drug, and 
                                Cosmetic Act; or
                                    ``(II) in an annual status report 
                                on the drug or device under such 
                                application;
                            ``(ii) acting with the Federal agency that 
                        funds such clinical trial in whole or in part 
                        by a grant to examine the results data for such 
                        clinical trials; and
                            ``(iii) acting through inspections under 
                        section 704 of the Federal Food, Drug, and 
                        Cosmetic Act to examine results data for such 
                        clinical trials not described in clause (i) or 
                        (ii).
                    ``(B) Notice of noncompliance.--If the Secretary 
                determines that the clinical trial information 
                submitted in such a summary document is false or 
                misleading in any particular, the Secretary shall 
                notify the responsible party and give such party an 
                opportunity to remedy such noncompliance by submitting 
                the required revised clinical trial information within 
                30 days of such notification.
    ``(f) Penalties for Noncompliance.--
            ``(1) In general.--The following acts and the causing 
        thereof are unlawful:
                    ``(A) The failure to submit clinical trial 
                information as required by this section.
                    ``(B) The submission of clinical trial information 
                under this section that is false or misleading in any 
                particular in violation of subsection (b)(5) or (c)(5).
            ``(2) Certain penalties.--Section 303(a) of the Federal 
        Food, Drug, and Cosmetic Act applies with respect to a 
        violation of paragraph (1) to the same extent and in the same 
        manner as such section 303(a) applies with respect to a 
        violation of section 301 of such Act.
            ``(3) Considerations.--In determining whether to apply a 
        penalty under paragraph (2) or under paragraph (4) for a 
        violation described in paragraph (1), the Secretary, acting 
        through the Commissioner of Food and Drugs, shall consider--
                    ``(A) whether the responsible party promptly 
                corrects the noncompliance when provided notice;
                    ``(B) whether the responsible party has engaged in 
                a pattern or practice of noncompliance; and
                    ``(C) the extent to which the noncompliance 
                involved may have significantly misled health care 
                providers or patients concerning the safety or 
                effectiveness of the drug involved.
            ``(4) Civil penalties.--
                    ``(A) In general.--A person is subject to a civil 
                penalty in accordance with this paragraph if the person 
                commits a violation described in paragraph (1) and 
                fails to correct the violation by the end of the 30-day 
                period described in subparagraph (B).
                    ``(B) Notification.--If a person is in violation of 
                paragraph (1), the Secretary shall notify the person of 
                such noncompliance and give the person a 30-day period 
                to correct such violation before imposing a civil 
                penalty under this paragraph.
                    ``(C) Amount of penalty.--The amount of a civil 
                penalty under this subsection shall be not more than a 
                total of $15,000 for all violations adjudicated in a 
                single proceeding in the case of an individual, and not 
                more than $10,000 per day until the violation is 
                corrected in the case of any other person, except that 
                if the person is a nonprofit entity the penalty may not 
                exceed a total of $15,000 for all violations 
                adjudicated in a single proceeding.
                    ``(D) Procedures.--The provisions of paragraphs (4) 
                through (6) of section 303(f) of the Federal Food, 
                Drug, and Cosmetic Act apply to the imposition of a 
                penalty under this subsection to the same extent and in 
                the same manner as such provisions apply to a penalty 
                imposed under such section 303(f).
    ``(g) Authorization of Appropriations.--There are authorized to be 
appropriated to carry out this section $10,000,000 for each fiscal 
year.''.
    (b) Conforming Amendments.--
            (1) Investigational new drugs.--Section 505(i) of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
        amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (C), by striking 
                        ``and'' after the semicolon;
                            (ii) in subparagraph (D)--
                                    (I) by aligning the indentation of 
                                such subparagraph with the indentation 
                                of subparagraphs (A), (B), and (C); and
                                    (II) by striking the period at the 
                                end and inserting ``; and''; and
                            (iii) by adding at the end the following:
            ``(E) the submission to the Director of NIH of clinical 
        trial information for the clinical investigation at issue 
        required under section 492C of the Public Health Service Act 
        for inclusion in the registry database and the results database 
        described in such section.'';
                    (B) in paragraph (3)(B)--
                            (i) in clause (i), by striking ``or'' after 
                        the semicolon;
                            (ii) in clause (ii), by striking the period 
                        at the end and inserting ``; or''; and
                            (iii) by adding at the end the following:
            ``(iii) clinical trial information for the clinical 
        investigation at issue was not submitted in compliance with 
        section 492C of the Public Health Service Act.''; and
                    (C) 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 will be 
                submitted for inclusion in the registry database and 
                results database, as applicable, described in section 
                492C of the Public Health Service Act.''.
            (2) Refusal to approve new drug application.--Section 
        505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(d)) is amended--
                    (A) in the first sentence, by inserting after ``in 
                any particular;'' the following: ``or (8) the applicant 
                failed to submit the clinical trial information for any 
                applicable clinical trial as required by section 492C 
                of the Public Health Service Act;''; and
                    (B) in the second sentence, by striking ``clauses 
                (1) through (6)'' and inserting ``paragraphs (1) 
                through (8)''.
            (3) Investigational new devices.--Subparagraph (B) of 
        section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 360j(g)(2)) is amended--
                    (A) by redesignating clause (iii) as clause (iv); 
                and
                    (B) by inserting after clause (ii) the following:
            ``(iii) A requirement that the person applying for an 
        exemption for a device assure that such person is in compliance 
        with the requirements of section 492C of the Public Health 
        Service Act for the submission of clinical trial information 
        for inclusion in the registry database and the results database 
        described in such section.''.
            (4) Refusal to clear new device premarket notification 
        report.--Subsection (k) of section 510 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
                    (A) in paragraph (1), by striking ``and'' at the 
                end; and
                    (B) in paragraph (2), by striking the period at the 
                end and inserting ``, and''; and
                    (C) by adding at the end the following:
            ``(3) action taken by such person to comply with 
        requirements under section 492C of the Public Health Service 
        Act for the submission of clinical trial information for 
        inclusion in the registry database and the results database 
        described in such section.''.
            (5) Refusal to approve new device application.--Paragraph 
        (2) of section 515(d) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360e(d)) is amended--
                    (A) in subparagraph (D), by striking ``or'' at the 
                end;
                    (B) in subparagraph (E), by striking the period at 
                the end and inserting ``; or''; and
                    (C) by inserting after subparagraph (E) the 
                following:
            ``(F) the applicant is in violation of the requirements 
        under section 492C of the Public Health Service Act for the 
        submission of clinical trial information for inclusion in the 
        registry database or the results database described in such 
        section.''.
    (c) Guidance.--Not later than 180 days after the date of the 
enactment of this Act, the Commissioner of Food and Drugs, in 
consultation with the Director of the National Institutes of Health, 
shall issue guidance to clarify which clinical trials are applicable 
clinical trials (as defined in section 492C of the Public Health 
Service Act, as amended by this section) and required to be submitted 
for inclusion in the clinical trial registry database described in such 
section.
    (d) 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 any requirement 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 
        section 492C 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 databases under subsections (b) 
        and (c) of such section 492C, if submitted in compliance with 
        such section 492C, 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.).
    (e) Effective Dates.--
            (1) Establishment of registry database and results 
        database.--Not later than 1 year after the date of the 
        enactment of this Act, the Director of NIH shall establish the 
        registry database and the results database of clinical trials 
        of drugs and devices in accordance with section 492C of the 
        Public Health Service Act (as amended by subsection (a)).
            (2) Clinical trials initiated prior to operation of 
        registry database.--The responsible party (as defined in such 
        section 492C) for an applicable clinical trial (as defined in 
        such section 492C) that is initiated after the date of the 
        enactment of this Act and before the date such registry 
        database is established under paragraph (1) of this subsection, 
        shall submit required clinical trial information not later than 
        120 days after the date such registry database is established.
            (3) Clinical trials initiated after operation of registry 
        database.--The responsible party (as defined in such section 
        492C) for an applicable clinical trial (as defined in such 
        section 492C) that is initiated after the date such registry 
        database is established under paragraph (1) of this subsection 
        shall submit required clinical trial information in accordance 
        with subsection (b) of such section 492C.
            (4) Trials completed before operation of results 
        database.--
                    (A) In general.--Subsection (c) of such section 
                492C shall take effect 90 days after the date the 
                results database is established under paragraph (1) of 
                this subsection with respect to any applicable clinical 
                trial (as defined in such section 492C) that--
                            (i) involves a drug to treat a serious or 
                        life-threatening condition; and
                            (ii) is completed between the date of the 
                        enactment of this Act and such date of 
                        establishment under paragraph (1) of this 
                        subsection.
                    (B) Other trials.--Except as provided in 
                subparagraph (A), subsection (c) of such section 492C 
                shall take effect 180 days after the date that the 
                results database is established under paragraph (1) of 
                this subsection with respect to any applicable clinical 
                trial that is completed between the date of the 
                enactment of this Act and such date of establishment 
                under paragraph (1).
            (5) Trials completed after establishment of results 
        database.--Subsection (c) of such section 492C shall apply to 
        any clinical trial that is completed after the date that the 
        results database is established under paragraph (1) of this 
        subsection.
            (6) Retroactivity of database.--
                    (A) Voluntary submissions.--The Secretary of Health 
                and Human Services (referred to in this paragraph as 
                the ``Secretary'') shall establish procedures and 
                mechanisms to allow for the voluntary submission to the 
                Secretary--
                            (i) of clinical trial information for 
                        inclusion in the registry database (as defined 
                        in such section 492C) on applicable clinical 
                        trials (as defined in such section 492C) 
                        initiated before the date of the enactment of 
                        this Act; and
                            (ii) of clinical trial information for 
                        inclusion in the results database (as defined 
                        in such section 492C) on applicable clinical 
                        trials (as defined in such section 492C) 
                        completed before the date of the enactment of 
                        this Act.
                    (B) Required submissions.--Notwithstanding the 
                preceding paragraphs of this subsection, in any case in 
                which the Secretary determines that submission of 
                clinical trial information for an applicable clinical 
                trial (as defined in such section 492C) described in 
                clause (i) or (ii) of subparagraph (A) is in the 
                interest of the public health--
                            (i) the Secretary may require that such 
                        information be submitted to the Secretary in 
                        accordance with such section 492C; and
                            (ii) failure to comply with such a 
                        requirement shall be treated as a violation of 
                        the corresponding requirement of such section 
                        492C.
            (7) Status of clinicaltrials.gov website.--
                    (A) In general.--After receiving public comment and 
                not later than 90 days after the date of the enactment 
                of this Act, the Secretary shall publish in the Federal 
                Register a notice determining the more efficient 
                approach to establishing the registry database 
                described in subsection (b) of such section 492C and 
                whether such approach is--
                            (i) that such registry database should 
                        expand and build upon the data bank described 
                        in section 402(i) of the Public Health Service 
                        Act (as in effect on the day before the date of 
                        the enactment of this Act); or
                            (ii) that such registry database should 
                        supplant the data bank described in such 
                        section 402(i) (as in effect on the day before 
                        the date of the enactment of this Act).
                    (B) Clinicaltrials.gov supplanted.--If the 
                Secretary determines to apply the approach described 
                under subparagraph (A)(ii), the Secretary shall 
                maintain an archive of the data bank described in such 
                section 402(i) (as in effect on the day before the date 
                of the enactment of this Act) on the Internet website 
                of the National Library of Medicine.

SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study to determine whether information on the trials registry 
and database is considered promotional and to evaluate the 
implementation of this database.
    (b) Report.--Not later than one year after the date of the 
enactment of this Act, the Comptroller General shall complete the study 
under subsection (a) and submit to the Congress a report on the results 
of such study.

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

SEC. 901. POSTMARKET STUDIES AND CLINICAL TRIALS REGARDING HUMAN DRUGS; 
              RISK EVALUATION AND MITIGATION STRATEGIES.

    (a) In General.--Section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the 
following subsections:
    ``(o) Postmarket Studies and Clinical Trials; Labeling.--
            ``(1) In general.--A responsible person may not introduce 
        or deliver for introduction into interstate commerce the new 
        drug involved if the person is in violation of a requirement 
        established under paragraph (3) or (4) with respect to the 
        drug.
            ``(2) Definitions.--For purposes of this subsection:
                    ``(A) Responsible person.--The term `responsible 
                person' means a person who--
                            ``(i) has submitted to the Secretary a 
                        covered application that is pending; or
                            ``(ii) is the holder of an approved covered 
                        application.
                    ``(B) Covered application.--The term `covered 
                application' means--
                            ``(i) an application under subsection (b) 
                        for a drug that is subject to section 503(b); 
                        and
                            ``(ii) an application under section 351 of 
                        the Public Health Service Act.
                    ``(C) New safety information; serious risk.--The 
                terms `new safety information', `serious risk', and 
                `signal of a serious risk' have the meanings given such 
                terms in section 505-1(b).
            ``(3) Studies and clinical trials.--
                    ``(A) In general.--For any or all of the purposes 
                specified in subparagraph (B), the Secretary may, 
                subject to subparagraph (C), require a responsible 
                person for a drug to conduct a postapproval study or 
                studies of the drug, or a postapproval clinical trial 
                or trials of the drug, on the basis of scientific 
                information, including information regarding 
                chemically-related or pharmacologically-related drugs.
                    ``(B) Purposes of study or trial.--The purposes 
                referred to in this subparagraph with respect to a 
                postapproval study or postapproval clinical trial are 
                the following:
                            ``(i) To assess a known serious risk 
                        related to the use of the drug involved.
                            ``(ii) To assess signals of serious risk 
                        related to the use of the drug.
                            ``(iii) To identify a serious risk.
                    ``(C) Establishment of requirement after approval 
                of covered application.--The Secretary may require a 
                postapproval study or studies or postapproval trial or 
                trials for a drug for which an approved covered 
                application is in effect as of the date on which the 
                Secretary seeks to establish such requirement only if 
                the Secretary becomes aware of new safety information. 
                For each study required to be conducted under this 
                subparagraph, the Secretary shall require that the 
                applicant submit a timetable for completion of the 
                study and shall require the applicant to periodically 
                report to the Secretary on the status of the study. 
                Unless the applicant demonstrates good cause for 
                failure to comply with such timeline, the applicant 
                shall be in violation of this subsection. The Secretary 
                shall determine what constitutes good cause under the 
                preceding sentence.
            ``(4) Safety labeling changes requested by secretary.--
                    ``(A) New safety information.--The Secretary shall 
                promptly notify the responsible person if the Secretary 
                becomes aware of new safety information that the 
                Secretary believes should be included in the labeling 
                of the drug.
                    ``(B) Response to notification.--Following 
                notification pursuant to subparagraph (A), the 
                responsible person shall within 30 days--
                            ``(i) submit 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; or
                            ``(ii) notify the Secretary that the 
                        responsible person does not believe a labeling 
                        change is warranted and submit a statement 
                        detailing the reasons why such a change is not 
                        warranted.
                    ``(C) Review.--Upon receipt of such supplement, the 
                Secretary shall promptly review and act upon such 
                supplement. If the Secretary disagrees with the 
                proposed changes in the supplement or with the 
                statement setting forth the responsible person's 
                reasons why no labeling change is necessary, the 
                Secretary shall initiate discussions with the 
                responsible person to reach agreement on whether the 
                labeling for the drug should be modified to reflect the 
                new safety information, and if so, the contents of such 
                labeling changes.
                    ``(D) Discussions.--Such discussions shall not 
                extend for more than 30 days after the response to the 
                notification under subparagraph (B), unless the 
                Secretary determines an extension of such discussion 
                period is warranted.
                    ``(E) Order.--Within 15 days of the conclusion of 
                the discussions under subparagraph (D), the Secretary 
                may issue an order directing the responsible person to 
                make such a labeling change as the Secretary deems 
                appropriate to address the new safety information. 
                Within 15 days of such an order, the responsible person 
                shall submit a supplement containing the labeling 
                change.
                    ``(F) Dispute resolution.--Within 5 days of 
                receiving an order under subparagraph (E), the 
                responsible person may appeal using the Food and Drug 
                Administration's normal dispute resolution procedures 
                established by the Secretary in regulation and 
                guidance.
                    ``(G) Violation.--If the change required by an 
                order under subparagraph (E) is not made by the date so 
                specified, the responsible person shall be considered 
                to be in violation of this section.
                    ``(H) Serious public health threat.--
                Notwithstanding subparagraphs (A) through (F), if the 
                Secretary concludes that failure to make such a 
                labeling change is necessary to protect against a 
                serious public health threat, the Secretary may 
                accelerate the timelines in such subparagraphs.
                    ``(I) Rule of construction.--This paragraph shall 
                not be construed to affect the responsibility of the 
                responsible person to maintain its label in accordance 
                with existing requirements, including subpart B and 
                section 314.70 of title 21, Code of Federal Regulations 
                (or any successor regulations).
    ``(p) Risk Evaluation and Mitigation Strategy.--
            ``(1) In general.--A person may not introduce or deliver 
        for introduction into interstate commerce a new drug if--
                    ``(A)(i) the application for such drug is approved 
                under subsection (b) or (j) and is subject to section 
                503(b); or
                    ``(ii) the application for such drug is approved 
                under section 351 of the Public Health Service Act; and
                    ``(B) a risk evaluation and mitigation strategy is 
                required under section 505-1 with respect to the drug 
                and--
                            ``(i) the person fails to maintain 
                        compliance with the requirements of the 
                        approved strategy or with other requirements 
                        under section 505-1, including requirements 
                        regarding assessments of approved strategies; 
                        or
                            ``(ii) in the case of a requirement for 
                        such a strategy that is first established after 
                        the applicable application referred to in 
                        subparagraph (A) was approved with respect to 
                        the drug, the Secretary, after notice and 
                        opportunity for a hearing, publishes in the 
                        Federal Register a statement that the person is 
                        not cooperating with the Secretary in 
                        developing such a strategy for the drug.
            ``(2) Required statement during approval process.--In the 
        case of an application approved under subsection (b) or (j) for 
        a new drug that is subject to section 503(b), or an application 
        approved under section 351 of the Public Health Service Act, or 
        a supplement to such an application that requires substantive 
        data, the Secretary may not approve the application or 
        supplement unless the person involved has complied with the 
        following:
                    ``(A) The person has submitted to the Secretary a 
                statement that provides the following information:
                            ``(i) Whether the person believes that a 
                        risk evaluation and mitigation strategy should 
                        be required under section 505-1.
                            ``(ii) Whether a postmarket study or 
                        clinical trial should be required under 
                        subsection (o)(3).
                    ``(B) In making the statement under subparagraph 
                (A), the person took into account each of the following 
                factors:
                            ``(i) The estimated size of the population 
                        likely to use the drug involved.
                            ``(ii) The seriousness of the disease or 
                        condition that is to be treated with the drug.
                            ``(iii) The expected benefit of the drug 
                        with respect to such disease or condition.
                            ``(iv) The expected or actual duration of 
                        treatment with the drug.
                            ``(v) The seriousness of any known or 
                        potential adverse events that may be related to 
                        the drug and the background incidence of such 
                        events in the population likely to use the 
                        drug.
            ``(3) Certain postmarket studies.--The failure to conduct a 
        postmarket study under subpart H of part 314 of title 21, Code 
        of Federal Regulations (or any successor regulation), is deemed 
        to be a violation of paragraph (1).''.
    (b) Requirements Regarding Strategies.--Chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amended by 
inserting after section 505 the following section:

``SEC. 505-1. RISK EVALUATION AND MITIGATION STRATEGIES.

    ``(a) Submission of Proposed Strategy.--
            ``(1) Initial approval.--A person who submits an 
        application referred to in section 505(p)(1)(A) (referred to in 
        this section as a `covered application') shall submit to the 
        Secretary as part of the application a proposed risk evaluation 
        and mitigation strategy if the Secretary determines such a 
        strategy is necessary to ensure that the benefits of the drug 
        involved outweigh the risks of the drug. In making such a 
        determination, the Secretary shall consider the statement 
        submitted by the person under section 505(p)(2) with respect to 
        the drug and shall consider the following factors:
                    ``(A) The estimated size of the population likely 
                to use the drug involved.
                    ``(B) The seriousness of the disease or condition 
                that is to be treated with the drug.
                    ``(C) The expected benefit of the drug with respect 
                to such disease or condition.
                    ``(D) The expected or actual duration of treatment 
                with the drug.
                    ``(E) The seriousness of any known or potential 
                adverse events that may be related to the drug and the 
                background incidence of such events in the population 
                likely to use the drug.
                    ``(F) The availability and safety of a drug or 
                other treatment, if any, for such disease or condition 
                to which the safety of the drug may be compared.
                    ``(G) Whether the drug is a new molecular entity.
            ``(2) Postapproval requirement.--
                    ``(A) In general.--If the Secretary approves a 
                covered application and does not when approving the 
                application require a risk evaluation and mitigation 
                strategy under paragraph (1), the Secretary may 
                subsequently require such a strategy for the drug 
                involved if the Secretary becomes aware of new safety 
                information and makes a determination that such a 
                strategy is necessary to ensure that the benefits of 
                the drug outweigh the risks of the drug.
                    ``(B) Submission of proposed strategy.--Not later 
                than 120 days after the Secretary notifies the holder 
                of an approved covered application that the Secretary 
                has made a determination under subparagraph (A) with 
                respect to the drug involved, or within such other time 
                as the Secretary requires to protect the public health, 
                the holder shall submit to the Secretary a proposed 
                risk evaluation and mitigation strategy.
            ``(3) Approval of new indication for use.--The 
        applicability of paragraph (2) includes applicability to a drug 
        for which an approved covered application was in effect on the 
        day before the effective date of this section and for which, on 
        or after such effective date, the holder of the approved 
        application submits to the Secretary a supplemental application 
        seeking approval of a new indication for use of the drug.
            ``(4) Abbreviated new drug applications.--The applicability 
        of this section to an application under section 505(j) is 
        subject to subsection (i).
    ``(b) Definitions.--For purposes of this section:
            ``(1) 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--
                    ``(A) an adverse event occurring in the course of 
                the use of the drug in professional practice;
                    ``(B) an adverse event occurring from an overdose 
                of the drug, whether accidental or intentional;
                    ``(C) an adverse event occurring from abuse of the 
                drug;
                    ``(D) an adverse event occurring from withdrawal of 
                the drug; and
                    ``(E) any failure of expected pharmacological 
                action of the drug.
            ``(2) Covered application.--The term `covered application' 
        has the meaning indicated for such term in subsection (a)(1).
            ``(3) New safety information.--The term `new safety 
        information' with respect to a drug means information about--
                    ``(A) a serious risk or an unexpected serious risk 
                associated with use of the drug that the Secretary has 
                become aware of since the drug was approved, since the 
                risk evaluation and mitigation strategy was required, 
                or since the last assessment of the approved risk 
                evaluation and mitigation strategy for the drug; or
                    ``(B) the effectiveness of the approved risk 
                evaluation and mitigation strategy for the drug 
                obtained since the last assessment of such strategy.
            ``(4) Serious adverse drug experience.--The term `serious 
        adverse drug experience' is an adverse event that--
                    ``(A) results in--
                            ``(i) death;
                            ``(ii) an adverse drug experience that 
                        places 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
                    ``(B) based on appropriate medical judgment, may 
                jeopardize the patient and may require a medical or 
                surgical intervention to prevent an outcome described 
                under subparagraph (A).
            ``(5) Serious risk.--The term `serious risk' means a risk 
        of a serious adverse drug experience.
            ``(6) Signal of a serious risk.--The term `signal of a 
        serious risk' means information related to a serious adverse 
        drug experience associated with use of a drug and derived 
        from--
                    ``(A) a clinical trial;
                    ``(B) adverse event reports;
                    ``(C) a postapproval study, including a study under 
                section 505(o)(3);
                    ``(D) peer-reviewed biomedical literature; or
                    ``(E) data derived from a postmarket risk 
                identification and analysis system under section 
                505(k)(3).
            ``(7) Responsible person.--The term `responsible person' 
        has the meaning indicated for such term in subsection (e)(2).
            ``(8) Unexpected serious risk.--The term `unexpected 
        serious risk' means a serious adverse drug experience that is 
        not listed in the labeling of a drug, or that may be 
        symptomatically and pathophysiologically related to an adverse 
        drug experience identified in the labeling, but differs from 
        such adverse drug experience because of greater severity, 
        specificity, or prevalence.
    ``(c) Contents.--A proposed risk evaluation and mitigation strategy 
under subsection (a) shall--
            ``(1) include the timetable required under subsection (d); 
        and
            ``(2) to the extent required by the Secretary, include 
        additional elements described in subsections (e) and (f).
    ``(d) Minimal Strategy.--For purposes of subsection (c)(1), the 
risk evaluation and mitigation strategy for a drug shall require a 
timetable for submission of assessments of the strategy that--
            ``(1) is not less frequent than once annually for the first 
        3 years after the strategy is initially approved;
            ``(2) includes an assessment in the seventh year after the 
        strategy is so approved; and
            ``(3) subject to paragraph (2), for subsequent years--
                    ``(A) is at a frequency specified in the strategy;
                    ``(B) is increased or reduced in frequency as 
                necessary as provided for in subsection (g)(4)(A); and
                    ``(C) is eliminated after the 3-year period 
                described in paragraph (1) if the Secretary determines 
                that serious risks of the drug have been adequately 
                identified and assessed and are being adequately 
                managed.
    ``(e) Additional Potential Elements of Strategy.--
            ``(1) In general.--The Secretary may under subsection 
        (c)(2) require that the risk evaluation and mitigation strategy 
        for a drug include 1 or more of the additional elements 
        described in this subsection if the Secretary makes the 
        determination required with respect to the element involved.
            ``(2) Medguide; patient package insert.--The risk 
        evaluation and mitigation strategy for a drug may require that, 
        as applicable, the person submitting the covered application or 
        the holder of the approved such application (referred to in 
        this section as the `responsible person') develop for 
        distribution to each patient when the drug is dispensed--
                    ``(A) a Medication Guide, as provided for under 
                part 208 of title 21, Code of Federal Regulations (or 
                any successor regulations); and
                    ``(B) a patient package insert, if the Secretary 
                determines that such insert may help mitigate a serious 
                risk of the drug.
            ``(3) Communication plan.--The risk evaluation and 
        mitigation strategy for a drug may require that the responsible 
        person conduct a communication plan to health care providers, 
        if, with respect to such drug, the Secretary determines that 
        such plan may support implementation of an element of the 
        strategy. Such plan may include--
                    ``(A) sending letters to health care providers;
                    ``(B) disseminating information about the elements 
                of the risk evaluation and mitigation 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
                    ``(C) disseminating information to health care 
                providers through professional societies about any 
                serious risks of the drug and any protocol to assure 
                safe use.
    ``(f) Restrictions on Distribution or Use.--
            ``(1) In general.--If the Secretary determines that a drug 
        shown to be effective can be safely used only if distribution 
        or use of such drug is restricted, the Secretary may under 
        subsection (c)(2) require as elements of the risk evaluation 
        and mitigation strategy such restrictions on distribution or 
        use as are needed to ensure safe use of the drug.
            ``(2) Assuring access and minimizing burden.--Elements of a 
        risk evaluation and mitigation strategy included under 
        paragraph (1) shall--
                    ``(A) be commensurate with a specific serious risk 
                listed in the labeling of the drug;
                    ``(B) be posted publicly by the Secretary with an 
                explanation of how such elements will mitigate the 
                observed safety risk, which posting shall be made 
                within 30 days after the date on which the Secretary 
                requires the element involved;
                    ``(C) considering the risk referred to in 
                subparagraph (A), 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
                    ``(D) 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.
            ``(3) Elements.--The restrictions on distribution or use 
        described in paragraph (1) shall include 1 or more goals to 
        evaluate or mitigate a serious risk listed in the labeling of 
        the drug, and may require that--
                    ``(A) health care providers that prescribe the drug 
                have special training or experience, or are specially 
                certified, which training or certification with respect 
                to the drug is available to any willing provider from a 
                frontier area;
                    ``(B) pharmacies, practitioners, or health care 
                settings that dispense the drug are specially 
                certified, which training or certification with respect 
                to the drug is available to any willing provider from a 
                frontier area;
                    ``(C) the drug be dispensed to patients only in 
                certain health care settings, such as hospitals;
                    ``(D) the drug be dispensed to patients with 
                evidence or other documentation of safe-use conditions, 
                such as laboratory test results;
                    ``(E) each patient using the drug be subject to 
                certain monitoring; or
                    ``(F) each patient using the drug be enrolled in a 
                registry.
            ``(4) Implementation system.--The restrictions on 
        distribution or use described in paragraph (1) may require a 
        system through which the responsible person is able to--
                    ``(A) monitor and evaluate implementation of the 
                restrictions by health care providers, pharmacists, 
                patients, and other parties in the health care system 
                who are responsible for implementing the restrictions;
                    ``(B) work to improve implementation of the 
                restrictions by health care providers, pharmacists, 
                patients, and other parties in the health care system 
                who are responsible for implementing the restrictions; 
                and
                    ``(C) notify wholesalers of the drug of those 
                health care providers--
                            ``(i) who are responsible for implementing 
                        the restrictions; and
                            ``(ii) whom the responsible person knows 
                        have failed to meet their responsibilities for 
                        implementing the restrictions, after the 
                        responsible person has informed such party of 
                        such failure and such party has not remedied 
                        such failure.
            ``(5) Limitation.--No holder of an approved application 
        shall use any restriction on distribution required by the 
        Secretary as necessary to assure safe use of the drug to block 
        or delay approval of an application under section 505(b)(2) or 
        (j) or to prevent application of such restriction under 
        subsection (i)(1)(B) to a drug that is the subject of an 
        abbreviated new drug application.
            ``(6) Bioequivalence testing.--Notwithstanding any other 
        provisions in this subsection, the holder of an approved 
        application that is subject to distribution restrictions 
        required under this subsection that limit the ability of a 
        sponsor seeking approval of an application under subsection 
        505(b)(2) or (j) to purchase on the open market a sufficient 
        quantity of drug to conduct bioequivalence testing shall 
        provide to such a sponsor a sufficient amount of drug to 
        conduct bioequivalence testing if the sponsor seeking approval 
        under section 505(b)(2) or (j)--
                    ``(A) agrees to such restrictions on distribution 
                as the Secretary finds necessary to assure safe use of 
                the drug during bioequivalence testing; and
                    ``(B) pays the holder of the approved application 
                the fair market value of the drug purchased for 
                bioequivalence testing.
            ``(7) Letter by secretary.--Upon a showing by the sponsor 
        seeking approval under section 505(b)(2) or (j) that the 
        sponsor has agreed to such restrictions necessary to assure 
        safe use of the drug during bioequivalence testing, the 
        Secretary shall issue to the sponsor seeking to conduct 
        bioequivalence testing a letter that describes the Secretary's 
        finding which shall serve as proof that the sponsor has 
        satisfied the requirements of subparagraph (6)(A).
            ``(8) Evaluation of elements to assure safe use.--The 
        Secretary, acting through the Drug Safety and Risk Management 
        Advisory Committee (or any successor committee) of the Food and 
        Drug Administration, shall--
                    ``(A) seek input from patients, physicians, 
                pharmacists, and other health care providers about how 
                elements to assure safe use under this subsection 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;
                    ``(B) 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
                    ``(C) considering such input and evaluations--
                            ``(i) issue or modify agency guidance about 
                        how to implement the requirements of this 
                        subsection; and
                            ``(ii) modify elements under this 
                        subsection for 1 or more drugs as appropriate.
            ``(9) Waiver in public health emergencies.--The Secretary 
        may waive any restriction on distribution or use under this 
        subsection 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 restriction or use under this subsection has 
        been applied, if the Secretary has--
                    ``(A) declared a public health emergency under such 
                section 319; and
                    ``(B) determined that such waiver is required to 
                mitigate the effects of, or reduce the severity of, 
                such public health emergency.
    ``(g) Assessment and Modification of Approved Strategy.--
            ``(1) Voluntary assessments.--After the approval of a risk 
        evaluation and mitigation strategy under subsection (a), the 
        responsible person involved may, subject to paragraph (2), 
        submit to the Secretary an assessment of, and propose a 
        modification to, the approved strategy for the drug involved at 
        any time.
            ``(2) Required assessments.--A responsible person shall, 
        subject to paragraph (5), submit an assessment of, and may 
        propose a modification to, the approved risk evaluation and 
        mitigation strategy for a drug--
                    ``(A) when submitting a supplemental application 
                for a new indication for use under section 505(b) or 
                under section 351 of the Public Health Service Act, 
                unless the drug is not subject to section 503(b) and 
                the risk evaluation and mitigation strategy for the 
                drug includes only the timetable under subsection (d);
                    ``(B) when required by the strategy, as provided 
                for in such timetable under subsection (d);
                    ``(C) within a time period to be determined by the 
                Secretary, if the Secretary determines that new safety 
                or effectiveness information indicates that--
                            ``(i) an element under subsection (d) or 
                        (e) should be modified or included in the 
                        strategy; or
                            ``(ii) an element under subsection (f) 
                        should be modified or included in the strategy; 
                        or
                    ``(D) within 15 days when ordered by the Secretary, 
                if the Secretary determines that there may be a cause 
                for action by the Secretary under section 505(e).
            ``(3) Requirements for assessments.--An assessment under 
        paragraph (1) or (2) of an approved risk evaluation and 
        mitigation strategy for a drug shall include--
                    ``(A) with respect to any goal under subsection 
                (f), an assessment of the extent to which the 
                restrictions on distribution or use are meeting the 
                goal or whether the goal or such restrictions should be 
                modified;
                    ``(B) with respect to any postapproval study 
                required under section 505(o)(3), the status of such 
                study, including whether any difficulties completing 
                the study have been encountered; and
                    ``(C) with respect to any postapproval clinical 
                trial required under section 505(o), 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 section 492C of the Public Health Service Act.
            ``(4) 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 subsection (d) or the addition, modification, 
        or removal of any element under subsection (e) or (f), such 
        as--
                    ``(A) modifying the timetable for assessments of 
                the strategy under subsection (d), including to 
                eliminate assessments; or
                    ``(B) adding, modifying, or removing a restriction 
                on distribution or use under subsection (f).
            ``(5) 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 paragraph (2) is not 
        required.
    ``(h) Review of Proposed Strategies; Review of Assessments of 
Approved Strategies.--
            ``(1) In general.--The Secretary shall promptly review each 
        proposed risk evaluation and mitigation strategy for a drug 
        submitted under subsection (a) and each assessment of an 
        approved risk evaluation and mitigation strategy for a drug 
        submitted under subsection (g).
            ``(2) Marketing plan.--As part of a review conducted under 
        this subsection, the Secretary may require the applicant to 
        submit information regarding its marketing plan and practices 
        for the drug, so as to allow the Secretary to determine whether 
        any of the proposed or ongoing marketing activities undermine 
        any of the requirements of the risk evaluation and mitigation 
        strategy.
            ``(3) Discussion.--The Secretary shall initiate discussions 
        with a responsible person for purposes of this subsection to 
        determine a strategy--
                    ``(A) if the proposed strategy is submitted as part 
                of an application or supplemental application under 
                subsection (a) or subsection (g)(2)(A), not less than 
                60 days before the action deadline for the application 
                that has been agreed to by the Secretary and that has 
                been set forth in goals identified in letters of the 
                Secretary (relating to the use of fees collected under 
                section 736 to expedite the drug development process 
                and the process for the review of human drug 
                applications);
                    ``(B) if the assessment is submitted under 
                subparagraph (B) or (C) or subsection (g)(2), not later 
                than 20 days after such submission;
                    ``(C) if the assessment is submitted under 
                subsection (g)(1) or subsection (g)(2)(D) , not later 
                than 30 days after such submission; or
                    ``(D) if the assessment is submitted under 
                subsection (g)(2)(D), not later than 10 days after such 
                submission.
            ``(4) Action.--
                    ``(A) In general.--Unless the responsible person 
                requests the dispute resolution process described under 
                paragraph (5), the Secretary shall approve and describe 
                the risk evaluation and mitigation strategy for a drug, 
                or any modification to the strategy--
                            ``(i) as part of the action letter on the 
                        application, when a proposed strategy is 
                        submitted under subsection (a) or an assessment 
                        of the strategy is submitted under subsection 
                        (g)(1); or
                            ``(ii) in an order issued not later than 50 
                        days after the date discussions of such 
                        modification begin under paragraph (3), when an 
                        assessment of the strategy is submitted under 
                        subsection (g)(1) or under any of subparagraphs 
                        (B) through (D) of subsection (g)(2).
                    ``(B) 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 subparagraph (A).
                    ``(C) Public availability.--Any action letter 
                described in subparagraph (A)(i) or order described in 
                subparagraph (A)(ii) shall be made publicly available.
            ``(5) Dispute resolution.--
                    ``(A) Request for review.--
                            ``(i) In general.--Not earlier than 15 
                        days, and not later than 35 days, after 
                        discussions under paragraph (3) have begun, the 
                        responsible person may request in writing that 
                        a dispute about the strategy be reviewed by the 
                        Drug Safety Oversight Board under subsection 
                        (j), except that the determination of the 
                        Secretary to require a risk evaluation and 
                        mitigation strategy is not subject to review 
                        under this paragraph. The preceding sentence 
                        does not prohibit review under this paragraph 
                        of the particular elements of such a strategy.
                            ``(ii) Scheduling.--Upon receipt of a 
                        request under clause (i), the Secretary shall 
                        schedule the dispute involved for review under 
                        subparagraph (B) and, not later than 5 business 
                        days of scheduling the dispute for review, 
                        shall publish by posting on the Internet or 
                        otherwise a notice that the dispute will be 
                        reviewed by the Drug Safety Oversight Board.
                    ``(B) Scheduling review.--If a responsible person 
                requests review under subparagraph (A), the Secretary--
                            ``(i) 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
                            ``(ii) 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).
                    ``(C) Agreement after discussion or administrative 
                appeals.--
                            ``(i) Further discussion or administrative 
                        appeals.--A request for review under 
                        subparagraph (A) shall not preclude further 
                        discussions to reach agreement on the risk 
                        evaluation and mitigation strategy, and such a 
                        request shall not preclude the use of 
                        administrative appeals within the Food and Drug 
                        Administration to reach agreement on the 
                        strategy, including appeals as described in 
                        letters of the Secretary (relating to the use 
                        of fees collected under section 736 to expedite 
                        the drug development process and the process 
                        for the review of human drug applications) for 
                        procedural or scientific matters involving the 
                        review of human drug applications and 
                        supplemental applications that cannot be 
                        resolved at the divisional level.
                            ``(ii) Agreement terminates dispute 
                        resolution.--At any time before a decision and 
                        order is issued under subparagraph (G) , the 
                        Secretary and the responsible person 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.
                    ``(D) Meeting of the board.--At a meeting of the 
                Drug Safety Oversight Board described in subparagraph 
                (B), the Board shall--
                            ``(i) hear from both parties; and
                            ``(ii) review the dispute.
                    ``(E) Record of proceedings.--The Secretary shall 
                ensure that the proceedings of any such meeting are 
                recorded, transcribed, and made public within 30 days 
                of the meeting. The Secretary shall redact the 
                transcript to protect any trade secrets or other 
                confidential information described in section 552(b)(4) 
                of title 5, United States Code.
                    ``(F) Recommendation of the board.--Not later than 
                5 days after any such meeting, the Drug Safety 
                Oversight Board shall provide a written recommendation 
                on resolving the dispute to the Secretary. Not later 
                than 5 days after the Board provides such written 
                recommendation to the Secretary, the Secretary shall 
                make the recommendation available to the public.
                    ``(G) Action by the secretary.--
                            ``(i) Action letter.--With respect to a 
                        proposal or assessment referred to in paragraph 
                        (1), the Secretary shall issue an action letter 
                        that resolves the dispute not later than the 
                        later of--
                                    ``(I) the action deadline referred 
                                to in paragraph (3)(A); or
                                    ``(II) 7 days after receiving the 
                                recommendation of the Drug Safety 
                                Oversight Board.
                            ``(ii) Order.--With respect to an 
                        assessment of an approved risk evaluation and 
                        mitigation strategy under subsection (g)(1) or 
                        under any of subparagraphs (B) through (D) of 
                        subsection (g)(2), the Secretary shall issue an 
                        order, which shall be made public, that 
                        resolves the dispute not later than 7 days 
                        after receiving the recommendation of the Drug 
                        Safety Oversight Board.
                    ``(H) 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 subparagraph (G).
                    ``(I) Effect on action deadline.--With respect to a 
                proposal or assessment referred to in paragraph (1), 
                the Secretary shall be considered to have met the 
                action deadline referred to in paragraph (3)(A) with 
                respect to the application involved if the responsible 
                person requests the dispute resolution process 
                described in this paragraph and if the Secretary--
                            ``(i) has initiated the discussions 
                        described under paragraph (3) not less than 60 
                        days before such action deadline; 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 subparagraphs (B), (F), and (G), 
                        respectively.
                    ``(J) 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 subparagraph (C)(i) with respect to such 
                drug may serve on the Drug Safety Oversight Board at a 
                meeting under subparagraph (D) to review a dispute 
                about the risk evaluation and mitigation strategy for 
                such drug.
                    ``(K) 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 subparagraph (D) of the Drug Safety Oversight 
                Board.
            ``(6) Use of advisory committees.--The Secretary may 
        convene a meeting of 1 or more advisory committees of the Food 
        and Drug Administration to--
                    ``(A) 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 any of subparagraphs (B) through (D) of 
                subsection (g)(2);
                    ``(B) review the risk evaluation and mitigation 
                strategy or strategies of a drug or group of drugs; or
                    ``(C) review a dispute under paragraph (5).
            ``(7) Process for addressing drug class effects.--
                    ``(A) In general.--When a concern about a serious 
                risk of a drug may be related to the pharmacological 
                class of the drug, the Secretary may defer assessments 
                of the approved risk evaluation and mitigation 
                strategies for such drugs until the Secretary has 
                convened 1 or more public meetings to consider possible 
                responses to such concern. If the Secretary defers an 
                assessment under this subparagraph, the Secretary shall 
                give notice to the public of the deferral not later 
                than 5 days of the deferral.
                    ``(B) Public meetings.--Such public meetings may 
                include--
                            ``(i) 1 or more meetings of the reviewed 
                        entities for such drugs;
                            ``(ii) 1 or more meetings of 1 or more 
                        advisory committees of the Food and Drug 
                        Administration, as provided for under paragraph 
                        (6); or
                            ``(iii) 1 or more workshops of scientific 
                        experts and other stakeholders.
                    ``(C) Action.--After considering the discussions 
                from any meetings under subparagraph (B), 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.
            ``(8) International coordination.--The Secretary may 
        coordinate the timetable for submission of assessments under 
        subsection (d), or a study or clinical trial under section 
        505(o)(3), 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. If the Secretary 
        takes action to coordinate such timetable, the Secretary shall 
        give notice to the public of the action not later than 5 days 
        after the action.
            ``(9) Effect.--Use of the processes described in paragraphs 
        (7) and (8) shall not delay action on an application or a 
        supplement to an application for a drug.
    ``(i) Abbreviated New Drug Applications.--
            ``(1) In general.--A drug that is the subject of an 
        abbreviated new drug application under section 505(j) is 
        subject to only the following elements of the risk evaluation 
        and mitigation strategy required under subsection (a) for the 
        applicable listed drug:
                    ``(A) A Medication Guide or patient package insert, 
                if required under subsection (e) for the applicable 
                listed drug.
                    ``(B) Restrictions on distribution or use, if 
                required under subsection (f) for the listed drug. A 
                drug that is the subject of an abbreviated new drug 
                application and the listed drug shall use a single, 
                shared system under subsection (f)(4). The Secretary 
                may waive the requirement under the preceding sentence 
                for a drug that is the subject of an abbreviated new 
                drug application if the Secretary determines that--
                            ``(i) it is not practical for the drug to 
                        use such single, shared system; or
                            ``(ii) the burden of using the single, 
                        shared system outweighs the benefit of using 
                        the single system.
            ``(2) Action by secretary.--For an applicable listed drug 
        for which a drug is approved under section 505(j), the 
        Secretary--
                    ``(A) shall undertake any communication plan to 
                health care providers required under subsection (e)(3) 
                for the applicable listed drug; and
                    ``(B) shall inform the responsible person for the 
                drug that is so approved if the risk evaluation and 
                mitigation strategy for the applicable listed drug is 
                modified.
    ``(j) Drug Safety Oversight Board.--
            ``(1) In general.--There is established a Drug Safety 
        Oversight Board.
            ``(2) Composition; meetings.--The Drug Safety Oversight 
        Board shall--
                    ``(A) be composed of scientists and health care 
                practitioners appointed by the Secretary, each of whom 
                is an employee of the Federal Government;
                    ``(B) include representatives from offices 
                throughout the Food and Drug Administration;
                    ``(C) include at least 1 representative from each 
                of the National Institutes of Health and the Department 
                of Health and Human Services (other than the Food and 
                Drug Administration);
                    ``(D) include such representatives as the Secretary 
                shall designate from other appropriate agencies that 
                wish to provide representatives; and
                    ``(E) meet at least monthly to provide oversight 
                and advice to the Secretary on the management of 
                important drug safety issues.''.
    (c) Regulation of 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 under this paragraph is subject to 
section 505(p) of the Federal Food, Drug, and Cosmetic Act.''; and
            (2) in subsection (j), by inserting ``, including the 
        requirements under section 505(p) of such Act,'' after ``, and 
        Cosmetic Act''.
    (d) Prereview of Advertisements.--
            (1) Sense of congress.--It is the sense of the Congress 
        that--
                    (A) ``Guidance for Industry Consumer-Directed 
                Broadcast Advertisements'' issued by the Food and Drug 
                Administration in August, 1999, represents generally 
                good guidance for direct-to-consumer (DTC) advertising 
                of prescription medicines and other treatments;
                    (B) direct-to-consumer advertising as an accurate 
                source of health information for all populations, 
                specifically including the elderly populations, 
                children, chronically ill and racial and ethnic 
                minority populations, should be made more reliable by 
                ensuring the truth and credibility of information 
                provided through such advertising; and
                    (C) the Congress will work with the Food and Drug 
                Administration to ensure that information provided 
                through direct-to-consumer advertising of prescription 
                medicines and other treatments is not false or 
                misleading and communicates clearly and sensitively to 
                all communities.
            (2) Prereview.--The Federal Food, Drug, and Cosmetic Act 
        (21 U.S.C. 301 et seq.) is amended--
                    (A) in section 301 (21 U.S.C. 331), by adding at 
                the end the following:
    ``(jj) The dissemination of a television advertisement without 
complying with section 503B.''; and
                    (B) by inserting after section 503A the following:

``SEC. 503B. PREREVIEW OF TELEVISION ADVERTISEMENTS.

    ``(a) In General.--The Secretary may require the submission of any 
television advertisement for a drug (including any script, story board, 
rough, or a completed video production of the television advertisement) 
to the Secretary for review under this section not later than 45 days 
before dissemination of the television advertisement.
    ``(b) Review.--In conducting a review of a television advertisement 
under this section, the Secretary may make recommendations--
            ``(1) on changes that are--
                    ``(A) necessary to protect the consumer good and 
                well-being; or
                    ``(B) consistent with prescribing information for 
                the product under review; and
            ``(2) if appropriate and if information exists, on 
        statements for inclusion in the advertisement to address the 
        specific efficacy of the drug as it relates to a specific 
        population group, including elderly populations, children, and 
        racially and ethnically diverse populations.
    ``(c) No Authority To Require Changes.--This section does not 
authorize the Secretary to make or direct changes in any material 
submitted pursuant to subsection (a).
    ``(d) Elderly Populations, Children, Racially and Ethnically 
Diverse Communities.--In formulating recommendations under subsection 
(b), the Secretary shall take into consideration the impact of the 
advertised drug on elderly populations, children, and racially and 
ethnically diverse communities.
    ``(e) Specific Disclosures.--
            ``(1) Serious risk; safety protocol.--In conducting a 
        review of a television advertisement under this section, if the 
        Secretary determines that the advertisement would be false or 
        misleading without a specific disclosure about a serious risk 
        listed in the labeling of the drug involved, the Secretary may 
        require inclusion of such disclosure in the advertisement.
            ``(2) Date of approval.--In conducting a review of a 
        television advertisement under this section, the Secretary may 
        require the advertisement to include, for a period not to 
        exceed 2 years from the date of the approval of the drug under 
        section 505, a specific disclosure of such date of approval if 
        the Secretary determines that the advertisement would otherwise 
        be false or misleading.
    ``(f) Rule of Construction.--Nothing in this section may be 
construed as having any effect on the authority of the Secretary under 
section 314.550, 314.640, 601.45, or 601.94 of title 21, Code of 
Federal Regulations (or successor regulations).''.
            (3) Direct-to-consumer advertisements.--
                    (A) In general.--Section 502(n) of the Federal 
                Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) is 
                amended by adding at the end the following: ``In the 
                case of an advertisement for a drug subject to section 
                503(b)(1) presented directly to consumers in television 
                or radio format and stating the name of the drug and 
                its conditions of use, the major statement relating to 
                side effects and contraindications shall be presented 
                in a clear and conspicuous manner.''.
                    (B) Regulations to determine clear and conspicuous 
                manner.--The Secretary of Health and Human Services 
                shall by regulation establish standards for determining 
                whether a major statement relating to side effects and 
                contraindications 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 subparagraph (A)) is 
                presented in the manner required under such section.
            (4) Civil penalties.--Section 303 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 333) is amended--
                    (A) by redesignating subsection (g) (relating to 
                civil penalties) as subsection (f); and
                    (B) by adding at the end the following:
    ``(g)(1) With respect to a person who is a holder of an approved 
application under section 505 for a drug subject to section 503(b) or 
under section 351 of the Public Health Service Act, any such person who 
disseminates a direct-to-consumer advertisement that is false or 
misleading shall be liable to the United States for a civil penalty in 
an amount not to exceed $250,000 for the first such violation in any 3-
year period, and not to exceed $500,000 for each subsequent violation 
in any 3-year period. No other civil monetary penalties in this Act 
(including the civil penalty in section 303(f)(3)) shall apply to a 
violation regarding direct-to-consumer advertising. For purposes of 
this paragraph: (A) 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 one 
violation. (B) On and after the date of the receipt of such a notice, 
all violations under this paragraph occurring in a single day shall be 
considered one 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 person 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 person 
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 person to be assessed a civil penalty 
under paragraph (1), the Secretary, in determining the amount of the 
civil penalty, shall take into account the nature, circumstances, 
extent, and gravity of the violation or violations, including the 
following factors:
            ``(A) Whether the person submitted the advertisement or a 
        similar advertisement for review under section 736A.
            ``(B) Whether the person submitted the advertisement for 
        review if required under section 503B.
            ``(C) Whether, after submission of the advertisement as 
        described in subparagraph (A) or (B), the person disseminated 
        the advertisement before the end of the 45-day comment period.
            ``(D) Whether the person incorporated any comments made by 
        the Secretary with regard to the advertisement into the 
        advertisement prior to its dissemination.
            ``(E) Whether the person ceased distribution of the 
        advertisement upon receipt of the written notice referred to in 
        paragraph (2) for such advertisement.
            ``(F) Whether the person had the advertisement reviewed by 
        qualified medical, regulatory, and legal reviewers prior to its 
        dissemination.
            ``(G) Whether the violations were material.
            ``(H) Whether the person who created the advertisement 
        acted in good faith.
            ``(I) Whether the person 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 person.
            ``(K) Such other matters, as justice may require.
    ``(4)(A) Subject to subparagraph (B), no person shall be required 
to pay a civil penalty under paragraph (1) if the person submitted the 
advertisement to the Secretary and disseminated such advertisement 
after incorporating any comment received from the Secretary other than 
a recommendation subject to subsection 503B(c).
    ``(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 person 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, or 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 
owed by the United States to the person charged.
    ``(6) Any person 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 person 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) On an annual basis, the Secretary shall report to the 
Congress on direct-to-consumer advertising and its ability to 
communicate to subsets of the general population, including elderly 
populations, children, and racial and ethnic minority communities. The 
Secretary shall establish a permanent advisory committee to advise the 
Secretary with respect to such report. The membership of the advisory 
committee shall consist of nationally recognized medical, advertising, 
and communications experts, including experts representing subsets of 
the general population. The members of the advisory committee shall 
serve without pay, but may receive travel expenses, including per diem 
in lieu of subsistence in accordance with applicable provisions under 
subchapter I of chapter 57 of title 5, United States Code. The advisory 
committee shall study direct-to-consumer advertising as it relates to 
increased access to health information and decreased health disparities 
for these populations. The annual report required by this paragraph 
shall recommend effective ways to present and disseminate information 
to these populations. Such report shall also make recommendations 
regarding impediments to the participation of elderly populations, 
children, racially and ethnically diverse communities, and medically 
underserved populations in clinical drug trials and shall recommend 
best practice approaches for increasing the inclusion of such subsets 
of the general population. The Secretary shall submit the first annual 
report under this paragraph to the Committee on Health, Education, 
Labor, and Pensions of the Senate and the Committee on Energy and 
Commerce of the House of Representatives not later than 18 months after 
the advisory committee has been convened by the Secretary.
    ``(8) If any person fails to pay an assessment of a civil penalty 
under paragraph (1)--
            ``(A) after the order making the assessment becomes final, 
        and if such person 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 of the United States 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 the 
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.''.
    (e) Rule of Construction Regarding Pediatric Studies.--This title 
and the amendments made by this title may not be construed as affecting 
the authority of the Secretary of Health and Human Services to request 
pediatric studies under section 505A of the Federal Food, Drug, and 
Cosmetic Act or to require such studies under section 505B of such Act.

SEC. 902. 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:
    ``(y) If it is a drug subject to an approved risk evaluation and 
mitigation strategy pursuant to section 505(p) and the person 
responsible for complying with the strategy fails to comply with a 
requirement of such strategy provided for under subsection (d), (e), or 
(f) of section 505-1.
    ``(z) If it is a drug, and the responsible person (as such term is 
used in section 505(o)) is in violation of a requirement established 
under paragraph (3) (relating to postmarket studies and clinical 
trials) or paragraph (4) (relating to labeling) of section 505(o) with 
respect to such drug.''.
    (b) Civil Penalties.--Section 303(f) of the Federal Food, Drug, and 
Cosmetic Act, as redesignated by section 901(d)(4), 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) Any applicant (as such term is used in section 505-1) who 
violates a requirement of section 505(o), section 505(p), or section 
505-1 shall be subject to a civil monetary penalty of--
            ``(A) not more than $250,000 per violation, and not to 
        exceed $1,000,000 for all such violations adjudicated in a 
        single proceeding; or
            ``(B) in the case of a violation that continues after the 
        Secretary provides notice of such violation to the applicant, 
        not more than $10,000,000 per violation, and not to exceed 
        $50,000,000 for all such violations adjudicated in a single 
        proceeding.
If a violation referred to in subparagraph (A) or (B) is continuing in 
nature and poses a substantial threat to the public health, the 
Secretary may impose a civil penalty not to exceed $1,000,000 per day 
during such time period such person is in violation.'';
            (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. 903. 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 section 505-1(g)(2)(D).''.

SEC. 904. BENEFIT-RISK ASSESSMENTS.

    Not later than 1 year after the date of the enactment of this Act, 
the Commissioner of Food and Drugs shall submit to the Congress a 
report on how best to communicate to the public the risks and benefits 
of new drugs and the role of the risk evaluation and mitigation 
strategy in assessing such risks and benefits. As part of such study, 
the Commissioner shall consider the possibility of including in the 
labeling and any direct-to-consumer advertisements of a newly approved 
drug or indication a unique symbol indicating the newly approved status 
of the drug or indication for a period after approval.

SEC. 905. POSTMARKET RISK IDENTIFICATION AND ANALYSIS SYSTEM FOR ACTIVE 
              SURVEILLANCE AND ASSESSMENT.

    (a) Findings.--Congress finds the following:
            (1) It is in the best interests of healthcare providers and 
        patients that a postmarketing surveillance system be developed 
        that will enable active surveillance of disparate sources of 
        data to identify signals of unexpected adverse events and 
        trends in the frequency of known adverse events, to provide 
        data on the outcomes of off label uses, and to enable 
        identification of safety issues earlier than can be done today.
            (2) Such a system can best be developed through public 
        private partnerships to develop methods and tools for 
        conducting surveillance using electronic databases that 
        currently contain data on millions of patient encounters and 
        are expected to grow significantly in the next decade, as well 
        as electronic databases that contain millions of medical 
        product purchases, health care claims, and similar information 
        relevant to product use, efficacy, and safety.
            (3) Therefore, this section directs the Secretary of Health 
        and Human Services to enter into such public private 
        partnerships as are necessary to develop such a surveillance 
        system and the tools and methods necessary to conduct active 
        surveillance using the system.
    (b) Development of the Postmarket Risk Identification and Analysis 
System.--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) The Secretary shall establish public private partnerships to 
develop tools and methods to enable the Secretary and others to use 
available electronic databases to create a robust surveillance system 
that will support active surveillance on important drug safety 
questions including detecting and assessing drug safety signals; 
monitoring the frequency of known adverse events; and evaluating the 
outcomes of off label uses. Such surveillance shall provide for adverse 
event surveillance using the following data sources:
            ``(A) Federal health-related electronic data (such as data 
        from the Medicare program and the health systems of the 
        Department of Veterans Affairs).
            ``(B) Private sector health-related electronic data (such 
        as pharmaceutical purchase data and health insurance claims 
        data).
            ``(C) Other information as the Secretary deems useful to 
        create a robust system to identify and assess adverse events 
        and potential drug safety signals and to evaluate the extent 
        and outcomes of off label uses of drugs.
    ``(4) Not later than 1 year after the date of the enactment of this 
paragraph, the Secretary, in consultation with experts including 
individuals who are recognized in the field of data privacy and 
security, shall develop methods for integrating and analyzing safety 
data from multiple sources and mechanisms for obtaining access to such 
data. Such methods and mechanisms shall not compromise the protection 
of individually identifiable health information.
    ``(5) Not later than 2 years after the date of the enactment of 
this paragraph, the Secretary shall have entered into partnerships that 
will allow the analysis of available data from the various data sources 
using the standards and methods to identify drug safety signals and 
trends. Such analysis shall not disclose individually identifiable 
health information when presenting such drug safety signals and trends 
or when responding to inquiries regarding such drug safety signals and 
trends.
    ``(6) Not later than 4 years after the date of the enactment of 
this paragraph, the Secretary shall report to the Congress on the ways 
in which the Secretary has used the surveillance system described in 
this subsection to identify specific drug safety signals and to better 
understand the outcomes associated with drugs marketed in the United 
States.
    ``(7) Disclosure of individually identifiable information is 
prohibited in the surveillance system described in this subsection. 
Nothing in this subsection prohibits lawful disclosure of such 
information for other purposes.
    ``(8) Nothing in this subsection shall be construed as limiting 
public health activities authorized under law.''.
    (c) Authorization of Appropriations.--To carry out activities under 
the amendment made by subsection (b) 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, in addition to 
such funds, $25,000,000 for each of fiscal years 2008 through 2012.
    (d) GAO Report.--Not later than 18 months after the date of the 
enactment of this Act, the Comptroller General of the United States 
shall evaluate data confidentiality and security issues relating to 
collection, transmission, and maintenance of data for the surveillance 
system developed pursuant to this section, and make recommendations to 
the Committee on Energy and Commerce of the House of Representatives 
and the Committee on Health, Education, Labor and Pensions of the 
Senate, and any other congressional committees of relevant 
jurisdiction, regarding the need for any additional legislative or 
regulatory actions to ensure confidentiality and security of this data 
or otherwise address confidentiality and security issues to ensure the 
effective operation of the surveillance system.

SEC. 907. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER ADVERTISEMENTS 
              OF DRUGS.

    Section 502(n) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 352), as amended by section 901(d)(3), is further amended by 
striking ``of this Act, except that'' and inserting ``of this Act, and 
in the case of any direct-to-consumer advertisement the following 
statement: `You are encouraged to report adverse effects of 
prescription drug medication to the FDA. Log onto www.fda.gov/medwatch 
or call 1-800-FDA-1088.', except that''.

SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 510 the following:

``SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

    ``(a) In General.--Not later than 1 year after the date of 
enactment of this section, the Secretary, acting through the 
Commissioner of Food and Drugs, shall issue guidance for the conduct of 
clinical trials with respect to antibiotic drugs, including 
antimicrobials to treat acute bacterial sinusitis, acute bacterial 
otitis media, and acute bacterial exacerbation of chronic bronchitis. 
Such guidelines shall indicate the appropriate animal models of 
infection, in vitro techniques, and valid microbiologic surrogate 
markers.
    ``(b) Review.--Not later than 5 years after the date of enactment 
of this section, the Secretary, acting through the Commissioner of Food 
and Drugs, shall review and update the guidance described under 
subsection (a) to reflect developments in scientific and medical 
information and technology.''.

SEC. 909. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR BIOLOGICAL 
              PRODUCTS HAVE BEEN ADDED.

    Section 301 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
331), as amended by section 901(d)(2)(A), is amended by adding at the 
end the following:
    ``(kk) The introduction or delivery for introduction into 
interstate commerce of any food to which has been added--
            ``(1) a drug approved under section 505,
            ``(2) a biological product licensed under section 351 of 
        the Public Health Service Act, or
            ``(3) a drug or biological product for which substantial 
        clinical investigations have been instituted and for which the 
        existence of such investigations has been made public,
unless such drug or biological product was marketed in food before any 
approval of the drug under section 505 of this Act, before licensure of 
the biological product under section 351 of the Public Health Service 
Act, and before any substantial clinical investigations involving the 
drug or biological product have been instituted, or unless the 
Secretary, in the Secretary's discretion, has issued a regulation, 
after notice and comment, approving the addition of such drug or 
biological product to the food.''.

SEC. 910. ASSURING PHARMACEUTICAL SAFETY.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 505B the following:

``SEC. 505C. PHARMACEUTICAL SECURITY.

    ``(a) In General.--The Secretary shall develop standards and 
identify and validate effective technologies for the purpose of 
securing the prescription drug distribution system against counterfeit, 
diverted, subpotent, substandard, adulterated, misbranded, or expired 
drugs.
    ``(b) Standards Development.--
            ``(1) In general.--The Secretary shall, in consultation 
        with the agencies specified in paragraph (3), prioritize and 
        develop standards for the identification, validation, 
        authentication, and tracking of prescription drugs.
            ``(2) Promising technologies.--The standards developed 
        under this subsection shall address promising technologies, 
        including--
                    ``(A) radio frequency identification technology;
                    ``(B) nanotechnology;
                    ``(C) encryption technologies; and
                    ``(D) other track-and-trace technologies.
            ``(3) Interagency collaboration.--In carrying out this 
        subsection, the Secretary shall consult with Federal health and 
        security agencies, including--
                    ``(A) the Administrator of the Drug Enforcement 
                Administration;
                    ``(B) the Secretary of the Department of Homeland 
                Security;
                    ``(C) the Secretary of Commerce; and
                    ``(D) other appropriate Federal and State agencies.
    ``(c) Inspection and Enforcement.--
            ``(1) In general.--The Secretary shall expand and enhance 
        the resources and facilities of the Office of Regulatory 
        Affairs of the Food and Drug Administration to protect the 
        prescription drug distribution system against counterfeit, 
        diverted, subpotent, substandard, adulterated, misbranded, or 
        expired drugs.
            ``(2) Activities.--The Secretary shall undertake enhanced 
        and joint enforcement activities with other Federal agencies 
        and State officials, and establish regional capacities for the 
        validation of prescription drugs and the inspection of the 
        prescription drug distribution system.
    ``(d) Definition.--In this section, the term `prescription drug' 
means a drug subject to section 503(b)(1).''.

SEC. 911. ORPHAN ANTIBIOTIC DRUGS.

    (a) Public Meeting.--The Commissioner of Food and Drugs shall 
convene a public meeting 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 section 5(a) 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.--
Section 5(c) 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 is 
authorized to be appropriated $30,000,000 for each of fiscal years 2008 
through 2012.''.

SEC. 912. AUTHORIZATION OF APPROPRIATIONS.

    (a) In General.--For carrying out this title and the amendments 
made by this title, there is authorized to be appropriated $25,000,000 
for each of fiscal years 2008 through 2012.
    (b) Relation to Other Funding.--The authorization of appropriations 
under subsection (a) is in addition to any other funds available for 
carrying out this title and the amendments made by this title.

SEC. 913. EFFECTIVE DATE AND APPLICABILITY.

    (a) Effective Date.--This title takes effect 180 days after the 
date of the enactment of this Act.
    (b) Drugs Deemed to Have Risk Evaluation and Mitigation 
Strategies.--
            (1) In general.--A drug that was approved before the 
        effective date of this Act is, in accordance with paragraph 
        (2), deemed to have in effect an approved risk evaluation and 
        mitigation strategy under section 505-1 of the Federal Food, 
        Drug, and Cosmetic Act (as added by section 901 of this title) 
        (referred to in this section as the ``Act'' ) if there are in 
        effect on the effective date of this Act 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) Elements of strategy; enforcement.--The approved risk 
        evaluation and mitigation strategy in effect for a drug under 
        paragraph (1)--
                    (A) is deemed to consist of the elements described 
                in paragraphs (1) and (2) of section 505-1(d) of the 
                Act and any additional elements under subsections (d) 
                and (e) of such section in effect for such drug on the 
                effective date of this Act; and
                    (B) is subject to enforcement by the Secretary to 
                the same extent as any other risk evaluation and 
                mitigation strategy under section 505-1 of the Act.
            (3) Submission.--Not later than 180 days after the 
        effective date of this Act, the holder of an approved 
        application for which a risk evaluation and mitigation strategy 
        is deemed to be in effect under paragraph (1) shall submit to 
        the Secretary a proposed risk evaluation and mitigation 
        strategy. Such proposed strategy is subject to section 505-1 of 
        the Act as if included in such application at the time of 
        submission of the application to the Secretary.
    (c) Other Drugs Approved Before the Effective Date.--The Secretary, 
on a case-by-case basis, may require the holder of an application 
approved before the effective date of this Act to which subsection (b) 
does not apply to submit a proposed risk evaluation and mitigation 
strategy in accordance with the timeframes provided for in 
subparagraphs (C) through (D) of section 505-1(g)(2) of the Act if the 
Secretary determines (with respect to such drug or with respect to the 
group of drugs to which such drug belongs) that--
            (1) an element described under section 505-1(d)(1) of the 
        Act may require modification; or
            (2) a standard for adding an element described in 
        subsection (e) or (d) of section 505-1 of the Act that is not 
        in effect with respect to such drug or class of drugs may 
        apply.
    (d) Use of Advisory Committees; Process for Addressing Drug Class 
Effects.--In imposing a requirement under subsection (c), the 
Secretary--
            (1) may convene a meeting of 1 or more advisory committees 
        of the Food and Drug Administration in accordance with 
        paragraph (6) of section 505-1(h) of the Act; and
            (2) may use the process described in paragraph (7) of such 
        section 505-1(h) (relating to addressing drug class effects).
                                 <all>