[Congressional Record (Bound Edition), Volume 153 (2007), Part 8]
[Senate]
[Pages 10624-10659]
[From the U.S. Government Publishing Office, www.gpo.gov]




             PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

  The PRESIDING OFFICER. Under the previous order, the Senate will 
proceed to the consideration of S. 1082, which the clerk will report by 
title.
  The assistant legislative clerk read as follows:

       A bill (S. 1082) to amend the Federal Food, Drug, and 
     Cosmetic Act to reauthorize and amend the prescription drug 
     user fee provisions, and for other purposes.

  The Senate proceeded to consider the bill, which had been reported 
from the Committee on Health, Education, Labor, and Pensions, with an 
amendment to strike all after the enacting clause and insert in lieu 
thereof the following:

     SECTION 1. SHORT TITLE.

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

                  TITLE I--PRESCRIPTION DRUG USER FEES

     SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

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

     SEC. 102. DRUG FEES.

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

     ``SEC. 735. DRUG FEES.

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

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

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``2003'' and inserting ``2008'';
       (2) in paragraph (1)--
       (A) in subparagraph (D)--
       (i) in the heading, by inserting ``or withdrawn before 
     filing'' after ``refund of fee if application refused for 
     filing''; and

[[Page 10625]]

       (ii) by inserting before the period at the end the 
     following: ``or withdrawn without a waiver before filing'';
       (B) by redesignating subparagraphs (E) and (F) as 
     subparagraphs (F) and (G), respectively; and
       (C) by inserting after subparagraph (D) the following:
       ``(E) Fee for application previously refused for filing or 
     withdrawn before filing.--An application or supplement that 
     has been refused for filing or that was withdrawn before 
     filing, if filed under protest or resubmitted, shall be 
     subject to the fee under subparagraph (A) (unless an 
     exception under subparagraph (C) or (F) applies or the fee is 
     waived or reduced under subsection (d)), without regard to 
     previous payment of such a fee and the refund of 75 percent 
     of that fee under subparagraph (D).''; and
       (3) in paragraph (2)--
       (A) in subparagraph (A), by striking ``subparagraph (B)'' 
     and inserting ``subparagraphs (B) and (C)''; and
       (B) by adding at the end the following:
       ``(C) Special rules for compounded positron emission 
     tomography drugs.--
       ``(i) In general.--Except as provided in clause (ii), each 
     person who is named as the applicant in an approved human 
     drug application for a compounded positron emission 
     tomography drug shall be subject under subparagraph (A) to 
     one-quarter of an annual establishment fee with respect to 
     each such establishment identified in the application as 
     producing compounded positron emission tomography drugs under 
     the approved application.
       ``(ii) Exception from annual establishment fee.--Each 
     person who is named as the applicant in an application 
     described in clause (i) shall not be assessed an annual 
     establishment fee for a fiscal year if the person certifies 
     to the Secretary, at a time specified by the Secretary and 
     using procedures specified by the Secretary, that--

       ``(I) the person is a not-for-profit medical center that 
     has only 1 establishment for the production of compounded 
     positron emission tomography drugs; and
       ``(II) at least 95 percent of the total number of doses of 
     each compounded positron emission tomography drug produced by 
     such establishment during such fiscal year will be used 
     within the medical center.''.

       (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 
     379h(b)) is amended to read as follows:
       ``(b) Fee Revenue Amounts.--Except as provided in 
     subsections (c), (d), (f), and (g), fees under subsection (a) 
     shall be established to generate the following revenue 
     amounts, in each fiscal year beginning with fiscal year 2008 
     and continuing through fiscal year 2012: $392,783,000, plus 
     an adjustment for workload on $354,893,000 of this amount. 
     Such adjustment shall be made in accordance with the workload 
     adjustment provisions in effect for fiscal year 2007, except 
     that instead of commercial investigational new drug 
     applications submitted to the Secretary, all commercial 
     investigational new drug applications with a submission 
     during the previous 12-month period shall be used in the 
     determination. One-third of the revenue amount shall be 
     derived from application fees, one-third from establishment 
     fees, and one-third from product fees.''.
       (c) Adjustments to Fees.--
       (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
     379h(c)(1)) is amended--
       (A) in the matter preceding subparagraph (A) by striking 
     ``The revenues established in subsection (b)'' and inserting 
     ``Beginning with fiscal year 2009, the revenues established 
     in subsection (b)'';
       (B) in subparagraph (A) by striking ``or'' at the end;
       (C) in subparagraph (B) by striking the period at the end 
     and inserting ``, or,'';
       (D) by inserting after subparagraph (B) the following:
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions, for the first 5 fiscal years of the previous 
     6 fiscal years.''; and
       (E) in the matter following subparagraph (C) (as added by 
     this paragraph), by striking ``fiscal year 2003'' and 
     inserting ``fiscal year 2008''.
       (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
     379h(c)(2)) is amended--
       (A) in the matter preceding subparagraph (A,) by striking 
     ``2004'' and inserting ``2009'';
       (B) in the first sentence of subparagraph (A)--
       (i) by striking ``, commercial investigational new drug 
     applications'' and inserting ``(adjusted for changes in 
     review activities)''; and
       (ii) by inserting before the period at the end ``, and the 
     change in the number of commercial investigational new drug 
     applications with a submission during the previous 12-month 
     period (adjusted for changes in review activities)'';
       (C) in subparagraph (B), by adding at the end the following 
     new sentence: ``Further, any adjustment for changes in review 
     activities made in setting fees and fee revenue amounts for 
     fiscal year 2009 may not result in the total workload 
     adjustment being more than 2 percentage points higher than it 
     would be absent the adjustment for changes in review 
     activities.''; and
       (D) by adding at the end the following:
       ``(C) The Secretary shall contract with an independent 
     accounting firm to study the adjustment for changes in review 
     activities applied in setting fees for fiscal year 2009 and 
     to make recommendations, if warranted, on future changes in 
     the methodology for calculating the adjustment for changes in 
     review activity. After review of the recommendations by the 
     independent accounting firm, the Secretary shall make 
     appropriate changes to the workload adjustment methodology in 
     setting fees for fiscal years 2010 through 2012. If the study 
     is not conducted, no adjustment for changes in review 
     activities shall be made after fiscal year 2009.''.
       (3) Rent and rent-related cost adjustment.--Section 736(c) 
     (21 U.S.C. 379h(c)) is amended--
       (A) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), respectively; and
       (B) by inserting after paragraph (2) the following:
       ``(3) Rent and rent-related cost adjustment.--Beginning 
     with fiscal year 2010, the Secretary shall, before making the 
     adjustments under paragraphs (1) and (2), reduce the fee 
     amounts established in subsection (b), if actual costs paid 
     for rent and rent-related expenses are less than $11,721,000. 
     The reductions made under this paragraph, if any, shall not 
     exceed the amounts by which costs fell below $11,721,000, and 
     shall not exceed $11,721,000 in any fiscal year.''.
       (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (A) in paragraph (4), as redesignated by this subsection--
       (i) by striking ``2007'' each place it appears and 
     inserting ``2012''; and
       (ii) by striking ``2008'' and inserting ``2013''; and
       (B) in paragraph (5), as redesignated by this subsection, 
     by striking ``2002'' and inserting ``2007''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) in paragraph (1), in the matter preceding subparagraph 
     (A), by--
       (A) inserting ``to a person who is named as the applicant'' 
     after ``The Secretary shall grant'';
       (B) inserting ``to that person'' after ``a waiver from or a 
     reduction of one or more fees assessed''; and
       (C) striking ``finds'' and inserting ``determines'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (3) by inserting after paragraph (1) the following:
       ``(2) Evaluation.--For the purpose of determining whether 
     to grant a waiver or reduction of a fee under paragraph (1), 
     the Secretary shall consider only the circumstances and 
     assets of the applicant and any affiliate of the 
     applicant.''; and
       (4) in paragraph (4), as redesignated by this subsection, 
     in subparagraph (A), by inserting before the period at the 
     end ``, and that does not have a drug product that has been 
     approved under a human drug application and introduced or 
     delivered for introduction into interstate commerce''.
       (e) Crediting and Availability of Fees.--
       (1) Authorization of appropriations.--Section 736(g)(3) (21 
     U.S.C. 379h(g)(3)) is amended to read as follows:
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section 
     such sums as are authorized to be assessed and collected 
     under this section in each of fiscal years 2008 through 
     2012.''.
       (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
     amended to read as follows:
       ``(4) Offset.--If the cumulative amount of fees collected 
     during fiscal years 2008, 2009, and 2010, plus the amount 
     estimated to be collected for fiscal year 2011, exceeds the 
     amount of fees specified in aggregate in appropriation Acts 
     for such fiscal years, the aggregate amount in excess shall 
     be credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.
       (f) Conforming Amendments.--
       (1) Section 736(a) (21 U.S.C. 379h(a)), as amended by this 
     section, is amended--
       (A) in paragraph (1)(A), by striking ``subsection (c)(4)'' 
     each place it appears and inserting ``subsection (c)(5)'';
       (B) in paragraph (2), by striking ``subsection (c)(4)'' and 
     inserting ``subsection (c)(5)''; and
       (C) in paragraph (3), by striking ``subsection (c)(4)'' and 
     inserting ``subsection (c)(5)''.
       (2) Section 736A(h)(3), as added by section 104 of this 
     title, is amended by striking ``735(3)'' and inserting 
     ``735(d)(3)''.

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

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

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

       ``(a) Types of Direct-to-Consumer Television Advertisement 
     Review Fees.--Beginning with fiscal year 2008, the Secretary 
     shall assess and collect fees in accordance with this section 
     as follows:
       ``(1) Advisory review fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each person that on or after October 1, 2007, submits a 
     proposed direct-to-consumer television advertisement for 
     advisory review by the Secretary prior to its initial public

[[Page 10626]]

     dissemination shall be subject to a fee established under 
     subsection (c)(3).
       ``(B) Exception for required submissions.--A direct-to-
     consumer television advertisement that is required to be 
     submitted to the Secretary prior to initial public 
     dissemination shall not be assessed a fee unless the sponsor 
     designates it as a submission for advisory review.
       ``(C) Payment.--The fee required by subparagraph (A) shall 
     be due not later than October 1 of the fiscal year in which 
     the direct-to-consumer television advertisement shall be 
     submitted to the Secretary for advisory review.
       ``(D) Modification of advisory review fee.--
       ``(i) Late payment.--If, on or before November 1 of the 
     fiscal year in which the fees are due, a person has not paid 
     all fees that were due and payable for advisory reviews 
     identified in response to the Federal Register notice 
     described in subsection (c)(3)(A), the fees shall be regarded 
     as late. Such fees shall be due and payable 20 days before 
     any direct-to-consumer television advertisement is submitted 
     by such person to the Secretary for advisory review. 
     Notwithstanding any other provision of this section, such 
     fees shall be due and payable for each of those advisory 
     reviews in the amount of 150 percent of the advisory review 
     fee established for that fiscal year pursuant to subsection 
     (c)(3).
       ``(ii) Late notice of submission.--If any person submits 
     any direct-to-consumer television advertisements for advisory 
     review that are in excess of the number identified by that 
     person in response to the Federal Register notice described 
     in subsection (c)(3)(A), that person must pay a fee for each 
     of those advisory reviews in the amount of 150 percent of the 
     advisory review fee established for that fiscal year pursuant 
     to subsection (c)(3). Fees under this subparagraph shall be 
     due 20 days before the direct-to-consumer television 
     advertisement is submitted by such person to the Secretary 
     for advisory review.
       ``(E) Limits.--
       ``(i) In general.--The payment of a fee under this 
     paragraph for a fiscal year entitles the person that pays the 
     fee to acceptance for advisory review by the Secretary of 1 
     direct-to-consumer television advertisement and acceptance of 
     1 resubmission for advisory review of the same advertisement. 
     The advertisement shall be submitted for review in the fiscal 
     year for which the fee was assessed, except that a person may 
     carry over no more than 1 paid advisory review submission to 
     the next fiscal year. Resubmissions may be submitted without 
     regard to the fiscal year of the initial advisory review 
     submission.
       ``(ii) No refund.--Except as provided by subsection (f), 
     fees paid under this paragraph shall not be refunded.
       ``(iii) No waiver, exemption, or reduction.--The Secretary 
     shall not grant a waiver, exemption, or reduction of any fees 
     due or payable under this section.
       ``(iv) Non-transferability.--The right to an advisory 
     review is not transferable, except to a successor in 
     interest.
       ``(2) Operating reserve fee.--
       ``(A) In general.--Each person that, on or after October 1, 
     2007, is assessed an advisory review fee under paragraph (1) 
     shall be subject to an operating reserve fee established 
     under subsection (d)(2) only in the first fiscal year in 
     which an advisory review fee is assessed.
       ``(B) Payment.--Except as provided in subparagraph (C), the 
     fee required by subparagraph (A) shall be due not later than 
     October 1 of the first fiscal year in which the person is 
     required to pay an advisory review fee under paragraph (1).
       ``(C) Late notice of submission.--If, in the first fiscal 
     year of a person's participation in the Program, that person 
     submits any direct-to-consumer television advertisements for 
     advisory review that are in excess of the number identified 
     by that person in response to the Federal Register notice 
     described in subsection (c)(3)(A), that person must pay an 
     operating reserve fee for each of those advisory reviews 
     equal to the advisory review fee for each submission 
     established under paragraph (1)(D)(ii). Fees required by this 
     subparagraph shall be in addition to the fees required under 
     subparagraph (B), if any. Fees under this subparagraph shall 
     be due 20 days before any direct-to-consumer television 
     advertisement is submitted by such person to the Secretary 
     for advisory review.
       ``(b) Advisory Review Fee Revenue Amounts.--Fees under 
     subsection (a)(1) shall be established to generate revenue 
     amounts of $6,250,000 for each of fiscal years 2008 through 
     2012, as adjusted pursuant to subsection (c).
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--Beginning with fiscal year 
     2009, the revenues established in subsection (b) shall be 
     adjusted by the Secretary by notice, published in the Federal 
     Register, for a fiscal year to reflect the greater of--
       ``(A) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; 
     United States city average), for the 12-month period ending 
     June 30 preceding the fiscal year for which fees are being 
     established;
       ``(B) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, as adjusted by any locality-
     based comparability payment pursuant to section 5304 of such 
     title for Federal employees stationed in the District of 
     Columbia; or
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions, for the first 5 fiscal years of the previous 
     6 fiscal years.
     The adjustment made each fiscal year by this paragraph shall 
     be added on a compounded basis to the sum of all adjustments 
     made each fiscal year after fiscal year 2008 under this 
     subsection.
       ``(2) Workload adjustment.--
       ``(A) In general.--Beginning with fiscal year 2009, after 
     the fee revenues established in subsection (b) of this 
     section are adjusted for a fiscal year for inflation in 
     accordance with paragraph (1), the fee revenues shall be 
     adjusted further for such fiscal year to reflect changes in 
     the workload of the Secretary with respect to the submission 
     of proposed direct-to-consumer television advertisements for 
     advisory review prior to initial broadcast.
       ``(B) Determination of workload adjustment.--
       ``(i) In general.--The workload adjustment under this 
     paragraph for a fiscal year shall be determined by the 
     Secretary--

       ``(I) based upon the number of direct-to-consumer 
     television advertisements identified pursuant to paragraph 
     (3)(A) for that fiscal year, excluding allowable previously 
     paid carry over submissions; and
       ``(II) by multiplying the number of such advertisements 
     projected for that fiscal year that exceeds 150 by $27,600 
     (adjusted each year beginning with fiscal year 2009 for 
     inflation in accordance with paragraph (1)).

       ``(ii) Publication in federal register.--The Secretary 
     shall publish in the Federal Register, as part of the notice 
     described in paragraph (1), the fee revenues and fees 
     resulting from the adjustment made under this paragraph and 
     the supporting methodologies.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment made under this paragraph result in fee revenues 
     for a fiscal year that are less than the fee revenues 
     established for the prior fiscal year.
       ``(3) Annual fee setting.--
       ``(A) Number of advertisements.--The Secretary shall, 120 
     days before the start of each fiscal year, publish a notice 
     in the Federal Register requesting any person to notify the 
     Secretary within 30 days of the number of direct-to-consumer 
     television advertisements the person intends to submit for 
     advisory review by the Secretary in the next fiscal year. 
     Notification to the Secretary of the number of advertisements 
     a person intends to submit for advisory review prior to 
     initial broadcast shall be a legally binding commitment by 
     that person to pay the annual advisory review fee for that 
     number of submissions on or before October 1 of the fiscal 
     year in which the advertisement is intended to be submitted. 
     A person shall at the same time also notify the Secretary if 
     such person intends to use a paid submission from the 
     previous fiscal year under subsection (a)(1)(E)(i). If such 
     person does not so notify the Secretary, all submissions for 
     advisory review shall be subject to advisory review fees.
       ``(B) Annual fee.--The Secretary shall, 60 days before the 
     start of each fiscal year, establish, for the next fiscal 
     year, the direct-to-consumer television advertisement 
     advisory review fee under subsection (a)(1), based on the 
     revenue amounts established under subsection (b), the 
     adjustments provided under this subsection and the number of 
     direct-to-consumer television advertisements identified 
     pursuant to subparagraph (A), excluding allowable previously 
     paid carry over submissions. The annual advisory review fee 
     shall be established by dividing the fee revenue for a fiscal 
     year (as adjusted pursuant to this subsection) by the number 
     of direct-to-consumer television advertisements identified 
     pursuant to subparagraph (A), excluding allowable previously 
     paid carry over submissions.
       ``(C) Fiscal year 2008 fee limit.--Notwithstanding 
     subsection (b), the fee established under subparagraph (B) 
     for fiscal year 2008 may not be more than $83,000 per 
     submission for advisory review.
       ``(D) Annual fee limit.--Notwithstanding subsection (b), 
     the fee established under subparagraph (B) for a fiscal year 
     after fiscal year 2008 may not be more than 50 percent more 
     than the fee established for the prior fiscal year.
       ``(E) Limit.--The total amount of fees obligated for a 
     fiscal year may not exceed the total costs for such fiscal 
     year for the resources allocated for the process for the 
     advisory review of prescription drug advertising.
       ``(d) Operating Reserves.--
       ``(1) In general.--The Secretary shall establish in the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation a 
     Direct-to-Consumer Advisory Review Operating Reserve, of at 
     least $6,250,000 in fiscal year 2008, to continue the Program 
     in the event the fees collected in any subsequent fiscal year 
     pursuant to subsection (c)(3) do not generate the fee revenue 
     amount established for that fiscal year.
       ``(2) Fee setting.--The Secretary shall establish the 
     operating reserve fee under subsection (a)(2)(A) for each 
     person required to pay the fee by multiplying the number of 
     direct-to-consumer television advertisements identified by 
     that person pursuant to subsection (c)(3)(A) by the advisory 
     review fee established pursuant to subsection (c)(3) for that 
     fiscal year. In no case shall the operating reserve fee 
     assessed be less than the operating reserve fee assessed if 
     the person had first participated in the Program in fiscal 
     year 2008.
       ``(3) Use of operating reserve.--The Secretary may use 
     funds from the reserves under this subsection only to the 
     extent necessary in

[[Page 10627]]

     any fiscal year to make up the difference between the fee 
     revenue amount established for that fiscal year under 
     subsection (b) and the amount of fees collected for that 
     fiscal year pursuant to subsection (a), or to pay costs of 
     ending the Program if it is terminated pursuant to subsection 
     (f) or if it is not reauthorized after fiscal year 2012.
       ``(4) Refund of operating reserves.--Within 120 days of the 
     end of fiscal year 2012, or if the Program is terminated 
     pursuant to subsection (f), the Secretary, after setting 
     aside sufficient operating reserve amounts to terminate the 
     Program, shall refund all amounts remaining in the operating 
     reserve on a pro rata basis to each person that paid an 
     operating reserve fee assessment. In no event shall the 
     refund to any person exceed the total amount of operating 
     reserve fees paid by such person pursuant to subsection 
     (a)(2).
       ``(e) Effect of Failure To Pay Fees.--Notwithstanding any 
     other law or regulation of the Secretary, a submission for 
     advisory review of a direct-to-consumer television 
     advertisement submitted by a person subject to fees under 
     subsection (a) shall be considered incomplete and shall not 
     be accepted for review by the Secretary until all fees owed 
     by such person under this section have been paid.
       ``(f) Effect of Inadequate Funding of Program.--
       ``(1) First fiscal year.--If on November 1, 2007, or 120 
     days after enactment of the Prescription Drug User Fee 
     Amendments of 2007, whichever is later, the Secretary has 
     received less than $11,250,000 in advisory review fees and 
     operating reserve fees combined, the Program shall be 
     terminated and all collected fees shall be refunded.
       ``(2) Subsequent fiscal years.--Beginning in fiscal year 
     2009, if, on November 1 of a fiscal year, the combination of 
     the operating reserves, annual fee revenues from that fiscal 
     year, and unobligated fee revenues from prior fiscal years is 
     less than $9,000,000, adjusted for inflation (in accordance 
     with subsection (c)(1)), the Program shall be terminated, and 
     the Secretary shall notify all participants, retain any money 
     from the unused advisory review fees and the operating 
     reserves needed to terminate the Program, and refund the 
     remainder of the unused fees and operating reserves. To the 
     extent required to terminate the Program, the Secretary shall 
     first use unobligated advisory review fee revenues from prior 
     fiscal years, then the operating reserves, and then unused 
     advisory review fees from the relevant fiscal year.
       ``(g) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation. The sums 
     transferred shall be available solely for the process for the 
     advisory review of prescription drug advertising.
       ``(2) Collections and appropriation acts.--The fees 
     authorized by this section--
       ``(A) shall be retained in each fiscal year in an amount 
     not to exceed the amount specified in appropriation Acts, or 
     otherwise made available for obligation for such fiscal year; 
     and
       ``(B) shall be available for obligation only if 
     appropriated budget authority continues to support at least 
     the total combined number of full-time equivalent employees 
     in the Food and Drug Administration, Center for Drug 
     Evaluation and Research, Division of Drug Marketing, 
     Advertising, and Communications, and the Center for Biologics 
     Evaluation and Research, Advertising and Promotional Labeling 
     Branch supported in fiscal year 2007.
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section not 
     less than $6,250,000 for each of fiscal years 2008, 2009, 
     2010, 2011, and 2012, as adjusted to reflect adjustments in 
     the total fee revenues made under this section, plus amounts 
     collected for the reserve fund under subsection (d).
       ``(4) Offset.--Any amount of fees collected for a fiscal 
     year under this section that exceeds the amount of fees 
     specified in appropriation Acts for such fiscal year shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     collected under this section pursuant to appropriation Acts 
     for a subsequent fiscal year.
       ``(h) Definitions.--For purposes of this section:
       ``(1) The term `advisory review' means reviewing and 
     providing advisory comments regarding compliance of a 
     proposed advertisement with the requirements of this Act 
     prior to its initial public dissemination.
       ``(2) The term `carry over submission' means a submission 
     for an advisory review for which a fee was paid in a fiscal 
     year that is submitted for review in the following fiscal 
     year.
       ``(3) The term `direct-to-consumer television 
     advertisement' means an advertisement for a prescription drug 
     product as defined in section 735(3) intended to be displayed 
     on any television channel for less than 2 minutes.
       ``(4) The term `person' includes an individual, a 
     partnership, a corporation, and an association, and any 
     affiliate thereof or successor in interest.
       ``(5) The term `process for the advisory review of 
     prescription drug advertising' means the activities necessary 
     to review and provide advisory comments on proposed direct-
     to-consumer television advertisements prior to public 
     dissemination and, to the extent the Secretary has additional 
     staff resources available under the Program that are not 
     necessary for the advisory review of direct-to-consumer 
     television advertisements, the activities necessary to review 
     and provide advisory comments on other proposed 
     advertisements and promotional material prior to public 
     dissemination.
       ``(6) The term `Program' means the Program to assess, 
     collect, and use fees for the advisory review of prescription 
     drug advertising established by this section.
       ``(7) The term `resources allocated for the process for the 
     advisory review of prescription drug advertising' means the 
     expenses incurred in connection with the process for the 
     advisory review of prescription drug advertising for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers, employees, and committees, and to contracts 
     with such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies;
       ``(D) collection of fees under this section and accounting 
     for resources allocated for the advisory review of 
     prescription drug advertising; and
       ``(E) terminating the Program under subsection (f)(2), if 
     necessary.
       ``(8) The term `resubmission' means a subsequent submission 
     for advisory review of a direct-to-consumer television 
     advertisement that has been revised in response to the 
     Secretary's comments on an original submission. A 
     resubmission may not introduce significant new concepts or 
     creative themes into the television advertisement.
       ``(9) The term `submission for advisory review' means an 
     original submission of a direct-to-consumer television 
     advertisement for which the sponsor voluntarily requests 
     advisory comments before the advertisement is publicly 
     disseminated.

     ``SEC. 736B. SUNSET.

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

     SEC. 105. SAVINGS CLAUSE.

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

     SEC. 106. TECHNICAL AMENDMENT.

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

     SEC. 107. EFFECTIVE DATES.

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

                         TITLE II--DRUG SAFETY

     SEC. 200. SHORT TITLE.

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

         Subtitle A--Risk Evaluation and Mitigation Strategies

     SEC. 201. RISK EVALUATION.

       (a) In General.--Subsection (k) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
     amended by adding at the end the following:
       ``(3) Risk identification and assessment.--
       ``(A) Routine active safety monitoring.--The Secretary 
     shall facilitate a public-private partnership to-
       ``(i) implement a routine active monitoring system for 
     postmarket drug safety; and
       ``(ii) focus postmarket studies under subsection (o)(4)(B) 
     and postapproval clinical trials under subsection (o)(4)(C) 
     more effectively on cases for which reports under paragraph 
     (1) and other safety signal detection is not sufficient to 
     resolve whether there is an elevated risk of a serious 
     adverse event associated with use of a drug.
       ``(B) Public-private partnership.--The public-private 
     partnership described in subparagraph (A) shall--
       ``(i) develop a mechanism for the pooling of relevant data 
     from Federal and private electronic health care population 
     databases that--

       ``(I) includes, in aggregate--

       ``(aa) at least 25,000,000 patients by January 1, 2009; and
       ``(bb) at least 100,000,000 patients by January 1, 2012;

[[Page 10628]]

       ``(II) allows access to full-text medical records, where 
     available;
       ``(III) takes into consideration the need for data 
     completeness, coding, cleansing, and transmission;
       ``(IV) may, on a temporary or permanent basis, implement 
     systems or products developed by private entities; and
       ``(V) complies with the requirements of the Health 
     Insurance Portability and Accountability Act of 1996;

       ``(ii) support the routine and systematic collection and 
     analysis of utilization and safety data from such pooled 
     databases and from the Food and Drug Administration with 
     respect to prescription drugs; and
       ``(iii) allow for prompt investigation of priority drug 
     safety questions, including--

       ``(I) unresolved safety questions for drugs or classes of 
     drugs; and
       ``(II) for a newly-approved drug--

       ``(aa) safety signals from clinical trials used to approve 
     the drug and from other preapproval trials;
       ``(bb) rare, serious drug adverse events; and
       ``(cc) the safety of use in domestic populations not 
     included in the trials used to approve the drug (such as 
     older people, people with comorbidities, pregnant women, or 
     children).
       ``(C) Other approaches.--
       ``(i) In general.--The Secretary shall develop, support, 
     and participate in other approaches, including in other 
     public-private partnerships, to gather and analyze data and 
     information relevant to priority drug safety questions, 
     including--

       ``(I) approaches that are complimentary to the routine 
     active safety monitoring described in subparagraphs (A) and 
     (B), especially with respect to assessing the safety of use 
     of a drug in domestic populations not included in the trials 
     used to approve the drug (such as older people, people with 
     comorbidities, pregnant women, or children); and
       ``(II) existing approaches such as the Vaccine Adverse 
     Event Reporting System and the Vaccine Safety Datalink or 
     successor databases.

       ``(ii) Best practices.--With respect to such other 
     approaches, the Secretary shall develop and implement best 
     practices in epidemiology and the use of improved analytic 
     tools.
       ``(D) Public process for priority questions.--At least 
     biannually, the Secretary shall seek recommendations from the 
     Drug Safety and Risk Management Advisory Committee (or 
     successor committee) and from other advisory committees, as 
     appropriate, to the Food and Drug Administration on--
       ``(i) priority drug safety questions; and
       ``(ii) mechanisms for answering such questions, including 
     through--

       ``(I) routine active safety monitoring; and
       ``(II) when such monitoring is not sufficient, postmarket 
     studies under subsection (o)(4)(B) and postapproval clinical 
     trials under subsection (o)(4)(C).

       ``(E) Analysis of drug safety data.--The Secretary shall 
     engage independent private research groups, including through 
     the Centers for Education and Research on Therapeutics 
     provided for under section 905 of the Public Health Service 
     Act, to conduct analyses of data relating to priority drug 
     safety questions.
       ``(F) Use of analyses.--The Secretary shall provide the 
     analyses described under subparagraph (E), including the 
     methods and results of such analyses, about a drug to the 
     sponsor or sponsors of such drug.
       ``(G) Public availability of analyses.--The Secretary shall 
     make the analyses described under subparagraph (E), including 
     the methods and results of such analyses, available to the 
     public for review and comment.
       ``(H) Qualified entities.--
       ``(i) In general.--The Secretary shall enter into contracts 
     with a sufficient number of qualified entities to develop and 
     provide information to the Secretary in a timely manner.
       ``(ii) Qualifications.--The Secretary shall enter into a 
     contract with an entity under clause (i) only if the 
     Secretary determines that the entity--

       ``(I) has the research capability and expertise to conduct 
     and complete the activities under this paragraph;
       ``(II) has in place an information technology 
     infrastructure to support adverse event surveillance data and 
     operational standards to provide security for such data;
       ``(III) has experience with, and expertise in, the 
     development of drug safety and effectiveness research using 
     electronic population data;
       ``(IV) has an understanding of drug development and risk/
     benefit balancing in a clinical setting; and
       ``(V) has a significant business presence in the United 
     States.

       ``(I) Contract requirements.--Each contract with a 
     qualified entity shall contain the following requirements:
       ``(i) Ensuring privacy.--The qualified entity shall provide 
     assurances that the entity will not use the data provided by 
     the Secretary in a manner that violates--

       ``(I) the Federal regulations promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996 (concerning the privacy of individually-
     identifiable beneficiary health information); or
       ``(II) sections 552 or 552a of title 5, United States Code, 
     with regard to the privacy of individually-identifiable 
     beneficiary health information.

       ``(ii) Component of another organization.--If a qualified 
     entity is a component of another organization--

       ``(I) the qualified entity shall maintain the data related 
     to the activities carried out under this paragraph separate 
     from the other components of the organization and establish 
     appropriate security measures to maintain the confidentiality 
     and privacy of such data; and
       ``(II) the entity shall not make an unauthorized disclosure 
     of such data to the other components of the organization in 
     breach of such confidentiality and privacy requirement.

       ``(iii) Termination or nonrenewal.--If a contract under 
     this paragraph is terminated or not renewed, the following 
     requirements shall apply:

       ``(I) Confidentiality and privacy regulations.--The entity 
     shall continue to comply with the confidentiality and privacy 
     requirements under this paragraph with respect to all data 
     disclosed to the entity.
       ``(II) Disposition of data.--The entity shall return to the 
     Secretary all data disclosed to the entity or, if returning 
     the data is not practicable, destroy the data.

       ``(J) Competitive procedures.--The Secretary shall use 
     competitive procedures (as defined in section 4(5) of the 
     Federal Procurement Policy Act) to enter into contracts under 
     subparagraph (H).
       ``(K) Review of contract in the event of a merger or 
     acquisition.--The Secretary shall review the contract with a 
     qualified entity under this paragraph in the event of a 
     merger or acquisition of the entity in order to ensure that 
     the requirements under this paragraph will continue to be 
     met.''.
       (b) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this section $30,000,000 for 
     each of fiscal years 2008 through 2012.

     SEC. 202. RISK EVALUATION AND MITIGATION STRATEGIES.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355) is amended by adding at the end the following:
       ``(o) Risk Evaluation and Mitigation Strategy.--
       ``(1) In general.--In the case of any drug subject to 
     subsection (b) or to section 351 of the Public Health Service 
     Act for which a risk evaluation and mitigation strategy is 
     approved as provided for in this subsection, the applicant 
     shall comply with the requirements of such strategy.
       ``(2) Definitions.--In this subsection:
       ``(A) Adverse drug experience.--The term `adverse drug 
     experience' means any adverse event associated with the use 
     of a drug in humans, whether or not considered drug related, 
     including--
       ``(i) an adverse event occurring in the course of the use 
     of the drug in professional practice;
       ``(ii) an adverse event occurring from an overdose of the 
     drug, whether accidental or intentional;
       ``(iii) an adverse event occurring from abuse of the drug;
       ``(iv) an adverse event occurring from withdrawal of the 
     drug; and
       ``(v) any failure of expected pharmacological action of the 
     drug.
       ``(B) New safety information.--The term `new safety 
     information' with respect to a drug means information about--
       ``(i) a serious risk or an unexpected serious risk with use 
     of the drug that the Secretary has become aware of since the 
     later of--

       ``(I) the date of initial approval of the drug under this 
     section or initial licensure of the drug under section 351 of 
     the Public Health Service Act; or
       ``(II) if applicable, the last assessment of the approved 
     risk evaluation and mitigation strategy for the drug; or

       ``(ii) the effectiveness of the approved risk evaluation 
     and mitigation strategy for the drug obtained since the later 
     of--

       ``(I) the approval of such strategy; or
       ``(II) the last assessment of such strategy.

       ``(C) Serious adverse drug experience.--The term `serious 
     adverse drug experience' is an adverse drug experience that--
       ``(i) results in--

       ``(I) death;
       ``(II) the placement of the patient at immediate risk of 
     death from the adverse drug experience as it occurred (not 
     including an adverse drug experience that might have caused 
     death had it occurred in a more severe form);
       ``(III) inpatient hospitalization or prolongation of 
     existing hospitalization;
       ``(IV) a persistent or significant incapacity or 
     substantial disruption of the ability to conduct normal life 
     functions; or
       ``(V) a congenital anomaly or birth defect; or

       ``(ii) based on appropriate medical judgment, may 
     jeopardize the patient and may require a medical or surgical 
     intervention to prevent an outcome described under clause 
     (i).
       ``(D) Serious risk.--The term `serious risk' means a risk 
     of a serious adverse drug experience.
       ``(E) Signal of a serious risk.--The term `signal of a 
     serious risk' means information related to a serious adverse 
     drug experience derived from--
       ``(i) a clinical trial;
       ``(ii) adverse event reports under subsection (k)(1);
       ``(iii) routine active safety monitoring under subsection 
     (k)(3);
       ``(iv) a postapproval study, including a study under 
     paragraph (4)(B); or
       ``(v) peer-reviewed biomedical literature.
       ``(F) Unexpected serious risk.--The term `unexpected 
     serious risk' means a serious adverse drug experience that--
       ``(i) is not listed in the labeling of a drug; or
       ``(ii) is symptomatically and pathophysiologically related 
     to an adverse drug

[[Page 10629]]

     experience listed in the labeling of the drug, but differs 
     from such adverse drug experience because of greater 
     severity, specificity, or prevalence.
       ``(3) Required elements of a risk evaluation and mitigation 
     strategy.--If a risk evaluation and mitigation strategy for a 
     drug is required, such strategy shall include--
       ``(A) the labeling for the drug for use by health care 
     providers as approved under subsection (c);
       ``(B) a timetable for submission of assessments of the 
     strategy, that--
       ``(i) for a drug no active ingredient (including any ester 
     or salt of the active ingredient) of which has been approved 
     in any other application under this section or section 351 of 
     the Public Health Service Act--

       ``(I) shall be no less frequently than 18 months and 3 
     years after the drug is initially approved and at a frequency 
     specified in the strategy for subsequent years; and
       ``(II) may be eliminated after the first 3 years if the 
     Secretary determines that serious risks of the drug have been 
     adequately identified and assessed and are being adequately 
     managed;

       ``(ii) for a drug other than a drug described under clause 
     (i), shall occur at a frequency determined by the Secretary; 
     and
       ``(iii) may be increased or reduced in frequency as 
     necessary as provided for in paragraph (7)(B)(v)(VI).
       ``(4) Additional potential evaluation elements of a risk 
     evaluation and mitigation strategy.--
       ``(A) Risk evaluation.--If a risk evaluation and mitigation 
     strategy for a drug is required, such strategy may include 1 
     or more of the additional evaluation elements described in 
     this paragraph, so long as the Secretary makes the 
     determination required with respect to each additional 
     included element.
       ``(B) Postapproval studies.--If the Secretary determines 
     that the reports under subsection (k)(1) and routine active 
     safety monitoring as available under subsection (k)(3) 
     (including available other approaches under subsection 
     (k)(3)(C)) are not sufficient to--
       ``(i) assess a signal of a serious risk with use of a drug; 
     or
       ``(ii) identify unexpected serious risks in a domestic 
     population who use the drug, including a population not 
     included in trials used to approve the drug (such as older 
     people, people with comorbidities, pregnant women, or 
     children),
     the risk evaluation and mitigation strategy for the drug may 
     require that the applicant conduct an appropriate 
     postapproval study, such as a prospective or retrospective 
     observational study, of the drug (which shall include a 
     timeframe specified by the Secretary for completing the study 
     and reporting the results to the Secretary).
       ``(C) Postapproval clinical trials.--If the Secretary 
     determines that the reports under subsection (k)(1), routine 
     active safety monitoring as available under subsection (k)(3) 
     (including available other approaches under subsection 
     (k)(3)(C)), and a study or studies under subparagraph (B) 
     will likely be inadequate to assess a signal of a serious 
     risk with use of a drug, and there is no effective approved 
     application for the drug under subsection (j) as of the date 
     that the requirement is first imposed, the risk evaluation 
     and mitigation strategy for the drug may require that the 
     applicant conduct an appropriate postapproval clinical trial 
     of the drug (which shall include a timeframe specified by the 
     Secretary for completing the clinical trial and reporting the 
     results to the Secretary) to be included in the clinical 
     trial registry data bank provided for under subsections (i) 
     and (j) of section 402 of the Public Health Service Act.
       ``(5) Additional potential communication elements of a risk 
     evaluation and mitigation strategy.--
       ``(A) Risk communication.--If a risk evaluation and 
     mitigation strategy for a drug is required, such strategy may 
     include 1 or more of the additional communication elements 
     described in this paragraph, so long as the Secretary makes 
     the determination required with respect to each additional 
     included element.
       ``(B) Medguide; patient package insert.--The risk 
     evaluation and mitigation strategy for a drug may require 
     that the applicant develop for distribution to each patient 
     when the drug is dispensed either or both of the following:
       ``(i) A Medication Guide, as provided for under part 208 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations).
       ``(ii) A patient package insert, if the Secretary 
     determines that such insert may help mitigate a serious risk 
     listed in the labeling of the drug.
       ``(C) Communication plan.--If the Secretary determines that 
     a communication plan to health care providers may support 
     implementation of an element of the risk evaluation and 
     mitigation strategy for a drug, such as a labeling change, 
     the strategy may require that the applicant conduct such a 
     plan, which may include--
       ``(i) sending letters to health care providers;
       ``(ii) disseminating information about the elements of the 
     strategy to encourage implementation by health care providers 
     of components that apply to such health care providers, or to 
     explain certain safety protocols (such as medical monitoring 
     by periodic laboratory tests); or
       ``(iii) disseminating information to health care providers 
     through professional societies about any serious risks of the 
     drug and any protocol to assure safe use.
       ``(D) Prereview.--
       ``(i) In general.--If the Secretary determines that 
     prereview of advertisements is necessary to ensure the 
     inclusion of a true statement in such advertisements of 
     information in brief summary relating to a serious risk 
     listed in the labeling of a drug, the risk evaluation and 
     mitigation strategy for the drug may require that the 
     applicant submit to the Secretary advertisements of the drug 
     for prereview not later than 45 days before dissemination of 
     the advertisement.
       ``(ii) Specification of advertisements.--The Secretary may 
     specify the advertisements required to be submitted under 
     clause (i).
       ``(E) Specific disclosures.--
       ``(i) Serious risk; safety protocol.--If the Secretary 
     determines that advertisements lacking a specific disclosure 
     about a serious risk listed in the labeling of a drug or 
     about a protocol to ensure safe use described in the labeling 
     of the drug would be false or misleading, the risk evaluation 
     and mitigation strategy for the drug may require that the 
     applicant include in advertisements of the drug such 
     disclosure.
       ``(ii) Date of approval.--If the Secretary determines that 
     advertisements lacking a specific disclosure of the date a 
     drug was approved and that the existing information may not 
     have identified or allowed for full assessment of all serious 
     risks of using the drug is necessary to protect public health 
     and safety, the risk evaluation and mitigation strategy for 
     the drug may require that the applicant include in 
     advertisements of the drug such disclosure.
       ``(iii) Specification of advertisements.--The Secretary may 
     specify the advertisements required to include a specific 
     disclosure under clause (i) or (ii).
       ``(F) Temporary moratorium.--To the extent consistent with 
     the Constitution, if the Secretary determines that disclosure 
     under subparagraph (E)(ii) is inadequate to protect public 
     health and safety, and that a prohibition of direct-to-
     consumer advertisements of the drug for a fixed period after 
     initial approval of the drug, not to exceed 2 years, is 
     necessary to protect public health and safety while 
     additional information about serious risks of the drug is 
     collected using the reports under subsection (k)(1) and the 
     routine active safety monitoring as available under 
     subsection (k)(3) (including available other approaches under 
     subsection (k)(3)(C)), the risk evaluation and mitigation 
     strategy for the drug may require that the applicant not 
     issue or cause to be issued direct-to-consumer advertisements 
     of the drug for such fixed period. In making such 
     determination, the Secretary shall consider--
       ``(i) the number of patients who may be treated with the 
     drug;
       ``(ii) the seriousness of the condition for which the drug 
     will be used;
       ``(iii) the serious risks listed in the labeling of the 
     drug;
       ``(iv) the extent to which patients have access to other 
     approved drugs in the pharmacological class of the drug and 
     with the same intended use as the drug; and
       ``(v) the extent to which clinical trials used to approve 
     the drug may not have identified serious risks that might 
     occur among patients expected to be treated with the drug.
       ``(6) Restrictions on distribution or use for drugs with 
     known unusual, serious risks.--
       ``(A) In general.--When a risk evaluation and mitigation 
     strategy for a drug is required, and considering the adequacy 
     of the labeling of the drug and 1 or more communication 
     elements under paragraph (5) to mitigate a specific serious 
     risk listed in the labeling of the drug, if the Secretary 
     determines that the drug, which has been shown to be 
     effective, can be safely used only if distribution or use of 
     such drug is restricted, the Secretary may require as 
     elements of such strategy such restrictions on distribution 
     or use as are needed to assure safe use of the drug.
       ``(B) Limits on restrictions to assure access and minimize 
     burden.--Such restrictions under subparagraph (A) shall--
       ``(i) be commensurate with the specific, serious risk 
     presented by the drug;
       ``(ii) 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 (such as patients in rural areas) who have 
     difficulty accessing health care; and

       ``(iii) to the extent practicable, so as to minimize the 
     burden on the health care delivery system--

       ``(I) conform with restrictions on distribution or use for 
     other drugs with similar, serious risks; and
       ``(II) be designed to be compatible with established 
     distribution, procurement, and dispensing systems for drugs.

       ``(C) Elements to protect patient safety.--The restrictions 
     on distribution or use described under subparagraph (A) shall 
     include 1 or more goals to evaluate or mitigate a specific 
     serious risk listed in the labeling of the drug and, to 
     mitigate such risk, may require that--
       ``(i) health care providers that prescribe the drug have 
     particular training or experience, or are specially 
     certified;
       ``(ii) pharmacies, practitioners, or health care settings 
     that dispense the drug are specially certified;
       ``(iii) the drug be dispensed to patients only in certain 
     health care settings, such as hospitals;
       ``(iv) the drug be dispensed to patients with evidence or 
     other documentation of safe-use conditions, such as 
     laboratory test results;
       ``(v) each patient using the drug be subject to certain 
     monitoring; or
       ``(vi) each patient using the drug be enrolled in a 
     registry.

[[Page 10630]]

       ``(D) Implementation system.--The restrictions on 
     distribution or use described under subparagraph (A) that 
     employ elements described in clauses (ii), (iii), or (iv) of 
     subparagraph (C) may include a system through which the 
     applicant is able to take reasonable steps to--
       ``(i) monitor and evaluate implementation of such elements 
     by health care providers, pharmacists, and other parties in 
     the health care system who are responsible for implementing 
     such elements; and
       ``(ii) work to improve implementation of such elements by 
     such persons.
       ``(E) Evaluation of restrictions.--The Secretary, through 
     the Drug Safety and Risk Management Advisory Committee (or 
     successor committee) of the Food and Drug Administration, 
     shall--
       ``(i) seek input from patients, physicians, pharmacists, 
     and other health care providers about how restrictions on 
     distribution or use under this paragraph for 1 or more drugs 
     may be standardized so as not to be--

       ``(I) unduly burdensome on patient access to the drug; and
       ``(II) to the extent practicable, minimize the burden on 
     the health care delivery system;

       ``(ii) at least annually, evaluate, for 1 or more drugs, 
     the restrictions on distribution or use of such drug to 
     assess whether the restrictions--

       ``(I) assure safe use of the drug;
       ``(II) are not unduly burdensome on patient access to the 
     drug; and
       ``(III) to the extent practicable, minimize the burden on 
     the health care delivery system; and

       ``(iii) considering such input and evaluations--

       ``(I) issue or modify agency guidance about how to 
     implement the requirements of this paragraph; and
       ``(II) modify restrictions under this paragraph for 1 or 
     more drugs as appropriate.

       ``(7) Submission and review of risk evaluation and 
     mitigation strategy.--
       ``(A) Proposed risk evaluation and mitigation strategy.--
       ``(i) Voluntary proposal.--An applicant may include a 
     proposed risk evaluation and mitigation strategy for a drug 
     in an application, including in a supplemental application, 
     under subsection (b) or section 351 of the Public Health 
     Service Act for the drug.
       ``(ii) Required proposal.--The applicant shall submit a 
     proposed risk evaluation and mitigation strategy for a drug--

       ``(I) within a timeframe specified by the Secretary, not to 
     be less than 45 days, when ordered by the Secretary (acting 
     through the office responsible for reviewing the drug and the 
     office responsible for postapproval safety with respect to 
     the drug), if the Secretary determines that new safety 
     information indicates that--

       ``(aa) the labeling of the drug should be changed; or
       ``(bb) an element under paragraph (4) or (5) should be 
     included in a strategy for the drug; or

       ``(II) within 90 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that new 
     safety information indicates that an element under paragraph 
     (6) should be included in a strategy for the drug.

       ``(iii) Content of order.--An order under subclauses (I) or 
     (II) of clause (ii) shall describe--

       ``(I) the new safety information with respect to the drug 
     that warrants the proposal of a risk evaluation and 
     mitigation strategy for the drug; and
       ``(II) whether and how the labeling of the drug should be 
     changed and what elements under paragraphs (4), (5), or (6) 
     should be included in a strategy for the drug.

       ``(iv) Content of proposal.--A proposed risk evaluation and 
     mitigation strategy--

       ``(I) shall include a timetable as described under 
     paragraph (3)(B); and
       ``(II) may also include additional elements as provided for 
     under paragraphs (4), (5), and (6).

       ``(B) Assessment and modification of a risk evaluation and 
     mitigation strategy.--
       ``(i) Voluntary assessments.--If a risk evaluation and 
     mitigation strategy for a drug is required, the applicant may 
     submit to the Secretary an assessment of, and propose a 
     modification to, such approved strategy for the drug at any 
     time.
       ``(ii) Required assessments.--If a risk evaluation and 
     mitigation strategy for a drug is required, the applicant 
     shall submit an assessment of, and may propose a modification 
     to, such approved strategy for the drug--

       ``(I) when submitting an application, including a 
     supplemental application, for a new indication under 
     subsection (b) or section 351 of the Public Health Service 
     Act;
       ``(II) when required by the strategy, as provided for in 
     the timetable under paragraph (3)(B);
       ``(III) within a timeframe specified by the Secretary, not 
     to be less than 45 days, when ordered by the Secretary 
     (acting through the offices described in subparagraph 
     (A)(ii)(I)), if the Secretary determines that new safety 
     information indicates that an element under paragraph (3) or 
     (4) should be modified or added to the strategy;
       ``(IV) within 90 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that new 
     safety information indicates that an element under paragraph 
     (6) should be modified or added to the strategy; or
       ``(V) within 15 days when ordered by the Secretary (acting 
     through such offices), if the Secretary determines that there 
     may be a cause for action by the Secretary under subsection 
     (e).

       ``(iii) Content of order.--An order under subclauses (III), 
     (IV), or (V) of clause (ii) shall describe--

       ``(I) the new safety information with respect to the drug 
     that warrants an assessment of the approved risk evaluation 
     and mitigation strategy for the drug; and
       ``(II) whether and how such strategy should be modified 
     because of such information.

       ``(iv) Assessment.--An assessment of the approved risk 
     evaluation and mitigation strategy for a drug shall include--

       ``(I) a description of new safety information, if any, with 
     respect to the drug;
       ``(II) whether and how to modify such strategy because of 
     such information;
       ``(III) with respect to any postapproval study required 
     under paragraph (4)(B) or otherwise undertaken by the 
     applicant to investigate a safety issue, the status of such 
     study, including whether any difficulties completing the 
     study have been encountered;
       ``(IV) with respect to any postapproval clinical trial 
     required under paragraph (4)(C) or otherwise undertaken by 
     the applicant to investigate a safety issue, the status of 
     such clinical trial, including whether enrollment has begun, 
     the number of participants enrolled, the expected completion 
     date, whether any difficulties completing the clinical trial 
     have been encountered, and registration information with 
     respect to requirements under subsections (i) and (j) of 
     section 402 of the Public Health Service Act; and
       ``(V) with respect to any goal under paragraph (6) and 
     considering input and evaluations, if applicable, under 
     paragraph (6)(E), an assessment of how well the restrictions 
     on distribution or use are meeting the goal or whether the 
     goal or such restrictions should be modified.

       ``(v) Modification.--A modification (whether an enhancement 
     or a reduction) to the approved risk evaluation and 
     mitigation strategy for a drug may include the addition or 
     modification of any element under subparagraph (A) or (B) of 
     paragraph (3) or the addition, modification, or removal of 
     any element under paragraph (4), (5), or (6), such as--

       ``(I) a labeling change, including the addition of a boxed 
     warning;
       ``(II) adding a postapproval study or clinical trial 
     requirement;
       ``(III) modifying a postapproval study or clinical trial 
     requirement (such as a change in trial design due to 
     legitimate difficulties recruiting participants);
       ``(IV) adding, modifying, or removing a restriction on 
     advertising under subparagraph (D), (E), or (F) of paragraph 
     (5);
       ``(V) adding, modifying, or removing a restriction on 
     distribution or use under paragraph (6); or
       ``(VI) modifying the timetable for assessments of the 
     strategy under paragraph (3)(B), including to eliminate 
     assessments.

       ``(C) Review.--The Secretary (acting through the offices 
     described in subparagraph (A)(ii)(I)) shall promptly review 
     the proposed risk evaluation and mitigation strategy for a 
     drug submitted under subparagraph (A), or an assessment of 
     the approved risk evaluation and mitigation strategy for a 
     drug submitted under subparagraph (B).
       ``(D) Discussion.--The Secretary (acting through the 
     offices described in subparagraph (A)(ii)(I)) shall initiate 
     discussions of the proposed risk evaluation and mitigation 
     strategy for a drug submitted under subparagraph (A)(i), or 
     of an assessment of the approved risk evaluation and 
     mitigation strategy for a drug submitted under subparagraph 
     (B), with the applicant to determine a strategy--
       ``(i) if the proposed strategy or assessment is submitted 
     as part of an application (including a supplemental 
     application) under subparagraph (A)(i) or (B)(ii)(I), by the 
     target date for communication of feedback from the review 
     team to the applicant regarding proposed labeling and 
     postmarketing study commitments, as set forth in the letters 
     described in section 735(a);
       ``(ii) if the proposed strategy is submitted under 
     subparagraph (A)(ii)(I) or the assessment is submitted under 
     subclause (II) or (III) of subparagraph (B)(ii), not later 
     than 20 days after such submission;
       ``(iii) if the proposed strategy is submitted under 
     subparagraph (A)(ii)(II) or the assessment is submitted under 
     subparagraph (B)(i) or under subparagraph (B)(ii)(IV), not 
     later than 30 days after such submission; or
       ``(iv) if the assessment is submitted under subparagraph 
     (B)(ii)(V), not later than 10 days after such submission.
       ``(E) Action.--
       ``(i) In general.--Unless the applicant requests the 
     dispute resolution process as described under subparagraph 
     (F) or (G), the Secretary (acting through the offices 
     described in subparagraph (A)(ii)(I)) shall approve and 
     include the risk evaluation and mitigation strategy for a 
     drug, or any modification to the strategy (including a 
     timeframe for implementing such modification), with--

       ``(I) the action letter on the application, if a proposed 
     strategy is submitted under subparagraph (A)(i) or an 
     assessment of the strategy is submitted under subparagraph 
     (B)(ii)(I); or
       ``(II) an order, which shall be made public, issued not 
     later than 50 days after the date discussions of such 
     proposed strategy or modification begin under subparagraph 
     (D), if a proposed strategy is submitted under subparagraph 
     (A)(ii) or an assessment of the strategy is submitted under 
     subparagraph (B)(i) or under subclause (II), (III), (IV), or 
     (V) of subparagraph (B)(ii).

       ``(ii) Inaction.--An approved risk evaluation and 
     mitigation strategy shall remain in effect

[[Page 10631]]

     until the Secretary acts, if the Secretary fails to act as 
     provided under clause (i).
       ``(F) Dispute resolution at initial approval.--If a 
     proposed risk evaluation and mitigation strategy is submitted 
     under subparagraph (A)(i) in an application for initial 
     approval of a drug and there is a dispute about the strategy, 
     the applicant shall use the major dispute resolution 
     procedures as set forth in the letters described in section 
     735(a).
       ``(G) Dispute resolution in all other cases.--
       ``(i) Request for review.--In any case other than a 
     submission under subparagraph (A)(i) in an application for 
     initial approval of a drug if there is a dispute about the 
     strategy, not earlier than 15 days, and not later than 35 
     days, after discussions under subparagraph (D) have begun, 
     the applicant shall request in writing that the dispute be 
     reviewed by the Drug Safety Oversight Board.
       ``(ii) Scheduling review.--If the applicant requests review 
     under clause (i), the Secretary--

       ``(I)(aa) shall schedule the dispute for review at 1 of the 
     next 2 regular meetings of the Drug Safety Oversight Board, 
     whichever meeting date is more practicable; or
       ``(bb) may convene a special meeting of the Drug Safety 
     Oversight Board to review the matter more promptly, including 
     to meet an action deadline on an application (including a 
     supplemental application);
       ``(II) shall give advance notice to the public through the 
     Federal Register and on the Internet website of the Food and 
     Drug Administration--

       ``(aa) that the drug is to be discussed by the Drug Safety 
     Oversight Board; and
       ``(bb) the date on which the Drug Safety Oversight Board 
     shall discuss such drug; and

       ``(III) shall apply section 301(j), section 552 of title 5, 
     and section 1905 of title 18, United States Code, to any 
     request for information about such review.

       ``(iii) Agreement after discussion or administrative 
     appeals.--

       ``(I) Further discussion or administrative appeals.--A 
     request for review under clause (i) shall not preclude--

       ``(aa) further discussions to reach agreement on the risk 
     evaluation and mitigation strategy; or
       ``(bb) the use of administrative appeals within the Food 
     and Drug Administration to reach agreement on the strategy, 
     including the major dispute resolution procedures as set 
     forth in the letters described in section 735(a).

       ``(II) Agreement terminates dispute resolution.--At any 
     time before a decision and order is issued under clause (vi), 
     the Secretary (acting through the offices described in 
     subparagraph (A)(ii)(I)) and the applicant may reach an 
     agreement on the risk evaluation and mitigation strategy 
     through further discussion or administrative appeals, 
     terminating the dispute resolution process, and the Secretary 
     shall issue an action letter or order, as appropriate, that 
     describes the strategy.

       ``(iv) Meeting of the board.--At the meeting of the Drug 
     Safety Oversight Board described in clause (ii), the Board 
     shall--

       ``(I) hear from both parties; and
       ``(II) review the dispute.

       ``(v) Recommendation of the board.--Not later than 5 days 
     after such meeting of the Drug Safety Oversight Board, the 
     Board shall provide a written recommendation on resolving the 
     dispute to the Secretary.
       ``(vi) Action by the secretary.--

       ``(I) Action letter.--With respect to a proposed risk 
     evaluation and mitigation strategy submitted under 
     subparagraph (A)(i) or to an assessment of the strategy 
     submitted under subparagraph (B)(ii)(I), the Secretary shall 
     issue an action letter that resolves the dispute not later 
     than the later of--

       ``(aa) the action deadline for the action letter on the 
     application; or
       ``(bb) 7 days after receiving the recommendation of the 
     Drug Safety Oversight Board.

       ``(II) Order.--With respect to a proposed risk evaluation 
     and mitigation strategy submitted under subparagraph (A)(ii) 
     or an assessment of the risk evaluation and mitigation 
     strategy under subparagraph (B)(i) or under subclause (II), 
     (III), (IV), or (V) of subparagraph (B)(ii), the Secretary 
     shall issue an order, which (with the recommendation of the 
     Drug Safety Oversight Board) shall be made public, that 
     resolves the dispute not later than 7 days after receiving 
     the recommendation of the Drug Safety Oversight Board.

       ``(vii) Inaction.--An approved risk evaluation and 
     mitigation strategy shall remain in effect until the 
     Secretary acts, if the Secretary fails to act as provided for 
     under clause (vi).
       ``(viii) Effect on action deadline.--With respect to the 
     application or supplemental application in which a proposed 
     risk evaluation and mitigation strategy is submitted under 
     subparagraph (A)(i) or in which an assessment of the strategy 
     is submitted under subparagraph (B)(ii)(I), the Secretary 
     shall be considered to have met the action deadline for the 
     action letter on such application if the applicant requests 
     the dispute resolution process described in this subparagraph 
     and if the Secretary--

       ``(I) has initiated the discussions described under 
     subparagraph (D) by the target date referred to in 
     subparagraph (D)(i); and
       ``(II) has complied with the timing requirements of 
     scheduling review by the Drug Safety Oversight Board, 
     providing a written recommendation, and issuing an action 
     letter under clauses (ii), (v), and (vi), respectively.

       ``(ix) Disqualification.--No individual who is an employee 
     of the Food and Drug Administration and who reviews a drug or 
     who participated in an administrative appeal under clause 
     (iii)(I) with respect to such drug may serve on the Drug 
     Safety Oversight Board at a meeting under clause (iv) to 
     review a dispute about the risk evaluation and mitigation 
     strategy for such drug.
       ``(x) Additional expertise.--The Drug Safety Oversight 
     Board may add members with relevant expertise from the Food 
     and Drug Administration, including the Office of Pediatrics, 
     the Office of Women's Health, or the Office of Rare Diseases, 
     or from other Federal public health or health care agencies, 
     for a meeting under clause (iv) of the Drug Safety Oversight 
     Board.
       ``(H) Use of advisory committees.--The Secretary (acting 
     through the offices described in subparagraph (A)(ii)(I)) may 
     convene a meeting of 1 or more advisory committees of the 
     Food and Drug Administration to--
       ``(i) review a concern about the safety of a drug or class 
     of drugs, including before an assessment of the risk 
     evaluation and mitigation strategy or strategies of such drug 
     or drugs is required to be submitted under subclause (II), 
     (III), (IV), or (V) of subparagraph (B)(ii);
       ``(ii) review the risk evaluation and mitigation strategy 
     or strategies of a drug or group of drugs; or
       ``(iii) with the consent of the applicant, review a dispute 
     under subparagraph (G).
       ``(I) Process for addressing drug class effects.--
       ``(i) In general.--When a concern about a serious risk of a 
     drug may be related to the pharmacological class of the drug, 
     the Secretary (acting through the offices described in 
     subparagraph (A)(ii)(I)) may defer assessments of the 
     approved risk evaluation and mitigation strategies for such 
     drugs until the Secretary has--

       ``(I) convened, after appropriate public notice, 1 or more 
     public meetings to consider possible responses to such 
     concern; or
       ``(II) gathered additional information or data about such 
     concern.

       ``(ii) Public meetings.--Such public meetings may include--

       ``(I) 1 or more meetings of the applicants for such drugs;
       ``(II) 1 or more meetings of 1 or more advisory committees 
     of the Food and Drug Administration, as provided for under 
     subparagraph (H); or
       ``(III) 1 or more workshops of scientific experts and other 
     stakeholders.

       ``(iii) Action.--After considering the discussions from any 
     meetings under clause (ii), the Secretary may--

       ``(I) announce in the Federal Register a planned regulatory 
     action, including a modification to each risk evaluation and 
     mitigation strategy, for drugs in the pharmacological class;
       ``(II) seek public comment about such action; and
       ``(III) after seeking such comment, issue an order 
     addressing such regulatory action.

       ``(J) International coordination.--The Secretary (acting 
     through the offices described in subparagraph (A)(ii)(I)) may 
     coordinate the timetable for submission of assessments under 
     paragraph (3)(B), a study under paragraph (4)(B), or a 
     clinical trial under paragraph (4)(C), with efforts to 
     identify and assess the serious risks of such drug by the 
     marketing authorities of other countries whose drug approval 
     and risk management processes the Secretary deems comparable 
     to the drug approval and risk management processes of the 
     United States.
       ``(K) Effect.--Use of the processes described in 
     subparagraphs (I) and (J) shall not delay action on an 
     application or a supplement to an application for a drug.
       ``(L) No effect on labeling changes that do not require 
     preapproval.--In the case of a labeling change to which 
     section 314.70 of title 21, Code of Federal Regulations (or 
     any successor regulation), applies for which the submission 
     of a supplemental application is not required or for which 
     distribution of the drug involved may commence upon the 
     receipt by the Secretary of a supplemental application for 
     the change, the submission of an assessment of the approved 
     risk evaluation and mitigation strategy for the drug under 
     this subsection is not required.
       ``(8) Drug safety oversight board.--
       ``(A) In general.--There is established a Drug Safety 
     Oversight Board.
       ``(B) Composition; meetings.--The Drug Safety Oversight 
     Board shall--
       ``(i) be composed of scientists and health care 
     practitioners appointed by the Secretary, each of whom is an 
     employee of the Federal Government;
       ``(ii) include representatives from offices throughout the 
     Food and Drug Administration (including the offices 
     responsible for postapproval safety of drugs);
       ``(iii) include at least 1 representative each from the 
     National Institutes of Health, the Department of Health and 
     Human Services (other than the Food and Drug Administration), 
     and the Veterans Health Administration; and
       ``(iv) meet at least monthly to provide oversight and 
     advice to the Secretary on the management of important drug 
     safety issues.''.

     SEC. 203. ENFORCEMENT.

       (a) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
     end the following:
       ``(x) If it is a drug subject to an approved risk 
     evaluation and mitigation strategy under section 505(o) and 
     the applicant for such drug fails to--
       ``(1) make a labeling change required by such strategy 
     after the Secretary has approved such strategy or completed 
     review of, and acted on,

[[Page 10632]]

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

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

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

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

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

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

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

     SEC. 207. RESOURCES.

       (a) User Fees.--Subparagraph (F) of section 735(d)(6) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     379g(d)(6)), as amended by section 103, is amended--
       (1) in clause (ii), by striking ``systems); and'' and 
     inserting ``systems);''
       (2) in clause (iii), by striking ``bases).'' and inserting 
     ``bases); and''; and
       (3) by adding at the end the following:
       ``(iv) reviewing, implementing, and ensuring compliance 
     with risk evaluation and mitigation strategies.''.
       (b) Workload Adjustment.--Subparagraph (A) of section 
     736(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379h(c)(2)), as amended by section 103, is amended in 
     the first sentence by striking ``and manufacturing changes 
     submitted to the Secretary, and'' and inserting 
     ``manufacturing changes, and assessments of risk evaluation 
     and mitigation strategies submitted to the Secretary, uses of 
     dispute resolution under the process for reviewing and 
     assessing risk evaluation and mitigation strategies, and''.
       (c) Additional Fee Revenues for Drug Safety.--Section 736 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), 
     as amended by section 103, is amended by--
       (1) striking the subsection designation and all that 
     follows through ``.--Except'' and inserting the following:
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--Except''; and
       (2) adding at the end the following:
       ``(2) Additional fee revenues for drug safety.--
       ``(A) In general.--Subject to subparagraph (C), in each of 
     fiscal years 2008 through 2012, paragraph (1) shall be 
     applied by substituting the amount determined under 
     subparagraph (B) for `$392,783,000'.
       ``(B) Amount determined.--For any fiscal year 2008 through 
     2012, the amount determined under this subparagraph is the 
     sum of--
       ``(i) $392,783,000; plus
       ``(ii) the amount equal to--

       ``(I) $50,000,000; minus
       ``(II) the amount equal to one-fifth of the amount by which 
     the appropriations for salaries and expenses of the Food and 
     Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) exceed the 
     amount of appropriations for the salaries and expenses of the 
     Food and Drug Administration for the fiscal year 2007 
     (excluding the amount of fees appropriated for such fiscal 
     year), adjusted as provided under subsection (c)(1).

     In making the adjustment under subclause (II) for any fiscal 
     year 2008 through 2012, subsection (c)(1) shall be applied by 
     substituting `2007' for `2008'.
       ``(C) Limitation.--This paragraph shall not apply for any 
     fiscal year if the amount described under subparagraph 
     (B)(ii) is less than 0.''.
       (d) Strategic Plan for Information Technology.--Not later 
     than 1 year after the date of enactment of this title, the 
     Secretary of Health and Human Services (referred to in this 
     title as the ``Secretary'') shall submit to the Committee on 
     Health, Education, Labor, and Pensions and the Committee on 
     Appropriations of the Senate and the Committee on Energy and 
     Commerce and the Committee on Appropriations of the House of 
     Representatives, a strategic plan on information technology 
     that includes--
       (1) an assessment of the information technology 
     infrastructure, including systems for data collection, access 
     to data in external health care databases, data mining 
     capabilities, personnel, and personnel training programs, 
     needed by the Food and Drug Administration to--
       (A) comply with the requirements of this subtitle (and the 
     amendments made by this subtitle);
       (B) achieve interoperability within and among the centers 
     of the Food and Drug Administration and between the Food and 
     Drug Administration and product application sponsors;
       (C) utilize electronic health records; and
       (D) implement routine active safety monitoring under 
     section 505(k)(3) (including other approaches under 
     subsection (c) of such section) of the Federal Food, Drug, 
     and Cosmetic Act, as added by section 201 of this Act;
       (2) an assessment of the extent to which the current 
     information technology assets of the Food and Drug 
     Administration are sufficient to meet the needs assessments 
     under paragraph (1);
       (3) a plan for enhancing the information technology assets 
     of the Food and Drug Administration toward meeting the needs 
     assessments under paragraph (1); and
       (4) an assessment of additional resources needed to so 
     enhance the information technology assets of the Food and 
     Drug Administration.

     SEC. 208. SAFETY LABELING CHANGES.

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

     ``SEC. 506D. SAFETY LABELING CHANGES.

       ``(a) New Safety Information.--
       ``(1) Notification.--The holder of an approved application 
     under section 505 of this Act or a license under section 351 
     of the Public Health Service Act (referred to in this section 
     as a `holder') shall promptly notify the Secretary if the 
     holder becomes aware of new safety information that the 
     holder believes should be included in the labeling of the 
     drug. The Secretary

[[Page 10633]]

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

     SEC. 209. DRUG LABELING.

       (a) Accessible Repository of Drug Labeling.--Not later than 
     the effective date of this subtitle, the Secretary, through 
     the Commissioner of Food and Drugs, and the Director of the 
     National Institutes of Health, shall establish a searchable 
     repository of structured, electronic product information, 
     including the approved professional labeling and any required 
     patient labeling of each drug approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
     licensed under section 351 of the Public Health Service Act 
     (42 U.S.C. 262) in order to improve patient safety through 
     accessible product information, support initiatives to 
     improve patient care by better management of health care 
     information, and provide standards for drug information. Such 
     repository shall be made publicly accessible on the Internet 
     website of the National Library of Medicine and through a 
     link on the homepage of the Internet website of the Food and 
     Drug Administration.
       (b) Posting Upon Approval.--The Secretary shall post in the 
     repository under subsection (a) the approved professional 
     labeling and any required patient labeling of a drug approved 
     under such section 505 or licensed under such section 351 not 
     later than 21 days after the date the drug is approved, 
     including in a supplemental application with respect to a 
     labeling change.
       (c) Report.--The Secretary shall report annually to the 
     Committee on Health, Education, Labor and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives on the status of the repository under 
     subsection (a), and on progress in posting structured 
     electronic product information, including posting of 
     information regarding drugs approved prior to the effective 
     date of this subtitle.
       (d) Medication Guides.--Not later than the effective date 
     of this subtitle, the Secretary, through the Commissioner of 
     Food and Drugs, shall establish on the Internet website for 
     the repository under subsection (a), a link to a list of each 
     drug, whether approved under such section 505 or licensed 
     under such section 351, for which a Medication Guide, as 
     provided for under part 208 of title 21, Code of Federal 
     Regulations (or any successor regulations), is required.

     SEC. 210. ACTION PACKAGE FOR APPROVAL.

       Section 505(l) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(l)) is amended by--
       (1) redesignating paragraphs (1), (2), (3), (4), and (5) as 
     subparagraphs (A), (B), (C), (D), and (E), respectively;
       (2) striking ``(l) Safety and'' and inserting ``(l)(1) 
     Safety and''; and
       (3) adding at the end the following:
       ``(2) Action Package for Approval.--
       ``(A) Action package.--The Secretary shall publish the 
     action package for approval of an application under 
     subsection (b) or section 351 of the Public Health Service 
     Act on the Internet website of the Food and Drug 
     Administration-
       ``(i) not later than 30 days after the date of approval of 
     such application for a drug no active ingredient (including 
     any ester or salt of the active ingredient) of which has been 
     approved in any other application under this section or 
     section 351 of the Public Health Service Act; and

[[Page 10634]]

       ``(ii) not later than 30 days after the third request for 
     such action package for approval received under section 552 
     of title 5, United States Code, for any other drug.
       ``(B) Immediate publication of summary review.--
     Notwithstanding subparagraph (A), the Secretary shall 
     publish, on the Internet website of the Food and Drug 
     Administration, the materials described in subparagraph 
     (C)(iv) not later than 48 hours after the date of approval of 
     the drug, except where such materials require redaction by 
     the Secretary.
       ``(C) Contents.--An action package for approval of an 
     application under subparagraph (A) shall be dated and shall 
     include the following:
       ``(i) Documents generated by the Food and Drug 
     Administration related to review of the application.
       ``(ii) Documents pertaining to the format and content of 
     the application generated during drug development.
       ``(iii) Labeling submitted by the applicant.
       ``(iv) A summary review that documents conclusions from all 
     reviewing disciplines about the drug, noting any critical 
     issues and disagreements with the applicant and how they were 
     resolved, recommendation for action, and an explanation of 
     any nonconcurrence with review conclusions.
       ``(v) If applicable, a separate review from a supervisor 
     who does not concur with the summary review.
       ``(vi) Identification by name of each officer or employee 
     of the Food and Drug Administration who--
       ``(I) participated in the decision to approve the 
     application; and
       ``(II) consents to have his or her name included in the 
     package.
       ``(D) Disagreements.--A scientific review of an application 
     is considered the work of the reviewer and shall not be 
     altered by management or the reviewer once final. 
     Disagreements by team leaders, division directors, or office 
     directors with any or all of the major conclusions of a 
     reviewer shall be document in a separate review or in an 
     addendum to the review.
       ``(E) Confidential information.--This paragraph does not 
     authorize the disclosure of any trade secret or confidential 
     commercial or financial information described in section 
     552(b)(4) of title 5, United States Code, unless the 
     Secretary declares an emergency under section 319 of the 
     Public Health Service Act and such disclosure is necessary to 
     mitigate the effects of such emergency.''.

     SEC. 211. RISK COMMUNICATION.

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

     ``SEC. 566. ADVISORY COMMITTEE ON RISK COMMUNICATION.

       ``(a) In General.--The Secretary shall establish an 
     advisory committee to be known as the `Advisory Committee on 
     Risk Communication' (referred to in this section as the 
     `Committee').
       ``(b) Duties of Committee.--The Committee shall advise the 
     Commissioner on methods to effectively communicate risks 
     associated with the products regulated by the Food and Drug 
     Administration.
       ``(c) Members.--The Secretary shall ensure that the 
     Committee is composed of experts on risk communication, 
     experts on the risks described in subsection (b), and 
     representatives of patient, consumer, and health professional 
     organizations.
       ``(d) Permanence of Committee.--Section 14 of the Federal 
     Advisory Committee Act shall not apply to the Committee 
     established under this section.''.

     SEC. 212. REFERRAL TO ADVISORY COMMITTEE.

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

     SEC. 213. RESPONSE TO THE INSTITUTE OF MEDICINE.

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

     SEC. 214. EFFECTIVE DATE AND APPLICABILITY.

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

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

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

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

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

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

       ``(a) In General.--A nonprofit corporation to be known as 
     the Reagan-Udall Foundation for the Food and Drug 
     Administration (referred to in this subchapter as the 
     `Foundation') shall be established in accordance with this 
     section. The Foundation shall be headed by an Executive 
     Director, appointed by the members of the Board of Directors 
     under subsection (e). The Foundation shall not be an agency 
     or instrumentality of the United States Government.
       ``(b) Purpose of Foundation.--The purpose of the Foundation 
     is to advance the mission of the Food and Drug Administration 
     to modernize medical, veterinary, food, food ingredient, and 
     cosmetic product development, accelerate innovation, and 
     enhance product safety.
       ``(c) Duties of the Foundation.--The Foundation shall--
       ``(1) taking into consideration the Critical Path reports 
     and priorities published by the Food and Drug Administration, 
     identify unmet needs in the development, manufacture, and 
     evaluation of the safety and effectiveness, including 
     postapproval, of devices, including diagnostics, biologics, 
     and drugs, and the safety of food, food ingredients, and 
     cosmetics;
       ``(2) establish goals and priorities in order to meet the 
     unmet needs identified in paragraph (1);
       ``(3) in consultation with the Secretary, identify existing 
     and proposed Federal intramural and extramural research and 
     development programs relating to the goals and priorities 
     established under paragraph (2), coordinate Foundation 
     activities with such programs, and minimize Foundation 
     duplication of existing efforts;
       ``(4) award grants to, or enter into contracts, memoranda 
     of understanding, or cooperative agreements with, scientists 
     and entities, which may include the Food and Drug 
     Administration, university consortia, public-private 
     partnerships, institutions of higher education, entities 
     described in section 501(c)(3) of the Internal Revenue Code 
     (and exempt from tax under section 501(a) of such Code), and 
     industry, to efficiently and effectively advance the goals 
     and priorities established under paragraph (2);
       ``(5) recruit meeting participants and hold or sponsor (in 
     whole or in part) meetings as appropriate to further the 
     goals and priorities established under paragraph (2);

[[Page 10635]]

       ``(6) release and publish information and data and, to the 
     extent practicable, license, distribute, and release 
     material, reagents, and techniques to maximize, promote, and 
     coordinate the availability of such material, reagents, and 
     techniques for use by the Food and Drug Administration, 
     nonprofit organizations, and academic and industrial 
     researchers to further the goals and priorities established 
     under paragraph (2);
       ``(7) ensure that--
       ``(A) action is taken as necessary to obtain patents for 
     inventions developed by the Foundation or with funds from the 
     Foundation;
       ``(B) action is taken as necessary to enable the licensing 
     of inventions developed by the Foundation or with funds from 
     the Foundation; and
       ``(C) executed licenses, memoranda of understanding, 
     material transfer agreements, contracts, and other such 
     instruments, promote, to the maximum extent practicable, the 
     broadest conversion to commercial and noncommercial 
     applications of licensed and patented inventions of the 
     Foundation to further the goals and priorities established 
     under paragraph (2);
       ``(8) provide objective clinical and scientific information 
     to the Food and Drug Administration and, upon request, to 
     other Federal agencies to assist in agency determinations of 
     how to ensure that regulatory policy accommodates scientific 
     advances and meets the agency's public health mission;
       ``(9) conduct annual assessments of the unmet needs 
     identified in paragraph (1); and
       ``(10) carry out such other activities consistent with the 
     purposes of the Foundation as the Board determines 
     appropriate.
       ``(d) Board of Directors.--
       ``(1) Establishment.--
       ``(A) In general.--The Foundation shall have a Board of 
     Directors (referred to in this subchapter as the `Board'), 
     which shall be composed of ex officio and appointed members 
     in accordance with this subsection. All appointed members of 
     the Board shall be voting members.
       ``(B) Ex officio members.--The ex officio members of the 
     Board shall be the following individuals or their designees:
       ``(i) The Commissioner.
       ``(ii) The Director of the National Institutes of Health.
       ``(iii) The Director of the Centers for Disease Control and 
     Prevention.
       ``(iv) The Director of the Agency for Healthcare Research 
     and Quality.
       ``(C) Appointed members.--
       ``(i) In general.--The ex officio members of the Board 
     under subparagraph (B) shall, by majority vote, appoint to 
     the Board 12 individuals, from a list of candidates to be 
     provided by the National Academy of Sciences. Of such 
     appointed members--

       ``(I) 4 shall be representatives of the general 
     pharmaceutical, device, food, cosmetic, and biotechnology 
     industries;
       ``(II) 3 shall be representatives of academic research 
     organizations;
       ``(III) 2 shall be representatives of Government agencies, 
     including the Food and Drug Administration and the National 
     Institutes of Health;
       ``(IV) 2 shall be representatives of patient or consumer 
     advocacy organizations; and
       ``(V) 1 shall be a representative of health care providers.

       ``(ii) Requirement.--The ex officio members shall ensure 
     the Board membership includes individuals with expertise in 
     areas including the sciences of developing, manufacturing, 
     and evaluating the safety and effectiveness of devices, 
     including diagnostics, biologics, and drugs, and the safety 
     of food, food ingredients, and cosmetics.
       ``(D) Initial meeting.--
       ``(i) In general.--Not later than 30 days after the date of 
     the enactment of the Enhancing Drug Safety and Innovation Act 
     of 2007, the Secretary shall convene a meeting of the ex 
     officio members of the Board to--

       ``(I) incorporate the Foundation; and
       ``(II) appoint the members of the Board in accordance with 
     subparagraph (C).

       ``(ii) Service of ex officio members.--Upon the appointment 
     of the members of the Board under clause (i)(II), the terms 
     of service of the ex officio members of the Board as members 
     of the Board shall terminate.
       ``(iii) Chair.--The ex officio members of the Board under 
     subparagraph (B) shall designate an appointed member of the 
     Board to serve as the Chair of the Board.
       ``(2) Duties of board.--The Board shall--
       ``(A) establish bylaws for the Foundation that--
       ``(i) are published in the Federal Register and available 
     for public comment;
       ``(ii) establish policies for the selection of the 
     officers, employees, agents, and contractors of the 
     Foundation;
       ``(iii) establish policies, including ethical standards, 
     for the acceptance, solicitation, and disposition of 
     donations and grants to the Foundation and for the 
     disposition of the assets of the Foundation, including strict 
     limits on the ability of donors to include stipulations or 
     restrictions on the use 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;

[[Page 10636]]

       ``(9) take such action as may be necessary to obtain 
     patents and licenses for devices and procedures developed by 
     the Foundation and its employees;
       ``(10) sue and be sued in its corporate name, and complain 
     and defend in courts of competent jurisdiction;
       ``(11) appoint other groups of advisors as may be 
     determined necessary to carry out the functions of the 
     Foundation; and
       ``(12) exercise other powers as set forth in this section, 
     and such other incidental powers as are necessary to carry 
     out its powers, duties, and functions in accordance with this 
     subchapter.
       ``(i) Acceptance of Funds From Other Sources.--The 
     Executive Director may solicit and accept on behalf of the 
     Foundation, any funds, gifts, grants, devises, or bequests of 
     real or personal property made to the Foundation, including 
     from private entities, for the purposes of carrying out the 
     duties of the Foundation.
       ``(j) Service of Federal Employees.--Federal Government 
     employees may serve on committees advisory to the Foundation 
     and otherwise cooperate with and assist the Foundation in 
     carrying out its functions, so long as such employees do not 
     direct or control Foundation activities.
       ``(k) Detail of Government Employees; Fellowships.--
       ``(1) Detail from federal agencies.--Federal Government 
     employees may be detailed from Federal agencies with or 
     without reimbursement to those agencies to the Foundation at 
     any time, and such detail shall be without interruption or 
     loss of civil service status or privilege. Each such employee 
     shall abide by the statutory, regulatory, ethical, and 
     procedural standards applicable to the employees of the 
     agency from which such employee is detailed and those of the 
     Foundation.
       ``(2) Voluntary service; acceptance of federal employees.--
       ``(A) Foundation.--The Executive Director of the Foundation 
     may accept the services of employees detailed from Federal 
     agencies with or without reimbursement to those agencies.
       ``(B) Food and drug administration.--The Commissioner may 
     accept the uncompensated services of Foundation fellows or 
     trainees. Such services shall be considered to be undertaking 
     an activity under contract with the Secretary as described in 
     section 708.
       ``(l) Annual Reports.--
       ``(1) Reports to foundation.--Any recipient of a grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement from the Foundation under this section 
     shall submit to the Foundation a report on an annual basis 
     for the duration of such grant, contract, fellowship, 
     memorandum of understanding, or cooperative agreement, that 
     describes the activities carried out under such grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement.
       ``(2) Report to congress and the fda.--Beginning with 
     fiscal year 2009, the Executive Director shall submit to 
     Congress and the Commissioner an annual report that--
       ``(A) describes the activities of the Foundation and the 
     progress of the Foundation in furthering the goals and 
     priorities established under subsection (c)(2), including the 
     practical impact of the Foundation on regulated product 
     development;
       ``(B) provides a specific accounting of the source and use 
     of all funds used by the Foundation to carry out such 
     activities; and
       ``(C) provides information on how the results of Foundation 
     activities could be incorporated into the regulatory and 
     product review activities of the Food and Drug 
     Administration.
       ``(m) Separation of Funds.--The Executive Director shall 
     ensure that the funds received from the Treasury are held in 
     separate accounts from funds received from entities under 
     subsection (i).
       ``(n) Funding.--From amounts appropriated to the Food and 
     Drug Administration for each fiscal year, the Commissioner 
     shall transfer not less than $500,000 and not more than 
     $1,250,000, to the Foundation to carry out subsections (a), 
     (b), and (d) through (m).''.
       (b) Other Foundation Provisions.--Chapter VII (21 U.S.C. 
     371 et seq.) (as amended by subsection (a)) is amended by 
     adding at the end the following:

     ``SEC. 771. LOCATION OF FOUNDATION.

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

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

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

     SEC. 222. OFFICE OF THE CHIEF SCIENTIST.

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

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

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

                      Subtitle C--Clinical Trials

     SEC. 231. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

       (a) In General.--Section 402 of the Public Health Service 
     Act (42 U.S.C. 282) is amended by--
       (1) redesignating subsections (j) and (k) as subsections 
     (k) and (l), respectively; and
       (2) inserting after subsection (i) the following:
       ``(j) Expanded Clinical Trial Registry Data Bank.--
       ``(1) Definitions; requirement.--
       ``(A) Definitions.--In this subsection:
       ``(i) Applicable device clinical trial.--The term 
     `applicable device clinical trial' means--

       ``(I) a prospective study of health outcomes comparing an 
     intervention against a control in human subjects intended to 
     support an application under section 515 or 520(m), or a 
     report under section 510(k), of the Federal Food, Drug, and 
     Cosmetic Act (other than a limited study to gather essential 
     information used to refine the device or design a pivotal 
     trial and that is not intended to determine safety and 
     effectiveness of a device); and
       ``(II) a pediatric postmarket surveillance as required 
     under section 522 of the Federal Food, Drug, and Cosmetic 
     Act.

       ``(ii) Applicable drug clinical trial.--

       ``(I) In general.--The term `applicable drug clinical 
     trial' means a controlled clinical investigation, other than 
     a phase I clinical investigation, of a product subject to 
     section 505 of the Federal Food, Drug, and Cosmetic Act or to 
     section 351 of this Act.
       ``(II) Clinical investigation.--For purposes of subclause 
     (I), the term `clinical investigation' has the meaning given 
     that term in section 312.3 of title 21, Code of Federal 
     Regulations.
       ``(III) Phase i.--The term `phase I' has the meaning given 
     that term in section 312.21 of title 21, Code of Federal 
     Regulations.

       ``(iii) Clinical trial information.--The term `clinical 
     trial information' means those data elements that are 
     necessary to complete an entry in the clinical trial registry 
     data bank under paragraph (2).
       ``(iv) Completion date.--The term `completion date' means, 
     with respect to an applicable drug clinical trial or an 
     applicable device clinical trial, the date on which the last 
     patient enrolled in the clinical trial has completed his or 
     her last medical visit of the clinical trial, whether the 
     clinical trial concluded according to the prespecified 
     protocol plan or was terminated.
       ``(v) Device.--The term `device' means a device as defined 
     in section 201(h) of the Federal Food, Drug, and Cosmetic 
     Act.
       ``(vi) Drug.--The term `drug' means a drug as defined in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act or 
     a biological product as defined in section 351 of this Act.
       ``(vii) Responsible party.--The term `responsible party', 
     with respect to a clinical trial of a drug or device, means--

       ``(I) the sponsor of the clinical trial (as defined in 
     section 50.3 of title 21, Code of Federal Regulations (or any 
     successor regulations)) or the principal investigator of such 
     clinical trial if so designated by such sponsor; or
       ``(II) if no sponsor exists, the grantee, contractor, or 
     awardee for a trial funded by a Federal agency or the 
     principal investigator of such clinical trial if so 
     designated by such grantee, contractor, or awardee.

       ``(B) Requirement.--The Secretary shall develop a mechanism 
     by which--

[[Page 10637]]

       ``(i) the responsible party for each applicable drug 
     clinical trial and applicable device clinical trial shall 
     submit the identity and contact information of such 
     responsible party to the Secretary at the time of submission 
     of clinical trial information under paragraph (2); and
       ``(ii) other Federal agencies may identify the responsible 
     party for an applicable drug clinical trial or applicable 
     device clinical trial.
       ``(2) Expansion of clinical trial registry data bank with 
     respect to clinical trial information.--
       ``(A) In general.--
       ``(i) Expansion of data bank.--To enhance patient 
     enrollment and provide a mechanism to track subsequent 
     progress of clinical trials, the Secretary, acting through 
     the Director of NIH, shall expand, in accordance with this 
     subsection, the clinical trials registry of the data bank 
     described under subsection (i)(3)(A) (referred to in this 
     subsection as the `registry data bank'). The Director of NIH 
     shall ensure that the registry data bank is made publicly 
     available through the Internet.
       ``(ii) Content.--Not later than 18 months after the date of 
     enactment of the Enhancing Drug Safety and Innovation Act of 
     2007, and after notice and comment, the Secretary shall 
     promulgate regulations to expand the registry data bank to 
     require the submission to the registry data bank of clinical 
     trial information for applicable drug clinical trials and 
     applicable device clinical trials that--

       ``(I) conforms to the International Clinical Trials 
     Registry Platform trial registration data set of the World 
     Health Organization;
       ``(II) includes the city, State, and zip code for each 
     clinical trial location, or a toll-free number through which 
     such location information may be accessed;
       ``(III) if the drug is not approved under section 505 of 
     the Federal Food, Drug, and Cosmetic Act or licensed under 
     section 351 of this Act, specifies whether or not there is 
     expanded access to the drug under section 561 of the Federal 
     Food, Drug, and Cosmetic Act for those who do not qualify for 
     enrollment in the clinical trial and how to obtain 
     information about such access;
       ``(IV) requires the inclusion of such other data elements 
     to the registry data bank as appropriate; and
       ``(V) becomes effective 90 days after issuance of the final 
     rule.

       ``(B) Format and structure.--
       ``(i) Searchable categories.--The Director of NIH shall 
     ensure that the public may search the entries in the registry 
     data bank by 1 or more of the following criteria:

       ``(I) The disease or condition being studied in the 
     clinical trial, using Medical Subject Headers (MeSH) 
     descriptors.
       ``(II) The treatment being studied in the clinical trial.
       ``(III) The location of the clinical trial.
       ``(IV) The age group studied in the clinical trial, 
     including pediatric subpopulations.
       ``(V) The study phase of the clinical trial.
       ``(VI) The source of support for the clinical trial, which 
     may be the National Institutes of Health or other Federal 
     agency, a private industry source, or a university or other 
     organization.
       ``(VII) The recruitment status of the clinical trial.
       ``(VIII) The National Clinical Trial number or other study 
     identification for the clinical trial.

       ``(ii) Format.--The Director of the NIH shall ensure that 
     the registry data bank is easily used by the public, and that 
     entries are easily compared.
       ``(C) Data submission.--The responsible party for an 
     applicable drug clinical trial shall submit to the Director 
     of NIH for inclusion in the registry data bank the clinical 
     trial information described in subparagraph (A)(ii).
       ``(D) Truthful clinical trial information.--
       ``(i) In general.--The clinical trial information submitted 
     by a responsible party under this paragraph shall not be 
     false or misleading in any particular.
       ``(ii) Effect.--Clause (i) shall not have the effect of 
     requiring clinical trial information with respect to an 
     applicable drug clinical trial or an applicable device 
     clinical trial to include information from any source other 
     than such clinical trial involved.
       ``(E) Changes in clinical trial status.--
       ``(i) Enrollment.--The responsible party for an applicable 
     drug clinical trial or an applicable device clinical trial 
     shall update the enrollment status not later than 30 days 
     after the enrollment status of such clinical trial changes.
       ``(ii) Completion.--The responsible party for an applicable 
     drug clinical trial or applicable device clinical trial shall 
     report to the Director of NIH that such clinical trial is 
     complete not later than 30 days after the completion date of 
     the clinical trial.
       ``(F) Timing of submission.--The clinical trial information 
     for an applicable drug clinical trial or an applicable device 
     clinical trial required to be submitted under this paragraph 
     shall be submitted not later than 21 days after the first 
     patient is enrolled in such clinical trial.
       ``(G) Posting of data.--
       ``(i) Applicable drug clinical trial.--The Director of NIH 
     shall ensure that clinical trial information for an 
     applicable drug clinical trial submitted in accordance with 
     this paragraph is posted publicly within 30 days of such 
     submission.
       ``(ii) Applicable device clinical trial.--The Director of 
     NIH shall ensure that clinical trial information for an 
     applicable device clinical trial submitted in accordance with 
     this paragraph is posted publicly within 30 days of clearance 
     under section 510(k) of the Federal Food, Drug, and Cosmetic 
     Act, or approval under section 515 or section 520(m) of such 
     Act, as applicable.
       ``(H) Voluntary submissions.--A responsible party for a 
     clinical trial that is not an applicable drug clinical trial 
     or an applicable device clinical trial may submit clinical 
     trial information to the registry data bank in accordance 
     with this subsection.
       ``(3) Expansion of registry data bank to include results of 
     clinical trials.--
       ``(A) Linking registry data bank to existing results.--
       ``(i) In general.--Beginning not later than 90 days after 
     the date of enactment of the Enhancing Drug Safety and 
     Innovation Act of 2007, for those clinical trials that form 
     the primary basis of an efficacy claim or are conducted after 
     the drug involved is approved or after the device involved is 
     cleared or approved, the Secretary shall ensure that the 
     registry data bank includes links to results information for 
     such clinical trial--

       ``(I) not earlier than 30 days after the date of the 
     approval of the drug involved or clearance or approval of the 
     device involved; or
       ``(II) not later than 30 days after such information 
     becomes publicly available, as applicable.

       ``(ii) Required information.--

       ``(I) FDA information.--The Secretary shall ensure that the 
     registry data bank includes links to the following 
     information:

       ``(aa) If an advisory committee considered at a meeting an 
     applicable drug clinical trial or an applicable device 
     clinical trial, any posted Food and Drug Administration 
     summary document regarding such applicable drug clinical 
     trial or applicable clinical device trial.
       ``(bb) If an applicable drug clinical trial was conducted 
     under section 505A or 505B of the Federal Food, Drug, and 
     Cosmetic Act, a link to the posted Food and Drug 
     Administration assessment of the results of such trial.
       ``(cc) Food and Drug Administration public health 
     advisories regarding the drug or device that is the subject 
     of the applicable drug clinical trial or applicable device 
     clinical trial, respectively, if any.
       ``(dd) For an applicable drug clinical trial, the Food and 
     Drug Administration action package for approval document 
     required under section 505(l)(2) of the Food Drug and 
     Cosmetic Act.
       ``(ee) For an applicable device clinical trial, in the case 
     of a premarket application, the detailed summary of 
     information respecting the safety and effectiveness of the 
     device required under section 520(h)(1) of the Federal Food, 
     Drug, and Cosmetic Act, or, in the case of a report under 
     section 510(k) of such Act, the section 510(k) summary of the 
     safety and effectiveness data required under section 
     807.95(d) of title 21, Code of Federal Regulations (or any 
     successor regulations).

       ``(II) NIH information.--The Secretary shall ensure that 
     the registry data bank includes links to the following 
     information:

       ``(aa) Medline citations to any publications regarding each 
     applicable drug clinical trial and applicable device clinical 
     trial.
       ``(bb) The entry for the drug that is the subject of an 
     applicable drug clinical trial in the National Library of 
     Medicine database of structured product labels, if available.
       ``(iii) Results for existing data bank entries.--The 
     Secretary may include the links described in clause (ii) for 
     data bank entries for clinical trials submitted to the data 
     bank prior to enactment of the Enhancing Drug Safety and 
     Innovation Act of 2007, as available.
       ``(B) Feasibility study.--The Director of NIH shall--
       ``(i) conduct a study to determine the best, validated 
     methods of making the results of clinical trials publicly 
     available after the approval of the drug that is the subject 
     of an applicable drug clinical trial; and
       ``(ii) not later than 18 months after initiating such 
     study, submit to the Secretary any findings and 
     recommendations of such study.
       ``(C) Negotiated rulemaking.--
       ``(i) In general.--The Secretary shall establish a 
     negotiated rulemaking process pursuant to subchapter IV of 
     chapter 5 of title 5, United States Code, to determine, for 
     applicable drug clinical trials--

       ``(I) how to ensure quality and validate methods of 
     expanding the registry data bank to include clinical trial 
     results information for trials not within the scope of this 
     Act;
       ``(II) the clinical trials of which the results information 
     is appropriate for adding to the expanded registry data bank; 
     and
       ``(III) the appropriate timing of the posting of such 
     results information.

       ``(ii) Time requirement.--The process described in 
     paragraph (1) shall be conducted in a timely manner to ensure 
     that--

       ``(I) any recommendation for a proposed rule--

       ``(aa) is provided to the Secretary not later than 21 
     months after the date of the enactment of the Enhancing Drug 
     Safety and Innovation Act of 2007; and
       ``(bb) includes an assessment of the benefits and costs of 
     the recommendation; and

       ``(II) a final rule is promulgated not later than 30 months 
     after the date of the enactment of the Enhancing Drug Safety 
     and Innovation Act of 2007, taking into account the 
     recommendations under subclause (I) and the results of the 
     feasibility study conducted under subparagraph (B).

       ``(iii) Representation on negotiated rulemaking 
     committee.--The negotiated rulemaking committee established 
     by the Secretary

[[Page 10638]]

     pursuant to clause (i) shall include members representing--

       ``(I) the Food and Drug Administration;
       ``(II) the National Institutes of Health;
       ``(III) other Federal agencies as the Secretary determines 
     appropriate;
       ``(IV) patient advocacy and health care provider groups;
       ``(V) the pharmaceutical industry;
       ``(VI) contract clinical research organizations;
       ``(VII) the International Committee of Medical Journal 
     Editors; and
       ``(VIII) other interested parties, including experts in 
     privacy protection, pediatrics, health information 
     technology, health literacy, communication, clinical trial 
     design and implementation, and health care ethics.

       ``(iv) Content of regulations.--The regulations promulgated 
     pursuant to clause (i) shall establish--

       ``(I) procedures to determine which clinical trials results 
     information data elements shall be included in the registry 
     data bank, taking into account the needs of different 
     populations of users of the registry data bank;
       ``(II) a standard format for the submission of clinical 
     trials results to the registry data bank;
       ``(III) a standard procedure for the submission of clinical 
     trial results information, including the timing of submission 
     and the timing of posting of results information, to the 
     registry data bank, taking into account the possible impacts 
     on publication of manuscripts based on the clinical trial;
       ``(IV) a standard procedure for the verification of 
     clinical trial results information, including ensuring that 
     free text data elements are non-promotional; and
       ``(V) an implementation plan for the prompt inclusion of 
     clinical trials results information in the registry data 
     bank.

       ``(D) Consideration of world health organization data 
     set.--The Secretary shall consider the status of the 
     consensus data elements set for reporting clinical trial 
     results of the World Health Organization when promulgating 
     the regulations under subparagraph (C).
       ``(E) Truthful clinical trial information.--
       ``(i) In general.--The clinical trial information submitted 
     by a responsible party under this paragraph shall not be 
     false or misleading in any particular.
       ``(ii) Effect.--Clause (i) shall not have the effect of 
     requiring clinical trial information with respect to an 
     applicable drug clinical trial or an applicable device 
     clinical trial to include information from any source other 
     than such clinical trial involved.
       ``(F) Waivers regarding certain clinical trial results.--
     The Secretary may waive any applicable requirements of this 
     paragraph for an applicable drug clinical trial or an 
     applicable device clinical trial, upon a written request from 
     the responsible person, if the Secretary determines that 
     extraordinary circumstances justify the waiver and that 
     providing the waiver is in the public interest, consistent 
     with the protection of public health, or in the interest of 
     national security. Not later than 30 days after any part of a 
     waiver is granted, the Secretary shall notify, in writing, 
     the appropriate committees of Congress of the waiver and 
     provide an explanation for why the waiver was granted.
       ``(4) Coordination and compliance.--
       ``(A) Clinical trials supported by grants from federal 
     agencies.--
       ``(i) In general.--No Federal agency may release funds 
     under a research grant to an awardee who has not complied 
     with paragraph (2) for any applicable drug clinical trial or 
     applicable device clinical trial for which such person is the 
     responsible party.
       ``(ii) Grants from certain federal agencies.--If an 
     applicable drug clinical trial or applicable device clinical 
     trial is funded in whole or in part by a grant from the Food 
     and Drug Administration, National Institutes of Health, the 
     Agency for Healthcare Research and Quality, or the Department 
     of Veterans Affairs, any grant or progress report forms 
     required under such grant shall include a certification that 
     the responsible party has made all required submissions to 
     the Director of NIH under paragraph (2).
       ``(iii) Verification by federal agencies.--The heads of the 
     agencies referred to in clause (ii), as applicable, shall 
     verify that the clinical trial information for each 
     applicable drug clinical trial or applicable device clinical 
     trial for which a grantee is the responsible party has been 
     submitted under paragraph (2) before releasing any remaining 
     funding for a grant or funding for a future grant to such 
     grantee.
       ``(iv) Notice and opportunity to remedy.--If the head of an 
     agency referred to in clause (ii), as applicable, verifies 
     that a grantee has not submitted clinical trial information 
     as described in clause (iii), such agency head shall provide 
     notice to such grantee of such non-compliance and allow such 
     grantee 30 days to correct such non-compliance and submit the 
     required clinical trial information.
       ``(v) Consultation with other federal agencies.--The 
     Secretary shall--

       ``(I) consult with other agencies that conduct research 
     involving human subjects in accordance with any section of 
     part 46 of title 45, Code of Federal Regulations (or any 
     successor regulations), to determine if any such research is 
     an applicable drug clinical trial or an applicable device 
     clinical trial under paragraph (1); and
       ``(II) develop with such agencies procedures comparable to 
     those described in clauses (ii), (iii), and (iv) to ensure 
     that clinical trial information for such applicable drug 
     clinical trials and applicable device clinical trial is 
     submitted under paragraph (2).

       ``(B) Certification to accompany drug, biological product, 
     and device submissions.--At the time of submission of an 
     application under section 505 of the Federal Food, Drug, and 
     Cosmetic Act, section 515 of such Act, section 520(m) of such 
     Act, or section 351 of this Act, or submission of a report 
     under section 510(k) of such Act, such application or 
     submission shall be accompanied by a certification that all 
     applicable requirements of this subsection have been met. 
     Where available, such certification shall include the 
     appropriate National Clinical Trial control numbers.
       ``(C) Verification of submission prior to posting.--In the 
     case of clinical trial information that is submitted under 
     paragraph (2), but is not made publicly available pending 
     regulatory approval or clearance, as applicable, the Director 
     of NIH shall respond to inquiries from other Federal agencies 
     and peer-reviewed scientific journals to confirm that such 
     clinical trial information has been submitted but has not yet 
     been posted.
       ``(5) Limitation on disclosure of clinical trial 
     information.--
       ``(A) In general.--Nothing in this subsection (or under 
     section 552 of title 5, United States Code) shall require the 
     Secretary to publicly disclose, from any record or source 
     other than the registry data bank expanded under this 
     subsection, information described in subparagraph (B).
       ``(B) Information described.--Information described in this 
     subparagraph is--
       ``(i) information submitted to the Director of NIH under 
     this subsection, or information of the same general nature as 
     (or integrally associated with) the information so submitted; 
     and
       ``(ii) not otherwise publicly available, including because 
     it is protected from disclosure under section 552 of title 5, 
     United States Code.
       ``(6) Authorization of appropriations.--There are 
     authorized to be appropriated to carry out this subsection 
     $10,000,000 for each fiscal year.''.
       (b) Conforming Amendments.--
       (1) Prohibited acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
     at the end the following:
       ``(jj)(1) The failure to submit the certification required 
     by section 402(j)(4)(B) of the Public Health Service Act, or 
     knowingly submitting a false certification under such 
     section.
       ``(2) The submission of clinical trial information under 
     subsection (i) or (j) of section 402 of the Public Health 
     Service Act that is promotional or false or misleading in any 
     particular under paragraph (2) or (3) of such subsection 
     (j).''.
       (2) Civil money penalties.--Section 303(f) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 333(f)), as amended 
     by section 203, is further amended by--
       (A) redesignating paragraphs (4), (5), and (6) as 
     paragraphs (5), (6), and (7), respectively;
       (B) inserting after paragraph (3) the following:
       ``(d) Any person who violates section 301(jj) shall be 
     subject to a civil monetary penalty of not more than $10,000 
     for the first violation, and not more than $20,000 for each 
     subsequent violation.'';
       (C) in paragraph (2)(C), by striking ``paragraph (4)(A)'' 
     and inserting ``paragraph (5)(A)'';
       (D) in paragraph (5), as so redesignated, by striking 
     ``paragraph (1), (2), or (3)'' each place it appears and 
     inserting ``paragraph (1), (2), (3), or (4)''; and
       (E) in paragraph (7), as so redesignated, by striking 
     ``paragraph (5)'' each place it appears and inserting 
     ``paragraph (6)''.
       (3) New drugs and devices.--
       (A) Investigational new drugs.--Section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
     amended in paragraph (4), by adding at the end the following: 
     ``The Secretary shall update such regulations to require 
     inclusion in the informed consent form a statement that 
     clinical trial information for such clinical investigation 
     has been or will be submitted for inclusion in the registry 
     data bank pursuant to subsections (i) and (j) of section 402 
     of the Public Health Service Act.''.
       (B) New drug applications.--Section 505(b) of the Federal, 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by 
     adding at the end the following:
       ``(6) An application submitted under this subsection shall 
     be accompanied by the certification required under section 
     402(j)(4)(B) of the Public Health Service Act. Such 
     certification shall not be considered an element of such 
     application.''.
       (C) Device reports under section 510(k).--Section 510(k) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) 
     is amended by adding at the end the following:
     ``A notification submitted under this subsection that 
     contains clinical trial data for an applicable device 
     clinical trial (as defined in section 402(j)(1) of the Public 
     Health Service Act) shall be accompanied by the certification 
     required under section 402(j)(4)(B) of such Act. Such 
     certification shall not be considered an element of such 
     notification.''.
       (D) Device premarket approval application.--Section 515(c) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     360e(c)) is amended--
       (i) in subparagraph (F), by striking ``; and'' and 
     inserting a semicolon;
       (ii) by redesignating subparagraph (G) as subparagraph (H); 
     and
       (iii) by inserting after subparagraph (F) the following:

[[Page 10639]]

       ``(G) the certification required under section 402(j)(4)(B) 
     of the Public Health Service Act (which shall not be 
     considered an element of such application); and''.
       (E) Humanitarian device exemption.--Section 520(m)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 
     is amended in the first sentence in the matter following 
     subparagraph (C), by inserting at the end before the period 
     ``and such application shall include the certification 
     required under section 402(j)(4)(B) of the Public Health 
     Service Act (which shall not be considered an element of such 
     application)''.
       (c) Preemption.--
       (1) In general.--No State or political subdivision of a 
     State may establish or continue in effect any requirement for 
     the registration of clinical trials or for the inclusion of 
     information relating to the results of clinical trials in a 
     database.
       (2) Rule of construction.--The fact of submission of 
     clinical trial information, if submitted in compliance with 
     subsection (i) and (j) of section 402 of the Public Health 
     Service Act (as amended by this section), that relates to a 
     use of a drug or device not included in the official labeling 
     of the approved drug or device shall not be construed by the 
     Secretary or in any administrative or judicial proceeding, as 
     evidence of a new intended use of the drug or device that is 
     different from the intended use of the drug or device set 
     forth in the official labeling of the drug or device. The 
     availability of clinical trial information through the data 
     bank under such subsections (i) and (j), if submitted in 
     compliance with such subsections, shall not be considered as 
     labeling, adulteration, or misbranding of the drug or device 
     under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 
     et seq.).
       (d) Transition Rule; Effective Date of Funding 
     Restrictions.--
       (1) Transition rule for clinical trials initiated prior to 
     expansion of registry data bank.--The responsible party (as 
     defined in paragraph (1) of section 402(j) of the Public 
     Health Service Act (as added by this section)) for an 
     applicable drug clinical trial or applicable device clinical 
     trial (as defined under such paragraph (1)) that is initiated 
     after the date of enactment of this subtitle and before the 
     effective date of the regulations promulgated under paragraph 
     (2) of such section 402(j), shall submit required clinical 
     trial information under such section not later than 120 days 
     after such effective date.
       (2) Funding restrictions.--Subparagraph (A) of paragraph 
     (4) of such section 402(j) shall take effect 210 days after 
     the effective date of the regulations promulgated under 
     paragraph (2) of such section 402(j).
       (e) Effective Date.--Beginning 90 days after the date of 
     enactment of this title, the responsible party for an 
     applicable drug clinical trial or an applicable device 
     clinical trial (as that term is defined in such section 
     402(j)) that is initiated after the date of enactment of this 
     title and before the effective date of the regulations issued 
     under subparagraph (A) of paragraph (2) of such subsection, 
     shall submit clinical trial information under such paragraph 
     (2).

                   Subtitle D--Conflicts of Interest

     SEC. 241. CONFLICTS OF INTEREST.

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

     ``SEC. 712. CONFLICTS OF INTEREST.

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

[[Page 10640]]

     Food and Drug Administration as academicians or 
     practitioners.
       ``(f) Periodic Review of Guidance.--Not less than once 
     every 5 years, the Secretary shall review guidance of the 
     Food and Drug Administration regarding conflict of interest 
     waiver determinations with respect to advisory committees and 
     update such guidance as necessary.''.
       (b) Conforming Amendment.--Section 505(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended 
     by--
       (1) striking paragraph (4); and
       (2) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (4), (5), (6), and (7), respectively.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on October 1, 2007.

                Subtitle E--Other Drug Safety Provisions

     SEC. 251. DATABASE FOR AUTHORIZED GENERIC DRUGS.

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

     SEC. 252. MEDICAL MARIJUANA.

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

                       TITLE III--MEDICAL DEVICES

     SEC. 301. SHORT TITLE; REFERENCES.

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

                      Subtitle A--Device User Fees

     SEC. 302. DEVICE FEES.

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

     ``SEC. 737. DEVICE FEES.

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

[[Page 10641]]

       ``(13) The term `establishment registration fee' means a 
     fee assessed under section 738(a)(3) for the registration of 
     an establishment subject to a registration fee.
       ``(e) Sunset.--This part shall cease to be effective on 
     October 1, 2012, except that subsection (b) with respect to 
     reports shall cease to be effective January 31, 2013.''.

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

       Section 738 (21 U.S.C. 379j) is amended--
       (1) in subsection (a)--
       (A) in paragraph (2)--
       (i) in the header, by inserting ``, and annual fee for 
     periodic reporting concerning a class iii device'' after 
     ``fee'';
       (ii) in subparagraph (A)--

       (I) in clause (iii), by inserting ``75 percent of'' after 
     ``a fee equal to'';
       (II) in clause (iv), by striking ``21.5'' and inserting 
     ``15'';
       (III) in clause (v), by striking ``7.2'' and inserting 
     ``7'';
       (IV) by redesignating clauses (vi) and (vii) as clauses 
     (vii) and (viii), respectively;
       (V) by inserting after clause (v) the following:

       ``(vi) For a 30-day notice, a fee equal to 1.6 percent of 
     the fee that applies under clause (i).'';

       (VI) in clause (viii), as redesignated by subclause (IV)--

       (aa) by striking ``1.42'' and inserting ``1.84''; and
       (bb) by striking ``, subject to any adjustment under 
     subsection (e)(2)(C)(ii)''; and

       (VII) by adding at the end the following:

       ``(ix) For a request for classification information, a fee 
     equal to 1.35 percent of the fee that applies under clause 
     (i).
       ``(x) For periodic reporting concerning a class III device, 
     the annual fee shall be equal to 3.5 percent of the fee that 
     applies under clause (i).'';
       (iii) in subparagraph (C)--

       (I) in the first sentence--

       (aa) by striking ``or''; and
       (bb) by striking ``except that'' and all that follows 
     through the period and inserting ``, 30-day notice, request 
     for classification information, or periodic report concerning 
     a class III device.''; and

       (II) by striking the third sentence; and

       (iv) in subparagraph (D)--

       (I) in clause (iii), by striking the last two sentences; 
     and
       (II) by adding at the end the following:

       ``(iv) Modular application withdrawn before first action.--
     The Secretary shall refund 75 percent of the application fee 
     paid for a modular application submitted under section 
     515(c)(4) that is withdrawn before a second module is 
     submitted and before a first action on the first module. If 
     the modular application is withdrawn after a second or 
     subsequent module is submitted but before any first action, 
     the Secretary may return a portion of the fee. The amount of 
     refund, if any, shall be based on the level of effort already 
     expended on the review of the modules submitted.
       ``(v) Sole discretion to refund.--The Secretary shall have 
     sole discretion to refund a fee or portion of the fee under 
     this subparagraph. A determination by the Secretary 
     concerning a refund under this paragraph shall not be 
     reviewable.''; and
       (B) by adding at the end the following:
       ``(3) Annual establishment registration fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each establishment subject to a registration fee shall be 
     subject to a fee for each initial or annual registration 
     beginning with its registration for fiscal year 2008.
       ``(B) Exception for federal or state government 
     establishment.--No fee shall be required under subparagraph 
     (A) for an establishment operated by a Federal or State 
     Government entity unless a device manufactured by the 
     establishment is to be distributed commercially.
       ``(C) Payment.--The annual establishment registration fee 
     shall be due once each fiscal year, upon the initial 
     registration of the establishment or upon the annual 
     registration under section 510.'';
       (2) by striking subsection (b) and inserting the following:
       ``(b) Fee Amounts.--Except as provided in subsections (c), 
     (d), and (e), the fees under subsection (a) shall be based on 
     the following fee amounts:


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

       (3) in subsection (c)--
       (A) in the heading, by striking ``Annual Fee Setting'' and 
     inserting ``Annual Fee Setting'';
       (B) in paragraph (1), by striking the second sentence;
       (C) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (D) by inserting after paragraph (1) the following:
       ``(2) Adjustment of annual establishment registration 
     fee.--
       ``(A) In general.--When setting the fees for fiscal year 
     2010, the Secretary may increase the establishment 
     registration fee specified in subsection (b) only if the 
     Secretary estimates that the number of establishments 
     submitting fees for fiscal year 2009 is less than 12,250. The 
     percent increase shall be the percent by which the estimate 
     of establishments submitting fees in fiscal year 2009 is less 
     than 12,750, but in no case shall the percent increase be 
     more than 8.5 percent over the amount for such fee specified 
     in subsection (b) for fiscal year 2010. If the Secretary 
     makes any adjustment to the establishment registration fee 
     for fiscal year 2010, then the establishment registration fee 
     for fiscal years 2011 and 2012 under subsection (b) shall be 
     adjusted as follows: the fee for fiscal year 2011 shall be 
     equal to the adjusted fee for fiscal year 2010, increased by 
     8.5 percent, and the fee for fiscal year 2012 shall be equal 
     to the adjusted fee for fiscal year 2011, increased by 8.5 
     percent.
       ``(B) Publication in the federal register.--The Secretary 
     shall publish any determination with respect to any 
     establishment registration fee adjustment made under 
     subparagraph (A), and the rationale for such determination, 
     in the Federal Register.''; and
       (E) in paragraph (4)(A), as so redesignated--
       (i) by striking ``For fiscal years 2006 and 2007, the'' and 
     inserting ``The''; and
       (ii) by striking ``of fiscal year 2008'' and inserting ``of 
     the next fiscal year'';
       (4) in subsection (d)--
       (A) in paragraph (1), by striking ``, partners, and parent 
     firms'';
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``, partners, and 
     parent firms'';
       (ii) in subparagraph (B)--

       (I) by striking ``An applicant shall'' and inserting the 
     following:

       ``(i) In general.--An applicant shall'';

       (II) by striking ``The applicant shall support'' and 
     inserting the following:

       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support'';

       (III) by striking ``, partners, and parent firms'' both 
     places the term appears;
       (IV) by striking ``partners, or parent firms, the'' and 
     inserting ``the'';
       (V) by striking ``, partners, or parent firms, 
     respectively''; and
       (VI) by adding at the end the following:

       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--The applicant shall support 
     its claim that it meets the definition under subparagraph (A) 
     by submission of the following:

       ``(I) A signed certification, in such form as the Secretary 
     may direct through a notice published in the Federal 
     Register, that the applicant meets the criteria for a small 
     business.
       ``(II) A certification, in English, from the national 
     taxing authority of the country in which it is headquartered. 
     Such certification shall provide the applicant's gross 
     receipts and sales for the most recent year, in both the 
     local currency and in United States dollars, the exchange 
     rate used in making this conversion to dollars, and the dates 
     during which these receipts and sales were collected, and it 
     shall bear the official seal of the national taxing 
     authority.
       ``(III) Identical certifications shall be provided for each 
     of the applicant's affiliates.
       ``(IV) A statement signed by the head of the applicant or 
     its chief financial officer that it has submitted 
     certifications for all of its affiliates, or that it had no 
     affiliates, whichever is applicable.''; and

       (iii) in subparagraph (C)--

       (I) by striking ``reduced rate of'' and inserting ``reduced 
     rate of--''; and
       (II) by striking ``38 percent'' and all that follows 
     through the period and inserting the following:

       ``(i) 25 percent of the fee established under such 
     subsection for a premarket application, a premarket report, a 
     supplement, or a periodic report concerning a class III 
     device; and
       ``(ii) 50 percent of the fee established under such 
     subsection for a 30-day notice or a request for 
     classification information.'';
       (5) in subsection (e)--
       (A) in paragraph (1), by striking ``2004'' and inserting 
     ``2008''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``, partners, and 
     parent firms'';
       (ii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) Evidence of qualification.--
       ``(i) In general.--An applicant shall pay the higher fees 
     established by the Secretary each year unless the applicant 
     submits evidence that it qualifies for the lower fee rate.
       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support its 
     claim that it meets the definition under subparagraph (A) by 
     submission of a copy of its most recent Federal income tax 
     return for a taxable year, and a copy of such returns of its 
     affiliates, which show an amount of gross sales or receipts 
     that is less than the maximum established in subparagraph 
     (A). The applicant, and each of such affiliates, shall 
     certify that the information provided is a true and accurate 
     copy of the actual tax forms

[[Page 10642]]

     they submitted to the Internal Revenue Service. If no tax 
     forms are submitted for affiliates, the applicant shall 
     certify that the applicant has no affiliates.
       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--The applicant shall support 
     its claim that it meets the definition under subparagraph (A) 
     by submission of the following:

       ``(I) A signed certification, in such form as the Secretary 
     may direct through a notice published in the Federal 
     Register, that the applicant meets the criteria for a small 
     business.
       ``(II) A certification, in English, from the national 
     taxing authority of the country in which it is headquartered. 
     Such certification shall provide the applicant's gross 
     receipts and sales for the most recent year, in both the 
     local currency and in United States dollars, and the exchange 
     rate used in making such conversion to dollars, and the dates 
     during which such receipts and sales were collected, and it 
     shall bear the official seal of the national taxing 
     authority.
       ``(III) Identical certifications shall be provided for each 
     of the applicant's affiliates.
       ``(IV) A statement signed by the head of the applicant or 
     its chief financial officer that it has submitted 
     certifications for all of its affiliates, or that it had no 
     affiliates, whichever is applicable.''; and

       (iii) by striking subparagraph (C) and inserting the 
     following:
       ``(C) Reduced fees.--For fiscal year 2008 and each 
     subsequent fiscal year, where the Secretary finds that the 
     applicant involved meets the definition under subparagraph 
     (A), the fee for a premarket notification submission may be 
     paid at 50 percent of the fee that applies under subsection 
     (a)(2)(A)(viii) and as established under subsection 
     (c)(1).'';
       (6) by striking subsection (f) and inserting the following:
       ``(f) Effect of Failure To Pay Fees.--
       ``(1) In general.--A premarket application, premarket 
     report, supplement, or premarket notification submission, 30-
     day notice, request for classification information, or 
     periodic report concerning a class III device submitted by a 
     person subject to fees under paragraphs (2) and (3) of 
     subsection (a) shall be considered incomplete and shall not 
     be accepted by the Secretary until all fees owed by such 
     person have been paid.
       ``(2) Registration information.--Registration information 
     submitted by an establishment subject to a registration fee 
     under subsection (a)(3) shall be considered incomplete and 
     shall not be accepted by the Secretary until the registration 
     fee owed for the establishment has been paid. Until the fee 
     is paid and the registration is complete, the establishment 
     shall be deemed to have failed to register in accordance with 
     section 510.'';
       (7) in subsection (g)--
       (A) by striking paragraph (1) and inserting the following:
       ``(1) Performance goals; termination of program.--With 
     respect to the amount that, under the salaries and expenses 
     account of the Food and Drug Administration, is appropriated 
     for a fiscal year for devices and radiological products, fees 
     may not be assessed under subsection (a) for the fiscal year, 
     and the Secretary is not expected to meet any performance 
     goals identified for the fiscal year, if--
       ``(A) the amount so appropriated for the fiscal year, 
     excluding the amount of fees appropriated for the fiscal 
     year, is more than 1 percent less than $205,720,000 
     multiplied by the adjustment factor applicable to such fiscal 
     year; or
       ``(B) fees were not assessed under subsection (a) for the 
     previous fiscal year.''; and
       (B) in paragraph (2), by striking ``and premarket 
     notification submissions, and'' and inserting ``premarket 
     notification submissions, 30-day notices, requests for 
     classification information, periodic reports concerning a 
     class III device, and establishment registrations''; and
       (8) in subsection (h), by striking paragraphs (3) and (4) 
     and inserting the following:
       ``(3) Authorization of appropriations.--There are 
     authorized to be appropriated for fees under this section--
       ``(A) $48,431,000 for fiscal year 2008;
       ``(B) $52,547,000 for fiscal year 2009;
       ``(C) $57,014,000 for fiscal year 2010;
       ``(D) $61,860,000 for fiscal year 2011; and
       ``(E) $67,118,000 for fiscal year 2012.
       ``(4) Offset.--If the cumulative amount of fees collected 
     during fiscal years 2008, 2009, and 2010, added to the amount 
     estimated to be collected for fiscal year 2011 (which 
     estimate shall be based upon the amount of fees received by 
     the Secretary through June 30, 2011), exceeds the amount of 
     fees specified in aggregate in paragraph (3) for such 4 
     fiscal years, the aggregate amount in excess shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.

     SEC. 304. SAVINGS CLAUSE.

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

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this subtitle shall take effect on 
     the date of the enactment of this subtitle.

     Subtitle B--Amendments Regarding Regulation of Medical Devices

     SEC. 311. INSPECTIONS BY ACCREDITED PERSONS.

       Section 704(g) (21 U.S.C. 374(g)) is amended--
       (1) in paragraph (1) by striking ``not later than one year 
     after the date of enactment of this subsection, the 
     Secretary'' and inserting ``The Secretary'';
       (2) in paragraph (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 manufacturer 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).'';
       (3) by amending paragraph (6) to read as follows:
       ``(6) A device establishment is eligible for inspections by 
     persons accredited under paragraph (2) if the following 
     conditions are met:
       ``(A) With respect to inspections to be conducted by an 
     accredited person--
       ``(i) the owner or operator of the establishment submits to 
     the Secretary a notice indicating the intent to use such a 
     person to conduct the inspection, and the date on which the 
     inspection is scheduled to begin; and
       ``(ii) the accredited person whom the establishment selects 
     to conduct the inspection is listed on the Internet site of 
     the Food and Drug Administration referred to in paragraph 
     (4).
       ``(B) As requested by the Secretary, the establishment or 
     the accredited person identified in the notice under 
     subparagraph (A) provides information concerning the 
     relationship between the establishment and such accredited 
     person.'';
       (4) in paragraph (7)--
       (A) by amending subparagraph (A) to read as follows:
       ``(A) Persons accredited under paragraph (2) to conduct 
     inspections shall record in writing their inspection 
     observations and shall present the observations to the device 
     establishment's designated representative and describe each 
     observation. Additionally, such accredited person shall 
     prepare an inspection report in a form and manner designated 
     by the Secretary, 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 new subparagraph:
       ``(F) The Secretary shall accept reports of audits 
     assessing conformance with an appropriate quality systems 
     standard set by the International Organization for 
     Standardization (ISO) identified by the Secretary in public 
     notice for the purpose of setting risk-based inspectional 
     priorities.''.

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

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

     SEC. 313. REGISTRATION.

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

[[Page 10643]]



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

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

     SEC. 315. ELECTRONIC REGISTRATION AND LISTING.

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

                  TITLE IV--PEDIATRIC MEDICAL PRODUCTS

             Subtitle A--Best Pharmaceuticals for Children

     SEC. 401. SHORT TITLE.

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

     SEC. 402. PEDIATRIC STUDIES OF DRUGS.

       (a) In General.--Section 505A of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355a) is amended--
       (1) in subsection (a), by inserting before the period at 
     the end the following: ``, and, at the discretion of the 
     Secretary, may include preclinical studies'';
       (2) in subsection (b)--
       (A) in paragraph (1)(A)(i), by striking ``(D)'' both places 
     it appears and inserting ``(E)'';
       (B) in paragraph (1)(A)(ii), by striking ``(D)'' and 
     inserting ``(E)'';
       (C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
       (D) by striking ``(ii) the'' and inserting ``(II) the'';
       (E) by striking ``(B) if the drug is designated'' and 
     inserting ``(ii) if the drug is designated'';
       (F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
       (G) by striking ``(i) a listed patent'' and inserting ``(I) 
     a listed patent'';
       (H) by striking ``(ii) a listed patent'' and inserting 
     ``(II) a listed patent'';
       (I) by striking ``(B) if the drug is the subject'' and 
     inserting ``(ii) if the drug is the subject'';
       (J) by striking ``If'' and all that follows through 
     ``subsection (d)(3)'' and inserting the following:
       ``(1) In general.--Except as provided in paragraph (2), if, 
     prior to approval of an application that is submitted under 
     section 505(b)(1), the Secretary determines that information 
     relating to the use of a new drug in the pediatric population 
     may produce health benefits in that population, the Secretary 
     makes a written request for pediatric studies (which shall 
     include a timeframe for completing such studies), the 
     applicant agrees to the request, such studies are completed 
     using appropriate formulations for each age group for which 
     the study is requested within any such timeframe, and the 
     reports thereof are submitted and accepted in accordance with 
     subsection (d)(3), and if the Secretary determines that 
     labeling changes are appropriate, such changes are made 
     within the timeframe requested by the Secretary--''; and
       (K) by adding at the end the following:
       ``(2) Exception.--The Secretary shall not extend a period 
     referred to in paragraph (1)(A) or in paragraph (1)(B) later 
     than 9 months prior to the expiration of such period.'';
       (3) in subsection (c)--
       (A) in paragraph (1)(A)(i), by striking ``(D)'' both places 
     it appears and inserting ``(E)'';
       (B) in paragraph (1)(A)(ii), by striking ``(D)'' and 
     inserting ``(E)'';
       (C) by striking ``(1)(A)(i)'' and inserting ``(A)(i)(I)'';
       (D) by striking ``(ii) the'' and inserting ``(II) the'';
       (E) by striking ``(B) if the drug is designated'' and 
     inserting ``(ii) if the drug is designated'';
       (F) by striking ``(2)(A)'' and inserting ``(B)(i)'';
       (G) by striking ``(i) a listed patent'' and inserting ``(I) 
     a listed patent'';
       (H) by striking ``(ii) a listed patent'' and inserting 
     ``(II) a listed patent'';
       (I) by striking ``(B) if the drug is the subject'' and 
     inserting ``(ii) if the drug is the subject'';
       (J) by striking ``If'' and all that follows through 
     ``subsection (d)(3)'' and inserting the following:
       ``(1) In general.--Except as provided in paragraph (2), if 
     the Secretary determines that information relating to the use 
     of an approved drug in the pediatric population may produce 
     health benefits in that population and makes a written 
     request to the holder of an approved application under 
     section 505(b)(1) for pediatric studies (which shall include 
     a timeframe for completing such studies), the holder agrees 
     to the request, such studies are completed using appropriate 
     formulations for each age group for which the study is 
     requested within any such timeframe, and the reports thereof 
     are submitted and accepted in accordance with subsection 
     (d)(3), and if the Secretary determines that labeling changes 
     are appropriate, such changes are made within the timeframe 
     requested by the Secretary--''; and
       (K) by adding at the end the following:
       ``(2) Exception.--The Secretary shall not extend a period 
     referred to in paragraph (1)(A) or in paragraph (1)(B) later 
     than 9 months prior to the expiration of such period.'';
       (4) by striking subsection (d) and inserting the following:
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Request for studies.--
       ``(A) In general.--The Secretary may, after consultation 
     with the sponsor of an application for an investigational new 
     drug under section 505(i), the sponsor of an application for 
     a new drug under section 505(b)(1), or the holder of an 
     approved application for a drug under section 505(b)(1), 
     issue to the sponsor or holder a written request for the 
     conduct of pediatric studies for such drug. In issuing such 
     request, the Secretary shall take into account adequate 
     representation of children of ethnic and racial minorities. 
     Such request to conduct pediatric studies shall be in writing 
     and shall include a timeframe for such studies and a request 
     to the sponsor or holder to propose pediatric labeling 
     resulting from such studies.
       ``(B) Single written request.--A single written request--
       ``(i) may relate to more than 1 use of a drug; and
       ``(ii) may include uses that are both approved and 
     unapproved.
       ``(2) Written request for pediatric studies.--
       ``(A) Request and response.--
       ``(i) In general.--If the Secretary makes a written request 
     for pediatric studies (including neonates, as appropriate) 
     under subsection (b) or (c), the applicant or holder, not 
     later than 180 days after receiving the written request, 
     shall respond to the Secretary as to the intention of the 
     applicant or holder to act on the request by--

       ``(I) indicating when the pediatric studies will be 
     initiated, if the applicant or holder agrees to the request; 
     or
       ``(II) indicating that the applicant or holder does not 
     agree to the request and the reasons for declining the 
     request.

       ``(ii) Disagree with request.--If, on or after the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, the applicant or holder does not agree to the 
     request on the grounds that it is not possible to develop the 
     appropriate pediatric formulation, the applicant or holder 
     shall submit to the Secretary the reasons such pediatric 
     formulation cannot be developed.
       ``(B) Adverse event reports.--An applicant or holder that, 
     on or after the date of enactment of the Best Pharmaceuticals 
     for Children Amendments of 2007, agrees to the request for 
     such studies shall provide the Secretary, at the same time as 
     submission of the reports of such studies, with all 
     postmarket adverse event reports regarding the drug that is 
     the subject of such studies and are available prior to 
     submission of such reports.
       ``(3) Meeting the studies requirement.--Not later than 180 
     days after the submission of the reports of the studies, the 
     Secretary shall accept or reject such reports and so notify 
     the sponsor or holder. The Secretary's only responsibility in 
     accepting or rejecting the reports shall be to determine, 
     within the 180 days, whether the studies fairly respond to 
     the written request, have been conducted in accordance with 
     commonly accepted scientific principles and protocols, and 
     have been reported in accordance with the requirements of the 
     Secretary for filing.
       ``(4) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.'';
       (5) by striking subsections (e) and (f) and inserting the 
     following:
       ``(e) Notice of Determinations on Studies Requirement.--
       ``(1) In general.--The Secretary shall publish a notice of 
     any determination, made on or after the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, 
     that the requirements of subsection (d) have been met and 
     that submissions and approvals under subsection (b)(2) or (j) 
     of section 505 for a drug will be subject to the provisions 
     of this section. Such notice shall be published not later 
     than 30 days after the date of the Secretary's determination 
     regarding market exclusivity and shall include a copy of the 
     written request made under subsection (b) or (c).
       ``(2) Identification of certain drugs.--The Secretary shall 
     publish a notice identifying any drug for which, on or after 
     the date of enactment of the Best Pharmaceuticals for 
     Children Amendments of 2007, a pediatric formulation was 
     developed, studied, and found to be safe and effective in the 
     pediatric population (or specified subpopulation) if the 
     pediatric formulation for such drug is not introduced onto 
     the market within 1 year of the date that the Secretary 
     publishes the notice described in paragraph (1). Such notice 
     identifying such drug

[[Page 10644]]

     shall be published not later than 30 days after the date of 
     the expiration of such 1 year period.
       ``(f) Internal Review of Written Requests and Pediatric 
     Studies.--
       ``(1) Internal review.--
       ``(A) In general.--The Secretary shall create an internal 
     review committee to review all written requests issued and 
     all reports submitted on or after the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, in 
     accordance with paragraphs (2) and (3).
       ``(B) Members.--The committee under subparagraph (A) shall 
     include individuals, each of whom is an employee of the Food 
     and Drug Administration, with the following expertise:
       ``(i) Pediatrics.
       ``(ii) Biopharmacology.
       ``(iii) Statistics.
       ``(iv) Drugs and drug formulations.
       ``(v) Legal issues.
       ``(vi) Appropriate expertise pertaining to the pediatric 
     product under review.
       ``(vii) One or more experts from the Office of Pediatric 
     Therapeutics, including an expert in pediatric ethics.
       ``(viii) Other individuals as designated by the Secretary.
       ``(2) Review of written requests.--All written requests 
     under this section shall be reviewed and approved by the 
     committee established under paragraph (1) prior to being 
     issued.
       ``(3) Review of pediatric studies.--The committee 
     established under paragraph (1) shall review all studies 
     conducted pursuant to this section to determine whether to 
     accept or reject such reports under subsection (d)(3).
       ``(4) Tracking pediatric studies and labeling changes.--The 
     committee established under paragraph (1) shall be 
     responsible for tracking and making available to the public, 
     in an easily accessible manner, including through posting on 
     the website of the Food and Drug Administration--
       ``(A) the number of studies conducted under this section;
       ``(B) the specific drugs and drug uses, including labeled 
     and off-labeled indications, studied under this section;
       ``(C) the types of studies conducted under this section, 
     including trial design, the number of pediatric patients 
     studied, and the number of centers and countries involved;
       ``(D) the number of pediatric formulations developed and 
     the number of pediatric formulations not developed and the 
     reasons such formulations were not developed;
       ``(E) the labeling changes made as a result of studies 
     conducted under this section;
       ``(F) an annual summary of labeling changes made as a 
     result of studies conducted under this section for 
     distribution pursuant to subsection (k)(2); and
       ``(G) information regarding reports submitted on or after 
     the date of enactment of the Best Pharmaceuticals for 
     Children Amendments of 2007.'';
       (6) in subsection (g)--
       (A) in paragraph (1)--
       (i) by striking ``(c)(1)(A)(ii)'' and inserting 
     ``(c)(1)(A)(i)(II)''; and
       (ii) by striking ``(c)(2)'' and inserting ``(c)(1)(B)'';
       (B) in paragraph (2), by striking ``(c)(1)(B)'' and 
     inserting ``(c)(1)(A)(ii)'';
       (C) by redesignating paragraphs (1) and (2) as 
     subparagraphs (A) and (B), respectively;
       (D) by striking ``Limitations.--A drug'' and inserting 
     ``Limitations.--
       ``(1) In general.--Notwithstanding subsection (c)(2), a 
     drug''; and
       (E) by adding at the end the following:
       ``(2) Exclusivity adjustment.--
       ``(A) Adjustment.--
       ``(i) In general.--With respect to any drug, if the 
     organization designated under subparagraph (B) notifies the 
     Secretary that the combined annual gross sales for all drugs 
     with the same active moiety exceeded $1,000,000,000 in any 
     calendar year prior to the time the sponsor or holder agrees 
     to the initial written request pursuant to subsection (d)(2), 
     then each period of market exclusivity deemed or extended 
     under subsection (b) or (c) shall be reduced by 3 months for 
     such drug.
       ``(ii) Determination.--The determination under clause (i) 
     of the combined annual gross sales shall be determined--

       ``(I) taking into account only those sales within the 
     United States; and
       ``(II) taking into account only the sales of all drugs with 
     the same active moiety of the sponsor or holder and its 
     affiliates.

       ``(B) Designation.--The Secretary shall designate an 
     organization other than the Food and Drug Administration to 
     evaluate whether the combined annual gross sales for all 
     drugs with the same active moiety exceeded $1,000,000,000 in 
     a calendar year as described in subparagraph (A). Prior to 
     designating such organization, the Secretary shall determine 
     that such organization is independent and is qualified to 
     evaluate the sales of pharmaceutical products. The Secretary 
     shall re-evaluate the designation of such organization once 
     every 3 years.
       ``(C) Notification.--Once a year at a time designated by 
     the Secretary, the organization designated under subparagraph 
     (B) shall notify the Food and Drug Administration of all 
     drugs with the same active moiety with combined annual gross 
     sales that exceed $1,000,000,000 during the previous calendar 
     year.'';
       (7) in subsection (i)--
       (A) in the heading, by striking ``Supplements'' and 
     inserting ``Changes'';
       (B) in paragraph (1)--
       (i) in the heading, by inserting ``applications and'' after 
     ``pediatric'';
       (ii) by inserting ``application or'' after ``Any'';
       (iii) by striking ``change pursuant to a report on a 
     pediatric study under'' and inserting ``change as a result of 
     any pediatric study conducted pursuant to''; and
       (iv) by inserting ``application or'' after ``to be a 
     priority''; and
       (C) in paragraph (2)(A), by--
       (i) striking ``If the Commissioner'' and inserting ``If, on 
     or after the date of enactment of the Best Pharmaceuticals 
     for Children Amendments of 2007, the Commissioner''; and
       (ii) striking ``an application with'' and all that follows 
     through ``on appropriate'' and inserting ``the sponsor and 
     the Commissioner have been unable to reach agreement on 
     appropriate'';
       (8) by striking subsection (m);
       (9) by redesignating subsections (j), (k), (l), and (n), as 
     subsections (k), (m), (o), and (p), respectively;
       (10) by inserting after subsection (i) the following:
       ``(j) Other Labeling Changes.--If, on or after the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, the Secretary determines that a pediatric study 
     conducted under this section does or does not demonstrate 
     that the drug that is the subject of the study is safe and 
     effective, including whether such study results are 
     inconclusive, in pediatric populations or subpopulations, the 
     Secretary shall order the labeling of such product to include 
     information about the results of the study and a statement of 
     the Secretary's determination.'';
       (11) in subsection (k), as redesignated by paragraph (9)--
       (A) in paragraph (1)--
       (i) by striking ``a summary of the medical and'' and 
     inserting ``the medical, statistical, and''; and
       (ii) by striking ``for the supplement'' and all that 
     follows through the period and inserting ``under subsection 
     (b) or (c).'';
       (B) by redesignating paragraph (2) as paragraph (3); and
       (C) by inserting after paragraph (1) the following:
       ``(2) Dissemination of information regarding labeling 
     changes.--Beginning on the date of enactment of the Best 
     Pharmaceuticals for Children Amendments of 2007, the 
     Secretary shall require that the sponsors of the studies that 
     result in labeling changes that are reflected in the annual 
     summary developed pursuant to subsection (f)(4)(F) 
     distribute, at least annually (or more frequently if the 
     Secretary determines that it would be beneficial to the 
     public health), such information to physicians and other 
     health care providers.'';
       (12) by inserting after subsection (k), as redesignated by 
     paragraph (9), the following:
       ``(l) Adverse Event Reporting.--
       ``(1) Reporting in year one.--Beginning on the date of 
     enactment of the Best Pharmaceuticals for Children Amendments 
     of 2007, during the 1-year period beginning on the date a 
     labeling change is made pursuant to subsection (i), the 
     Secretary shall ensure that all adverse event reports that 
     have been received for such drug (regardless of when such 
     report was received) are referred to the Office of Pediatric 
     Therapeutics established under section 6 of the Best 
     Pharmaceuticals for Children Act (Public Law 107-109). In 
     considering such reports, the Director of such Office shall 
     provide for the review of the report by the Pediatric 
     Advisory Committee, including obtaining any recommendations 
     of such Committee regarding whether the Secretary should take 
     action under this section in response to such reports.
       ``(2) Reporting in subsequent years.--Following the 1-year 
     period described in paragraph (1), the Secretary shall, as 
     appropriate, refer to the Office of Pediatric Therapeutics 
     all pediatric adverse event reports for a drug for which a 
     pediatric study was conducted under this section. In 
     considering such reports, the Director of such Office may 
     provide for the review of such reports by the Pediatric 
     Advisory Committee, including obtaining any recommendation of 
     such Committee regarding whether the Secretary should take 
     action in response to such reports.
       ``(3) Effect.--The requirements of this subsection shall 
     supplement, not supplant, other review of such adverse event 
     reports by the Secretary.'';
       (13) by inserting after subsection (m), as redesignated by 
     paragraph (9), the following:
       ``(n) Referral if Pediatric Studies Not Completed.--
       ``(1) In general.--Beginning on the date of enactment of 
     the Best Pharmaceuticals for Children Amendments of 2007, if 
     pediatric studies of a drug have not been completed under 
     subsection (d) and if the Secretary, through the committee 
     established under subsection (f), determines that there is a 
     continuing need for information relating to the use of the 
     drug in the pediatric population (including neonates, as 
     appropriate), the Secretary shall carry out the following:
       ``(A) For a drug for which a listed patent has not expired, 
     make a determination regarding whether an assessment shall be 
     required to be submitted under section 505B. Prior to making 
     such determination, the Secretary may take not more than 60 
     days to certify whether the Foundation for the National 
     Institutes of Health has sufficient funding at the time of 
     such certification to initiate 1 or more of the pediatric 
     studies of such drug referred to in the sentence preceding 
     this paragraph and fund 1 or more of such studies in their 
     entirety. Only if the Secretary makes such certification in 
     the affirmative, the Secretary shall refer such pediatric

[[Page 10645]]

     study or studies to the Foundation for the National 
     Institutes of Health for the conduct of such study or 
     studies.
       ``(B) For a drug that has no listed patents or has 1 or 
     more listed patents that have expired, the Secretary shall 
     refer the drug for inclusion on the list established under 
     section 409I of the Public Health Service Act for the conduct 
     of studies.
       ``(2) Public notice.--The Secretary shall give the public 
     notice of--
       ``(A) a decision under paragraph (1)(A) not to require an 
     assessment under section 505B and the basis for such 
     decision; and
       ``(B) any referral under paragraph (1)(B) of a drug for 
     inclusion on the list established under section 409I of the 
     Public Health Service Act.
       ``(3) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.''; 
     and
       (14) in subsection (p), as redesignated by paragraph (9)--
       (A) striking ``6-month period'' and inserting ``3-month or 
     6-month period'';
       (B) by striking ``subsection (a)'' and inserting 
     ``subsection (b)''; and
       (C) by striking ``2007'' both places it appears and 
     inserting ``2012''.
       (b) Effective Date.--Except as otherwise provided in the 
     amendments made by subsection (a), such amendments shall 
     apply to written requests under section 505A of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made after the 
     date of enactment of this subtitle.

     SEC. 403. PROGRAM FOR PEDIATRIC STUDIES OF DRUGS.

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

     SEC. 404. REPORTS AND STUDIES.

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

[[Page 10646]]

     requests made and studies conducted pursuant to such section 
     in order to conduct such study. Such study shall--
       (1) review such representative written requests issued by 
     the Secretary since 1997 under subsections (b) and (c) of 
     such section 505A;
       (2) review and assess such representative pediatric studies 
     conducted under such subsections (b) and (c) since 1997 and 
     labeling changes made as a result of such studies; and
       (3) review the use of extrapolation for pediatric 
     subpopulations, the use of alternative endpoints for 
     pediatric populations, neonatal assessment tools, and ethical 
     issues in pediatric clinical trials.

     SEC. 405. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

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

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

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

     SEC. 407. CONTINUATION OF OPERATION OF COMMITTEE.

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

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

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

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

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

               Subtitle B--Pediatric Research Improvement

     SEC. 411. SHORT TITLE.

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

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

       Section 505B(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c(a)) is amended--
       (1) in paragraph (4)(C), by adding at the end the 
     following: ``An applicant seeking either a partial or full 
     waiver on this ground shall submit to the Secretary 
     documentation detailing why a pediatric formulation cannot be 
     developed, and, if the waiver is granted, the applicant's 
     submission shall promptly be made available to the public in 
     an easily accessible manner, including through posting on the 
     website of the Food and Drug Administration'';
       (2) in paragraph (2)(B), by adding at the end the 
     following:
       ``(iii) Information on extrapolation.--A brief 
     documentation of the scientific data supporting the 
     conclusion under clauses (i) and (ii) shall be included in 
     any pertinent reviews for the application under section 505 
     or section 351 of the Public Health Service Act.''; and
       (3) by striking paragraph (3) and inserting the following:
       ``(3) Deferral.--
       ``(A) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may defer 
     submission of some or all assessments required under 
     paragraph (1) until a specified date after approval of the 
     drug or issuance of the license for a biological product if--
       ``(i) the Secretary finds that--

       ``(I) the drug or biological product is ready for approval 
     for use in adults before pediatric studies are complete;
       ``(II) pediatric studies should be delayed until additional 
     safety or effectiveness data have been collected; or
       ``(III) there is another appropriate reason for deferral; 
     and

       ``(ii) the applicant submits to the Secretary--

       ``(I) certification of the grounds for deferring the 
     assessments;
       ``(II) a description of the planned or ongoing studies;
       ``(III) evidence that the studies are being conducted or 
     will be conducted with due diligence and at the earliest 
     possible time; and
       ``(IV) a timeline for the completion of such studies.

       ``(B) Annual review.--
       ``(i) In general.--On an annual basis following the 
     approval of a deferral under subparagraph (A), the applicant 
     shall submit to the Secretary the following information:

       ``(I) Information detailing the progress made in conducting 
     pediatric studies.
       ``(II) If no progress has been made in conducting such 
     studies, evidence and documentation that such studies will be 
     conducted with due diligence and at the earliest possible 
     time.

       ``(ii) Public availability.--The information submitted 
     through the annual review under clause (i) shall promptly be 
     made available to the public in an easily accessible manner, 
     including through the website of the Food and Drug 
     Administration.''.

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

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

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

       Section 505B of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355c) is amended--
       (1) redesignating subsection (h) as subsection (j);
       (2) in subsection (j), as so redesignated, by striking 
     ``505A(n)'' and inserting ``505A(p)'';
       (3) by redesignating subsection (f) as subsection (k);
       (4) by redesignating subsection (g) as subsection (l); and
       (5) by inserting after subsection (e) the following:

[[Page 10647]]

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

     SEC. 415. MEANINGFUL THERAPEUTIC BENEFIT.

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

     SEC. 416. REPORTS.

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

[[Page 10648]]

     505B, and possible reasons for the lack of testing; and
       (3) the number of drugs for which testing is being done and 
     labeling changes required, including the date labeling 
     changes are made and which labeling changes required the use 
     of the dispute resolution process established under such 
     section 505B, together with a description of the outcomes of 
     such process, including a description of the disputes and the 
     recommendations of the Pediatric Advisory Committee.

     SEC. 417. TECHNICAL CORRECTIONS.

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

                 Subtitle C--Pediatric Medical Devices

     SEC. 421. SHORT TITLE.

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

     SEC. 422. TRACKING PEDIATRIC DEVICE APPROVALS.

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

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

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

     SEC. 423. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

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

[[Page 10649]]

       (9) existing obstacles to pediatric device development; and
       (10) an evaluation of the demonstration grants described in 
     section 425, which shall include an evaluation of the number 
     of pediatric medical devices--
       (A) that have been or are being studied in children; and
       (B) that have been submitted to the Food and Drug 
     Administration for approval, clearance, or review under such 
     section 520(m) (as amended by this Act) and any regulatory 
     actions taken.
       (c) Guidance.--Not later than 180 days after the date of 
     enactment of this subtitle, the Commissioner of Food and 
     Drugs shall issue guidance for institutional review 
     committees on how to evaluate requests for approval for 
     devices for which a humanitarian device exemption under 
     section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(m)(2)) has been granted.

     SEC. 424. CONTACT POINT FOR AVAILABLE FUNDING.

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

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

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

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

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

     SEC. 427. SURVEILLANCES.

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

     SEC. 428. SEVERABILITY CLAUSE.

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

  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.

[[Page 10650]]


  Mr. KENNEDY. Madam President, this week the Senate has the 
opportunity to set a new and better direction for the safety of the 
prescription drugs and medical devices that make such a profound 
difference in the lives of our people.
  Every day, families across America rely on the Food and Drug 
Administration in ways they barely realize. When they put dinner on the 
table, they are counting on the FDA to see that the food is free from 
contamination. They trust the FDA to make sure the drugs they take are 
safe and effective. From prescription drugs, to pacemakers, to 
chemotherapy, to the food we eat, the FDA protects the health of 
hundreds of millions of Americans and monitors products that account 
for a quarter of the Nation's economy.
  The FDA should be the ``gold standard'' for safety, but its luster 
has been tarnished in recent years for failure to protect the American 
people from unsafe drugs. The public was shocked that the arthritis 
drug Vioxx was able to stay on the market for 5 years, even though it 
nearly doubled the risk of heart attack and stroke. Antidepressants 
used by millions were found to increase the risk of suicide in 
adolescents. Millions of Americans have needlessly been put at risk, 
and they want action by Congress to reform and strengthen the agency.
  We are responding now with bipartisan legislation that is the product 
of months of work in our committee. I commend my colleague and friend 
in this effort, Senator Enzi, for his work on this proposal that will 
improve the way FDA oversees the safety of drugs. Almost half of all 
Americans take at least one pill a day, so this legislation will make a 
difference in the lives of every American family. Our proposals were 
strengthened by our colleague from New Hampshire, Senator Gregg.
  Safety is at the core. Our legislation was guided by the 
recommendations of the impressive report by the Institute of Medicine 
on the ``Future of Drug Safety.'' Its major recommendations for reform 
are included in this legislation.
  This chart I have in the Chamber gives the major recommendations for 
the Food and Drug Administration: Build the internal epidemiology and 
informatics capacity in order to improve the postmarket assessment of 
drugs, have postclinical trial results in a public database, have 
regularly analyzed postmarket study results. This aspect about 
postmarketing surveillance is a key in terms of drug safety. We have 
included their recommendations. Another is: Give the FDA better 
enforcement tools. I am going to refer to that in a moment. Another is: 
Conduct regular evaluation of new drug safety profiles. We have 
included that. I will expand on that point in a few moments. Another 
is: Substantially increase drug safety resources available to the FDA. 
We have also included those.
  So those were recommendations from the Institute of Medicine. We have 
reviewed the same subject matter. We evaluated those very carefully and 
we have taken the major recommendations in terms of safety and included 
them in this legislation.
  A small number of health systems in America--now referring to 
postmarketing surveillance and the use of electronic records--
effectively links the surveillance of various kinds of prescription 
drugs to safety databases. These systems--Kaiser Permanente, Mayo 
Clinic, Veterans' Administration--have the means to examine whether 
Vioxx and other drugs were being used effectively. They found these 
drugs were being prescribed inappropriately, and they took steps to 
curb their overuse. As a result, they approved the use of these 
medications only for patients who had no other options. Overuse went 
down and safety improved.
  The use of these databases should not be limited to the few health 
systems that currently use them. FDA should make use of every aspect of 
modern health care technology to safeguard the public's health. Mark 
McClellan, the former FDA Commissioner, calls these kinds of systems 
health IT for drug safety. Our proposal includes his recommendations.
  Surveillance is essential, but effective action is needed when a 
safety problem is detected. Each drug has unique risks and benefits. 
There can be no one-size-fits-all approach to drug safety. That is why 
our legislation includes a flexible but effective program for safety. 
We call it a risk evaluation and management system. It can be tailored 
to the unique characteristics of each drug. It gives the FDA the 
authority to act when action is needed to protect public health, but it 
also contains safeguards to prevent such action from being imposed when 
there is no reason to do so.
  For some drugs, it is essential to require postmarket studies, yet 
FDA today lacks the basic authority to require such trials to be 
conducted. FDA can request them but it cannot require them, and has few 
ways to see they are completed. As a result, companies routinely 
promise to conduct studies that are never even started, much less 
completed.
  This chart I have in the Chamber shows how, under current law, 
postmarket studies are not completed. These are the studies that have 
been requested by the FDA because they are for sound safety reasons. 
Yet 71 percent of them were not even started. Our legislation says when 
they are required and recommended by the company, they must move ahead.
  In its recent report on drug safety, GAO pointed out the failure of 
the current system. Its report states:

       In the absence of specific authority, FDA often relies on 
     drug sponsors voluntarily agreeing to conduct such 
     postmarketing studies. But the postmarketing studies that 
     drug sponsors agree to conduct have not consistently been 
     completed. The FDA has little leverage to ensure that the 
     studies are carried out by imposing administrative penalties.

  Our legislation solves this problem. It gives the FDA clear authority 
to require the conduct of the postmarketing studies when there is a 
public health need to do so, and it gives the FDA the ability to assess 
fines on those who ignore their responsibilities.
  Databases and postmarketing studies help detect problems, but the FDA 
needs the ability to take other action to protect the public health. 
Here, too, the current law is inadequate. FDA lacks clear authority to 
require measures to protect public health. When lives are on the line, 
doctors are making the critical decisions. But because FDA's authority 
is so unclear, it must first call the lawyers for their opinion as to 
whether the agency can act. The Institute of Medicine identified this 
major weakness of current law and called on Congress to give FDA the 
authority to require risk management programs when needed to protect 
health. These programs can be as simple as new information on a drug 
label or an advisory notice to doctors or as sophisticated as special 
monitoring of programs for patients who use a particular drug. The 
legislation does not make the decision about which measures should be 
taken for which drugs, but it does give the FDA the authority to make 
the right choice for the public health. This authority has been lacking 
in the past.
  For Vioxx, it took 14 months to change the drug's label to warn 
doctors and patients of the danger. Because FDA had weak authority, it 
had to ask the manufacturer to change the label voluntarily, and the 
manufacturer stalled and stalled. When patients are in danger, FDA 
should not have to wait to get legal opinions to decide how to protect 
health. It should be able to act immediately, and our bill gives them 
that authority.
  In many cases, companies have hidden evidence of safety problems. Our 
bill addresses this abuse by including a public database of all 
clinical trials and their results. Listen to that: all clinical trials 
and their results. We protect the trademark aspects of the particular 
item but require the publication of all clinical trials and their 
results. A company will no longer be able to hide the results if they 
do not show what the company wanted.
  Some would say any increase in drug safety will inevitably decrease 
access to needed drugs, but that is a false argument. Consider the 
situation now.

[[Page 10651]]

When the FDA is confronted with a new drug that may impose safety 
risks, or where additional study may be required, with little 
expectations that those risks will be mitigated by a voluntary 
approach--and with no ability to ensure that the studies are going to 
be conducted--FDA might reasonably conclude the risks of approving the 
drug are too great and, therefore, not approve it.
  Under our legislation, the calculation is reversed. With this bill in 
place, FDA could allow patients to have access to the drug, secure in 
the knowledge that effective safety measures were in place. That is not 
my judgment; it is the judgment of a coalition of advocacy 
organizations representing over 30 million patients. This coalition, 
the Alliance for Drug Safety and Access, wrote Congress a letter 
saying:

       [T]his legislation gives the FDA the ability to continue to 
     study the safety of drugs after approval, flexible 
     enforcement tools necessary to ensure compliance with these 
     new safety protections, and additional funding to support 
     these new activities. Allowing the agency to act on clear 
     safety signals could actually allow the FDA to approve drugs 
     more quickly, knowing it will have the ability to respond on 
     behalf of patients if safety concerns appear postmarket.

  That is support from the organization that has been put together that 
is protecting safety for the consumers. That is the balance our 
legislation strikes: greater safety, hand in hand with better access.
  As our debate continues, I will discuss additional aspects of the 
legislation, especially its new ideas for accelerating drug 
development, its renewal of our commitment to safe and effective drugs 
for children, and its provisions to improve drug science, and increase 
the transparency of the FDA.
  We are also working with our colleagues from Iowa and Kansas, Senator 
Harkin and Senator Roberts, on ways to refine our provisions on direct-
to-consumer advertising, to make certain they are consistent with the 
Constitution. We are working with Senator Durbin and other colleagues 
on the committee on proposals for food safety on pet food. These 
bipartisan proposals are being readied for floor action shortly. I look 
forward to further discussions on them.
  Our committee will continue to work to improve the ways FDA can 
monitor and improve food safety. In this new era of life sciences, 
medical advances will continue to bring immense benefit for our 
citizens. To fulfil the potential of that bright future, we need not 
only brilliant researchers to develop the drugs of tomorrow but also 
strong and vigilant watchdogs for public health to guarantee that new 
drugs and medical devices are safe and beneficial, and that they 
actually reach the patients who urgently need them.
  Congress has ample power to restore the luster the FDA has lost in 
recent years. The legislation we are now considering represents a 
bipartisan consensus on the best way to get the job done.
  I want to mention a few additional items. I am quoting now from the 
FDA's report brief on 2006:

       The Food and Drug Administration's authorities must be 
     clarified and strengthened to empower the agency to take 
     rapid, decisive action when necessary and appropriate. FDA 
     lacks the clear, unambiguous authority needed to enforce 
     sponsor compliance with regulatory requirements and, instead, 
     relies on the process of productive negotiations with the 
     industry.

  We have taken that. That is their No. 1 statement.
  Included in that we have--this is the IOM committee.

       The committee recommends that the FDA ensure that the FDA 
     has the ability to require postmarketing risk assessment and 
     to monitor and ensure the safe use of drugs.

  We have done it.

       These conditions may be imposed both before and after 
     approval of a new drug, a new indication or a new dosage.

  We have incorporated those concepts, as well as the identification of 
some new contraindications or patterns of adverse effects.
  It talks about the distribution, conditioned on compliance, with 
agency-initiated changes and drug labels. We have achieved that. 
Conditioned on specific warnings, proposal materials, distribution 
conditioned on a moratorium, on direct consumer advertising. We have at 
least addressed that.
  It also includes distribution of restrictions for special training, 
if need be, for pharmacists and physicians. It also has distribution 
conditions on the performance of specific medical procedures. It talks 
about clinical trials. FDA needs increased enforcement authority, 
better enforcement tools directed at drug sponsors which should include 
fines and injunctions and withdrawal of drug approval.
  We haven't taken every one of these recommendations--not every one 
precisely--but we have taken the essence of these recommendations, and 
we have included those that are as a result of our extensive hearings. 
I could go on with this, and will later on perhaps, but I won't today. 
I wish to mention, finally, the various groups.
  We mentioned the Alliance for Drug Safety and Access. I will include 
these letters of support. This is to Senators Kennedy and Enzi:

       On behalf of the Alliance for Drug Safety and Access, we 
     write today to express our support for the goals of titles I 
     and II of S. 1082, the Food and Drug Administration 
     Revitalization Act.
       It will continue the timely access of patients to new 
     therapies and will improve the ability of the Food and Drug 
     Administration to ensure safety of drugs already on the 
     market.
       S. 1082 takes a life-cycle approach to the risk-benefit 
     assessment of drugs and biologics--

  This is so, though we have not included biologics in this proposal 
with regard to drugs as endorsed by the Alliance and recommended by the 
Institute.

       We are pleased that this legislation gives the FDA the 
     ability to continue to study the safety of drugs after 
     approval, flexible enforcement tools necessary to ensure 
     compliance with the new safety protections, and additional 
     funding to support these new activities.

  It allows the FDA to approve drugs more quickly, knowing it will have 
the ability to respond to the patients if safety concerns appear 
afterwards.
  This represents a group of at least 30 different health organizations 
that have followed this most closely.
  We have a letter that has been sent to Senator Enzi and myself, 
Senator Dodd and Senator Clinton, talking about how this legislation 
impacts children and giving special recognition, as they should, to our 
colleagues and friends, Senator Dodd, who has been such a leader in 
this area, and Senator Clinton as well, who has been so thoughtful in 
this area.
  It points out the Pediatric Medical Device Safety Improvement Act of 
2000 provides a comprehensive approach to ensure that children are not 
left behind in cutting-edge research and revolutionary technologies for 
medical devices. It talks about swift action and passage.
  The American Psychiatric Association talks about how the provisions 
of this bill will ensure the Food and Drug Administration is equipped 
with the necessary tools to enhance its consistency, transparency, and 
accountability in ensuring the safety of drugs postapproval.
  The American Psychiatric Association advocates for patient safety and 
supports further postmarket research of medications to ensure the 
safety and efficacy of medications used to treat mental illnesses. The 
letter says:

       We look forward to working with you to rebuild the 
     Administration's reputation and creating a universal drug 
     safety monitoring system that is reliable and dependable.

  They indicate their strong support for the legislation.
  Again, another letter of support from the American College of 
Pharmacy, and it talks about the particular emphasis we have placed on 
improving science knowledge, which improves their decisionmaking 
regulatory oversight. Science knowledge grows on a daily basis. We know 
we are in the life science century. We want that agency, the FDA, to 
have the best in terms of science and science knowledge, and we have 
included special provisions to enhance that particular effort, and this 
association has recognized that.
  We also have a letter from the Consumers Union, and they talk about 
their strong support for this legislation. They oppose any weakening

[[Page 10652]]

amendments of this important legislation. It also has some reference to 
some of the recent polls which point out that 96 percent of Americans 
agree that Government should have the power to require warning labels 
if safety problems are identified, with 80 percent of those strongly 
agreeing to that authority. Right now the FDA has to negotiate safety 
warnings.
  It also talks about the strong support the American people have for 
the FDA, which doesn't have the authority to provide studies to be 
performed once the drug is on the market. The American people are way 
ahead of us. They also show strong support to make public the clinical 
trial studies. This bill does that. Sixty-eight percent of the American 
people strongly agree the drug studies should be made public.
  Eighty-four percent of the American people believe advertising for 
prescription drugs with safety concerns should be prohibited. Then it 
continues: Three-quarters of consumers agree that drug ads lead to 
overprescribing, with 38 percent strongly agreeing and 59 percent 
agreeing that the Government should restrict advertising by 
pharmaceutical companies altogether. We haven't gone that route, but we 
have taken safety considerations to heart.
  Then the other letters from the Cardiovascular Association that talk 
about the particular provisions dealing with children, the pediatric 
provisions in here which are enormously important, and other letters. I 
ask unanimous consent that the appropriate representative group of 
letters be printed in the Record and the references to some of the 
editorials from across the country--I am not going to ask that they all 
be printed, but I will ask that selected ones be printed in the Record 
and that other newspapers be referenced showing strong support.
  There being no objection, the material was ordered to be printed in 
the Record, as follows:

                                             The Alliance for Drug


                                            Safety and Access,

                                                   April 17, 2007.
     Hon. Edward M. Kennedy,
     Chairman, Senate Health, Education, Labor, and Pensions 
         Committee, U.S. Senate, Washington, DC.
     Hon. Michael B. Enzi,
     Ranking Member, Senate Health, Education, Labor, and Pensions 
         Committee, U.S. Senate, Washington, DC.
       Dear Senators Kennedy and Enzi: On behalf of the Alliance 
     for Drug Safety and Access (ADSA), we write today to express 
     our support for the goals of Titles I and II of S. 1082, the 
     ``Food and Drug Administration Revitalization Act''. We 
     appreciate your leadership in introducing this bipartisan 
     legislation, which will both continue the timely access of 
     patients to new therapies and improve the ability of the Food 
     and Drug Administration (FDA) to ensure the safety of drugs 
     already on the market. While we would appreciate the 
     opportunity to continue to work with you on strengthening 
     this legislation as it moves forward, we urge the Committee 
     on Health, Education, Labor and Pensions to report out this 
     legislation for consideration by the full Senate.
       ADSA members advocate on behalf of over 31 million 
     patients, including those suffering from HIV/AIDS, 
     Parkinson's disease, spinal cord injuries, paralysis, 
     multiple sclerosis, leukodystrophies, Tourette syndrome, and 
     over 6,000 known rare diseases. Our members also represent 
     over 100,000 providers of care to pediatric patients and 
     individuals with mental illnesses.
       S. 1082 takes a life-cycle approach to the risk-benefit 
     assessment of drugs and biologics, as endorsed by ADSA and 
     recommended by the Institute of Medicine. We are pleased that 
     this legislation gives the FDA the ability to continue to 
     study the safety of drugs after approval, flexible 
     enforcement tools necessary to ensure compliance with these 
     new safety protections, and additional funding to support 
     these new activities. Allowing the agency to act on clear 
     safety signals could actually allow the FDA to approve drugs 
     more quickly, knowing it will have the ability to respond on 
     behalf of patients if safety concerns appear post-market.
       We know that you share our interest in both speeding life-
     saving drugs to patients while also strengthening oversight 
     of drugs post-market. And, we believe that with sufficient 
     resources both goals are achievable through the legislation 
     you have authored. ADSA looks forward to working with you 
     toward these goals and toward strengthening provisions of 
     your legislation related to patient access to clinical trial 
     information and the FDA's enforcement authorities.
       Thank you again for your leadership on this critical issue 
     and the opportunity to share our views.
       AIDS Treatment Action Coalition
       American Academy of Pediatrics
       American Academy of Child and Adolescent Psychiatry
       American Psychiatric Association
       Christopher and Dana Reeve Foundation
       Elizabeth Glaser Pediatric AIDS Foundation
       National Multiple Sclerosis Society
       National Organization for Rare Disorders (NORD)
       Parkinson's Action Network
       Tourette Sydrome Association.
                                  ____

                                                   April 17, 2007.
     Hon. Edward Kennedy,
     U.S. Senate, Washington, DC.
     Hon. Michael B. Enzi,
     U.S. Senate, Washington, DC.
     Hon. Christopher J. Dodd,
     U.S. Senate, Washington, DC.
     Hon. Hillary Rodham Clinton,
     U.S. Senate, Washington, DC.
       Dear Senators Kennedy, Enzi, Dodd and Clinton: As 
     organizations working to ensure better health care for the 
     nation's children, we write to thank you for your long-
     standing commitment to children's health and to express our 
     support for legislation to reauthorize the Best 
     Pharmaceuticals for Children Act (BPCA) and the Pediatric 
     Research Equity Act (PREA) and to improve children's access 
     to safe medical devices. We are very pleased that BPCA and 
     PREA reauthorization language and S. 830, the Pediatric 
     Medical Device Safety and Improvement Act, have been included 
     in the Chairman's mark of S. 1082, the ``Food and Drug 
     Administration Revitalization Act,'' for consideration by the 
     Senate Health, Education, Labor and Pensions Committee 
     tomorrow.
       Over the past decade, Congress has enacted bipartisan 
     legislation that has dramatically increased the number of 
     drugs tested and labeled for children. The results from BPCA 
     are extraordinary--over 336 requests have been generated for 
     over 780 pediatric studies, resulting in over 115 new drug 
     labels for children. Sen. Dodd's BPCA reauthorization 
     language strengthens this very successful existing program in 
     several important ways, including ensuring prompt label 
     changes, requiring that all study protocols and results be 
     made public, improving adverse events reporting for children, 
     and identifying and addressing important gaps in treatments 
     for children's diseases, In addition, the BPCA language 
     includes a reasoned approach to address the small percentage 
     of drugs for which the exclusivity provision has far exceeded 
     the incentive it was intended to provide pharmaceutical 
     companies.
       S. 993, the Pediatric Research Improvement Act (PRIA), 
     introduced by Sen. Clinton and included in the Chairman's 
     mark, reauthorizes the Pediatric Research Equity Act of 2003 
     (PREA), which requires drug manufacturers to test their 
     products for use in children. This law ensures that children 
     are not a therapeutic afterthought and has generated 
     impressive and invaluable safety and dosing information for 
     children. Since the 2003 passage of PREA, 55 drugs have new 
     or improved pediatric labeling. These drugs range from 
     treatment of ear infections to the prevention of rejection of 
     organ transplants. S. 993 places children on equal 
     therapeutic footing with adults by creating the presumption 
     that medicines coming onto the market for illnesses and 
     conditions that occur in children will be labeled for 
     pediatric use and be available in formulations (e.g., 
     liquids, chewable tablets) that children can take.
       The Pediatric Medical Device Safety and Improvement Act of 
     2007 provides a comprehensive approach to ensuring that 
     children are not left behind as cutting-edge research and 
     revolutionary technologies for medical devices advance. Like 
     drugs, where for too long children were treated like small 
     adults, many essential medical devices used extensively by 
     pediatricians are not designed or sized for children. 
     According to pediatricians, the development of new medical 
     devices suitable for children's smaller and growing bodies 
     can lag 5-10 years behind those for adults. S. 830 improves 
     incentives for devices for small markets--while still 
     preserving the ability to ensure the safety of new products 
     once on the market. It provides assistance to innovators, 
     streamlines regulatory processes, and elevates pediatric 
     device issues at the Food and Drug Administration (FDA) and 
     the National Institutes of Health.
       Despite our support for the Chairman's mark, we are 
     disappointed that a key provision to make PRIA permanent has 
     been omitted. As this legislation moves to the floor of the 
     Senate, we urge you to restore the permanent authority of the 
     FDA to ensure that children have properly studied medications 
     as a matter of fact, not chance.
       We are grateful for your long-standing leadership and 
     commitment to improving the health of our nation's children 
     and look forward to working with you toward swift Committee 
     action and passage of these pediatric therapeutic bills by 
     the full Senate.
           Sincerely,
       American Academy of Pediatrics.
       Elizabeth Glaser Pediatric AIDS Foundation.
       AIDS Alliance for Children, Youth & Families.
       American Academy of Child and Adolescent Psychiatry.

[[Page 10653]]

       American Brain Coalition.
       American Pediatric Society.
       American Psychiatric Association.
       American Thoracic Society.
       Arthritis Foundation.
       Association of Medical School Pediatric Department Chairs.
       Children's Cause for Cancer Advocacy.
       National Association of Children's Hospitals (N.A.C.H.).
       National Organization for Rare Disorders.
       National Research Center for Women and Families.
       Society for Pediatric Research.
                                  ____

                                              American Psychiatric


                                                  Association,

                                  Arlington, VA, February 6, 2007.
       The American Psychiatric Association (APA) would like to 
     thank Senators Edward Kennedy and Mike Enzi for their 
     introduction of the bipartisan bill, ``Enhancing Drug Safety 
     and Innovation Act of 2007'' (S.484). The provisions of the 
     bill will help ensure that the Food and Drug Administration 
     is equipped with the necessary tools to enhance its 
     consistency, transparency and accountability in assuring the 
     safety of drugs post approval.
       The APA is the national medical specialty society 
     representing more than 37,000 psychiatric physicians 
     nationwide who specialize in the diagnosis and treatment of 
     mental and emotional illnesses and substance use disorders. 
     APA advocates for patient safety and supports further post-
     market research of medications to ensure the safety and 
     efficacy of medications used to treat mental illnesses.
       The APA thanks you again for your dedication and commitment 
     to enhance the nation's drug safety monitoring system. We 
     look forward to working with you to rebuild the 
     Administration's reputation and creating a universal drug 
     safety monitoring system that is reliable and dependable in 
     order for patients to make well informed decisions. As your 
     staffs move forward with further action on legislation, 
     Lizbet Boroughs, Deputy Director, Government Relations for 
     the APA or Chatrane Birbal, Federal Legislative Coordinator 
     may be reached at [email protected] 703/489-5907 or 
     [email protected] 703/907-8584 respectively.
           Sincerely,

                             James H. Scully, Jr., M.D., Sc.D.

                                         CEO and Medical Director,
     American Psychiatric Association.
                                  ____



                                              Consumers Union,

                                   Washington, DC, April 26, 2007.
     Senator XXXXX,
     U.S. Senate,
     Washington, DC.
       Dear Senator: Consumers Union, the nonprofit, independent 
     publisher of Consumer Reports, urges you to support S. 1082, 
     the Food and Drug Administration Revitalization Act, when it 
     comes to the Senate floor, and oppose any weakening 
     amendments to this important patient-safety legislation.
       S. 1082 will save countless lives in the years to come by 
     giving the FDA more funding and flexible tools to ensure the 
     safety of prescription drugs and medical devices in the 
     marketplace. It also will help return public trust in an 
     agency that has been severely damaged by Vioxx, Paxil and 
     other recent drug safety disasters.
       There is nothing in this legislation that would slow down 
     the approval of important, life-saving drugs. Rather, it 
     gives the FDA effective authority to ensure safety once drugs 
     come to market by improving the surveillance of post-market 
     adverse events and communicating possible risks to doctors 
     and patients.
       Americans are extremely concerned about prescription drug 
     safety and support Congressional action on the issue. A 
     national poll recently conducted by the Consumer Reports 
     National Research Center found that more than 60 percent of 
     Americans agree that the FDA and Congress have failed to 
     adequately protect consumers from harmful prescription drugs. 
     It also found that 84 percent agree the government should 
     ``have the authority to take any action necessary'' to ensure 
     drug safety.
       Please support S. 1082. We also urge you to oppose any 
     attempts to weaken its drug safety sections, such as 
     amendments making it much harder to trigger a quick safety 
     action when there are signs of danger, or blocking the FDA--
     in very rare cases--from moderating the mass marketing of a 
     new drug which has indications of safety problems. We also 
     hope that as the Senate considers FDA-related legislation, a 
     pro-consumer biogenerics bill can be added, and the FDA's 
     advisory committee conflict-of-interest provisions 
     strengthened.
       We know that you share our interest in both speeding life-
     saving drugs to patients while also strengthening oversight 
     of drugs post-market. We believe that with sufficient 
     resources and authority, both goals are achievable through 
     this legislation.
       If you have any questions or concerns as to why the public 
     and the FDA need this legislation, please contact William 
     Vaughan either by phone (202) 462-6262 or by e-mail, 
     [email protected].
           Sincerely,

                                                    Jim Guest,

     President and CEO, Headquarters Office.
                                  ____


    Poll: Consumers Say Govt Failed To Protect Them From Dangerous 
     Prescription Drugs; Americans Back Host of Drug Safety Reforms

       Washington, DC.--As Congress prepares to vote on the most 
     significant prescription drug safety legislation in 45 years, 
     a new Consumer Reports poll finds that the American public 
     strongly backs a host of key safety reforms. Nine out of 10 
     agree that all clinical drug trial results should be made 
     public, and that the government should have the power to 
     require warning labels and follow-up studies on drugs with 
     safety problems.
       In general, the survey found consumers support the 
     government taking whatever steps necessary to ensure the 
     safety of prescription drugs--84 percent agree that the 
     government should ``have the authority to take any action 
     necessary'' to ensure drug safety, with 50 percent strongly 
     agreeing.
       Also, more than 60 percent of Americans agree that the Food 
     and Drug Administration and Congress have failed to 
     adequately protect consumers from harmful prescription drugs.
       ``The message we're hearing from consumers couldn't be 
     clearer--they want strong laws to ensure our prescription 
     drugs are as safe and effective as possible,'' said Jim 
     Guest, CEO of Consumers Union, publisher of Consumer Reports.
       ``Right now drug companies can game the system by touting 
     the positive results from their drug studies, while 
     downplaying information about harmful side effects,'' Guest 
     added. ``Americans are fed up with being kept in the dark 
     about critical health and safety information, and they 
     overwhelmingly want change.''
       The telephone survey of 1,026 randomly selected adults, 
     conducted March 15-18 by the Consumer Reports National 
     Research Center, asked about reforms that would strengthen 
     the nation's drug safety system. The margin of error is +/
     -3.1 percent. Among the responses:
       96 percent agree that the government should have the power 
     to require warning labels if safety problems are identified--
     with 80 percent of those ``strongly agreeing'' to that 
     authority. Right now, the Food and Drug Administration must 
     negotiate safety warning labels with a drug maker.
       93 percent agree that the FDA should have the power to 
     order follow-up safety studies, with 65 percent ``strongly 
     agreeing'' to that authority. Today, the FDA generally does 
     not have the authority to require safety studies be performed 
     once a drug is on the market.
       92 percent of Americans agree that pharmaceutical companies 
     should make public the results of all of their clinical trial 
     studies, which reveal a drug's effectiveness as well as 
     possible hazardous side effects. Of those, 68 percent 
     ``strongly agreed'' that drug studies should be made public.
       Such studies are used to get a drug approved and generally 
     are conducted on human subjects. The makers of Vioxx and 
     Paxil had studies that indicated safety problems for years, 
     but failed to release those results to the public. Vioxx 
     eventually was removed from the market after being linked to 
     increased risk of heart attack and stroke; antidepressants in 
     the class of Paxil now carry black-box warnings about 
     increased suicide risk in adolescents and adults under 25.
       84 percent agree that advertisements for a prescription 
     drug with safety concerns should be prohibited; with 59 
     percent ``strongly agreeing'' to such limits.
       ``Consumers expect Congress to take their concerns about 
     drug safety seriously, and deliver legislation that will 
     prevent future Vioxx-type disasters,'' said Bill Vaughan, 
     Consumers Union senior policy analyst.
       ``Failure to act this year on the strongest possible bill, 
     when more than 80 percent of Americans agree that Congress 
     should do whatever is necessary to ensure drug safety, would 
     equate to gross legislative malpractice,'' Vaughan added.
       The Senate Health Committee is expected to vote Wednesday 
     on a bill that includes important drug safety measures, as 
     well as reauthorizing pharmaceutical industry user fees to 
     support the FDA drug-approval and safety process (S. 1082). 
     The last significant drug safety legislation in 1962 required 
     manufacturers to prove their drugs had some positive effect, 
     but failed to give the FDA power to quickly protect the 
     public when safety questions were raised.
       Consumers Union and other patient and safety organizations 
     are working to further strengthen the drug safety legislation 
     to require the public release of all clinical trial data, 
     make safety disputes open to public scrutiny, and raise the 
     profile of drug safety and science in the FDA.


    Conflict-of-interests between Pharma and FDA also a top concern

       The survey found that 84 percent of consumers agree that 
     drug companies have too much influence over the government 
     officials who regulate them. More than two-thirds (67 
     percent) are concerned that much of the FDA's funding comes 
     from the pharmaceutical industry, with more than half--54 
     percent--``very concerned'' about that funding situation.
       Congress is expected this summer to reauthorize the 
     Prescription Drug User Fee Act,

[[Page 10654]]

     first passed in 1992 to speed up drug approvals by having the 
     industry help fund the FDA approval process. The original act 
     has been extended twice and is slated to expire this fall 
     unless Congress reauthorizes it. The FDA-industry proposal 
     calls for industry to pay $393 million annually to the FDA, 
     an increase of $87 million over the previous PDUFA agreement. 
     S. 1082 adds additional user fees for safety.
       Consumers also were concerned about conflicts of interest 
     on advisory boards that approve drugs for market. Six in 10 
     disapproved of allowing doctors and scientists with a 
     conflicting financial interest to participate on advisory 
     boards.
       More than half of consumers say they currently take a 
     prescription drug, which translates to 124 million adults. A 
     significant number--40 percent--say they had experienced an 
     adverse reaction to a medication.
       ``Four out of 10 Americans say they've had a bad reaction 
     to a prescription drug, yet the FDA only receives about half 
     a million adverse-event reports a year,'' Vaughan said. 
     ``Clearly, the FDA needs to do a better job fielding 
     consumers'' experiences with side effects. ``


Prescription drug advertising influences prescribing; should be limited

       Americans are very aware of prescription drug advertising, 
     with nine out of 10 Americans (91 percent) reporting they had 
     seen a drug ad on television or in print, or heard one on 
     radio. More than a quarter of those (26 percent) said they 
     asked for a specific medication they learned about in an ad.
       Three-quarters of consumers (75 percent) agreed that drug 
     ads lead to over-prescribing, with 38 percent ``strongly 
     agreeing.'' And 59 percent agreed the government should 
     restrict advertising by pharmaceutical companies, with 26 
     percent strongly agreeing to such restrictions.
       Yet some consumers find drug ads useful in talking to their 
     doctor (63 percent agree, 24 percent strongly agree) and 
     others agreed they help consumers take charge of their health 
     care (54 percent agree, 14 percent strongly agree).
       ``Consumers are very concerned that advertising drives up 
     the prescription drug use and health-care costs, and they'd 
     like to see restrictions on those ads,'' Vaughan said.
                                  ____

                                    The Society for Cardiovascular


                                Angiography and Interventions,

                                   Washington, DC, April 17, 2007.
     Hon. Edward Kennedy,
     U.S. Senate,
     Washington, DC.
     Hon. Christopher J. Dodd,
     U.S. Senate,
     Washington, DC.
     Hon. Hillary Clinton,
     U.S. Senate,
     Washington, DC.
       Dear Senators Kennedy, Dodd and Clinton: I am writing to 
     express our support for your long-standing commitment to 
     children's health and to express our support for your efforts 
     to improve children's access to safe medical devices. We are 
     very pleased that the Pediatric Medical Device Safety and 
     Improvement Act has been included in the Chairman's mark of 
     S. 1082, the ``Food and Drug Administration Revitalization 
     Act,'' for consideration by the Senate Health, Education, 
     Labor and Pensions Committee tomorrow. Your proposal is an 
     important step forward.
       The Society for Cardiovascular Angiography and 
     Interventions is a professional association representing over 
     3,700 invasive and interventional cardiologists. SCAI 
     promotes excellence in cardiac catheterization, angiography, 
     and interventional cardiology through physician education and 
     representation, and quality initiatives to enhance patient 
     care.
       Fortunately, cardiovascular disease is far less common in 
     the pediatric population than it is in the adult population. 
     This good fortune does however frequently lead to unique 
     challenges for the pediatric interventional cardiologist who 
     treats these patients. Some of the challenges are clinical 
     and we are more frequently solving those problems, saving 
     children's lives and avoiding the trauma of surgery. Other 
     challenges, and perhaps the most frustrating ones are related 
     to obtaining the safe medical devices necessary to treat 
     these patients. Devices that are available to our colleagues 
     in Europe are not available in America. We support the FDA's 
     efforts to ensure that only safe and effective medical 
     devices are used on patients in our country, but when the 
     entry barriers into the American markets are so high that 
     manufactures refuse to enter--some patients suffer and die 
     needlessly. Required is an appropriate balance between the 
     sometimes mutually exclusive goals of safety and 
     availability.
       We are especially pleased that your legislation will 
     require the FDA to issue guidance to institutional review 
     committees (IRCs) on how to appropriately consider the use of 
     the humanitarian device exemption (HDE) at their institution. 
     When HDE devices are not part of an ongoing trial, IRC's 
     (which focus on reviewing the care of patients in trials) are 
     sometimes confused.
       We believe that giving the FDA explicit statutory authority 
     to extrapolate from adult to pediatric patients in 
     appropriate situations could help FDA officials expedite 
     their review of some pediatric medical devices.
       We applaud the provision that allows companies to make a 
     profit on HDE devices designed for children. This change will 
     encourage the development of more devices by providing an 
     opportunity for profit and also by reducing concerns about 
     audits, specifically those using different assumptions which 
     could determine a profit was made when a manufacturer 
     calculated their financial situation differently. We note 
     that the 4,000 cap is arbitrary and far below the patient 
     limit that is placed on orphan drugs. We believe that more 
     devices will be available to pediatric patients and those 
     with congenital heart disease if that cap is raised. We 
     encourage you to consider such an increase either as a part 
     of this legislation or broader FDA reform legislation.
       We look forward to working with you and your staff to 
     support passage of this legislation and thank you once again 
     for your efforts. Our contact person for this effort is Wayne 
     Powell and he may be reached at (202) 375-6341 or 
     [email protected].
           Sincerely,

                               Gregory J. Dehmer, M.D., FSCAI,

     President.
                                  ____



                                         Heart Rhythm Society,

                                    Washington, DC, April 3, 2007.
     Hon. Christopher J. Dodd,
     Chair, Subcommittee on Education and Early Childhood 
         Development,
     Senate Committee on Health, Education, Labor and Pensions, 
         Russell Senate Office Building, Washington, DC.
       Dear Chairman Dodd: I am writing to express the Heart 
     Rhythm Society's support for passage of the Pediatric Medical 
     Device Safety Act of 2007. We greatly appreciate your efforts 
     to expand pediatric patients' access to safe medical devices. 
     Your proposal is an important step forward.
       The Heart Rhythm Society is the international leader in 
     science, education and advocacy for cardiac arrhythmia 
     professionals and patients, and the primary information 
     resource on heart rhythm disorders. Our mission is to improve 
     the care of patients by promoting research, education and 
     optimal health care policies and standards. We represent over 
     4300 specialists in cardiac pacing and electrophysiology.
       We believe the Pediatric Medical Device Safety Act of 2007 
     would help promote needed innovation and focus efforts on 
     defining and then attempting to meet the unique needs of the 
     pediatric population. In our area this would translate into 
     improved medical device treatments for arrhythmias, such as 
     use of pacemakers and Internal Cardioverter Defibrillators 
     (ICDs) tailored to pediatric patients.
       Also of great interest to the field of pediatric 
     electrophysiology are the proposed grants for research and 
     the crafting of an agenda for evaluation of ``long-term 
     safety and effectiveness of pediatric medical devices.'' 
     Additional funds could potentially be utilized to create a 
     pediatric version of the ICD RegistryTM a database 
     registry which captures implant and outcomes data ICDs used 
     in patients at risk for sudden cardiac arrest. This project 
     would go a long way to achieve the goal outlined in Section 
     7(b)2, to ``assess the impact of growth, development, 
     activity level and other factors on the safety and efficacy 
     of the devices.''
       We look forward to supporting you and your staff in 
     securing passage of this legislation and we thank you for 
     your efforts to enable the youngest of our patients life-
     saving access to safe and effective medical devices. Amy 
     Melnick, Vice President, Health Policy will coordinate the 
     Heart Rhythm Society efforts to support this bill. She can be 
     reached at (202) 464-3434 or [email protected]. Please 
     do not hesitate to contact us and thank you for accepting our 
     endorsement.
           Sincerely,

                                    Dwight Reynolds, MD, FHRS,

                                                        President,
     Heart Rhythm Society.
                                  ____

                                   Washington, DC, April 19, 2007.
     Hon. Edward Kennedy,
     Chairman, Senate Committee on Health, Education, Labor, and 
         Pensions.
     Hon. Mike Enzi,
     Ranking Member, Senate Committee on Health, Education, Labor, 
         and Pensions.
       Dear Chairman Kennedy and Ranking Member Enzi: On behalf of 
     the American Association of Colleges of Pharmacy (AACP) and 
     our nation's 97 accredited colleges and schools of pharmacy 
     we thank you for your efforts to protect the public's health 
     through the introduction of the ``Food and Drug 
     Administration Revitalization Act of 2007.'' AACP, the 
     national organization representing and supporting colleges 
     and schools of pharmacy and their faculties, is committed to 
     education and scholarship for improving drug therapy.
       In particular we appreciate the legislation's provisions 
     that will support the Food and Drug Administration's (FDA) 
     publicly stated need to improve the science knowledge which 
     supports and improves their decision making and regulatory 
     oversight. Science knowledge grows on a daily basis and the 
     academic community, including academic pharmacy, is the best 
     place to look for

[[Page 10655]]

     individuals whose research is creating that new knowledge. 
     Your legislation helps the FDA increase its science knowledge 
     in partnership with academic pharmacy through:
       Opportunities to engage in extramural research; Influencing 
     FDA directly through nominations from academic pharmacy to 
     advisory committees, and the Reagan-Udall Foundation Board of 
     Directors; and actively engaging in the multiple 
     opportunities for public comment on the implementation of 
     many of the legislation's provisions.
       Your recognition that the academic biomedical research 
     community is a cutting-edge knowledge resource recognizes the 
     important trend of translational research. AACP members are 
     already engaged with the Agency for Healthcare Research and 
     Quality (AHRQ) Centers for Education and Research on 
     Therapeutics (CERTs) program and the DEcIDE Network. This 
     provides the FDA with an excellent network of researchers 
     prepared to analyze drug safety data. Our members are in the 
     initial stages of developing practice-based research networks 
     (PBRN) that can further assist the Committee and the FDA in 
     reaching the goal of improved risk evaluation and mitigation. 
     This broad research capacity extends to medical devices, 
     pediatric care, and manufacturing.
       The members of AACP appreciate your commitment to 
     protecting the public's health and stand ready to assist you 
     as your legislation continues the process of congressional 
     action. Please do not hesitate to contact me should you need 
     additional information regarding the role of academic 
     pharmacy in revitalizing the FDA.
           Sincerely,
                                               William G. Lang IV,
                                           VP Policy and Advocacy.

  Mr. KENNEDY. Madam President, we have very solid legislation that is 
going to make a very important difference--very important difference in 
protecting the American consumer. We now have in place leadership at 
the Food and Drug Administration; for 5 of the last 6 years that has 
not been so. We have in place leadership, and we are going to give that 
agency the kind of tools necessary for protection the American people 
are entitled to and to restore the kind of luster that should go with 
the Food and Drug Administration, which is so important to the health 
and well-being of American families.
  The PRESIDING OFFICER. The Senator from Wyoming is recognized.
  Mr. ENZI. Madam President, I wish to thank the Senator from 
Massachusetts, Senator Kennedy, for his outstanding presentation on 
what is in the bill.
  I rise to speak about S. 1082 as well. It is a comprehensive bill to 
enhance drug safety and provide key resources to the Food and Drug 
Administration--the FDA--for the review of new drugs, for the review of 
medical devices, and to ensure that drugs and devices for children are 
safe and effective. It has been a long and careful road for this bill.
  The Senate Committee on Health, Education, Labor and Pensions 
embarked on a top-to-bottom review of the FDA's drug safety and 
approval process over 2 years ago. This bill is the culmination of our 
review and the input of hundreds of stakeholders. I wish to speak for a 
few minutes discussing why the drug safety components and the changes 
that are being made are so critical to restoring the peace of mind to 
Americans who want to be assured the drugs they purchase to address 
illnesses and chronic medical conditions can be relied on and trusted.
  ``Bipartisan'' is a word that is kind of thrown around in this 
Chamber a lot, and sometimes it means that one person from one party 
joins several people from the other party. For Senator Kennedy and me, 
bipartisan means you actually work together to find out what the 
problem is, what the potential solutions are, and how you can meet 
those needs. I mentioned it has been a long process--over 2 years--and 
it is still a work in progress--and we are making progress.
  We held hearings on the FDA. A lot of those hearings were held in the 
heat of the moment, when certain drugs were having problems, and we 
recognize that is a problem. One of the problems with Congress is we 
usually see that if it is worth reacting to, it is worth overreacting 
to. We have always taken a very careful view in our committee to make 
sure that was not the case.
  Other committees held hearings on the FDA, even though the FDA is 
under the jurisdiction of our committee, and we have no problem with 
that. We have taken the suggestions we have gotten through those 
hearings and considered them for this legislation. Then we drew up a 
list of principles, and we took that to the stakeholders to see what 
all the people involved thought about the principles we had. Then we 
did the tough part. We drafted the details. It is easy to sell 
concepts, but details are tough. Until you have those details put down 
in writing and have people look at every word that is in them, you 
can't tell whether you have a bill. But we went through that process. 
We took it back to the stakeholders. We redrafted. We filed the bill. 
We had more hearings. This year, we have had more hearings on FDA, and 
we have had a markup. That is when all the Committee Members are 
offered a chance to request or suggest amendments to the bill.
  We probably had about 50 amendments and we worked on the 12 major 
categories of amendments. Some of those were worked into the bill as 
part of the markup. Some of them have been put into the manager's 
amendment. I mentioned this is a work in progress. We are still looking 
at some of those, figuring out what is needed and how to get there. I 
appreciate the cooperation we have had from the Members with their 
suggestions and the staffs of the Members with their suggestions, 
because throughout the last weekend, there were hours and hours and 
hours spent by Senator Kennedy's staff and my staff and the interested 
Senators and their staffs to arrive at the best possible solution. We 
are not there yet. We are close. That is the way we work on bills--a 
long process with decisions being made up to the last possible moment 
so that we can have the best possible solution for the people of this 
country. That is bipartisan.
  It was mentioned there have been some hearings on food safety. 
Recently, there has been some real criticism of the FDA on food safety. 
We held hearings on food safety. I don't want the people of this 
country to think it is all bad. In fact, I was amazed that three 
Federal agencies have to work together on a food problem. The CDC, the 
Department of Agriculture, and the Food and Drug Administration have to 
work together because each of them has a role in discovering whether 
there is a problem. I was amazed to find out that with as few as 50 
cases spread out across the whole United States, they can diagnose and 
determine there is a problem and get products off the market. If you 
are not amazed with that, you are not paying attention. We have 
agencies that work together, and they work together in critical times 
to solve problems for the people of America. They can notice, with a 
real small sampling--when you consider the millions of people in this 
country, the millions of people who are being fed every day,--they can 
recognize a problem with the food supply and get the harmful product 
off the market. It would be nice if they could prevent that. They are 
working on that.
  But when you consider the number of producers in this country and 
other countries, they have a tremendous job, and we have to be sure 
they have the tools to do that job as well. But that is a job that is 
in addition to the drug approvals. This bill concentrates on the drug 
approvals.
  Vioxx was one of the triggers of these discussions. As we saw with 
Vioxx, the FDA doesn't have enough tools to deal with newly identified 
risks when those risks become evident after a drug has been on the 
market for some time. Most of the FDA's current authority is based on 
information and plans available at the time of approval. They have a 
massive job determining if a drug is ready to go to market. What is 
amazing is that once they have given that approval, their options are 
very limited. Now, that creates a little bit of a dilemma for them. 
They don't know everything that will happen with that drug. Yes, it has 
been through clinical trials. What is a clinical trial? It is a 
controlled study of people taking the drug, and sometimes people who 
are not taking the drug--a controlled

[[Page 10656]]

study. Once that drug is approved, it goes out to the whole market--not 
controlled people, not people that we know what other drugs they are 
taking or what other kinds of things they are doing. That can have a 
different result than under a controlled situation.
  The FDA's choice has been to take the information and approve the 
drug and then monitor the drug, but have relatively few tools after 
that point. What can be the result of that? The FDA can say let's 
really be careful before we approve this because we will have expended 
our toolbox. They have said: If you will give us a bigger toolbox for 
after the approval, we can approve the drugs quicker. We can have some 
assurance that because of the controlled study things will be fine. But 
we won't have to worry quite as much about preapproval because we will 
have tools after approval--tools for quick recognition of additional 
problems as it goes out to the major markets.
  We need to have that happen if we are going to have safe drugs in 
this country. We have always relied on that, and we expect that. The 
FDA, for the most part, has delivered.
  So much more needs to be done to clarify the FDA's authority, to give 
them the bigger toolbox so that FDA can proactively react to additional 
safety information whenever that safety information is discovered. That 
is the purpose of this underlying legislation. The FDA does have some 
authority to manage the risks of drugs--for drugs such as novel cancer 
therapies approved under subpart H for accelerated approval. Is that 
faster approval? The FDA has the authority to apply restrictions on 
distribution and use for those drugs at the time of approval to provide 
further safeguards against misuse and adverse reactions. However, if 
such a risk is determined after the drug is on the market, the only 
option FDA has now is to pull the drug from the market, disrupting 
patient care.
  Some of the people who have that drug are deriving a tremendous 
benefit from it and are not having the adverse reaction and would feel 
hurt if it is pulled away from them as the only option that the FDA 
has. The FDA does not want to disrupt patient care. The FDA just wants 
to protect patients. Those who need the protection they want to help; 
those who don't need the protection ought to be able to get the 
continuing patient care. The option now, I repeat, is to pull the drug 
from everybody. Then, of course, they can put it back on the market so 
it can apply those special risk management tools. We have chosen to 
give the FDA in this bill the authority to impose those restrictions 
after a drug comes on the market, too, so there is no disruption in 
patient care.
  The bill also makes several key improvements to how patients get 
their information through advertising and labeling. The changes ensure 
that patients get access to new and changing information in a timely 
manner. As Vioxx made clear, FDA has very little authority to require 
labeling changes postmarket. Those changes are primarily negotiated and 
they don't have any time limits on the two parties coming to agreement 
to the labeling change.
  Now, we have included provisions that ensure that those discussions 
between the FDA and a drug manufacturer come to a close, rather than 
relying on the FDA's ``nuclear option,'' which is pulling the drug from 
the market. It hurts a lot of patients and disrupts their care.
  Imagine a system that gives the FDA, through sound science and 
remarkable innovation, the tools to get drugs to the market quickly and 
efficiently, especially when lives are on the line and people need new 
drugs and therapies. Imagine a system that gives the FDA new authority 
to take swift, appropriate, and decisive action to ensure patient 
safety and protect consumers when new information comes to light to 
expose unexpected risks. We can make this a reality with the passage of 
this bill.
  FDA doesn't have a current mechanism for active, routine surveillance 
of potential safety problems. Thus, it cannot as readily detect safety 
problems after a drug has been put on the market--short of a 
catastrophe. FDA has minimal authority to require additional 
observational studies or clinical trials after the product is already 
on the market. FDA cannot even make companies finish studies they have 
agreed to pursue concerning safety impacts on patients.
  Given the current FDA limitations, I strongly felt it was necessary 
to correct those problems and ensure that FDA has the right tools and 
toolbox to address drug safety after the drug is on the market. That is 
why this bill creates the risk evaluation and mitigation strategy, or 
REMS. The REMS gives FDA a full toolbox of options for dealing with 
potential safety problems, even if they are discovered after a drug is 
first marketed. I hope you are noticing a trend.
  With this new toolbox, FDA has the ability to identify side effects 
after the drug is marketed through active surveillance. FDA also has 
the authority to request a separate study or clinical trial to learn 
more about a particular potential safety problem. FDA can also obtain 
timely label changes for the first time under the new REMS system.
  How does this all work together? A house cannot be built without a 
foundation. Routine, active safety monitoring using large linked 
databases--what I like to call ``health IT for drug safety''--is the 
foundation. Risk evaluation and mitigation strategy, or REMS, is the 
house.
  I thank the Senator from New Hampshire, Mr. Gregg, for all of his 
work on health IT for drug safety and his emphasis on being able to 
have the right surveillance and the right triggers to be able to put 
these things into place at an appropriate time. In designing that 
house, you can have a small, simple house, or you can have a big fancy 
house. The size and complexity of your house should match your needs. 
The REMS is customizable, buildable to address whatever risks are 
present for the drug in question. The REMS allows you to build an 
addition for your house if your family grows, for example. You can also 
move into a smaller home if you find you don't need so much space.
  Let's talk about how this would work. Let's say drug A treats high 
blood pressure, has very few side effects. Therefore, the label and use 
of routine, active safety monitoring will be enough to manage the risk. 
Drug A doesn't need a REMS. However, drug B, which also treats high 
blood pressure, has serious side effects, including occasional liver 
failure. The label and use of routine, active safety monitoring is not 
enough to manage the risk. Therefore, drug B needs REMS.
  The REMS will include extra warnings on the label, perhaps periodic 
letters to doctors to remind them of the risks, and require testing and 
a system to test patients for liver enzyme levels before they are 
allowed to fill a prescription. As I said, not every drug needs a REMS. 
However, every drug will need a very active FDA with all of the 
necessary tools to identify and quickly manage additional risks.
  Like everyone else, when I purchase a product for myself, my 
children, or my grandchildren, I want the assurance that the product is 
safe and beneficial. This bill gives the FDA the necessary resources 
and tools so that moms and dads are able to trust that product at the 
pharmacy counter and know that it is safe and effective.
  As I mentioned, this bill is still a work in progress. There are a 
dozen amendments, several of which have been in the managers' 
amendment, and several are still being worked on. We do want faster 
drug approval, but we want assurances that as the whole population 
becomes a clinical trial, connections can be made quickly to any 
problems without the need to pull the drug off the market and away from 
those who could benefit. I will have more to say about other potential 
things that will not be in this bill that I think would complicate the 
bill or maybe be adverse to what we are trying to do in the bill, and 
some of them that have not had enough study yet. I will comment on 
those as they come up, if they come up.
  At this point, I yield the floor.
  The PRESIDING OFFICER. The Senator from Ohio is recognized.
  Mr. BROWN. Madam President, I appreciate the words of my colleague, 
the

[[Page 10657]]

Senator from Wyoming, Mr. Enzi. S. 1082 is a major piece of legislation 
that aims to--and will--achieve a profoundly important goal. It will 
improve the public health.
  When it is riskier to take a drug than to skip it, the public health 
is compromised. When a lifesaving prescription drug or medical device 
languishes at the FDA because of backlogs in the approval process, the 
public health is compromised.
  When pediatricians are forced to fly by the seat of their pants 
because there is no data to guide the use of a drug or medical device 
in children specifically, the public health is compromised.
  When FDA has the responsibility but lacks the tools to assess the 
safety or effectiveness of a new drug or device, the public health is 
compromised.
  S. 1082 tackles each of these problems. It gives FDA more authority 
and drugmakers a greater incentive to assure the safety of medicines 
before and after drug approval.
  It reauthorizes user fees, an additional source of funding that 
enables FDA to speed up the approval of new prescription drugs and 
medical devices.
  It reauthorizes financial incentives to encourage drugmakers to test 
their products for use in children, and it establishes similar 
incentives for medical device manufacturers.
  At the same time, it puts more teeth in FDA's authority to require 
studies when the health or safety of children is clearly at risk.
  S. 1082 creates a new institute charged with developing up-to-date 
methods of assessing the safety and effectiveness of cutting-edge 
medical interventions.
  You are no doubt going to hear complaints about this bill. Some 
Members will tell you that it is overly bureaucratic. Coincidentally, 
that is exactly what the brand-name drug industry says about it.
  Nobody can accuse the drugmakers of inconsistency. They consistently 
place their own self-interest ahead of health care safety, access, and 
affordability.
  The drug industry doesn't want FDA to take additional steps to 
prevent prescription-drug-related injury or death, although the drug 
industry is open to being shielded from liability when those tragedies 
happen. When Members of this body stand up and claim this bill is too 
bureaucratic, don't buy into it.
  This is a carefully crafted bipartisan bill. It is less stringent 
than consumer groups want and more stringent than the drug industry 
wants. In other words, it is a compromise--a compromise that will 
improve the public health. There will be amendments to this bill. As 
Members on both sides of the aisle review them, I urge them to remember 
this: Amendments that improve drug safety will benefit consumers and 
reduce health care costs. Amendments that increase price competition in 
the prescription drug market will benefit consumers and reduce health 
care costs. And amendments that weaken this bill or block price 
competition in the marketplace will benefit--who else--the brand-name 
drug industry.
  The drug industry has more than 3,000 lobbyists here and in the House 
of Representatives. Last year alone, the drug industry spent more than 
$150 million lobbying at the Federal level. That is quite a home court 
advantage. As one might imagine, people who have lost loved ones to 
unsafe drugs and people who cannot afford to fill their prescriptions 
don't have quite as deep pockets as the drug industry. Still, this is a 
drug safety bill, this is a drug access bill, this is not a drug 
industry bill.
  I hope every Member will consider the bill and every amendment in 
that context because in that context, when we vote on the final bill, 
if we vote yes, we will be voting to improve the public health.
  Madam President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The legislative clerk proceeded to call the roll.
  Mr. KENNEDY. Madam President, I ask unanimous consent that the order 
for the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.
  Mr. KENNEDY. Madam President, I was necessarily absent from the 
Senate at the conclusion of Senator Enzi's remarks. I again thank him 
for an excellent presentation, with the emphasis on the safety aspects 
of this legislation.
  I think all of us are reassured we are on the right track, not only 
as a result of the extensive hearings we held but the very extensive 
review the Institute of Medicine gave, a highly regarded, highly 
respected agency. During the course of the hearings, we had very good 
attendance and exchange of the representatives of the Institute of 
Medicine, and we have worked with them subsequently in terms of the 
language and refinements.
  As we said, we didn't just copy everything, but the essential aspect 
of the safety provisions in our legislation is, quite frankly, 
preferable.
  I look forward to working closely with Senator Enzi as well on the 
other areas of public policy in terms of food safety and the follow-on 
biologics which we are very much involved in as well.
  I thank the Senator from Ohio for his comments. We know him for being 
someone who has spent a great deal of time making sure safe drugs are 
going to get to people who need them. There are many dimensions to this 
debate. He has certainly been one whom, over the course of time, on the 
Health Committee in the House of Representatives, I have had an 
opportunity to work with on a number of health issues. He has been very 
active and involved with this issue on our committee and also on making 
sure we are going to have not only safe drugs but also have access to 
them.
  I will take a moment, because I think it is probably worthwhile in 
the opening presentation, to go through one of the real safety crises 
we had with prescription drugs and look at what existing authority was 
there and then how that could have been handled under that legislation.
  People will look through this legislation--it is not all that long, 
but it is complex. The results are enormously important and very basic 
and very fundamental. I use Vioxx as a point of illustration, which I 
think most Americans remember the circumstances where hundreds of 
thousands of Americans with heart needs were put at risk.
  This was really the question--this is the FDA Reauthorization Act--
how we could have averted the Vioxx disaster. I think people are 
beginning to study this legislation, and also our colleagues who are 
reviewing the record ask about how this legislation can make a 
difference on a particular drug. This chart is very useful in 
understanding that point.
  Can the FDA quickly detect safety problems with a drug? Vioxx, no. 
Under our legislation, the answer is yes. Senator Enzi gave an 
excellent presentation about how that can be done using the most modern 
technology, using the greatest availability of public and private 
collections of adverse reactions, and bringing those together within 
the agency. We know all of that is going to gradually expand in the 
future, so that agency will have the best of science. They will be able 
to protect safety. The answer with this legislation is yes.
  Can the FDA require label changes to warn of safety problems? The 
answer with Vioxx was no. They spent 14 months trying to negotiate the 
issue of the labels. Under our legislation, they would be able to do 
that.
  I mention that as one of the things they will be able to do. They can 
either take the drug off the market--they have the power to do it. It 
is not done because you don't want to take the chance that there may be 
some people in the public, given the health risks, who are justified in 
taking that particular medication, but for the great mass of people, it 
might not be. Can we put label changes on? They would be able to do it 
very quickly.
  Are companies stopped from hiding safety problems? This comes back to 
what both Senator Enzi and I referenced in making public clinical 
trials. That is enormously important. Senator Mikulski has been very 
involved in the transparency parts of this

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legislation. I hope those in the Senate who are interested and 
concerned about the issues of transparency might take a moment and talk 
with Senator Mikulski. Hopefully, she will speak on these issues 
because she has made a very important contribution.
  Part of this transparency is that these clinical trials will be 
available, to understand the significance of any safety problems, which 
hasn't been the case, but they will also be available to people who may 
want to enroll in a clinical trial, who have a particular illness, a 
particular disease and know there is a particular trial that is going 
to take place and say: I think I want to enroll in that particular 
trial because it is taking place. People don't know that now. That is 
enormously important and valuable to people. Whoever becomes part of a 
clinical trial and finds out a particular drug can be lifesaving, it is 
of enormous importance and consequence.
  We have the knowledge of the clinical trial in terms of safety but 
also in terms of the opportunities that are coming up, particularly in 
this period of life sciences, with these extraordinary breakthroughs we 
are seeing now--the mapping of the human genome, sequencing of the 
gene, and I think before long in stem cell research we are going to see 
incredible possibilities, and people are going to want to become part 
of clinical trials.
  But with regard to responding to this--are companies stopped from 
hiding safety problems, yes; does FDA have flexible tools to enforce 
safety decisions--it was expressed very well by Senator Enzi. He was 
talking about the big toolbox. That is the way we should look at it. 
There is a variety of tools in that toolbox. He explained that. There 
are a number of different ways that those who are committed to safety 
can titrate these different availabilities to ensure safety. Some may 
require a heavier hand than others. What we want, obviously, is to do 
enough to provide protection but not enough to discourage use where it 
is necessary.
  Finally, is FDA the gold standard for protecting public health and 
assuring access? We are strongly committed to making sure it is. We 
believe that with the safety protections we have put in the bill and 
also the inclusions, working with the pharmaceutical industry in terms 
of PDUFA and MDUFA to try to always find ways of expediting the 
consideration of these lifesaving drugs--that was one of the very 
important purposes, giving emphasis for research of many of the areas 
of health that are of such concern to the American people: cancer, 
cardiovascular issues, Parkinson's disease, Alzheimer's disease, 
juvenile diabetes disease, the AIDS virus, and many others--we can try 
to move toward a better relationship between the companies and FDA, in 
the sense that we can move this process, move more quickly, but do it 
more safely. That is what we are attempting to do, to ensure, in this 
life science century, that these breakthrough opportunities are going 
to be available and also do it in a way that will be safe. This is an 
example of one of the challenges the country has been facing recently, 
between the old and the new.
  We have tried this afternoon to describe in greater detail the 
various provisions of the legislation. We have not spent a great deal 
of time on the provisions which were supported by the Senator from 
Wyoming and myself with regard to children. Our committee has 
recognized, through the good work of Senator Dodd and Senator Clinton, 
the fact that children are not just little grownups; they are children. 
Many of these substances have different reactions, different impacts in 
terms of their development. It has taken special kinds of focus and 
attention to try to be more responsive to those needs. Our committee 
has done that. As a result, we see strong support from the American 
Pediatric Society and others for the way we have addressed those issues 
and modernized provisions to encourage greater research but also to 
protect the interests of children. We have strong support from the 
various groups that have spent their lifetime speaking for children.
  We will probably have an opportunity to get into some greater detail 
in discussion of those provisions. As I mentioned briefly in our 
comments, we have recognized the importance of developing and upgrading 
the science function in this agency. We think the FDA--at a time we are 
having breakthroughs in knowledge, in science, in so many areas, we 
want to make sure the FDA is out there on the cutting edge with respect 
to these breakthroughs and know where they are going. We have paid 
particular attention to those as well.
  Then the Udall-Reagan Foundation is to try to look longer term at 
ways in which the agency functions and take a longer look to make 
recommendations to the private sector and to the public sector about 
how it can be more effective generally. That kind of idea has not been 
included in the past. It can very well be enormously valuable and 
helpful to legislators in the future.
  We have tried to get legislation that will provide the protection 
presently, help and assist breakthrough technologies, and provide a 
faster track for the American people in the future, but to do it with 
greater safety protections for all families, and to recognize we are at 
a time of breakthrough science, which that agency has to have, and 
there are going to be breakthroughs in different modalities in that 
agency working in the future. We have tried to build into this an 
agency that can give us advice so we can be more effective in the 
future.
  I hope we will be able to move ahead. I know we have gone through, in 
careful detail, the administration's positions over the weekend. We 
certainly respect those. We have had a good exchange with the 
administration.
  For those who are interested, if they read through the letter they 
sent to Senator Enzi and myself, and then if they look at the 
recommendation of the Institute of Medicine, they will find we are much 
closer to the recommendations of the Institute of Medicine. We may face 
some amendments in those areas. We look forward to having a good 
discussion and debate and the opportunity to expand some of the points 
we have made this evening.
  Mr. ENZI. I thank particularly Secretary Leavitt and those people on 
his staff. We had discussions over the weekend. They had some 
suggestions for changes. We asked for more detail on those changes. We 
also asked for them to be prioritized. I was pleased they were 
delivered within a matter of a very short period of time. That shows 
people in Government can work together and that they do work on the 
weekends to get these things done. A lot of people think when we go 
into recess for a weekend, all work around here stops. But there are 
dedicated staff who put their best effort into getting together and 
working together, sometimes in very tense situations and long hours, 
mostly through the night--last night. Then they have to draft what has 
actually been decided. It is a very difficult process. We owe them a 
great deal of credit. I want the American people to know that, too.
  I yield the floor.
  The PRESIDING OFFICER. The Senator from Massachusetts is recognized.
  Mr. KENNEDY. Madam President, we have the legislation before us. We 
hope those who have an interest and have some ideas, have some 
amendments, will be in touch with Senator Enzi and ourselves through 
this late afternoon, early evening, or first thing in the morning. We 
want to try to address those amendments early in the day, as early as 
we can. We understand both parties have their lunches and have 
important matters to discuss, and I am sure this will be among them. 
But we are ready for any of the amendments, as I underline what Senator 
Enzi has said. We had great participation in our markup with the 
members of our committee. As he mentioned as well, we have had enormous 
involvement of our committee members and many others over the period 
since the legislation was reported out of our committee until now.
  We are still in the process of trying to do business because we think 
this legislation is so important. We hope those who do have amendments 
will be in touch with us at the earliest possible time.

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