[Congressional Record Volume 153, Number 110 (Wednesday, July 11, 2007)]
[House]
[Pages H7568-H7606]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




          FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007

  Mr. DINGELL. Mr. Speaker, I move to suspend the rules and pass the 
bill (H.R. 2900) to amend the Federal Food, Drug, and Cosmetic Act to 
revise and extend the user-fee programs for prescription drugs and for 
medical devices, to enhance the postmarket authorities of the Food and 
Drug Administration with respect to the safety of drugs, and for other 
purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 2900

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

     SECTION 1. SHORT TITLE.

       This Act may be cited as the ``Food and Drug Administration 
     Amendments Act of 2007''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents for this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

Sec. 101. Short title; references in title.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug 
              television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title.

              Subtitle A--Fees Related to Medical Devices

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

     Subtitle B--Amendments Regarding Regulation of Medical Devices

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

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

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

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Government Accountability Office report.

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

Sec. 501. Short title.
Sec. 502. Reauthorization of Best Pharmaceuticals for Children Act.

                   TITLE VI--REAGAN-UDALL FOUNDATION

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

                    TITLE VII--CONFLICTS OF INTEREST

Sec. 701. Conflicts of interest.

                  TITLE VIII--CLINICAL TRIAL DATABASES

Sec. 801. Clinical trial registry database and clinical trial results 
              database.
Sec. 802. Study by Government Accountability Office.

[[Page H7569]]

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

Sec. 901. Postmarket studies and clinical trials regarding human drugs; 
              risk evaluation and mitigation strategies.
Sec. 902. Enforcement.
Sec. 903. No effect on withdrawal or suspension of approval.
Sec. 904. Benefit-risk assessments.
Sec. 905. Postmarket risk identification and analysis system for active 
              surveillance and assessment.
Sec. 907. Statement for inclusion in direct-to-consumer advertisements 
              of drugs.
Sec. 908. Clinical trial guidance for antibiotic drugs.
Sec. 909. Prohibition against food to which drugs or biological 
              products have been added.
Sec. 910. Assuring pharmaceutical safety.
Sec. 911. Orphan antibiotic drugs.
Sec. 912. Citizen petitions and petitions for stay of agency action.
Sec. 913. Authorization of appropriations.
Sec. 914. Effective date and applicability.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

     SEC. 101. SHORT TITLE; REFERENCES IN TITLE.

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

     SEC. 102. DEFINITIONS.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``505(b)(1),'' and 
     inserting ``505(b), or'';
       (B) by striking subparagraph (B); and
       (C) by redesignating subparagraph (C) as subparagraph (B);
       (2) in paragraph (3)(C)--
       (A) by striking ``505(j)(7)(A)'' and inserting 
     ``505(j)(7)(A) (not including the discontinued section of 
     such list),''; and
       (B) by inserting before the period ``(not including the 
     discontinued section of such list)'';
       (3) in paragraph (4), by inserting before the period at the 
     end the following: ``(such as capsules, tablets, or 
     lyophilized products before reconstitution)'';
       (4) by amending paragraph (6)(F) to read as follows:
       ``(F) Postmarket safety activities with respect to drugs 
     approved under human drug applications or supplements, 
     including the following activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on approved drugs, including adverse event 
     reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies).
       ``(v) Preparing and making publicly available (including on 
     the website of the Food and Drug Administration) a summary 
     analysis of the adverse drug reaction reports received for 
     recently approved drugs, including identification of any new 
     risks not previously identified, potential new risks, or 
     known risks reported in unusual number not previously 
     identified within 18 months of the drug's initial marketing 
     or after exposure of 10,000 individuals to the drug, 
     whichever is later.
       ``(vi) Conducting regular, bi-weekly screening of the 
     Adverse Event Reporting System database and developing a 
     report every 15 days on any new safety concerns.
       ``(vii) Ensuring that the reports available to the public 
     under the Adverse Event Reporting System are updated at least 
     every 6 months.
       ``(viii) Reporting to the Congress on--

       ``(I) the recommendations received in consultations with, 
     and reports from, the Office of Surveillance and Epidemiology 
     within the Food and Drug Administration on postmarket safety 
     activities;
       ``(II) a description of the actions taken on those 
     recommendations; and
       ``(III) if no action is taken, or a different action is 
     taken relative to the action recommended by the Office of 
     Surveillance and Epidemiology, an explanation of why no 
     action or a different action was taken.

       ``(ix) On an annual basis, reviewing the entire backlog of 
     postmarket safety commitments to determine which commitments 
     require revision or should be eliminated, reporting to the 
     Congress on these determinations, and assigning start dates 
     and estimated completion dates for such commitments.
       ``(x) Developing postmarket safety performance measures, 
     including those listed in clauses (v) through (ix), that are 
     as measurable and rigorous as the ones already developed for 
     premarket review.'';
       (5) in paragraph (8)--
       (A) by striking ``April of the preceding fiscal year'' and 
     inserting ``October of the preceding fiscal year''; and
       (B) by striking ``April 1997'' and inserting ``October 
     1996'';
       (6) by redesignating paragraph (9) as paragraph (11); and
       (7) by inserting after paragraph (8) the following 
     paragraphs:
       ``(9) The term `person' includes an affiliate thereof.
       ``(10) The term `active', with respect to a commercial 
     investigational new drug application, means such an 
     application to which information was submitted during the 
     relevant period.''.  

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

       (a) Types of Fees.--Section 736(a) (21 U.S.C. 379h(a)) is 
     amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``2003'' and inserting ``2008'';
       (2) in paragraph (1)--
       (A) in subparagraph (D)--
       (i) in the heading, by inserting ``or withdrawn before 
     filing'' after ``refused for filing''; and
       (ii) by inserting before the period at the end the 
     following: ``or withdrawn without a waiver before filing'';
       (B) by redesignating subparagraphs (E) and (F) as 
     subparagraphs (F) and (G), respectively; and
       (C) by inserting after subparagraph (D) the following:
       ``(E) Fees for applications previously refused for filing 
     or withdrawn before filing.--A human drug application or 
     supplement that was submitted but was refused for filing, or 
     was withdrawn before being accepted or refused for filing, 
     shall be subject to the full fee under subparagraph (A) upon 
     being resubmitted or filed over protest, unless the fee is 
     waived or reduced under subsection (d).''; and
       (3) in paragraph (2)--
       (A) in subparagraph (A), by striking ``subparagraph (B)'' 
     and inserting ``subparagraphs (B) and (C)''; and
       (B) by adding at the end the following:
       ``(C) Special rules for positron emission tomography 
     drugs.--
       ``(i) In general.--Except as provided in clause (ii), each 
     person who is named as the applicant in an approved human 
     drug application for a positron emission tomography drug 
     shall be subject under subparagraph (A) to one-sixth of an 
     annual establishment fee with respect to each such 
     establishment identified in the application as producing 
     positron emission tomography drugs under the approved 
     application.
       ``(ii) Exception from annual establishment fee.--Each 
     person who is named as the applicant in an application 
     described in clause (i) shall not be assessed an annual 
     establishment fee for a fiscal year if the person certifies 
     to the Secretary, at a time specified by the Secretary and 
     using procedures specified by the Secretary, that--

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

       ``(iii) Definition.--For purposes of this subparagraph, the 
     term `positron emission tomography drug' has the meaning 
     given to the term `compounded positron emission tomography 
     drug' in section 201(ii), except that subparagraph (1)(B) of 
     such section shall not apply.''.
       (b) Fee Revenue Amounts.--Section 736(b) (21 U.S.C. 
     379h(b)) is amended to read as follows:
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--For each of the fiscal years 2008 
     through 2012, fees under subsection (a) shall, except as 
     provided in subsections (c), (d), (f), and (g), be 
     established to generate a total revenue amount under such 
     subsection that is equal to the sum of--
       ``(A) $392,783,000; and
       ``(B) an amount equal to the modified workload adjustment 
     factor for fiscal year 2007 (as determined under paragraph 
     (3)).
       ``(2) Types of fees.--Of the total revenue amount 
     determined for a fiscal year under paragraph (1)--
       ``(A) one-third shall be derived from fees under subsection 
     (a)(1) (relating to human drug applications and supplements);
       ``(B) one-third shall be derived from fees under subsection 
     (a)(2) (relating to prescription drug establishments); and
       ``(C) one-third shall be derived from fees under subsection 
     (a)(3) (relating to prescription drug products).
       ``(3) Modified workload adjustment factor for fiscal year 
     2007.--For purposes of paragraph (1)(B), the Secretary shall 
     determine the modified workload adjustment factor by 
     determining the dollar amount that results from applying the 
     methodology that was in effect under subsection (c)(2) for 
     fiscal year 2007 to the amount $354,893,000, except that, 
     with respect to the portion of such determination that is 
     based on the change in the total number of commercial 
     investigational new drug applications, the Secretary shall 
     count the number of such applications that were active during 
     the most recent 12-month period for which data on such 
     submissions is available.
       ``(4) Additional fee revenues for drug safety.--
       ``(A) In general.--For each of the fiscal years 2008 
     through 2012, paragraph (1)(A) shall, subject to subparagraph 
     (C), be applied

[[Page H7570]]

     by substituting the amount determined under subparagraph (B) 
     for `$392,783,000'.
       ``(B) Amount determined.--For each of the fiscal years 2008 
     through 2012, the amount determined under this subparagraph 
     is the sum of--
       ``(i) $392,783,000; plus
       ``(ii) an amount equal to--

       ``(I)(aa) for fiscal year 2008, $25,000,000;
       ``(bb) for fiscal year 2009, $35,000,000;
       ``(cc) for fiscal year 2010, $45,000,000;
       ``(dd) for fiscal year 2011, $55,000,000; and
       ``(ee) for fiscal year 2012, $65,000,000; minus
       ``(II) the amount equal to the excess amount in item (bb), 
     provided that--

       ``(aa) the amount of the total appropriation for the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) exceeds the 
     amount of the total appropriation for the Food and Drug 
     Administration for fiscal year 2007 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under subsection (c)(1); and
       ``(bb) the amount of the total appropriations for the 
     process of human drug review at the Food and Drug 
     Administration for such fiscal year (excluding the amount of 
     fees appropriated for such fiscal year) exceeds the amount of 
     appropriations for the process of human drug review at the 
     Food and Drug Administration for fiscal year 2007 (excluding 
     the amount of fees appropriated for such fiscal year), 
     adjusted as provided under subsection (c)(1).

     In making the adjustment under subclause (II) for any of 
     fiscal years 2008 through 2012, subsection (c)(1) shall be 
     applied by substituting `2007' for `2008'.

       ``(C) Limitation.--This paragraph shall not apply for any 
     fiscal year if the amount described under subparagraph 
     (B)(ii) is less than 0.''.
       (c) Adjustments to Fees.--
       (1) Inflation adjustment.--Section 736(c)(1) (21 U.S.C. 
     379h(c)(1)) is amended--
       (A) in the matter preceding subparagraph (A), by striking 
     ``The revenues established in subsection (b)'' and inserting 
     ``For fiscal year 2009 and subsequent fiscal years, the 
     revenues established in subsection (b)'';
       (B) in subparagraph (A), by striking ``or'' at the end;
       (C) in subparagraph (B), by striking the period at the end 
     and inserting ``, or'';
       (D) by inserting after subparagraph (B) the following:
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions for the first 5 years of the preceding 6 
     fiscal years.''; and
       (E) in the matter following subparagraph (C) (as added 
     under this paragraph), by striking ``fiscal year 2003'' and 
     inserting ``fiscal year 2008''.
       (2) Workload adjustment.--Section 736(c)(2) (21 U.S.C. 
     379h(c)(2)) is amended--
       (A) in the matter preceding subparagraph (A), by striking 
     ``Beginning with fiscal year 2004,'' and inserting ``For 
     fiscal year 2009 and subsequent fiscal years,'';
       (B) in subparagraph (A), in the first sentence--
       (i) by striking ``human drug applications,'' and inserting 
     ``human drug applications (adjusted for changes in review 
     activities, as described in the notice that the Secretary is 
     required to publish in the Federal Register under this 
     subparagraph),'';
       (ii) by striking ``commercial investigational new drug 
     applications,''; and
       (iii) by inserting before the period the following: ``, and 
     the change in the total number of active commercial 
     investigational new drug applications (adjusted for changes 
     in review activities, as so described) during the most recent 
     12-month period for which data on such submissions is 
     available'';
       (C) in subparagraph (B), by adding at the end the 
     following: ``Any adjustment for changes in review activities 
     made in setting fees and revenue amounts for fiscal year 2009 
     may not result in the total workload adjustment being more 
     than 2 percentage points higher than it would have been in 
     the absence of the adjustment for changes in review 
     activities.''; and
       (D) by adding at the end the following:
       ``(C) The Secretary shall contract with an independent 
     accounting firm to study the adjustment for changes in review 
     activities applied in setting fees and revenue amounts for 
     fiscal year 2009 and to make recommendations, if warranted, 
     for future changes in the methodology for calculating the 
     adjustment. After review of the recommendations, the 
     Secretary shall, if warranted, make appropriate changes to 
     the methodology, and the changes shall be effective for each 
     of the fiscal years 2010 through 2012. The Secretary shall 
     not make any adjustment for changes in review activities for 
     any fiscal year after 2009 unless such study has been 
     completed.''.
       (3) Rent and rent-related cost adjustment.--Section 736(c) 
     (21 U.S.C. 379h(c)) is amended--
       (A) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), respectively; and
       (B) by inserting after paragraph (2) the following:
       ``(3) Rent and rent-related cost adjustment.--For fiscal 
     year 2010 and each subsequent fiscal year, the Secretary 
     shall, before making adjustments under paragraphs (1) and 
     (2), decrease the fee revenue amount established in 
     subsection (b) if actual costs paid for rent and rent-related 
     expenses for the preceding fiscal year are less than 
     estimates made for such year in fiscal year 2006. Any 
     reduction made under this paragraph shall not exceed the 
     amount by which such costs fall below the estimates made in 
     fiscal year 2006 for such fiscal year, and shall not exceed 
     $11,721,000 for any fiscal year.''.
       (4) Final year adjustment.--Section 736(c) (21 U.S.C. 
     379h(c)) is amended--
       (A) in paragraph (4) (as redesignated by paragraph 
     (3)(A))--
       (i) by striking ``2007'' each place it appears and 
     inserting ``2012'';
       (ii) by striking ``paragraphs (1) and (2)'' and inserting 
     ``paragraphs (1), (2), and (3)''; and
       (iii) by striking ``2008'' and inserting ``2013''; and
       (B) in paragraph (5) (as so redesignated), by striking 
     ``2002'' and inserting ``2007''.
       (d) Fee Waiver or Reduction.--Section 736(d) (21 U.S.C. 
     379h(d)) is amended--
       (1) in paragraph (1), in the matter preceding subparagraph 
     (A)--
       (A) by inserting after ``The Secretary shall grant'' the 
     following: ``to a person who is named as the applicant in a 
     human drug application''; and
       (B) by inserting ``to that person'' after ``one or more 
     fees assessed'';
       (2) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (3) by inserting after paragraph (1) the following:
       ``(2) Considerations.--In determining whether to grant a 
     waiver or reduction of a fee under paragraph (1), the 
     Secretary shall consider only the circumstances and assets of 
     the applicant involved and any affiliate of the applicant.''; 
     and
       (4) in paragraph (4) (as redesignated by paragraph (2)), in 
     subparagraph (A), by inserting before the period the 
     following: ``, and that does not have a drug product that has 
     been approved under a human drug application and introduced 
     or delivered for introduction into interstate commerce''.
       (e) Crediting and Availability of Fees.--
       (1) Authorization of appropriations.--Section 736(g)(3) (21 
     U.S.C. 379h(g)(3)) is amended to read as follows:
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2008 through 2012, there is authorized to be 
     appropriated for fees under this section an amount equal to 
     the total revenue amount determined under subsection (b) for 
     the fiscal year, as adjusted or otherwise affected under 
     subsection (c) and paragraph (4) of this subsection.''.
       (2) Offset.--Section 736(g)(4) (21 U.S.C. 379h(g)(4)) is 
     amended to read as follows:
       ``(4) Offset.--If the sum of the cumulative amount of fees 
     collected under this section for the fiscal years 2008 
     through 2010 and the amount of fees estimated to be collected 
     under this section for fiscal year 2011 exceeds the 
     cumulative amount appropriated under paragraph (3) for the 
     fiscal years 2008 through 2011, the excess shall be credited 
     to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.
       (f) Exemption for Orphan Drugs.--Section 736 (21 U.S.C. 
     379h) is further amended by adding at the end the following:
       ``(k) Orphan Drugs.--A drug designated under section 526 
     for a rare disease or condition and approved under section 
     505 or under section 351 of the Public Health Service Act 
     shall be exempt from product and facility fees under this 
     section, provided that the drug meets all of the following:
       ``(1) The drug had United States sales in the previous year 
     of less than $25,000,000 for the active moiety, for all 
     indications, dosage forms, and strengths for which the drug 
     is approved and for any off-label uses.
       ``(2) The drug meets the public health requirements 
     contained in this Act as such requirements are applied to 
     requests for waivers for product and facility fees.
       ``(3) The drug is owned or licensed and marketed by a 
     company that had less than $100,000,000 in gross worldwide 
     revenue during the previous year.''.
       (g) Conforming Amendment.--Section 736(a) (21 U.S.C. 
     379h(a)) is amended in paragraphs (1)(A)(i), (1)(A)(ii), 
     (2)(A), and (3)(A) by striking ``(c)(4)'' each place such 
     term appears and inserting ``(c)(5)''.

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

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

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

       ``(a) Types of Direct-to-Consumer Television Advertisement 
     Review Fees.--Beginning in fiscal year 2008, the Secretary 
     shall assess and collect fees in accordance with this section 
     as follows:
       ``(1) Advisory review fee.--
       ``(A) In general.--With respect to a proposed direct-to-
     consumer television advertisement (referred to in this 
     section as a `DTC advertisement'), each person that on or 
     after October 1, 2007, submits such an advertisement for 
     advisory review by the Secretary prior to its initial public 
     broadcast (referred to in this section as `prebroadcast 
     advisory review') shall, except as provided in subparagraph 
     (B), be subject to a fee established under subsection (c)(3).
       ``(B) Exception for required submissions.--A DTC 
     advertisement that is required under section 502(n) to be 
     submitted

[[Page H7571]]

     to the Secretary prior to initial public broadcast is not 
     subject to a fee under subparagraph (A) unless the sponsor 
     designates the submission as a submission for prebroadcast 
     advisory review.
       ``(C) Notice to secretary of number of advertisements.--Not 
     later than June 1 of each fiscal year, the Secretary shall 
     publish a notice in the Federal Register requesting any 
     person to notify the Secretary within 30 days of the number 
     of DTC advertisements the person intends to submit for 
     prebroadcast advisory review in the next fiscal year.
       ``(D) Payment.--
       ``(i) In general.--The fee required by subparagraph (A) 
     (referred to in this section as `an advisory review fee') 
     shall be due not later than October 1 of the fiscal year in 
     which the DTC advertisement involved is intended be submitted 
     for prebroadcast advisory review, subject to subparagraph 
     (F)(i).
       ``(ii) Effect of submission.--Notification of the Secretary 
     under subparagraph (C) of the number of DTC advertisements a 
     person intends to submit for prebroadcast advisory review is 
     a legally binding commitment by that person to pay the annual 
     advisory review fee for that number of submissions on or 
     before October 1 of the fiscal year in which the 
     advertisement is intended to be submitted.
       ``(iii) Notice regarding carryover submissions.--In making 
     a notification under subparagraph (C), the person involved 
     shall in addition notify the Secretary if under subparagraph 
     (F)(i) the person intends to submit a DTC advertisement for 
     which the advisory review fee has already been paid. If the 
     person does not so notify the Secretary, each DTC 
     advertisement submitted by the person for prebroadcast 
     advisory review in the fiscal year involved shall be subject 
     to the advisory review fee.
       ``(E) Modification of advisory review fee.--
       ``(i) Late payment.--If a person has submitted a 
     notification under subparagraph (C) with respect to a fiscal 
     year and has not paid all advisory review fees due under 
     subparagraph (D) on or before November 1 of such fiscal year, 
     the fees are regarded as late and a revised due date and an 
     increase in the amount of fees applies in accordance with 
     this clause, notwithstanding any other provision of this 
     section. For such person, the advisory review fee for each 
     DTC advertisement submitted in such fiscal year for 
     prebroadcast advisory review shall be due and payable 20 days 
     before the advertisement is submitted to the Secretary, and 
     each such fee shall be revised to be equal to 150 percent of 
     the fee that otherwise would have applied pursuant to 
     subsection (c)(3).
       ``(ii) Exceeding identified number of submissions.--If a 
     person submits a number of DTC ads for prebroadcast advisory 
     review in a fiscal year that exceeds the number identified by 
     the person under subparagraph (C), a revised due date and an 
     increase in the amount of fees applies under this clause for 
     each submission in excess of such number, notwithstanding any 
     other provision of this section. For each such DTC ad, the 
     advisory review fee shall be due and payable 20 days before 
     the advertisement is submitted to the Secretary, and the fee 
     shall be revised to be equal to 150 percent of the fee that 
     otherwise would have applied pursuant to subsection (c)(3).
       ``(F) Limits.--
       ``(i) Submissions.--For each advisory review fee paid by a 
     person for a fiscal year, the person is entitled to 
     acceptance for advisory review by the Secretary of one DTC 
     advertisement and acceptance of one resubmission for advisory 
     review of the same advertisement. The advertisement shall be 
     submitted for review in the fiscal year for which the fee was 
     assessed, except that a person may carry over not more than 
     one paid advisory review submission to the next fiscal year. 
     Resubmissions may be submitted without regard to the fiscal 
     year of the initial advisory review submission.
       ``(ii) No refunds.--Except as provided by subsection (f), 
     fees paid under subparagraph (A) shall not be refunded.
       ``(iii) No waivers, exemptions, or reductions.--The 
     Secretary shall not grant a waiver, exemption, or reduction 
     of any fees due or payable under this section.
       ``(iv) Right to advisory review not transferable.--The 
     right to an advisory review under this paragraph is not 
     transferable, except to a successor in interest.
       ``(2) Operating reserve fee.--
       ``(A) In general.--Each person that on or after October 1, 
     2007, is assessed an advisory review fee under paragraph (1) 
     shall be subject to fee established under subsection (d)(2) 
     referred to in this section as an `operating reserve fee' for 
     the first fiscal year in which an advisory review fee is 
     assessed to such person. The person is not subject to an 
     operating reserve fee for any other fiscal year.
       ``(B) Payment.--Except as provided in subparagraph (C), the 
     operating reserve fee shall be due no later than October 1 of 
     the first fiscal year in which the person is required to pay 
     an advisory review fee under paragraph (1).
       ``(C) Late notice of submission.--If, in the first fiscal 
     year of a person's participation in the program under this 
     section, that person submits any DTC advertisements for 
     prebroadcast advisory review that are in excess of the number 
     identified by that person in response to the Federal Register 
     notice described in subsection (a)(1)(C), that person shall 
     pay an operating reserve fee for each of those advisory 
     reviews equal to the advisory review fee for each submission 
     established under paragraph (1)(D)(ii). Fees required by this 
     subparagraph shall be in addition to any fees required by 
     subparagraph (A). Fees under this subparagraph shall be due 
     20 days before any DTC advertisement is submitted by such 
     person to the Secretary for prebroadcast advisory review.
       ``(b) Advisory Review Fee Revenue Amounts.--Fees under 
     subsection (a)(1) shall be established to generate revenue 
     amounts of $6,250,000 for each of fiscal years 2008 through 
     2012, as adjusted pursuant to subsections (c) and (g)(4).
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--Beginning with fiscal year 
     2009, the revenues established in subsection (b) shall be 
     adjusted by the Secretary by notice, published in the Federal 
     Register, for a fiscal year to reflect the greater of--
       ``(A) the total percentage change that occurred in the 
     Consumer Price Index for all urban consumers (all items; U.S. 
     city average), for the 12-month period ending June 30 
     preceding the fiscal year for which fees are being 
     established;
       ``(B) the total percentage change for the previous fiscal 
     year in basic pay under the General Schedule in accordance 
     with section 5332 of title 5, United States Code, as adjusted 
     by any locality-based comparability payment pursuant to 
     section 5304 of such title for Federal employees stationed in 
     the District of Columbia; or
       ``(C) the average annual change in the cost, per full-time 
     equivalent position of the Food and Drug Administration, of 
     all personnel compensation and benefits paid with respect to 
     such positions for the first 5 fiscal years of the previous 6 
     fiscal years.
     The adjustment made each fiscal year by this subsection will 
     be added on a compounded basis to the sum of all adjustments 
     made each fiscal year after fiscal year 2008 under this 
     subsection.
       ``(2) Workload adjustment.--Beginning with fiscal year 
     2009, after the fee revenues established in subsection (b) 
     are adjusted for a fiscal year for inflation in accordance 
     with paragraph (1), the fee revenues shall be adjusted 
     further for such fiscal year to reflect changes in the 
     workload of the Secretary with respect to the submission of 
     DTC advertisements for advisory review prior to initial 
     broadcast. With respect to such adjustment:
       ``(A) The adjustment shall be determined by the Secretary 
     based upon the number of DTC advertisements identified 
     pursuant to subsection (a)(1)(C) for the upcoming fiscal 
     year, excluding allowable previously paid carry over 
     submissions. The adjustment shall be determined by 
     multiplying the number of such advertisements projected for 
     that fiscal year that exceeds 150 by $27,600 (adjusted each 
     year beginning with fiscal year 2009 for inflation in 
     accordance with paragraph (1)). The Secretary shall publish 
     in the Federal Register the fee revenues and fees resulting 
     from the adjustment and the supporting methodologies.
       ``(B) Under no circumstances shall the adjustment result in 
     fee revenues for a fiscal year that are less than the fee 
     revenues established for the prior fiscal year.
       ``(3) Annual fee setting for advisory review.--
       ``(A) In general.--Not later than August 1 of each fiscal 
     year, the Secretary shall establish for the next fiscal year 
     the DTC advertisement advisory review fee under subsection 
     (a)(1), based on the revenue amounts established under 
     subsection (b), the adjustments provided under paragraphs (1) 
     and (2), and the number of DTC advertisements identified 
     pursuant to subsection (a)(1)(C), excluding allowable 
     previously-paid carry over submissions. The annual advisory 
     review fee shall be established by dividing the fee revenue 
     for a fiscal year (as adjusted pursuant to this subsection) 
     by the number of DTC advertisements so identified, excluding 
     allowable previously-paid carry over submissions.
       ``(B) Fiscal year 2008 fee limit.--Notwithstanding 
     subsection (b) and the adjustments pursuant to this 
     subsection, the fee established under subparagraph (A) for 
     fiscal year 2008 may not be more than $83,000 per submission 
     for advisory review.
       ``(C) Annual fee limit.--Notwithstanding subsection (b) and 
     the adjustments pursuant to this subsection, the fee 
     established under subparagraph (A) for a fiscal year after 
     fiscal year 2008 may not be more than 50 percent more than 
     the fee established for the prior fiscal year.
       ``(D) Limit.--The total amount of fees obligated for a 
     fiscal year may not exceed the total costs for such fiscal 
     year for the resources allocated for the process for the 
     advisory review of prescription drug advertising.
       ``(d) Operating Reserves.--
       ``(1) In general.--The Secretary shall establish in the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation a 
     Direct-to-Consumer Advisory Review Operating Reserve, of at 
     least $6,250,000 in fiscal year 2008, to continue the program 
     under this section in the event the fees collected in any 
     subsequent fiscal year pursuant to subsection (a)(1) do not 
     generate the fee revenue amount established for that fiscal 
     year.
       ``(2) Fee setting.--The Secretary shall establish the 
     operating reserve fee under subsection (a)(2)(A) for each 
     person required to pay the fee by multiplying the number of 
     DTC advertisements identified by that person pursuant to 
     subsection (a)(1)(C) by the advisory review fee established 
     pursuant to subsection (c)(3) for that fiscal year, except

[[Page H7572]]

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

     SEC. 105. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Performance Report.--Beginning with fiscal year 2008, 
     not later than 120 days after the end of each fiscal year for 
     which fees are collected under part 2 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 379g et seq.), the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall prepare and submit to the Committee on Energy and 
     Commerce of the House of Representatives and the Committee on 
     Health, Education, Labor, and Pensions of the Senate a report 
     concerning the progress of the Food and Drug Administration 
     in achieving the goals identified in the letters described in 
     section 502(4) of the Prescription Drug User Fee Amendments 
     of 2002 (Subtitle A of title V of Public Law 107-188) during 
     such fiscal year and the future plans of the Food and Drug 
     Administration for meeting the goals.
       (b) Fiscal Report.--Beginning with fiscal year 2008, not 
     later than 120 days after the end of each fiscal year for 
     which fees are collected under the part described in 
     subsection (a), the Secretary shall prepare and submit to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate a report on the 
     implementation of the authority for such fees during such 
     fiscal year and the use, by the Food and Drug Administration, 
     of the fees collected for such fiscal year.
       (c) Reauthorization.--
       (1) Consultation.--In developing recommendations to present 
     to the Congress

[[Page H7573]]

     with respect to the goals, and plans for meeting the goals, 
     for the process for the review of human drug applications for 
     the first 5 fiscal years after fiscal year 2012, and for the 
     reauthorization of this part for such fiscal years, the 
     Secretary shall consult with--
       (A) the Committee on Energy and Commerce of the House of 
     Representatives;
       (B) the Committee on Health, Education, Labor, and Pensions 
     of the Senate;
       (C) scientific and academic experts;
       (D) health care professionals;
       (E) representatives of patient and consumer advocacy 
     groups; and
       (F) the regulated industry.
       (2) Public review of recommendations.--After negotiations 
     with the regulated industry and representatives of patient 
     and consumer advocacy groups, the Secretary shall--
       (A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       (B) publish such recommendations in the Federal Register;
       (C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       (D) hold a meeting at which the public may present its 
     views on such recommendations; and
       (E) after consideration of such public views and comments, 
     revise such recommendations as necessary.
       (3) Transmittal of recommendations.--Not later than January 
     15, 2012, the Secretary shall transmit to Congress the 
     revised recommendations under paragraph (2), a summary of the 
     views and comments received under such paragraph, and any 
     changes made to the recommendations in response to such views 
     and comments.
       (4) Public availability of minutes.--Before presenting the 
     recommendations developed under paragraphs (1) and (2) to the 
     Congress, the Secretary shall make publicly available, on the 
     public website of the Food and Drug Administration, the 
     minutes of all negotiations conducted under paragraph (1) or 
     (2), as applicable, between the Food and Drug Administration 
     and the regulated industry and representatives of patient and 
     consumer advocacy groups.

     SEC. 106. SUNSET DATES.

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

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

     SEC. 201. SHORT TITLE; REFERENCES IN TITLE.

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

              Subtitle A--Fees Related to Medical Devices

     SEC. 211. DEFINITIONS.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) in paragraph (4)--
       (A) in subparagraph (A), by striking ``or an efficacy 
     supplement,'' and inserting ``an efficacy supplement, or a 
     30-day notice,''; and
       (B) by adding after subparagraph (E) the following:
       ``(F) The term `30-day notice' means a supplement to an 
     approved premarket application or premarket report under 
     section 515 that is limited to a request to make 
     modifications to manufacturing procedures or methods of 
     manufacture affecting the safety and effectiveness of the 
     device.'';
       (2) by redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (7), (8), (9), and (11), respectively;
       (3) by inserting after paragraph (4), as amended by 
     paragraph (1) of this section, the following:
       ``(5) The term `request for classification information' 
     means a request made under section 513(g) for information 
     respecting the class in which a device has been classified or 
     the requirements applicable to a device.
       ``(6) The term `annual fee', with respect to periodic 
     reporting concerning a class III device, means the annual fee 
     associated with periodic reports required by a PMA approval 
     order (as described in section 814.82(a)(7) of title 21, Code 
     of Federal Regulations (or any successor regulation)).'';
       (4) in paragraph (9), as so redesignated--
       (A) by striking ``April of the preceding fiscal year'' and 
     inserting ``October of the preceding fiscal year''; and
       (B) by striking ``April 2002'' and inserting ``October 
     2001'';
       (5) by inserting after paragraph (9), as so amended, the 
     following:
       ``(10) The term `person' includes an affiliate thereof.''; 
     and
       (6) by inserting after paragraph (11), as redesignated by 
     paragraph (2) of this section, the following:
       ``(12) The term `establishment subject to registration' 
     means an establishment that is required to register with the 
     Secretary under section 510 and is one of the following types 
     of establishments:
       ``(A) Manufacturer.--An establishment that makes by any 
     means any article that is a device, as defined in section 
     201(h), including an establishment that sterilizes or 
     otherwise makes such article for or on behalf of a 
     specification developer or any other person.
       ``(B) Single-use device reprocessor.--An establishment that 
     performs manufacturing operations on a single-use device.
       ``(C) Specification developer.--An establishment that 
     develops specifications for a device that is distributed 
     under the establishment's name but which performs no 
     manufacturing, including an establishment that, in addition 
     to developing specifications, also arranges for the 
     manufacturing of devices labeled with another establishment's 
     name by a contract manufacturer.''.

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

       (a) Types of Fees.--
       (1) In general.--The designation and heading of paragraph 
     (2) of section 738(a) (21 U.S.C. 379j(a)(2)) are amended to 
     read as follows:
       ``(2) Premarket application, premarket report, supplement, 
     and submission fee, and annual fee for periodic reporting 
     concerning a class iii device.--''.
       (2) Fee amounts.--Section 738(a)(2)(A) (21 U.S.C. 
     379j(a)(2)(A)) is amended--
       (A) in clause (iii), by striking ``a fee equal to the fee 
     that applies'' and inserting ``a fee equal to 75 percent of 
     the fee that applies'';
       (B) in clause (iv), by striking ``21.5 percent'' and 
     inserting ``15 percent'';
       (C) in clause (v), by striking ``7.2 percent'' and 
     inserting ``7 percent'';
       (D) by redesignating clauses (vi) and (vii) as clauses 
     (vii) and (viii), respectively;
       (E) by inserting after clause (v), as amended by this 
     paragraph, the following:
       ``(vi) For a 30-day notice, a fee equal to 1.6 percent of 
     the fee that applies under clause (i).'';
       (F) in clause (viii), as so redesignated, by striking 
     ``1.42 percent'' and inserting ``1.84 percent''; and
       (G) by inserting after such clause (viii) the following:
       ``(ix) For a request for classification information, a fee 
     equal to 1.35 percent of the fee that applies under clause 
     (i).
       ``(x) For periodic reporting concerning a class III device, 
     the annual fee shall be equal to 3.5 percent of the fee that 
     applies under clause (i).''.
       (3) Payment.--Section 738(a)(2)(C) (21 U.S.C. 
     379j(a)(2)(C)) is amended to read as follows:
       ``(C) Payment.--The fee required by subparagraph (A) shall 
     be due upon submission of the premarket application, 
     premarket report, supplement, premarket notification 
     submission, 30-day notice, request for classification 
     information, or periodic reporting concerning a class III 
     device. Applicants submitting portions of applications 
     pursuant to section 515(c)(3) shall pay such fees upon 
     submission of the first portion of such applications.''.
       (4) Refunds.--Section 738(a)(2)(D) (21 U.S.C. 
     379j(a)(2)(D)) is amended by adding after clause (iii) the 
     following:
       ``(iv) Modular applications withdrawn before first 
     action.--The Secretary shall refund 75 percent of the 
     application fee paid for a modular application submitted 
     under section 515(c)(4) that is withdrawn before a second 
     module is submitted and before a first action on the first 
     module. If the modular application is withdrawn after a 
     second or subsequent module is submitted but before any first 
     action, the Secretary may return a portion of the fee. The 
     amount of refund, if any, shall be based on the level of 
     effort already expended on the review of the modules 
     submitted.''.
       (5) Annual establishment registration fee.--Section 738(a) 
     (21 U.S.C. 379j(a)) is amended by adding after paragraph (2) 
     the following:
       ``(3) Annual establishment registration fee.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     each establishment subject to registration shall be subject 
     to a fee for each initial or annual registration under 
     section 510 beginning with its registration for fiscal year 
     2008.
       ``(B) Exception.--No fee shall be required under 
     subparagraph (A) for an establishment operated by a State or 
     Federal governmental entity or an Indian tribe (as defined in 
     the Indian Self Determination and Educational Assistance 
     Act), unless a device manufactured by the establishment is to 
     be distributed commercially.
       ``(C) Payment.--The fee required under subparagraph (A) 
     shall be due once each fiscal year, upon the initial 
     registration of the establishment or upon the annual 
     registration under section 510.''.
       (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is 
     amended to read as follows:
       ``(b) Fee amounts.--Except as provided in subsections (c), 
     (d), and (e), the fees under subsection (a) shall be based on 
     the following fee amounts:


----------------------------------------------------------------------------------------------------------------
                                                            Fiscal     Fiscal     Fiscal     Fiscal     Fiscal
                        Fee Type                          Year 2008  Year 2009  Year 2010  Year 2011   Year 2012
----------------------------------------------------------------------------------------------------------------
Premarket Application...................................   $185,000   $200,725   $217,787   $236,298    $256,384

[[Page H7574]]

 
Establishment Registration..............................     $1,706     $1,851     $2,008     $2,179  $2,364.''.
----------------------------------------------------------------------------------------------------------------

       (c) Annual Fee Setting.--
       (1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is 
     amended--
       (A) in the subsection heading, by striking ``Annual Fee 
     Setting'' and inserting ``Annual Fee Setting''; and
       (B) in paragraph (1), by striking the last sentence.
       (2) Adjustment of annual establishment fee.--Section 738(c) 
     (21 U.S.C. 379j(c)), as amended by paragraph (1), is further 
     amended--
       (A) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (B) by inserting after paragraph (1) the following:
       ``(2) Adjustment.--
       ``(A) In general.--When setting fees for fiscal year 2010, 
     the Secretary may increase the fee under subsection (a)(3)(A) 
     (applicable to establishments subject to registration) only 
     if the Secretary estimates that the number of establishments 
     submitting fees for fiscal year 2009 is less than 12,250. The 
     percentage increase shall be the percentage by which the 
     estimate of establishments submitting fees in fiscal year 
     2009 is less than 12,750, but in no case may the percentage 
     increase be more than 8.5 percent over that specified in 
     subsection (b) for fiscal year 2010. If the Secretary makes 
     any adjustment to the fee under subsection (a)(3)(A) for 
     fiscal year 2010, then such fee for fiscal years 2011 and 
     2012 shall be adjusted so that such fee for fiscal year 2011 
     is equal to the adjusted fee for fiscal year 2010 increased 
     by 8.5 percent, and such fee for fiscal year 2012 is equal to 
     the adjusted fee for fiscal year 2011 increased by 8.5 
     percent.
       ``(B) Publication.--For any adjustment made under 
     subparagraph (A), the Secretary shall publish in the Federal 
     Register the Secretary's determination to make the adjustment 
     and the rationale for the determination.''; and
       (C) in paragraph (4), as redesignated by this paragraph, in 
     subparagraph (A)--
       (i) by striking ``For fiscal years 2006 and 2007, the 
     Secretary'' and inserting ``The Secretary''; and
       (ii) by striking ``for the first month of fiscal year 
     2008'' and inserting ``for the first month of the next fiscal 
     year''.
       (d) Small Businesses; Fee Waiver and Fee Reduction 
     Regarding Premarket Approval.--
       (1) In general.--Section 738(d)(1) (21 U.S.C. 379j(d)(1)) 
     is amended--
       (A) by striking ``, partners, and parent firms''; and
       (B) by striking ``clauses (i) through (vi) of subsection 
     (a)(2)(A)'' and inserting ``clauses (i) through (v) and 
     clauses (vii), (ix), and (x) of subsection (a)(2)(A)''.
       (2) Rules relating to premarket approval fees.--
       (A) Definition.--Section 738(d)(2)(A) (21 U.S.C. 
     379j(d)(2)(A)) is amended by striking ``, partners, and 
     parent firms''.
       (B) Evidence of qualification.--Section 738(d)(2)(B) (21 
     U.S.C. 379j(d)(2)(B)) is amended--
       (i) by striking ``(B) Evidence of qualification.--An 
     applicant'' and inserting the following:
       ``(B) Evidence of qualification.--
       ``(i) In general.--An applicant'';
       (ii) by striking ``The applicant shall support its claim'' 
     and inserting the following:
       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support its 
     claim'';
       (iii) by striking ``, partners, and parent firms'' each 
     place it appears;
       (iv) by striking the last sentence and inserting ``If no 
     tax forms are submitted for any affiliate, the applicant 
     shall certify that the applicant has no affiliates.''; and
       (v) by adding at the end the following:
       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--In the case of an applicant 
     that has not previously submitted a Federal income tax 
     return, the applicant and each of its affiliates shall 
     demonstrate that it meets the definition under subparagraph 
     (A) by submission of a signed certification, in such form as 
     the Secretary may direct through a notice published in the 
     Federal Register, that the applicant or affiliate meets the 
     criteria for a small business and a certification, in 
     English, from the national taxing authority of the country in 
     which the applicant or, if applicable, affiliate is 
     headquartered. The certification from such taxing authority 
     shall bear the official seal of such taxing authority and 
     shall provide the applicant's or affiliate's gross receipts 
     and sales for the most recent year in both the local currency 
     of such country and in United States dollars, the exchange 
     rate used in converting such local currency to dollars, and 
     the dates during which these receipts and sales were 
     collected. The applicant shall also submit a statement signed 
     by the head of the applicant's firm or by its chief financial 
     officer that the applicant has submitted certifications for 
     all of its affiliates, or that the applicant has no 
     affiliates.''.
       (3) Reduced fees.--Section 738(d)(2)(C) (21 U.S.C. 
     379j(d)(2)(C)) is amended to read as follows:
       ``(C) Reduced fees.--Where the Secretary finds that the 
     applicant involved meets the definition under subparagraph 
     (A), the fees established under subsection (c)(1) may be paid 
     at a reduced rate of--
       ``(i) 25 percent of the fee established under such 
     subsection for a premarket application, a premarket report, a 
     supplement (other than a 30-day notice), or periodic 
     reporting concerning a class III device; and
       ``(ii) 50 percent of the fee established under such 
     subsection for a 30-day notice or a request for 
     classification information.''.
       (e) Small Businesses; Fee Reduction Regarding Premarket 
     Notification Submissions.--
       (1) In general.--Section 738(e)(1) (21 U.S.C. 379j(e)(1)) 
     is amended--
       (A) by striking ``2004'' and inserting ``2008''; and
       (B) by striking ``(a)(2)(A)(vii)'' and inserting 
     ``(a)(2)(A)(viii)''.
       (2) Rules relating to premarket notification submissions.--
       (A) Definition.--Section 738(e)(2)(A) (21 U.S.C. 
     379j(e)(2)(A)) is amended by striking ``, partners, and 
     parent firms''.
       (B) Evidence of qualification.--Section 738(e)(2)(B) (21 
     U.S.C. 379j(e)(2)(A)) is amended--
       (i) by striking ``(B) Evidence of qualification.--An 
     applicant'' and inserting the following:
       ``(B) Evidence of qualification.--
       ``(i) In general.--An applicant'';
       (ii) by striking ``The applicant shall support its claim'' 
     and inserting the following:
       ``(ii) Firms submitting tax returns to the united states 
     internal revenue service.--The applicant shall support its 
     claim'';
       (iii) by striking ``, partners, and parent firms'' each 
     place it appears;
       (iv) by striking the last sentence and inserting ``If no 
     tax forms are submitted for any affiliate, the applicant 
     shall certify that the applicant has no affiliates.''; and
       (v) by adding at the end the following:
       ``(iii) Firms not submitting tax returns to the united 
     states internal revenue service.--In the case of an applicant 
     that has not previously submitted a Federal income tax 
     return, the applicant and each of its affiliates shall 
     demonstrate that it meets the definition under subparagraph 
     (A) by submission of a signed certification, in such form as 
     the Secretary may direct through a notice published in the 
     Federal Register, that the applicant or affiliate meets the 
     criteria for a small business and a certification, in 
     English, from the national taxing authority of the country in 
     which the applicant or, if applicable, affiliate is 
     headquartered. The certification from such taxing authority 
     shall bear the official seal of such taxing authority and 
     shall provide the applicant's or affiliate's gross receipts 
     and sales for the most recent year in both the local currency 
     of such country and in United States dollars, the exchange 
     rate used in converting such local currency to dollars, and 
     the dates during which these receipts and sales were 
     collected. The applicant shall also submit a statement signed 
     by the head of the applicant's firm or by its chief financial 
     officer that the applicant has submitted certifications for 
     all of its affiliates, or that the applicant has no 
     affiliates.''.
       (3) Reduced fees.--Section 738(e)(2)(C) (21 U.S.C. 
     379j(e)(2)(C)) is amended to read as follows:
       ``(C) Reduced fees.--For fiscal year 2008 and each 
     subsequent fiscal year, where the Secretary finds that the 
     applicant involved meets the definition under subparagraph 
     (A), the fee for a premarket notification submission may be 
     paid at 50 percent of the fee that applies under subsection 
     (a)(2)(A)(viii), and as established under subsection 
     (c)(1).''.
       (f) Effect of Failure To Pay Fees.--Section 738(f) (21 
     U.S.C. 379j(f)) is amended to read as follows:
       ``(f) Effect of Failure To Pay Fees.--
       ``(1) No acceptance of submissions.--A premarket 
     application, premarket report, supplement, premarket 
     notification submission, 30-day notice, request for 
     classification information, or periodic reporting concerning 
     a class III device submitted by a person subject to fees 
     under subsection (a)(2) and (a)(3) shall be considered 
     incomplete and shall not be accepted by the Secretary until 
     all fees owed by such person have been paid.
       ``(2) No registration.--Registration information submitted 
     under section 510 by an establishment subject to registration 
     shall be considered incomplete and shall not be accepted by 
     the Secretary until the registration fee under subsection 
     (a)(3) owed for the establishment has been paid. Until the 
     fee is paid and the registration is complete, the 
     establishment is deemed to have failed to register in 
     accordance with section 510.''.
       (g) Conditions.--Section 738(g) (21 U.S.C. 379j(g)) is 
     amended--
       (1) in paragraph (1)(D)--
       (A) in the matter preceding clause (i), by striking ``For 
     fiscal year 2007'' and inserting ``For fiscal year 2007 and 
     for each subsequent year'';

[[Page H7575]]

       (B) in clause (i), by striking ``applicable to fiscal year 
     2007'' and inserting ``applicable to such fiscal year''; and
       (C) in clause (ii)--
       (i) by striking ``subparagraph (C)'' and inserting ``this 
     subparagraph''; and
       (ii) by striking ``for fiscal year 2006'' and inserting 
     ``for the previous fiscal year''; and
       (2) by amending paragraph (2) to read as follows:
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year 
     because of subparagraph (C) or (D) of paragraph (1) and if at 
     a later date in such fiscal year the Secretary may assess 
     such fees, the Secretary may assess and collect such fees, 
     without any modification in the rate for premarket 
     applications, supplements, premarket reports, premarket 
     notification submissions, 30-day notices, requests for 
     classification information, periodic reporting concerning a 
     class III device, and establishment registrations at any time 
     in such fiscal year, notwithstanding the provisions of 
     subsection (a) relating to the date fees are to be paid.''.
       (h) Crediting and Availability of Fees.--
       (1) Authorization of appropriations.--Section 738(h)(3) (21 
     U.S.C. 379j(h)(3)) is amended to read as follows:
       ``(3) Authorizations of appropriations.--There are 
     authorized to be appropriated for fees under this section--
       ``(A) $48,431,000 for fiscal year 2008;
       ``(B) $52,547,000 for fiscal year 2009;
       ``(C) $57,014,000 for fiscal year 2010;
       ``(D) $61,860,000 for fiscal year 2011; and
       ``(E) $67,118,000 for fiscal year 2012.''.
       (2) Offset.--Section 738(h)(4) (21 U.S.C. 379j(h)(3)) is 
     amended to read as follows:
       ``(4) Offset.--If the cumulative amount of fees collected 
     during fiscal years 2008, 2009, and 2010, added to the amount 
     estimated to be collected for fiscal year 2011, which 
     estimate shall be based upon the amount of fees received by 
     the Secretary through June 30, 2011, exceeds the amount of 
     fees specified in aggregate in paragraph (3) for these four 
     fiscal years, the aggregate amount in excess shall be 
     credited to the appropriation account of the Food and Drug 
     Administration as provided in paragraph (1), and shall be 
     subtracted from the amount of fees that would otherwise be 
     authorized to be collected under this section pursuant to 
     appropriation Acts for fiscal year 2012.''.

     SEC. 213. ANNUAL REPORTS.

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

     SEC. 214. CONSULTATION.

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

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

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

     SEC. 216. EFFECTIVE DATE.

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

     SEC. 217. SUNSET CLAUSE.

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

     Subtitle B--Amendments Regarding Regulation of Medical Devices

     SEC. 221. EXTENSION OF AUTHORITY FOR THIRD PARTY REVIEW OF 
                   PREMARKET NOTIFICATION.

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

     SEC. 222. REGISTRATION.

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

     SEC. 223. FILING OF LISTS OF DRUGS AND DEVICES MANUFACTURED, 
                   PREPARED, PROPAGATED, AND COMPOUNDED BY 
                   REGISTRANTS; STATEMENTS; ACCOMPANYING 
                   DISCLOSURES.

       Section 510(j)(2) (21 U.S.C. 360(j)(2)) is amended, in the 
     matter preceding subparagraph (A), by striking ``Each 
     person'' and all that follows through ``the following 
     information:'' and inserting ``Each person who registers with 
     the Secretary under this section shall report to the 
     Secretary, with regard to drugs once during the month of June 
     of each year and once during the month of December of each 
     year, and with regard to devices once each year during the 
     period beginning on October 1 and ending on December 31, the 
     following information:''.

     SEC. 224. ELECTRONIC REGISTRATION AND LISTING.

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

     SEC. 225. REPORT BY GOVERNMENT ACCOUNTABILITY OFFICE.

       (a) In General.--The Comptroller General of the United 
     States shall conduct a study on the appropriate use of the 
     process under section 510(k) of the Federal Food, Drug, and 
     Cosmetic Act as part of the device classification process to 
     determine whether a new device is as safe and effective as a 
     classified device.
       (b) Consideration.--In determining the effectiveness of the 
     premarket notification and classification authority under 
     section 510(k) and subsections (f) and (i) of section 513, 
     the study under subsection (a) shall consider the Secretary's 
     evaluation of the respective intended uses and technologies 
     of such devices, including the effectiveness of the 
     Secretary's comparative assessment of technological 
     characteristics such as device

[[Page H7576]]

     materials, principles of operations, and power sources.
       (c) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Comptroller General shall complete 
     the study under subsection (a) and submit to the Congress a 
     report on the results of such study.

     SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.

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

                 ``Unique Device Identification System

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

     SEC. 227. FREQUENCY OF REPORTING FOR CERTAIN DEVICES.

       Subparagraph (B) of section 519(a)(1) (21 U.S.C. 
     360i(a)(1)) is amended by striking ``were to recur;'' and 
     inserting the following: ``were to recur, which report under 
     this subparagraph--
       ``(i) shall be submitted in accordance with part 803 of 
     title 21, Code of Federal Regulations (or successor 
     regulations), if the device involved is--

       ``(I) a class III device;
       ``(II) a class II device that is permanently implantable, 
     is life supporting, or is life sustaining; or
       ``(III) a type of device that the Secretary has by 
     regulation determined should be subject to such part 803 in 
     order to protect the public health; or

       ``(ii) shall, if the device is not subject to clause (i), 
     be submitted in accordance with criteria established by the 
     Secretary for reports made pursuant to this clause, which 
     criteria shall require the reports to be in summary form and 
     made on a quarterly basis;''.

     SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.

       Section 704(g) (21 U.S.C. 374(g)) is amended--
       (1) in paragraph (1), by striking ``Not later than one year 
     after the date of the enactment of this subsection, the 
     Secretary'' and inserting ``The Secretary'';
       (2) in paragraph (2), by--
       (A) striking ``Not later than 180 days after the date of 
     enactment of this subsection, the Secretary'' and inserting 
     ``The Secretary''; and
       (B) striking the fifth sentence;
       (3) in paragraph (3), by adding at the end the following:
       ``(F) Such person shall notify the Secretary of any 
     withdrawal, suspension, restriction, or expiration of 
     certificate of conformance with the quality systems standard 
     referred to in paragraph (7) for any device establishment 
     that such person inspects under this subsection not later 
     than 30 days after such withdrawal, suspension, restriction, 
     or expiration.
       ``(G) Such person may conduct audits to establish 
     conformance with the quality systems standard referred to in 
     paragraph (7).'';
       (4) by amending paragraph (6) to read as follows:
       ``(6)(A) Subject to subparagraphs (B) and (C), a device 
     establishment is eligible for inspection by persons 
     accredited under paragraph (2) if the following conditions 
     are met:
       ``(i) The Secretary classified the results of the most 
     recent inspection of the establishment as `no action 
     indicated' or `voluntary action indicated'.
       ``(ii) With respect to inspections of the establishment to 
     be conducted by an accredited person, the owner or operator 
     of the establishment submits to the Secretary a notice that--
       ``(I) provides the date of the last inspection of the 
     establishment by the Secretary and the classification of that 
     inspection;
       ``(II) states the intention of the owner or operator to use 
     an accredited person to conduct inspections of the 
     establishment;
       ``(III) identifies the particular accredited person the 
     owner or operator intends to select to conduct such 
     inspections; and
       ``(IV) includes a certification that, with respect to the 
     devices that are manufactured, prepared, propagated, 
     compounded, or processed in the establishment--
       ``(aa) at least 1 of such devices is marketed in the United 
     States; and
       ``(bb) at least 1 of such devices is marketed, or is 
     intended to be marketed, in 1 or more foreign countries, 1 of 
     which countries certifies, accredits, or otherwise recognizes 
     the person accredited under paragraph (2) and identified 
     under subclause (III) as a person authorized to conduct 
     inspections of device establishments.
       ``(B)(i) Except with respect to the requirement of 
     subparagraph (A)(i), a device establishment is deemed to have 
     clearance to participate in the program and to use the 
     accredited person identified in the notice under subparagraph 
     (A)(ii) for inspections of the establishment unless the 
     Secretary, not later than 30 days after receiving such 
     notice, issues a response that--
       ``(I) denies clearance to participate as provided under 
     subparagraph (C); or
       ``(II) makes a request under clause (ii).
       ``(ii) The Secretary may request from the owner or operator 
     of a device establishment in response to the notice under 
     subparagraph (a)(ii) with respect to the establishment, or 
     from the particular accredited person identified in such 
     notice--
       ``(I) compliance data for the establishment in accordance 
     with clause (iii)(I); or
       ``(II) information concerning the relationship between the 
     owner or operator of the establishment and the accredited 
     person identified in such notice in accordance with clause 
     (iii)(II).

     The owner or operator of the establishment, or such 
     accredited person, as the case may be, shall respond to such 
     a request not later than 60 days after receiving such 
     request.
       ``(iii)(I) The compliance data to be submitted by the owner 
     or operation of a device establishment in response to a 
     request under clause (ii)(I) are data describing whether the 
     quality controls of the establishment have been sufficient 
     for ensuring consistent compliance with current good 
     manufacturing practice within the meaning of section 501(h) 
     and with other applicable provisions of this Act. Such data 
     shall include complete reports of inspectional findings 
     regarding good manufacturing practice or other quality 
     control audits that, during the preceding 2-year period, were 
     conducted at the establishment by persons other than the 
     owner or operator of the establishment, together with all 
     other compliance data the Secretary deems necessary. Data 
     under the preceding sentence shall demonstrate to the 
     Secretary whether the establishment has facilitated 
     consistent compliance by promptly correcting any compliance 
     problems identified in such inspections.
       ``(II) A request to an accredited person under clause 
     (ii)(II) may not seek any information that is not required to 
     be maintained by such person in records under subsection 
     (f)(1).
       ``(iv) A device establishment is deemed to have clearance 
     to participate in the program and to use the accredited 
     person identified in the notice under subparagraph (A)(ii) 
     for inspections of the establishment unless the Secretary, 
     not later than 60 days after receiving the information 
     requested under clause (ii), issues a response that denies 
     clearance to participate as provided under subparagraph (C).
       ``(C)(i) The Secretary may deny clearance to a device 
     establishment if the Secretary has evidence that the 
     certification under subparagraph (A)(ii)(IV) is untrue and 
     the Secretary provides to the owner or operator of the 
     establishment a statement summarizing such evidence.
       ``(ii) The Secretary may deny clearance to a device 
     establishment if the Secretary determines that the 
     establishment has failed to demonstrate consistent compliance 
     for purposes of subparagraph (B)(iii)(I) and the Secretary 
     provides to the owner or operator of the establishment a 
     statement of the reasons for such determination.
       ``(iii)(I) The Secretary may reject the selection of the 
     accredited person identified in the notice under subparagraph 
     (A)(ii) if the Secretary provides to the owner or operator of 
     the establishment a statement of the reasons for such 
     rejection. Reasons for the rejection may include that the 
     establishment or the accredited person, as the case may be, 
     has failed to fully respond to the request, or that the 
     Secretary has concerns regarding the relationship between the 
     establishment and such accredited person.
       ``(II) If the Secretary rejects the selection of an 
     accredited person by the owner or operator of a device 
     establishment, the owner or operator may make an additional 
     selection of an accredited person by submitting to the 
     Secretary a notice that identifies the additional selection. 
     Clauses (i) and (ii) of subparagraph (B), and subclause (I) 
     of this clause, apply to the selection of an accredited 
     person through a notice under the preceding sentence in the 
     same manner and to the same extent as such provisions apply 
     to a selection of an accredited person through a notice under 
     subparagraph (A)(ii).
       ``(iv) In the case of a device establishment that is denied 
     clearance under clause (i) or (ii) or with respect to which 
     the selection of the accredited person is rejected under 
     clause (iii), the Secretary shall designate a person to 
     review the statement of reasons, or statement summarizing 
     such evidence, as the case may be, of the Secretary under 
     such clause if, during the 30-day period beginning on the 
     date on which the owner or operator of the establishment 
     receives such statement, the owner or operator requests the 
     review. The review shall commence not later than 30 days 
     after the owner or operator requests the review, unless the 
     Secretary and the owner or operator otherwise agree.'';
       (5) in paragraph (7)--
       (A) in subparagraph (A), by striking ``(A) Persons'' and 
     all that follows through the end and inserting the following: 
     ``(A) Persons accredited under paragraph (2) to conduct 
     inspections shall record in writing their inspection 
     observations and shall present the observations to the device 
     establishment's designated representative and describe each 
     observation. Additionally, such accredited person shall 
     prepare an inspection report in a form and manner designated 
     by the Secretary to conduct inspections, taking into 
     consideration the goals of international harmonization of 
     quality systems standards. Any official classification of the 
     inspection shall be determined by the Secretary.''; and
       (B) by adding at the end the following:
       ``(F) For the purpose of setting risk-based inspectional 
     priorities, the Secretary shall accept voluntary submissions 
     of reports of audits assessing conformance with appropriate 
     quality systems standards set by the International 
     Organization for Standardization (ISO) and identified by the 
     Secretary in

[[Page H7577]]

     public notice. If the owner or operator of an establishment 
     elects to submit audit reports under this subparagraph, the 
     owner or operator shall submit all such audit reports with 
     respect to the establishment during the preceding 2-year 
     periods.''; and
       (6) in paragraph (10)(C)(iii), by striking ``based'' and 
     inserting ``base''.

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

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

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

     SEC. 301. SHORT TITLE.

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

     SEC. 302. TRACKING PEDIATRIC DEVICE APPROVALS.

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

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

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

     SEC. 303. MODIFICATION TO HUMANITARIAN DEVICE EXEMPTION.

       (a) In General.--Section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(m)) is amended--
       (1) in paragraph (3), by striking ``No'' and inserting 
     ``Except as provided in paragraph (6), no'';
       (2) in paragraph (5)--
       (A) by inserting ``, if the Secretary has reason to believe 
     that the requirements of paragraph (6) are no longer met,'' 
     after ``public health''; and
       (B) by adding at the end the following: ``If the person 
     granted an exemption under paragraph (2) fails to demonstrate 
     continued compliance with the requirements of this 
     subsection, the Secretary may suspend or withdraw the 
     exemption from the effectiveness requirements of sections 514 
     and 515 for a humanitarian device only after providing notice 
     and an opportunity for an informal hearing.''; and
       (3) by striking paragraph (6) and inserting after paragraph 
     (5) the following new paragraphs:
       ``(6)(A) Except as provided in subparagraph (D), the 
     prohibition in paragraph (3) shall not apply with respect to 
     a person granted an exemption under paragraph (2) if each of 
     the following conditions apply:
       ``(i)(I) The device with respect to which the exemption is 
     granted is intended for the treatment or diagnosis of a 
     disease or condition that occurs in pediatric patients or in 
     a pediatric subpopulation, and such device is labeled for use 
     in pediatric patients or in a pediatric subpopulation in 
     which the disease or condition occurs.
       ``(II) The device was not previously approved under this 
     subsection for the pediatric patients or the pediatric 
     subpopulation described in subclause (I) prior to the date of 
     enactment of the Pediatric Medical Device Safety and 
     Improvement Act of 2007.
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year does not exceed the annual 
     distribution number specified by the Secretary when the 
     Secretary grants such exemption. The annual distribution 
     number shall be based on the number of individuals affected 
     by the disease or condition that such device is intended to 
     treat, diagnose, or cure, and of that number, the number of 
     individuals likely to use the device, and the number of 
     devices reasonably necessary to treat such individuals. In no 
     case shall the annual distribution number exceed the number 
     identified in paragraph (2)(A).
       ``(iii) Such person immediately notifies the Secretary if 
     the number of such devices distributed during any calendar 
     year exceeds the annual distribution number referred to in 
     clause (ii).
       ``(iv) The request for such exemption is submitted on or 
     before October 1, 2013.
       ``(B) The Secretary may inspect the records relating to the 
     number of devices distributed during any calendar year of a 
     person granted an exemption under paragraph (2) for which the 
     prohibition in paragraph (3) does not apply.
       ``(C) A person may petition the Secretary to modify the 
     annual distribution number specified by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information on the number of individuals affected by the 
     disease or condition arises, and the Secretary may modify 
     such number but in no case shall the annual distribution 
     number exceed the number identified in paragraph (2)(A).
       ``(D) If a person notifies the Secretary, or the Secretary 
     determines through an inspection under subparagraph (B), that 
     the number of devices distributed during any calendar year 
     exceeds the annual distribution number, as required under 
     subparagraph (A)(iii), and modified under subparagraph (C), 
     if applicable, then the prohibition in paragraph (3) shall 
     apply with respect to such person for such device for any 
     sales of such device after such notification.
       ``(E)(i) In this subsection, the term `pediatric patients' 
     means patients who are 21 years of age or younger at the time 
     of the diagnosis or treatment.
       ``(ii) In this subsection, the term `pediatric 
     subpopulation' means 1 of the following populations:
       ``(I) Neonates.
       ``(II) Infants.
       ``(III) Children.
       ``(IV) Adolescents.
       ``(7) The Secretary shall refer any report of an adverse 
     event regarding a device for which the prohibition under 
     paragraph (3) does not apply pursuant to paragraph (6)(A) 
     that the Secretary receives to the Office of Pediatric 
     Therapeutics, established under section 6 of the Best 
     Pharmaceuticals for Children Act (Public Law 107-109). In 
     considering the report, the Director of the Office of 
     Pediatric Therapeutics, in consultation with experts in the 
     Center for Devices and Radiological Health, shall provide for 
     periodic review of the report by the Pediatric Advisory 
     Committee, including obtaining any recommendations of such 
     committee regarding whether the Secretary should take action 
     under this Act in response to the report.
       ``(8) In consultation with the Office of Pediatric 
     Therapeutics and the Center for Devices and Radiological 
     Health, the Secretary shall provide for an annual review by 
     the Pediatric Advisory Committee of all devices described in 
     paragraph (6) to ensure that the exemption under paragraph 
     (2) remains appropriate for the pediatric populations for 
     which it is granted.''.
       (b) Report.--Not later than January 1, 2012, the 
     Comptroller General of the United States shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report on the impact of allowing persons 
     granted an exemption under section 520(m)(2) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
     respect to a device to profit from such device pursuant to 
     section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as 
     amended by subsection (a)), including--

[[Page H7578]]

       (1) an assessment of whether such section 520(m)(6) (as 
     amended by subsection (a)) has increased the availability of 
     pediatric devices for conditions that occur in small numbers 
     of children, including any increase or decrease in the number 
     of--
       (A) exemptions granted under such section 520(m)(2) for 
     pediatric devices; and
       (B) applications approved under section 515 of such Act (21 
     U.S.C. 360e) for devices intended to treat, diagnose, or cure 
     conditions that occur in pediatric patients or for devices 
     labeled for use in a pediatric population;
       (2) the conditions or diseases the pediatric devices were 
     intended to treat or diagnose and the estimated size of the 
     pediatric patient population for each condition or disease;
       (3) the costs of the pediatric devices, based on a survey 
     of children's hospitals;
       (4) the extent to which the costs of such devices are 
     covered by health insurance;
       (5) the impact, if any, of allowing profit on access to 
     such devices for patients;
       (6) the profits made by manufacturers for each device that 
     receives an exemption;
       (7) an estimate of the extent of the use of the pediatric 
     devices by both adults and pediatric populations for a 
     condition or disease other than the condition or disease on 
     the label of such devices;
       (8) recommendations of the Comptroller General of the 
     United States regarding the effectiveness of such section 
     520(m)(6) (as amended by subsection (a)) and whether any 
     modifications to such section 520(m)(6) (as amended by 
     subsection (a)) should be made;
       (9) existing obstacles to pediatric device development; and
       (10) an evaluation of the demonstration grants described in 
     section 305.
       (c) Guidance.--Not later than 180 days after the date of 
     enactment of this Act, the Commissioner of Food and Drugs 
     shall issue guidance for institutional review committees on 
     how to evaluate requests for approval for devices for which a 
     humanitarian device exemption under section 520(m)(2) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) 
     has been granted.

     SEC. 304. ENCOURAGING PEDIATRIC MEDICAL DEVICE RESEARCH.

       (a) Access to Funding.--The Director of the National 
     Institutes of Health shall designate a contact point or 
     office at the National Institutes of Health to help 
     innovators and physicians access funding for pediatric 
     medical device development.
       (b) Plan for Pediatric Medical Device Research.--
       (1) In general.--Not later than 180 days after the date of 
     enactment of this Act, the Commissioner of Food and Drugs, in 
     collaboration with the Director of the National Institutes of 
     Health and the Director of the Agency for Healthcare Research 
     and Quality, shall submit to the Committee on Health, 
     Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives a plan for expanding pediatric medical device 
     research and development. In developing such plan, the 
     Commissioner of Food and Drugs shall consult with individuals 
     and organizations with appropriate expertise in pediatric 
     medical devices.
       (2) Contents.--The plan under paragraph (1) shall include--
       (A) the current status of federally funded pediatric 
     medical device research;
       (B) any gaps in such research, which may include a survey 
     of pediatric medical providers regarding unmet pediatric 
     medical device needs, as needed; and
       (C) a research agenda for improving pediatric medical 
     device development and Food and Drug Administration clearance 
     or approval of pediatric medical devices, and for evaluating 
     the short- and long-term safety and effectiveness of 
     pediatric medical devices.

     SEC. 305. DEMONSTRATION GRANTS FOR IMPROVING PEDIATRIC DEVICE 
                   AVAILABILITY.

       (a) In General.--
       (1) Request for proposals.--Not later than 90 days after 
     the date of enactment of this Act, the Secretary of Health 
     and Human Services shall issue a request for proposals for 1 
     or more grants or contracts to nonprofit consortia for 
     demonstration projects to promote pediatric device 
     development.
       (2) Determination on grants or contracts.--Not later than 
     180 days after the date the Secretary of Health and Human 
     Services issues a request for proposals under paragraph (1), 
     the Secretary shall make a determination on the grants or 
     contracts under this section.
       (b) Application.--A nonprofit consortium that desires to 
     receive a grant or contract under this section shall submit 
     an application to the Secretary of Health and Human Services 
     at such time, in such manner, and containing such information 
     as the Secretary may require.
       (c) Use of Funds.--A nonprofit consortium that receives a 
     grant or contract under this section shall--
       (1) encourage innovation by connecting qualified 
     individuals with pediatric device ideas with potential 
     manufacturers;
       (2) mentor and manage pediatric device projects through the 
     development process, including product identification, 
     prototype design, device development, and marketing;
       (3) connect innovators and physicians to existing Federal 
     resources, including resources from the Food and Drug 
     Administration, the National Institutes of Health, the Small 
     Business Administration, the Department of Energy, the 
     Department of Education, the National Science Foundation, the 
     Department of Veterans Affairs, the Agency for Healthcare 
     Research and Quality, and the National Institute of Standards 
     and Technology;
       (4) assess the scientific and medical merit of proposed 
     pediatric device projects;
       (5) assess business feasibility and provide business 
     advice;
       (6) provide assistance with prototype development; and
       (7) provide assistance with postmarket needs, including 
     training, logistics, and reporting.
       (d) Coordination.--
       (1) National institutes of health.--Each consortium that 
     receives a grant or contract under this section shall--
       (A) coordinate with the National Institutes of Health's 
     pediatric device contact point or office, designated under 
     section 304; and
       (B) provide to the National Institutes of Health any 
     identified pediatric device needs that the consortium lacks 
     sufficient capacity to address or those needs in which the 
     consortium has been unable to stimulate manufacturer 
     interest.
       (2) Food and drug administration.--Each consortium that 
     receives a grant or contract under this section shall 
     coordinate with the Commissioner of Food and Drugs and device 
     companies to facilitate the application for approval or 
     clearance of devices labeled for pediatric use.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this section $6,000,000 for 
     each of fiscal years 2008 through 2012.

     SEC. 306. AMENDMENTS TO OFFICE OF PEDIATRIC THERAPEUTICS AND 
                   PEDIATRIC ADVISORY COMMITTEE.

       (a) Office of Pediatric Therapeutics.--Section 6(b) of the 
     Best Pharmaceuticals for Children Act (21 U.S.C. 393a(b)) is 
     amended by inserting ``, including increasing pediatric 
     access to medical devices'' after ``pediatric issues''.
       (b) Pediatric Advisory Committee.--Section 14 of the Best 
     Pharmaceuticals for Children Act (42 U.S.C. 284m note) is 
     amended--
       (1) in subsection (a), by inserting ``(including drugs and 
     biological products) and medical devices'' after 
     ``therapeutics''; and
       (2) in subsection (b)--
       (A) in paragraph (1), by inserting ``(including drugs and 
     biological products) and medical devices'' after 
     ``therapeutics''; and
       (B) in paragraph (2)--
       (i) in subparagraph (A), by striking ``and 505B'' and 
     inserting ``505B, 510(k), 515, and 520(m)'';
       (ii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) identification of research priorities related to 
     therapeutics (including drugs and biological products) and 
     medical devices for pediatric populations and the need for 
     additional diagnostics and treatments for specific pediatric 
     diseases or conditions;''; and
       (iii) in subparagraph (C), by inserting ``(including drugs 
     and biological products) and medical devices'' after 
     ``therapeutics''.

     SEC. 307. POSTMARKET STUDIES.

       Section 522 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360l) is amended--
       (1) in subsection (a)--
       (A) by inserting ``, or as a condition to approval of an 
     application (or a supplement to an application) or a product 
     development protocol under section 515 or as a condition to 
     clearance of a premarket notification under section 510(k), 
     for a pediatric population or pediatric subpopulation,'' 
     after ``The Secretary may by order''; and
       (B) by inserting ``, or that is indicated for pediatric 
     populations or subpopulations or is expected to have 
     significant use in pediatric populations,'' after ``health 
     consequences''; and
       (2) in subsection (b)--
       (A) by striking ``(b) Surveillance Approval.--Each'' and 
     inserting the following:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each'';
       (B) by striking ``The Secretary, in consultation'' and 
     inserting ``Except as provided in paragraph (2), the 
     Secretary, in consultation'';
       (C) by striking ``Any determination'' and inserting 
     ``Except as provided in paragraph (2), any determination''; 
     and
       (D) by adding at the end the following:
       ``(2) Longer studies for pediatric devices.--The Secretary 
     may by order require a prospective surveillance period of 
     more than 36 months with respect to a device that is expected 
     to have significant use in pediatric populations if such 
     period of more than 36 months is necessary in order to assess 
     the impact of the device on growth and development, or the 
     effects of growth, development, activity level, or other 
     factors on the safety or efficacy of the device.
       ``(c) Dispute Resolution.--A manufacturer may request 
     review under section 562 of any order or condition requiring 
     postmarket surveillance under this section. During the 
     pendency of such review, the device subject to such a 
     postmarket surveillance order or condition shall not be 
     deemed misbranded under section 502(t) or otherwise in 
     violation of such order or condition or a related requirement 
     of this Act unless deemed necessary to protect the public 
     health.''.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

     SEC. 401. SHORT TITLE.

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

[[Page H7579]]

     SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

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

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

       ``(a) New Drugs and Biological Products.--
       ``(1) In general.--A person that submits, on or after the 
     date of enactment of the Pediatric Research Equity Act of 
     2007, an application (or supplement to an application)--
       ``(A) under section 505 for a new active ingredient, new 
     indication, new dosage form, new dosing regimen, or new route 
     of administration, or
       ``(B) under section 351 of the Public Health Service Act 
     (42 U.S.C. 262) for a new active ingredient, new indication, 
     new dosage form, new dosing regimen, or new route of 
     administration,

     shall submit with the application the assessments described 
     in paragraph (2).
       ``(2) Assessments.--
       ``(A) In general.--The assessments referred to in paragraph 
     (1) shall contain data, gathered using appropriate 
     formulations for each age group for which the assessment is 
     required, that are adequate--
       ``(i) to assess the safety and effectiveness of the drug or 
     the biological product for the claimed indications in all 
     relevant pediatric subpopulations; and
       ``(ii) to support dosing and administration for each 
     pediatric subpopulation for which the drug or the biological 
     product is safe and effective.
       ``(B) Similar course of disease or similar effect of drug 
     or biological product.--
       ``(i) In general.--If the course of the disease and the 
     effects of the drug are sufficiently similar in adults and 
     pediatric patients, the Secretary may conclude that pediatric 
     effectiveness can be extrapolated from adequate and well-
     controlled studies in adults, usually supplemented with other 
     information obtained in pediatric patients, such as 
     pharmacokinetic studies.
       ``(ii) Extrapolation between age groups.--A study may not 
     be needed in each pediatric age group if data from one age 
     group can be extrapolated to another age group.
       ``(iii) Information on extrapolation.--A brief 
     documentation of the scientific data supporting the 
     conclusion under clauses (i) and (ii) shall be included in 
     the medical review that is collected as part of the 
     application under section 505 of this Act or section 351 of 
     the Public Health Service Act (42 U.S.C. 262).
       ``(3) Deferral.--
       ``(A) In general.--On the initiative of the Secretary or at 
     the request of the applicant, the Secretary may defer 
     submission of some or all assessments required under 
     paragraph (1) until a specified date after approval of the 
     drug or issuance of the license for a biological product if--
       ``(i) the Secretary finds that--

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

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

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

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

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

       ``(ii) Public availability.--The information submitted 
     through the annual review under clause (i) shall promptly be 
     made available to the public in an easily accessible manner, 
     including through the website of the Food and Drug 
     Administration.
       ``(4) Waivers.--
       ``(A) Full waiver.--On the initiative of the Secretary or 
     at the request of an applicant, the Secretary shall grant a 
     full waiver, as appropriate, of the requirement to submit 
     assessments for a drug or biological product under this 
     subsection if the applicant certifies and the Secretary finds 
     that--
       ``(i) necessary studies are impossible or highly 
     impracticable (because, for example, the number of patients 
     is so small or the patients are geographically dispersed);
       ``(ii) there is evidence strongly suggesting that the drug 
     or biological product would be ineffective or unsafe in all 
     pediatric age groups; or
       ``(iii) The drug or biological product--

       ``(I) does not represent a meaningful therapeutic benefit 
     over existing therapies for pediatric patients; and
       ``(II) is not likely to be used in a substantial number of 
     pediatric patients.

       ``(B) Partial waiver.--On the initiative of the Secretary 
     or at the request of an applicant, the Secretary shall grant 
     a partial waiver, as appropriate, of the requirement to 
     submit assessments for a drug or biological product under 
     this subsection with respect to a specific pediatric age 
     group if the applicant certifies and the Secretary finds 
     that--
       ``(i) necessary studies are impossible or highly 
     impracticable (because, for example, the number of patients 
     in that age group is so small or patients in that age group 
     are geographically dispersed);
       ``(ii) there is evidence strongly suggesting that the drug 
     or biological product would be ineffective or unsafe in that 
     age group;
       ``(iii) the drug or biological product--

       ``(I) does not represent a meaningful therapeutic benefit 
     over existing therapies for pediatric patients in that age 
     group; and
       ``(II) is not likely to be used by a substantial number of 
     pediatric patients in that age group; or

       ``(iv) the applicant can demonstrate that reasonable 
     attempts to produce a pediatric formulation necessary for 
     that age group have failed.
       ``(C) Pediatric formulation not possible.--If a waiver is 
     granted on the ground that it is not possible to develop a 
     pediatric formulation, the waiver shall cover only the 
     pediatric groups requiring that formulation. An applicant 
     seeking either a full or partial waiver shall submit to the 
     Secretary documentation detailing why a pediatric formulation 
     cannot be developed and, if the waiver is granted, the 
     applicant's submission shall promptly be made available to 
     the public in an easily accessible manner, including through 
     posting on the website of the Food and Drug Administration.
       ``(D) Labeling requirement.--If the Secretary grants a full 
     or partial waiver because there is evidence that a drug or 
     biological product would be ineffective or unsafe in 
     pediatric populations, the information shall be included in 
     the labeling for the drug or biological product.
       ``(b) Marketed Drugs and Biological Products.--
       ``(1) In general.--Beginning on the date of enactment of 
     the Pediatric Research Equity Act of 2007, after providing 
     notice in the form of a letter and an opportunity for written 
     response and a meeting, which may include an advisory 
     committee meeting, the Secretary may (by order in the form of 
     a letter) require the sponsor or holder of an approved 
     application for a drug under section 505 or the holder of a 
     license for a biological product under section 351 of the 
     Public Health Service Act to submit by a specified date the 
     assessments described in subsection (a)(2), if the Secretary 
     finds that--
       ``(A)(i) the drug or biological product is used for a 
     substantial number of pediatric patients for the labeled 
     indications; and
       ``(ii) adequate pediatric labeling could confer a benefit 
     on pediatric patients;
       ``(B) there is reason to believe that the drug or 
     biological product would represent a meaningful therapeutic 
     benefit over existing therapies for pediatric patients for 1 
     or more of the claimed indications; or
       ``(C) the absence of adequate pediatric labeling could pose 
     a risk to pediatric patients.
       ``(2) Waivers.--
       ``(A) Full waiver.--At the request of an applicant, the 
     Secretary shall grant a full waiver, as appropriate, of the 
     requirement to submit assessments under this subsection if 
     the applicant certifies and the Secretary finds that--
       ``(i) necessary studies are impossible or highly 
     impracticable (because, for example, the number of patients 
     in that age group is so small or patients in that age group 
     are geographically dispersed); or
       ``(ii) there is evidence strongly suggesting that the drug 
     or biological product would be ineffective or unsafe in all 
     pediatric age groups.
       ``(B) Partial waiver.--At the request of an applicant, the 
     Secretary shall grant a partial waiver, as appropriate, of 
     the requirement to submit assessments under this subsection 
     with respect to a specific pediatric age group if the 
     applicant certifies and the Secretary finds that--
       ``(i) necessary studies are impossible or highly 
     impracticable (because, for example, the number of patients 
     in that age group is so small or patients in that age group 
     are geographically dispersed);
       ``(ii) there is evidence strongly suggesting that the drug 
     or biological product would be ineffective or unsafe in that 
     age group;
       ``(iii)(I) the drug or biological product--

       ``(aa) does not represent a meaningful therapeutic benefit 
     over existing therapies for pediatric patients in that age 
     group; and
       ``(bb) is not likely to be used in a substantial number of 
     pediatric patients in that age group; and

       ``(II) the absence of adequate labeling could not pose 
     significant risks to pediatric patients; or
       ``(iv) the applicant can demonstrate that reasonable 
     attempts to produce a pediatric formulation necessary for 
     that age group have failed.
       ``(C) Pediatric formulation not possible.--If a waiver is 
     granted on the ground that it is not possible to develop a 
     pediatric formulation, the waiver shall cover only the 
     pediatric groups requiring that formulation. An applicant 
     seeking either a full or partial waiver shall submit to the 
     Secretary documentation detailing why a pediatric formulation 
     cannot be developed and, if the waiver is granted, the 
     applicant's submission shall

[[Page H7580]]

     promptly be made available to the public in an easily 
     accessible manner, including through posting on the website 
     of the Food and Drug Administration.
       ``(D) Labeling requirement.--If the Secretary grants a full 
     or partial waiver because there is evidence that a drug or 
     biological product would be ineffective or unsafe in 
     pediatric populations, the information shall be included in 
     the labeling for the drug or biological product.
       ``(c) Meaningful Therapeutic Benefit.--For the purposes of 
     paragraph (4)(A)(iii)(I) and (4)(B)(iii)(I) of subsection (a) 
     and paragraphs (1)(B)(I) and (2)(B)(iii)(I)(aa) of subsection 
     (b), a drug or biological product shall be considered to 
     represent a meaningful therapeutic benefit over existing 
     therapies if the Secretary determines that--
       ``(1) if approved, the drug or biological product could 
     represent an improvement in the treatment, diagnosis, or 
     prevention of a disease, compared with marketed products 
     adequately labeled for that use in the relevant pediatric 
     population; or
       ``(2) the drug or biological product is in a class of 
     products or for an indication for which there is a need for 
     additional options.
       ``(d) Submission of Assessments.--If a person fails to 
     submit an assessment described in subsection (a)(2), or a 
     request for approval of a pediatric formulation described in 
     subsection (a) or (b), in accordance with applicable 
     provisions of subsections (a) and (b)--
       ``(1) the drug or biological product that is the subject of 
     the assessment or request may be considered misbranded solely 
     because of that failure and subject to relevant enforcement 
     action (except that the drug or biological product shall not 
     be subject to action under section 303); but
       ``(2) the failure to submit the assessment or request shall 
     not be the basis for a proceeding--
       ``(A) to withdraw approval for a drug under section 505(e); 
     or
       ``(B) to revoke the license for a biological product under 
     section 351 of the Public Health Service Act.
       ``(e) Meetings.--Before and during the investigational 
     process for a new drug or biological product, the Secretary 
     shall meet at appropriate times with the sponsor of the new 
     drug or biological product to discuss--
       ``(1) information that the sponsor submits on plans and 
     timelines for pediatric studies; or
       ``(2) any planned request by the sponsor for waiver or 
     deferral of pediatric studies.
       ``(f) Review of Pediatric Plans, Deferrals, and Waivers.--
       ``(1) Review.--Beginning not later than 30 days after the 
     date of enactment of the Pediatric Research Equity Act of 
     2007, the Secretary shall utilize an internal committee to 
     provide consultation to reviewing divisions on all pediatric 
     plans and assessments prior to approval of an application or 
     supplement for which a pediatric assessment is required under 
     this section and all deferral and waiver requests granted 
     pursuant to this section. Such internal committee shall 
     include employees of the Food and Drug Administration, with 
     expertise in pediatrics (including representation from the 
     Office of Pediatric Therapeutics), biopharmacology, 
     statistics, chemistry, legal issues, pediatric ethics, and 
     the appropriate expertise pertaining to the pediatric product 
     under review, and other individuals designated by the 
     Secretary.
       ``(2) Activity by committee.--The committee referred to in 
     paragraph (1) may operate using appropriate members of such 
     committee and need not convene all members of the committee.
       ``(3) Documentation of committee action.--For each drug or 
     biological product, the committee referred to in paragraph 
     (1) shall document, for each activity described in paragraph 
     (4), which members of the committee participated in such 
     activity.
       ``(4) Review of pediatric plans, deferrals and waivers.--
     Consultation on pediatric plans and assessments by the 
     internal committee pursuant to this section shall occur prior 
     to approval of an application or supplement for which a 
     pediatric assessment is required under this section. The 
     internal committee shall review all requests for deferrals 
     and waivers from the requirement to submit a pediatric 
     assessment granted under this section and shall provide 
     recommendations as needed to reviewing divisions.
       ``(5) Retrospective review of pediatric plans, deferrals 
     and waivers.--Within one year after enactment of the 
     Pediatric Research Equity Act of 2007, the committee shall 
     conduct a retrospective review and analysis of a 
     representative sample of assessments submitted and deferrals 
     and waivers approved under this section since enactment of 
     the Pediatric Research Equity Act of 2003. Such review shall 
     include an analysis of the quality and consistency of 
     pediatric information in pediatric assessments and the 
     appropriateness of waivers and deferrals granted. Based on 
     such review, the Secretary shall issue recommendations to the 
     review divisions for improvements and initiate guidance to 
     industry related to the scope of pediatric studies required 
     under this section.
       ``(6) Tracking of assessments and labeling changes.--
     Beginning on the date of enactment of the Pediatric Research 
     Equity Act of 2007, the Secretary shall track and make 
     available to the public in an easily accessible manner, 
     including through posting on the website of the Food and Drug 
     Administration--
       ``(A) the number of assessments conducted under this 
     section;
       ``(B) the specific drugs and biological products and their 
     uses assessed under this section;
       ``(C) the types of assessments conducted under this 
     section, including trial design, the number of pediatric 
     patients studied, and the number of centers and countries 
     involved;
       ``(D) the total number of deferrals requested and granted 
     under this section and, if granted, the reasons for such 
     deferrals, the timeline for completion, and the number 
     completed and pending by the specified date, as outlined in 
     subsection (a)(3);
       ``(E) the number of waivers requested and granted under 
     this section and, if granted, the reasons for the waivers;
       ``(F) the number of pediatric formulations developed and 
     the number of pediatric formulations not developed and the 
     reasons any such formulation was not developed;
       ``(G) the labeling changes made as a result of assessments 
     conducted under this section;
       ``(H) an annual summary of labeling changes made as a 
     result of assessments conducted under this section for 
     distribution pursuant to subsection (h)(2); and
       ``(I) an annual summary of information submitted pursuant 
     to subsection (a)(3)(B).
       ``(7) Committee.--The committee utilized under paragraph 
     (1) shall be the committee established under section 
     505A(f)(1).
       ``(g) Labeling Changes.--
       ``(1) Priority status for pediatric applications.--Any 
     supplement to an application under section 505 and section 
     351 of the Public Health Service Act proposing a labeling 
     change as a result of any pediatric assessments conducted 
     pursuant to this section--
       ``(A) shall be considered a priority application or 
     supplement; and
       ``(B) shall be subject to the performance goals established 
     by the Commissioner for priority drugs.
       ``(2) Dispute resolution.--
       ``(A) Request for labeling change and failure to agree.--
     If, on or after the date of enactment of the Pediatric 
     Research Equity Act of 2007, the Commissioner determines that 
     a sponsor and the Commissioner have been unable to reach 
     agreement on appropriate changes to the labeling for the drug 
     that is the subject of the application or supplement, not 
     later than 180 days after the date of the submission of the 
     application or supplement--
       ``(i) the Commissioner shall request that the sponsor of 
     the application make any labeling change that the 
     Commissioner determines to be appropriate; and
       ``(ii) if the sponsor does not agree within 30 days after 
     the Commissioner's request to make a labeling change 
     requested by the Commissioner, the Commissioner shall refer 
     the matter to the Pediatric Advisory Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A)(ii), the Pediatric Advisory Committee 
     shall--
       ``(i) review the pediatric study reports; and
       ``(ii) make a recommendation to the Commissioner concerning 
     appropriate labeling changes, if any.
       ``(C) Consideration of recommendations.--The Commissioner 
     shall consider the recommendations of the Pediatric Advisory 
     Committee and, if appropriate, not later than 30 days after 
     receiving the recommendation, make a request to the sponsor 
     of the application to make any labeling changes that the 
     Commissioner determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application, 
     within 30 days after receiving a request under subparagraph 
     (C), does not agree to make a labeling change requested by 
     the Commissioner, the Commissioner may deem the drug that is 
     the subject of the application to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Committee process or an enforcement action 
     referred to in the preceding sentence) shall preclude, delay, 
     or serve as the basis to stay the other course of action.
       ``(3) Other labeling changes.--If, on or after the date of 
     enactment of the Pediatric Research Equity Act of 2007, the 
     Secretary makes a determination that a pediatric assessment 
     conducted under this section does or does not demonstrate 
     that the drug that is the subject of such assessment is safe 
     and effective in pediatric populations or subpopulations, 
     including whether such assessment results are inconclusive, 
     the Secretary shall order the label of such product to 
     include information about the results of the assessment and a 
     statement of the Secretary's determination.
       ``(h) Dissemination of Pediatric Information.--
       ``(1) In general.--Not later than 180 days after the date 
     of submission of a pediatric assessment under this section, 
     the Secretary shall make available to the public in an easily 
     accessible manner the medical, statistical, and clinical 
     pharmacology reviews of such pediatric assessments, and shall 
     post such assessments on the website of the Food and Drug 
     Administration.
       ``(2) Dissemination of information regarding labeling 
     changes.--Beginning on the date of enactment of the Pediatric 
     Research Equity Act of 2007, the Secretary shall require that 
     the sponsors of the assessments that result in labeling 
     changes that

[[Page H7581]]

     are reflected in the annual summary developed pursuant to 
     subsection (f)(6)(H) distribute such information to 
     physicians and other health care providers.
       ``(3) Effect of subsection.--Nothing in this subsection 
     shall alter or amend Section 301(j) of this Act or section 
     552 of title 5 or section 1905 of title 18, United States 
     Code.
       ``(i) Adverse Event Reporting.--
       ``(1) Reporting in year one.--Beginning on the date of 
     enactment of the Pediatric Research Equity Act of 2007, 
     during the one-year period beginning on the date a labeling 
     change is made pursuant to subsection (g), the Secretary 
     shall ensure that all adverse event reports that have been 
     received for such drug (regardless of when such report was 
     received) are referred to the Office of Pediatric 
     Therapeutics. In considering the report, the Director of such 
     Office shall provide for the review of the report by the 
     Pediatric Advisory Committee, including obtaining any 
     recommendations of such committee regarding whether the 
     Secretary should take action under this Act in response to 
     such report.
       ``(2) Reporting in subsequent years.--Following the one-
     year period described in paragraph (1), the Secretary shall, 
     as appropriate, refer to the Office of Pediatric Therapeutics 
     all pediatric adverse event reports for a drug for which a 
     pediatric study was conducted under this section. In 
     considering the report, the Director of such Office may 
     provide for the review of the report by the Pediatric 
     Advisory Committee, including obtaining any recommendation of 
     such Committee regarding whether the Secretary should take 
     action in response to such report.
       ``(3) Effect.--The requirements of this subsection shall 
     supplement, not supplant, other review of such adverse event 
     reports by the Secretary.
       ``(j) Scope of Authority.--Nothing in this section provides 
     to the Secretary any authority to require a pediatric 
     assessment of any drug or biological product, or any 
     assessment regarding other populations or uses of a drug or 
     biological product, other than the pediatric assessments 
     described in this section.
       ``(k) Orphan Drugs.--Unless the Secretary requires 
     otherwise by regulation, this section does not apply to any 
     drug for an indication for which orphan designation has been 
     granted under section 526.
       ``(l) Institute of Medicine Study.--
       ``(1) In general.--Not later than three years after the 
     date of the enactment of the Pediatric Research Equity Act of 
     2007, the Secretary shall contract with the Institute of 
     Medicine to conduct a study and report to Congress regarding 
     the pediatric studies conducted pursuant to this section 
     since 1997 and labeling changes made as a result of such 
     studies.
       ``(2) Content of study.--The study under paragraph (1) 
     shall review and assess the use of extrapolation for 
     pediatric subpopulations, the use of alternative endpoints 
     for pediatric populations, neonatal assessment tools, the 
     number and type of pediatric adverse events, and ethical 
     issues in pediatric clinical trials.
       ``(3) Representative sample.--The Institute of Medicine may 
     devise an appropriate mechanism to review a representative 
     sample of studies conducted pursuant to this section from 
     each review division within the Center for Drug Evaluation 
     and Research in order to make the requested assessment.''.
       (b) Applicability.--The amendment made in subsection (a) 
     applies to assessments required under section 505B on or 
     after the date of enactment of this Act.

     SEC. 403. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

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

         TITLE V--BEST PHARMACEUTICALS FOR CHILDREN ACT OF 2007

     SEC. 501. SHORT TITLE.

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

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

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

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

       ``(a) Definitions.--As used in this section, the term 
     `pediatric studies' or `studies' means at least one clinical 
     investigation (that, at the Secretary's discretion, may 
     include pharmacokinetic studies) in pediatric age groups 
     (including neonates in appropriate cases) in which a drug is 
     anticipated to be used, and at the discretion of the 
     Secretary, may include preclinical studies.
       ``(b) Market Exclusivity for New Drugs.--
       ``(1) In general.--Except as provided in paragraph (2), if, 
     prior to approval of an application that is submitted under 
     section 505(b)(1), the Secretary determines that information 
     relating to the use of a new drug in the pediatric population 
     may produce health benefits in that population, the Secretary 
     makes a written request for pediatric studies (which shall 
     include a timeframe for completing such studies), the 
     applicant agrees to the request, such studies are completed 
     using appropriate formulations for each age group for which 
     the study is requested within any such timeframe, and the 
     reports thereof are submitted and accepted in accordance with 
     subsection (d)(3), and if the Secretary has determined that 
     labeling changes are appropriate, such changes are approved 
     within the timeframe requested by the Secretary--
       ``(A)(i)(I) the period referred to in subsection 
     (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) 
     of such section, is deemed to be five years and six months 
     rather than five years, and the references in subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four 
     years, to forty-eight months, and to seven and one-half years 
     are deemed to be four and one-half years, fifty-four months, 
     and eight years, respectively; or
       ``(II) the period referred to in clauses (iii) and (iv) of 
     subsection (c)(3)(E) of such section, and in clauses (iii) 
     and (iv) of subsection (j)(5)(F) of such section, is deemed 
     to be three years and six months rather than three years; and
       ``(ii) if the drug is designated under section 526 for a 
     rare disease or condition, the period referred to in section 
     527(a) is deemed to be seven years and six months rather than 
     seven years; and
       ``(B)(i) if the drug is the subject of--
       ``(I) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(II) a listed patent for which a certification has been 
     submitted under subsections (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under section 505(c)(3) or section 505(j)(5)(B) shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(ii) if the drug is the subject of a listed patent for 
     which a certification has been submitted under subsection 
     (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in 
     the patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(5)(B) shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions).
       ``(2) Exception.--The Secretary shall not extend the period 
     referred to in paragraph (1)(A) or (1)(B) if the 
     determination is made later than one year prior to the 
     expiration of such period.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--
       ``(1) In general.--Except as provided in paragraph (2), if 
     the Secretary determines that information relating to the use 
     of an approved drug in the pediatric population may produce 
     health benefits in that population and makes a written 
     request to the holder of an approved application under 
     section 505(b)(1) for pediatric studies (which shall include 
     a timeframe for completing such studies), the holder agrees 
     to the request, such studies are completed using appropriate 
     formulations for each age group for which the study is 
     requested within any such

[[Page H7582]]

     timeframe and the reports thereof are submitted and accepted 
     in accordance with subsection (d)(3), and if the Secretary 
     determines that labeling changes are appropriate and such 
     changes are approved within the timeframe requested by the 
     Secretary--
       ``(A)(i)(I) the period referred to in subsection 
     (c)(3)(E)(ii) of section 505, and in subsection (j)(5)(F)(ii) 
     of such section, is deemed to be five years and six months 
     rather than five years, and the references in subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii) of such section to four 
     years, to forty-eight months, and to seven and one-half years 
     are deemed to be four and one-half years, fifty-four months, 
     and eight years, respectively; or
       ``(II) the period referred to in clauses (iii) and (iv) of 
     subsection (c)(3)(D) of such section, and in clauses (iii) 
     and (iv) of subsection (j)(5)(F) of such section, is deemed 
     to be three years and six months rather than three years; and
       ``(ii) if the drug is designated under section 526 for a 
     rare disease or condition, the period referred to in section 
     527(a) is deemed to be seven years and six months rather than 
     seven years; and
       ``(B)(i) if the drug is the subject of--
       ``(I) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(ii) or 
     (j)(2)(A)(vii)(II) of section 505 and for which pediatric 
     studies were submitted prior to the expiration of the patent 
     (including any patent extensions); or
       ``(II) a listed patent for which a certification has been 
     submitted under subsection (b)(2)(A)(iii) or 
     (j)(2)(A)(vii)(III) of section 505,

     the period during which an application may not be approved 
     under section 505(c)(3) or section 505(j)(5)(B)(ii) shall be 
     extended by a period of six months after the date the patent 
     expires (including any patent extensions); or
       ``(ii) if the drug is the subject of a listed patent for 
     which a certification has been submitted under subsection 
     (b)(2)(A)(iv) or (j)(2)(A)(vii)(IV) of section 505, and in 
     the patent infringement litigation resulting from the 
     certification the court determines that the patent is valid 
     and would be infringed, the period during which an 
     application may not be approved under section 505(c)(3) or 
     section 505(j)(5)(B) shall be extended by a period of six 
     months after the date the patent expires (including any 
     patent extensions)
       ``(2) Exception.--The Secretary shall not extend the period 
     referred to in paragraph (1)(A) or (1)(B) if the 
     determination is made later than one year prior to the 
     expiration of such period.
       ``(d) Conduct of Pediatric Studies.--
       ``(1) Request for studies.--
       ``(A) In general.--The Secretary may, after consultation 
     with the sponsor of an application for an investigational new 
     drug under section 505(i), the sponsor of an application for 
     a new drug under section 505(b)(1), or the holder of an 
     approved application for a drug under section 505(b)(1) issue 
     to the sponsor or holder a written request for the conduct of 
     pediatric studies for such drug. In issuing such request, the 
     Secretary shall take into account adequate representation of 
     children of ethnic and racial minorities. Such request to 
     conduct pediatric studies shall be in writing and shall 
     include a timeframe for such studies and a request to the 
     sponsor or holder to propose pediatric labeling resulting 
     from such studies.
       ``(B) Single written request.--A single written request--
       ``(i) may relate to more than one use of a drug; and
       ``(ii) may include uses that are both approved and 
     unapproved.
       ``(2) Written request for pediatric studies.--
       ``(A) Request and response.--
       ``(i) In general.--If the Secretary makes a written request 
     for pediatric studies (including neonates, as appropriate) 
     under subsection (b) or (c), the applicant or holder, not 
     later than 180 days after receiving the written request, 
     shall respond to the Secretary as to the intention of the 
     applicant or holder to act on the request by--

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

       ``(ii) Disagree with request.--If, on or after the date of 
     the enactment of the Best Pharmaceuticals for Children Act of 
     2007, the applicant or holder does not agree to the request 
     on the grounds that it is not possible to develop the 
     appropriate pediatric formulation, the applicant or holder 
     shall submit to the Secretary the reasons such pediatric 
     formulation cannot be developed.
       ``(B) Adverse event reports.--An applicant or holder that, 
     on or after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, agrees to the 
     request for such studies shall provide the Secretary, at the 
     same time as the submission of the reports of such studies, 
     with all postmarket adverse event reports regarding the drug 
     that is the subject of such studies and are available prior 
     to submission of such reports.
       ``(3) Meeting the studies requirement.--Not later than 180 
     days after the submission of the reports of the studies, the 
     Secretary shall accept or reject such reports and so notify 
     the sponsor or holder. The Secretary's only responsibility in 
     accepting or rejecting the reports shall be to determine, 
     within the 180-day period, whether the studies fairly respond 
     to the written request, have been conducted in accordance 
     with commonly accepted scientific principles and protocols, 
     and have been reported in accordance with the requirements of 
     the Secretary for filing.
       ``(4) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.
       ``(e) Notice of Determinations on Studies Requirement.--
       ``(1) In general.--The Secretary shall publish a notice of 
     any determination, made on or after the date of the enactment 
     of the Best Pharmaceuticals for Children Act of 2007, that 
     the requirements of subsection (d) have been met and that 
     submissions and approvals under subsection (b)(2) or (j) of 
     section 505 for a drug will be subject to the provisions of 
     this section. Such notice shall be published not later than 
     30 days after the date of the Secretary's determination 
     regarding market exclusivity and shall include a copy of the 
     written request made under subsection (b) or (c).
       ``(2) Identification of certain drugs.--The Secretary shall 
     publish a notice identifying any drug for which, on or after 
     the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007, a pediatric formulation was developed, 
     studied, and found to be safe and effective in the pediatric 
     population (or specified subpopulation) if the pediatric 
     formulation for such drug is not introduced onto the market 
     within one year after the date that the Secretary publishes 
     the notice described in paragraph (1). Such notice 
     identifying such drug shall be published not later than 30 
     days after the date of the expiration of such one year 
     period.
       ``(f) Internal Review of Written Requests and Pediatric 
     Studies.--
       ``(1) Internal review.--
       ``(A) In general.--The Secretary shall establish an 
     internal review committee to review all written requests 
     issued on or after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, in accordance with 
     paragraph (2).
       ``(B) Members.--The committee established under 
     subparagraph (A) shall include individuals with expertise in 
     pediatrics, biopharmacology, statistics, drugs and drug 
     formulations, legal issues, pediatric ethics, the appropriate 
     expertise, such as expertise in child and adolescent 
     psychiatry, pertaining to the pediatric product under review, 
     one or more experts from the Office of Pediatric 
     Therapeutics, and other individuals designated by the 
     Secretary.
       ``(2) Review of written requests.--The committee 
     established under paragraph (1) shall review all written 
     requests issued pursuant to this section prior to being 
     issued.
       ``(3) Tracking pediatric studies and labeling changes.--The 
     Secretary shall track and make available to the public, in an 
     easily accessible manner, including through posting on the 
     website of the Food and Drug Administration--
       ``(A) the number of studies conducted under this section 
     and under section 409I of the Public Health Service Act;
       ``(B) the specific drugs and biological products and their 
     uses, including labeled and off-labeled indications, studied 
     under such sections;
       ``(C) the types of studies conducted under such sections, 
     including trial design, the number of pediatric patients 
     studied, and the number of centers and countries involved;
       ``(D) the number of pediatric formulations developed and 
     the number of pediatric formulations not developed and the 
     reasons such formulations were not developed;
       ``(E) the labeling changes made as a result of studies 
     conducted under such sections;
       ``(F) an annual summary of labeling changes made as a 
     result of studies conducted under such sections for 
     distribution pursuant to subsection (k)(2); and
       ``(G) information regarding reports submitted on or after 
     the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007.
       ``(4) Committee.--The committee established under paragraph 
     (1) shall be the committee utilized under section 505B(f)(1).
       ``(g) Limitations.--Notwithstanding subsection (c)(2), a 
     drug to which the six-month period under subsection (b) or 
     (c) has already been applied--
       ``(1) may receive an additional six-month period under 
     subsection (c)(1)(A)(i)(II) for a supplemental application if 
     all other requirements under this section are satisfied; and
       ``(2) may not receive any additional such period under 
     subsection (c)(1)(A)(ii).
       ``(h) Relationship to Pediatric Research Requirements.--
     Notwithstanding any other provision of law, if any pediatric 
     study is required by a provision of law (including a 
     regulation) other than this section and such study meets the 
     completeness, timeliness, and other requirements of this 
     section, such study shall be deemed to satisfy the 
     requirement for market exclusivity pursuant to this section.
       ``(i) Labeling Changes.--
       ``(1) Priority status for pediatric applications and 
     supplements.--Any application or supplement to an application 
     under section 505 proposing a labeling change as a result of 
     any pediatric study conducted pursuant to this section--
       ``(A) shall be considered to be a priority application or 
     supplement; and
       ``(B) shall be subject to the performance goals established 
     by the Commissioner for priority drugs.
       ``(2) Dispute resolution.--

[[Page H7583]]

       ``(A) Request for labeling change and failure to agree.--
     If, on or after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, the Commissioner 
     determines that the sponsor and the Commissioner have been 
     unable to reach agreement on appropriate changes to the 
     labeling for the drug that is the subject of the application, 
     not later than 180 days after the date of submission of the 
     application--
       ``(i) the Commissioner shall request that the sponsor of 
     the application make any labeling change that the 
     Commissioner determines to be appropriate; and
       ``(ii) if the sponsor of the application does not agree 
     within 30 days after the Commissioner's request to make a 
     labeling change requested by the Commissioner, the 
     Commissioner shall refer the matter to the Pediatric Advisory 
     Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A)(ii), the Pediatric Advisory Committee 
     shall--
       ``(i) review the pediatric study reports; and
       ``(ii) make a recommendation to the Commissioner concerning 
     appropriate labeling changes, if any.
       ``(C) Consideration of recommendations.--The Commissioner 
     shall consider the recommendations of the Pediatric Advisory 
     Committee and, if appropriate, not later than 30 days after 
     receiving the recommendation, make a request to the sponsor 
     of the application to make any labeling change that the 
     Commissioner determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application, 
     within 30 days after receiving a request under subparagraph 
     (C), does not agree to make a labeling change requested by 
     the Commissioner, the Commissioner may deem the drug that is 
     the subject of the application to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Committee process or an enforcement action 
     referred to in the preceding sentence) shall preclude, delay, 
     or serve as the basis to stay the other course of action.
       ``(j) Other Labeling Changes.--If, on or after the date of 
     the enactment of the Best Pharmaceuticals for Children Act of 
     2007, the Secretary determines that a pediatric study 
     conducted under this section does or does not demonstrate 
     that the drug that is the subject of the study is safe and 
     effective in pediatric populations or subpopulations, 
     including whether such study results are inconclusive, the 
     Secretary shall order the labeling of such product to include 
     information about the results of the study and a statement of 
     the Secretary's determination.
       ``(k) Dissemination of Pediatric Information.--
       ``(1) In general.--Not later than 180 days after the date 
     of submission of a report on a pediatric study under this 
     section, the Secretary shall make available to the public the 
     medical, statistical, and clinical pharmacology reviews of 
     pediatric studies conducted under subsection (b) or (c).
       ``(2) Dissemination of information regarding labeling 
     changes.--Beginning on the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, the Secretary shall 
     include as a requirement of a written request that the 
     sponsors of the studies that result in labeling changes that 
     are reflected in the annual summary developed pursuant to 
     subsection (f)(3)(F) distribute, at least annually (or more 
     frequently if the Secretary determines that it would be 
     beneficial to the public health), such information to 
     physicians and other health care providers.
       ``(3) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.
       ``(l) Adverse Event Reporting.--
       ``(1) Reporting in year one.--Beginning on the date of the 
     enactment of the Best Pharmaceuticals for Children Act of 
     2007, during the one-year period beginning on the date a 
     labeling change is approved pursuant to subsection (i), the 
     Secretary shall ensure that all adverse event reports that 
     have been received for such drug (regardless of when such 
     report was received) are referred to the Office of Pediatric 
     Therapeutics established under section 6 of the Best 
     Pharmaceuticals for Children Act (Public Law 107-109). In 
     considering the reports, the Director of such Office shall 
     provide for the review of the reports by the Pediatric 
     Advisory Committee, including obtaining any recommendations 
     of such Committee regarding whether the Secretary should take 
     action under this Act in response to such reports.
       ``(2) Reporting in subsequent years.--Following the one-
     year period described in paragraph (1), the Secretary shall, 
     as appropriate, refer to the Office of Pediatric Therapeutics 
     all pediatric adverse event reports for a drug for which a 
     pediatric study was conducted under this section. In 
     considering such reports, the Director of such Office may 
     provide for the review of such reports by the Pediatric 
     Advisory Committee, including obtaining any recommendation of 
     such Committee regarding whether the Secretary should take 
     action in response to such reports.
       ``(3) Effect.--The requirements of this subsection shall 
     supplement, not supplant, other review of such adverse event 
     reports by the Secretary.
       ``(m) Clarification of Interaction of Market Exclusivity 
     Under This Section and Market Exclusivity Awarded to An 
     Applicant for Approval of A Drug Under Section 505(j).--If a 
     180-day period under section 505(j)(5)(B)(iv) overlaps with a 
     6-month exclusivity period under this section, so that the 
     applicant for approval of a drug under section 505(j) 
     entitled to the 180-day period under that section loses a 
     portion of the 180-day period to which the applicant is 
     entitled for the drug, the 180-day period shall be extended 
     from--
       ``(1) the date on which the 180-day period would have 
     expired by the number of days of the overlap, if the 180-day 
     period would, but for the application of this subsection, 
     expire after the 6-month exclusivity period; or
       ``(2) the date on which the 6-month exclusivity period 
     expires, by the number of days of the overlap if the 180-day 
     period would, but for the application of this subsection, 
     expire during the six-month exclusivity period.
       ``(n) Referral if Pediatric Studies Not Completed.--
       ``(1) In general.--Beginning on the date of the enactment 
     of the Best Pharmaceuticals for Children Act of 2007, if 
     pediatric studies have not been completed under subsection 
     (d) and if the Secretary, through the committee established 
     under subsection (f), determines that there is a continuing 
     need for information relating to the use of the drug in the 
     pediatric population (including neonates, as appropriate), 
     the Secretary shall--
       ``(A) for a drug for which listed patents have not expired, 
     make a determination regarding whether an assessment shall be 
     required to be submitted under section 505B; or
       ``(B) for a drug that has no listed patents or has 1 or 
     more listed patents that have expired, determine whether 
     there are funds available under section 736 to award a grant 
     to conduct the requested studies pursuant to paragraph (2).
       ``(2) Funding of studies.--If, pursuant to paragraph (1), 
     the Secretary determines that there are funds available under 
     section 736 to award a grant to conduct the requested 
     pediatric studies, then the Secretary shall issue a proposal 
     to award a grant to conduct the requested studies. If the 
     Secretary determines that funds are not available under 
     section 736, the Secretary shall refer the drug for inclusion 
     on the list established under section 409I of the Public 
     Health Service Act or the conduct of studies.
       ``(3) Public notice.--The Secretary shall give the public 
     notice of--
       ``(A) a decision under paragraph (1)(A) not to require an 
     assessment under section 505B and the basis for such 
     decision;
       ``(B) the name of any drug, its manufacturer, and the 
     indications to be studied pursuant to a grant made under 
     paragraph (2); and
       ``(C) any decision under paragraph (2) to include a drug on 
     the list established under section 409I of the Public Health 
     Service Act.
       ``(4) Effect of subsection.--Nothing in this subsection 
     alters or amends section 301(j) of this Act or section 552 of 
     title 5 or section 1905 of title 18, United States Code.
       ``(o) Prompt Approval of Drugs Under Section 505(j) When 
     Pediatric Information Is Added to Labeling.--
       ``(1) General rule.--A drug for which an application has 
     been submitted or approved under section 505(j) shall not be 
     considered ineligible for approval under that section or 
     misbranded under section 502 on the basis that the labeling 
     of the drug omits a pediatric indication or any other aspect 
     of labeling pertaining to pediatric use when the omitted 
     indication or other aspect is protected by patent or by 
     exclusivity under clause (iii) or (iv) of section 
     505(j)(5)(F).
       ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
     section 505(j)(5)(F), the Secretary may require that the 
     labeling of a drug approved under section 505(j) that omits a 
     pediatric indication or other aspect of labeling as described 
     in paragraph (1) include--
       ``(A) a statement that, because of marketing exclusivity 
     for a manufacturer--
       ``(i) the drug is not labeled for pediatric use; or
       ``(ii) in the case of a drug for which there is an 
     additional pediatric use not referred to in paragraph (1), 
     the drug is not labeled for the pediatric use under paragraph 
     (1); and
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, or precautions that the 
     Secretary considers necessary.
       ``(3) Preservation of pediatric exclusivity and other 
     provisions.--This subsection does not affect--
       ``(A) the availability or scope of exclusivity under this 
     section;
       ``(B) the availability or scope of exclusivity under 
     section 505 for pediatric formulations;
       ``(C) the question of the eligibility for approval of any 
     application under section 505(j) that omits any other 
     conditions of approval entitled to exclusivity under clause 
     (iii) or (iv) of section 505(j)(5)(F); or
       ``(D) except as expressly provided in paragraphs (1) and 
     (2), the operation of section 505.
       ``(p) Institute of Medicine Study.--Not later than 3 years 
     after the date of the enactment of the Best Pharmaceuticals 
     for Children Act of 2007, the Secretary shall enter into a 
     contract with the Institute of Medicine to conduct a study 
     and report to Congress regarding the written requests made 
     and the studies conducted pursuant to this section. The 
     Institute of Medicine may devise an appropriate mechanism to 
     review a

[[Page H7584]]

     representative sample of requests made and studies conducted 
     pursuant to this section in order to conduct such study. Such 
     study shall--
       ``(1) review such representative written requests issued by 
     the Secretary since 1997 under subsections (b) and (c);
       ``(2) review and assess such representative pediatric 
     studies conducted under subsections (b) and (c) since 1997 
     and labeling changes made as a result of such studies;
       ``(3) review the use of extrapolation for pediatric 
     subpopulations, the use of alternative endpoints for 
     pediatric populations, neonatal assessment tools, and ethical 
     issues in pediatric clinical trials; and
       ``(4) make recommendations regarding appropriate incentives 
     for encouraging pediatric studies of biologics.
       ``(q) Sunset.--A drug may not receive any 6-month period 
     under subsection (b) or (c) unless--
       ``(1) on or before October 1, 2012, the Secretary makes a 
     written request for pediatric studies of the drug;
       ``(2) on or before October 1, 2012, an application for the 
     drug is accepted for filing under section 505(b); and
       ``(3) all requirements of this section are met.''.
       (2) Effective date.--The amendment made by this subsection 
     shall apply to written requests under section 505A of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) made 
     after the date of the enactment of this Act.
       (b) Program for Pediatric Studies of Drugs.--Section 409I 
     of the Public Health Service Act (42 U.S.C. 284m) is amended 
     to read as follows:

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

       ``(a) List of Priority Issues in Pediatric Therapeutics.--
       ``(1) In general.--Not later than one year after the date 
     of the enactment of the Best Pharmaceuticals for Children Act 
     of 2007, the Secretary, acting through the Director of the 
     National Institutes of Health and in consultation with the 
     Commissioner of Food and Drugs and experts in pediatric 
     research, shall develop and publish a priority list of needs 
     in pediatric therapeutics, including drugs or indications 
     that require study. The list shall be revised every three 
     years.
       ``(2) Consideration of available information.--In 
     developing and prioritizing the list under paragraph (1), the 
     Secretary shall consider--
       ``(A) therapeutic gaps in pediatrics that may include 
     developmental pharmacology, pharmacogenetic determinants of 
     drug response, metabolism of drugs and biologics in children, 
     and pediatric clinical trials;
       ``(B) particular pediatric diseases, disorders or 
     conditions where more complete knowledge and testing of 
     therapeutics, including drugs and biologics, may be 
     beneficial in pediatric populations; and
       ``(C) the adequacy of necessary infrastructure to conduct 
     pediatric pharmacological research, including research 
     networks and trained pediatric investigators.
       ``(b) Pediatric Studies and Research.--The Secretary, 
     acting through the National Institutes of Health, shall award 
     funds to entities that have the expertise to conduct 
     pediatric clinical trials or other research (including 
     qualified universities, hospitals, laboratories, contract 
     research organizations, practice groups, federally funded 
     programs such as pediatric pharmacology research units, other 
     public or private institutions, or individuals) to enable the 
     entities to conduct the drug studies or other research on the 
     issues described in subsection (a). The Secretary may use 
     contracts, grants, or other appropriate funding mechanisms to 
     award funds under this subsection.
       ``(c) Process for Proposed Pediatric Study Requests and 
     Labeling Changes.--
       ``(1) Submission of proposed pediatric study request.--The 
     Director of the National Institutes of Health shall, as 
     appropriate, submit proposed pediatric study requests for 
     consideration by the Commissioner of Food and Drugs for 
     pediatric studies of a specific pediatric indication 
     identified under subsection (a). Such a proposed pediatric 
     study request shall be made in a manner equivalent to a 
     written request made under subsection (b) or (c) of section 
     505A of the Federal Food, Drug, and Cosmetic Act, including 
     with respect to the information provided on the pediatric 
     studies to be conducted pursuant to the request. The Director 
     of the National Institutes of Health may submit a proposed 
     pediatric study request for a drug for which--
       ``(A)(i) there is an approved application under section 
     505(j) of the Federal Food, Drug, and Cosmetic Act; or
       ``(ii) there is a submitted application that could be 
     approved under the criteria of such section; and
       ``(B) there is no patent protection or market exclusivity 
     protection for at least one form of the drug under the 
     Federal Food, Drug, and Cosmetic Act; and
       ``(C) additional studies are needed to assess the safety 
     and effectiveness of the use of the drug in the pediatric 
     population.
       ``(2) Written request to holders of approved applications 
     for drugs lacking exclusivity.--The Commissioner of Food and 
     Drugs, in consultation with the Director of the National 
     Institutes of Health, may issue a written request based on 
     the proposed pediatric study request for the indication or 
     indications submitted pursuant to paragraph (1) (which shall 
     include a timeframe for negotiations for an agreement) for 
     pediatric studies concerning a drug identified under 
     subsection (a) to all holders of an approved application for 
     the drug under section 505 of the Federal Food, Drug, and 
     Cosmetic Act. Such a written request shall be made in a 
     manner equivalent to the manner in which a written request is 
     made under subsection (b) or (c) of section 505A of such Act, 
     including with respect to information provided on the 
     pediatric studies to be conducted pursuant to the request and 
     using appropriate formulations for each age group for which 
     the study is requested.
       ``(3) Requests for proposals.--If the Commissioner of Food 
     and Drugs does not receive a response to a written request 
     issued under paragraph (2) not later than 30 days after the 
     date on which a request was issued, the Secretary, acting 
     through the Director of the National Institutes of Health and 
     in consultation with the Commissioner of Food and Drugs, 
     shall publish a request for proposals to conduct the 
     pediatric studies described in the written request in 
     accordance with subsection (b).
       ``(4) Disqualification.--A holder that receives a first 
     right of refusal shall not be entitled to respond to a 
     request for proposals under paragraph (3).
       ``(5) Contracts, grants, or other funding mechanisms.--A 
     contract, grant, or other funding may be awarded under this 
     section only if a proposal is submitted to the Secretary in 
     such form and manner, and containing such agreements, 
     assurances, and information as the Secretary determines to be 
     necessary to carry out this section.
       ``(6) Reporting of studies.--
       ``(A) In general.--On completion of a pediatric study in 
     accordance with an award under this section, a report 
     concerning the study shall be submitted to the Director of 
     the National Institutes of Health and the Commissioner of 
     Food and Drugs. The report shall include all data generated 
     in connection with the study, including a written request if 
     issued.
       ``(B) Availability of reports.--Each report submitted under 
     subparagraph (A) shall be considered to be in the public 
     domain (subject to section 505A(d)(4) of the Federal Food, 
     Drug, and Cosmetic Act) and shall be assigned a docket number 
     by the Commissioner of Food and Drugs. An interested person 
     may submit written comments concerning such pediatric studies 
     to the Commissioner of Food and Drugs, and the written 
     comments shall become part of the docket file with respect to 
     each of the drugs.
       ``(C) Action by commissioner.--The Commissioner of Food and 
     Drugs shall take appropriate action in response to the 
     reports submitted under subparagraph (A) in accordance with 
     paragraph (7).
       ``(7) Requests for labeling change.--During the 180-day 
     period after the date on which a report is submitted under 
     paragraph (6)(A), the Commissioner of Food and Drugs shall--
       ``(A) review the report and such other data as are 
     available concerning the safe and effective use in the 
     pediatric population of the drug studied;
       ``(B) negotiate with the holders of approved applications 
     for the drug studied for any labeling changes that the 
     Commissioner of Food and Drugs determines to be appropriate 
     and requests the holders to make; and
       ``(C)(i) place in the public docket file a copy of the 
     report and of any requested labeling changes; and
       ``(ii) publish in the Federal Register and through a 
     posting on the website of the Food and Drug Administration a 
     summary of the report and a copy of any requested labeling 
     changes.
       ``(8) Dispute resolution.--
       ``(A) Referral to pediatric advisory committee.--If, not 
     later than the end of the 180-day period specified in 
     paragraph (7), the holder of an approved application for the 
     drug involved does not agree to any labeling change requested 
     by the Commissioner of Food and Drugs under that paragraph, 
     the Commissioner of Food and Drugs shall refer the request to 
     the Pediatric Advisory Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A), the Pediatric Advisory Committee shall--
       ``(i) review the available information on the safe and 
     effective use of the drug in the pediatric population, 
     including study reports submitted under this section; and
       ``(ii) make a recommendation to the Commissioner of Food 
     and Drugs as to appropriate labeling changes, if any.
       ``(9) FDA determination.--Not later than 30 days after 
     receiving a recommendation from the Pediatric Advisory 
     Committee under paragraph (8)(B)(ii) with respect to a drug, 
     the Commissioner of Food and Drugs shall consider the 
     recommendation and, if appropriate, make a request to the 
     holders of approved applications for the drug to make any 
     labeling change that the Commissioner of Food and Drugs 
     determines to be appropriate.
       ``(10) Failure to agree.--If a holder of an approved 
     application for a drug, within 30 days after receiving a 
     request to make a labeling change under paragraph (9), does 
     not agree to make a requested labeling change, the 
     Commissioner of Food and Drugs may deem the drug to be 
     misbranded under the Federal Food, Drug, and Cosmetic Act.
       ``(11) No effect on authority.--Nothing in this subsection 
     limits the authority of the

[[Page H7585]]

     United States to bring an enforcement action under the 
     Federal Food, Drug, and Cosmetic Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Committee process or an enforcement action 
     referred to in the preceding sentence) shall preclude, delay, 
     or serve as the basis to stay the other course of action.
       ``(d) Dissemination of Pediatric Information.--Not later 
     than one year after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, the Secretary, 
     acting through the Director of the National Institutes of 
     Health, shall study the feasibility of establishing a 
     compilation of information on pediatric drug use and report 
     the findings to Congress.
       ``(e) Authorization of Appropriations.--
       ``(1) In general.--There are authorized to be appropriated 
     to carry out this section--
       ``(A) $200,000,000 for fiscal year 2008; and
       ``(B) such sums as are necessary for each of the four 
     succeeding fiscal years.
       ``(2) Availability.--Any amount appropriated under 
     paragraph (1) shall remain available to carry out this 
     section until expended.''.
       (c) Fees Relating to Drugs.--Section 735(6) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379(6)) is amended by 
     adding at the end the following new subparagraph:
       ``(G) Activities relating to the support of studies of 
     drugs on pediatric populations under section 505A(n)(1).''.
       (d) Foundation for the National Institutes of Health.--
     Section 499(c)(1)(C) of the Public Health Service Act (42 
     U.S.C. 290b(c)(1)(C)) is amended by striking ``and studies 
     listed by the Secretary pursuant to section 409I(a)(1)(A) of 
     this Act and referred under section 505A(d)(4)(C) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(a)(d)(4)(C))''.
       (e) Continuation of Operation of Committee.--Section 14 of 
     the Best Pharmaceuticals for Children Act (42 U.S.C. 284m 
     note) is amended by adding at the end the following new 
     subsection:
       ``(d) Continuation of Operation of Committee.--
     Notwithstanding section 14 of the Federal Advisory Committee 
     Act, the advisory committee shall continue to operate during 
     the five-year period beginning on the date of the enactment 
     of the Best Pharmaceuticals for Children Act of 2007.''.
       (f) Pediatric Subcommittee of the Oncologic Drugs Advisory 
     Committee.--Section 15 of the Best Pharmaceuticals for 
     Children Act (42 U.S.C. 284m note) is amended--
       (1) in subsection (a)--
       (A) in paragraph (1)--
       (i) in subparagraph (B), by striking ``and'' after the 
     semicolon;
       (ii) in subparagraph (C), by striking the period at the end 
     and inserting ``; and''; and
       (iii) by adding at the end the following new subparagraph:
       ``(D) provide recommendations to the internal review 
     committee created under section 505A(f) of the Federal Food, 
     Drug, and Cosmetic Act regarding the implementation of 
     amendments to sections 505A and 505B of the Federal Food, 
     Drug, and Cosmetic Act with respect to the treatment of 
     pediatric cancers.''; and
       (B) by adding at the end the following new paragraph:
       ``(3) Continuation of operation of subcommittee.--
     Notwithstanding section 14 of the Federal Advisory Committee 
     Act, the Subcommittee shall continue to operate during the 
     five-year period beginning on the date of the enactment of 
     the Best Pharmaceuticals for Children Act of 2007.''; and
       (2) in subsection (d), by striking ``2003'' and inserting 
     ``2009''.
       (g) Effective Date and Limitation for Rule Relating to 
     Toll-Free Number for Adverse Events on Labeling for Human 
     Drug Products.--
       (1) In general.--Notwithstanding subchapter II of chapter 
     5, and chapter 7, of title 5, United States Code (commonly 
     known as the ``Administrative Procedure Act'') and any other 
     provision of law, the proposed rule issued by the 
     Commissioner of Food and Drugs entitled ``Toll-Free Number 
     for Reporting Adverse Events on Labeling for Human Drug 
     Products,'' 69 Fed. Reg. 21778, (April 22, 2004) shall take 
     effect on January 1, 2008, unless such Commissioner issues 
     the final rule before such date.
       (2) Limitation.--The proposed rule that takes effect under 
     subsection (a), or the final rule described under subsection 
     (a), shall, notwithstanding section 17(a) of the Best 
     Pharmaceuticals for Children Act (21 U.S.C. 355b(a)), not 
     apply to a drug--
       (A) for which an application is approved under section 505 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
       (B) that is not described under section 503(b)(1) of such 
     Act (21 U.S.C. 353(b)(1)); and
       (C) the packaging of which includes a toll-free number 
     through which consumers can report complaints to the 
     manufacturer or distributor of the drug.

                   TITLE VI--REAGAN-UDALL FOUNDATION

     SEC. 601. THE REAGAN-UDALL FOUNDATION FOR THE FOOD AND DRUG 
                   ADMINISTRATION.

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

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

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

       ``(a) In General.--A nonprofit corporation to be known as 
     the Reagan-Udall Foundation for the Food and Drug 
     Administration (referred to in this subchapter as the 
     `Foundation') shall be established in accordance with this 
     section. The Foundation shall be headed by an Executive 
     Director, appointed by the members of the Board of Directors 
     under subsection (e). The Foundation shall not be an agency 
     or instrumentality of the United States Government.
       ``(b) Purpose of Foundation.--The purpose of the Foundation 
     is to advance the mission of the Food and Drug Administration 
     to modernize medical, veterinary, food, food ingredient, and 
     cosmetic product development, accelerate innovation, and 
     enhance product safety.
       ``(c) Duties of the Foundation.--The Foundation shall--
       ``(1) taking into consideration the Critical Path reports 
     and priorities published by the Food and Drug Administration, 
     identify unmet needs in the development, manufacture, and 
     evaluation of the safety and effectiveness, including 
     postapproval, of devices, including diagnostics, biologics, 
     and drugs, and the safety of food, food ingredients, and 
     cosmetics, and including the incorporation of more sensitive 
     and predictive tools and devices to measure safety;
       ``(2) establish goals and priorities in order to meet the 
     unmet needs identified in paragraph (1);
       ``(3) in consultation with the Secretary, identify existing 
     and proposed Federal intramural and extramural research and 
     development programs relating to the goals and priorities 
     established under paragraph (2), coordinate Foundation 
     activities with such programs, and minimize Foundation 
     duplication of existing efforts;
       ``(4) award grants to, or enter into contracts, memoranda 
     of understanding, or cooperative agreements with, scientists 
     and entities, which may include the Food and Drug 
     Administration, university consortia, public-private 
     partnerships, institutions of higher education, entities 
     described in section 501(c)(3) of the Internal Revenue Code 
     (and exempt from tax under section 501(a) of such Code), and 
     industry, to efficiently and effectively advance the goals 
     and priorities established under paragraph (2);
       ``(5) recruit meeting participants and hold or sponsor (in 
     whole or in part) meetings as appropriate to further the 
     goals and priorities established under paragraph (2);
       ``(6) release and publish information and data and, to the 
     extent practicable, license, distribute, and release 
     material, reagents, and techniques to maximize, promote, and 
     coordinate the availability of such material, reagents, and 
     techniques for use by the Food and Drug Administration, 
     nonprofit organizations, and academic and industrial 
     researchers to further the goals and priorities established 
     under paragraph (2);
       ``(7) ensure that--
       ``(A) action is taken as necessary to obtain patents for 
     inventions developed by the Foundation or with funds from the 
     Foundation;
       ``(B) action is taken as necessary to enable the licensing 
     of inventions developed by the Foundation or with funds from 
     the Foundation; and
       ``(C) executed licenses, memoranda of understanding, 
     material transfer agreements, contracts, and other such 
     instruments, promote, to the maximum extent practicable, the 
     broadest conversion to commercial and noncommercial 
     applications of licensed and patented inventions of the 
     Foundation to further the goals and priorities established 
     under paragraph (2);
       ``(8) provide objective clinical and scientific information 
     to the Food and Drug Administration and, upon request, to 
     other Federal agencies to assist in agency determinations of 
     how to ensure that regulatory policy accommodates scientific 
     advances and meets the agency's public health mission;
       ``(9) conduct annual assessments of the unmet needs 
     identified in paragraph (1); and
       ``(10) carry out such other activities consistent with the 
     purposes of the Foundation as the Board determines 
     appropriate.
       ``(d) Board of Directors.--
       ``(1) Establishment.--
       ``(A) In general.--The Foundation shall have a Board of 
     Directors (referred to in this subchapter as the `Board'), 
     which shall be composed of ex officio and appointed members 
     in accordance with this subsection. All appointed members of 
     the Board shall be voting members.
       ``(B) Ex officio members.--The ex officio members of the 
     Board shall be the following individuals or their designees:
       ``(i) The Commissioner.
       ``(ii) The Director of the National Institutes of Health.
       ``(iii) The Director of the Centers for Disease Control and 
     Prevention.
       ``(iv) The Director of the Agency for Healthcare Research 
     and Quality.
       ``(C) Appointed members.--
       ``(i) In general.--The ex officio members of the Board 
     under subparagraph (B) shall, by majority vote, appoint to 
     the Board 12 individuals, from a list of candidates to be 
     provided by the National Academy of Sciences. Of such 
     appointed members--

       ``(I) 4 shall be representatives of the general 
     pharmaceutical, device, food, cosmetic, and biotechnology 
     industries;
       ``(II) 3 shall be representatives of academic research 
     organizations;
       ``(III) 2 shall be representatives of Government agencies, 
     including the Food and Drug

[[Page H7586]]

     Administration and the National Institutes of Health;
       ``(IV) 2 shall be representatives of patient or consumer 
     advocacy organizations; and
       ``(V) 1 shall be a representative of health care providers.

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

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

       ``(ii) Service of ex officio members.--Upon the appointment 
     of the members of the Board under clause (i)(II), the terms 
     of service of the ex officio members of the Board as members 
     of the Board shall terminate.
       ``(iii) Chair.--The ex officio members of the Board under 
     subparagraph (B) shall designate an appointed member of the 
     Board to serve as the Chair of the Board.
       ``(2) Duties of board.--The Board shall--
       ``(A) establish bylaws for the Foundation that--
       ``(i) are published in the Federal Register and available 
     for public comment;
       ``(ii) establish policies for the selection of the 
     officers, employees, agents, and contractors of the 
     Foundation;
       ``(iii) establish policies, including ethical standards, 
     for the acceptance, solicitation, and disposition of 
     donations and grants to the Foundation and for the 
     disposition of the assets of the Foundation, including 
     appropriate limits on the ability of donors to designate, by 
     stipulation or restriction, the use or recipient of donated 
     funds;
       ``(iv) establish policies that would subject all employees, 
     fellows, and trainees of the Foundation to the conflict of 
     interest standards under section 208 of title 18, United 
     States Code;
       ``(v) establish licensing, distribution, and publication 
     policies that support the widest and least restrictive use by 
     the public of information and inventions developed by the 
     Foundation or with Foundation funds to carry out the duties 
     described in paragraphs (6) and (7) of subsection (c), and 
     may include charging cost-based fees for published material 
     produced by the Foundation;
       ``(vi) specify principles for the review of proposals and 
     awarding of grants and contracts that include peer review and 
     that are consistent with those of the Foundation for the 
     National Institutes of Health, to the extent determined 
     practicable and appropriate by the Board;
       ``(vii) specify a cap on administrative expenses for 
     recipients of a grant, contract, or cooperative agreement 
     from the Foundation;
       ``(viii) establish policies for the execution of memoranda 
     of understanding and cooperative agreements between the 
     Foundation and other entities, including the Food and Drug 
     Administration;
       ``(ix) establish policies for funding training fellowships, 
     whether at the Foundation, academic or scientific 
     institutions, or the Food and Drug Administration, for 
     scientists, doctors, and other professionals who are not 
     employees of regulated industry, to foster greater 
     understanding of and expertise in new scientific tools, 
     diagnostics, manufacturing techniques, and potential barriers 
     to translating basic research into clinical and regulatory 
     practice;
       ``(x) specify a process for annual Board review of the 
     operations of the Foundation; and
       ``(xi) establish specific duties of the Executive Director;
       ``(B) prioritize and provide overall direction to the 
     activities of the Foundation;
       ``(C) evaluate the performance of the Executive Director; 
     and
       ``(D) carry out any other necessary activities regarding 
     the functioning of the Foundation.
       ``(3) Terms and vacancies.--
       ``(A) Term.--The term of office of each member of the Board 
     appointed under paragraph (1)(C) shall be 4 years, except 
     that the terms of offices for the initial appointed members 
     of the Board shall expire on a staggered basis as determined 
     by the ex officio members.
       ``(B) Vacancy.--Any vacancy in the membership of the 
     Board--
       ``(i) shall not affect the power of the remaining members 
     to execute the duties of the Board; and
       ``(ii) shall be filled by appointment by the appointed 
     members described in paragraph (1)(C) by majority vote.
       ``(C) Partial term.--If a member of the Board does not 
     serve the full term applicable under subparagraph (A), the 
     individual appointed under subparagraph (B) to fill the 
     resulting vacancy shall be appointed for the remainder of the 
     term of the predecessor of the individual.
       ``(D) Serving past term.--A member of the Board may 
     continue to serve after the expiration of the term of the 
     member until a successor is appointed.
       ``(4) Compensation.--Members of the Board may not receive 
     compensation for service on the Board. Such members may be 
     reimbursed for travel, subsistence, and other necessary 
     expenses incurred in carrying out the duties of the Board, as 
     set forth in the bylaws issued by the Board.
       ``(e) Incorporation.--The ex officio members of the Board 
     shall serve as incorporators and shall take whatever actions 
     necessary to incorporate the Foundation.
       ``(f) Nonprofit Status.--The Foundation shall be considered 
     to be a corporation under section 501(c) of the Internal 
     Revenue Code of 1986, and shall be subject to the provisions 
     of such section.
       ``(g) Executive Director.--
       ``(1) In general.--The Board shall appoint an Executive 
     Director who shall serve at the pleasure of the Board. The 
     Executive Director shall be responsible for the day-to-day 
     operations of the Foundation and shall have such specific 
     duties and responsibilities as the Board shall prescribe.
       ``(2) Compensation.--The compensation of the Executive 
     Director shall be fixed by the Board but shall not be greater 
     than the compensation of the Commissioner.
       ``(h) Administrative Powers.--In carrying out this 
     subchapter, the Board, acting through the Executive Director, 
     may--
       ``(1) adopt, alter, and use a corporate seal, which shall 
     be judicially noticed;
       ``(2) hire, promote, compensate, and discharge 1 or more 
     officers, employees, and agents, as may be necessary, and 
     define their duties;
       ``(3) prescribe the manner in which--
       ``(A) real or personal property of the Foundation is 
     acquired, held, and transferred;
       ``(B) general operations of the Foundation are to be 
     conducted; and
       ``(C) the privileges granted to the Board by law are 
     exercised and enjoyed;
       ``(4) with the consent of the applicable executive 
     department or independent agency, use the information, 
     services, and facilities of such department or agencies in 
     carrying out this section;
       ``(5) enter into contracts with public and private 
     organizations for the writing, editing, printing, and 
     publishing of books and other material;
       ``(6) hold, administer, invest, and spend any gift, devise, 
     or bequest of real or personal property made to the 
     Foundation under subsection (i);
       ``(7) enter into such other contracts, leases, cooperative 
     agreements, and other transactions as the Board considers 
     appropriate to conduct the activities of the Foundation;
       ``(8) modify or consent to the modification of any contract 
     or agreement to which it is a party or in which it has an 
     interest under this subchapter;
       ``(9) take such action as may be necessary to obtain 
     patents and licenses for devices and procedures developed by 
     the Foundation and its employees;
       ``(10) sue and be sued in its corporate name, and complain 
     and defend in courts of competent jurisdiction;
       ``(11) appoint other groups of advisors as may be 
     determined necessary to carry out the functions of the 
     Foundation; and
       ``(12) exercise other powers as set forth in this section, 
     and such other incidental powers as are necessary to carry 
     out its powers, duties, and functions in accordance with this 
     subchapter.
       ``(i) Acceptance of Funds From Other Sources.--The 
     Executive Director may solicit and accept on behalf of the 
     Foundation, any funds, gifts, grants, devises, or bequests of 
     real or personal property made to the Foundation, including 
     from private entities, for the purposes of carrying out the 
     duties of the Foundation.
       ``(j) Service of Federal Employees.--Federal Government 
     employees may serve on committees advisory to the Foundation 
     and otherwise cooperate with and assist the Foundation in 
     carrying out its functions, so long as such employees do not 
     direct or control Foundation activities.
       ``(k) Detail of Government Employees; Fellowships.--
       ``(1) Detail from federal agencies.--Federal Government 
     employees may be detailed from Federal agencies with or 
     without reimbursement to those agencies to the Foundation at 
     any time, and such detail shall be without interruption or 
     loss of civil service status or privilege. Each such employee 
     shall abide by the statutory, regulatory, ethical, and 
     procedural standards applicable to the employees of the 
     agency from which such employee is detailed and those of the 
     Foundation.
       ``(2) Voluntary service; acceptance of federal employees.--
       ``(A) Foundation.--The Executive Director of the Foundation 
     may accept the services of employees detailed from Federal 
     agencies with or without reimbursement to those agencies.
       ``(B) Food and drug administration.--The Commissioner may 
     accept the uncompensated services of Foundation fellows or 
     trainees. Such services shall be considered to be undertaking 
     an activity under contract with the Secretary as described in 
     section 708.
       ``(l) Annual Reports.--
       ``(1) Reports to foundation.--Any recipient of a grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement from the Foundation under this section 
     shall submit to the Foundation a report on an annual basis 
     for the duration of such grant, contract, fellowship, 
     memorandum of understanding, or cooperative agreement, that 
     describes the activities carried out under such grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement.

[[Page H7587]]

       ``(2) Report to congress and the fda.--Beginning with 
     fiscal year 2009, the Executive Director shall submit to 
     Congress and the Commissioner an annual report that--
       ``(A) describes the activities of the Foundation and the 
     progress of the Foundation in furthering the goals and 
     priorities established under subsection (c)(2), including the 
     practical impact of the Foundation on regulated product 
     development;
       ``(B) provides a specific accounting of the source and use 
     of all funds used by the Foundation to carry out such 
     activities; and
       ``(C) provides information on how the results of Foundation 
     activities could be incorporated into the regulatory and 
     product review activities of the Food and Drug 
     Administration.
       ``(m) Separation of Funds.--The Executive Director shall 
     ensure that the funds received from the Treasury are held in 
     separate accounts from funds received from entities under 
     subsection (i).
       ``(n) Funding.--From amounts appropriated to the Food and 
     Drug Administration for each fiscal year, the Commissioner 
     shall transfer not less than $500,000 and not more than 
     $1,250,000, to the Foundation to carry out subsections (a), 
     (b), and (d) through (m).''.
       (b) Other Foundation Provisions.--Chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) 
     (as amended by subsection (a)) is amended by adding at the 
     end the following:

     ``SEC. 771. LOCATION OF FOUNDATION.

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

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

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

     SEC. 602. OFFICE OF THE CHIEF SCIENTIST.

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

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

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

     SEC. 603. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

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

     ``SEC. 566. CRITICAL PATH PUBLIC-PRIVATE PARTNERSHIPS.

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

                    TITLE VII--CONFLICTS OF INTEREST

     SEC. 701. CONFLICTS OF INTEREST.

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

     ``SEC. 712. CONFLICTS OF INTEREST.

       ``(a) Definitions.--For purposes of this section:
       ``(1) Advisory committee.--The term `advisory committee' 
     means an advisory committee under the Federal Advisory 
     Committee Act that provides advice or recommendations to the 
     Secretary regarding activities of the Food and Drug 
     Administration.
       ``(2) Financial interest.--The term `financial interest' 
     means a financial interest under section 208(a) of title 18, 
     United States Code.
       ``(b) Appointments to Advisory Committees.--
       ``(1) Recruitment.--
       ``(A) In general.--Given the importance of advisory 
     committees to the review process at the Food and Drug 
     Administration, the Secretary, through the Office of Women's 
     Health, the Office of Orphan Product Development, the Office 
     of Pediatric Therapeutics, and other offices within the Food 
     and Drug Administration with relevant expertise, shall 
     develop and implement strategies on effective outreach to 
     potential members of advisory committees at universities, 
     colleges, other academic research centers, professional and 
     medical societies, and patient and consumer groups. The 
     Secretary shall

[[Page H7588]]

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

                  TITLE VIII--CLINICAL TRIAL DATABASES

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

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

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

       ``(a) Definitions.--In this section:
       ``(1) Applicable clinical trial.--The term `applicable 
     clinical trial'--
       ``(A) means a clinical trial that is conducted to test the 
     safety or effectiveness (including comparative effectiveness) 
     of a drug or device (irrespective of whether the clinical 
     trial is federally or privately funded, and whether the 
     clinical trial involves an approved or unapproved drug or 
     device);
       ``(B) includes such a clinical trial that is conducted 
     outside of the United States if--
       ``(i) there is an application or premarket notification 
     pending before the Food and Drug Administration for approval 
     or clearance of the drug or device involved under section 
     505, 510(k), or 515 of the Federal Food, Drug, and Cosmetic 
     Act or section 351 of this Act; or
       ``(ii) the drug or device involved is so approved or 
     cleared; and
       ``(C) notwithstanding subparagraphs (A) and (B), excludes--
       ``(i) a clinical trial to determine the safety of a use of 
     a drug that is designed solely to detect major toxicities in 
     the drug or to investigate pharmacokinetics, unless the 
     clinical trial is designed to investigate pharmacokinetics in 
     a special population or populations; and
       ``(ii) a small clinical trial to determine the feasibility 
     of a device, or a clinical trial to test prototype devices 
     where the primary focus is feasibility.
       ``(2) Clinical trial information.--The term `clinical trial 
     information' means those data elements that are necessary to 
     complete an entry in the clinical trial registry database 
     under subsection (b) or the clinical trial results database 
     under subsection (c), as applicable.

[[Page H7589]]

       ``(3) Completion date.--The term `completion date' means 
     the date of the final collection of data from subjects in the 
     clinical trial for the primary and secondary outcomes to be 
     examined in the trial.
       ``(4) Device.--The term `device' has the meaning given to 
     that term in section 201(h) of the Federal Food, Drug, and 
     Cosmetic Act.
       ``(5) Drug.--The term `drug' means a drug as defined in 
     section 201(g) of the Federal Food, Drug, and Cosmetic Act or 
     a biological product as defined in section 351 of this Act.
       ``(6) Responsible party.--The term `responsible party', 
     with respect to an applicable clinical trial, means--
       ``(A) the primary sponsor (as defined in the International 
     Clinical Trials Registry Platform trial registration data set 
     of the World Health Organization) of the clinical trial; or
       ``(B) the principal investigator of such clinical trial if 
     so designated by such sponsor, so long as the principal 
     investigator is responsible for conducting the trial, has 
     access to and control over the data, has the right to publish 
     the results of the trial, and has the responsibility to meet 
     all of the requirements under this section that are 
     applicable to responsible parties.
       ``(b) Clinical Trials Registry Database.--
       ``(1) Establishment.--To enhance patient enrollment and 
     provide a mechanism to track subsequent progress of clinical 
     trials, the Secretary, acting through the Director of NIH, 
     shall establish and administer a clinical trial registry 
     database in accordance with this section (referred to in this 
     section as the `registry database'). The Director of NIH 
     shall ensure that the registry database is made publicly 
     available through the Internet.
       ``(2) Content.--The Secretary shall promulgate regulations 
     for the submission to the registry database of clinical trial 
     information that--
       ``(A) conforms to the International Clinical Trials 
     Registry Platform trial registration data set of the World 
     Health Organization;
       ``(B) includes the city, State, and zip code for each 
     clinical trial location or a toll free number through which 
     such location information may be accessed;
       ``(C) includes a statement of the estimated completion date 
     for the clinical trial;
       ``(D) includes the identity and contact information of the 
     responsible party;
       ``(E) if the drug is not approved under section 505 of the 
     Federal Food, Drug, and Cosmetic Act or licensed under 
     section 351 of this Act, or the device is not cleared under 
     section 510(k) or approved under section 515 of the Federal 
     Food, Drug, and Cosmetic Act, specifies whether or not there 
     is expanded access to the drug or device under section 561 of 
     the Federal Food, Drug, and Cosmetic Act for those who do not 
     qualify for enrollment in the clinical trial and how to 
     obtain information about such access;
       ``(F) includes, with respect to any individual who is not 
     an employee of the responsible party for the clinical trial 
     or of the manufacturer of the drug or device involved, 
     information on whether the responsible party or manufacturer 
     has entered into any agreement with such individual that 
     restricts in any manner the ability of the individual--
       ``(i) to discuss the results of the trial at a scientific 
     meeting or any other public or private forum; or
       ``(ii) to publish the results of the trial, or a 
     description or discussion of the results of the trial, in a 
     scientific or academic journal; and
       ``(G) requires the inclusion of such other data elements to 
     the registry database as appropriate.
       ``(3) Format and structure.--
       ``(A) Searchable categories.--The Director of NIH shall 
     ensure that the public may search the entries in the registry 
     database by 1 or more of the following criteria:
       ``(i) The indication being studied in the clinical trial, 
     using Medical Subject Headers (MeSH) descriptors.
       ``(ii) The safety issue being studied in the clinical 
     trial.
       ``(iii) The enrollment status of the clinical trial.
       ``(iv) The sponsor of the clinical trial.
       ``(B) Format.--The Director of the NIH shall ensure that 
     the registry database is easily used by patients, and that 
     entries are easily compared.
       ``(4) Data submission.--The responsible party for an 
     applicable clinical trial shall submit to the Director of NIH 
     for inclusion in the registry database the clinical trial 
     information described in paragraph (2).
       ``(5) Truthful clinical trial information.--
       ``(A) In general.--The clinical trial information submitted 
     by a responsible party under this subsection shall not be 
     false or misleading.
       ``(B) Effect.--Subparagraph (A) shall not have the effect 
     of requiring clinical trial information to include 
     information from any source other than the clinical trial 
     involved.
       ``(6) Timing of submission.--Except as provided in 
     paragraph (7), the clinical trial information for a clinical 
     trial required to be submitted under this subsection shall be 
     submitted not later than 14 days after the first patient is 
     enrolled in such clinical trial.
       ``(7) Updates.--The responsible party for an applicable 
     clinical trial shall submit to the Director of NIH for 
     inclusion in the registry database periodic updates to 
     reflect changes to the clinical trial information submitted 
     under this subsection. Such updates--
       ``(A) shall be provided not less than once every 6 months 
     until information on the results of the trial is submitted 
     under subsection (c);
       ``(B) shall include identification of the dates of any such 
     changes;
       ``(C) not later than 30 days after the enrollment status of 
     such clinical trial changes, shall include an update of the 
     enrollment status; and
       ``(D) not later than 30 days after the completion date of 
     the clinical trial, shall include a report to the Director 
     that such clinical trial is complete.
       ``(8) Applicability of device trials.--In the case of an 
     applicable clinical trial regarding a device, the responsible 
     person for the trial shall submit to the Director of NIH the 
     clinical trial information as required in paragraph (4), but 
     the Director may not make the information publicly available 
     through the registry database until the device is approved or 
     cleared (as the case may be).
       ``(c) Clinical Trials Results Database.--
       ``(1) Establishment.--To ensure that results of clinical 
     trials are made public and that patients and providers have 
     current information regarding the results of clinical trials, 
     the Secretary, acting through the Director of NIH, shall 
     establish and administer a clinical trial results database in 
     accordance with this section (referred to in this section as 
     the `results database'). The Director of NIH shall ensure 
     that the results database is made publicly available through 
     the Internet.
       ``(2) Searchable categories.--The Director of NIH shall 
     ensure that the public may search the entries in the results 
     database by 1 or more of the following:
       ``(A) The indication studied in the clinical trial, using 
     Medical Subject Headers (MeSH) descriptors.
       ``(B) The safety issue studied in the clinical trial.
       ``(C) Whether an application for the tested indication is 
     approved, pending approval, withdrawn, or not submitted.
       ``(D) The phase of the clinical trial.
       ``(E) The name of the drug or device that is the subject of 
     the clinical trial.
       ``(F) Within the documents described in clauses (i) and 
     (ii) of paragraph (3)(B), the following information, as 
     applicable:
       ``(i) The sponsor of the clinical trial.
       ``(ii) Each financial sponsor of the clinical trial.
       ``(3) Contents.--
       ``(A) In general.--The responsible party for an applicable 
     clinical trial shall submit to the Director of NIH for 
     inclusion in the results database the clinical trial 
     information described in subparagraph (B).
       ``(B) Required elements.--In submitting clinical trial 
     information for a clinical trial to the Director of NIH for 
     inclusion in the results database, the responsible party 
     shall include, with respect to such clinical trial, the 
     following information:
       ``(i) The information described in subparagraphs (A) 
     through (E) of subsection (b)(2).
       ``(ii) A summary that is written in non-technical, 
     understandable language for patients that includes the 
     following:

       ``(I) The purpose of the clinical trial.
       ``(II) The sponsor of the clinical trial.
       ``(III) A point of contact for information about the 
     clinical trial.
       ``(IV) A description of the patient population tested in 
     the clinical trial.
       ``(V) A general description of the clinical trial and 
     results, including a description of and the reasons for any 
     changes in the clinical trial design that occurred since the 
     date of submission of clinical trial information for 
     inclusion in the registry database established under 
     subsection (b) and a description of any significant safety 
     information.

       ``(iii) A summary that is technical in nature that includes 
     the following:

       ``(I) The purpose of the clinical trial.
       ``(II) The sponsor of the clinical trial.
       ``(III) Each financial sponsor of the clinical trial.
       ``(IV) A point of contact for scientific information about 
     the clinical trial.
       ``(V) A description of the patient population tested in the 
     clinical trial.
       ``(VI) A general description of the clinical trial and 
     results, including a description of and the reasons for any 
     changes in the clinical trial design that occurred since the 
     date of submission of clinical trial information for the 
     clinical trial in the registry database established under 
     subsection (b).
       ``(VII) Summary data describing the results, including--

       ``(aa) whether the primary endpoint was achieved, including 
     relevant statistics;
       ``(bb) an assessment of any secondary endpoints, if 
     applicable, including relevant statistics; and
       ``(cc) any significant safety information, including a 
     summary of the incidence of serious adverse events observed 
     in the clinical trial and a summary of the most common 
     adverse events observed in the clinical trial and the 
     frequencies of such events.
       ``(iv) With respect to the group of subjects receiving the 
     drug or device involved, and each comparison group of 
     subjects, the percentage of individuals who ceased 
     participation as subjects and the reasons for ceasing 
     participation.
       ``(v) With respect to an individual who is not an employee 
     of the responsible party for the clinical trial or of the 
     manufacturer of the drug or device involved, information (to 
     the extent not submitted under subsection (b)(2)(F)) on any 
     agreement that the responsible party or manufacturer has 
     entered into

[[Page H7590]]

     with such individual that restricts in any manner the ability 
     of the individual--

       ``(I) to discuss the results of the trial at a scientific 
     meeting or any other public or private forum; or
       ``(II) to publish the results of the trial, or a 
     description or discussion of the results of the trial, in a 
     scientific or academic journal.

       ``(vi) The completion date of the clinical trial.
       ``(vii) A link to the Internet web posting of any adverse 
     regulatory actions taken by the Food and Drug Administration, 
     such as a warning letter, that was substantively based on the 
     clinical trial design, outcome, or representation made by the 
     applicant about the design or outcome of the clinical trial.
       ``(C) Links in database.--The Director of NIH shall ensure 
     that the results database includes the following:
       ``(i) Links to Medline citations to publications reporting 
     results from each applicable drug clinical trial and 
     applicable device clinical trial.
       ``(ii) Links to the entry for the product that is the 
     subject of an applicable drug clinical trial in the National 
     Library of Medicine database of structured product labels, if 
     available.
       ``(iii) Links described in clauses (i) and (ii) for data 
     bank entries for clinical trials submitted to the data bank 
     prior to enactment of this section, as available.
       ``(4) Timing.--
       ``(A) In general.--Except as provided in subparagraphs (B) 
     and (C), a responsible party shall submit to the Director of 
     NIH for inclusion in the results database clinical trial 
     information for an applicable clinical trial not later than 1 
     year after the earlier of--
       ``(i) the estimated completion date of the trial, as 
     submitted under subsection (b)(2); or
       ``(ii) the actual date of the completion, or termination 
     before completion, of the trial, as applicable.
       ``(B) Extensions.--The Director of NIH may provide an 
     extension of the deadline for submission of clinical trial 
     information under subparagraph (A) if the responsible party 
     for the trial submits to the Director a written request that 
     demonstrates good cause for the extension and provides an 
     estimate of the date on which the information will be 
     submitted. The Director of NIH may grant more than one such 
     extension for the clinical trial involved.
       ``(C) Updates.--The responsible party for an applicable 
     clinical trial shall submit to the Director of NIH for 
     inclusion in the results database periodic updates to reflect 
     changes in the clinical trial information submitted under 
     this subsection. Such updates--
       ``(i) shall be provided not less frequently than once every 
     6 months during the 10-year period beginning on the date on 
     which information is due under subparagraph (A);
       ``(ii) shall identify the dates on which the changes were 
     made; and
       ``(iii) shall include, not later than 30 days after any 
     change in the regulatory status of the drug or device 
     involved, an update informing the Director of NIH of such 
     change.
       ``(5) Truthful clinical trial information.--
       ``(A) In general.--The clinical trial information submitted 
     by a responsible party under this subsection shall not be 
     false or misleading in any particular.
       ``(B) Effect.--Subparagraph (A) shall not have the effect 
     of requiring clinical trial information with respect to a 
     clinical trial to include information from any source other 
     than such clinical trial.
       ``(6) Public availability of results.--
       ``(A) Pre-approval studies.--Except as provided in 
     subparagraph (E), with respect to an applicable clinical 
     trial that is completed before the drug is initially approved 
     under section 505 of the Federal Food, Drug, and Cosmetic Act 
     or initially licensed under section 351 of this Act, or the 
     device is initially cleared under section 510(k) or approved 
     under section 515 of the Federal Food, Drug, and Cosmetic 
     Act, the Director of NIH shall make publicly available on the 
     results database the clinical trial information submitted for 
     such clinical trial not later than 30 days after--
       ``(i) the drug or device is approved under such section 
     505, licensed under such section 351, cleared under such 
     section 510(k), or approved under such section 515, as 
     applicable; or
       ``(ii) the Secretary issues a not approvable letter or a 
     not substantially equivalent letter for the drug or device 
     under such section 505, 351, 510(k), or 515, as applicable.
       ``(B) Medical and clinical pharmacology reviews of pre-
     approval studies.--Not later than 90 days after the date 
     applicable under clause (i) or (ii) of subparagraph (A) with 
     respect to an applicable clinical trial, the Director of NIH 
     shall make publicly available on the results database a 
     summary of the available medical and clinical pharmacology 
     reviews conducted by the Food and Drug Administration for 
     such trial.
       ``(C) Post-approval studies.--Except as provided in 
     subparagraphs (D) and (E), with respect to an applicable 
     clinical trial that is completed after the drug is initially 
     approved under such section 505 or licensed under such 
     section 351, or the device is initially cleared under such 
     section 510(k) or approved under such section 515, the 
     Director of NIH shall make publicly available on the results 
     database the clinical trial information submitted for such 
     clinical trial not later than 30 days after the date of such 
     submission.
       ``(D) Seeking approval of a new use for the drug or 
     device.--
       ``(i) In general.--If the manufacturer of the drug or 
     device is the sponsor or a financial sponsor of an applicable 
     clinical trial, and such manufacturer certifies to the 
     Director of NIH that such manufacturer has filed, or will 
     file within 1 year, an application seeking approval under 
     such section 505, licensing under such section 351, clearance 
     under such section 510(k), or approval under such section 515 
     for the use studied in such clinical trial (which use is not 
     included in the labeling of the approved drug or device), 
     then the Director of NIH shall make publicly available on the 
     results database the clinical trial information submitted for 
     such clinical trial on the earlier of the date that is 30 
     days after the date--

       ``(I) the new use of the drug or device is approved under 
     such section 505, licensed under such section 351, cleared 
     under such section 510(k), or approved under such section 
     515;
       ``(II) the Secretary issues a not approvable letter or a 
     not substantially equivalent letter for the new use of the 
     drug or device under such section 505, 351, 510(k), or 515; 
     or
       ``(III) the application or premarket notification under 
     such section 505, 351, 510(k), or 515 is withdrawn.

       ``(ii) Limitation on certification.--If a manufacturer 
     makes a certification under clause (i) with respect to a 
     clinical trial, the manufacturer shall make such a 
     certification with respect to each applicable clinical trial 
     that is required to be submitted in an application for 
     approval of the use studied in the clinical trial.
       ``(iii) 2-year limitation.--The clinical trial information 
     subject to clause (i) shall be made publicly available on the 
     results database on the date that is 2 years after the date 
     the certification referred to in clause (i) was made to the 
     Director of NIH, if a regulatory action referred to in 
     subclause (I), (II), or (III) of clause (i) has not occurred 
     by such date.
       ``(iv) Medical and clinical pharmacology reviews.--Not 
     later than 90 days after the date applicable under subclause 
     (I), (II), or (III) of clause (i) or clause (iii) with 
     respect to an applicable clinical trial, the Director of NIH 
     shall make publicly available on the results database a 
     summary of the available medical and clinical pharmacology 
     reviews conducted by the Food and Drug Administration for 
     such trial.
       ``(E) Seeking publication.--
       ``(i) In general.--If the principal investigator of an 
     applicable clinical trial is seeking publication in a peer-
     reviewed biomedical journal of a manuscript based on the 
     results of the clinical trial and the responsible party so 
     certifies to the Director of NIH--

       ``(I) the responsible party shall notify the Director of 
     NIH of the publication date of such manuscript not later than 
     15 days after such date; and
       ``(II) the Director of NIH shall make publicly available on 
     the results database the clinical trial information submitted 
     for such clinical trial on the date that is 30 days after the 
     publication date of such manuscript.

       ``(ii) Limitations.--The clinical trial information subject 
     to clause (i)--

       ``(I) shall be made publicly available on the results 
     database on the date that is 2 years after the date that the 
     clinical trial information was required to be submitted to 
     the Director of NIH if the manuscript referred to in such 
     clause has not been published by such date; and
       ``(II) shall not be required to be made publicly available 
     under section 552 of title 5, United States Code (commonly 
     known as the `Freedom of Information Act'), prior to the date 
     applicable to such clinical trial information under this 
     subparagraph.

       ``(7) Verification of submission prior to public 
     availability.--In the case of clinical trial information that 
     is submitted under this subsection, but is not made publicly 
     available pending either regulatory action or publication 
     under subparagraph (D) or (E) of paragraph (6), as 
     applicable, the Director of NIH shall respond to inquiries 
     from other Federal agencies and peer-reviewed journals to 
     confirm that such clinical trial information has been 
     submitted but has not yet been made publicly available on the 
     results database.
       ``(d) Updates; Tracking of Changes in Submitted 
     Information.--The Director of NIH shall ensure that updates 
     submitted to the Director under subsections (b)(7) and (c)(4) 
     do not result in the removal from the registry database or 
     the results database of the original submissions or of any 
     preceding updates, and that information in such databases is 
     presented in a manner that enables users to readily access 
     each original submission and to track the changes made by the 
     updates.
       ``(e) Coordination and Compliance.--
       ``(1) Consultation with other federal agencies.--The 
     Secretary shall--
       ``(A) consult with other agencies that conduct human 
     studies in accordance with part 46 of title 45, Code of 
     Federal Regulations (or any successor regulations), to 
     determine if any such studies are applicable clinical trials; 
     and
       ``(B) develop with such agencies appropriate procedures to 
     ensure that clinical trial information for such applicable 
     clinical trials is submitted under subsection (b) and (c).
       ``(2) Coordination of registry database and results 
     database.--

[[Page H7591]]

       ``(A) In general.--Each entry in the registry database 
     under subsection (b) or the results database under subsection 
     (c) shall include a link to the corresponding entry in the 
     results database or the registry database, respectively.
       ``(B) Missing entries.--
       ``(i) In general.--If, based on a review of the entries in 
     the registry database under subsection (b), the Director of 
     NIH determines that a responsible party has failed to submit 
     required clinical trial information to the results database 
     under subsection (c), the Director of NIH shall inform the 
     responsible party involved of such failure and permit the 
     responsible party to correct the failure within 30 days.
       ``(ii) Failure to correct.--If the responsible party does 
     not correct a failure to submit required clinical trial 
     information within the 30-day period described under clause 
     (i), the Director of NIH shall report such noncompliance to 
     the scientific peer review committees of the Federal research 
     agencies and to the Office of Human Research Protections.
       ``(iii) Public notice of failure to correct.--The Director 
     of NIH shall include in the clinical trial registry database 
     entry and the clinical trial results database entry for each 
     applicable clinical trial a notice of any uncorrected failure 
     to submit required clinical trial information and shall 
     provide that the public may easily search for such entries.
       ``(3) Action on applications.--
       ``(A) Verification prior to filing.--The Secretary, acting 
     through the Commissioner of Food and Drugs, shall verify that 
     the clinical trial information required under subsections (b) 
     and (c) for an applicable clinical trial is submitted 
     pursuant to such subsections, as applicable--
       ``(i) when considering a drug or device for an exemption 
     under section 505(i) or section 520(g) of the Federal Food, 
     Drug, and Cosmetic Act; and
       ``(ii) prior to filing an application or premarket 
     notification under section 505, 510(k), or 515 of the Federal 
     Food, Drug, and Cosmetic Act or section 351 of this Act, that 
     includes information from such clinical trial.
       ``(B) Notification.--If the Secretary determines under 
     subparagraph (A) that clinical trial information has not been 
     submitted as required by subsection (b) or (c), the Secretary 
     shall notify the applicant and the responsible party of such 
     noncompliance and require submission of such information 
     within 30 days.
       ``(C) Refusal to file.--If the responsible party does not 
     remedy such noncompliance within 30 days of receipt of 
     notification under subparagraph (B), the Secretary shall 
     refuse to file, approve, or clear such application or 
     premarket notification.
       ``(4) Content review.--
       ``(A) In general.--To ensure that the summary documents 
     described in subsection (c)(3) are non-promotional, and are 
     not false or misleading in any particular under subsection 
     (c)(5), the Secretary shall compare such documents to the 
     results data of the clinical trial for a representative 
     sample of applicable clinical trials by--
       ``(i) acting through the Commissioner of Food and Drugs to 
     examine the results data for such clinical trials submitted 
     to Secretary when such data are submitted--

       ``(I) for review as part of an application under section 
     505 or 515 of the Federal Food, Drug, and Cosmetic Act or 
     under section 351 of this Act or a premarket notification 
     under section 510(k) of the Federal Food, Drug, and Cosmetic 
     Act; or
       ``(II) in an annual status report on the drug or device 
     under such application;

       ``(ii) acting with the Federal agency that funds such 
     clinical trial in whole or in part by a grant to examine the 
     results data for such clinical trials; and
       ``(iii) acting through inspections under section 704 of the 
     Federal Food, Drug, and Cosmetic Act to examine results data 
     for such clinical trials not described in clause (i) or (ii).
       ``(B) Notice of noncompliance.--If the Secretary determines 
     that the clinical trial information submitted in such a 
     summary document is false or misleading in any particular, 
     the Secretary shall notify the responsible party and give 
     such party an opportunity to remedy such noncompliance by 
     submitting the required revised clinical trial information 
     within 30 days of such notification.
       ``(f) Penalties for Noncompliance.--
       ``(1) In general.--The following acts and the causing 
     thereof are unlawful:
       ``(A) The failure to submit clinical trial information as 
     required by this section.
       ``(B) The submission of clinical trial information under 
     this section that is false or misleading in any particular in 
     violation of subsection (b)(5) or (c)(5).
       ``(2) Certain penalties.--Section 303(a) of the Federal 
     Food, Drug, and Cosmetic Act applies with respect to a 
     violation of paragraph (1) to the same extent and in the same 
     manner as such section 303(a) applies with respect to a 
     violation of section 301 of such Act.
       ``(3) Considerations.--In determining whether to apply a 
     penalty under paragraph (2) or under paragraph (4) for a 
     violation described in paragraph (1), the Secretary, acting 
     through the Commissioner of Food and Drugs, shall consider--
       ``(A) whether the responsible party promptly corrects the 
     noncompliance when provided notice;
       ``(B) whether the responsible party has engaged in a 
     pattern or practice of noncompliance; and
       ``(C) the extent to which the noncompliance involved may 
     have significantly misled health care providers or patients 
     concerning the safety or effectiveness of the drug involved.
       ``(4) Civil penalties.--
       ``(A) In general.--A person is subject to a civil penalty 
     in accordance with this paragraph if the person commits a 
     violation described in paragraph (1) and fails to correct the 
     violation by the end of the 30-day period described in 
     subparagraph (B).
       ``(B) Notification.--If a person is in violation of 
     paragraph (1), the Secretary shall notify the person of such 
     noncompliance and give the person a 30-day period to correct 
     such violation before imposing a civil penalty under this 
     paragraph.
       ``(C) Amount of penalty.--The amount of a civil penalty 
     under this subsection shall be not more than a total of 
     $15,000 for all violations adjudicated in a single proceeding 
     in the case of an individual, and not more than $10,000 per 
     day until the violation is corrected in the case of any other 
     person, except that if the person is a nonprofit entity the 
     penalty may not exceed a total of $15,000 for all violations 
     adjudicated in a single proceeding.
       ``(D) Procedures.--The provisions of paragraphs (4) through 
     (6) of section 303(f) of the Federal Food, Drug, and Cosmetic 
     Act apply to the imposition of a penalty under this 
     subsection to the same extent and in the same manner as such 
     provisions apply to a penalty imposed under such section 
     303(f).
       ``(g) Authorization of Appropriations.--There are 
     authorized to be appropriated to carry out this section 
     $10,000,000 for each fiscal year.''.
       (b) Conforming Amendments.--
       (1) Investigational new drugs.--Section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
     amended--
       (A) in paragraph (1)--
       (i) in subparagraph (C), by striking ``and'' after the 
     semicolon;
       (ii) in subparagraph (D)--

       (I) by aligning the indentation of such subparagraph with 
     the indentation of subparagraphs (A), (B), and (C); and
       (II) by striking the period at the end and inserting ``; 
     and''; and

       (iii) by adding at the end the following:
       ``(E) the submission to the Director of NIH of clinical 
     trial information for the clinical investigation at issue 
     required under section 492C of the Public Health Service Act 
     for inclusion in the registry database and the results 
     database described in such section.'';
       (B) in paragraph (3)(B)--
       (i) in clause (i), by striking ``or'' after the semicolon;
       (ii) in clause (ii), by striking the period at the end and 
     inserting ``; or''; and
       (iii) by adding at the end the following:
       ``(iii) clinical trial information for the clinical 
     investigation at issue was not submitted in compliance with 
     section 492C of the Public Health Service Act.''; and
       (C) in paragraph (4), by adding at the end the following: 
     ``The Secretary shall update such regulations to require 
     inclusion in the informed consent form a statement that 
     clinical trial information for such clinical investigation 
     will be submitted for inclusion in the registry database and 
     results database, as applicable, described in section 492C of 
     the Public Health Service Act.''.
       (2) Refusal to approve new drug application.--Section 
     505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(d)) is amended--
       (A) in the first sentence, by inserting after ``in any 
     particular;'' the following: ``or (8) the applicant failed to 
     submit the clinical trial information for any applicable 
     clinical trial as required by section 492C of the Public 
     Health Service Act;''; and
       (B) in the second sentence, by striking ``clauses (1) 
     through (6)'' and inserting ``paragraphs (1) through (8)''.
       (3) Investigational new devices.--Subparagraph (B) of 
     section 520(g)(2) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 360j(g)(2)) is amended--
       (A) by redesignating clause (iii) as clause (iv); and
       (B) by inserting after clause (ii) the following:
       ``(iii) A requirement that the person applying for an 
     exemption for a device assure that such person is in 
     compliance with the requirements of section 492C of the 
     Public Health Service Act for the submission of clinical 
     trial information for inclusion in the registry database and 
     the results database described in such section.''.
       (4) Refusal to clear new device premarket notification 
     report.--Subsection (k) of section 510 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 360) is amended--
       (A) in paragraph (1), by striking ``and'' at the end; and
       (B) in paragraph (2), by striking the period at the end and 
     inserting ``, and''; and
       (C) by adding at the end the following:
       ``(3) action taken by such person to comply with 
     requirements under section 492C of the Public Health Service 
     Act for the submission of clinical trial information for 
     inclusion in the registry database and the results database 
     described in such section.''.
       (5) Refusal to approve new device application.--Paragraph 
     (2) of section 515(d) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360e(d)) is amended--

[[Page H7592]]

       (A) in subparagraph (D), by striking ``or'' at the end;
       (B) in subparagraph (E), by striking the period at the end 
     and inserting ``; or''; and
       (C) by inserting after subparagraph (E) the following:
       ``(F) the applicant is in violation of the requirements 
     under section 492C of the Public Health Service Act for the 
     submission of clinical trial information for inclusion in the 
     registry database or the results database described in such 
     section.''.
       (c) Guidance.--Not later than 180 days after the date of 
     the enactment of this Act, the Commissioner of Food and 
     Drugs, in consultation with the Director of the National 
     Institutes of Health, shall issue guidance to clarify which 
     clinical trials are applicable clinical trials (as defined in 
     section 492C of the Public Health Service Act, as amended by 
     this section) and required to be submitted for inclusion in 
     the clinical trial registry database described in such 
     section.
       (d) Preemption.--
       (1) In general.--No State or political subdivision of a 
     State may establish or continue in effect any requirement for 
     the registration of clinical trials or any requirement for 
     the inclusion of information relating to the results of 
     clinical trials in a database.
       (2) Rule of construction.--The fact of submission of 
     clinical trial information, if submitted in compliance with 
     section 492C of the Public Health Service Act (as amended by 
     this section), that relates to a use of a drug or device not 
     included in the official labeling of the approved drug or 
     device shall not be construed by the Secretary or in any 
     administrative or judicial proceeding, as evidence of a new 
     intended use of the drug or device that is different from the 
     intended use of the drug or device set forth in the official 
     labeling of the drug or device. The availability of clinical 
     trial information through the databases under subsections (b) 
     and (c) of such section 492C, if submitted in compliance with 
     such section 492C, shall not be considered as labeling, 
     adulteration, or misbranding of the drug or device under the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.).
       (e) Effective Dates.--
       (1) Establishment of registry database and results 
     database.--Not later than 1 year after the date of the 
     enactment of this Act, the Director of NIH shall establish 
     the registry database and the results database of clinical 
     trials of drugs and devices in accordance with section 492C 
     of the Public Health Service Act (as amended by subsection 
     (a)).
       (2) Clinical trials initiated prior to operation of 
     registry database.--The responsible party (as defined in such 
     section 492C) for an applicable clinical trial (as defined in 
     such section 492C) that is initiated after the date of the 
     enactment of this Act and before the date such registry 
     database is established under paragraph (1) of this 
     subsection, shall submit required clinical trial information 
     not later than 120 days after the date such registry database 
     is established.
       (3) Clinical trials initiated after operation of registry 
     database.--The responsible party (as defined in such section 
     492C) for an applicable clinical trial (as defined in such 
     section 492C) that is initiated after the date such registry 
     database is established under paragraph (1) of this 
     subsection shall submit required clinical trial information 
     in accordance with subsection (b) of such section 492C.
       (4) Trials completed before operation of results 
     database.--
       (A) In general.--Subsection (c) of such section 492C shall 
     take effect 90 days after the date the results database is 
     established under paragraph (1) of this subsection with 
     respect to any applicable clinical trial (as defined in such 
     section 492C) that--
       (i) involves a drug to treat a serious or life-threatening 
     condition; and
       (ii) is completed between the date of the enactment of this 
     Act and such date of establishment under paragraph (1) of 
     this subsection.
       (B) Other trials.--Except as provided in subparagraph (A), 
     subsection (c) of such section 492C shall take effect 180 
     days after the date that the results database is established 
     under paragraph (1) of this subsection with respect to any 
     applicable clinical trial that is completed between the date 
     of the enactment of this Act and such date of establishment 
     under paragraph (1).
       (5) Trials completed after establishment of results 
     database.--Subsection (c) of such section 492C shall apply to 
     any clinical trial that is completed after the date that the 
     results database is established under paragraph (1) of this 
     subsection.
       (6) Retroactivity of database.--
       (A) Voluntary submissions.--The Secretary of Health and 
     Human Services (referred to in this paragraph as the 
     ``Secretary'') shall establish procedures and mechanisms to 
     allow for the voluntary submission to the Secretary--
       (i) of clinical trial information for inclusion in the 
     registry database (as defined in such section 492C) on 
     applicable clinical trials (as defined in such section 492C) 
     initiated before the date of the enactment of this Act; and
       (ii) of clinical trial information for inclusion in the 
     results database (as defined in such section 492C) on 
     applicable clinical trials (as defined in such section 492C) 
     completed before the date of the enactment of this Act.
       (B) Required submissions.--Notwithstanding the preceding 
     paragraphs of this subsection, in any case in which the 
     Secretary determines that submission of clinical trial 
     information for an applicable clinical trial (as defined in 
     such section 492C) described in clause (i) or (ii) of 
     subparagraph (A) is in the interest of the public health--
       (i) the Secretary may require that such information be 
     submitted to the Secretary in accordance with such section 
     492C; and
       (ii) failure to comply with such a requirement shall be 
     treated as a violation of the corresponding requirement of 
     such section 492C.
       (7) Status of clinicaltrials.gov website.--
       (A) In general.--After receiving public comment and not 
     later than 90 days after the date of the enactment of this 
     Act, the Secretary shall publish in the Federal Register a 
     notice determining the more efficient approach to 
     establishing the registry database described in subsection 
     (b) of such section 492C and whether such approach is--
       (i) that such registry database should expand and build 
     upon the data bank described in section 402(i) of the Public 
     Health Service Act (as in effect on the day before the date 
     of the enactment of this Act); or
       (ii) that such registry database should supplant the data 
     bank described in such section 402(i) (as in effect on the 
     day before the date of the enactment of this Act).
       (B) Clinicaltrials.gov supplanted.--If the Secretary 
     determines to apply the approach described under subparagraph 
     (A)(ii), the Secretary shall maintain an archive of the data 
     bank described in such section 402(i) (as in effect on the 
     day before the date of the enactment of this Act) on the 
     Internet website of the National Library of Medicine.

     SEC. 802. STUDY BY GOVERNMENT ACCOUNTABILITY OFFICE.

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

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

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

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355) is amended by adding at the end 
     the following subsections:
       ``(o) Postmarket Studies and Clinical Trials; Labeling.--
       ``(1) In general.--A responsible person may not introduce 
     or deliver for introduction into interstate commerce the new 
     drug involved if the person is in violation of a requirement 
     established under paragraph (3) or (4) with respect to the 
     drug.
       ``(2) Definitions.--For purposes of this subsection:
       ``(A) Responsible person.--The term `responsible person' 
     means a person who--
       ``(i) has submitted to the Secretary a covered application 
     that is pending; or
       ``(ii) is the holder of an approved covered application.
       ``(B) Covered application.--The term `covered application' 
     means--
       ``(i) an application under subsection (b) for a drug that 
     is subject to section 503(b); and
       ``(ii) an application under section 351 of the Public 
     Health Service Act.
       ``(C) New safety information; serious risk.--The terms `new 
     safety information', `serious risk', and `signal of a serious 
     risk' have the meanings given such terms in section 505-1(b).
       ``(3) Studies and clinical trials.--
       ``(A) In general.--For any or all of the purposes specified 
     in subparagraph (B), the Secretary may, subject to 
     subparagraph (C), require a responsible person for a drug to 
     conduct a postapproval study or studies of the drug, or a 
     postapproval clinical trial or trials of the drug, on the 
     basis of scientific information, including information 
     regarding chemically-related or pharmacologically-related 
     drugs.
       ``(B) Purposes of study or trial.--The purposes referred to 
     in this subparagraph with respect to a postapproval study or 
     postapproval clinical trial are the following:
       ``(i) To assess a known serious risk related to the use of 
     the drug involved.
       ``(ii) To assess signals of serious risk related to the use 
     of the drug.
       ``(iii) To identify a serious risk.
       ``(C) Establishment of requirement after approval of 
     covered application.--The Secretary may require a 
     postapproval study or studies or postapproval trial or trials 
     for a drug for which an approved covered application is in 
     effect as of the date on which the Secretary seeks to 
     establish such requirement only if the Secretary becomes 
     aware of new safety information. For each study required to 
     be conducted under this subparagraph, the Secretary shall 
     require that the applicant submit a timetable for completion 
     of the study and shall require the applicant to periodically 
     report to the Secretary on the status of the study. Unless 
     the applicant demonstrates good cause for failure to comply 
     with such timeline, the applicant shall be in violation of 
     this subsection.

[[Page H7593]]

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

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

       ``(a) Submission of Proposed Strategy.--
       ``(1) Initial approval.--A person who submits an 
     application referred to in section 505(p)(1)(A) (referred to 
     in this section as a `covered application') shall submit to 
     the Secretary as part of the application a proposed risk 
     evaluation and mitigation strategy if the Secretary 
     determines such a strategy is necessary to ensure that the 
     benefits of the drug involved outweigh the risks of the drug. 
     In making such a determination, the Secretary shall consider 
     the statement submitted by the person under section 505(p)(2) 
     with respect to the drug and shall consider the following 
     factors:
       ``(A) The estimated size of the population likely to use 
     the drug involved.
       ``(B) The seriousness of the disease or condition that is 
     to be treated with the drug.
       ``(C) The expected benefit of the drug with respect to such 
     disease or condition.
       ``(D) The expected or actual duration of treatment with the 
     drug.
       ``(E) The seriousness of any known or potential adverse 
     events that may be related to the drug and the background 
     incidence of such events in the population likely to use the 
     drug.
       ``(F) The availability and safety of a drug or other 
     treatment, if any, for such disease or condition to which the 
     safety of the drug may be compared.
       ``(G) Whether the drug is a new molecular entity.
       ``(2) Postapproval requirement.--
       ``(A) In general.--If the Secretary approves a covered 
     application and does not when approving the application 
     require a risk evaluation and mitigation strategy under 
     paragraph (1), the Secretary may subsequently require such a 
     strategy for the drug involved if the Secretary becomes aware 
     of new safety information and makes a determination that such 
     a strategy is necessary to ensure that the benefits of the 
     drug outweigh the risks of the drug.
       ``(B) Submission of proposed strategy.--Not later than 120 
     days after the Secretary notifies the holder of an approved 
     covered application that the Secretary has made a 
     determination under subparagraph (A) with respect to the drug 
     involved, or within such other time as the Secretary requires 
     to protect the public health, the holder shall submit to the 
     Secretary a proposed risk evaluation and mitigation strategy.
       ``(3) Approval of new indication for use.--The 
     applicability of paragraph (2) includes applicability to a 
     drug for which an approved covered application was in effect 
     on the day before the effective date of this section and for 
     which, on or after such effective date, the holder of the 
     approved application submits to the Secretary a supplemental 
     application seeking approval of a new indication for use of 
     the drug.
       ``(4) Abbreviated new drug applications.--The applicability 
     of this section to an application under section 505(j) is 
     subject to subsection (i).
       ``(b) Definitions.--For purposes of this section:
       ``(1) Adverse drug experience.--The term `adverse drug 
     experience' means any adverse event associated with the use 
     of a drug in humans, whether or not considered drug related, 
     including--
       ``(A) an adverse event occurring in the course of the use 
     of the drug in professional practice;
       ``(B) an adverse event occurring from an overdose of the 
     drug, whether accidental or intentional;
       ``(C) an adverse event occurring from abuse of the drug;
       ``(D) an adverse event occurring from withdrawal of the 
     drug; and
       ``(E) any failure of expected pharmacological action of the 
     drug.
       ``(2) Covered application.--The term `covered application' 
     has the meaning indicated for such term in subsection (a)(1).
       ``(3) New safety information.--The term `new safety 
     information' with respect to a drug means information about--
       ``(A) a serious risk or an unexpected serious risk 
     associated with use of the drug that the Secretary has become 
     aware of since the drug was approved, since the risk 
     evaluation and mitigation strategy was required, or since the 
     last assessment of the approved risk evaluation and 
     mitigation strategy for the drug; or
       ``(B) the effectiveness of the approved risk evaluation and 
     mitigation strategy for the drug obtained since the last 
     assessment of such strategy.

[[Page H7594]]

       ``(4) Serious adverse drug experience.--The term `serious 
     adverse drug experience' is an adverse event that--
       ``(A) results in--
       ``(i) death;
       ``(ii) an adverse drug experience that places the patient 
     at immediate risk of death from the adverse drug experience 
     as it occurred (not including an adverse drug experience that 
     might have caused death had it occurred in a more severe 
     form);
       ``(iii) inpatient hospitalization or prolongation of 
     existing hospitalization;
       ``(iv) a persistent or significant incapacity or 
     substantial disruption of the ability to conduct normal life 
     functions; or
       ``(v) a congenital anomaly or birth defect; or
       ``(B) based on appropriate medical judgment, may jeopardize 
     the patient and may require a medical or surgical 
     intervention to prevent an outcome described under 
     subparagraph (A).
       ``(5) Serious risk.--The term `serious risk' means a risk 
     of a serious adverse drug experience.
       ``(6) Signal of a serious risk.--The term `signal of a 
     serious risk' means information related to a serious adverse 
     drug experience associated with use of a drug and derived 
     from--
       ``(A) a clinical trial;
       ``(B) adverse event reports;
       ``(C) a postapproval study, including a study under section 
     505(o)(3);
       ``(D) peer-reviewed biomedical literature; or
       ``(E) data derived from a postmarket risk identification 
     and analysis system under section 505(k)(3).
       ``(7) Responsible person.--The term `responsible person' 
     has the meaning indicated for such term in subsection (e)(2).
       ``(8) Unexpected serious risk.--The term `unexpected 
     serious risk' means a serious adverse drug experience that is 
     not listed in the labeling of a drug, or that may be 
     symptomatically and pathophysiologically related to an 
     adverse drug experience identified in the labeling, but 
     differs from such adverse drug experience because of greater 
     severity, specificity, or prevalence.
       ``(c) Contents.--A proposed risk evaluation and mitigation 
     strategy under subsection (a) shall--
       ``(1) include the timetable required under subsection (d); 
     and
       ``(2) to the extent required by the Secretary, include 
     additional elements described in subsections (e) and (f).
       ``(d) Minimal Strategy.--For purposes of subsection (c)(1), 
     the risk evaluation and mitigation strategy for a drug shall 
     require a timetable for submission of assessments of the 
     strategy that--
       ``(1) is not less frequent than once annually for the first 
     3 years after the strategy is initially approved;
       ``(2) includes an assessment in the seventh year after the 
     strategy is so approved; and
       ``(3) subject to paragraph (2), for subsequent years--
       ``(A) is at a frequency specified in the strategy;
       ``(B) is increased or reduced in frequency as necessary as 
     provided for in subsection (g)(4)(A); and
       ``(C) is eliminated after the 3-year period described in 
     paragraph (1) if the Secretary determines that serious risks 
     of the drug have been adequately identified and assessed and 
     are being adequately managed.
       ``(e) Additional Potential Elements of Strategy.--
       ``(1) In general.--The Secretary may under subsection 
     (c)(2) require that the risk evaluation and mitigation 
     strategy for a drug include 1 or more of the additional 
     elements described in this subsection if the Secretary makes 
     the determination required with respect to the element 
     involved.
       ``(2) Medguide; patient package insert.--The risk 
     evaluation and mitigation strategy for a drug may require 
     that, as applicable, the person submitting the covered 
     application or the holder of the approved such application 
     (referred to in this section as the `responsible person') 
     develop for distribution to each patient when the drug is 
     dispensed--
       ``(A) a Medication Guide, as provided for under part 208 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations); and
       ``(B) a patient package insert, if the Secretary determines 
     that such insert may help mitigate a serious risk of the 
     drug.
       ``(3) Communication plan.--The risk evaluation and 
     mitigation strategy for a drug may require that the 
     responsible person conduct a communication plan to health 
     care providers, if, with respect to such drug, the Secretary 
     determines that such plan may support implementation of an 
     element of the strategy. Such plan may include--
       ``(A) sending letters to health care providers;
       ``(B) disseminating information about the elements of the 
     risk evaluation and mitigation strategy to encourage 
     implementation by health care providers of components that 
     apply to such health care providers, or to explain certain 
     safety protocols (such as medical monitoring by periodic 
     laboratory tests); or
       ``(C) disseminating information to health care providers 
     through professional societies about any serious risks of the 
     drug and any protocol to assure safe use.
       ``(f) Restrictions on Distribution or Use.--
       ``(1) In general.--If the Secretary determines that a drug 
     shown to be effective can be safely used only if distribution 
     or use of such drug is restricted, the Secretary may under 
     subsection (c)(2) require as elements of the risk evaluation 
     and mitigation strategy such restrictions on distribution or 
     use as are needed to ensure safe use of the drug.
       ``(2) Assuring access and minimizing burden.--Elements of a 
     risk evaluation and mitigation strategy included under 
     paragraph (1) shall--
       ``(A) be commensurate with a specific serious risk listed 
     in the labeling of the drug;
       ``(B) be posted publicly by the Secretary with an 
     explanation of how such elements will mitigate the observed 
     safety risk, which posting shall be made within 30 days after 
     the date on which the Secretary requires the element 
     involved;
       ``(C) considering the risk referred to in subparagraph (A), 
     not be unduly burdensome on patient access to the drug, 
     considering in particular--
       ``(i) patients with serious or life-threatening diseases or 
     conditions; and
       ``(ii) patients who have difficulty accessing health care 
     (such as patients in rural or medically underserved areas); 
     and
       ``(D) to the extent practicable, so as to minimize the 
     burden on the health care delivery system--
       ``(i) conform with elements to assure safe use for other 
     drugs with similar, serious risks; and
       ``(ii) be designed to be compatible with established 
     distribution, procurement, and dispensing systems for drugs.
       ``(3) Elements.--The restrictions on distribution or use 
     described in paragraph (1) shall include 1 or more goals to 
     evaluate or mitigate a serious risk listed in the labeling of 
     the drug, and may require that--
       ``(A) health care providers that prescribe the drug have 
     special training or experience, or are specially certified, 
     which training or certification with respect to the drug is 
     available to any willing provider from a frontier area;
       ``(B) pharmacies, practitioners, or health care settings 
     that dispense the drug are specially certified, which 
     training or certification with respect to the drug is 
     available to any willing provider from a frontier area;
       ``(C) the drug be dispensed to patients only in certain 
     health care settings, such as hospitals;
       ``(D) the drug be dispensed to patients with evidence or 
     other documentation of safe-use conditions, such as 
     laboratory test results;
       ``(E) each patient using the drug be subject to certain 
     monitoring; or
       ``(F) each patient using the drug be enrolled in a 
     registry.
       ``(4) Implementation system.--The restrictions on 
     distribution or use described in paragraph (1) may require a 
     system through which the responsible person is able to--
       ``(A) monitor and evaluate implementation of the 
     restrictions by health care providers, pharmacists, patients, 
     and other parties in the health care system who are 
     responsible for implementing the restrictions;
       ``(B) work to improve implementation of the restrictions by 
     health care providers, pharmacists, patients, and other 
     parties in the health care system who are responsible for 
     implementing the restrictions; and
       ``(C) notify wholesalers of the drug of those health care 
     providers--
       ``(i) who are responsible for implementing the 
     restrictions; and
       ``(ii) whom the responsible person knows have failed to 
     meet their responsibilities for implementing the 
     restrictions, after the responsible person has informed such 
     party of such failure and such party has not remedied such 
     failure.
       ``(5) Limitation.--No holder of an approved application 
     shall use any restriction on distribution required by the 
     Secretary as necessary to assure safe use of the drug to 
     block or delay approval of an application under section 
     505(b)(2) or (j) or to prevent application of such 
     restriction under subsection (i)(1)(B) to a drug that is the 
     subject of an abbreviated new drug application.
       ``(6) Bioequivalence testing.--Notwithstanding any other 
     provisions in this subsection, the holder of an approved 
     application that is subject to distribution restrictions 
     required under this subsection that limit the ability of a 
     sponsor seeking approval of an application under subsection 
     505(b)(2) or (j) to purchase on the open market a sufficient 
     quantity of drug to conduct bioequivalence testing shall 
     provide to such a sponsor a sufficient amount of drug to 
     conduct bioequivalence testing if the sponsor seeking 
     approval under section 505(b)(2) or (j)--
       ``(A) agrees to such restrictions on distribution as the 
     Secretary finds necessary to assure safe use of the drug 
     during bioequivalence testing; and
       ``(B) pays the holder of the approved application the fair 
     market value of the drug purchased for bioequivalence 
     testing.
       ``(7) Letter by secretary.--Upon a showing by the sponsor 
     seeking approval under section 505(b)(2) or (j) that the 
     sponsor has agreed to such restrictions necessary to assure 
     safe use of the drug during bioequivalence testing, the 
     Secretary shall issue to the sponsor seeking to conduct 
     bioequivalence testing a letter that describes the 
     Secretary's finding which shall serve as proof that the 
     sponsor has satisfied the requirements of subparagraph 
     (6)(A).
       ``(8) Evaluation of elements to assure safe use.--The 
     Secretary, acting through

[[Page H7595]]

     the Drug Safety and Risk Management Advisory Committee (or 
     any successor committee) of the Food and Drug Administration, 
     shall--
       ``(A) seek input from patients, physicians, pharmacists, 
     and other health care providers about how elements to assure 
     safe use under this subsection for 1 or more drugs may be 
     standardized so as not to be--
       ``(i) unduly burdensome on patient access to the drug; and
       ``(ii) to the extent practicable, minimize the burden on 
     the health care delivery system;
       ``(B) at least annually, evaluate, for 1 or more drugs, the 
     elements to assure safe use of such drug to assess whether 
     the elements--
       ``(i) assure safe use of the drug;
       ``(ii) are not unduly burdensome on patient access to the 
     drug; and
       ``(iii) to the extent practicable, minimize the burden on 
     the health care delivery system; and
       ``(C) considering such input and evaluations--
       ``(i) issue or modify agency guidance about how to 
     implement the requirements of this subsection; and
       ``(ii) modify elements under this subsection for 1 or more 
     drugs as appropriate.
       ``(9) Waiver in public health emergencies.--The Secretary 
     may waive any restriction on distribution or use under this 
     subsection during the period described in section 319(a) of 
     the Public Health Service Act with respect to a qualified 
     countermeasure described under section 319F-1(a)(2) of such 
     Act, to which a restriction or use under this subsection has 
     been applied, if the Secretary has--
       ``(A) declared a public health emergency under such section 
     319; and
       ``(B) determined that such waiver is required to mitigate 
     the effects of, or reduce the severity of, such public health 
     emergency.
       ``(g) Assessment and Modification of Approved Strategy.--
       ``(1) Voluntary assessments.--After the approval of a risk 
     evaluation and mitigation strategy under subsection (a), the 
     responsible person involved may, subject to paragraph (2), 
     submit to the Secretary an assessment of, and propose a 
     modification to, the approved strategy for the drug involved 
     at any time.
       ``(2) Required assessments.--A responsible person shall, 
     subject to paragraph (5), submit an assessment of, and may 
     propose a modification to, the approved risk evaluation and 
     mitigation strategy for a drug--
       ``(A) when submitting a supplemental application for a new 
     indication for use under section 505(b) or under section 351 
     of the Public Health Service Act, unless the drug is not 
     subject to section 503(b) and the risk evaluation and 
     mitigation strategy for the drug includes only the timetable 
     under subsection (d);
       ``(B) when required by the strategy, as provided for in 
     such timetable under subsection (d);
       ``(C) within a time period to be determined by the 
     Secretary, if the Secretary determines that new safety or 
     effectiveness information indicates that--
       ``(i) an element under subsection (d) or (e) should be 
     modified or included in the strategy; or
       ``(ii) an element under subsection (f) should be modified 
     or included in the strategy; or
       ``(D) within 15 days when ordered by the Secretary, if the 
     Secretary determines that there may be a cause for action by 
     the Secretary under section 505(e).
       ``(3) Requirements for assessments.--An assessment under 
     paragraph (1) or (2) of an approved risk evaluation and 
     mitigation strategy for a drug shall include--
       ``(A) with respect to any goal under subsection (f), an 
     assessment of the extent to which the restrictions on 
     distribution or use are meeting the goal or whether the goal 
     or such restrictions should be modified;
       ``(B) with respect to any postapproval study required under 
     section 505(o)(3), the status of such study, including 
     whether any difficulties completing the study have been 
     encountered; and
       ``(C) with respect to any postapproval clinical trial 
     required under section 505(o), the status of such clinical 
     trial, including whether enrollment has begun, the number of 
     participants enrolled, the expected completion date, whether 
     any difficulties completing the clinical trial have been 
     encountered, and registration information with respect to 
     requirements under section 492C of the Public Health Service 
     Act.
       ``(4) Modification.--A modification (whether an enhancement 
     or a reduction) to the approved risk evaluation and 
     mitigation strategy for a drug may include the addition or 
     modification of any element under subsection (d) or the 
     addition, modification, or removal of any element under 
     subsection (e) or (f), such as--
       ``(A) modifying the timetable for assessments of the 
     strategy under subsection (d), including to eliminate 
     assessments; or
       ``(B) adding, modifying, or removing a restriction on 
     distribution or use under subsection (f).
       ``(5) No effect on labeling changes that do not require 
     preapproval.--In the case of a labeling change to which 
     section 314.70 of title 21, Code of Federal Regulations (or 
     any successor regulation), applies for which the submission 
     of a supplemental application is not required or for which 
     distribution of the drug involved may commence upon the 
     receipt by the Secretary of a supplemental application for 
     the change, the submission of an assessment of the approved 
     risk evaluation and mitigation strategy for the drug under 
     paragraph (2) is not required.
       ``(h) Review of Proposed Strategies; Review of Assessments 
     of Approved Strategies.--
       ``(1) In general.--The Secretary shall promptly review each 
     proposed risk evaluation and mitigation strategy for a drug 
     submitted under subsection (a) and each assessment of an 
     approved risk evaluation and mitigation strategy for a drug 
     submitted under subsection (g).
       ``(2) Marketing plan.--
       ``(A) In general.--As part of a review conducted under this 
     subsection, the Secretary may require the applicant to submit 
     information regarding its marketing plan and practices for 
     the drug, so as to allow the Secretary to determine whether 
     any of the proposed or ongoing marketing activities undermine 
     any of the requirements of the risk evaluation and mitigation 
     strategy.
       ``(B) Rule of construction.--Subparagraph (A) may not be 
     construed as authorizing the Secretary to make or direct any 
     change in the marketing plan or practices involved. The 
     preceding sentence does not affect any authority of the 
     Secretary under this Act, other than the authority of the 
     Secretary under subparagraph (A).
       ``(3) Discussion.--The Secretary shall initiate discussions 
     with a responsible person for purposes of this subsection to 
     determine a strategy--
       ``(A) if the proposed strategy is submitted as part of an 
     application or supplemental application under subsection (a) 
     or subsection (g)(2)(A), not less than 60 days before the 
     action deadline for the application that has been agreed to 
     by the Secretary and that has been set forth in goals 
     identified in letters of the Secretary (relating to the use 
     of fees collected under section 736 to expedite the drug 
     development process and the process for the review of human 
     drug applications);
       ``(B) if the assessment is submitted under subparagraph (B) 
     or (C) or subsection (g)(2), not later than 20 days after 
     such submission;
       ``(C) if the assessment is submitted under subsection 
     (g)(1) or subsection (g)(2)(D) , not later than 30 days after 
     such submission; or
       ``(D) if the assessment is submitted under subsection 
     (g)(2)(D), not later than 10 days after such submission.
       ``(4) Action.--
       ``(A) In general.--Unless the responsible person requests 
     the dispute resolution process described under paragraph (5), 
     the Secretary shall approve and describe the risk evaluation 
     and mitigation strategy for a drug, or any modification to 
     the strategy--
       ``(i) as part of the action letter on the application, when 
     a proposed strategy is submitted under subsection (a) or an 
     assessment of the strategy is submitted under subsection 
     (g)(1); or
       ``(ii) in an order issued not later than 50 days after the 
     date discussions of such modification begin under paragraph 
     (3), when an assessment of the strategy is submitted under 
     subsection (g)(1) or under any of subparagraphs (B) through 
     (D) of subsection (g)(2).
       ``(B) Inaction.--An approved risk evaluation and mitigation 
     strategy shall remain in effect until the Secretary acts, if 
     the Secretary fails to act as provided under subparagraph 
     (A).
       ``(C) Public availability.--Any action letter described in 
     subparagraph (A)(i) or order described in subparagraph 
     (A)(ii) shall be made publicly available.
       ``(5) Dispute resolution.--
       ``(A) Request for review.--
       ``(i) In general.--Not earlier than 15 days, and not later 
     than 35 days, after discussions under paragraph (3) have 
     begun, the responsible person may request in writing that a 
     dispute about the strategy be reviewed by the Drug Safety 
     Oversight Board under subsection (j), except that the 
     determination of the Secretary to require a risk evaluation 
     and mitigation strategy is not subject to review under this 
     paragraph. The preceding sentence does not prohibit review 
     under this paragraph of the particular elements of such a 
     strategy.
       ``(ii) Scheduling.--Upon receipt of a request under clause 
     (i), the Secretary shall schedule the dispute involved for 
     review under subparagraph (B) and, not later than 5 business 
     days of scheduling the dispute for review, shall publish by 
     posting on the Internet or otherwise a notice that the 
     dispute will be reviewed by the Drug Safety Oversight Board.
       ``(B) Scheduling review.--If a responsible person requests 
     review under subparagraph (A), the Secretary--
       ``(i) shall schedule the dispute for review at 1 of the 
     next 2 regular meetings of the Drug Safety Oversight Board, 
     whichever meeting date is more practicable; or
       ``(ii) may convene a special meeting of the Drug Safety 
     Oversight Board to review the matter more promptly, including 
     to meet an action deadline on an application (including a 
     supplemental application).
       ``(C) Agreement after discussion or administrative 
     appeals.--
       ``(i) Further discussion or administrative appeals.--A 
     request for review under subparagraph (A) shall not preclude 
     further discussions to reach agreement on the risk evaluation 
     and mitigation strategy, and such a request shall not 
     preclude the use of administrative appeals within the Food 
     and

[[Page H7596]]

     Drug Administration to reach agreement on the strategy, 
     including appeals as described in letters of the Secretary 
     (relating to the use of fees collected under section 736 to 
     expedite the drug development process and the process for the 
     review of human drug applications) for procedural or 
     scientific matters involving the review of human drug 
     applications and supplemental applications that cannot be 
     resolved at the divisional level.
       ``(ii) Agreement terminates dispute resolution.--At any 
     time before a decision and order is issued under subparagraph 
     (G) , the Secretary and the responsible person may reach an 
     agreement on the risk evaluation and mitigation strategy 
     through further discussion or administrative appeals, 
     terminating the dispute resolution process, and the Secretary 
     shall issue an action letter or order, as appropriate, that 
     describes the strategy.
       ``(D) Meeting of the board.--At a meeting of the Drug 
     Safety Oversight Board described in subparagraph (B), the 
     Board shall--
       ``(i) hear from both parties; and
       ``(ii) review the dispute.
       ``(E) Record of proceedings.--The Secretary shall ensure 
     that the proceedings of any such meeting are recorded, 
     transcribed, and made public within 30 days of the meeting. 
     The Secretary shall redact the transcript to protect any 
     trade secrets or other confidential information described in 
     section 552(b)(4) of title 5, United States Code.
       ``(F) Recommendation of the board.--Not later than 5 days 
     after any such meeting, the Drug Safety Oversight Board shall 
     provide a written recommendation on resolving the dispute to 
     the Secretary. Not later than 5 days after the Board provides 
     such written recommendation to the Secretary, the Secretary 
     shall make the recommendation available to the public.
       ``(G) Action by the secretary.--
       ``(i) Action letter.--With respect to a proposal or 
     assessment referred to in paragraph (1), the Secretary shall 
     issue an action letter that resolves the dispute not later 
     than the later of--

       ``(I) the action deadline referred to in paragraph (3)(A); 
     or
       ``(II) 7 days after receiving the recommendation of the 
     Drug Safety Oversight Board.

       ``(ii) Order.--With respect to an assessment of an approved 
     risk evaluation and mitigation strategy under subsection 
     (g)(1) or under any of subparagraphs (B) through (D) of 
     subsection (g)(2), the Secretary shall issue an order, which 
     shall be made public, that resolves the dispute not later 
     than 7 days after receiving the recommendation of the Drug 
     Safety Oversight Board.
       ``(H) Inaction.--An approved risk evaluation and mitigation 
     strategy shall remain in effect until the Secretary acts, if 
     the Secretary fails to act as provided for under subparagraph 
     (G).
       ``(I) Effect on action deadline.--With respect to a 
     proposal or assessment referred to in paragraph (1), the 
     Secretary shall be considered to have met the action deadline 
     referred to in paragraph (3)(A) with respect to the 
     application involved if the responsible person requests the 
     dispute resolution process described in this paragraph and if 
     the Secretary--
       ``(i) has initiated the discussions described under 
     paragraph (3) not less than 60 days before such action 
     deadline; and
       ``(ii) has complied with the timing requirements of 
     scheduling review by the Drug Safety Oversight Board, 
     providing a written recommendation, and issuing an action 
     letter under subparagraphs (B), (F), and (G), respectively.
       ``(J) Disqualification.--No individual who is an employee 
     of the Food and Drug Administration and who reviews a drug or 
     who participated in an administrative appeal under 
     subparagraph (C)(i) with respect to such drug may serve on 
     the Drug Safety Oversight Board at a meeting under 
     subparagraph (D) to review a dispute about the risk 
     evaluation and mitigation strategy for such drug.
       ``(K) Additional expertise.--The Drug Safety Oversight 
     Board may add members with relevant expertise from the Food 
     and Drug Administration, including the Office of Pediatrics, 
     the Office of Women's Health, or the Office of Rare Diseases, 
     or from other Federal public health or health care agencies, 
     for a meeting under subparagraph (D) of the Drug Safety 
     Oversight Board.
       ``(6) Use of advisory committees.--The Secretary may 
     convene a meeting of 1 or more advisory committees of the 
     Food and Drug Administration to--
       ``(A) review a concern about the safety of a drug or class 
     of drugs, including before an assessment of the risk 
     evaluation and mitigation strategy or strategies of such drug 
     or drugs is required to be submitted under any of 
     subparagraphs (B) through (D) of subsection (g)(2);
       ``(B) review the risk evaluation and mitigation strategy or 
     strategies of a drug or group of drugs; or
       ``(C) review a dispute under paragraph (5).
       ``(7) Process for addressing drug class effects.--
       ``(A) In general.--When a concern about a serious risk of a 
     drug may be related to the pharmacological class of the drug, 
     the Secretary may defer assessments of the approved risk 
     evaluation and mitigation strategies for such drugs until the 
     Secretary has convened 1 or more public meetings to consider 
     possible responses to such concern. If the Secretary defers 
     an assessment under this subparagraph, the Secretary shall 
     give notice to the public of the deferral not later than 5 
     days of the deferral.
       ``(B) Public meetings.--Such public meetings may include--
       ``(i) 1 or more meetings of the reviewed entities for such 
     drugs;
       ``(ii) 1 or more meetings of 1 or more advisory committees 
     of the Food and Drug Administration, as provided for under 
     paragraph (6); or
       ``(iii) 1 or more workshops of scientific experts and other 
     stakeholders.
       ``(C) Action.--After considering the discussions from any 
     meetings under subparagraph (B), the Secretary may--
       ``(i) announce in the Federal Register a planned regulatory 
     action, including a modification to each risk evaluation and 
     mitigation strategy, for drugs in the pharmacological class;
       ``(ii) seek public comment about such action; and
       ``(iii) after seeking such comment, issue an order 
     addressing such regulatory action.
       ``(8) International coordination.--The Secretary may 
     coordinate the timetable for submission of assessments under 
     subsection (d), or a study or clinical trial under section 
     505(o)(3), with efforts to identify and assess the serious 
     risks of such drug by the marketing authorities of other 
     countries whose drug approval and risk management processes 
     the Secretary deems comparable to the drug approval and risk 
     management processes of the United States. If the Secretary 
     takes action to coordinate such timetable, the Secretary 
     shall give notice to the public of the action not later than 
     5 days after the action.
       ``(9) Effect.--Use of the processes described in paragraphs 
     (7) and (8) shall not delay action on an application or a 
     supplement to an application for a drug.
       ``(i) Abbreviated New Drug Applications.--
       ``(1) In general.--A drug that is the subject of an 
     abbreviated new drug application under section 505(j) is 
     subject to only the following elements of the risk evaluation 
     and mitigation strategy required under subsection (a) for the 
     applicable listed drug:
       ``(A) A Medication Guide or patient package insert, if 
     required under subsection (e) for the applicable listed drug.
       ``(B) Restrictions on distribution or use, if required 
     under subsection (f) for the listed drug. A drug that is the 
     subject of an abbreviated new drug application and the listed 
     drug shall use a single, shared system under subsection 
     (f)(4). The Secretary may waive the requirement under the 
     preceding sentence for a drug that is the subject of an 
     abbreviated new drug application if the Secretary determines 
     that--
       ``(i) it is not practical for the drug to use such single, 
     shared system; or
       ``(ii) the burden of using the single, shared system 
     outweighs the benefit of using the single system.
       ``(2) Action by secretary.--For an applicable listed drug 
     for which a drug is approved under section 505(j), the 
     Secretary--
       ``(A) shall undertake any communication plan to health care 
     providers required under subsection (e)(3) for the applicable 
     listed drug; and
       ``(B) shall inform the responsible person for the drug that 
     is so approved if the risk evaluation and mitigation strategy 
     for the applicable listed drug is modified.
       ``(j) Drug Safety Oversight Board.--
       ``(1) In general.--There is established a Drug Safety 
     Oversight Board.
       ``(2) Composition; meetings.--The Drug Safety Oversight 
     Board shall--
       ``(A) be composed of scientists and health care 
     practitioners appointed by the Secretary, each of whom is an 
     employee of the Federal Government;
       ``(B) include representatives from offices throughout the 
     Food and Drug Administration;
       ``(C) include at least 1 representative from each of the 
     National Institutes of Health and the Department of Health 
     and Human Services (other than the Food and Drug 
     Administration);
       ``(D) include such representatives as the Secretary shall 
     designate from other appropriate agencies that wish to 
     provide representatives; and
       ``(E) meet at least monthly to provide oversight and advice 
     to the Secretary on the management of important drug safety 
     issues.''.
       (c) Regulation of Biological Products.--Section 351 of the 
     Public Health Service Act (42 U.S.C. 262) is amended--
       (1) in subsection (a)(2), by adding at the end the 
     following:
       ``(D) Risk Evaluation and Mitigation Strategy.--A person 
     that submits an application for a license under this 
     paragraph is subject to section 505(p) of the Federal Food, 
     Drug, and Cosmetic Act.''; and
       (2) in subsection (j), by inserting ``, including the 
     requirements under section 505(p) of such Act,'' after ``, 
     and Cosmetic Act''.
       (d) Prereview of Advertisements.--
       (1) Sense of congress.--It is the sense of the Congress 
     that--
       (A) ``Guidance for Industry Consumer-Directed Broadcast 
     Advertisements'' issued by the Food and Drug Administration 
     in August, 1999, represents generally good guidance for 
     direct-to-consumer (DTC) advertising of prescription 
     medicines and other treatments;
       (B) direct-to-consumer advertising as an accurate source of 
     health information for all populations, specifically 
     including the elderly populations, children, chronically ill 
     and racial and ethnic minority populations,

[[Page H7597]]

     should be made more reliable by ensuring the truth and 
     credibility of information provided through such advertising; 
     and
       (C) the Congress will work with the Food and Drug 
     Administration to ensure that information provided through 
     direct-to-consumer advertising of prescription medicines and 
     other treatments is not false or misleading and communicates 
     clearly and sensitively to all communities.
       (2) Prereview.--The Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 301 et seq.) is amended--
       (A) in section 301 (21 U.S.C. 331), by adding at the end 
     the following:
       ``(jj) The dissemination of a television advertisement 
     without complying with section 503B.''; and
       (B) by inserting after section 503A the following:

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

       ``(a) In General.--The Secretary may require the submission 
     of any television advertisement for a drug (including any 
     script, story board, rough, or a completed video production 
     of the television advertisement) to the Secretary for review 
     under this section not later than 45 days before 
     dissemination of the television advertisement.
       ``(b) Review.--In conducting a review of a television 
     advertisement under this section, the Secretary may make 
     recommendations--
       ``(1) on changes that are--
       ``(A) necessary to protect the consumer good and well-
     being; or
       ``(B) consistent with prescribing information for the 
     product under review; and
       ``(2) if appropriate and if information exists, on 
     statements for inclusion in the advertisement to address the 
     specific efficacy of the drug as it relates to a specific 
     population group, including elderly populations, children, 
     and racially and ethnically diverse populations.
       ``(c) No Authority To Require Changes.--This section does 
     not authorize the Secretary to make or direct changes in any 
     material submitted pursuant to subsection (a).
       ``(d) Elderly Populations, Children, Racially and 
     Ethnically Diverse Communities.--In formulating 
     recommendations under subsection (b), the Secretary shall 
     take into consideration the impact of the advertised drug on 
     elderly populations, children, and racially and ethnically 
     diverse communities.
       ``(e) Specific Disclosures.--
       ``(1) Serious risk; safety protocol.--In conducting a 
     review of a television advertisement under this section, if 
     the Secretary determines that the advertisement would be 
     false or misleading without a specific disclosure about a 
     serious risk listed in the labeling of the drug involved, the 
     Secretary may require inclusion of such disclosure in the 
     advertisement.
       ``(2) Date of approval.--In conducting a review of a 
     television advertisement under this section, the Secretary 
     may require the advertisement to include, for a period not to 
     exceed 2 years from the date of the approval of the drug 
     under section 505, a specific disclosure of such date of 
     approval if the Secretary determines that the advertisement 
     would otherwise be false or misleading.
       ``(f) Rule of Construction.--Nothing in this section may be 
     construed as having any effect on the authority of the 
     Secretary under section 314.550, 314.640, 601.45, or 601.94 
     of title 21, Code of Federal Regulations (or successor 
     regulations).''.
       (3) Direct-to-consumer advertisements.--
       (A) In general.--Section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) is amended by adding at 
     the end the following: ``In the case of an advertisement for 
     a drug subject to section 503(b)(1) presented directly to 
     consumers in television or radio format and stating the name 
     of the drug and its conditions of use, the major statement 
     relating to side effects and contraindications shall be 
     presented in a clear and conspicuous manner.''.
       (B) Regulations to determine clear and conspicuous 
     manner.--The Secretary of Health and Human Services shall by 
     regulation establish standards for determining whether a 
     major statement relating to side effects and 
     contraindications of a drug, described in section 502(n) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352(n)) 
     (as amended by subparagraph (A)) is presented in the manner 
     required under such section.
       (4) Civil penalties.--Section 303 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 333) is amended--
       (A) by redesignating subsection (g) (relating to civil 
     penalties) as subsection (f); and
       (B) by adding at the end the following:
       ``(g)(1) With respect to a person who is a holder of an 
     approved application under section 505 for a drug subject to 
     section 503(b) or under section 351 of the Public Health 
     Service Act, any such person who disseminates a direct-to-
     consumer advertisement that is false or misleading shall be 
     liable to the United States for a civil penalty in an amount 
     not to exceed $250,000 for the first such violation in any 3-
     year period, and not to exceed $500,000 for each subsequent 
     violation in any 3-year period. No other civil monetary 
     penalties in this Act (including the civil penalty in section 
     303(f)(3)) shall apply to a violation regarding direct-to-
     consumer advertising. For purposes of this paragraph: (A) 
     Repeated dissemination of the same or similar advertisement 
     prior to the receipt of the written notice referred to in 
     paragraph (2) for such advertisements shall be considered one 
     violation. (B) On and after the date of the receipt of such a 
     notice, all violations under this paragraph occurring in a 
     single day shall be considered one violation
       ``(2) A civil penalty under paragraph (1) shall be assessed 
     by the Secretary by an order made on the record after 
     providing written notice to the person to be assessed a civil 
     penalty and an opportunity for a hearing in accordance with 
     this paragraph and section 554 of title 5, United States 
     Code. If upon receipt of the written notice, the person to be 
     assessed a civil penalty objects and requests a hearing, then 
     in the course of any investigation related to such hearing, 
     the Secretary may issue subpoenas requiring the attendance 
     and testimony of witnesses and the production of evidence 
     that relates to the matter under investigation, including 
     information pertaining to the factors described in paragraph 
     (3).
       ``(3) Upon the request of the person to be assessed a civil 
     penalty under paragraph (1), the Secretary, in determining 
     the amount of the civil penalty, shall take into account the 
     nature, circumstances, extent, and gravity of the violation 
     or violations, including the following factors:
       ``(A) Whether the person submitted the advertisement or a 
     similar advertisement for review under section 736A.
       ``(B) Whether the person submitted the advertisement for 
     review if required under section 503B.
       ``(C) Whether, after submission of the advertisement as 
     described in subparagraph (A) or (B), the person disseminated 
     the advertisement before the end of the 45-day comment 
     period.
       ``(D) Whether the person incorporated any comments made by 
     the Secretary with regard to the advertisement into the 
     advertisement prior to its dissemination.
       ``(E) Whether the person ceased distribution of the 
     advertisement upon receipt of the written notice referred to 
     in paragraph (2) for such advertisement.
       ``(F) Whether the person had the advertisement reviewed by 
     qualified medical, regulatory, and legal reviewers prior to 
     its dissemination.
       ``(G) Whether the violations were material.
       ``(H) Whether the person who created the advertisement 
     acted in good faith.
       ``(I) Whether the person who created the advertisement has 
     been assessed a civil penalty under this provision within the 
     previous 1-year period.
       ``(J) The scope and extent of any voluntary, subsequent 
     remedial action by the person.
       ``(K) Such other matters, as justice may require.
       ``(4)(A) Subject to subparagraph (B), no person shall be 
     required to pay a civil penalty under paragraph (1) if the 
     person submitted the advertisement to the Secretary and 
     disseminated such advertisement after incorporating any 
     comment received from the Secretary other than a 
     recommendation subject to subsection 503B(c).
       ``(B) The Secretary may retract or modify any prior 
     comments the Secretary has provided to an advertisement 
     submitted to the Secretary based on new information or 
     changed circumstances, so long as the Secretary provides 
     written notice to the person of the new views of the 
     Secretary on the advertisement and provides a reasonable time 
     for modification or correction of the advertisement prior to 
     seeking any civil penalty under paragraph (1).
       ``(5) The Secretary may compromise, modify, or remit, with 
     or without conditions, any civil penalty which may be 
     assessed under paragraph (1). The amount of such penalty, 
     when finally determined, or the amount charged upon in 
     compromise, may be deducted from any sums owed by the United 
     States to the person charged.
       ``(6) Any person who requested, in accordance with 
     paragraph (2), a hearing with respect to the assessment of a 
     civil penalty and who is aggrieved by an order assessing a 
     civil penalty, may file a petition for de novo judicial 
     review of such order with the United States Court of Appeals 
     for the District of Columbia Circuit or for any other circuit 
     in which such person resides or transacts business. Such a 
     petition may only be filed within the 60-day period beginning 
     on the date the order making such assessments was issued.
       ``(7) On an annual basis, the Secretary shall report to the 
     Congress on direct-to-consumer advertising and its ability to 
     communicate to subsets of the general population, including 
     elderly populations, children, and racial and ethnic minority 
     communities. The Secretary shall establish a permanent 
     advisory committee to advise the Secretary with respect to 
     such report. The membership of the advisory committee shall 
     consist of nationally recognized medical, advertising, and 
     communications experts, including experts representing 
     subsets of the general population. The members of the 
     advisory committee shall serve without pay, but may receive 
     travel expenses, including per diem in lieu of subsistence in 
     accordance with applicable provisions under subchapter I of 
     chapter 57 of title 5, United States Code. The advisory 
     committee shall study direct-to-consumer advertising as it 
     relates to increased access to health information and 
     decreased health disparities for these populations. The 
     annual report required by this paragraph shall recommend 
     effective ways to present and disseminate information to 
     these populations. Such report shall also make 
     recommendations regarding impediments to the

[[Page H7598]]

     participation of elderly populations, children, racially and 
     ethnically diverse communities, and medically underserved 
     populations in clinical drug trials and shall recommend best 
     practice approaches for increasing the inclusion of such 
     subsets of the general population. The Secretary shall submit 
     the first annual report under this paragraph to the Committee 
     on Health, Education, Labor, and Pensions of the Senate and 
     the Committee on Energy and Commerce of the House of 
     Representatives not later than 18 months after the advisory 
     committee has been convened by the Secretary.
       ``(8) If any person fails to pay an assessment of a civil 
     penalty under paragraph (1)--
       ``(A) after the order making the assessment becomes final, 
     and if such person does not file a petition for judicial 
     review of the order in accordance with paragraph (6), or
       ``(B) after a court in an action brought under paragraph 
     (6) has entered a final judgment in favor of the Secretary,

     the Attorney General of the United States shall recover the 
     amount assessed (plus interest at currently prevailing rates 
     from the date of the expiration of the 60-day period referred 
     to in paragraph (6) or the date of such final judgment, as 
     the case may be) in an action brought in any appropriate 
     district court of the United States. In such an action, the 
     validity, amount, and appropriateness of such penalty shall 
     not be subject to review.''.
       (e) Rule of Construction Regarding Pediatric Studies.--This 
     title and the amendments made by this title may not be 
     construed as affecting the authority of the Secretary of 
     Health and Human Services to request pediatric studies under 
     section 505A of the Federal Food, Drug, and Cosmetic Act or 
     to require such studies under section 505B of such Act.

     SEC. 902. ENFORCEMENT.

       (a) Misbranding.--Section 502 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352) is amended by adding at the 
     end the following:
       ``(y) If it is a drug subject to an approved risk 
     evaluation and mitigation strategy pursuant to section 505(p) 
     and the person responsible for complying with the strategy 
     fails to comply with a requirement of such strategy provided 
     for under subsection (d), (e), or (f) of section 505-1.
       ``(z) If it is a drug, and the responsible person (as such 
     term is used in section 505(o)) is in violation of a 
     requirement established under paragraph (3) (relating to 
     postmarket studies and clinical trials) or paragraph (4) 
     (relating to labeling) of section 505(o) with respect to such 
     drug.''.
       (b) Civil Penalties.--Section 303(f) of the Federal Food, 
     Drug, and Cosmetic Act, as redesignated by section 901(d)(4), 
     is amended--
       (1) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (4), (5), and (6), respectively;
       (2) by inserting after paragraph (2) the following:
       ``(3) Any applicant (as such term is used in section 505-1) 
     who violates a requirement of section 505(o), section 505(p), 
     or section 505-1 shall be subject to a civil monetary penalty 
     of--
       ``(A) not more than $250,000 per violation, and not to 
     exceed $1,000,000 for all such violations adjudicated in a 
     single proceeding; or
       ``(B) in the case of a violation that continues after the 
     Secretary provides notice of such violation to the applicant, 
     not more than $10,000,000 per violation, and not to exceed 
     $50,000,000 for all such violations adjudicated in a single 
     proceeding.

     If a violation referred to in subparagraph (A) or (B) is 
     continuing in nature and poses a substantial threat to the 
     public health, the Secretary may impose a civil penalty not 
     to exceed $1,000,000 per day during such time period such 
     person is in violation.'';
       (3) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
     and inserting ``paragraph (4)(A)'';
       (4) in paragraph (4), as so redesignated, by striking 
     ``paragraph (1) or (2)'' each place it appears and inserting 
     ``paragraph (1), (2), or (3)''; and
       (5) in paragraph (6), as so redesignated, by striking 
     ``paragraph (4)'' each place it appears and inserting 
     ``paragraph (5)''.

     SEC. 903. NO EFFECT ON WITHDRAWAL OR SUSPENSION OF APPROVAL.

       Section 505(e) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(e)) is amended by adding at the end the 
     following: ``The Secretary may withdraw the approval of an 
     application submitted under this section, or suspend the 
     approval of such an application, as provided under this 
     subsection, without first ordering the applicant to submit an 
     assessment of the approved risk evaluation and mitigation 
     strategy for the drug under section 505-1(g)(2)(D).''.

     SEC. 904. BENEFIT-RISK ASSESSMENTS.

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

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

       (a) Findings.--Congress finds the following:
       (1) It is in the best interests of healthcare providers and 
     patients that a postmarketing surveillance system be 
     developed that will enable active surveillance of disparate 
     sources of data to identify signals of unexpected adverse 
     events and trends in the frequency of known adverse events, 
     to provide data on the outcomes of off label uses, and to 
     enable identification of safety issues earlier than can be 
     done today.
       (2) Such a system can best be developed through public 
     private partnerships to develop methods and tools for 
     conducting surveillance using electronic databases that 
     currently contain data on millions of patient encounters and 
     are expected to grow significantly in the next decade, as 
     well as electronic databases that contain millions of medical 
     product purchases, health care claims, and similar 
     information relevant to product use, efficacy, and safety.
       (3) Therefore, this section directs the Secretary of Health 
     and Human Services to enter into such public private 
     partnerships as are necessary to develop such a surveillance 
     system and the tools and methods necessary to conduct active 
     surveillance using the system.
       (b) Development of the Postmarket Risk Identification and 
     Analysis System.--Subsection (k) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
     amended by adding at the end the following:
       ``(3) The Secretary shall establish public private 
     partnerships to develop tools and methods to enable the 
     Secretary and others to use available electronic databases to 
     create a robust surveillance system that will support active 
     surveillance on important drug safety questions including 
     detecting and assessing drug safety signals; monitoring the 
     frequency of known adverse events; and evaluating the 
     outcomes of off label uses. Such surveillance shall provide 
     for adverse event surveillance using the following data 
     sources:
       ``(A) Federal health-related electronic data (such as data 
     from the Medicare program and the health systems of the 
     Department of Veterans Affairs).
       ``(B) Private sector health-related electronic data (such 
     as pharmaceutical purchase data and health insurance claims 
     data).
       ``(C) Other information as the Secretary deems useful to 
     create a robust system to identify and assess adverse events 
     and potential drug safety signals and to evaluate the extent 
     and outcomes of off label uses of drugs.
       ``(4) Not later than 1 year after the date of the enactment 
     of this paragraph, the Secretary, in consultation with 
     experts including individuals who are recognized in the field 
     of data privacy and security, shall develop methods for 
     integrating and analyzing safety data from multiple sources 
     and mechanisms for obtaining access to such data. Such 
     methods and mechanisms shall not compromise the protection of 
     individually identifiable health information.
       ``(5) Not later than 2 years after the date of the 
     enactment of this paragraph, the Secretary shall have entered 
     into partnerships that will allow the analysis of available 
     data from the various data sources using the standards and 
     methods to identify drug safety signals and trends. Such 
     analysis shall not disclose individually identifiable health 
     information when presenting such drug safety signals and 
     trends or when responding to inquiries regarding such drug 
     safety signals and trends.
       ``(6) Not later than 4 years after the date of the 
     enactment of this paragraph, the Secretary shall report to 
     the Congress on the ways in which the Secretary has used the 
     surveillance system described in this subsection to identify 
     specific drug safety signals and to better understand the 
     outcomes associated with drugs marketed in the United States.
       ``(7) Disclosure of individually identifiable information 
     is prohibited in the surveillance system described in this 
     subsection. Nothing in this subsection prohibits lawful 
     disclosure of such information for other purposes.
       ``(8) Nothing in this subsection shall be construed as 
     limiting public health activities authorized under law.''.
       (c) Authorization of Appropriations.--To carry out 
     activities under the amendment made by subsection (b) for 
     which funds are made available under section 736 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there 
     are authorized to be appropriated, in addition to such funds, 
     $25,000,000 for each of fiscal years 2008 through 2012.
       (d) GAO Report.--Not later than 18 months after the date of 
     the enactment of this Act, the Comptroller General of the 
     United States shall evaluate data confidentiality and 
     security issues relating to collection, transmission, and 
     maintenance of data for the surveillance system developed 
     pursuant to this section, and make recommendations to the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, Labor 
     and Pensions of the Senate, and any other congressional 
     committees of relevant jurisdiction, regarding the need for 
     any additional legislative or regulatory actions to ensure 
     confidentiality and security of this data or otherwise 
     address confidentiality and security issues to ensure the 
     effective operation of the surveillance system.

[[Page H7599]]

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

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

     SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC DRUGS.

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

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

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

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

       Section 301 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 331), as amended by section 901(d)(2)(A), is amended 
     by adding at the end the following:
       ``(kk) The introduction or delivery for introduction into 
     interstate commerce of any food to which has been added--
       ``(1) a drug approved under section 505,
       ``(2) a biological product licensed under section 351 of 
     the Public Health Service Act, or
       ``(3) a drug or biological product for which substantial 
     clinical investigations have been instituted and for which 
     the existence of such investigations has been made public,

     unless such drug or biological product was marketed in food 
     before any approval of the drug under section 505 of this 
     Act, before licensure of the biological product under section 
     351 of the Public Health Service Act, and before any 
     substantial clinical investigations involving the drug or 
     biological product have been instituted, or unless the 
     Secretary, in the Secretary's discretion, has issued a 
     regulation, after notice and comment, approving the addition 
     of such drug or biological product to the food.''.

     SEC. 910. ASSURING PHARMACEUTICAL SAFETY.

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

     ``SEC. 505C. PHARMACEUTICAL SECURITY.

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

     SEC. 911. ORPHAN ANTIBIOTIC DRUGS.

       (a) Public Meeting.--The Commissioner of Food and Drugs 
     shall convene a public meeting regarding which serious and 
     life threatening infectious diseases, such as diseases due to 
     gram-negative bacteria and other diseases due to antibiotic-
     resistant bacteria, potentially qualify for available grants 
     and contracts under section 5(a) of the Orphan Drug Act (21 
     U.S.C. 360ee(a)) or other incentives for development.
       (b) Grants and Contracts for the Development of Orphan 
     Drugs.--Section 5(c) of the Orphan Drug Act (21 U.S.C. 
     360ee(c)) is amended to read as follows:
       ``(c) For grants and contracts under subsection (a), there 
     is authorized to be appropriated $30,000,000 for each of 
     fiscal years 2008 through 2012.''.

     SEC. 912. CITIZEN PETITIONS AND PETITIONS FOR STAY OF AGENCY 
                   ACTION.

       (a) In General.--Section 505 of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355), as amended by section 901(a), 
     is amended by adding at the end the following:
       ``(q) Petitions and Civil Actions Regarding Approval of 
     Certain Applications.--
       ``(1) In general.--With respect to a pending application 
     under subsection (b)(2) or (j), if a petition is submitted to 
     the Secretary that seeks to have the Secretary take, or 
     refrain from taking, any form of action relating to the 
     approval of the application, including a delay in the 
     effective date of the application, the following applies, 
     subject to paragraph (5):
       ``(A) The Secretary may not, on the basis of the petition, 
     delay approval of the application unless the Secretary 
     determines that a delay is necessary to protect the public 
     health and provides the applicant with a written explanation 
     of the reasons for the delay. Consideration of a petition 
     shall be separate and apart from the review and approval of 
     the application.
       ``(B) The Secretary shall take final agency action on the 
     petition not later than 180 days after the date on which the 
     petition is submitted. The Secretary shall not extend such 
     period, even with the consent of the petitioner, for any 
     reason, including based upon the submission of comments 
     relating to the petition or supplemental information supplied 
     by the petitioner.
       ``(C) If the Secretary determines that the petition was 
     submitted with the primary purpose of delaying approval of a 
     drug under subsection (b)(2) or (j), the Secretary may deny 
     the petition at any point.
       ``(D) If the filing of the application resulted in first-
     applicant status under subsection (j)(5)(D)(i)(IV), the 30-
     month period under such subsection is deemed to be extended 
     by a period of time equal to the period beginning on the date 
     on which the Secretary received the petition and ending on 
     the date of final agency action on the petition (inclusive of 
     such beginning and ending dates), without regard to whether 
     the Secretary grants, in whole or in part, or denies, in 
     whole or in part, the petition.
       ``(E) The Secretary may not consider the petition for 
     review unless it is signed and contains the following 
     certification: `I certify that, to my best knowledge and 
     belief: (a) this petition includes all information and views 
     upon which the petition relies; (b) this petition includes 
     representative data and/or information known to the 
     petitioner which are unfavorable to the petition; and (c) I 
     have taken reasonable steps to ensure that any representative 
     data and/or information which are unfavorable to the petition 
     were disclosed to me. I further certify that the information 
     upon which I have based the action requested herein first 
     became known to the party on whose behalf this petition is 
     submitted on or about the following date: __________. I 
     received or expect to receive payments, including cash and 
     other forms of consideration, from the following persons or 
     organizations to file this petition: _____________. I verify 
     under penalty of perjury that the foregoing is true and 
     correct.'.
       ``(2) Exhaustion of administrative remedies.--
       ``(A) Final agency action within 180 days.--The Secretary 
     shall be considered to have taken final agency action on a 
     petition referred to in paragraph (1) if--
       ``(i) during the 180-day period referred to in subparagraph 
     (B) of such paragraph, the Secretary makes a final decision 
     within the meaning of section 10.45(d) of title 21, Code of 
     Federal Regulations (or any successor regulation); or
       ``(ii) such period expires without the Secretary having 
     made such a final decision.
       ``(B) Dismissal of certain civil actions.--If a civil 
     action is filed with respect to any issue raised in a 
     petition under paragraph (1) before the Secretary has taken 
     final agency action on the petition within the meaning of 
     subparagraph (A), the court shall dismiss the action for 
     failure to exhaust administrative remedies.
       ``(3) Applicability of certain regulations.--The provisions 
     of this section are in addition to the requirements for the 
     submission of a petition to the Secretary that apply under 
     section 10.30 or 10.35 of title 21, Code of Federal 
     Regulations (or any successor regulations).
       ``(4) Annual report on delays in approvals per petitions.--
     The Secretary shall annually submit to the Congress a report 
     that specifies--
       ``(A) the number of applications under subsections (b)(2) 
     and (j) that were approved during the preceding 12-month 
     period;

[[Page H7600]]

       ``(B) the number of such applications whose effective dates 
     were delayed by petitions referred to in paragraph (1) during 
     such period; and
       ``(C) the number of days by which the applications were so 
     delayed.
       ``(5) Exceptions.--This subsection does not apply to--
       ``(A) a petition that relates solely to the timing of the 
     approval of an application pursuant to subsection 
     (j)(5)(B)(iv); or
       ``(B) a petition that is made by the sponsor of an 
     application under subsection (b)(2) or (j) and that seeks 
     only to have the Secretary take or refrain from taking any 
     form of action with respect to that application.
       ``(6) Definition.--For purposes of this subsection, the 
     term `petition' includes any request to the Secretary for an 
     action described in paragraph (1), without regard to whether 
     the request is characterized as a petition.''.
       (b) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services shall submit a report to the Congress on ways to 
     encourage the early submission of petitions under section 
     505(q), as added by subsection (a).

     SEC. 913. AUTHORIZATION OF APPROPRIATIONS.

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

     SEC. 914. EFFECTIVE DATE AND APPLICABILITY.

       (a) Effective Date.--This title takes effect 180 days after 
     the date of the enactment of this Act.
       (b) Drugs Deemed to Have Risk Evaluation and Mitigation 
     Strategies.--
       (1) In general.--A drug that was approved before the 
     effective date of this Act is, in accordance with paragraph 
     (2), deemed to have in effect an approved risk evaluation and 
     mitigation strategy under section 505-1 of the Federal Food, 
     Drug, and Cosmetic Act (as added by section 901 of this 
     title) (referred to in this section as the ``Act'' ) if there 
     are in effect on the effective date of this Act restrictions 
     on distribution or use--
       (A) required under section 314.520 or section 601.42 of 
     title 21, Code of Federal Regulations; or
       (B) otherwise agreed to by the applicant and the Secretary 
     for such drug.
       (2) Elements of strategy; enforcement.--The approved risk 
     evaluation and mitigation strategy in effect for a drug under 
     paragraph (1)--
       (A) is deemed to consist of the elements described in 
     paragraphs (1) and (2) of section 505-1(d) of the Act and any 
     additional elements under subsections (d) and (e) of such 
     section in effect for such drug on the effective date of this 
     Act; and
       (B) is subject to enforcement by the Secretary to the same 
     extent as any other risk evaluation and mitigation strategy 
     under section 505-1 of the Act.
       (3) Submission.--Not later than 180 days after the 
     effective date of this Act, the holder of an approved 
     application for which a risk evaluation and mitigation 
     strategy is deemed to be in effect under paragraph (1) shall 
     submit to the Secretary a proposed risk evaluation and 
     mitigation strategy. Such proposed strategy is subject to 
     section 505-1 of the Act as if included in such application 
     at the time of submission of the application to the 
     Secretary.
       (c) Other Drugs Approved Before the Effective Date.--The 
     Secretary, on a case-by-case basis, may require the holder of 
     an application approved before the effective date of this Act 
     to which subsection (b) does not apply to submit a proposed 
     risk evaluation and mitigation strategy in accordance with 
     the timeframes provided for in subparagraphs (C) through (D) 
     of section 505-1(g)(2) of the Act if the Secretary determines 
     (with respect to such drug or with respect to the group of 
     drugs to which such drug belongs) that--
       (1) an element described under section 505-1(d)(1) of the 
     Act may require modification; or
       (2) a standard for adding an element described in 
     subsection (e) or (d) of section 505-1 of the Act that is not 
     in effect with respect to such drug or class of drugs may 
     apply.
       (d) Use of Advisory Committees; Process for Addressing Drug 
     Class Effects.--In imposing a requirement under subsection 
     (c), the Secretary--
       (1) may convene a meeting of 1 or more advisory committees 
     of the Food and Drug Administration in accordance with 
     paragraph (6) of section 505-1(h) of the Act; and
       (2) may use the process described in paragraph (7) of such 
     section 505-1(h) (relating to addressing drug class effects).

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Burgess) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.
  Mr. DINGELL. Mr. Speaker, I yield myself 5 minutes.
  (Mr. DINGELL asked and was given permission to revise and extend his 
remarks.)
  Mr. DINGELL. I rise to express my strong support for H.R. 2900, the 
Food and Drug Administration Amendments Act of 2007.
  This is significant legislation, and in the best traditions of the 
Committee on Energy and Commerce, it is bipartisan. I want to thank and 
commend my Republican colleagues for their assistance in bringing this 
bill to the floor, and I want to commend all of the members of the 
committee for their hard work, which was done in an extraordinarily 
friendly and proper fashion on the legislation.
  I rise to inform my colleagues that the bill text before the House 
today contains three useful changes in the bill that was reported by 
the committee.
  There is a section on citizen petitions that is designed to prevent 
or minimize delays to the introduction of generic drugs. In addition to 
good public policy, it also reduces Federal expenditures and completely 
offsets the costs of H.R. 2900 so that the bill we consider today meets 
applicable budget pay-as-you-go standards.
  The other changes are two clarifications. One, that the Secretary is 
not authorized to order changes in the marketing plans or product 
sponsors; and two, that PDUFA fees can be used to carry out the bill's 
postmarket safety activities under the risk evaluation and mitigation 
strategies authorized by the bill, known as REMS.
  H.R. 2900 has nine distinct titles. Title I reauthorizes the 
Prescription Drug User Fee Act, a very successful piece of legislation. 
It significantly boosts resources to have new drugs or biological 
products reviewed through a thorough yet timely and careful manner, and 
gives greater attention and resources to postmarket drug safety 
activities.
  Title II reauthorizes the Medical Device User Fee and Modernization 
Act, providing increased user fee resources for review of medical 
devices. The fee structure is broadened to both stabilize revenue and 
decrease the cost of application fees.
  Title III is the Pediatric Medical Device Safety and Improvement Act 
of 2007. This will foster development of medical devices for use by 
children. It fills an important gap in therapies for one of our most 
vulnerable and important patient groups who are, after all, the future 
of the country. I commend my colleagues, Mr. Markey and Mr. Rogers, for 
their fine efforts in this title.
  Titles IV and V address the need for drugs that are tested and 
labeled for use by children.
  Title IV reauthorizes the Pediatric Research Equity Act. This title 
will provide FDA permanent authority to test and label drugs for 
pediatric patients.
  Title V reauthorizes the Best Pharmaceuticals for Children Act, 
providing incentive for testing and labeling drugs for pediatric 
patients. Together, these two pediatric drug programs provide for the 
method to achieve an important common purpose, better therapies for our 
children.
  I want to recognize the efforts of our dear friend, Representative 
Eshoo, on both of these titles.
  Titles VI, VII, VIII and IX represent the drug safety component of 
the bill.
  Title VI establishes the Reagan-Udall Foundation for the Food and 
Drug Administration. This will foster public-private partnerships for 
the purposes of advancing FDA's mission to modernize product 
development, accelerate innovation, and enhance product safety. Our 
good friends and colleagues, Mr. Engel and Ms. Giffords, are to be 
commended for their work on this title.
  Title VII addresses concerns about conflicts of interest amongst 
those who serve on the expert advisory panels that play a crucial role 
in FDA's work. Title VII establishes a clinical trials registry and 
database. This title will expand the amount of information available to 
patients, scientists and other stakeholders regarding clinical tests.
  Finally, title IX represents a major enhancement of the safety in the 
drug program of this country through an active postmarket surveillance 
program with the goal of reducing the likelihood of another Vioxx 
situation and the reported aftereffects which went unheard. Congressmen 
Markey and Waxman made important contributions in this matter.

[[Page H7601]]

  I wish also to thank my friend, the committee's ranking member, Mr. 
Barton, and the ranking member of the Subcommittee on Health, Mr. Deal. 
They worked with us throughout this process and brought forth good 
suggestions that make this a better bill. For that I commend them, and 
for their hard work I thank them.
  Finally, I wish to recognize the outstanding work of the chairman of 
the Subcommittee on Health, Mr. Pallone. His firm and steady hand and 
hard work brought forth a strong bill out of the subcommittee, and the 
House should applaud his extraordinary leadership.
  Mr. Speaker, this legislation strikes proper balance between new drug 
safety regulations and measures and ensuring consumers have the access 
to innovative prescription pharmaceuticals without undue delay.
  I urge my colleagues to support H.R. 2900 and ask for a favorable 
vote on this legislation.
  Mr. Speaker, I reserve the balance of my time, and I ask unanimous 
consent that I be permitted to yield the remainder of my time on this 
matter to the distinguished gentleman from New Jersey (Mr. Pallone), 
the subcommittee chairman, and that he be permitted to control the 
time. He will do a splendid job.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  Before he leaves, I want to thank Chairman Dingell for his 
willingness to work with the minority side on this. We had a lot of 
give-and-take, both at the staff level and certainly at the 
subcommittee level and the full committee level, and for that I am 
grateful.
  I think this is a good piece of legislation, and I think it was 
improved by the work of the staff, both on the majority and the 
minority side, and I think it was improved by the committee process as 
we worked this bill through committee.
  I am pleased to support H.R. 2900, and this bill, of course, will 
improve the drug and medical device safety approval by the FDA.
  Over the past several weeks, members of the Energy and Commerce 
Committee, both Republican and Democrat, have come together to hammer 
out a bill that will ensure that the American people can rely on the 
decisions made by the Food and Drug Administration, that their drugs 
are safe, and that regulatory requirements don't overly infringe on 
innovation or sound clinical practice of medicine.
  H.R. 2900 will achieve several goals, such as providing additional 
resources to the Food and Drug Administration to improve premarket drug 
and device approval, create new postmarket surveillance authorities, 
enhance clinical trial transparency and data mining, and ensure the 
adequacy of pediatric studies for drugs and devices.
  I would like to thank, again, Chairman Dingell and Chairman Pallone 
for working with our Republican staff to improve this legislation 
before we convened the markup, and of course during the process of the 
markup, again, both at the subcommittee and at the full committee 
level.
  I'm pleased that we were able to modify the Direct to Consumer 
Advertising provision to protect this bill from a constitutional 
challenge, Mr. Speaker, and in a manner relying on the existing Food 
and Drug Administration regulatory standards.
  In regard to pediatric exclusivity, the committee was able to find a 
workable standard as opposed to the original proposal that would have 
required the Food and Drug Administration accountants to post a lot of 
overtime in their jobs.
  I'm also pleased with regard to one of my concerns about how the new 
postmarket surveillance regime would impact the independent practice of 
medicine. I'm pleased that Mr. Waxman, Mr. Pallone and Dingell and 
their staffs worked with me to improve the language relating to the 
restrictions on distribution and use pursuant to elements of a drug's 
risk evaluation and mitigation strategy. Certainly, Mr. Speaker, it was 
not the intent, or I did not feel it was the intent of our legislation 
to be circumventing clinical judgment of trained and experienced 
practitioners. The original language threatened clinical decision 
making that is both lawful and based on scientific evidence and sound 
medical opinion, but I'm pleased that it has been tempered by the 
concerns that I raised to the above-mentioned gentlemen.
  One issue that I hope we will continue to work on as this bill moves 
toward conference committee relates to the provision on conflicts of 
interest.
  The Food and Drug Administration advisory panel serves a vital 
science function when it comes to the approval of drugs and devices.

                              {time}  1700

  I believe that we should strive to weed out any conflicts of interest 
for those that serve on these panels.
  But in reality, Mr. Speaker, that is easier said than done. The 
standard established in this bill, limiting panels to one waiver for a 
conflict of interest, could severely impair the Food and Drug 
Administration's advisory panel process, especially for panels convened 
to review drugs or devices targeted at very small patient populations, 
such as those with very rare diseases. For drugs or devices that would 
fall into these categories, it can be extremely difficult to find sound 
scientific experts. This irrational standard will only make it harder 
to perform that function. Moving forward, I hope we can find and strike 
the acceptable balance.
  It has already been shown that our collaboration on this endeavor has 
produced better legislation. I hope we continue that as the process 
moves forward.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I rise in strong support of this legislation. I am 
extremely proud to say that the bill before us is a product of a 
bipartisan effort to ensure that the Food and Drug Administration has 
the authority and resources it needs to ensure that American consumers 
have timely access to safe and effective prescription drugs and medical 
devices.
  This bill accomplishes a number of important goals. First and 
foremost, the legislation will empower the FDA to protect patients from 
potentially harmful prescription drugs. Over the past few years, it has 
become clear that consumers have been placed in harm's way due to the 
failing of our current drug safety system. The legislation we are 
passing today will lay the groundwork for restoring public confidence 
in the FDA by giving it the tools it needs to safeguard the public 
health.
  There are many other significant measures included in the bill before 
us, such as the reauthorization of two important user-fee programs that 
will provide the FDA with the financial resources it needs to approve 
applications for new drugs and devices to be marketed. In addition to 
new funding for the pre-market review activities of FDA, this bill 
includes a substantial amount of new funding for post-market safety 
activities.
  The bill will also reauthorize two important programs that will help 
encourage drug makers to conduct research into the appropriate use of 
prescription drugs in pediatric populations. Similarly, we are 
providing new incentives to device manufacturers to develop products 
that are specifically designed for use in children. Finally, this bill 
establishes the Reagan-Udall Foundation, which will help build public-
private partnerships designed to advance the mission of the FDA.
  I would like to thank all the Members who devoted so many hours and 
days to developing this bill. Specifically, I would like to thank 
Chairman Dingell, Ranking Member Barton, Mr. Deal, Mr. Waxman, Mr. 
Markey, Ms. Eshoo, Mr. Rogers and Dr. Burgess, as well, all of them, 
for their hard work and devoted staff, as well, because of all the 
support that the staff did in their efforts in making this bill 
possible.
  In closing, I would just like to reiterate that this bill has strong 
bipartisan support as well as support from the pharmaceutical and 
medical device industries and a number of consumer advocacy 
organizations. Few times in the past do I recall that we have

[[Page H7602]]

achieved such a wide-ranging consensus on a bill of this size or 
importance. I strongly urge my colleagues to support its passage.
  Mr. BURGESS. Mr. Speaker, I am expecting additional speakers, but at 
present, I will reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 4 minutes to the gentleman from 
California (Mr. Waxman).
  Mr. WAXMAN. Mr. Speaker, I rise in support of this legislation. It is 
becoming increasingly clear that FDA needs more of two things; it needs 
more resources and more authority. This is particularly true in the 
area of post-market drug safety. We are all familiar with the series of 
high profile drug safety problems with drugs like Vioxx and Avandia. It 
is no secret that FDA's ability to protect the safety of our drugs is 
in serious jeopardy. H.R. 2900 makes significant strides in getting FDA 
both the authorities and resources to improve its oversight of drug 
safety.
  I am pleased this bill incorporates many of the provisions in a bill 
that I introduced with Representative Markey called the Enhancing Drug 
Safety and Innovation Act of 2007. Our bill incorporates many of the 
recommendations of a high-profile study by the Institute of Medicine. 
For example, it will give the FDA the ability to require post-market 
studies and labeling changes, as well as the ability to impose 
significant civil monetary penalties to ensure that these things get 
done in an appropriate and timely way.
  Another section of the bill would establish mandatory clinical trial 
registry and results databases. This would bring much-needed 
transparency to the clinical trials conducted on our fellow citizens 
and will prevent drug and device companies from hiding negative trial 
results that cast their products in a negative light.
  I do regret that one of the most important recommendations made by 
the IOM was stripped from the committee-reported bill: that Congress 
give FDA the authority to restrict direct-to-consumer advertising of 
new drugs with unknown safety risks. If a new drug is heavily marketed 
as a result of direct-to-consumer ads and a serious risk does emerge, 
many people will have been unnecessarily exposed to that risk.
  Similarly, I regret H.R. 2900 does not contain a provision to 
appropriately tailor the period of exclusivity that blockbuster drugs 
receive in exchange for conducting pediatric trials under the Best 
Pharmaceuticals for Children Act. We all share the goal of ensuring 
that our children get the same benefit from FDA approved drugs and all 
medical devices, as do adults. But we must make sure that the American 
consumers are not paying an unjustified price tag for those tests.
  Nevertheless, the bill as a whole makes significant contributions to 
the work of the FDA and deserves our support. I do want to emphasize 
that the FDA will need a significant influx of resources to do what we 
are asking them to do in this bill. Although H.R. 2900 gives FDA the 
enhanced ability to dedicate user fee dollars to these activities, it 
will be critical for Congress to come forward with additional 
appropriated dollars. We simply have got to get FDA the funds it needs 
to do their job well.
  Every day, Americans rely on FDA to protect them from dangerous 
medicines and devices. Today, we have the opportunity to take a 
critically important step toward ensuring that FDA can fulfill this 
mission.
  Mr. Speaker, I encourage Members to support the bill.
  Mr. BURGESS. Mr. Speaker, I am pleased to yield 4 minutes to the 
gentleman from Pennsylvania (Mr. Murphy), a member of the committee.
  Mr. TIM MURPHY of Pennsylvania. Mr. Speaker, I thank the gentleman. I 
am here to speak on behalf of this bill and my support for it.
  Under the Medical Device User Fee Modernization Act reprocessed or 
reused medical devices are brought under the regulation of the FDA.
  Now, there is a problem with reusing medical devices sometimes, and 
that is these devices were designed for optimal performance and safety 
under their intended conditions of use, not necessarily designed for 
their ease of cleaning or even secondary use, which make it extremely 
difficult to effectively clean and resterilize. Reusing medical devices 
can compromise their safety and performance and even destroy some of 
these devices. This can also lead to deadly hospital-acquired or 
nosocomial infections.
  At least half, half, of all cases of nosocomial infections are 
associated with medical devices. Let me give some examples of the rates 
of infection from these devices: 23 percent of peritoneal dialysis 
catheters; 7 percent of pacemakers; 7.2 percent of implantable 
cardioverter defibrillators; up to 50 percent of ventricular assist 
devices; and 30 percent of bladder catheters, just to name a few.
  I would like to thank Chairman Dingell and Ranking Member Barton as 
well as Chairman Pallone and Ranking Member Deal for working with me to 
include language in the Medical Device User Fee amendments of H.R. 
2900, the Food and Drug Administration Act of 2007, for a study on the 
causes of these infections, from reprocessed single-use devices; from 
handling of sterilized medical devices; from in-hospital sterilization 
of medical devices; from health care professionals' practices for 
patient examination and treatment; hospital-based policies and 
procedures for patient examination and treatment; hospital-based 
policies and procedures for infection control and prevention; and 
hospital-based practices for handling medical waste and other relevant 
hospital practices.
  Let me explain why and what this means in terms of real lives and 
dollars. A CDC report from a couple of years ago said that learning to 
prevent these infections has the potential to save over 90,000 lives 
and $50 billion annually, according to the CDC. A more recent report 
just came out and said perhaps we are up to even 119,000 lives a year.
  Health care providers should work with medical device companies to 
provide patients with information if a medical device has been reused. 
Patients have the right to know whether or not a medical device 
designed for single use has already been used in another patient before 
a device is used on them and what can be done and what was done in 
terms of sterilization and cleaning that equipment. Otherwise, patients 
will be exposed to an unnecessary risk for hospital-acquired infections 
and medical device failures.
  This study has the potential to save thousands of lives and billions 
of dollars. Eliminating infections from medical devices will move us 
towards a safer patient-centered health care system that promotes 
patient choice, patient safety and patient quality.
  We all know that physicians and nurses and hospital personnel are all 
dedicated to providing the best health care possible. We also know when 
hospitals have worked together to eliminate infections, indeed, that is 
what they do. The VA Hospital in Pittsburgh and a number of hospitals 
in the Pittsburgh area that I am familiar with and worked with have 
indeed brought some post-surgical infection rates down to zero. And 
there have been occasional lapses in these throughout the nation where 
post-surgical infections or infections associated with medical devices 
have been unnecessarily high.
  We can prevent these infections. We can save lives. We could save not 
only the Federal Government, but other insurance companies, billions of 
dollars, and I look forward to passing this bill.
  Mr. PALLONE. Mr. Speaker, I would ask unanimous consent that the 
gentleman from New York (Mr. Hinchey) be given 5 minutes time in 
addition to what we have already allocated to speak in opposition to 
the bill.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. HINCHEY. Mr. Speaker, I very much appreciate the kindness of my 
friend and colleague from New Jersey for providing me with this time.
  Mr. Speaker, I am a member of the Appropriations Committee and the 
subcommittee which has oversight over the Food and Drug Administration, 
so over the course of a number of years now, I have been deeply engaged 
in this issue.
  I am glad that the FDA Amendments Act that we are discussing here 
this evening addresses a number of the problems that we have confronted 
over the course of the last number of years. These problems include 
giving the agency enhanced authority on post-

[[Page H7603]]

market drug safety and developing a strengthened system for oversight 
of direct-to-consumer advertising. That is a very good move in the 
right direction.
  However, I am deeply disappointed that this bill neglects to 
sufficiently address a number of other major issues that are 
jeopardizing the trustworthiness of the Food and Drug Administration, 
the agency that is supposed to represent the gold standard for consumer 
protection in America.
  First, the FDA Amendments Act reauthorizes the Prescription Drug User 
Fee Act through which drug companies provide funding to the FDA for its 
drug safety approval and oversight activities. So, in other words, what 
we have is the regulated industry paying money to the agency that 
judges the worthiness of the industry's products and how they put those 
products on the market. To make matters worse, before each 
reauthorization of the Prescription Drug User Fee Act, the FDA sits 
down with representatives from this industry to negotiate out 
performance standards that the agency will achieve in return for those 
funds.
  In fact, representatives from the FDA met 112 times with 
representatives from the big pharmaceutical industry before the agency 
sent their recommendations with regard to this bill to Capitol Hill. 
Meanwhile, the FDA only met five times with other groups, groups like 
consumers, medical professionals and advocates; only five times with 
groups like that to hear their perspective on reauthorization of the 
Prescription Drug User Fee Act.
  The FDA is in bed with the drug companies, and put simply, the FDA 
Amendments Act does not sufficiently sever this inappropriate 
relationship between the agency and the regulated industry.
  Under this bill, the FDA will continue to collect funding from a 
regulated industry and will continue to meet industry standards and put 
those standards above everyone else's interest.
  Second, the FDA Amendment Act does not sufficiently address financial 
conflict of interest among members of agency advisory committees.

                              {time}  1715

  These committees exist to provide the agency with unbiased scientific 
advice on controversial issues, and such advice can easily be tainted 
by these conflicts; and we have seen numerous examples of how it has 
been.
  Many of my colleagues will remember voting to end such conflicts 
during our consideration of the fiscal year 2006 Agricultural 
appropriations bill. Since that time, the FDA has come forward with a 
new policy of its own that would stop those members with over $5,000 
worth of inappropriate financial holdings from even participating on 
advisory committees and stop all conflicted members from voting on the 
committees regardless of the size of that conflict.
  Unfortunately, the FDA Amendment Act does not continue the movement 
for change that has been espoused by both the House and now internally 
by the FDA. Instead, this legislation would enable the agency to 
continue to waive conflicted members on to advisory committees. There 
is simply no need for this policy to continue.
  Finally, this legislation does nothing to keep the FDA from its 
current misinformed policy of preempting State law on drug policy.
  The Bush FDA's relentless arguments in favor of preemption robs 
consumers of recourse from injury and issues drug companies a free pass 
from accountability.
  As we have seen from recent flu vaccine crises, revelations of 
conflicts of interest, and failures of post-market drugs such as Vioxx, 
the FDA is clearly not a perfect agency.
  At the same time, drug companies are not sufficiently forthcoming 
about side effects related to their products. It is illogical for the 
Federal Government to close the door on a method of recourse for 
Americans who have been affected by these imperfections. In a world in 
which drug companies are not fully clear about the safety of their 
drugs, and the FDA is not sufficiently on the side of consumers, the 
role of the State courts in protecting Americans is more important than 
ever.
  I am very disappointed in these provisions, and I think that they all 
should be considered carefully in the examination of this legislation.
  Mr. BURGESS. Mr. Speaker, I yield myself such time as I may consume.
  Number one, my understanding is as we took this bill through the 
subcommittee and committee that we accepted legislative language on an 
amendment that would provide for a reverse trigger so that if the 
gentleman and other appropriators want to provide more money for the 
evaluation of new drugs and devices, the actual contribution from the 
user fees will decrease. After all, it was a Democratic Congress in 
1992 that began the first Prescription Drug User Fee Act, and the 
reason for that legislation was because it simply took too long to get 
drugs and devices through the regulatory maze. And as a consequence, 
practicing physicians such as myself were denied access to life-saving 
medications for their patients. So the Democrats in the early 1990s 
improved the process by adding the prescription drug user fees, but we 
would all be happy with the appropriators if they would step up to the 
plate and appropriate the correct amount of money.
  Additionally, let me just point out that consumer groups and patient 
groups actually are going to be involved in the negotiations for the 
next prescription drug user fee authorization. That is language that 
was brought to us, I don't remember by which side, but it was an 
amendment that was accepted by the full committee. So, Mr. Speaker, 
although there are concerns expressed by the gentleman who just spoke, 
the reality is many of those things were actually addressed through the 
committee and subcommittee process.
  I will speak a little further on the conflicts issue as I do my 
closing remarks on this bill, but Mr. Waxman so eloquently spoke about 
how unfortunate it was we stripped out an Institute of Medicine 
recommendation in his previous remarks. The reality is that the 
Institute of Medicine recommended that waivers be available for up to 
40 percent of FDA panels. Those are the individuals who are the exerts 
and who understand what these compounds can and cannot do.
  Mr. Speaker, I recognized throughout the committee process that I had 
a responsibility as the only member on the committee on either side who 
had ever picked up a pen and written a prescription for a patient, who 
had ever sat down face to face with a patient and talked about benefits 
and potential risks from medications, and who had ever talked to a 
patient about the cost of their medication.
  I think this legislation was well crafted and well worked up between 
both sides as we went through the committee process.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from 
North Carolina (Mr. Butterfield).
  Mr. BUTTERFIELD. Mr. Speaker, first let me thank the chairman of the 
subcommittee, the gentleman from New Jersey (Mr. Pallone), for yielding 
me this time and thank him for his leadership as chairman of the Health 
Subcommittee.
  Mr. Speaker, the subject of public health remains a top priority for 
rural America, including my home district of eastern North Carolina, 
the First Congressional District. Health has been an issue that has not 
always included the topic of disparities and the lack of access for 
minority communities and low-income communities. But under the 
leadership of this chairman, I am confident that we are now going in 
another direction and we are going to confront head on the issue of 
disparities. I want to thank the chairman and the committee for making 
the decision to go in that direction.
  But, Mr. Speaker, I have come to the floor today to address the 
subject of medications that are intended to combat tropical diseases 
and their access to the developing world. My desire, Mr. Speaker, is 
for the House to further cooperate and work with the other Chamber in 
search of a solution to the tropical disease epidemic facing the 
developing world. These diseases, such as HIV/AIDS and malaria and 
tuberculosis, continue to inflict millions of impoverished people 
because of the lack of medicines. In addition to perpetuating extreme 
poverty, these diseases also prevent millions of people from working 
and participating in family or community life. So as we discuss

[[Page H7604]]

this very important issue, I would like for us to also consider the 
issue of tropical disease-combating medications in developing 
countries.
  Mr. BURGESS. Mr. Speaker, I yield 3 minutes to the gentleman from 
Georgia (Mr. Deal), the ranking member on the Health Subcommittee.
  Mr. DEAL of Georgia. Mr. Speaker, I am pleased to support H.R. 2900. 
I think this bill plays an important role in ensuring that patients 
have timely access to approved, safe, and effective medications and 
medical devices. This legislation creates an entirely new post-
marketing drug safety program that will help address some of the 
troubling recent drug scares that we have all been aware of.
  The Subcommittee on Health in our Energy and Commerce Committee held 
numerous hearings on the programs authorized in this bill, and I am 
pleased that members of the committee were able to come together to 
work out a bipartisan compromise that continues many important programs 
of the FDA. For instance, the Prescription Drug and User Fee Amendments 
and the Medical Device User Fee Amendments allow the FDA to continue 
important programs which provide the agency with resources for the 
expeditious review of life-saving drugs and devices.
  One important addition in the prescription drug user fee amendments 
addresses direct-to-consumer advertisements. I share concern with many 
members on the committee about the drug advertisements being presented 
to patients, and I am glad the bill takes steps to provide for the 
FDA's review of these television ads while at the same time protecting 
freedom of speech.
  However, our main concern is the FDA's increasing reliance on the 
regulated industry to fund its drug review activities, and hope that 
future appropriations will take advantage of the amendment I offered at 
the full committee to help reduce FDA's dependence on user fees by 
replacing them with appropriations. This amendment stated there should 
be a dollar-for-dollar reduction in the new user fee for every new 
dollar appropriated for post-market safety. The amendment was a step in 
the right direction, but I believe more should be done to restore the 
balance between user fees and appropriations for drug review.
  The bill also continues important programs which encourage the study 
of medications in pediatric populations. Meeting the unique medical 
needs of children presents special challenges, and H.R. 2900 
reauthorizes two programs which have effectively promoted the study of 
drugs in children. It also encourages the development of medical 
devices for use in pediatric populations.
  This legislation also improves FDA drug safety authorities. Recent 
incidents have undermined consumer confidence in the FDA's ability to 
ensure that the medications they take on a regular basis are safe. H.R. 
2900 provides the agency with new tools to better monitor products that 
might present greater risk to patients. I believe these reforms will 
help maintain the FDA's position as the world leader in protecting 
patient safety and access to safe medications.
  In conclusion, I think this is a good compromise. Our committee 
worked hard on it. Both sides came together in an effort to try to 
present this House with a package that I hope will be approved today.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from 
Massachusetts (Mr. Markey) who had a great deal to do with putting this 
bill together.
  Mr. MARKEY. I thank the gentleman and congratulate the chairman, the 
gentleman from New Jersey (Mr. Pallone), for his enormously successful 
work; and Mr. Dingell as well, as well as the key Republicans who 
worked on this legislation.
  I am pleased that the bill before the House includes language from 
the drug safety bill that Mr. Waxman and I introduced in March to 
strengthen the FDA's ability to monitor drugs after they have been 
approved and create a true post-market safety net system.
  As we have seen with drugs such as Vioxx, new side effects and health 
risks may only surface after drugs are approved and are used by the 
general population. Yet the FDA has not had the authority to mandate 
label changes or require further studies to get more information about 
these risks once the drugs have been approved. This bill will empower 
the FDA with those important new authorities, and it will also 
establish a new post-market risk identification and analysis system to 
identify harmful side effects and uncover signals of unexpected adverse 
events without compromising patient privacy.
  I am also pleased that the package includes a strong clinical trials 
registry and results database that is consistent with the bill that Mr. 
Waxman and I have been championing since 2004 when we learned that some 
drug companies were painting distorted pictures of their products by 
hiding negative trial results.
  The current system, which allows companies to pick and choose which 
trials they want to make public, is like allowing students to just pick 
the grades they want to bring home. Everyone would have straight A's.
  Our bill will establish one central mandatory registry of all 
clinical trials with strong enforcement mechanisms to require companies 
to make their clinical trials and the result of those trials available 
to the public, all of the trials. This is historic because the database 
of trial results will ensure that doctors and their patients have 
current, complete, and accurate information about all drugs on the 
market.
  Finally, I want to thank Mr. Rogers from Michigan for working with me 
on the pediatric devices bill. It is an important bill that will help 
children get the devices that they need. I thank again Mr. Pallone, Mr. 
Dingell, and all the others who worked on this bill.
  Mr. BURGESS. Mr. Speaker, may I inquire as to the time remaining.
  The SPEAKER pro tempore. The gentleman from Texas has 6\1/2\ minutes 
and the gentleman from New Jersey has 5 minutes.
  Mr. BURGESS. Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman 
from Arizona (Ms. Giffords).
  Ms. GIFFORDS. Mr. Speaker, I rise today in support of the Safe and 
Effective Drug Development Act, which was adopted as an amendment to 
H.R. 2900 in committee. I would like to thank Mr. Dingell, Mr. Engel, 
Mr. Hall, and Mrs. Blackburn for their work on this legislation.
  An op-ed in today's Washington Post by Dr. Lichtenberg from Columbia 
University identified medical innovation as the key factor contributing 
to the increase in life expectancy here in the United States over the 
last 15 years. I think we would all agree that living longer is a very 
good thing.
  However, in 2004, the FDA identified 76 specific problems that have 
caused a critical slow down in medical innovation. This legislation 
formalizes public-private partnerships between the FDA, nonprofits, and 
universities. These partnerships help solve the problems that stand 
between new biomedical discoveries and how quickly and safely these 
discoveries are translated to consumers.
  I want to thank the gentleman for allowing me to speak and thank all 
of those staff and of course the committee members who worked so hard 
on this legislation.

                              {time}  1730

  Mr. BURGESS. Mr. Speaker, I yield myself the balance of my time.
  Again, Mr. Speaker, I want to point out, Mr. Waxman in his remarks 
discussed the Institute of Medicine study, and in fact, when we talked 
about the issue that's still the unresolved issue of the conflict-of-
interest waivers, the Institute of Medicine itself recommended that the 
Food and Drug Administration advisory panels, those panels that are 
convened to advise the Food and Drug Administration on the acceptance 
or rejection of new drugs and new devices, that that panel could be 
comprised of up to 40 percent of individuals for whom a conflict-of-
interest waiver was obtained.
  The current legislation has language in it that will restrict that 
waiver to one such individual, and as we've already heard from the 
other side, even that one conflict waiver is too much for some people 
to tolerate. But the reality, if the FDA is allowed to issue only one 
waiver per panel meeting, they will find themselves seeking the 
guidance of fellows that have just

[[Page H7605]]

passed their boards and are beginning their practice of medicine. The 
drafters of the code of Federal regulations did not intend that only 
the most recent graduates of a fellowship program or residency program 
be considered the so-called expert.
  At present, medical societies find restrictions on the FDA panel 
nominees increasingly difficult due to a number of criteria that must 
be met in addition to considerations for the conflicts of interest.
  The Food and Drug Administration panels must have geographic, ethnic 
and gender diversity. We've already heard discussion from the other 
side of how they're concerned about aggravating ethnic disparities. 
Here's another place where we could perhaps reverse that trend.
  For clinical representation, panel members on those Food and Drug 
Administration advisory panels, panel members should be practicing 
physicians and, in fact, should have practiced for many years. They 
should have accumulated a body of experience. They should have 
knowledge of the conduct of clinical trials. They should have knowledge 
of statistics.
  They should have intricate knowledge of the specific anatomy if 
they're on a device panel. They may need to know about the 
biomechanical forces imposed on the anatomy if a device is implanted or 
the cellular biology to determine wear and tear on the devices and 
knowledge of the American Society for Testing and Materials or 
international standards organizations. Members may also need to know 
about the packaging and the effects of radiation on many of the device 
components.
  For some panels, such as on March 29 of this year, the Cellular 
Tissue and Gene Therapies Advisory Committee meeting to provide 
guidance to the Food and Drug Administration on biological license 
applications, such as the medicine that might be used for treatment of 
men with asymptomatic metastatic hormone refractory prostate cancer; 
these panels must have a specific knowledge base that far exceeds that 
of a practicing physician.
  And indeed, I heard from other individuals where the universe of 
patients may be quite small for patients who have a certain type of 
brain malignancy. The universe of patients may be only 1,000 or 1,500.
  The people that develop the drugs are of necessity going to be people 
who have been employed by those industries that were developing the 
drugs. Why exclude them from the panel? Why craft a law where the only 
people in the room are, by law, going to be people who have no 
knowledge of the intricacy of the specific disease being treated or no 
knowledge of the surgical procedures required to implant those medical 
devices? Why restrict ourselves in that way?
  We just heard eloquent testimony from the gentlewoman from Arizona 
talking about the devices and those medications and treatments that are 
just over the horizon to us right now that we can't imagine, we can't 
envision. Why restrict those Food and Drug Administration advisory 
panels to one conflict-of-interest waiver?
  Mr. Speaker, I will submit being in public service can be expensive, 
it can be time-consuming, and it can be embarrassing. Why make it 
harder for these individuals to participate in these panels? Frankly, I 
do not understand that. I hope we will continue to work on that process 
as we get to the conference activity on this bill. I'm looking forward 
to those discussions.
  But in reality, the bill that is before us today is, in fact, a good 
bill. The committee staff on both sides did great work as far as 
getting language that would be acceptable to both sides, and we were 
not an easy audience to please on many occasions through the debate on 
that bill.
  But Mr. Speaker, I do rise in support of the bill. I do think it is 
worthy of the House's consideration and passage.
  Mr. Speaker, I yield back the balance of my time.


                             General Leave

  Mr. PALLONE. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days to revise and extend their remarks and 
include extraneous material on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from New Jersey?
  There was no objection.
  Mr. PALLONE. Mr. Speaker, before we proceed to the vote on H.R. 2900, 
I yield myself time to acknowledge the months of work that Members have 
done leading to this bill coming before the House today. It truly was a 
bipartisan effort, and everyone worked so hard.
  I also wish to take a moment to recognize the efforts of the staff 
who worked long hours in ensuring we produced a quality piece of 
legislation. In particular, I thank Warren Burke and Ellen Sutherland, 
professional staff with the Office of Legislative Counsel, for their 
outstanding service.
  I also want to thank the staff of the Committee on Energy and 
Commerce. I'm not going to mention the Republicans, not because they 
didn't do as much work, because they certainly did, but I don't 
remember all their names. I don't want to eliminate anybody.
  As far as the Democratic staff is concerned, I do want to 
specifically mention John Ford, Pete Goodloe, Jack Maniko, Melissa 
Sidman, Jessica McNiece, Bob Clark and Virgil Miller. And from Mr. 
Waxman's staff, because Mr. Waxman and Mr. Markey played a major role 
in this bill and Mr. Waxman's staff in particular, Karen Nelson, Rachel 
Sher and Stephen Cha. And again, everyone worked very hard on this.
  I think it is really remarkable that we were able to achieve a 
consensus and bring this up today, particularly under suspension.
  Mr. HALL of New York. Mr. Speaker, this evening, the House of 
Representatives considered H.R. 2900, The Food and Drug Administration 
Amendments of 2007, which, among other things reauthorized the FDA 
through 2012. I voted for this bill because I believe it's vital for 
our national interests that the FDA be authorized, and I am aware that 
the current authorization is due to expire very shortly. That said, I 
cast this vote with great reservations. The current funding of the FDA 
is too dependent on the companies that the Agency is supposed to be 
regulating. There is an inherent and unacceptable conflict of interest 
in this arrangement. To be a truly effective regulator, the FDA must be 
a completely independent entity, with no outside relationships. Only 
then can the American people be absolutely certain that the agency is 
always acting with their best interests in mind.
  It is my hope that during conference with the Senate some greater 
protections can be added to this legislation to ensure that it is an 
independent entity in which we can place our full and complete trust.
  Mr. VAN HOLLEN. Mr. Speaker, I rise in support of H.R. 2900, the Food 
and Drug Administration Amendments Act of 2007.
  I am proud that the headquarters of the Food and Drug Administration 
(FDA) is located in the Congressional District that I represent. I 
commend the hard working employees at FDA for their service and 
dedication to our country. However, serious gaps have been exposed in 
FDA's ability to protect the American public due to recent outbreaks of 
food-borne illnesses as well as high-profile post-market safety 
problems. It has become clear that FDA lacks the adequate resources to 
fulfill its vast and vital public health mission.
  In light of these events, we need to ensure that the FDA has the 
necessary tools and resources to protect the American public from 
unsafe products. H.R. 2900 takes a good first step in providing FDA 
with those resources in reauthorizing the Prescription Drug User Fee 
Act (PDUFA). Since its inception in 1992, PDUFA has helped enable FDA 
to approve more than 1,100 new medicines and reduce review times for 
innovative drugs and biologics, providing patients and doctors with 
earlier access to breakthrough treatments. Congress must reauthorize 
the prescription drug and medical device user fee programs in a timely 
manner to avoid any workforce disruptions at FDA. Without this bill, 
FDA will not have adequate resources to fulfill its mission. In 
addition, the innovation and development of new therapies will be 
hampered if PDUFA is not renewed--the FDA approval process will be too 
long for new potential treatments. With this reauthorization, the FDA 
will be permitted to collect a total of $393 million in prescription 
drug user fees per year through FY 2012.
  H.R. 2900 also expands the FDA's ability to monitor the safety of 
drugs after they have been approved and marketed. In addition, the 
legislation creates a public database for ongoing and completed 
clinical trials. It is important to have all the information about any 
drug during the trial stage be disclosed to the public so that doctors 
can make sound medical decisions and provide their patients with the 
best possible care.
  I am also pleased that the legislation includes a provision that 
expands on the successful Critical Path Initiative. FDA established

[[Page H7606]]

the Critical Path Initiative in 2004 to improve the efficiency and 
safety of drug and medical product development. This provision 
authorizes the FDA to enter into Critical Path Public-Private 
Partnerships with universities and non-profit organizations to 
modernize the process to develop prescription drugs and other medical 
products. These collaborations will help the FDA move drugs and medical 
devices through the approval process in a quicker, safer and more 
reliable manner at a lower cost.
  Mr. Speaker, the Food and Drug Administration Amendments Act is only 
one important step in providing FDA with the necessary tools and 
resources to do its job. Congress must also significantly increase 
federal appropriations to FDA so that the agency is able to fulfill its 
most basic responsibilities. Such an increase will not only make foods, 
drugs and devices safer, but it will also lead to a stronger, more 
effective FDA that can restore public confidence, speed innovation and 
ensure that America remains competitive in foreign markets.
  I believe H.R. 2900 will help ensure the timely access to safe and 
effective prescription drugs and medical devices as well as improve the 
integrity of the drug approval process at FDA. I urge my colleagues to 
support H.R. 2900.
  Mr. GENE GREEN of Texas. Mr. Speaker, I rise in strong support of 
H.R. 2900, legislation to reauthorize important user fee programs at 
the Food and Drug Administration and enact critical drug safety reforms 
at the agency.
  This legislation is the result of years of hard work by the Energy 
and Commerce Committee and particularly the Oversight and 
Investigations Subcommittee and the Health Subcommittee. I am proud to 
serve on both of these subcommittees. The Oversight and Investigations 
Subcommittee has worked on a bi-partisan basis to investigate the drug 
safety concerns brought to light by scandals associated with drugs such 
as Vioxx, Ketek and Selective Serotonin Reuptake Inhibitors, or SSRIs, 
which are typically used to treat depression. These investigations 
uncovered significant safety lapses at the FDA and shed a bright light 
on the FDA's bias toward drug approval with too little attention paid 
to post-market safety concerns.
  The FDA Amendments Act of 2007 makes important changes at the FDA to 
place a greater emphasis on post-market surveillance within the agency. 
Specifically, this legislation would establish a Risk, Evaluation, and 
Mitigation Strategy whereby drugs approved by the agency are monitored 
throughout their life-cycle for adverse events or other signs of safety 
concerns. A critical aspect of this strategy is the additional 
authority this bill gives the Secretary of HHS to mandate that drug 
manufacturers conduct post-market studies.
  Under this bill, the additional post-market activities extend to the 
user fee programs that help fund the drug approval process. 
Specifically, this bill directs drug manufacturers utilizing the FDA's 
drug approval process to dedicate an additional $225 million over five 
years for post-market surveillance activities at the FDA. This 
additional funding represents an important investment by the 
pharmaceutical industry in the FDA's postmarket safety activities, 
while also ensuring that pre-market user fees are adequate to bring 
potentially life-saving medicines to market in a reasonable time.
  This legislation also reauthorizes the Medical Device User Fee Act, 
as well as the Best Pharmaceuticals For Children Act and the Pediatric 
Research Equity Act. The unanimous support of the committee for this 
bill is a testament to the open process and bi-partisan nature in which 
the committee members and staff on both sides of the aisle conducted 
these negotiations.
  I would like to thank our Chairman, Mr. Dingell, and our Health 
Subcommittee Chairman, Mr. Pallone, for their work on this important 
legislation, and encourage my colleagues to support this important 
bill. These necessary changes at the FDA will go a long way toward 
restoring the American public's confidence in the agency and its 
ability to ensure the safety of the nation's drug supply.
  Ms. HOOLEY. Mr. Speaker, I am particularly pleased that H.R. 2900 
includes a provision I authored and worked on with my colleague Mr. 
Doyle from Pennsylvania that will require the FDA to establish a unique 
device identification (UDI) system for medical devices.
  Currently, most medical devices cannot be tracked or identified in 
any systemic fashion. A UDI will enable the FDA to better pinpoint 
devices associated with adverse events and look for patterns across 
event reports. A more sophisticated reporting system will thus 
strengthen FDA's post-market surveillance capabilities.
  A UDI system will not only provide FDA with the tools to discover 
warning signs of a defective device earlier, thus potentially savings 
lives, but will also improve the agency's ability to promptly respond 
to device recalls. I believe our current system for notifying patients 
in the event of a recall is deficient. When defective medical devices 
are recalled, the absence of a standard identification system hinders 
the FDA's ability to notify patients. These UDI provisions take an 
important step toward improving the ability of the FDA, device 
manufacturers, and physicians to quickly and effectively communicate 
risk information to patients.
  Ms. ESHOO. Mr. Speaker, I rise in full support of H.R. 2900, the Food 
and Drug Administration Amendments Act of 2007. An extraordinary amount 
of time was put into negotiating this bill and the fact that it's 
coming to the floor without contention is a testament to the leadership 
of our Committee and Subcommittee Chairmen, Ranking Member, and 
Majority and Minority staffs.
  The bill is important for ensuring the safety and efficacy of 
pharmaceuticals and medical devices available to the American public. 
It includes necessary funding for vital FDA functions, such as drug and 
device review and approval, and also enhances post-market surveillance 
activities for these products.
  I want to focus my remarks on the sections of the bill that renew the 
Pediatric Research Equity Act (PREA), and the Best Pharmaceuticals for 
Children Act (BPCA). I championed the original enactments of these 
successful programs which have helped to increase the number of drugs 
tested and labeled for use in children, and I'm proud these programs 
will be renewed and further improved under this bill.
  According to the American Academy of Pediatrics, only about 25% of 
drugs administered to children have been appropriately tested for use 
in kids. Pediatricians often have to prescribe drugs for ``off-label'' 
use, because the drug has not been studied in appropriate FDA-approved 
pediatric clinical trials. Children have specific medical needs that 
have to be considered when drugs are used. Children have died or 
suffered serious side effects after taking drugs that were shown safe 
for use in adults but had different results in children.
  I've worked with stakeholders on all sides of this issue to update 
BPCA and PREA to increase the amount and quality of pediatric 
information available to doctors, parents, and researchers. I've also 
enhanced labeling and post-market safety requirements. The bill also 
makes permanent the FDA's authority to require pediatric studies of 
drugs, which is consistent with its permanent authority to require 
studies of adult formulations. Together, these changes will help to 
generate important new information about the safety and efficacy of 
drugs prescribed to children.
  A coalition of children's groups has endorsed H.R. 2900. The bill was 
unanimously passed out of the Energy and Commerce Committee before the 
July 4th Recess and I urge my colleagues to support it.
  In closing I want to thank the staff members who have worked 
exceedingly hard to bring this bill to the Floor today: John Ford, 
Bobby Clark, Pete Goodloe and Jack Maniko of the Energy and Commerce 
Committee Majority staff, Ryan Long and John Little of the Minority 
staff, and Jennifer Nieto from my office.
  I'm proud to be an original cosponsor of H.R. 2900 and I urge my 
colleagues to vote for it.
  Mr. PALLONE. Mr. Speaker, I yield back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from New Jersey (Mr. Pallone) that the House suspend the 
rules and pass the bill, H.R. 2900, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PALLONE. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX and the 
Chair's prior announcement, further proceedings on this question will 
be postponed.

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