[Congressional Record Volume 153, Number 139 (Wednesday, September 19, 2007)]
[House]
[Pages H10551-H10599]
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. 3580) 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.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 3580

       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; finding.

[[Page H10552]]

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.
Sec. 107. Effective date.
Sec. 108. Savings clause.
Sec. 109. Technical amendment; conforming amendment.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

Sec. 201. Short title; references in title; finding.

              Subtitle A--Fees Related to Medical Devices

Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Reauthorization; reporting requirements.
Sec. 214. Savings clause.
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.
Sec. 230. Report by the Food and Drug Administration regarding labeling 
              information on the relationship between the use of indoor 
              tanning devices and development of skin cancer or other 
              skin damage.

 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 surveillance.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

Sec. 401. Short title.
Sec. 402. Reauthorization of Pediatric Research Equity Act.
Sec. 403. Establishment of internal committee.
Sec. 404. 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.
Sec. 503. Training of pediatric pharmacologists.

                   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. Expanded clinical trial registry data bank.

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

            Subtitle A--Postmarket Studies and Surveillance

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. Active postmarket risk identification and analysis.
Sec. 906. Statement for inclusion in direct-to-consumer advertisements 
              of drugs.
Sec. 907. No effect on veterinary medicine.
Sec. 908. Authorization of appropriations.
Sec. 909. Effective date and applicability.

  Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance

Sec. 911. Clinical trial guidance for antibiotic drugs.
Sec. 912. Prohibition against food to which drugs or biological 
              products have been added.
Sec. 913. Assuring pharmaceutical safety.
Sec. 914. Citizen petitions and petitions for stay of agency action.
Sec. 915. Postmarket drug safety information for patients and 
              providers.
Sec. 916. Action package for approval.
Sec. 917. Risk communication.
Sec. 918. Referral to advisory committee.
Sec. 919. Response to the institute of medicine.
Sec. 920. Database for authorized generic drugs.
Sec. 921. Adverse drug reaction reports and postmarket safety.

                          TITLE X--FOOD SAFETY

Sec. 1001. Findings.
Sec. 1002. Ensuring the safety of pet food.
Sec. 1003. Ensuring efficient and effective communications during a 
              recall.
Sec. 1004. State and Federal Cooperation.
Sec. 1005. Reportable Food Registry.
Sec. 1006. Enhanced aquaculture and seafood inspection.
Sec. 1007. Consultation regarding genetically engineered seafood 
              products.
Sec. 1008. Sense of Congress.
Sec. 1009. Annual report to Congress.
Sec. 1010. Publication of annual reports.
Sec. 1011. Rule of construction.

                       TITLE XI--OTHER PROVISIONS

                         Subtitle A--In General

Sec. 1101. Policy on the review and clearance of scientific articles 
              published by FDA employees.
Sec. 1102. Priority review to encourage treatments for tropical 
              diseases.
Sec. 1103. Improving genetic test safety and quality.
Sec. 1104. NIH Technical amendments.
Sec. 1105. Severability clause.

              Subtitle B--Antibiotic Access and Innovation

Sec. 1111. Identification of clinically susceptible concentrations of 
              antimicrobials.
Sec. 1112. Orphan antibiotic drugs.
Sec. 1113. Exclusivity of certain drugs containing single enantiomers.
Sec. 1114. Report.

         TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007

     SEC. 101. SHORT TITLE; REFERENCES IN TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2007''.
       (b) References in Title.--Except as otherwise specified, 
     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.).
       (c) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated toward 
     expediting the drug development process and the process for 
     the review of human drug applications, including postmarket 
     drug safety activities, as set forth in the goals identified 
     for purposes of part 2 of subchapter C of chapter VII of the 
     Federal Food, Drug, and Cosmetic Act, in the letters from the 
     Secretary of Health and Human Services to the Chairman of the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Chairman of the Committee on Energy and 
     Commerce of the House of Representatives, as set forth in the 
     Congressional Record.

     SEC. 102. DEFINITIONS.

       Section 735 (21 U.S.C. 379g) is amended--
       (1) in the matter before paragraph (1), by striking ``For 
     purposes of this subchapter'' and inserting ``For purposes of 
     this part'';
       (2) in paragraph (1)--
       (A) in subparagraph (A), by striking ``505(b)(1),'' and 
     inserting ``505(b), or'';
       (B) by striking subparagraph (B);
       (C) by redesignating subparagraph (C) as subparagraph (B); 
     and
       (D) in the matter following subparagraph (B), as so 
     redesignated, by striking ``subparagraph (C)'' and inserting 
     ``subparagraph (B)'';
       (3) 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)'';
       (4) in paragraph (4), by inserting before the period at the 
     end the following: ``(such as capsules, tablets, or 
     lyophilized products before reconstitution)'';
       (5) 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

[[Page H10553]]

     clinical trials and labeling changes) and section 505(p) 
     (relating to risk evaluation and mitigation strategies).
       ``(v) Carrying out section 505(k)(5) (relating to adverse 
     event reports and postmarket safety activities).'';
       (6) 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'';
       (7) by redesignating paragraph (9) as paragraph (11); and
       (8) 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 paragraph (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 be applied by 
     substituting the amount determined under subparagraph (B) for 
     `$392,783,000'.
       ``(B) Amount determined.--For each of the fiscal years 2008 
     through 2012, the amount determined under this subparagraph 
     is the sum of--
       ``(i) $392,783,000; plus
       ``(ii)(I) for fiscal year 2008, $25,000,000;
       ``(II) for fiscal year 2009, $35,000,000;
       ``(III) for fiscal year 2010, $45,000,000;
       ``(IV) for fiscal year 2011, $55,000,000; and
       ``(V) for fiscal year 2012, $65,000,000.''.
       (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 by 
     subparagraph (D)), 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.--Paragraph (4) of section 736(c) 
     (21 U.S.C. 379h(c)), as redesignated by paragraph (3)(A), is 
     amended to read as follows:
       ``(4) Final year adjustment.--
       ``(A) Increase in fees.--For fiscal year 2012, the 
     Secretary may, in addition to adjustments under this 
     paragraph and paragraphs (1), (2), and (3), further increase 
     the fee revenues and fees established in subsection (b) if 
     such an adjustment is necessary to provide for not more than 
     3 months of operating reserves of carryover user fees for the 
     process for the review of human drug applications for the 
     first 3 months of fiscal year 2013. If such an adjustment is 
     necessary, the rationale for the amount of the increase

[[Page H10554]]

     shall be contained in the annual notice establishing fee 
     revenues and fees for fiscal year 2012. If the Secretary has 
     carryover balances for such process in excess of 3 months of 
     such operating reserves, the adjustment under this 
     subparagraph shall not be made.
       ``(B) Decrease in fees.--
       ``(i) In general.--For fiscal year 2012, the Secretary may, 
     in addition to adjustments under this paragraph and 
     paragraphs (1), (2), and (3), decrease the fee revenues and 
     fees established in subsection (b) by the amount determined 
     in clause (ii), if, for fiscal year 2009 or 2010--

       ``(I) the amount of the total appropriations 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 appropriations for the Food and Drug 
     Administration for fiscal year 2008 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under paragraph (1); and
       ``(II) the amount of the total appropriations expended for 
     the process for the review of human drug applications 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 expended for the process for the 
     review of human drug applications at the Food and Drug 
     Administration for fiscal year 2008 (excluding the amount of 
     fees appropriated for such fiscal year), adjusted as provided 
     under paragraph (1).

       ``(ii) Amount of decrease.--The amount determined in this 
     clause is the lesser of--

       ``(I) the amount equal to the sum of the amounts that, for 
     each of fiscal years 2009 and 2010, is the lesser of--

       ``(aa) the excess amount described in clause (i)(II) for 
     such fiscal year; or
       ``(bb) the amount specified in subsection (b)(4)(B)(ii) for 
     such fiscal year; or

       ``(II) $65,000,000.

       ``(iii) Limitations.--

       ``(I) Fiscal year condition.--In making the determination 
     under clause (ii), an amount described in subclause (I) of 
     such clause for fiscal year 2009 or 2010 shall be taken into 
     account only if subclauses (I) and (II) of clause (i) apply 
     to such fiscal year.
       ``(II) Relation to subparagraph (A).--The Secretary shall 
     limit any decrease under this paragraph if such a limitation 
     is necessary to provide for the 3 months of operating 
     reserves described in subparagraph (A).''.

       (5) Limit.--Paragraph (5) of section 736(c) (21 U.S.C. 
     379h(c)), as redesignated by paragraph (3)(A), is amended 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.--
       ``(1) Exemption.--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 establishment fees under this 
     section, if the drug meets all of the following conditions:
       ``(A) The drug meets the public health requirements 
     contained in this Act as such requirements are applied to 
     requests for waivers for product and establishment fees.
       ``(B) The drug is owned or licensed and is marketed by a 
     company that had less than $50,000,000 in gross worldwide 
     revenue during the previous year.
       ``(2) Evidence of qualification.--An exemption under 
     paragraph (1) applies with respect to a drug only if the 
     applicant involved submits a certification that its gross 
     annual revenues did not exceed $50,000,000 for the preceding 
     12 months before the exemption was requested.''.
       (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)''.
       (h) Technical Amendment.--
       (1) Amendment.--Section 736(g)(1) (21 U.S.C. 379h(g)(1)) is 
     amended by striking the first sentence and inserting the 
     following: ``Fees authorized under subsection (a) shall be 
     collected and available for obligation only to the extent and 
     in the amount provided in advance in appropriations Acts. 
     Such fees are authorized to remain available until 
     expended.''.
       (2) Effective date.--Paragraph (1) shall take effect as if 
     included in section 504 of the Prescription Drug User Fee 
     Amendments of 2002 (Public Law 107-188; 116 Stat. 687).

     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 
     dissemination 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 to be submitted to the 
     Secretary prior to initial public dissemination is not 
     subject to a fee under subparagraph (A) unless the sponsor 
     designates the submission as a submission for 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 
     advisory review in the next fiscal year. Notwithstanding the 
     preceding sentence, for fiscal year 2008, the Secretary shall 
     publish such a notice in the Federal Register not later than 
     30 days after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007.
       ``(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 to be 
     submitted for advisory review, subject to subparagraph 
     (F)(i). Notwithstanding the preceding sentence, the advisory 
     review fee for any DTC advertisement that is intended to be 
     submitted for advisory review during fiscal year 2008 shall 
     be due not later than 120 days after the date of the 
     enactment of the Food and Drug Administration Amendments of 
     2007 or an earlier date as specified by the Secretary.
       ``(ii) Effect of submission.--Notification of the Secretary 
     under subparagraph (C) of the number of DTC advertisements a 
     person intends to submit for 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. Notwithstanding the preceding 
     sentence, the commitment shall be a legally binding 
     commitment by that person to pay the annual advisory review 
     fee for that number of submissions for fiscal year 2008 by 
     the date specified in clause (i).
       ``(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 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) not later than November 1 of such fiscal 
     year (or, in the case of such a notification submitted with 
     respect to fiscal year 2008, not later than 150 days after 
     the date of the enactment of the Food and Drug Administration 
     Amendments Act of 2007 or an earlier date specified by the 
     Secretary), the fees

[[Page H10555]]

     shall be regarded as late and an increase in the amount of 
     fees applies in accordance with this clause, notwithstanding 
     any other provision of this section. For such person, all 
     advisory review fees for such fiscal year shall be due and 
     payable 20 days before any direct-to-consumer advertisement 
     is submitted to the Secretary for advisory review, and each 
     such fee shall 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 advertisements for advisory 
     review in a fiscal year that exceeds the number identified by 
     the person under subparagraph (C), 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 advertisement, the advisory 
     review fee shall be due and payable 20 days before the 
     advertisement is submitted to the Secretary, and the fee 
     shall 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 subsections 
     (d)(4) and (f), fees paid under this section 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--
       ``(i) October 1 of the first fiscal year in which the 
     person is required to pay an advisory review fee under 
     paragraph (1); or
       ``(ii) for fiscal year 2008, 120 days after the date of the 
     enactment of the Food and Drug Administration Amendments Act 
     of 2007 or an earlier date specified by the Secretary.
       ``(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 
     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)(E)(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 advisory review.
       ``(D) Late payment.--
       ``(i) In general.--Notwithstanding subparagraph (B), and 
     subject to clause (ii), an operating reserve fee shall be 
     regarded as late if the person required to pay the fee has 
     not paid the complete operating reserve fee by--

       ``(I) for fiscal year 2008, 150 days after the date of the 
     enactment of the Food and Drug Administration Amendments Act 
     of 2007 or an earlier date specified by the Secretary; or
       ``(II) in any subsequent year, November 1.

       ``(ii) Complete payment.--The complete operating reserve 
     fee shall be due and payable 20 days before any DTC 
     advertisement is submitted by such person to the Secretary 
     for advisory review.
       ``(iii) Amount.--Notwithstanding any other provision of 
     this section, an operating reserve fee that is regarded as 
     late under this subparagraph shall be equal to 150 percent of 
     the operating reserve fee that otherwise would have applied 
     pursuant to subsection (d).
       ``(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 shall 
     be added on a compounded basis to the sum of all adjustments 
     made each fiscal year after fiscal year 2008 under this 
     subsection.
       ``(2) Workload adjustment.--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 
     dissemination. 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 (or, with respect to fiscal year 2008, not later than 90 
     days after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007), 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 under subsection 
     (a)(1)(F)(i).
       ``(B) Fiscal year 2008 fee limit.--Notwithstanding 
     subsection (b) and the adjustments pursuant to this 
     subsection, the fee established under subparagraph (A) for 
     fiscal year 2008 may not be more than $83,000 per submission 
     for advisory review.
       ``(C) Annual fee limit.--Notwithstanding subsection (b) and 
     the adjustments pursuant to this subsection, the fee 
     established under subparagraph (A) for a fiscal year after 
     fiscal year 2008 may not be more than 50 percent more than 
     the fee established for the prior fiscal year.
       ``(D) Limit.--The total amount of fees obligated for a 
     fiscal year may not exceed the total costs for such fiscal 
     year for the resources allocated for the process for the 
     advisory review of prescription drug advertising.
       ``(d) Operating Reserves.--
       ``(1) In general.--The Secretary shall establish in the 
     Food and Drug Administration salaries and expenses 
     appropriation account without fiscal year limitation a 
     Direct-to-Consumer Advisory Review Operating Reserve, of at 
     least $6,250,000 in fiscal year 2008, to continue the program 
     under this section in the event the fees collected in any 
     subsequent fiscal year pursuant to subsection (a)(1) do not 
     generate the fee revenue amount established for that fiscal 
     year.
       ``(2) Fee setting.--The Secretary shall establish the 
     operating reserve fee under subsection (a)(2)(A) for each 
     person required to pay the fee by multiplying the number of 
     DTC advertisements identified by that person pursuant to 
     subsection (a)(1)(C) by the advisory review fee established 
     pursuant to subsection (c)(3) for that fiscal year, except 
     that in no case shall the operating reserve fee assessed be 
     less than the operating reserve fee assessed if the person 
     had first participated in the program under this section in 
     fiscal year 2008.
       ``(3) Use of operating reserve.--The Secretary may use 
     funds from the reserves only to the extent necessary in any 
     fiscal year to make up the difference between the fee revenue 
     amount established for that fiscal year under subsections (b) 
     and (c) and the amount of fees actually collected for that 
     fiscal year pursuant to subsection (a)(1), or to pay costs of 
     ending the program under this section if it is terminated 
     pursuant to subsection (f) or not reauthorized beyond fiscal 
     year 2012.
       ``(4) Refund of operating reserves.--Within 120 days after 
     the end of fiscal year 2012, or if the program under this 
     section ends early pursuant to subsection (f), the

[[Page H10556]]

     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 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 the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007, 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 
     terminate, and the Secretary shall notify all participants, 
     retain any money from the unused advisory review fees and the 
     operating reserves needed to terminate the program, and 
     refund the remainder of the unused fees and operating 
     reserves. To the extent required to terminate the program, 
     the Secretary shall first use unobligated advisory review fee 
     revenues from prior fiscal years, then the operating 
     reserves, and finally, unused advisory review fees from the 
     relevant fiscal year.
       ``(g) Crediting and Availability of Fees.--
       ``(1) In general.--Fees authorized under subsection (a) 
     shall be collected and available for obligation only to the 
     extent and in the amount provided in advance in 
     appropriations Acts. Such fees are authorized to remain 
     available until expended. Such sums as may be necessary may 
     be transferred from the Food and Drug Administration salaries 
     and expenses appropriation account without fiscal year 
     limitation to such appropriation account for salaries and 
     expenses with such fiscal year limitation. The sums 
     transferred shall be available solely for the process for the 
     advisory review of prescription drug advertising.
       ``(2) Collections and appropriation acts.--
       ``(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 section:
       ``(1) The term `advisory review' means reviewing and 
     providing advisory comments on DTC advertisements regarding 
     compliance of a proposed advertisement with the requirements 
     of this Act prior to its initial public dissemination.
       ``(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 `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 dissemination 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 dissemination.
       ``(9) The term `resources allocated for the process for the 
     advisory review of prescription drug advertising' means the 
     expenses incurred in connection with the process for the 
     advisory review of prescription drug advertising for--
       ``(A) officers and employees of the Food and Drug 
     Administration, contractors of the Food and Drug 
     Administration, advisory committees, and costs related to 
     such officers, employees, and committees, and to contracts 
     with such contractors;
       ``(B) management of information, and the acquisition, 
     maintenance, and repair of computer resources;
       ``(C) leasing, maintenance, renovation, and repair of 
     facilities and acquisition, maintenance, and repair of 
     fixtures, furniture, scientific equipment, and other 
     necessary materials and supplies;
       ``(D) collection of fees under this section and accounting 
     for resources allocated for the advisory review of 
     prescription drug advertising; and
       ``(E) terminating the program under this section pursuant 
     to subsection (f)(2) if that becomes necessary.
       ``(10) 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.
       ``(11) 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.

       Part 2 of subchapter C of chapter VII (21 U.S.C. 379g et 
     seq.), as amended by section 104, is further amended by 
     inserting after section 736A the following:

     ``SEC. 736B. 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 this part, 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 101(c) of the Food and Drug Administration Amendments 
     Act of 2007 during such fiscal year and the future plans of 
     the Food and Drug Administration for meeting the goals. The 
     report for a fiscal year shall include information on all 
     previous cohorts for which the Secretary has not given a 
     complete response on all human drug applications and 
     supplements in the cohort.
       ``(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 this part, 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) Public Availability.--The Secretary shall make the 
     reports required under subsections (a) and (b) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(d) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals, and plans 
     for meeting the goals, for the process for the review of 
     human drug applications for the first 5 fiscal years after 
     fiscal year 2012, and for the reauthorization of this part 
     for such fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;

[[Page H10557]]

       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the regulated industry on the reauthorization of this 
     part, the Secretary shall--
       ``(A) publish a notice in the Federal Register requesting 
     public input on the reauthorization;
       ``(B) hold a public meeting at which the public may present 
     its views on the reauthorization, including specific 
     suggestions for changes to the goals referred to in 
     subsection (a);
       ``(C) provide a period of 30 days after the public meeting 
     to obtain written comments from the public suggesting changes 
     to this part; and
       ``(D) publish the comments on the Food and Drug 
     Administration's Internet Web site.
       ``(3) Periodic consultation.--Not less frequently than once 
     every month during negotiations with the regulated industry, 
     the Secretary shall hold discussions with representatives of 
     patient and consumer advocacy groups to continue discussions 
     of their views on the reauthorization and their suggestions 
     for changes to this part as expressed under paragraph (2).
       ``(4) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the Congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(5) Transmittal of recommendations.--Not later than 
     January 15, 2012, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (4), 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.
       ``(6) Minutes of negotiation meetings.--
       ``(A) Public availability.--Before presenting the 
     recommendations developed under paragraphs (1) through (5) to 
     the Congress, the Secretary shall make publicly available, on 
     the public Web site of the Food and Drug Administration, 
     minutes of all negotiation meetings conducted under this 
     subsection between the Food and Drug Administration and the 
     regulated industry.
       ``(B) Content.--The minutes described under subparagraph 
     (A) shall summarize any substantive proposal made by any 
     party to the negotiations as well as significant 
     controversies or differences of opinion during the 
     negotiations and their resolution.''.

     SEC. 106. SUNSET DATES.

       (a) Authorization.--The amendments made by sections 102, 
     103, and 104 cease to be effective October 1, 2012.
       (b) Reporting Requirements.--The amendment made by section 
     105 ceases to be effective January 31, 2013.

     SEC. 107. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2007, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 2 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act shall be assessed for all human drug 
     applications received on or after October 1, 2007, regardless 
     of the date of the enactment of this Act.

     SEC. 108. SAVINGS CLAUSE.

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

     SEC. 109. TECHNICAL AMENDMENT; CONFORMING AMENDMENT.

       (a) Section 739 (21 U.S.C. 379j-11) is amended in the 
     matter preceding paragraph (1) by striking ``subchapter'' and 
     inserting ``part''.
       (b) Paragraph (11) of section 739 (21 U.S.C. 379j-11) is 
     amended by striking ``735(9)'' and inserting ``735(11)''.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007

     SEC. 201. SHORT TITLE; REFERENCES IN TITLE; FINDING.

       (a) Short Title.--This title may be cited as the ``Medical 
     Device User Fee Amendments of 2007''.
       (b) References in Title.--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.).
       (c) Finding.--The Congress finds that the fees authorized 
     under the amendments made by this title will be dedicated 
     toward expediting the process for the review of device 
     applications and for assuring the safety and effectiveness of 
     devices, as set forth in the goals identified for purposes of 
     part 3 of subchapter C of chapter VII of the Federal Food, 
     Drug, and Cosmetic Act in the letters from the Secretary of 
     Health and Human Services to the Chairman of the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Chairman of the Committee on Energy and Commerce of the House 
     of Representatives, as set forth in the Congressional Record.

              Subtitle A--Fees Related to Medical Devices

     SEC. 211. DEFINITIONS.

       Section 737 is amended--
       (1) in the matter preceding paragraph (1), by striking 
     ``For purposes of this subchapter'' and inserting ``For 
     purposes of this part'';
       (2) by redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (8), (9), (10), and (12), respectively;
       (3) by inserting after paragraph (4) the following:
       ``(5) The term `30-day notice' means a notice under section 
     515(d)(6) that is limited to a request to make modifications 
     to manufacturing procedures or methods of manufacture 
     affecting the safety and effectiveness of the device.
       ``(6) 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.
       ``(7) The term `annual fee', for periodic reporting 
     concerning a class III device, means the annual fee 
     associated with periodic reports required by a premarket 
     application approval order.'';
       (4) in paragraph (10), 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 (10), as so amended, the 
     following:
       ``(11) The term `person' includes an affiliate thereof.''; 
     and
       (6) by inserting after paragraph (12), as so redesignated, 
     the following:
       ``(13) The term `establishment subject to a registration 
     fee' 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, 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, within the meaning of section 201(ll)(2)(A), performs 
     additional processing and manufacturing operations on a 
     single-use device that has previously been used on a patient.
       ``(C) Specification developer.--An establishment that 
     develops specifications for a device that is distributed 
     under the establishment's name but 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.--Section 738(a) (21 U.S.C. 379j(a)) is 
     amended--
       (A) in paragraph (1), by striking ``Beginning on the date 
     of the enactment of the Medical Device User Fee and 
     Modernization Act of 2002'' and inserting ``Beginning in 
     fiscal year 2008''; and
       (B) by amending the designation and heading of paragraph 
     (2) 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) 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--
       (i) by striking ``1.42 percent'' and inserting ``1.84 
     percent''; and
       (ii) by striking ``, subject to any adjustment under 
     subsection (e)(2)(C)(ii)''; 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, 
     an annual fee 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:

[[Page H10558]]

       ``(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)(4) 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--
       (A) in clause (iii), by striking the last two sentences; 
     and
       (B) 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 an application submitted under 
     section 515(c)(4) that is withdrawn before a second portion 
     is submitted and before a first action on the first portion.
       ``(v) Later withdrawn modular applications.--If an 
     application submitted under section 515(c)(4) is withdrawn 
     after a second or subsequent portion 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 
     portions submitted.
       ``(vi) Sole discretion to refund.--The Secretary shall have 
     sole discretion to refund a fee or portion of the fee under 
     clause (iii) or (v). A determination by the Secretary 
     concerning a refund under clause (iii) or (v) shall not be 
     reviewable.''.
       (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 a registration fee 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), (e), and (h) the fees under subsection (a) shall be 
     based on the following fee amounts:


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

       (c) Annual Fee Setting.--
       (1) In general.--Section 738(c) (21 U.S.C. 379j(c)(1)) is 
     amended--
       (A) in the subsection heading, by striking ``Annual Fee 
     Setting'' and inserting ``Annual Fee Setting''; and
       (B) in paragraph (1), by striking the last sentence.
       (2) Adjustment of annual establishment fee.--Section 738(c) 
     (21 U.S.C. 379j(c)), as amended by paragraph (1), is further 
     amended--
       (A) by redesignating paragraphs (2) and (3) as paragraphs 
     (3) and (4), respectively;
       (B) by inserting after paragraph (1) the following:
       ``(2) Adjustment.--
       ``(A) In general.--When setting fees for fiscal year 2010, 
     the Secretary may increase the fee under subsection (a)(3)(A) 
     (applicable to establishments subject to registration) only 
     if the Secretary estimates that the number of establishments 
     submitting fees for fiscal year 2009 is fewer than 12,250. 
     The percentage increase shall be the percentage by which the 
     estimate of establishments submitting fees in fiscal year 
     2009 is fewer 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 
     or 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 or 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, 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)(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:

[[Page H10559]]

       ``(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 
     or 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 or 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 a 
     registration fee 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) by striking paragraph (1) and inserting the following:
       ``(1) Performance goals; termination of program.--With 
     respect to the amount that, under the salaries and expenses 
     account of the Food and Drug Administration, is appropriated 
     for a fiscal year for devices and radiological products, fees 
     may not be assessed under subsection (a) for the fiscal year, 
     and the Secretary is not expected to meet any performance 
     goals identified for the fiscal year, if--
       ``(A) the amount so appropriated for the fiscal year, 
     excluding the amount of fees appropriated for the fiscal 
     year, is more than 1 percent less than $205,720,000 
     multiplied by the adjustment factor applicable to such fiscal 
     year; or
       ``(B) fees were not assessed under subsection (a) for the 
     previous fiscal year.''; and
       (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 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. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 3 of subchapter C of chapter VII is amended by 
     inserting after section 738 the following:

     ``SEC. 738A. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Reports.--
       ``(1) Performance report.--For fiscal years 2008 through 
     2012, not later than 120 days after the end of each fiscal 
     year during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report concerning the progress of the Food 
     and Drug Administration in achieving the goals identified in 
     the letters described in section 201(c) of the Food and Drug 
     Administration Amendments Act of 2007 during such fiscal year 
     and the future plans of the Food and Drug Administration for 
     meeting the goals. The report for a fiscal year shall include 
     information on all previous cohorts for which the Secretary 
     has not given a complete response on all device premarket 
     applications and reports, supplements, and premarket 
     notifications in the cohort.
       ``(2) Fiscal report.--For fiscal years 2008 through 2012, 
     not later than 120 days after the end of each fiscal year 
     during which fees are collected under this part, the 
     Secretary shall prepare and submit to the Committee on 
     Health, Education, Labor, and Pensions of the Senate and the 
     Committee on Energy and Commerce of the House of 
     Representatives, a report on the implementation of the 
     authority for such fees during such fiscal year and the use, 
     by the Food and Drug Administration, of the fees collected 
     during such fiscal year for which the report is made.
       ``(3) Public availability.--The Secretary shall make the 
     reports required under paragraphs (1) and (2) available to 
     the public on the Internet Web site of the Food and Drug 
     Administration.
       ``(b) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to Congress with respect to the goals, and plans for 
     meeting the goals, for the process for the review of device 
     applications for the first 5 fiscal years after fiscal year 
     2012, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the regulated industry on the reauthorization of this 
     part, the Secretary shall--
       ``(A) publish a notice in the Federal Register requesting 
     public input on the reauthorization;
       ``(B) hold a public meeting at which the public may present 
     its views on the reauthorization, including specific 
     suggestions for changes to the goals referred to in 
     subsection (a)(1);
       ``(C) provide a period of 30 days after the public meeting 
     to obtain written comments from the public suggesting changes 
     to this part; and
       ``(D) publish the comments on the Food and Drug 
     Administration's Internet Web site.
       ``(3) Periodic consultation.--Not less frequently than once 
     every month during negotiations with the regulated industry, 
     the Secretary shall hold discussions with representatives of 
     patient and consumer advocacy groups to continue discussions 
     of their views on the reauthorization and their suggestions 
     for changes to this part as expressed under paragraph (2).
       ``(4) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the Congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(5) Transmittal of recommendations.--Not later than 
     January 15, 2012, the Secretary shall transmit to Congress 
     the revised recommendations under paragraph (4), a summary of 
     the views and comments received under such paragraph, and any

[[Page H10560]]

     changes made to the recommendations in response to such views 
     and comments.
       ``(6) Minutes of negotiation meetings.--
       ``(A) Public availability.--Before presenting the 
     recommendations developed under paragraphs (1) through (5) to 
     the Congress, the Secretary shall make publicly available, on 
     the public Web site of the Food and Drug Administration, 
     minutes of all negotiation meetings conducted under this 
     subsection between the Food and Drug Administration and the 
     regulated industry.
       ``(B) Content.--The minutes described under subparagraph 
     (A) shall summarize any substantive proposal made by any 
     party to the negotiations as well as significant 
     controversies or differences of opinion during the 
     negotiations and their resolution.''.

     SEC. 214. SAVINGS CLAUSE.

       Notwithstanding section 107 of the Medical Device User Fee 
     and Modernization Act of 2002 (Public Law 107-250), and 
     notwithstanding the amendments made by this subtitle, part 3 
     of subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the 
     day before the date of the enactment of this subtitle, shall 
     continue to be in effect with respect to premarket 
     applications, premarket reports, premarket notification 
     submissions, and supplements (as defined in such part as of 
     such day) that on or after October 1, 2002, but before 
     October 1, 2007, were accepted by the Food and Drug 
     Administration for filing with respect to assessing and 
     collecting any fee required by such part for a fiscal year 
     prior to fiscal year 2008.

     SEC. 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--
       (1) $7,100,000 for fiscal year 2008;
       (2) $7,455,000 for fiscal year 2009;
       (3) $7,827,750 for fiscal year 2010;
       (4) $8,219,138 for fiscal year 2011; and
       (5) $8,630,094 for fiscal year 2012.

     SEC. 216. EFFECTIVE DATE.

       The amendments made by this subtitle shall take effect on 
     October 1, 2007, or the date of the enactment of this Act, 
     whichever is later, except that fees under part 3 of 
     subchapter C of chapter VII of the Federal Food, Drug, and 
     Cosmetic Act shall be assessed for all premarket 
     applications, premarket reports, supplements, 30-day notices, 
     and premarket notification submissions received on or after 
     October 1, 2007, regardless of the date of the enactment of 
     this Act.

     SEC. 217. SUNSET CLAUSE.

       The amendments made by this subtitle cease to be effective 
     October 1, 2012, except that section 738A of the Federal 
     Food, Drug, and Cosmetic Act (regarding annual performance 
     and financial 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 ``(b) On or before'' and inserting ``(b)(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) 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.''.

     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 of 
     the Federal Food, Drug, and Cosmetic Act, the study under 
     subsection (a) shall consider the Secretary of Health and 
     Human Services's evaluation of the respective intended uses 
     and technologies of such devices, including the effectiveness 
     of such Secretary's comparative assessment of technological 
     characteristics such as device materials, principles of 
     operations, and power sources.
       (c) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Comptroller General shall complete 
     the study under subsection (a) and submit to the Congress a 
     report on the results of such study.

     SEC. 226. UNIQUE DEVICE IDENTIFICATION SYSTEM.

       (a) In General.--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 label of devices to bear a 
     unique identifier, unless the Secretary requires an 
     alternative placement or provides an exception for a 
     particular device or type of device. The unique identifier 
     shall adequately identify the device through distribution and 
     use, and may include information on the lot or serial 
     number.''.
       (b) Conforming Amendment.--Section 303 (21 U.S.C. 333) is 
     amended--
       (1) by redesignating the subsection that follows subsection 
     (e) as subsection (f); and
       (2) in paragraph (1)(B)(ii) of subsection (f), as so 
     redesignated, by striking ``519(f)'' and inserting 
     ``519(g)''.

     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), unless the Secretary grants an exemption or 
     variance from, or an alternative to, a requirement under such 
     regulations pursuant to section 803.19 of such part, 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 which the Secretary has, by notice 
     published in the Federal Register or letter to the person who 
     is the manufacturer or importer of the device, indicated 
     should be subject to such part 803 in order to protect the 
     public health;

       ``(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; or
       ``(iii) shall, if the device is imported into the United 
     States and for which part 803 of title 21, Code of Federal 
     Regulations (or successor regulations) requires an importer 
     to submit a report to the manufacturer, be submitted by the 
     importer to the manufacturer in accordance with part 803 of 
     title 21, Code of Federal Regulations (or successor 
     regulations)''.

     SEC. 228. INSPECTIONS BY ACCREDITED PERSONS.

       Section 704(g) (21 U.S.C. 374(g)) is amended--

[[Page H10561]]

       (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 operator of a device establishment in response to a 
     request under clause (ii)(I) are data describing whether the 
     quality controls of the establishment have been sufficient 
     for ensuring consistent compliance with current good 
     manufacturing practice within the meaning of section 501(h) 
     and with other applicable provisions of this Act. Such data 
     shall include complete reports of inspectional findings 
     regarding good manufacturing practice or other quality 
     control audits that, during the preceding 2-year period, were 
     conducted at the establishment by persons other than the 
     owner or operator of the establishment, together with all 
     other compliance data the Secretary deems necessary. Data 
     under the preceding sentence shall demonstrate to the 
     Secretary whether the establishment has facilitated 
     consistent compliance by promptly correcting any compliance 
     problems identified in such inspections.
       ``(II) A request to an accredited person under clause 
     (ii)(II) may not seek any information that is not required to 
     be maintained by such person in records under subsection 
     (f)(1).
       ``(iv) A device establishment is deemed to have clearance 
     to participate in the program and to use the accredited 
     person identified in the notice under subparagraph (A)(ii) 
     for inspections of the establishment unless the Secretary, 
     not later than 60 days after receiving the information 
     requested under clause (ii), issues a response that denies 
     clearance to participate as provided under subparagraph (C).
       ``(C)(i) The Secretary may deny clearance to a device 
     establishment if the Secretary has evidence that the 
     certification under subparagraph (A)(ii)(IV) is untrue and 
     the Secretary provides to the owner or operator of the 
     establishment a statement summarizing such evidence.
       ``(ii) The Secretary may deny clearance to a device 
     establishment if the Secretary determines that the 
     establishment has failed to demonstrate consistent compliance 
     for purposes of subparagraph (B)(iii)(I) and the Secretary 
     provides to the owner or operator of the establishment a 
     statement of the reasons for such determination.
       ``(iii)(I) The Secretary may reject the selection of the 
     accredited person identified in the notice under subparagraph 
     (A)(ii) if the Secretary provides to the owner or operator of 
     the establishment a statement of the reasons for such 
     rejection. Reasons for the rejection may include that the 
     establishment or the accredited person, as the case may be, 
     has failed to fully respond to the request, or that the 
     Secretary has concerns regarding the relationship between the 
     establishment and such accredited person.
       ``(II) If the Secretary rejects the selection of an 
     accredited person by the owner or operator of a device 
     establishment, the owner or operator may make an additional 
     selection of an accredited person by submitting to the 
     Secretary a notice that identifies the additional selection. 
     Clauses (i) and (ii) of subparagraph (B), and subclause (I) 
     of this clause, apply to the selection of an accredited 
     person through a notice under the preceding sentence in the 
     same manner and to the same extent as such provisions apply 
     to a selection of an accredited person through a notice under 
     subparagraph (A)(ii).
       ``(iv) In the case of a device establishment that is denied 
     clearance under clause (i) or (ii) or with respect to which 
     the selection of the accredited person is rejected under 
     clause (iii), the Secretary shall designate a person to 
     review the statement of reasons, or statement summarizing 
     such evidence, as the case may be, of the Secretary under 
     such clause if, during the 30-day period beginning on the 
     date on which the owner or operator of the establishment 
     receives such statement, the owner or operator requests the 
     review. The review shall commence not later than 30 days 
     after the owner or operator requests the review, unless the 
     Secretary and the owner or operator otherwise agree.'';
       (5) in paragraph (7)--
       (A) in subparagraph (A), by striking ``(A) Persons'' and 
     all that follows through the end and inserting the following: 
     ``(A) Persons accredited under paragraph (2) to conduct 
     inspections shall record in writing their inspection 
     observations and shall present the observations to the device 
     establishment's designated representative and describe each 
     observation. Additionally, such accredited person shall 
     prepare an inspection report in a form and manner designated 
     by the Secretary to conduct inspections, taking into 
     consideration the goals of international harmonization of 
     quality systems standards. Any official classification of the 
     inspection shall be determined by the Secretary.''; and
       (B) by adding at the end the following:
       ``(F) For the purpose of setting risk-based inspectional 
     priorities, the Secretary shall accept voluntary submissions 
     of reports of audits assessing conformance with appropriate 
     quality systems standards set by the International 
     Organization for Standardization (ISO) and identified by the 
     Secretary in public notice. If the owner or operator of an 
     establishment elects to submit audit reports under this 
     subparagraph, the owner or operator shall submit all such 
     audit reports with respect to the establishment during the 
     preceding 2-year periods.''; and
       (6) in paragraph (10)(C)(iii), by striking ``based'' and 
     inserting ``base''.

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

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

     SEC. 230. REPORT BY THE FOOD AND DRUG ADMINISTRATION 
                   REGARDING LABELING INFORMATION ON THE 
                   RELATIONSHIP BETWEEN THE USE OF INDOOR TANNING 
                   DEVICES AND DEVELOPMENT OF SKIN CANCER OR OTHER 
                   SKIN DAMAGE.

       (a) In General.--The Secretary of Health and Human Services 
     (referred to in this section as the ``Secretary''), acting 
     through the Commissioner of Food and Drugs, shall determine--

[[Page H10562]]

       (1) whether the labeling requirements for indoor tanning 
     devices, including the positioning requirements, provide 
     sufficient information to consumers regarding the risks that 
     the use of such devices pose for the development of 
     irreversible damage to the eyes and skin, including skin 
     cancer; and
       (2)(A) whether modifying the warning label required on 
     tanning beds to read, ``Ultraviolet radiation can cause skin 
     cancer'', or any other additional warning, would communicate 
     the risks of indoor tanning more effectively; or
       (B) whether there is no warning that would be capable of 
     adequately communicating such risks.
       (b) Consumer Testing.--In making the determinations under 
     subsection (a), the Secretary shall conduct appropriate 
     consumer testing to determine consumer understanding of label 
     warnings.
       (c) Report.--Not later than 1 year after the date of the 
     enactment of this Act, the Secretary shall submit to the 
     Congress a report that provides the determinations under 
     subsection (a). In addition, the Secretary shall include in 
     the report the measures being implemented by the Secretary to 
     significantly reduce the risks associated with indoor tanning 
     devices.

 TITLE 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 the 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 
     the enactment of the Pediatric Medical Device Safety and 
     Improvement Act of 2007.
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year does not exceed the annual 
     distribution number specified by the Secretary when the 
     Secretary grants such exemption. The annual distribution 
     number shall be based on the number of individuals affected 
     by the disease or condition that such device is intended to 
     treat, diagnose, or cure, and of that number, the number of 
     individuals likely to use the device, and the number of 
     devices reasonably necessary to treat such individuals. In no 
     case shall the annual distribution number exceed the number 
     identified in paragraph (2)(A).
       ``(iii) Such person immediately notifies the Secretary if 
     the number of such devices distributed during any calendar 
     year exceeds the annual distribution number referred to in 
     clause (ii).
       ``(iv) The request for such exemption is submitted on or 
     before October 1, 2012.
       ``(B) The Secretary may inspect the records relating to the 
     number of devices distributed during any calendar year of a 
     person granted an exemption under paragraph (2) for which the 
     prohibition in paragraph (3) does not apply.
       ``(C) A person may petition the Secretary to modify the 
     annual distribution number specified by the Secretary under 
     subparagraph (A)(ii) with respect to a device if additional 
     information on the number of individuals affected by the 
     disease or condition arises, and the Secretary may modify 
     such number but in no case shall the annual distribution 
     number exceed the number identified in paragraph (2)(A).
       ``(D) If a person notifies the Secretary, or the Secretary 
     determines through an inspection under subparagraph (B), that 
     the number of devices distributed during any calendar year 
     exceeds the annual distribution number, as required under 
     subparagraph (A)(iii), and modified under subparagraph (C), 
     if applicable, then the prohibition in paragraph (3) shall 
     apply with respect to such person for such device for any 
     sales of such device after such notification.
       ``(E)(i) In this subsection, the term `pediatric patients' 
     means patients who are 21 years of age or younger at the time 
     of the diagnosis or treatment.
       ``(ii) In this subsection, the term `pediatric 
     subpopulation' means 1 of the following populations:
       ``(I) Neonates.
       ``(II) Infants.
       ``(III) Children.
       ``(IV) Adolescents.
       ``(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) The Secretary, acting through the Office of Pediatric 
     Therapeutics and the Center for Devices and Radiological 
     Health, shall provide for an annual review by the Pediatric 
     Advisory Committee of all devices described in paragraph (6) 
     to ensure that the exemption under paragraph (2) remains 
     appropriate for the pediatric populations for which it is 
     granted.''.
       (b) Report.--Not later than January 1, 2012, the 
     Comptroller General of the United States shall submit to the 
     Committee on Health, Education, Labor, and Pensions of the 
     Senate and the Committee on Energy and Commerce of the House 
     of Representatives a report on the impact of allowing persons 
     granted an exemption under section 520(m)(2) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(2)) with 
     respect to a device to profit from such device pursuant to 
     section 520(m)(6) of such Act (21 U.S.C. 360j(m)(6)) (as 
     amended by subsection (a)), including--
       (1) an assessment of whether such section 520(m)(6) (as 
     amended by subsection (a)) has increased the availability of 
     pediatric devices for conditions that occur in small numbers 
     of children, including any increase or decrease in the number 
     of--
       (A) exemptions granted under such section 520(m)(2) for 
     pediatric devices; and
       (B) applications approved under section 515 of such Act (21 
     U.S.C. 360e) for devices intended to treat, diagnose, or cure 
     conditions

[[Page H10563]]

     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 purchasing pediatric devices, based on a 
     representative sampling 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, which shall include an evaluation of the number 
     of pediatric medical devices--
       (A) that have been or are being studied in children; and
       (B) that have been submitted to the Food and Drug 
     Administration for approval, clearance, or review under such 
     section 520(m) (as amended by this Act) and any regulatory 
     actions taken.
       (c) Guidance.--Not later than 180 days after the date of 
     the 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) Contact Point for Available Funding.--Section 402(b) of 
     the Public Health Service Act (42 U.S.C. 282(b)) is amended--
       (1) in paragraph (21), by striking ``and'' after the 
     semicolon at the end;
       (2) in paragraph (22), by striking the period at the end 
     and inserting ``; and''; and
       (3) by inserting after paragraph (22) the following:
       ``(23) shall designate a contact point or office to help 
     innovators and physicians identify sources of funding 
     available for pediatric medical device development.''.
       (b) Plan for Pediatric Medical Device Research.--
       (1) In general.--Not later than 180 days after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services, acting through the Commissioner of Food and Drugs, 
     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 Secretary of Health and Human 
     Services 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 the 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 facilitate the 
     development, production, and distribution of pediatric 
     medical devices by--
       (1) encouraging innovation and connecting qualified 
     individuals with pediatric device ideas with potential 
     manufacturers;
       (2) mentoring and managing pediatric device projects 
     through the development process, including product 
     identification, prototype design, device development, and 
     marketing;
       (3) connecting innovators and physicians to existing 
     Federal and non-Federal resources, including resources from 
     the Food and Drug Administration, the National Institutes of 
     Health, the Small Business Administration, the Department of 
     Energy, the Department of Education, the National Science 
     Foundation, the Department of Veterans Affairs, the Agency 
     for Healthcare Research and Quality, and the National 
     Institute of Standards and Technology;
       (4) assessing the scientific and medical merit of proposed 
     pediatric device projects; and
       (5) providing assistance and advice as needed on business 
     development, personnel training, prototype development, 
     postmarket needs, and other activities consistent with the 
     purposes of this section.
       (d) Coordination.--
       (1) National institutes of health.--Each consortium that 
     receives a grant or contract under this section shall--
       (A) coordinate with the National Institutes of Health's 
     pediatric device contact point or office, designated under 
     section 402(b)(23) of the Public Health Service Act, as added 
     by section 304(a) of this Act; and
       (B) provide to the National Institutes of Health any 
     identified pediatric device needs that the consortium lacks 
     sufficient capacity to address or those needs in which the 
     consortium has been unable to stimulate manufacturer 
     interest.
       (2) Food and drug administration.--Each consortium that 
     receives a grant or contract under this section shall 
     coordinate with the Commissioner of Food and Drugs and device 
     companies to facilitate the application for approval or 
     clearance of devices labeled for pediatric use.
       (3) Effectiveness and outcomes.--Each consortium that 
     receives a grant or contract under this section shall 
     annually report to the Secretary of Health and Human Services 
     on the status of pediatric device development, production, 
     and distribution that has been facilitated by the consortium.
       (e) Authorization of Appropriations.--There are authorized 
     to be appropriated to carry out this section $6,000,000 for 
     each of fiscal years 2008 through 2012.

     SEC. 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 SURVEILLANCE.

       Section 522 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360l) is amended--
       (1) by amending the section heading and designation to read 
     as follows:

     ``SEC. 522. POSTMARKET SURVEILLANCE.'';

       (2) by striking subsection (a) and inserting the following:
       ``(a) Postmarket Surveillance.--
       ``(1) In general.--
       ``(A) Conduct.--The Secretary may by order require a 
     manufacturer to conduct postmarket surveillance for any 
     device of the manufacturer that is a class II or class III 
     device--
       ``(i) the failure of which would be reasonably likely to 
     have serious adverse health consequences;
       ``(ii) that is expected to have significant use in 
     pediatric populations; or
       ``(iii) that is intended to be--

       ``(I) implanted in the human body for more than 1 year; or
       ``(II) a life-sustaining or life-supporting device used 
     outside a device user facility.

       ``(B) Condition.--The Secretary may order a postmarket 
     surveillance under subparagraph (A) as a condition to 
     approval or clearance of a device described in subparagraph 
     (A)(ii).
       ``(2) Rule of construction.--The provisions of paragraph 
     (1) shall have no effect on authorities otherwise provided 
     under the Act or regulations issued under this Act.''; and
       (3) in subsection (b)--
       (A) by striking ``(b) Surveillance Approval.--Each'' and 
     inserting the following:
       ``(b) Surveillance Approval.--
       ``(1) In general.--Each'';

[[Page H10564]]

       (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 surveillance 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, because 
     of noncompliance with such order or condition, be deemed in 
     violation of section 301(q)(1)(C), adulterated under section 
     501(f)(1), misbranded under section 502(t)(3), or in 
     violation of, as applicable, section 510(k) or section 515, 
     unless deemed necessary to protect the public health.''.

            TITLE IV--PEDIATRIC RESEARCH EQUITY ACT OF 2007

     SEC. 401. SHORT TITLE.

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

     SEC. 402. REAUTHORIZATION OF PEDIATRIC RESEARCH EQUITY ACT.

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

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

       ``(a) New Drugs and Biological Products.--
       ``(1) In general.--A person that submits, on or after the 
     date of the 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 
     any pertinent reviews for 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 Web site 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 Web site 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.--After providing notice in the form of a 
     letter (that, for a drug approved under section 505, 
     references a declined written request under section 505A for 
     a labeled indication which written request is not referred 
     under section 505A(n)(1)(A) to the Foundation of the National 
     Institutes of Health for the pediatric studies), 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

[[Page H10565]]

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

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

       ``(II) the absence of adequate labeling could not pose 
     significant risks to pediatric patients; or
       ``(iv) the applicant can demonstrate that reasonable 
     attempts to produce a pediatric formulation necessary for 
     that age group have failed.
       ``(C) Pediatric formulation not possible.--If a waiver is 
     granted on the ground that it is not possible to develop a 
     pediatric formulation, the waiver shall cover only the 
     pediatric groups requiring that formulation. An applicant 
     seeking either a full or partial waiver shall submit to the 
     Secretary documentation detailing why a pediatric formulation 
     cannot be developed and, if the waiver is granted, the 
     applicant's submission shall promptly be made available to 
     the public in an easily accessible manner, including through 
     posting on the Web site 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.
       ``(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.
       ``(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) 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, Assessments, Deferrals, 
     and Waivers.--
       ``(1) Review.--Beginning not later than 30 days after the 
     date of the enactment of the Pediatric Research Equity Act of 
     2007, the Secretary shall utilize the internal committee 
     established under section 505C 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.
       ``(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) or (5), which members of the committee participated in 
     such activity.
       ``(4) Review of pediatric plans, assessments, deferrals, 
     and waivers.--Consultation on pediatric plans and assessments 
     by the committee referred to in paragraph (1) 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 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, 
     including with respect to whether such a supplement, when 
     submitted, shall be considered for priority review.
       ``(5) Retrospective review of pediatric assessments, 
     deferrals, and waivers.--Not later than 1 year after the date 
     of the enactment of the Pediatric Research Equity Act of 
     2007, the committee referred to in paragraph (1) shall 
     conduct a retrospective review and analysis of a 
     representative sample of assessments submitted and deferrals 
     and waivers approved under this section since the 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.--The 
     Secretary, in consultation with the committee referred to in 
     paragraph (1), shall track and make available to the public 
     in an easily accessible manner, including through posting on 
     the Web site 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);
       ``(I) an annual summary of information submitted pursuant 
     to subsection (a)(3)(B); and
       ``(J) the number of times the committee referred to in 
     paragraph (1) made a recommendation to the Secretary under 
     paragraph (4) regarding priority review, the number of times 
     the Secretary followed or did not follow such a 
     recommendation, and, if not followed, the reasons why such a 
     recommendation was not followed.
       ``(g) Labeling Changes.--
       ``(1) Dispute resolution.--
       ``(A) Request for labeling change and failure to agree.--
     If, on or after the date of the 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 or supplement to make any labeling changes 
     that the Commissioner determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application or 
     supplement, within 30 days after receiving a request under 
     subparagraph (C), does not agree to make a labeling change 
     requested by the Commissioner, the Commissioner may deem the 
     drug that is the subject of the application or supplement to 
     be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Committee process or an enforcement action 
     referred to in the preceding sentence) shall preclude,

[[Page H10566]]

     delay, or serve as the basis to stay the other course of 
     action.
       ``(2) Other labeling changes.--If, on or after the date of 
     the 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 210 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 Web site of the Food and Drug 
     Administration.
       ``(2) Dissemination of information regarding labeling 
     changes.--Beginning on the date of the enactment of the 
     Pediatric Research Equity Act of 2007, the Secretary shall 
     require that the sponsors of the assessments that result in 
     labeling changes that are reflected in the annual summary 
     developed pursuant to subsection (f)(6)(H) distribute such 
     information to physicians and other health care providers.
       ``(3) Effect of subsection.--Nothing in this subsection 
     shall alter or amend section 301(j) of this Act or section 
     552 of title 5 or section 1905 of title 18, United States 
     Code.
       ``(i) Adverse Event Reporting.--
       ``(1) Reporting in year one.--Beginning on the date of the 
     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 such reports, the Director of 
     such Office shall provide for the review of such 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.
       ``(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 or 
     precursor regulations 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.
       ``(m) Integration With Other Pediatric Studies.--The 
     authority under this section shall remain in effect so long 
     as an application subject to this section may be accepted for 
     filing by the Secretary on or before the date specified in 
     section 505A(q).''.
       (b) Applicability.--
       (1) In general.--Notwithstanding subsection (h) of section 
     505B of the Federal Food, Drug and Cosmetic Act, as in effect 
     on the day before the date of the enactment of this Act, a 
     pending assessment, including a deferred assessment, required 
     under such section 505B shall be deemed to have been required 
     under section 505B of the Federal Food, Drug and Cosmetic Act 
     as in effect on or after the date of the enactment of this 
     Act.
       (2) Certain assessments and waiver requests.--An assessment 
     pending on or after the date that is 1 year prior to the date 
     of the enactment of this Act shall be subject to the tracking 
     and disclosure requirements established under such section 
     505B, as in effect on or after such date of enactment, except 
     that any such assessments submitted or waivers of such 
     assessments requested before such date of enactment shall not 
     be subject to subsections (a)(4)(C), (b)(2)(C), (f)(6)(F), 
     and (h) of such section 505B.

     SEC. 403. ESTABLISHMENT OF INTERNAL COMMITTEE.

       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. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC 
                   PLANS, ASSESSMENTS, DEFERRALS, AND WAIVERS.

       ``The Secretary shall establish an internal committee 
     within the Food and Drug Administration to carry out the 
     activities as described in sections 505A(f) and 505B(f). 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, such as expertise in 
     child and adolescent psychiatry, and other individuals 
     designated by the Secretary.''.

     SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

       Not later than January 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;
       (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)--

[[Page H10567]]

       ``(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 made under subsection (d)(3) is made later than 
     9 months prior to the expiration of such period.
       ``(c) Market Exclusivity for Already-Marketed Drugs.--
       ``(1) In general.--Except as provided in paragraph (2), if 
     the Secretary determines that information relating to the use 
     of an approved drug in the pediatric population may produce 
     health benefits in that population and makes a written 
     request to the holder of an approved application under 
     section 505(b)(1) for pediatric studies (which shall include 
     a timeframe for completing such studies), the holder agrees 
     to the request, such studies are completed using appropriate 
     formulations for each age group for which the study is 
     requested within any such timeframe, and the reports thereof 
     are submitted and accepted in accordance with subsection 
     (d)(3)--
       ``(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 made under subsection (d)(3) is made later than 
     9 months 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.--The Secretary shall utilize the 
     internal review committee established under section 505C 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).
       ``(2) Review of written requests.--The committee referred 
     to in paragraph (1) shall review all written requests issued 
     pursuant to this section prior to being issued.
       ``(3) Review of pediatric studies.--The committee referred 
     to in paragraph (1) may review studies conducted pursuant to 
     this section to make a recommendation to the Secretary 
     whether to accept or reject such reports under subsection 
     (d)(3).

[[Page H10568]]

       ``(4) 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.
       ``(5) Documentation of committee action.--For each drug, 
     the committee referred to in paragraph (1) shall document, 
     for each activity described in paragraph (2) or (3), which 
     members of the committee participated in such activity.
       ``(6) Tracking pediatric studies and labeling changes.--The 
     Secretary, in consultation with the committee referred to in 
     paragraph (1), shall track and make available to the public, 
     in an easily accessible manner, including through posting on 
     the Web site 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 drug 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.
       ``(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, 
     except that such drug may not receive any additional such 
     period under subsection (c)(1)(B); and
       ``(2) may not receive any additional such period under 
     subsection (c)(1)(A)(ii).
       ``(h) Relationship to Pediatric Research Requirements.--
     Notwithstanding any other provision of law, if any pediatric 
     study is required by a provision of law (including a 
     regulation) other than this section and such study meets the 
     completeness, timeliness, and other requirements of this 
     section, such study shall be deemed to satisfy the 
     requirement for market exclusivity pursuant to this section.
       ``(i) Labeling Changes.--
       ``(1) Priority status for pediatric applications and 
     supplements.--Any application or supplement to an application 
     under section 505 proposing a labeling change as a result of 
     any pediatric study conducted pursuant to this section--
       ``(A) shall be considered to be a priority application or 
     supplement; and
       ``(B) shall be subject to the performance goals established 
     by the Commissioner for priority drugs.
       ``(2) Dispute resolution.--
       ``(A) Request for labeling change and failure to agree.--
     If, on or after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, the Commissioner 
     determines that the sponsor and the Commissioner have been 
     unable to reach agreement on appropriate changes to the 
     labeling for the drug that is the subject of the application, 
     not later than 180 days after the date of submission of the 
     application--
       ``(i) the Commissioner shall request that the sponsor of 
     the application make any labeling change that the 
     Commissioner determines to be appropriate; and
       ``(ii) if the sponsor of the application does not agree 
     within 30 days after the Commissioner's request to make a 
     labeling change requested by the Commissioner, the 
     Commissioner shall refer the matter to the Pediatric Advisory 
     Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A)(ii), the Pediatric Advisory Committee 
     shall--
       ``(i) review the pediatric study reports; and
       ``(ii) make a recommendation to the Commissioner concerning 
     appropriate labeling changes, if any.
       ``(C) Consideration of recommendations.--The Commissioner 
     shall consider the recommendations of the Pediatric Advisory 
     Committee and, if appropriate, not later than 30 days after 
     receiving the recommendation, make a request to the sponsor 
     of the application to make any labeling change that the 
     Commissioner determines to be appropriate.
       ``(D) Misbranding.--If the sponsor of the application, 
     within 30 days after receiving a request under subparagraph 
     (C), does not agree to make a labeling change requested by 
     the Commissioner, the Commissioner may deem the drug that is 
     the subject of the application to be misbranded.
       ``(E) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under this Act when a drug lacks 
     appropriate pediatric labeling. Neither course of action (the 
     Pediatric Advisory Committee process or an enforcement action 
     referred to in the preceding sentence) shall preclude, delay, 
     or serve as the basis to stay the other course of action.
       ``(j) Other Labeling Changes.--If, on or after the date of 
     the enactment of the Best Pharmaceuticals for Children Act of 
     2007, the Secretary determines that a pediatric study 
     conducted under this section does or does not demonstrate 
     that the drug that is the subject of the study is safe and 
     effective, including whether such study results are 
     inconclusive, in pediatric populations or subpopulations, the 
     Secretary shall order the labeling of such product to include 
     information about the results of the study and a statement of 
     the Secretary's determination.
       ``(k) Dissemination of Pediatric Information.--
       ``(1) In general.--Not later than 210 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 of a drug have not been completed under 
     subsection (d) and if the Secretary, through the committee 
     established under section 505C, determines that there is a 
     continuing need for information relating to the use of the 
     drug in the pediatric population (including neonates, as 
     appropriate), the Secretary shall carry out the following:
       ``(A) For a drug for which a listed patent has not expired, 
     make a determination regarding whether an assessment shall be 
     required to be submitted under section 505B(b). Prior to 
     making such a determination, the Secretary may not take more 
     than 30 days to certify whether the Foundation for the 
     National Institutes of Health has sufficient funding at the 
     time of such certification to initiate and fund all of the 
     studies in the written request in their entirety within the 
     timeframes specified within the written request. Only if the 
     Secretary makes such certification in the affirmative, the 
     Secretary

[[Page H10569]]

     shall refer all pediatric studies in the written request to 
     the Foundation for the National Institutes of Health for the 
     conduct of such studies, and such Foundation shall fund such 
     studies. If no certification has been made at the end of the 
     30-day period, or if the Secretary certifies that funds are 
     not sufficient to initiate and fund all the studies in their 
     entirety, the Secretary shall consider whether assessments 
     shall be required under section 505B(b) for such drug.
       ``(B) For a drug that has no listed patents or has 1 or 
     more listed patents that have expired, the Secretary shall 
     refer the drug for inclusion on the list established under 
     section 409I of the Public Health Service Act for the conduct 
     of studies.
       ``(2) Public notice.--The Secretary shall give the public 
     notice of a decision under paragraph (1)(A) not to require an 
     assessment under section 505B and the basis for such 
     decision.
       ``(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.
       ``(o) Prompt Approval of Drugs Under Section 505(j) When 
     Pediatric Information Is Added to Labeling.--
       ``(1) General rule.--A drug for which an application has 
     been submitted or approved under section 505(j) shall not be 
     considered ineligible for approval under that section or 
     misbranded under section 502 on the basis that the labeling 
     of the drug omits a pediatric indication or any other aspect 
     of labeling pertaining to pediatric use when the omitted 
     indication or other aspect is protected by patent or by 
     exclusivity under clause (iii) or (iv) of section 
     505(j)(5)(F).
       ``(2) Labeling.--Notwithstanding clauses (iii) and (iv) of 
     section 505(j)(5)(F), the Secretary may require that the 
     labeling of a drug approved under section 505(j) that omits a 
     pediatric indication or other aspect of labeling as described 
     in paragraph (1) include--
       ``(A) a statement that, because of marketing exclusivity 
     for a manufacturer--
       ``(i) the drug is not labeled for pediatric use; or
       ``(ii) in the case of a drug for which there is an 
     additional pediatric use not referred to in paragraph (1), 
     the drug is not labeled for the pediatric use under paragraph 
     (1); and
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, or precautions that the 
     Secretary considers necessary.
       ``(3) Preservation of pediatric exclusivity and other 
     provisions.--This subsection does not affect--
       ``(A) the availability or scope of exclusivity under this 
     section;
       ``(B) the availability or scope of exclusivity under 
     section 505 for pediatric formulations;
       ``(C) the question of the eligibility for approval of any 
     application under section 505(j) that omits any other 
     conditions of approval entitled to exclusivity under clause 
     (iii) or (iv) of section 505(j)(5)(F); or
       ``(D) except as expressly provided in paragraphs (1) and 
     (2), the operation of section 505.
       ``(p) Institute of Medicine Study.--Not later than 3 years 
     after the date of the enactment of the Best Pharmaceuticals 
     for Children Act of 2007, the Secretary shall enter into a 
     contract with the Institute of Medicine to conduct a study 
     and report to Congress regarding the written requests made 
     and the studies conducted pursuant to this section. The 
     Institute of Medicine may devise an appropriate mechanism to 
     review a representative sample of requests made and studies 
     conducted pursuant to this section in order to conduct such 
     study. Such study shall--
       ``(1) review such representative written requests issued by 
     the Secretary since 1997 under subsections (b) and (c);
       ``(2) review and assess such representative pediatric 
     studies conducted under subsections (b) and (c) since 1997 
     and labeling changes made as a result of such studies;
       ``(3) review the use of extrapolation for pediatric 
     subpopulations, the use of alternative endpoints for 
     pediatric populations, neonatal assessment tools, and ethical 
     issues in pediatric clinical trials;
       ``(4) review and assess the pediatric studies of biological 
     products as required under subsections (a) and (b) of section 
     505B; and
       ``(5) 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) Applicability.--
       (A) In general.--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) issued 
     on or after the date of the enactment of this Act.
       (B) Certain written requests.--A written request issued 
     under section 505A of the Federal Food, Drug, and Cosmetic 
     Act, as in effect on the day before the date of the enactment 
     of this Act, which has been accepted and for which no 
     determination under subsection (d)(2) of such section has 
     been made before such date of enactment, shall be subject to 
     such section 505A, except that such written requests shall be 
     subject to subsections (d)(2)(A)(ii), (e)(1) and (2), (f), 
     (i)(2)(A), (j), (k)(1), ( l)(1), and (n) of section 505A of 
     the Federal Food, Drug, and Cosmetic Act, as in effect on or 
     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).

[[Page H10570]]

       ``(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 Web site of the Food and Drug Administration a 
     summary of the report and a copy of any requested labeling 
     changes.
       ``(8) Dispute resolution.--
       ``(A) Referral to pediatric advisory committee.--If, not 
     later than the end of the 180-day period specified in 
     paragraph (7), the holder of an approved application for the 
     drug involved does not agree to any labeling change requested 
     by the Commissioner of Food and Drugs under that paragraph, 
     the Commissioner of Food and Drugs shall refer the request to 
     the Pediatric Advisory Committee.
       ``(B) Action by the pediatric advisory committee.--Not 
     later than 90 days after receiving a referral under 
     subparagraph (A), the Pediatric Advisory Committee shall--
       ``(i) review the available information on the safe and 
     effective use of the drug in the pediatric population, 
     including study reports submitted under this section; and
       ``(ii) make a recommendation to the Commissioner of Food 
     and Drugs as to appropriate labeling changes, if any.
       ``(9) FDA determination.--Not later than 30 days after 
     receiving a recommendation from the Pediatric Advisory 
     Committee under paragraph (8)(B)(ii) with respect to a drug, 
     the Commissioner of Food and Drugs shall consider the 
     recommendation and, if appropriate, make a request to the 
     holders of approved applications for the drug to make any 
     labeling change that the Commissioner of Food and Drugs 
     determines to be appropriate.
       ``(10) Failure to agree.--If a holder of an approved 
     application for a drug, within 30 days after receiving a 
     request to make a labeling change under paragraph (9), does 
     not agree to make a requested labeling change, the 
     Commissioner of Food and Drugs may deem the drug to be 
     misbranded under the Federal Food, Drug, and Cosmetic Act.
       ``(11) No effect on authority.--Nothing in this subsection 
     limits the authority of the United States to bring an 
     enforcement action under the Federal Food, Drug, and Cosmetic 
     Act when a drug lacks appropriate pediatric labeling. Neither 
     course of action (the Pediatric Advisory Committee process or 
     an enforcement action referred to in the preceding sentence) 
     shall preclude, delay, or serve as the basis to stay the 
     other course of action.
       ``(d) Dissemination of Pediatric Information.--Not later 
     than one year after the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007, the Secretary, 
     acting through the Director of the National Institutes of 
     Health, shall study the feasibility of establishing a 
     compilation of information on pediatric drug use and report 
     the findings to Congress.
       ``(e) Authorization of Appropriations.--
       ``(1) In general.--There are authorized to be appropriated 
     to carry out this section--
       ``(A) $200,000,000 for fiscal year 2008; and
       ``(B) such sums as are necessary for each of the four 
     succeeding fiscal years.
       ``(2) Availability.--Any amount appropriated under 
     paragraph (1) shall remain available to carry out this 
     section until expended.''.
       (c) 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)' '' and inserting ``and studies for which the 
     Secretary issues a certification in the affirmative under 
     section 505A(n)(1)(A) of the Federal Food, Drug, and Cosmetic 
     Act''.
       (d) 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.''.
       (e) 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 505B(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''.
       (f) 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.

     SEC. 503. TRAINING OF PEDIATRIC PHARMACOLOGISTS.

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

                   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

[[Page H10571]]

     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 14 individuals, of which 9 shall be from a list of 
     candidates to be provided by the National Academy of Sciences 
     and 5 shall be from lists of candidates provided by patient 
     and consumer advocacy groups, professional scientific and 
     medical societies, and industry trade organizations. 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 patient or consumer 
     advocacy organizations;
       ``(IV) 1 shall be a representative of health care 
     providers; and
       ``(V) 4 shall be at-large members with expertise or 
     experience relevant to the purpose of the Foundation.

       ``(ii) Requirements.--

       ``(I) Expertise.--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.
       ``(II) Federal employees.--No employee of the Federal 
     Government shall be appointed as a member of the Board under 
     this subparagraph or under paragraph (3)(B).

       ``(D) Initial meeting.--
       ``(i) In general.--Not later than 30 days after the date of 
     the enactment of this subchapter, 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)--

       ``(I) the terms of service of the Director of the Centers 
     for Disease Control and Prevention and of the Director of the 
     Agency for Healthcare Research and Quality as ex officio 
     members of the Board shall terminate; and
       ``(II) the Commissioner and the Director of the National 
     Institutes of Health shall continue to serve as ex officio 
     members of the Board, but shall be nonvoting members.

       ``(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.

[[Page H10572]]

       ``(f) Nonprofit Status.--In carrying out subsection (b), 
     the Board shall establish such policies and bylaws under 
     subsection (d), and the Executive Director shall carry out 
     such activities under subsection (g), as may be necessary to 
     ensure that the Foundation maintains status as an 
     organization that--
       ``(1) is described in subsection (c)(3) of section 501 of 
     the Internal Revenue Code of 1986; and
       ``(2) is, under subsection (a) of such section, exempt from 
     taxation.
       ``(g) Executive Director.--
       ``(1) In general.--The Board shall appoint an Executive 
     Director who shall serve at the pleasure of the Board. The 
     Executive Director shall be responsible for the day-to-day 
     operations of the Foundation and shall have such specific 
     duties and responsibilities as the Board shall prescribe.
       ``(2) Compensation.--The compensation of the Executive 
     Director shall be fixed by the Board but shall not be greater 
     than the compensation of the Commissioner.
       ``(h) Administrative Powers.--In carrying out this 
     subchapter, the Board, acting through the Executive Director, 
     may--
       ``(1) adopt, alter, and use a corporate seal, which shall 
     be judicially noticed;
       ``(2) hire, promote, compensate, and discharge 1 or more 
     officers, employees, and agents, as may be necessary, and 
     define their duties;
       ``(3) prescribe the manner in which--
       ``(A) real or personal property of the Foundation is 
     acquired, held, and transferred;
       ``(B) general operations of the Foundation are to be 
     conducted; and
       ``(C) the privileges granted to the Board by law are 
     exercised and enjoyed;
       ``(4) with the consent of the applicable executive 
     department or independent agency, use the information, 
     services, and facilities of such department or agencies in 
     carrying out this section;
       ``(5) enter into contracts with public and private 
     organizations for the writing, editing, printing, and 
     publishing of books and other material;
       ``(6) hold, administer, invest, and spend any gift, devise, 
     or bequest of real or personal property made to the 
     Foundation under subsection (i);
       ``(7) enter into such other contracts, leases, cooperative 
     agreements, and other transactions as the Board considers 
     appropriate to conduct the activities of the Foundation;
       ``(8) modify or consent to the modification of any contract 
     or agreement to which it is a party or in which it has an 
     interest under this subchapter;
       ``(9) take such action as may be necessary to obtain 
     patents and licenses for devices and procedures developed by 
     the Foundation and its employees;
       ``(10) sue and be sued in its corporate name, and complain 
     and defend in courts of competent jurisdiction;
       ``(11) appoint other groups of advisors as may be 
     determined necessary to carry out the functions of the 
     Foundation; and
       ``(12) exercise other powers as set forth in this section, 
     and such other incidental powers as are necessary to carry 
     out its powers, duties, and functions in accordance with this 
     subchapter.
       ``(i) Acceptance of Funds From Other Sources.--The 
     Executive Director may solicit and accept on behalf of the 
     Foundation, any funds, gifts, grants, devises, or bequests of 
     real or personal property made to the Foundation, including 
     from private entities, for the purposes of carrying out the 
     duties of the Foundation.
       ``(j) Service of Federal Employees.--Federal Government 
     employees may serve on committees advisory to the Foundation 
     and otherwise cooperate with and assist the Foundation in 
     carrying out its functions, so long as such employees do not 
     direct or control Foundation activities.
       ``(k) Detail of Government Employees; Fellowships.--
       ``(1) Detail from federal agencies.--Federal Government 
     employees may be detailed from Federal agencies with or 
     without reimbursement to those agencies to the Foundation at 
     any time, and such detail shall be without interruption or 
     loss of civil service status or privilege. Each such employee 
     shall abide by the statutory, regulatory, ethical, and 
     procedural standards applicable to the employees of the 
     agency from which such employee is detailed and those of the 
     Foundation.
       ``(2) Voluntary service; acceptance of federal employees.--
       ``(A) Foundation.--The Executive Director of the Foundation 
     may accept the services of employees detailed from Federal 
     agencies with or without reimbursement to those agencies.
       ``(B) Food and drug administration.--The Commissioner may 
     accept the uncompensated services of Foundation fellows or 
     trainees. Such services shall be considered to be undertaking 
     an activity under contract with the Secretary as described in 
     section 708.
       ``(l) Annual Reports.--
       ``(1) Reports to foundation.--Any recipient of a grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement from the Foundation under this section 
     shall submit to the Foundation a report on an annual basis 
     for the duration of such grant, contract, fellowship, 
     memorandum of understanding, or cooperative agreement, that 
     describes the activities carried out under such grant, 
     contract, fellowship, memorandum of understanding, or 
     cooperative agreement.
       ``(2) Report to congress and the fda.--Beginning with 
     fiscal year 2009, the Executive Director shall submit to 
     Congress and the Commissioner an annual report that--
       ``(A) describes the activities of the Foundation and the 
     progress of the Foundation in furthering the goals and 
     priorities established under subsection (c)(2), including the 
     practical impact of the Foundation on regulated product 
     development;
       ``(B) provides a specific accounting of the source and use 
     of all funds used by the Foundation to carry out such 
     activities; and
       ``(C) provides information on how the results of Foundation 
     activities could be incorporated into the regulatory and 
     product review activities of the Food and Drug 
     Administration.
       ``(m) Separation of Funds.--The Executive Director shall 
     ensure that the funds received from the Treasury are held in 
     separate accounts from funds received from entities under 
     subsection (i).
       ``(n) Funding.--From amounts appropriated to the Food and 
     Drug Administration for each fiscal year, the Commissioner 
     shall transfer not less than $500,000 and not more than 
     $1,250,000, to the Foundation to carry out subsections (a), 
     (b), and (d) through (m).''.
       (b) Other Foundation Provisions.--Chapter VII of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371 et seq.) 
     (as amended by subsection (a)) is amended by adding at the 
     end the following:

     ``SEC. 771. LOCATION OF FOUNDATION.

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

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

       ``(a) In General.--The Commissioner shall receive and 
     assess the report submitted to the Commissioner by the 
     Executive Director of the Foundation under section 770(l)(2).
       ``(b) Report to Congress.--Beginning with fiscal year 2009, 
     the Commissioner shall submit to Congress an annual report 
     summarizing the incorporation of the information provided by 
     the Foundation in the report described under section 
     770(l)(2) and by other recipients of grants, contracts, 
     memoranda of understanding, or cooperative agreements into 
     regulatory and product review activities of the Food and Drug 
     Administration.
       ``(c) Extramural Grants.--The provisions of this subchapter 
     and section 566 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 the 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;
       ``(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; and
       ``(6) develop postmarket safety performance measures that 
     are as measurable and rigorous as the ones already developed 
     for premarket review.''.

     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, may enter into collaborative 
     agreements, to be known as Critical Path Public-

[[Page H10573]]

     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, manufacturing, 
     and translational therapeutics, 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 a consortium of such institutions; 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, which 
     may include graduate training programs in areas relevant to 
     priorities of the Critical Path Initiative.
       ``(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 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 as defined in 
     section 351 of the Public Health Service Act, 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.--The Secretary shall--
       ``(i) 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;
       ``(ii) seek input from professional medical and scientific 
     societies to determine the most effective informational and 
     recruitment activities; and
       ``(iii) 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)(2) of this 
     section for service on the committee at a meeting of the 
     committee.
       ``(c) Disclosures; Prohibitions on Participation; 
     Waivers.--
       ``(1) Disclosure of financial interest.--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) Prohibitions and waivers on participation.--
       ``(A) In general.--Except as provided under subparagraph 
     (B), a member of an advisory committee may not participate 
     with respect to a particular matter considered in an advisory 
     committee meeting 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.
       ``(B) Waiver.--If the Secretary determines it necessary to 
     afford the advisory committee essential expertise, the 
     Secretary may grant a waiver of the prohibition in 
     subparagraph (A) to permit a member described in such 
     subparagraph to--
       ``(i) participate as a non-voting member with respect to a 
     particular matter considered in a committee meeting; or
       ``(ii) participate as a voting member with respect to a 
     particular matter considered in a committee meeting.
       ``(C) Limitation on waivers and other exceptions.--
       ``(i) Definition.--For purposes of this subparagraph, the 
     term `exception' means each of the following with respect to 
     members of advisory committees:

       ``(I) A waiver under section 505(n)(4) (as in effect on the 
     day before the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007).
       ``(II) A written determination under section 208(b) of 
     title 18, United States Code.
       ``(III) A written certification under section 208(b)(3) of 
     such title.

       ``(ii) Determination of total number of members slots and 
     member exceptions during fiscal year 2007.--The Secretary 
     shall determine--

       ``(I)(aa) for each meeting held by any advisory committee 
     during fiscal year 2007, the number of members who 
     participated in the meeting; and
       ``(bb) the sum of the respective numbers determined under 
     item (aa) (referred to in this subparagraph as the ``total 
     number of 2007 meeting slots''); and
       ``(II)(aa) for each meeting held by any advisory committee 
     during fiscal year 2007, the number of members who received 
     an exception for the meeting; and
       ``(bb) the sum of the respective numbers determined under 
     item (aa) (referred to in this subparagraph as the ``total 
     number of 2007 meeting exceptions'').

       ``(iii) Determination of percentage regarding exceptions 
     during fiscal year 2007.--The Secretary shall determine the 
     percentage constituted by--

       ``(I) the total number of 2007 meeting exceptions; divided 
     by
       ``(II) the total number of 2007 meeting slots.

       ``(iv) Limitation for fiscal years 2008 through 2012.--The 
     number of exceptions at the Food and Drug Administration for 
     members of advisory committees for a fiscal year may not 
     exceed the following:

       ``(I) For fiscal year 2008, 95 percent of the percentage 
     determined under clause (iii) (referred to in this clause as 
     the ``base percentage'').
       ``(II) For fiscal year 2009, 90 percent of the base 
     percentage.

[[Page H10574]]

       ``(III) For fiscal year 2010, 85 percent of the base 
     percentage.
       ``(IV) For fiscal year 2011, 80 percent of the base 
     percentage.
       ``(V) For fiscal year 2012, 75 percent of the base 
     percentage.

       ``(v) Allocation of exceptions.--The exceptions authorized 
     under clause (iv) for a fiscal year may be allocated within 
     the centers or other organizational units of the Food and 
     Drug Administration as determined appropriate by the 
     Secretary.
       ``(3) 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 (except as provided in subparagraph (B)) not 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 (2)(B) 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 Web site 
     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 (2)(B) 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 Web site 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)(3) (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)(3) 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)(3) 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 Amendments.--Section 505(n) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(n)) is amended 
     by--
       (1) striking paragraph (4); and
       (2) redesignating paragraphs (5), (6), (7), and (8) as 
     paragraphs (4), (5), (6), and (7), respectively.
       (c) Effective Date.--The amendments made by this section 
     shall take effect on October 1, 2007.

                  TITLE VIII--CLINICAL TRIAL DATABASES

     SEC. 801. EXPANDED CLINICAL TRIAL REGISTRY DATA BANK.

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

       ``(I) a prospective clinical study of health outcomes 
     comparing an intervention with a device subject to section 
     510(k), 515, or 520(m) of the Federal Food, Drug, and 
     Cosmetic Act against a control in human subjects (other than 
     a small clinical trial to determine the feasibility of a 
     device, or a clinical trial to test prototype devices where 
     the primary outcome measure relates to feasibility and not to 
     health outcomes); and
       ``(II) a pediatric postmarket surveillance as required 
     under section 522 of the Federal Food, Drug, and Cosmetic 
     Act.

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

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

       ``(iv) Clinical trial information.--The term `clinical 
     trial information' means, with respect to an applicable 
     clinical trial, those data elements that the responsible 
     party is required to submit under paragraph (2) or under 
     paragraph (3).
       ``(v) Completion date.--The term `completion date' means, 
     with respect to an applicable clinical trial, the date that 
     the final subject was examined or received an intervention 
     for the purposes of final collection of data for the primary 
     outcome, whether the clinical trial concluded according to 
     the prespecified protocol or was terminated.
       ``(vi) Device.--The term `device' means a device as defined 
     in section 201(h) of the Federal Food, Drug, and Cosmetic 
     Act.
       ``(vii) 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.
       ``(viii) Ongoing.--The term `ongoing' means, with respect 
     to a clinical trial of a drug or a device and to a date, 
     that--

       ``(I) 1 or more patients is enrolled in the clinical trial; 
     and
       ``(II) the date is before the completion date of the 
     clinical trial.

       ``(ix) Responsible party.--The term `responsible party', 
     with respect to a clinical trial of a drug or device, means--

       ``(I) the sponsor of the clinical trial (as defined in 
     section 50.3 of title 21, Code of Federal Regulations (or any 
     successor regulation)); or
       ``(II) the principal investigator of such clinical trial if 
     so designated by a sponsor, grantee, contractor, or awardee, 
     so long as the principal investigator is responsible for 
     conducting the trial, has access to and control over the data 
     from the clinical trial, has the right to publish the results 
     of the trial, and has the ability to meet all of the 
     requirements under this subsection for the submission of 
     clinical trial information.

       ``(B) Requirement.--The Secretary shall develop a mechanism 
     by which the responsible party for each applicable clinical 
     trial shall submit the identity and contact information of 
     such responsible party to the Secretary at the time of 
     submission of clinical trial information under paragraph (2).
       ``(2) Expansion of clinical trial registry data bank with 
     respect to clinical trial information.--
       ``(A) In general.--
       ``(i) Expansion of data bank.--To enhance patient 
     enrollment and provide a mechanism to track subsequent 
     progress of clinical trials, the Secretary, acting through 
     the Director of NIH, shall expand, in accordance with this 
     subsection, the clinical trials registry of the data bank 
     described under subsection (i)(1) (referred to in this 
     subsection as the `registry data bank'). The Director of NIH 
     shall ensure that the registry data bank is made publicly 
     available through the Internet.
       ``(ii) Content.--The clinical trial information required to 
     be submitted under this paragraph for an applicable clinical 
     trial shall include--

       ``(I) descriptive information, including--

       ``(aa) a brief title, intended for the lay public;
       ``(bb) a brief summary, intended for the lay public;
       ``(cc) the primary purpose;
       ``(dd) the study design;
       ``(ee) for an applicable drug clinical trial, the study 
     phase;
       ``(ff) study type;
       ``(gg) the primary disease or condition being studied, or 
     the focus of the study;
       ``(hh) the intervention name and intervention type;
       ``(ii) the study start date;
       ``(jj) the expected completion date;
       ``(kk) the target number of subjects; and
       ``(ll) outcomes, including primary and secondary outcome 
     measures;

[[Page H10575]]

       ``(II) recruitment information, including--

       ``(aa) eligibility criteria;
       ``(bb) gender;
       ``(cc) age limits;
       ``(dd) whether the trial accepts healthy volunteers;
       ``(ee) overall recruitment status;
       ``(ff) individual site status; and
       ``(gg) in the case of an applicable drug clinical trial, 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, specify whether or not there is expanded access to 
     the drug under section 561 of the Federal Food, Drug, and 
     Cosmetic Act for those who do not qualify for enrollment in 
     the clinical trial and how to obtain information about such 
     access;

       ``(III) location and contact information, including--

       ``(aa) the name of the sponsor;
       ``(bb) the responsible party, by official title; and
       ``(cc) the facility name and facility contact information 
     (including the city, State, and zip code for each clinical 
     trial location, or a toll-free number through which such 
     location information may be accessed); and

       ``(IV) administrative data (which the Secretary may make 
     publicly available as necessary), including--

       ``(aa) the unique protocol identification number;
       ``(bb) other protocol identification numbers, if any; and
       ``(cc) the Food and Drug Administration IND/IDE protocol 
     number and the record verification date.
       ``(iii) Modifications.--The Secretary may by regulation 
     modify the requirements for clinical trial information under 
     this paragraph, if the Secretary provides a rationale for why 
     such a modification improves and does not reduce such 
     clinical trial information.
       ``(B) Format and structure.--
       ``(i) Searchable categories.--The Director of NIH shall 
     ensure that the public may, in addition to keyword searching, 
     search the entries in the registry data bank by 1 or more of 
     the following criteria:

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

       ``(ii) Additional searchable category.--Not later than 18 
     months after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007, the Director of NIH 
     shall ensure that the public may search the entries of the 
     registry data bank by the safety issue, if any, being studied 
     in the clinical trial as a primary or secondary outcome.
       ``(iii) Other elements.--The Director of NIH shall also 
     ensure that the public may search the entries of the registry 
     data bank by such other elements as the Director deems 
     necessary on an ongoing basis.
       ``(iv) Format.--The Director of the NIH shall ensure that 
     the registry data bank is easily used by the public, and that 
     entries are easily compared.
       ``(C) Data submission.--The responsible party for an 
     applicable clinical trial, including an applicable drug 
     clinical trial for a serious or life-threatening disease or 
     condition, that is initiated after, or is ongoing on the date 
     that is 90 days after, the date of the enactment of the Food 
     and Drug Administration Amendments Act of 2007, shall submit 
     to the Director of NIH for inclusion in the registry data 
     bank the clinical trial information described in of 
     subparagraph (A)(ii) not later than the later of--
       ``(i) 90 days after such date of enactment;
       ``(ii) 21 days after the first patient is enrolled in such 
     clinical trial; or
       ``(iii) in the case of a clinical trial that is not for a 
     serious or life-threatening disease or condition and that is 
     ongoing on such date of enactment, 1 year after such date of 
     enactment.
       ``(D) Posting of data.--
       ``(i) Applicable drug clinical trial.--The Director of NIH 
     shall ensure that clinical trial information for an 
     applicable drug clinical trial submitted in accordance with 
     this paragraph is posted in the registry data bank not later 
     than 30 days after such submission.
       ``(ii) Applicable device clinical trial.--The Director of 
     NIH shall ensure that clinical trial information for an 
     applicable device clinical trial submitted in accordance with 
     this paragraph is posted publicly in the registry data bank--

       ``(I) not earlier than the date of clearance under section 
     510(k) of the Federal Food, Drug, and Cosmetic Act, or 
     approval under section 515 or 520(m) of such Act, as 
     applicable, for a device that was not previously cleared or 
     approved, and not later than 30 days after such date; or
       ``(II) for a device that was previously cleared or 
     approved, not later than 30 days after the clinical trial 
     information under paragraph (3)(C) is required to be posted 
     by the Secretary.

       ``(3) Expansion of registry data bank to include results of 
     clinical trials.--
       ``(A) Linking registry data bank to existing results.--
       ``(i) In general.--Beginning not later than 90 days after 
     the date of the enactment of the Food and Drug Administration 
     Amendments Act of 2007, for those clinical trials that form 
     the primary basis of an efficacy claim or are conducted after 
     the drug involved is approved or after the device involved is 
     cleared or approved, the Secretary shall ensure that the 
     registry data bank includes links to results information as 
     described in clause (ii) for such clinical trial--

       ``(I) not earlier than 30 days after the date of the 
     approval of the drug involved or clearance or approval of the 
     device involved; or
       ``(II) not later than 30 days after the results information 
     described in clause (ii) becomes publicly available.

       ``(ii) Required information.--

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

       ``(aa) If an advisory committee considered at a meeting an 
     applicable clinical trial, any posted Food and Drug 
     Administration summary document regarding such applicable 
     clinical trial.
       ``(bb) If an applicable drug clinical trial was conducted 
     under section 505A or 505B of the Federal Food, Drug, and 
     Cosmetic Act, a link to the posted Food and Drug 
     Administration assessment of the results of such trial.
       ``(cc) Food and Drug Administration public health 
     advisories regarding the drug or device that is the subject 
     of the applicable clinical trial, if any.
       ``(dd) For an applicable drug clinical trial, the Food and 
     Drug Administration action package for approval document 
     required under section 505(l)(2) of the Federal Food, Drug, 
     and Cosmetic Act.
       ``(ee) For an applicable device clinical trial, in the case 
     of a premarket application under section 515 of the Federal 
     Food, Drug, and Cosmetic Act, the detailed summary of 
     information respecting the safety and effectiveness of the 
     device required under section 520(h)(1) of such Act, or, in 
     the case of a report under section 510(k) of such Act, the 
     section 510(k) summary of the safety and effectiveness data 
     required under section 807.95(d) of title 21, Code of Federal 
     Regulations (or any successor regulation).

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

       ``(aa) Medline citations to any publications focused on the 
     results of an applicable clinical trial.
       ``(bb) The entry for the drug that is the subject of an 
     applicable drug clinical trial in the National Library of 
     Medicine database of structured product labels, if available.
       ``(iii) Results for existing data bank entries.--The 
     Secretary may include the links described in clause (ii) for 
     data bank entries for clinical trials submitted to the data 
     bank prior to enactment of the Food and Drug Administration 
     Amendments Act of 2007, as available.
       ``(B) Inclusion of results.--The Secretary, acting through 
     the Director of NIH, shall--
       ``(i) expand the registry data bank to include the results 
     of applicable clinical trials (referred to in this subsection 
     as the `registry and results data bank');
       ``(ii) ensure that such results are made publicly available 
     through the Internet;
       ``(iii) post publicly a glossary for the lay public 
     explaining technical terms related to the results of clinical 
     trials; and
       ``(iv) in consultation with experts on risk communication, 
     provide information with the information included under 
     subparagraph (C) in the registry and results data bank to 
     help ensure that such information does not mislead the 
     patients or the public.
       ``(C) Basic results.--Not later than 1 year after the date 
     of the enactment of the Food and Drug Administration 
     Amendments Act of 2007, the Secretary shall include in the 
     registry and results data bank the following elements for 
     drugs that are approved under section 505 of the Federal 
     Food, Drug, and Cosmetic Act or licensed under section 351 of 
     this Act and devices that are cleared under section 510(k) of 
     the Federal Food, Drug, and Cosmetic Act or approved under 
     section 515 or 520(m) of such Act:
       ``(i) Demographic and baseline characteristics of patient 
     sample.--A table of the demographic and baseline data 
     collected overall and for each arm of the clinical trial to 
     describe the patients who participated in the clinical trial, 
     including the number of patients who dropped out of the 
     clinical trial and the number of patients excluded from the 
     analysis, if any.
       ``(ii) Primary and secondary outcomes.--The primary and 
     secondary outcome measures as submitted under paragraph 
     (2)(A)(ii)(I)(ll), and a table of values for each of the 
     primary and secondary outcome measures for each arm of the 
     clinical trial, including the results of scientifically 
     appropriate tests of the statistical significance of such 
     outcome measures.
       ``(iii) Point of contact.--A point of contact for 
     scientific information about the clinical trial results.

[[Page H10576]]

       ``(iv) Certain agreements.--Whether there exists an 
     agreement (other than an agreement solely to comply with 
     applicable provisions of law protecting the privacy of 
     participants) between the sponsor or its agent and the 
     principal investigator (unless the sponsor is an employer of 
     the principal investigator) that restricts in any manner the 
     ability of the principal investigator, after the completion 
     date of the trial, to discuss the results of the trial at a 
     scientific meeting or any other public or private forum, or 
     to publish in a scientific or academic journal information 
     concerning the results of the trial.
       ``(D) Expanded registry and results data bank.--
       ``(i) Expansion by rulemaking.--To provide more complete 
     results information and to enhance patient access to and 
     understanding of the results of clinical trials, not later 
     than 3 years after the date of the enactment of the Food and 
     Drug Administration Amendments Act of 2007, the Secretary 
     shall by regulation expand the registry and results data bank 
     as provided under this subparagraph.
       ``(ii) Clinical trials.--

       ``(I) Approved products.--The regulations under this 
     subparagraph shall require the inclusion of the results 
     information described in clause (iii) for--

       ``(aa) each applicable drug clinical trial for a drug that 
     is approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act or licensed under section 351 of this Act; and
       ``(bb) each applicable device clinical trial for a device 
     that is cleared under section 510(k) of the Federal Food, 
     Drug, and Cosmetic Act or approved under section 515 or 
     520(m) of such Act.

       ``(II) Unapproved products.--The regulations under this 
     subparagraph shall establish whether or not the results 
     information described in clause (iii) shall be required for--

       ``(aa) an applicable drug clinical trial for a drug that is 
     not approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act and not licensed under section 351 of this Act 
     (whether approval or licensure was sought or not); and
       ``(bb) an applicable device clinical trial for a device 
     that is not cleared under section 510(k) of the Federal Food, 
     Drug, and Cosmetic Act and not approved under section 515 or 
     section 520(m) of such Act (whether clearance or approval was 
     sought or not).
       ``(iii) Required elements.--The regulations under this 
     subparagraph shall require, in addition to the elements 
     described in subparagraph (C), information within each of the 
     following categories:

       ``(I) A summary of the clinical trial and its results that 
     is written in non-technical, understandable language for 
     patients, if the Secretary determines that such types of 
     summary can be included without being misleading or 
     promotional.
       ``(II) A summary of the clinical trial and its results that 
     is technical in nature, if the Secretary determines that such 
     types of summary can be included without being misleading or 
     promotional.
       ``(III) The full protocol or such information on the 
     protocol for the trial as may be necessary to help to 
     evaluate the results of the trial.
       ``(IV) Such other categories as the Secretary determines 
     appropriate.

       ``(iv) Results submission.--The results information 
     described in clause (iii) shall be submitted to the Director 
     of NIH for inclusion in the registry and results data bank as 
     provided by subparagraph (E), except that the Secretary shall 
     by regulation determine--

       ``(I) whether the 1-year period for submission of clinical 
     trial information described in subparagraph (E)(i) should be 
     increased from 1 year to a period not to exceed 18 months;
       ``(II) whether the clinical trial information described in 
     clause (iii) should be required to be submitted for an 
     applicable clinical trial for which the clinical trial 
     information described in subparagraph (C) is submitted to the 
     registry and results data bank before the effective date of 
     the regulations issued under this subparagraph; and
       ``(III) in the case when the clinical trial information 
     described in clause (iii) is required to be submitted for the 
     applicable clinical trials described in clause (ii)(II), the 
     date by which such clinical trial information shall be 
     required to be submitted, taking into account--

       ``(aa) the certification process under subparagraph 
     (E)(iii) when approval, licensure, or clearance is sought; 
     and
       ``(bb) whether there should be a delay of submission when 
     approval, licensure, or clearance will not be sought.
       ``(v) Additional provisions.--The regulations under this 
     subparagraph shall also establish--

       ``(I) a standard format for the submission of clinical 
     trial information under this paragraph to the registry and 
     results data bank;
       ``(II) additional information on clinical trials and 
     results that is written in nontechnical, understandable 
     language for patients;
       ``(III) considering the experience under the pilot quality 
     control project described in paragraph (5)(C), procedures for 
     quality control, including using representative samples, with 
     respect to completeness and content of clinical trial 
     information under this subsection, to help ensure that data 
     elements are not false or misleading and are non-promotional;
       ``(IV) the appropriate timing and requirements for updates 
     of clinical trial information, and whether and, if so, how 
     such updates should be tracked;
       ``(V) a statement to accompany the entry for an applicable 
     clinical trial when the primary and secondary outcome 
     measures for such clinical trial are submitted under 
     paragraph (4)(A) after the date specified for the submission 
     of such information in paragraph (2)(C); and
       ``(VI) additions or modifications to the manner of 
     reporting of the data elements established under subparagraph 
     (C).

       ``(vi) Consideration of world health organization data 
     set.--The Secretary shall consider the status of the 
     consensus data elements set for reporting clinical trial 
     results of the World Health Organization when issuing the 
     regulations under this subparagraph.
       ``(vii) Public meeting.--The Secretary shall hold a public 
     meeting no later than 18 months after the date of the 
     enactment of the Food and Drug Administration Amendments Act 
     of 2007 to provide an opportunity for input from interested 
     parties with regard to the regulations to be issued under 
     this subparagraph.
       ``(E) Submission of results information.--
       ``(i) In general.--Except as provided in clause (iii), 
     (iv), (v), and (vi) the responsible party for an applicable 
     clinical trial that is described in clause (ii) shall submit 
     to the Director of NIH for inclusion in the registry and 
     results data bank the clinical trial information described in 
     subparagraph (C) not later than 1 year, or such other period 
     as may be provided by regulation under subparagraph (D), 
     after the earlier of--

       ``(I) the estimated completion date of the trial as 
     described in paragraph (2)(A)(ii)(I)(jj)); or
       ``(II) the actual date of completion.

       ``(ii) Clinical trials described.--An applicable clinical 
     trial described in this clause is an applicable clinical 
     trial subject to--

       ``(I) paragraph (2)(C); and
       ``(II)(aa) subparagraph (C); or
       ``(bb) the regulations issued under subparagraph (D).

       ``(iii) Delayed submission of results with certification.--
     If the responsible party for an applicable clinical trial 
     submits a certification that clause (iv) or (v) applies to 
     such clinical trial, the responsible party shall submit to 
     the Director of NIH for inclusion in the registry and results 
     data bank the clinical trial information described in 
     subparagraphs (C) and (D) as required under the applicable 
     clause.
       ``(iv) Seeking initial approval of a drug or device.--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 initially approved 
     under section 515 or 520(m) of the Federal Food, Drug, and 
     Cosmetic Act, the responsible party shall submit to the 
     Director of NIH for inclusion in the registry and results 
     data bank the clinical trial information described in 
     subparagraphs (C) and (D) not later than 30 days after 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 or 520(m), as applicable.
       ``(v) Seeking approval of a new use for the drug or 
     device.--

       ``(I) In general.--With respect to an applicable clinical 
     trial where the manufacturer of the drug or device is the 
     sponsor of an applicable clinical trial, and such 
     manufacturer has filed, or will file within 1 year, an 
     application seeking approval under section 505 of the Federal 
     Food, Drug, and Cosmetic Act, licensing under section 351 of 
     this Act, or clearance under section 510(k), or approval 
     under section 515 or 520(m), of the Federal Food, Drug, and 
     Cosmetic Act for the use studied in such clinical trial 
     (which use is not included in the labeling of the approved 
     drug or device), then the responsible party shall submit to 
     the Director of NIH for inclusion in the registry and results 
     data bank the clinical trial information described in 
     subparagraphs (C) and (D) on the earlier of the date that is 
     30 days after the date--

       ``(aa) 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 
     or 520(m);
       ``(bb) the Secretary issues a letter, such as a complete 
     response letter, not approving the submission or not clearing 
     the submission, 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), 515, or 
     520(m); or
       ``(cc) except as provided in subclause (III), the 
     application or premarket notification under such section 505, 
     351, 510(k), 515, or 520(m) is withdrawn without resubmission 
     for no less than 210 days.

       ``(II) Requirement that each clinical trial in application 
     be treated the same.--If a manufacturer makes a certification 
     under clause (iii) that this clause applies 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 or report 
     for licensure, approval, or clearance (under section 351 of 
     this Act or section 505, 510(k), 515, or 520(m) of the 
     Federal Food, Drug, and Cosmetic Act, as applicable) of the 
     use studied in the clinical trial.

[[Page H10577]]

       ``(III) Two-year limitation.--The responsible party shall 
     submit to the Director of NIH for inclusion in the registry 
     and results data bank the clinical trial information subject 
     to subclause (I) on the date that is 2 years after the date a 
     certification under clause (iii) was made to the Director of 
     NIH, if an action referred to in item (aa), (bb), or (cc) of 
     subclause (I) has not occurred by such date.

       ``(vi) Extensions.--The Director of NIH may provide an 
     extension of the deadline for submission of clinical trial 
     information under clause (i) 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 a clinical trial.
       ``(F) Notice to director of nih.--The Commissioner of Food 
     and Drugs shall notify the Director of NIH when there is an 
     action described in subparagraph (E)(iv) or item (aa), (bb), 
     or (cc) of subparagraph (E)(v)(I) with respect to an 
     application or a report that includes a certification 
     required under paragraph (5)(B) of such action not later than 
     30 days after such action.
       ``(G) Posting of data.--The Director of NIH shall ensure 
     that the clinical trial information described in 
     subparagraphs (C) and (D) for an applicable clinical trial 
     submitted in accordance with this paragraph is posted 
     publicly in the registry and results database not later than 
     30 days after such submission.
       ``(H) Waivers regarding certain clinical trial results.--
     The Secretary may waive any applicable requirements of this 
     paragraph for an applicable clinical trial, upon a written 
     request from the responsible party, if the Secretary 
     determines that extraordinary circumstances justify the 
     waiver and that providing the waiver is consistent with the 
     protection of public health, or in the interest of national 
     security. Not later than 30 days after any part of a waiver 
     is granted, the Secretary shall notify, in writing, the 
     appropriate committees of Congress of the waiver and provide 
     an explanation for why the waiver was granted.
       ``(I) Adverse events.--
       ``(i) Regulations.--Not later than 18 months after the date 
     of the enactment of the Food and Drug Administration 
     Amendments Act of 2007, the Secretary shall by regulation 
     determine the best method for including in the registry and 
     results data bank appropriate results information on serious 
     adverse and frequent adverse events for drugs described in 
     subparagraph (C) in a manner and form that is useful and not 
     misleading to patients, physicians, and scientists.
       ``(ii) Default.--If the Secretary fails to issue the 
     regulation required by clause (i) by the date that is 24 
     months after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007, clause (iii) shall 
     take effect.
       ``(iii) Additional elements.--Upon the application of 
     clause (ii), the Secretary shall include in the registry and 
     results data bank for drugs described in subparagraph (C), in 
     addition to the clinical trial information described in 
     subparagraph (C), the following elements:

       ``(I) Serious adverse events.--A table of anticipated and 
     unanticipated serious adverse events grouped by organ system, 
     with number and frequency of such event in each arm of the 
     clinical trial.
       ``(II) Frequent adverse events.--A table of anticipated and 
     unanticipated adverse events that are not included in the 
     table described in subclause (I) that exceed a frequency of 5 
     percent within any arm of the clinical trial, grouped by 
     organ system, with number and frequency of such event in each 
     arm of the clinical trial.

       ``(iv) Posting of other information.--In carrying out 
     clause (iii), the Secretary shall, in consultation with 
     experts in risk communication, post with the tables 
     information to enhance patient understanding and to ensure 
     such tables do not mislead patients or the lay public.
       ``(v) Relation to subparagraph (C).--Clinical trial 
     information included in the registry and results data bank 
     pursuant to this subparagraph is deemed to be clinical trial 
     information included in such data bank pursuant to 
     subparagraph (C).
       ``(4) Additional submissions of clinical trial 
     information.--
       ``(A) Voluntary submissions.--A responsible party for a 
     clinical trial that is not an applicable clinical trial, or 
     that is an applicable clinical trial that is not subject to 
     paragraph (2)(C), may submit complete clinical trial 
     information described in paragraph (2) or paragraph (3) 
     provided the responsible party submits clinical trial 
     information for each applicable clinical trial that is 
     required to be submitted under section 351 or under section 
     505, 510(k), 515, or 520(m) of the Federal Food, Drug, and 
     Cosmetic Act in an application or report for licensure, 
     approval, or clearance of the drug or device for the use 
     studied in the clinical trial.
       ``(B) Required submissions.--
       ``(i) In general.--Notwithstanding paragraphs (2) and (3) 
     and subparagraph (A), in any case in which the Secretary 
     determines for a specific clinical trial described in clause 
     (ii) that posting in the registry and results data bank of 
     clinical trial information for such clinical trial is 
     necessary to protect the public health--

       ``(I) the Secretary may require by notification that such 
     information be submitted to the Secretary in accordance with 
     paragraphs (2) and (3) except with regard to timing of 
     submission;
       ``(II) unless the responsible party submits a certification 
     under paragraph (3)(E)(iii), such information shall be 
     submitted not later than 30 days after the date specified by 
     the Secretary in the notification; and
       ``(III) failure to comply with the requirements under 
     subclauses (I) and (II) shall be treated as a violation of 
     the corresponding requirement of such paragraphs.

       ``(ii) Clinical trials described.--A clinical trial 
     described in this clause is--

       ``(I) an applicable clinical trial for a drug that is 
     approved under section 505 of the Federal Food, Drug, and 
     Cosmetic Act or licensed under section 351 of this Act or for 
     a device that is cleared under section 510(k) of the Federal 
     Food, Drug, and Cosmetic Act or approved under section 515 or 
     section 520(m) of such Act, whose completion date is on or 
     after the date 10 years before the date of the enactment of 
     the Food and Drug Administration Amendments Act of 2007; or
       ``(II) an applicable clinical trial that is described by 
     both by paragraph (2)(C) and paragraph (3)(D)(ii)(II)).

       ``(C) Updates to clinical trial data bank.--
       ``(i) Submission of updates.--The responsible party for an 
     applicable clinical trial shall submit to the Director of NIH 
     for inclusion in the registry and results data bank updates 
     to reflect changes to the clinical trial information 
     submitted under paragraph (2). Such updates--

       ``(I) shall be provided not less than once every 12 months, 
     unless there were no changes to the clinical trial 
     information during the preceding 12-month period;
       ``(II) shall include identification of the dates of any 
     such changes;
       ``(III) not later than 30 days after the recruitment status 
     of such clinical trial changes, shall include an update of 
     the recruitment status; and
       ``(IV) not later than 30 days after the completion date of 
     the clinical trial, shall include notification to the 
     Director that such clinical trial is complete.

       ``(ii) Public availability of updates.--The Director of NIH 
     shall make updates submitted under clause (i) publicly 
     available in the registry data bank. Except with regard to 
     overall recruitment status, individual site status, location, 
     and contact information, the Director of NIH shall ensure 
     that updates to elements required under subclauses (I) to (V) 
     of paragraph (2)(A)(ii) do not result in the removal of any 
     information from the original submissions or any preceding 
     updates, and information in such databases is presented in a 
     manner that enables users to readily access each original 
     element submission and to track the changes made by the 
     updates. The Director of NIH shall provide a link from the 
     table of primary and secondary outcomes required under 
     paragraph (3)(C)(ii) to the tracked history required under 
     this clause of the primary and secondary outcome measures 
     submitted under paragraph (2)(A)(ii)(I)(ll).
       ``(5) Coordination and compliance.--
       ``(A) Clinical trials supported by grants from federal 
     agencies.--
       ``(i) Grants from certain federal agencies.--If an 
     applicable clinical trial is funded in whole or in part by a 
     grant from any agency of the Department of Health and Human 
     Services, including the Food and Drug Administration, the 
     National Institutes of Health, or the Agency for Healthcare 
     Research and Quality, any grant or progress report forms 
     required under such grant shall include a certification that 
     the responsible party has made all required submissions to 
     the Director of NIH under paragraph (2) and (3).
       ``(ii) Verification by federal agencies.--The heads of the 
     agencies referred to in clause (i), as applicable, shall 
     verify that the clinical trial information for each 
     applicable clinical trial for which a grantee is the 
     responsible party has been submitted under paragraph (2) and 
     (3) before releasing any remaining funding for a grant or 
     funding for a future grant to such grantee.
       ``(iii) Notice and opportunity to remedy.--If the head of 
     an agency referred to in clause (i), as applicable, verifies 
     that a grantee has not submitted clinical trial information 
     as described in clause (ii), such agency head shall provide 
     notice to such grantee of such non-compliance and allow such 
     grantee 30 days to correct such non-compliance and submit the 
     required clinical trial information.
       ``(iv) Consultation with other federal agencies.--The 
     Secretary shall--

       ``(I) consult with other agencies that conduct research 
     involving human subjects in accordance with any section of 
     part 46 of title 45, Code of Federal Regulations (or any 
     successor regulations), to determine if any such research is 
     an applicable clinical trial; and
       ``(II) develop with such agencies procedures comparable to 
     those described in clauses (i), (ii), and (iii) to ensure 
     that clinical trial information for such applicable clinical 
     trial is submitted under paragraph (2) and (3).

       ``(B) Certification to accompany drug, biological product, 
     and device submissions.--At the time of submission of an 
     application under section 505 of the Federal Food, Drug, and 
     Cosmetic Act, section 515 of such Act, section 520(m) of such 
     Act, or section 351 of this Act, or submission of a report 
     under section 510(k) of such Act, such application or 
     submission shall be accompanied by a certification that all 
     applicable requirements of this subsection have been met.

[[Page H10578]]

     Where available, such certification shall include the 
     appropriate National Clinical Trial control numbers.
       ``(C) Quality control.--
       ``(i) Pilot quality control project.--Until the effective 
     date of the regulations issued under paragraph (3)(D), the 
     Secretary, acting through the Director of NIH and the 
     Commissioner of Food and Drugs, shall conduct a pilot project 
     to determine the optimal method of verification to help to 
     ensure that the clinical trial information submitted under 
     paragraph (3)(C) is non-promotional and is not false or 
     misleading in any particular under subparagraph (D). The 
     Secretary shall use the publicly available information 
     described in paragraph (3)(A) and any other information 
     available to the Secretary about applicable clinical trials 
     to verify the accuracy of the clinical trial information 
     submitted under paragraph (3)(C).
       ``(ii) Notice of compliance.--If the Secretary determines 
     that any clinical trial information was not submitted as 
     required under this subsection, or was submitted but 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 not later than 30 days after such 
     notification.
       ``(D) Truthful clinical trial information.--
       ``(i) In general.--The clinical trial information submitted 
     by a responsible party under this subsection shall not be 
     false or misleading in any particular.
       ``(ii) Effect.--Clause (i) shall not have the effect of--

       ``(I) requiring clinical trial information with respect to 
     an applicable clinical trial to include information from any 
     source other than such clinical trial involved; or
       ``(II) requiring clinical trial information described in 
     paragraph (3)(D) to be submitted for purposes of paragraph 
     (3)(C).

       ``(E) Public notices.--
       ``(i) Notice of violations.--If the responsible party for 
     an applicable clinical trial fails to submit clinical trial 
     information for such clinical trial as required under 
     paragraphs (2) or (3), the Director of NIH shall include in 
     the registry and results data bank entry for such clinical 
     trial a notice--

       ``(I) that the responsible party is not in compliance with 
     this Act by--

       ``(aa) failing to submit required clinical trial 
     information; or
       ``(bb) submitting false or misleading clinical trial 
     information;

       ``(II) of the penalties imposed for the violation, if any; 
     and
       ``(III) whether the responsible party has corrected the 
     clinical trial information in the registry and results data 
     bank.

       ``(ii) Notice of failure to submit primary and secondary 
     outcomes.--If the responsible party for an applicable 
     clinical trial fails to submit the primary and secondary 
     outcomes as required under section 2(A)(ii)(I)(ll), the 
     Director of NIH shall include in the registry and results 
     data bank entry for such clinical trial a notice that the 
     responsible party is not in compliance by failing to register 
     the primary and secondary outcomes in accordance with this 
     act, and that the primary and secondary outcomes were not 
     publicly disclosed in the database before conducting the 
     clinical trial.
       ``(iii) Failure to submit statement.--The notice under 
     clause (i) for a violation described in clause (i)(I)(aa) 
     shall include the following statement: `The entry for this 
     clinical trial was not complete at the time of submission, as 
     required by law. This may or may not have any bearing on the 
     accuracy of the information in the entry.'.
       ``(iv) Submission of false information statement.--The 
     notice under clause (i) for a violation described in clause 
     (i)(I)(bb) shall include the following statement: `The entry 
     for this clinical trial was found to be false or misleading 
     and therefore not in compliance with the law.'.
       ``(v) Non-submission of statement.--The notice under clause 
     (ii) for a violation described in clause (ii) shall include 
     the following statement: `The entry for this clinical trial 
     did not contain information on the primary and secondary 
     outcomes at the time of submission, as required by law. This 
     may or may not have any bearing on the accuracy of the 
     information in the entry.'
       ``(vi) Compliance searches.--The Director of NIH shall 
     provide that the public may easily search the registry and 
     results data bank for entries that include notices required 
     under this subparagraph.
       ``(6) Limitation on disclosure of clinical trial 
     information.--
       ``(A) In general.--Nothing in this subsection (or under 
     section 552 of title 5, United States Code) shall require the 
     Secretary to publicly disclose, by any means other than the 
     registry and results data bank, information described in 
     subparagraph (B).
       ``(B) Information described.--Information described in this 
     subparagraph is--
       ``(i) information submitted to the Director of NIH under 
     this subsection, or information of the same general nature as 
     (or integrally associated with) the information so submitted; 
     and
       ``(ii) information not otherwise publicly available, 
     including because it is protected from disclosure under 
     section 552 of title 5, United States Code.
       ``(7) Authorization of appropriations.--There are 
     authorized to be appropriated to carry out this subsection 
     $10,000,000 for each fiscal year.''.
       (b) Conforming Amendments.--
       (1) Prohibited acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331) is amended by adding 
     at the end the following:
       ``(jj)(1) The failure to submit the certification required 
     by section 402(j)(5)(B) of the Public Health Service Act, or 
     knowingly submitting a false certification under such 
     section.
       ``(2) The failure to submit clinical trial information 
     required under subsection (j) of section 402 of the Public 
     Health Service Act.
       ``(3) The submission of clinical trial information under 
     subsection (j) of section 402 of the Public Health Service 
     Act that is false or misleading in any particular under 
     paragraph (5)(D) of such subsection (j).''.
       (2) Civil money penalties.--Subsection (f) of section 303 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333), 
     as redesignated by section 226, is amended--
       (A) by redesignating paragraphs (3), (4), and (5) as 
     paragraphs (5), (6), and (7), respectively;
       (B) by inserting after paragraph (2) the following:
       ``(3)(A) Any person who violates section 301(jj) shall be 
     subject to a civil monetary penalty of not more than $10,000 
     for all violations adjudicated in a single proceeding.
       ``(B) If a violation of section 301(jj) is not corrected 
     within the 30-day period following notification under section 
     402(j)(5)(C)(ii), the person shall, in addition to any 
     penalty under subparagraph (A), be subject to a civil 
     monetary penalty of not more than $10,000 for each day of the 
     violation after such period until the violation is 
     corrected.'';
       (C) in paragraph (2)(C), by striking ``paragraph (3)(A)'' 
     and inserting ``paragraph (5)(A)'';
       (D) in paragraph (5), as so redesignated, by striking 
     ``paragraph (1) or (2)'' each place it appears and inserting 
     ``paragraph (1), (2),or (3)'';
       (E) in paragraph (6), as so redesignated, by striking 
     ``paragraph (3)(A)'' and inserting ``paragraph (5)(A)''; and
       (F) in paragraph (7), as so redesignated, by striking 
     ``paragraph (4)'' each place it appears and inserting 
     ``paragraph (6)''.
       (3) New drugs and devices.--
       (A) Investigational new drugs.--Section 505(i) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) is 
     amended in paragraph (4), by adding at the end the following: 
     ``The Secretary shall update such regulations to require 
     inclusion in the informed consent documents and process a 
     statement that clinical trial information for such clinical 
     investigation has been or will be submitted for inclusion in 
     the registry data bank pursuant to subsection (j) of section 
     402 of the Public Health Service Act.''.
       (B) New drug applications.--Section 505(b) of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)) is amended by 
     adding at the end the following:
       ``(6) An application submitted under this subsection shall 
     be accompanied by the certification required under section 
     402(j)(5)(B) of the Public Health Service Act. Such 
     certification shall not be considered an element of such 
     application.''.
       (C) Device reports under section 510(k).--Section 510(k) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) 
     is amended by adding at the end the following:

     ``A notification submitted under this subsection that 
     contains clinical trial data for an applicable device 
     clinical trial (as defined in section 402(j)(1) of the Public 
     Health Service Act) shall be accompanied by the certification 
     required under section 402(j)(5)(B) of such Act. Such 
     certification shall not be considered an element of such 
     notification.''.
       (D) Device premarket approval application.--Section 
     515(c)(1) of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 360e(c)(1)) is amended--
       (i) in subparagraph (F), by striking ``; and'' and 
     inserting a semicolon;
       (ii) by redesignating subparagraph (G) as subparagraph (H); 
     and
       (iii) by inserting after subparagraph (F) the following:
       ``(G) the certification required under section 402(j)(5)(B) 
     of the Public Health Service Act (which shall not be 
     considered an element of such application); and''.
       (E) Humanitarian device exemption.--Section 520(m)(2) of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 
     is amended in the first sentence in the matter following 
     subparagraph (C), by inserting at the end before the period 
     ``and such application shall include the certification 
     required under section 402(j)(5)(B) of the Public Health 
     Service Act (which shall not be considered an element of such 
     application)''.
       (c) Surveillances.--Not later than 12 months after the date 
     of the enactment of this Act, the Secretary of Health and 
     Human Services shall issue guidance on how the requirements 
     of section 402(j) of the Public Health Service Act, as added 
     by this section, apply to a pediatric postmarket surveillance 
     described in paragraph (1)(A)(ii)(II) of such section 402(j) 
     that is not a clinical trial.
       (d) Preemption.--
       (1) In general.--Upon the expansion of the registry and 
     results data bank under section 402(j)(3)(D) of the Public 
     Health Service Act, as added by this section, no State or 
     political subdivision of a State may establish or continue in 
     effect any requirement for the registration of clinical 
     trials or for the inclusion of information relating to the 
     results of clinical trials in a database.
       (2) Rule of construction.--The fact of submission of 
     clinical trial information, if

[[Page H10579]]

     submitted in compliance with subsection (j) of section 402 of 
     the Public Health Service Act (as amended by this section), 
     that relates to a use of a drug or device not included in the 
     official labeling of the approved drug or device shall not be 
     construed by the Secretary of Health and Human Services 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 registry and results 
     data bank under such subsection (j), if submitted in 
     compliance with such subsection, 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.).

  TITLE IX--ENHANCED AUTHORITIES REGARDING POSTMARKET SAFETY OF DRUGS

            Subtitle A--Postmarket Studies and Surveillance

     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 (D), 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 data deemed appropriate by the Secretary, 
     including information regarding chemically-related or 
     pharmacologically-related drugs.
       ``(B) Purposes of study or clinical 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 an unexpected serious risk when 
     available data indicates the potential for a serious risk.
       ``(C) Establishment of requirement after approval of 
     covered application.--The Secretary may require a 
     postapproval study or studies or postapproval clinical 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.
       ``(D) Determination by secretary.--
       ``(i) Postapproval studies.--The Secretary may not require 
     the responsible person to conduct a study under this 
     paragraph, unless the Secretary makes a determination that 
     the reports under subsection (k)(1) and the active postmarket 
     risk identification and analysis system as available under 
     subsection (k)(3) will not be sufficient to meet the purposes 
     set forth in subparagraph (B).
       ``(ii) Postapproval clinical trials.--The Secretary may not 
     require the responsible person to conduct a clinical trial 
     under this paragraph, unless the Secretary makes a 
     determination that a postapproval study or studies will not 
     be sufficient to meet the purposes set forth in subparagraph 
     (B).
       ``(E) Notification; timetables; periodic reports.--
       ``(i) Notification.--The Secretary shall notify the 
     responsible person regarding a requirement under this 
     paragraph to conduct a postapproval study or clinical trial 
     by the target dates for communication of feedback from the 
     review team to the responsible person regarding proposed 
     labeling and postmarketing study commitments as set forth in 
     the letters described in section 101(c) of the Food and Drug 
     Administration Amendments Act of 2007.
       ``(ii) Timetable; periodic reports.--For each study or 
     clinical trial required to be conducted under this paragraph, 
     the Secretary shall require that the responsible person 
     submit a timetable for completion of the study or clinical 
     trial. With respect to each study required to be conducted 
     under this paragraph or otherwise undertaken by the 
     responsible person to investigate a safety issue, the 
     Secretary shall require the responsible person to 
     periodically report to the Secretary on the status of such 
     study including whether any difficulties in completing the 
     study have been encountered. With respect to each clinical 
     trial required to be conducted under this paragraph or 
     otherwise undertaken by the responsible person to investigate 
     a safety issue, the Secretary shall require the responsible 
     person to periodically report to the Secretary on 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 the requirements under section 
     402(j) of the Public Health Service Act. If the responsible 
     person fails to comply with such timetable or violates any 
     other requirement of this subparagraph, the responsible 
     person shall be considered in violation of this subsection, 
     unless the responsible person demonstrates good cause for 
     such noncompliance or such other violation. The Secretary 
     shall determine what constitutes good cause under the 
     preceding sentence.
       ``(F) Dispute resolution.--The responsible person may 
     appeal a requirement to conduct a study or clinical trial 
     under this paragraph using dispute resolution procedures 
     established by the Secretary in regulation and guidance.
       ``(4) Safety labeling changes requested by secretary.--
       ``(A) New safety information.--If the Secretary becomes 
     aware of new safety information that the Secretary believes 
     should be included in the labeling of the drug, the Secretary 
     shall promptly notify the responsible person or, if the same 
     drug approved under section 505(b) is not currently marketed, 
     the holder of an approved application under 505(j).
       ``(B) Response to notification.--Following notification 
     pursuant to subparagraph (A), the responsible person or the 
     holder of the approved application under section 505(j) 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 or 
     the holder of the approved application under section 505(j) 
     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 reasons 
     why no labeling change is necessary, the Secretary shall 
     initiate discussions 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 or the holder of 
     the approved application under section 505(j) 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 or the holder of the approved 
     application under section 505(j) shall submit a supplement 
     containing the labeling change.
       ``(F) Dispute resolution.--Within 5 days of receiving an 
     order under subparagraph (E), the responsible person or the 
     holder of the approved application under section 505(j) may 
     appeal using dispute resolution procedures established by the 
     Secretary in regulation and guidance.
       ``(G) Violation.--If the responsible person or the holder 
     of the approved application under section 505(j) has not 
     submitted a supplement within 15 days of the date of such 
     order under subparagraph (E), and there is no appeal or 
     dispute resolution proceeding pending, the responsible person 
     or holder shall be considered to be in violation of this 
     subsection. If at the conclusion of any dispute resolution 
     procedures the Secretary determines that a supplement must be 
     submitted and such a supplement is not submitted within 15 
     days of the date of that determination, the responsible 
     person or holder shall be in violation of this subsection.
       ``(H) Public health threat.--Notwithstanding subparagraphs 
     (A) through (F), if the Secretary concludes that such a 
     labeling change is necessary to protect the public health, 
     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 or the holder of the approved application under 
     section 505(j) to maintain its label in accordance with 
     existing requirements, including subpart B of part 201 and 
     sections 314.70 and 601.12 of title 21, Code of Federal 
     Regulations (or any successor regulations).
       ``(5) Non-delegation.--Determinations by the Secretary 
     under this subsection for a

[[Page H10580]]

     drug shall be made by individuals at or above the level of 
     individuals empowered to approve a drug (such as division 
     directors within the Center for Drug Evaluation and 
     Research).
       ``(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 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.
       ``(2) Certain postmarket studies.--The failure to conduct a 
     postmarket study under section 506, subpart H of part 314, or 
     subpart E of part 601 of title 21, Code of Federal 
     Regulations (or any successor regulations), 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.--If the Secretary, in consultation 
     with the office responsible for reviewing the drug and the 
     office responsible for postapproval safety with respect to 
     the drug, determines that a risk evaluation and mitigation 
     strategy is necessary to ensure that the benefits of the drug 
     outweigh the risks of the drug, and informs the person who 
     submits such application of such determination, then such 
     person shall submit to the Secretary as part of such 
     application a proposed risk evaluation and mitigation 
     strategy. In making such a determination, the Secretary 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) Whether the drug is a new molecular entity.
       ``(2) Postapproval requirement.--
       ``(A) In general.--If the Secretary has approved a covered 
     application (including an application approved before the 
     effective date of this section) and did not when approving 
     the application require a risk evaluation and mitigation 
     strategy under paragraph (1), the Secretary, in consultation 
     with the offices described in paragraph (1), may subsequently 
     require such a strategy for the drug involved (including when 
     acting on a supplemental application seeking approval of a 
     new indication for use of the drug) 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 reasonable 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) Abbreviated new drug applications.--The applicability 
     of this section to an application under section 505(j) is 
     subject to subsection (i).
       ``(4) Non-delegation.--Determinations by the Secretary 
     under this subsection for a drug shall be made by individuals 
     at or above the level of individuals empowered to approve a 
     drug (such as division directors within the Center for Drug 
     Evaluation and Research).
       ``(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' 
     means an application referred to in section 505(p)(1)(A).
       ``(3) New safety information.--The term `new safety 
     information', with respect to a drug, means information 
     derived from a clinical trial, an adverse event report, a 
     postapproval study (including a study under section 
     505(o)(3)), or peer-reviewed biomedical literature; data 
     derived from the postmarket risk identification and analysis 
     system under section 505(k); or other scientific data deemed 
     appropriate by the Secretary about--
       ``(A) a serious risk or an unexpected serious risk 
     associated with use of the drug that the Secretary has become 
     aware of (that may be based on a new analysis of existing 
     information) since the drug was approved, since the risk 
     evaluation and mitigation strategy was required, or since the 
     last assessment of the approved risk evaluation and 
     mitigation strategy for the drug; or
       ``(B) the effectiveness of the approved risk evaluation and 
     mitigation strategy for the drug obtained since the last 
     assessment of such strategy.
       ``(4) Serious adverse drug experience.--The term `serious 
     adverse drug experience' is an adverse drug experience 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;
       ``(E) data derived from the postmarket risk identification 
     and analysis system under section 505(k)(4); or
       ``(F) other scientific data deemed appropriate by the 
     Secretary.
       ``(7) Responsible person.--The term `responsible person' 
     means the person submitting a covered application or the 
     holder of the approved such application.
       ``(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, in 
     consultation with the office responsible for reviewing the 
     drug and the office responsible for postapproval safety with 
     respect to the drug, 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) includes an assessment, by the date that is 18 months 
     after the strategy is initially approved;
       ``(2) includes an assessment by the date that is 3 years 
     after the strategy is initially approved;
       ``(3) includes an assessment in the seventh year after the 
     strategy is so approved; and
       ``(4) subject to paragraphs (1), (2), and (3)--
       ``(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, in consultation with the 
     offices described in subsection (c)(2), may under such 
     subsection 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 each element 
     involved.
       ``(2) Medication guide; patient package insert.--The risk 
     evaluation and mitigation strategy for a drug may require 
     that, as applicable, 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

[[Page H10581]]

       ``(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 (including under this paragraph). 
     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) Providing Safe Access for Patients to Drugs With 
     Known Serious Risks That Would Otherwise Be Unavailable.--
       ``(1) Allowing safe access to drugs with known serious 
     risks.--The Secretary, in consultation with the offices 
     described in subsection (c)(2), may require that the risk 
     evaluation and mitigation strategy for a drug include such 
     elements as are necessary to assure safe use of the drug, 
     because of its inherent toxicity or potential harmfulness, if 
     the Secretary determines that--
       ``(A) the drug, which has been shown to be effective, but 
     is associated with a serious adverse drug experience, can be 
     approved only if, or would be withdrawn unless, such elements 
     are required as part of such strategy to mitigate a specific 
     serious risk listed in the labeling of the drug; and
       ``(B) for a drug initially approved without elements to 
     assure safe use, other elements under subsections (c), (d), 
     and (e) are not sufficient to mitigate such serious risk.
       ``(2) Assuring access and minimizing burden.--Such elements 
     to assure safe use under paragraph (1) shall--
       ``(A) be commensurate with the specific serious risk listed 
     in the labeling of the drug;
       ``(B) within 30 days of the date on which any element under 
     paragraph (1) is imposed, be posted publicly by the Secretary 
     with an explanation of how such elements will mitigate the 
     observed safety risk;
       ``(C) considering such risk, not be unduly burdensome on 
     patient access to the drug, considering in particular--
       ``(i) patients with serious or life-threatening diseases or 
     conditions; and
       ``(ii) patients who have difficulty accessing health care 
     (such as patients in rural or medically underserved areas); 
     and
       ``(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 to assure safe use.--The elements to assure 
     safe use under paragraph (1) shall include 1 or more goals to 
     mitigate a specific serious risk listed in the labeling of 
     the drug and, to mitigate such risk, may require that--
       ``(A) health care providers who prescribe the drug have 
     particular training or experience, or are specially certified 
     (the opportunity to obtain such training or certification 
     with respect to the drug shall be available to any willing 
     provider from a frontier area in a widely available training 
     or certification method (including an on-line course or via 
     mail) as approved by the Secretary at reasonable cost to the 
     provider);
       ``(B) pharmacies, practitioners, or health care settings 
     that dispense the drug are specially certified (the 
     opportunity to obtain such certification shall be 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 elements to assure safe 
     use under paragraph (1) that are described in subparagraphs 
     (B), (C), and (D) of paragraph (3) may include a system 
     through which the applicant is able to take reasonable steps 
     to--
       ``(A) monitor and evaluate implementation of such elements 
     by health care providers, pharmacists, and other parties in 
     the health care system who are responsible for implementing 
     such elements; and
       ``(B) work to improve implementation of such elements by 
     such persons.
       ``(5) Evaluation of elements to assure safe use.--The 
     Secretary, through the Drug Safety and Risk Management 
     Advisory Committee (or successor committee) of the Food and 
     Drug Administration, shall--
       ``(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.
       ``(6) Additional mechanisms to assure access.--The 
     mechanisms under section 561 to provide for expanded access 
     for patients with serious or life-threatening diseases or 
     conditions may be used to provide access for patients with a 
     serious or life-threatening disease or condition, the 
     treatment of which is not an approved use for the drug, to a 
     drug that is subject to elements to assure safe use under 
     this subsection. The Secretary shall promulgate regulations 
     for how a physician may provide the drug under the mechanisms 
     of section 561.
       ``(7) Waiver in public health emergencies.--The Secretary 
     may waive any requirement of 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 
     requirement 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.
       ``(8)  Limitation.--No holder of an approved covered 
     application shall use any element to assure safe use required 
     by the Secretary under this subsection to block or delay 
     approval of an application under section 505(b)(2) or (j) or 
     to prevent application of such element under subsection 
     (i)(1)(B) to a drug that is the subject of an abbreviated new 
     drug application.
       ``(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, in consultation with the offices 
     described in subsection (c)(2), 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, in 
     consultation with the offices described in subsection (c)(2), 
     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 elements to assure safe 
     use are meeting the goal or whether the goal or such elements 
     should be modified;
       ``(B) with respect to any postapproval study required under 
     section 505(o) or otherwise undertaken by the responsible 
     person to investigate a safety issue, 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) or otherwise undertaken by the 
     responsible party to investigate a safety issue, the status 
     of such clinical trial, including whether enrollment has 
     begun, the number of participants enrolled, the expected 
     completion date, whether any difficulties completing the 
     clinical trial have been encountered, and registration 
     information with respect to requirements under subsections 
     (i) and (j) of section 402 of the Public Health Service Act.
       ``(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

[[Page H10582]]

     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 as provided in subsection (d)(3), including to 
     eliminate assessments; or
       ``(B) adding, modifying, or removing an element to assure 
     safe use under subsection (f).
       ``(h) Review of Proposed Strategies; Review of Assessments 
     of Approved Strategies.--
       ``(1) In general.--The Secretary, in consultation with the 
     offices described in subsection (c)(2), 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) Discussion.--The Secretary, in consultation with the 
     offices described in subsection (c)(2), shall initiate 
     discussions with the responsible person for purposes of this 
     subsection to determine a strategy not later than 60 days 
     after any such assessment is submitted or, in the case of an 
     assessment submitted under subsection (g)(2)(D), not later 
     than 30 days after such assessment is submitted.
       ``(3) Action.--
       ``(A) In general.--Unless the dispute resolution process 
     described under paragraph (4) or (5) applies, the Secretary, 
     in consultation with the offices described in subsection 
     (c)(2), shall describe any required risk evaluation and 
     mitigation strategy for a drug, or any modification to any 
     required strategy--
       ``(i) as part of the action letter on the application, when 
     a proposed strategy is submitted under subsection (a) or a 
     modification to the strategy is proposed as part of an 
     assessment of the strategy submitted under subsection (g)(1); 
     or
       ``(ii) in an order issued not later than 90 days after the 
     date discussions of such modification begin under paragraph 
     (2), when a modification to the strategy is proposed as part 
     of an assessment of the strategy 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.
       ``(4) Dispute resolution at initial approval.--If a 
     proposed risk evaluation and mitigation strategy is submitted 
     under subsection (a)(1) in an application for initial 
     approval of a drug and there is a dispute about the strategy, 
     the responsible person shall use the major dispute resolution 
     procedures as set forth in the letters described in section 
     101(c) of the Food and Drug Administration Amendments Act of 
     2007.
       ``(5) Dispute resolution in all other cases.--
       ``(A) Request for review.--
       ``(i) In general.--Not earlier than 15 days, and not later 
     than 35 days, after discussions under paragraph (2) have 
     begun, the responsible person may request in writing that a 
     dispute about the strategy be reviewed by the Drug Safety 
     Oversight Board under subsection (j), except that the 
     determination of the Secretary to require a risk evaluation 
     and mitigation strategy is not subject to review under this 
     paragraph. The preceding sentence does not prohibit review 
     under this paragraph of the particular elements of such a 
     strategy.
       ``(ii) Scheduling.--Upon receipt of a request under clause 
     (i), the Secretary shall schedule the dispute involved for 
     review under subparagraph (B) and, not later than 5 business 
     days of scheduling the dispute for review, shall publish by 
     posting on the Internet or otherwise a notice that the 
     dispute will be reviewed by the Drug Safety Oversight Board.
       ``(B) Scheduling review.--If a responsible person requests 
     review under subparagraph (A), the Secretary--
       ``(i) shall schedule the dispute for review at 1 of the 
     next 2 regular meetings of the Drug Safety Oversight Board, 
     whichever meeting date is more practicable; or
       ``(ii) may convene a special meeting of the Drug Safety 
     Oversight Board to review the matter more promptly, including 
     to meet an action deadline on an application (including a 
     supplemental application).
       ``(C) Agreement after discussion or administrative 
     appeals.--
       ``(i) Further discussion or administrative appeals.--A 
     request for review under subparagraph (A) shall not preclude 
     further discussions to reach agreement on the risk evaluation 
     and mitigation strategy, and such a request shall not 
     preclude the use of administrative appeals within the Food 
     and Drug Administration to reach agreement on the strategy, 
     including appeals as described in the letters described in 
     section 101(c) of the Food and Drug Administration Amendments 
     Act of 2007 for procedural or scientific matters involving 
     the review of human drug applications and supplemental 
     applications that cannot be resolved at the divisional level. 
     At the time a review has been scheduled under subparagraph 
     (B) and notice of such review has been posted, the 
     responsible person shall either withdraw the request under 
     subparagraph (A) or terminate the use of such administrative 
     appeals.
       ``(ii) Agreement terminates dispute resolution.--At any 
     time before a decision and order is issued under subparagraph 
     (G) , the Secretary (in consultation with the offices 
     described in subsection (c)(2)) 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 via written or oral 
     presentation; 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 90 days of the meeting. 
     The Secretary shall redact the transcript to protect any 
     trade secrets and other information that is exempted from 
     disclosure under section 552 of title 5, United States Code, 
     or section 552a 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 for the action letter on the 
     application; 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 
     for the action letter on the application 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 (2) 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 (4) or (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, in consultation with the offices described in 
     subsection (c)(2), 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.
       ``(B) Notice.--If the Secretary defers an assessment under 
     subparagraph (A), the Secretary shall--

[[Page H10583]]

       ``(i) give notice of the deferral to the holder of the 
     approved covered application not later than 5 days after the 
     deferral;
       ``(ii) publish the deferral in the Federal Register; and
       ``(iii) give notice to the public of any public meetings to 
     be convened under subparagraph (A), including a description 
     of the deferral.
       ``(C) Public meetings.--Such public meetings may include--
       ``(i) 1 or more meetings of the responsible person 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.
       ``(D) Action.--After considering the discussions from any 
     meetings under subparagraph (A), 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, in 
     consultation with the offices described in subsection (c)(2), 
     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 responsible person.
       ``(9) Effect.--Use of the processes described in paragraphs 
     (7) and (8) shall not be the sole source of delay of 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) Elements to assure safe 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). 
     The Secretary may waive the requirement under the preceding 
     sentence for a drug that is the subject of an abbreviated new 
     drug application, and permit the applicant to use a 
     different, comparable aspect of the elements to assure safe 
     use, if the Secretary determines that--
       ``(i) the burden of creating a single, shared system 
     outweighs the benefit of a single, system, taking into 
     consideration the impact on health care providers, patients, 
     the applicant for the abbreviated new drug application, and 
     the holder of the reference drug product; or
       ``(ii) an aspect of the elements to assure safe use for the 
     applicable listed drug is claimed by a patent that has not 
     expired or is a method or process that, as a trade secret, is 
     entitled to protection, and the applicant for the abbreviated 
     new drug application certifies that it has sought a license 
     for use of an aspect of the elements to assure safe use for 
     the applicable listed drug and that it was unable to obtain a 
     license.
     A certification under clause (ii) shall include a description 
     of the efforts made by the applicant for the abbreviated new 
     drug application to obtain a license. In a case described in 
     clause (ii), the Secretary may seek to negotiate a voluntary 
     agreement with the owner of the patent, method, or process 
     for a license under which the applicant for such abbreviated 
     new drug application may use an aspect of the elements to 
     assure safe use, if required under subsection (f) for the 
     applicable listed drug, that is claimed by a patent that has 
     not expired or is a method or process that as a trade secret 
     is entitled to protection.
       ``(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, including the offices 
     responsible for postapproval safety of drugs;
       ``(C) include at least 1 representative each from 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) Postmarket Studies and Clinical Trials; Labeling; 
     Risk Evaluation and Mitigation Strategy.--A person that 
     submits an application for a license under this paragraph is 
     subject to sections 505(o), 505(p), and 505-1 of the Federal 
     Food, Drug, and Cosmetic Act.''; and
       (2) in subsection (j), by inserting ``, including the 
     requirements under sections 505(o), 505(p), and 505-1 of such 
     Act,'' after ``, and Cosmetic Act''.
       (d) Advertisements of Drugs.--The Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.), as amended by section 
     801(b), is amended--
       (1) in section 301 (21 U.S.C. 331), by adding at the end 
     the following:
       ``(kk) The dissemination of a television advertisement 
     without complying with section 503B.''; and
       (2) 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 with respect to information included in the 
     label of the drug--
       ``(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 specific 
     population groups, including elderly populations, children, 
     and racial and ethnic minorities.
       ``(c) No Authority to Require Changes.--Except as provided 
     by subsection (e), 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 or section 351 of the Public Health Service 
     Act, 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 requirements under section 
     502(n) or 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, conspicuous, and neutral manner.''.
       (B) Regulations to determine clear, conspicuous, and 
     neutral manner.--Not later than 30 months after the date of 
     the enactment of the Food and Drug Administration Amendments 
     Act of 2007, 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

[[Page H10584]]

     U.S.C. 333), as amended by section 801(b), is amended 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 or causes 
     another party to disseminate 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)(4)) 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. With respect to 
     advertisements that appear in magazines or other publications 
     that are published less frequently than daily, each issue 
     date (whether weekly or monthly) shall be treated as a single 
     day for the purpose of calculating the number of violations 
     under this paragraph.
       ``(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) The Secretary, in determining the amount of the civil 
     penalty under paragraph (1), 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 
     or caused another party to disseminate 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 or 
     caused the advertisement to be created acted in good faith.
       ``(I) Whether the person who created the advertisement or 
     caused the advertisement to be created 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 or caused another party to disseminate such 
     advertisement after incorporating each comment received from 
     the Secretary.
       ``(B) The Secretary may retract or modify any prior 
     comments the Secretary has provided to an advertisement 
     submitted to the Secretary based on new information or 
     changed circumstances, so long as the Secretary provides 
     written notice to the 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) 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.''.
       (5) Report on direct-to-consumer advertising.--Not later 
     than 24 months after the date of the enactment of this Act, 
     the Secretary of Health and Human Services 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 utilize the 
     Advisory Committee on Risk Communication established under 
     this Act to advise the Secretary with respect to such report. 
     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 report required by this paragraph shall 
     recommend effective ways to present and disseminate 
     information to these populations. Such report shall also make 
     recommendations regarding impediments to the participation of 
     elderly populations, children, racially and ethnically 
     diverse communities, and medically underserved populations in 
     clinical drug trials and shall recommend best practice 
     approaches for increasing the inclusion of such subsets of 
     the general population. The Secretary of Health and Human 
     Services shall submit the 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.
       (6) Rulemaking.--Section 502(n) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 352(n)) is amended by striking 
     ``the procedure specified in section 701(e) of this Act'' and 
     inserting ``section 701(a)''.
       (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 responsible person (as such term is used in section 
     505-1) 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 amended by section 801(b), is 
     amended--
       (1) by inserting after paragraph (3), as added by section 
     801(b)(2), the following:
       ``(4)(A) Any responsible person (as such term is used in 
     section 505-1) that violates a requirement of section 505(o), 
     505(p), or 505-1 shall be subject to a civil monetary penalty 
     of--
       ``(i) not more than $250,000 per violation, and not to 
     exceed $1,000,000 for all such violations adjudicated in a 
     single proceeding; or
       ``(ii) in the case of a violation that continues after the 
     Secretary provides written notice to the responsible person, 
     the responsible person shall be subject to a civil monetary 
     penalty of $250,000 for the first 30-day period (or any 
     portion thereof) that the responsible person continues to be 
     in violation, and such amount shall double for every 30-day 
     period thereafter that the violation continues, not to exceed 
     $1,000,000 for any 30-day period, and not to exceed 
     $10,000,000 for all such violations adjudicated in a single 
     proceeding.
       ``(B) In determining the amount of a civil penalty under 
     subparagraph (A)(ii), the Secretary shall take into 
     consideration whether the responsible person is making 
     efforts toward correcting the violation of the requirement of 
     section 505(o), 505(p), or 505-1 for which the responsible 
     person is subject to such civil penalty.''; and
       (2) in paragraph (5), as redesignated by section 
     801(b)(2)(A), by striking ``paragraph (1), (2), or (3)'' each 
     place it appears and inserting ``paragraph (1), (2), (3), or 
     (4)''.

     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

[[Page H10585]]

     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 
     may 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. ACTIVE POSTMARKET RISK IDENTIFICATION AND ANALYSIS.

       (a) In General.--Subsection (k) of section 505 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is 
     amended by adding at the end the following:
       ``(3) Active postmarket risk identification.--
       ``(A) Definition.--In this paragraph, the term `data' 
     refers to information with respect to a drug approved under 
     this section or under section 351 of the Public Health 
     Service Act, including claims data, patient survey data, 
     standardized analytic files that allow for the pooling and 
     analysis of data from disparate data environments, and any 
     other data deemed appropriate by the Secretary.
       ``(B) Development of postmarket risk identification and 
     analysis methods.--The Secretary shall, not later than 2 
     years after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007, in collaboration with 
     public, academic, and private entities--
       ``(i) develop methods to obtain access to disparate data 
     sources including the data sources specified in subparagraph 
     (C);
       ``(ii) develop validated methods for the establishment of a 
     postmarket risk identification and analysis system to link 
     and analyze safety data from multiple sources, with the goals 
     of including, in aggregate--

       ``(I) at least 25,000,000 patients by July 1, 2010; and
       ``(II) at least 100,000,000 patients by July 1, 2012; and

       ``(iii) convene a committee of experts, including 
     individuals who are recognized in the field of protecting 
     data privacy and security, to make recommendations to the 
     Secretary on the development of tools and methods for the 
     ethical and scientific uses for, and communication of, 
     postmarketing data specified under subparagraph (C), 
     including recommendations on the development of effective 
     research methods for the study of drug safety questions.
       ``(C) Establishment of the postmarket risk identification 
     and analysis system.--
       ``(i) In general.--The Secretary shall, not later than 1 
     year after the development of the risk identification and 
     analysis methods under subparagraph (B), establish and 
     maintain procedures--

       ``(I) for risk identification and analysis based on 
     electronic health data, in compliance with the regulations 
     promulgated under section 264(c) of the Health Insurance 
     Portability and Accountability Act of 1996, and in a manner 
     that does not disclose individually identifiable health 
     information in violation of paragraph (4)(B);
       ``(II) for the reporting (in a standardized form) of data 
     on all serious adverse drug experiences (as defined in 
     section 505-1(b)) submitted to the Secretary under paragraph 
     (1), and those adverse events submitted by patients, 
     providers, and drug sponsors, when appropriate;
       ``(III) to provide for active adverse event surveillance 
     using the following data sources, as available:

       ``(aa) Federal health-related electronic data (such as data 
     from the Medicare program and the health systems of the 
     Department of Veterans Affairs);
       ``(bb) private sector health-related electronic data (such 
     as pharmaceutical purchase data and health insurance claims 
     data); and
       ``(cc) other data as the Secretary deems necessary to 
     create a robust system to identify adverse events and 
     potential drug safety signals;

       ``(IV) to identify certain trends and patterns with respect 
     to data accessed by the system;
       ``(V) to provide regular reports to the Secretary 
     concerning adverse event trends, adverse event patterns, 
     incidence and prevalence of adverse events, and other 
     information the Secretary determines appropriate, which may 
     include data on comparative national adverse event trends; 
     and
       ``(VI) to enable the program to export data in a form 
     appropriate for further aggregation, statistical analysis, 
     and reporting.

       ``(ii) Timeliness of reporting.--The procedures established 
     under clause (i) shall ensure that such data are accessed, 
     analyzed, and reported in a timely, routine, and systematic 
     manner, taking into consideration the need for data 
     completeness, coding, cleansing, and standardized analysis 
     and transmission.
       ``(iii) Private sector resources.--To ensure the 
     establishment of the active postmarket risk identification 
     and analysis system under this subsection not later than 1 
     year after the development of the risk identification and 
     analysis methods under subparagraph (B), as required under 
     clause (i), the Secretary may, on a temporary or permanent 
     basis, implement systems or products developed by private 
     entities.
       ``(iv) Complementary approaches.--To the extent the active 
     postmarket risk identification and analysis system under this 
     subsection is not sufficient to gather data and information 
     relevant to a priority drug safety question, the Secretary 
     shall develop, support, and participate in complementary 
     approaches to gather and analyze such data and information, 
     including--

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

       ``(v) Authority for contracts.--The Secretary may enter 
     into contracts with public and private entities to fulfill 
     the requirements of this subparagraph.
       ``(4) Advanced analysis of drug safety data.--
       ``(A) Purpose.--The Secretary shall establish 
     collaborations with public, academic, and private entities, 
     which may include the Centers for Education and Research on 
     Therapeutics under section 912 of the Public Health Service 
     Act, to provide for advanced analysis of drug safety data 
     described in paragraph (3)(C) and other information that is 
     publicly available or is provided by the Secretary, in order 
     to--
       ``(i) improve the quality and efficiency of postmarket drug 
     safety risk-benefit analysis;
       ``(ii) provide the Secretary with routine access to outside 
     expertise to study advanced drug safety questions; and
       ``(iii) enhance the ability of the Secretary to make timely 
     assessments based on drug safety data.
       ``(B) Privacy.--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.
       ``(C) Public process for priority questions.--At least 
     biannually, the Secretary shall seek recommendations from the 
     Drug Safety and Risk Management Advisory Committee (or any 
     successor committee) and from other advisory committees, as 
     appropriate, to the Food and Drug Administration on--
       ``(i) priority drug safety questions; and
       ``(ii) mechanisms for answering such questions, including 
     through--

       ``(I) active risk identification under paragraph (3); and
       ``(II) when such risk identification is not sufficient, 
     postapproval studies and clinical trials under subsection 
     (o)(3).

       ``(D) Procedures for the development of drug safety 
     collaborations.--
       ``(i) In general.--Not later than 180 days after the date 
     of the establishment of the active postmarket risk 
     identification and analysis system under this subsection, the 
     Secretary shall establish and implement procedures under 
     which the Secretary may routinely contract with one or more 
     qualified entities to--

       ``(I) classify, analyze, or aggregate data described in 
     paragraph (3)(C) and information that is publicly available 
     or is provided by the Secretary;
       ``(II) allow for prompt investigation of priority drug 
     safety questions, including--

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

       ``(III) perform advanced research and analysis on 
     identified drug safety risks;
       ``(IV) focus postapproval studies and clinical trials under 
     subsection (o)(3) more effectively on cases for which reports 
     under paragraph (1) and other safety signal detection is not 
     sufficient to resolve whether there is an elevated risk of a 
     serious adverse event associated with the use of a drug; and
       ``(V) carry out other activities as the Secretary deems 
     necessary to carry out the purposes of this paragraph.

       ``(ii) Request for specific methodology.--The procedures 
     described in clause (i) shall permit the Secretary to request 
     that a specific methodology be used by the qualified entity. 
     The qualified entity shall work with the Secretary to 
     finalize the methodology to be used.
       ``(E) Use of analyses.--The Secretary shall provide the 
     analyses described in this paragraph, including the methods 
     and results of such analyses, about a drug to the sponsor or 
     sponsors of such drug.
       ``(F) Qualified entities.--
       ``(i) In general.--The Secretary shall enter into contracts 
     with a sufficient number of qualified entities to develop and 
     provide information to the Secretary in a timely manner.

[[Page H10586]]

       ``(ii) Qualification.--The Secretary shall enter into a 
     contract with an entity under clause (i) only if the 
     Secretary determines that the entity has a significant 
     presence in the United States and has one or more of the 
     following qualifications:

       ``(I) The research, statistical, epidemiologic, or clinical 
     capability and expertise to conduct and complete the 
     activities under this paragraph, including the capability and 
     expertise to provide the Secretary de-identified data 
     consistent with the requirements of this subsection.
       ``(II) An information technology infrastructure in place to 
     support electronic data and operational standards to provide 
     security for such data.
       ``(III) Experience with, and expertise on, the development 
     of drug safety and effectiveness research using electronic 
     population data.
       ``(IV) An understanding of drug development or risk/benefit 
     balancing in a clinical setting.
       ``(V) Other expertise which the Secretary deems necessary 
     to fulfill the activities under this paragraph.

       ``(G) Contract requirements.--Each contract with a 
     qualified entity under subparagraph (F)(i) shall contain the 
     following requirements:
       ``(i) Ensuring privacy.--The qualified entity shall ensure 
     that the entity will not use data under this subsection in a 
     manner that--

       ``(I) violates the regulations promulgated under section 
     264(c) of the Health Insurance Portability and Accountability 
     Act of 1996;
       ``(II) violates sections 552 or 552a of title 5, United 
     States Code, with regard to the privacy of individually-
     identifiable beneficiary health information; or
       ``(III) discloses individually identifiable health 
     information when presenting drug safety signals and trends or 
     when responding to inquiries regarding drug safety signals 
     and trends.

     Nothing in this clause prohibits lawful disclosure for other 
     purposes.
       ``(ii) Component of another organization.--If a qualified 
     entity is a component of another organization--

       ``(I) the qualified entity shall establish appropriate 
     security measures to maintain the confidentiality and privacy 
     of such data; and
       ``(II) the entity shall not make an unauthorized disclosure 
     of such data to the other components of the organization in 
     breach of such confidentiality and privacy requirement.

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

       ``(I) Confidentiality and privacy protections.--The entity 
     shall continue to comply with the confidentiality and privacy 
     requirements under this paragraph with respect to all data 
     disclosed to the entity.
       ``(II) Disposition of data.--The entity shall return any 
     data disclosed to such entity under this subsection to which 
     it would not otherwise have access or, if returning the data 
     is not practicable, destroy the data.

       ``(H) Competitive procedures.--The Secretary shall use 
     competitive procedures (as defined in section 4(5) of the 
     Federal Procurement Policy Act) to enter into contracts under 
     subparagraph (G).
       ``(I) Review of contract in the event of a merger or 
     acquisition.--The Secretary shall review the contract with a 
     qualified entity under this paragraph in the event of a 
     merger or acquisition of the entity in order to ensure that 
     the requirements under this paragraph will continue to be 
     met.
       ``(J) Coordination.--In carrying out this paragraph, the 
     Secretary shall provide for appropriate communications to the 
     public, scientific, public health, and medical communities, 
     and other key stakeholders, and to the extent practicable 
     shall coordinate with the activities of private entities, 
     professional associations, or other entities that may have 
     sources of drug safety data.''.
       (b) Rule of Construction.--Nothing in this section or the 
     amendment made by this section shall be construed to prohibit 
     the lawful disclosure or use of data or information by an 
     entity other than as described in paragraph (4)(B) or (4)(G) 
     of section 505(k) of the Federal Food, Drug, and Cosmetic 
     Act, as added by subsection (a).
       (c) Report to Congress.--Not later than 4 years after the 
     date of the enactment of this Act, the Secretary shall report 
     to the Congress on the ways in which the Secretary has used 
     the active postmarket risk identification and analysis system 
     described in paragraphs (3) and (4) of section 505(k) of the 
     Federal Food, Drug, and Cosmetic Act, as added by subsection 
     (a), to identify specific drug safety signals and to better 
     understand the outcomes associated with drugs marketed in the 
     United States.
       (d) Authorization of Appropriations.--To carry out 
     activities under the amendment made by this section for which 
     funds are made available under section 736 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 379h), there are 
     authorized to be appropriated to carry out the amendment made 
     by this section, in addition to such funds, $25,000,000 for 
     each of fiscal years 2008 through 2012.
       (e) 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 privacy, confidentiality, 
     and security issues relating to accessing, transmitting, and 
     maintaining data for the active postmarket risk 
     identification and analysis system described in paragraphs 
     (3) and (4) of section 505(k) of the Federal Food, Drug, and 
     Cosmetic Act, as added by subsection (a), 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 privacy, confidentiality, and security of this data 
     or otherwise address privacy, confidentiality, and security 
     issues to ensure the effective operation of such active 
     postmarket identification and analysis system.

     SEC. 906. STATEMENT FOR INCLUSION IN DIRECT-TO-CONSUMER 
                   ADVERTISEMENTS OF DRUGS.

       (a) Published Direct-to-Consumer Advertisements.--Section 
     502(n) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     352), as amended by section 901(d)(6), is further amended by 
     inserting ``and in the case of published direct-to-consumer 
     advertisements the following statement printed in conspicuous 
     text: `You are encouraged to report negative side effects of 
     prescription drugs to the FDA. Visit www.fda.gov/medwatch, or 
     call 1-800-FDA-1088.','' after ``section 701(a),''.
       (b) Study.--
       (1) In general.--In the case of direct-to-consumer 
     television advertisements, the Secretary of Health and Human 
     Services, in consultation with the Advisory Committee on Risk 
     Communication under section 567 of the Federal Food, Drug, 
     and Cosmetic Act (as added by section 917), shall, not later 
     than 6 months after the date of the enactment of this Act, 
     conduct a study to determine if the statement in section 
     502(n) of such Act (as added by subsection (a)) required with 
     respect to published direct-to-consumer advertisements is 
     appropriate for inclusion in such television advertisements.
       (2) Content.--As part of the study under paragraph (1), 
     such Secretary shall consider whether the information in the 
     statement described in paragraph (1) would detract from the 
     presentation of risk information in a direct-to-consumer 
     television advertisement. If such Secretary determines the 
     inclusion of such statement is appropriate in direct-to-
     consumer television advertisements, such Secretary shall 
     issue regulations requiring the implementation of such 
     statement in direct-to-consumer television advertisements, 
     including determining a reasonable length of time for 
     displaying the statement in such advertisements. The 
     Secretary shall report to the appropriate committees of 
     Congress the findings of such study and any plans to issue 
     regulations under this paragraph.

     SEC. 907. NO EFFECT ON VETERINARY MEDICINE.

       This subtitle, and the amendments made by this subtitle, 
     shall have no effect on the use of drugs approved under 
     section 505 of the Federal Food, Drug, and Cosmetic Act by, 
     or on the lawful written or oral order of, a licensed 
     veterinarian within the context of a veterinarian-client-
     patient relationship, as provided for under section 512(a)(5) 
     of such Act.

     SEC. 908. AUTHORIZATION OF APPROPRIATIONS.

       (a) In General.--For carrying out this subtitle and the 
     amendments made by this subtitle, 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 subtitle and the 
     amendments made by this subtitle.

     SEC. 909. EFFECTIVE DATE AND APPLICABILITY.

       (a) Effective Date.--This subtitle 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) (referred to 
     in this section as the ``Act'') if there are in effect on the 
     effective date of this Act elements to assure safe 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 timetable required under 
     section 505-1(d) and any additional elements under 
     subsections (e) and (f) 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, except that sections 
     303(f)(4) and 502(y) and (z) of the Act (as added by section 
     902) shall not apply to such strategy before the Secretary 
     has completed review of, and acted on, the first assessment 
     of such strategy under such section 505-1.
       (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

[[Page H10587]]

     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.

  Subtitle B--Other Provisions to Ensure Drug Safety and Surveillance

     SEC. 911. 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 
     the enactment of this section, the Secretary 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 guidance 
     shall indicate the appropriate models and valid surrogate 
     markers.
       ``(b) Review.--Not later than 5 years after the date of the 
     enactment of this section, the Secretary shall review and 
     update the guidance described under subsection (a) to reflect 
     developments in scientific and medical information and 
     technology.''.

     SEC. 912. PROHIBITION AGAINST FOOD TO WHICH DRUGS OR 
                   BIOLOGICAL PRODUCTS HAVE BEEN ADDED.

       (a) Prohibition.--Section 301 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 331), as amended by section 
     901(d), is amended by adding at the end the following:
       ``(ll) The introduction or delivery for introduction into 
     interstate commerce of any food to which has been added a 
     drug approved under section 505, a biological product 
     licensed under section 351 of the Public Health Service Act, 
     or a drug or a biological product for which substantial 
     clinical investigations have been instituted and for which 
     the existence of such investigations has been made public, 
     unless--
       ``(1) such drug or such biological product was marketed in 
     food before any approval of the drug under section 505, 
     before licensure of the biological product under such section 
     351, and before any substantial clinical investigations 
     involving the drug or the biological product have been 
     instituted;
       ``(2) the Secretary, in the Secretary's discretion, has 
     issued a regulation, after notice and comment, approving the 
     use of such drug or such biological product in the food;
       ``(3) the use of the drug or the biological product in the 
     food is to enhance the safety of the food to which the drug 
     or the biological product is added or applied and not to have 
     independent biological or therapeutic effects on humans, and 
     the use is in conformity with--
       ``(A) a regulation issued under section 409 prescribing 
     conditions of safe use in food;
       ``(B) a regulation listing or affirming conditions under 
     which the use of the drug or the biological product in food 
     is generally recognized as safe;
       ``(C) the conditions of use identified in a notification to 
     the Secretary of a claim of exemption from the premarket 
     approval requirements for food additives based on the 
     notifier's determination that the use of the drug or the 
     biological product in food is generally recognized as safe, 
     provided that the Secretary has not questioned the general 
     recognition of safety determination in a letter to the 
     notifier;
       ``(D) a food contact substance notification that is 
     effective under section 409(h); or
       ``(E) such drug or biological product had been marketed for 
     smoking cessation prior to the date of the enactment of the 
     Food and Drug Administration Amendments Act of 2007; or
       ``(4) the drug is a new animal drug whose use is not unsafe 
     under section 512.''.
       (b) Conforming Changes.--The Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 301 et seq.) is amended--
       (1) in section 304(a)(1), by striking ``section 404 or 
     505'' and inserting ``section 301(ll), 404, or 505''; and
       (2) in section 801(a), by striking ``is adulterated, 
     misbranded, or in violation of section 505,'' and inserting 
     ``is adulterated, misbranded, or in violation of section 505, 
     or prohibited from introduction or delivery for introduction 
     into interstate commerce under section 301(ll),''.

     SEC. 913. ASSURING PHARMACEUTICAL SAFETY.

       Chapter V of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 351 et seq.), as amended in section 403, is amended by 
     inserting after section 505C the following:

     ``SEC. 505D. PHARMACEUTICAL SECURITY.

       ``(a) In General.--The Secretary shall develop standards 
     and identify and validate effective technologies for the 
     purpose of securing the drug supply chain 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 (4), manufacturers, 
     distributors, pharmacies, and other supply chain 
     stakeholders, prioritize and develop standards for the 
     identification, validation, authentication, and tracking and 
     tracing of prescription drugs.
       ``(2) Standardized numeral identifier.--Not later than 30 
     months after the date of the enactment of the Food and Drug 
     Administration Amendments Act of 2007, the Secretary shall 
     develop a standardized numerical identifier (which, to the 
     extent practicable, shall be harmonized with international 
     consensus standards for such an identifier) to be applied to 
     a prescription drug at the point of manufacturing and 
     repackaging (in which case the numerical identifier shall be 
     linked to the numerical identifier applied at the point of 
     manufacturing) at the package or pallet level, sufficient to 
     facilitate the identification, validation, authentication, 
     and tracking and tracing of the prescription drug.
       ``(3) Promising technologies.--The standards developed 
     under this subsection shall address promising technologies, 
     which may include--
       ``(A) radio frequency identification technology;
       ``(B) nanotechnology;
       ``(C) encryption technologies; and
       ``(D) other track-and-trace or authentication technologies.
       ``(4) Interagency collaboration.--In carrying out this 
     subsection, the Secretary shall consult with Federal health 
     and security agencies, including--
       ``(A) the Department of Justice;
       ``(B) the Department of Homeland Security;
       ``(C) the Department 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 agency components of the Food 
     and Drug Administration involved with regulatory and criminal 
     enforcement of this Act to secure the drug supply chain 
     against counterfeit, diverted, subpotent, substandard, 
     adulterated, misbranded, or expired drugs including 
     biological products and active pharmaceutical ingredients 
     from domestic and foreign sources.
       ``(2) Activities.--The Secretary shall undertake enhanced 
     and joint enforcement activities with other Federal and State 
     agencies, and establish regional capacities for the 
     validation of prescription drugs and the inspection of the 
     prescription drug supply chain.
       ``(d) Definition.--In this section, the term `prescription 
     drug' means a drug subject to section 503(b)(1).''.

     SEC. 914. 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.--
       ``(A) Determination.--The Secretary shall not delay 
     approval of a pending application submitted under subsection 
     (b)(2) or (j) because of any request to take any form of 
     action relating to the application, either before or during 
     consideration of the request, unless--
       ``(i) the request is in writing and is a petition submitted 
     to the Secretary pursuant to section 10.30 or 10.35 of title 
     21, Code of Federal Regulations (or any successor 
     regulations); and
       ``(ii) the Secretary determines, upon reviewing the 
     petition, that a delay is necessary to protect the public 
     health.
       ``(B) Notification.--If the Secretary determines under 
     subparagraph (A) that a delay is necessary with respect to an 
     application, the Secretary shall provide to the applicant, 
     not later than 30 days after making such determination, the 
     following information:
       ``(i) Notification of the fact that a determination under 
     subparagraph (A) has been made.
       ``(ii) If applicable, any clarification or additional data 
     that the applicant should submit to the docket on the 
     petition to allow the Secretary to review the petition 
     promptly.
       ``(iii) A brief summary of the specific substantive issues 
     raised in the petition which form the basis of the 
     determination.
       ``(C) Format.--The information described in subparagraph 
     (B) shall be conveyed via either, at the discretion of the 
     Secretary--
       ``(i) a document; or
       ``(ii) a meeting with the applicant involved.
       ``(D) Public disclosure.--Any information conveyed by the 
     Secretary under subparagraph (C) shall be considered part of 
     the application and shall be subject to the disclosure 
     requirements applicable to information in such application.
       ``(E) Denial based on intent to delay.--If the Secretary 
     determines that a petition or a supplement to the petition 
     was submitted with the primary purpose of delaying the 
     approval of an application and the petition does not on its 
     face raise valid scientific or regulatory issues, the 
     Secretary may deny the petition at any point based on such 
     determination. The Secretary may issue guidance to describe 
     the factors that will be used to determine under this 
     subparagraph whether a petition is submitted with the primary 
     purpose of delaying the approval of an application.
       ``(F) Final agency action.--The Secretary shall take final 
     agency action on a petition not later than 180 days after the 
     date on which the petition is submitted. The Secretary shall 
     not extend such period for any reason, including--
       ``(i) any determination made under subparagraph (A);
       ``(ii) the submission of comments relating to the petition 
     or supplemental information supplied by the petitioner; or

[[Page H10588]]

       ``(iii) the consent of the petitioner.
       ``(G) Extension of 30-month period.--If the filing of an 
     application resulted in first-applicant status under 
     subsection (j)(5)(D)(i)(IV) and approval of the application 
     was delayed because of a petition, 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.
       ``(H) Certification.--The Secretary shall not consider a 
     petition for review unless the party submitting such petition 
     does so in written form and the subject document 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: __________. If I received or expect to 
     receive payments, including cash and other forms of 
     consideration, to file this information or its contents, I 
     received or expect to receive those payments from the 
     following persons or organizations: _____________. I verify 
     under penalty of perjury that the foregoing is true and 
     correct as of the date of the submission of this petition.', 
     with the date on which such information first became known to 
     such party and the names of such persons or organizations 
     inserted in the first and second blank space, respectively.
       ``(I) Verification.--The Secretary shall not accept for 
     review any supplemental information or comments on a petition 
     unless the party submitting such information or comments does 
     so in written form and the subject document is signed and 
     contains the following verification: `I certify that, to my 
     best knowledge and belief: (a) I have not intentionally 
     delayed submission of this document or its contents; and (b) 
     the information upon which I have based the action requested 
     herein first became known to me on or about __________. If I 
     received or expect to receive payments, including cash and 
     other forms of consideration, to file this information or its 
     contents, I received or expect to receive those payments from 
     the following persons or organizations: _____. I verify under 
     penalty of perjury that the foregoing is true and correct as 
     of the date of the submission of this petition.', with the 
     date on which such information first became known to the 
     party and the names of such persons or organizations inserted 
     in the first and second blank space, respectively.
       ``(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 if--
       ``(i) during the 180-day period referred to in paragraph 
     (1)(F), 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 against the Secretary with respect to any 
     issue raised in the petition before the Secretary has taken 
     final agency action on the petition within the meaning of 
     subparagraph (A), the court shall dismiss without prejudice 
     the action for failure to exhaust administrative remedies.
       ``(C) Administrative record.--For purposes of judicial 
     review related to the approval of an application for which a 
     petition under paragraph (1) was submitted, the 
     administrative record regarding any issue raised by the 
     petition shall include--
       ``(i) the petition filed under paragraph (1) and any 
     supplements and comments thereto;
       ``(ii) the Secretary's response to such petition, if 
     issued; and
       ``(iii) other information, as designated by the Secretary, 
     related to the Secretary's determinations regarding the 
     issues raised in such petition, as long as the information 
     was considered by the agency no later than the date of final 
     agency action as defined under subparagraph (2)(A), and 
     regardless of whether the Secretary responded to the petition 
     at or before the approval of the application at issue in the 
     petition.
       ``(3) 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 that were approved during 
     the preceding 12-month period;
       ``(B) the number of such applications whose effective dates 
     were delayed by petitions referred to in paragraph (1) during 
     such period;
       ``(C) the number of days by which such applications were so 
     delayed; and
       ``(D) the number of such petitions that were submitted 
     during such period.
       ``(4) 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 and that seeks only to have the Secretary take or 
     refrain from taking any form of action with respect to that 
     application.
       ``(5) Definitions.--
       ``(A) Application.--For purposes of this subsection, the 
     term `application' means an application submitted under 
     subsection (b)(2) or (j).
       ``(B) Petition.--For purposes of this subsection, other 
     than paragraph (1)(A)(i), the term `petition' means a request 
     described in paragraph (1)(A)(i).''.
       (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. 915. POSTMARKET DRUG SAFETY INFORMATION FOR PATIENTS AND 
                   PROVIDERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by section 914(a), is amended by 
     adding at the end the following:
       ``(r) Postmarket Drug Safety Information for Patients and 
     Providers.--
       ``(1) Establishment.--Not later than 1 year after the date 
     of the enactment of the Food and Drug Administration 
     Amendments Act of 2007, the Secretary shall improve the 
     transparency of information about drugs and allow patients 
     and health care providers better access to information about 
     drugs by developing and maintaining an Internet Web site 
     that--
       ``(A) provides links to drug safety information listed in 
     paragraph (2) for prescription drugs that are approved under 
     this section or licensed under section 351 of the Public 
     Health Service Act; and
       ``(B) improves communication of drug safety information to 
     patients and providers.
       ``(2) Internet web site.--The Secretary shall carry out 
     paragraph (1) by--
       ``(A) developing and maintaining an accessible, 
     consolidated Internet Web site with easily searchable drug 
     safety information, including the information found on United 
     States Government Internet Web sites, such as the United 
     States National Library of Medicine's Daily Med and Medline 
     Plus Web sites, in addition to other such Web sites 
     maintained by the Secretary;
       ``(B) ensuring that the information provided on the 
     Internet Web site is comprehensive and includes, when 
     available and appropriate--
       ``(i) patient labeling and patient packaging inserts;
       ``(ii) a link to a list of each drug, whether approved 
     under this section or licensed under such section 351, for 
     which a Medication Guide, as provided for under part 208 of 
     title 21, Code of Federal Regulations (or any successor 
     regulations), is required;
       ``(iii) a link to the registry and results data bank 
     provided for under subsections (i) and (j) of section 402 of 
     the Public Health Service Act;
       ``(iv) the most recent safety information and alerts issued 
     by the Food and Drug Administration for drugs approved by the 
     Secretary under this section, such as product recalls, 
     warning letters, and import alerts;
       ``(v) publicly available information about implemented 
     RiskMAPs and risk evaluation and mitigation strategies under 
     subsection (o);
       ``(vi) guidance documents and regulations related to drug 
     safety; and
       ``(vii) other material determined appropriate by the 
     Secretary;
       ``(C) providing access to summaries of the assessed and 
     aggregated data collected from the active surveillance 
     infrastructure under subsection (k)(3) to provide information 
     of known and serious side-effects for drugs approved under 
     this section or licensed under such section 351;
       ``(D) preparing, by 18 months after approval of a drug or 
     after use of the drug by 10,000 individuals, whichever is 
     later, a summary analysis of the adverse drug reaction 
     reports received for the drug, including identification of 
     any new risks not previously identified, potential new risks, 
     or known risks reported in unusual number;
       ``(E) enabling patients, providers, and drug sponsors to 
     submit adverse event reports through the Internet Web site;
       ``(F) providing educational materials for patients and 
     providers about the appropriate means of disposing of 
     expired, damaged, or unusable medications; and
       ``(G) supporting initiatives that the Secretary determines 
     to be useful to fulfill the purposes of the Internet Web 
     site.
       ``(3) Posting of drug labeling.--The Secretary shall post 
     on the Internet Web site established under paragraph (1) the 
     approved professional labeling and any required patient 
     labeling of a drug approved under this section or licensed 
     under such section 351 not later than 21 days after the date 
     the drug is approved or licensed, including in a supplemental 
     application with respect to a labeling change.
       ``(4) Private sector resources.--To ensure development of 
     the Internet Web site by the date described in paragraph (1), 
     the Secretary may, on a temporary or permanent basis, 
     implement systems or products developed by private entities.
       ``(5) Authority for contracts.--The Secretary may enter 
     into contracts with public

[[Page H10589]]

     and private entities to fulfill the requirements of this 
     subsection.
       ``(6) Review.--The Advisory Committee on Risk Communication 
     under section 567 shall, on a regular basis, perform a 
     comprehensive review and evaluation of the types of risk 
     communication information provided on the Internet Web site 
     established under paragraph (1) and, through other means, 
     shall identify, clarify, and define the purposes and types of 
     information available to facilitate the efficient flow of 
     information to patients and providers, and shall recommend 
     ways for the Food and Drug Administration to work with 
     outside entities to help facilitate the dispensing of risk 
     communication information to patients and providers.''.

     SEC. 916. ACTION PACKAGE FOR APPROVAL.

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

     SEC. 917. RISK COMMUNICATION.

       Subchapter E of chapter V of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 360bbb et seq.), as amended by 
     section 603, is amended by adding at the end the following:

     ``SEC. 567. RISK COMMUNICATION.

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

     SEC. 918. REFERRAL TO ADVISORY COMMITTEE.

       Section 505 of the Federal Food, Drug, and Cosmetic Act, as 
     amended by section 915, is further amended by adding at the 
     end the following:
       ``(s) Referral to Advisory Committee.--Prior to the 
     approval of a drug no active ingredient (including any ester 
     or salt of the active ingredient) of which has been approved 
     in any other application under this section or section 351 of 
     the Public Health Service Act, the Secretary shall--
       ``(1) refer such drug to a Food and Drug Administration 
     advisory committee for review at a meeting of such advisory 
     committee; or
       ``(2) if the Secretary does not refer such a drug to a Food 
     and Drug Administration advisory committee prior to the 
     approval of the drug, provide in the action letter on the 
     application for the drug a summary of the reasons why the 
     Secretary did not refer the drug to an advisory committee 
     prior to approval.''.

     SEC. 919. RESPONSE TO THE INSTITUTE OF MEDICINE.

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

     SEC. 920. DATABASE FOR AUTHORIZED GENERIC DRUGS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by section 918, is further amended by 
     adding at the end the following:
       ``(t) Database for Authorized Generic Drugs.--
       ``(1) In general.--
       ``(A) Publication.--The Commissioner shall--
       ``(i) not later than 9 months after the date of the 
     enactment of the Food and Drug Administration Amendments Act 
     of 2007, publish a complete list on the Internet Web site of 
     the Food and Drug Administration of all authorized generic 
     drugs (including drug trade name, brand company manufacturer, 
     and the date the authorized generic drug entered the market); 
     and
       ``(ii) update the list quarterly to include each authorized 
     generic drug included in an annual report submitted to the 
     Secretary by the sponsor of a listed drug during the 
     preceding 3-month period.
       ``(B) Notification.--The Commissioner shall notify relevant 
     Federal agencies, including the Centers for Medicare & 
     Medicaid Services and the Federal Trade Commission, when the 
     Commissioner first publishes the information described in 
     subparagraph (A) that the information has been published and 
     that the information will be updated quarterly.
       ``(2) Inclusion.--The Commissioner shall include in the 
     list described in paragraph (1) each authorized generic drug 
     included in an annual report submitted to the Secretary by 
     the sponsor of a listed drug after January 1, 1999.
       ``(3) Authorized generic drug.--In this section, the term 
     `authorized generic drug' means a listed drug (as that term 
     is used in subsection (j)) that--
       ``(A) has been approved under subsection (c); and
       ``(B) is marketed, sold, or distributed directly or 
     indirectly to retail class of trade under a different 
     labeling, packaging (other than repackaging as the listed 
     drug in blister packs, unit doses, or similar packaging for 
     use in institutions), product code, labeler code, trade name, 
     or trade mark than the listed drug.''.

     SEC. 921. ADVERSE DRUG REACTION REPORTS AND POSTMARKET 
                   SAFETY.

       Subsection (k) of section 505 of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355), as amended by section 905, 
     is amended by adding at the end the following:
       ``(5) The Secretary shall--
       ``(A) conduct regular, bi-weekly screening of the Adverse 
     Event Reporting System database and post a quarterly report 
     on the

[[Page H10590]]

     Adverse Event Reporting System Web site of any new safety 
     information or potential signal of a serious risk identified 
     by Adverse Event Reporting System within the last quarter;
       ``(B) report to Congress not later than 2 year after the 
     date of the enactment of the Food and Drug Administration 
     Amendments Act of 2007 on procedures and processes of the 
     Food and Drug Administration for addressing ongoing post 
     market safety issues identified by the Office of Surveillance 
     and Epidemiology and how recommendations of the Office of 
     Surveillance and Epidemiology are handled within the agency; 
     and
       ``(C) on an annual basis, review the entire backlog of 
     postmarket safety commitments to determine which commitments 
     require revision or should be eliminated, report to the 
     Congress on these determinations, and assign start dates and 
     estimated completion dates for such commitments.''.

                          TITLE X--FOOD SAFETY

     SEC. 1001. FINDINGS.

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

     SEC. 1002. ENSURING THE SAFETY OF PET FOOD.

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

     SEC. 1003. ENSURING EFFICIENT AND EFFECTIVE COMMUNICATIONS 
                   DURING A RECALL.

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

     SEC. 1004. STATE AND FEDERAL COOPERATION.

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

     SEC. 1005. REPORTABLE FOOD REGISTRY.

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

     ``SEC. 417. REPORTABLE FOOD REGISTRY.

       ``(a) Definitions.--In this section:
       ``(1) Responsible party.--The term `responsible party', 
     with respect to an article of food, means a person that 
     submits the registration under section 415(a) for a food 
     facility that is required to register under section 415(a), 
     at which such article of food is manufactured, processed, 
     packed, or held.
       ``(2) Reportable food.--The term `reportable food' means an 
     article of food (other than infant formula) for which there 
     is a reasonable probability that the use of, or exposure to, 
     such article of food will cause serious adverse health 
     consequences or death to humans or animals.
       ``(b) Establishment.--
       ``(1) In general.--Not later than 1 year after the date of 
     the enactment of this section, the Secretary shall establish 
     within the Food and Drug Administration a Reportable Food 
     Registry to which instances of reportable food may be 
     submitted by the Food and Drug Administration after receipt 
     of reports under subsection (d), via an electronic portal, 
     from--
       ``(A) Federal, State, and local public health officials; or
       ``(B) responsible parties.
       ``(2) Review by secretary.--The Secretary shall promptly 
     review and assess the information submitted under paragraph 
     (1) for the purposes of identifying reportable food, 
     submitting entries to the Reportable Food Registry, acting 
     under subsection (c), and exercising other existing food 
     safety authorities under this Act to protect the public 
     health.
       ``(c) Issuance of an Alert by the Secretary.--
       ``(1) In general.--The Secretary shall issue, or cause to 
     be issued, an alert or a notification with respect to a 
     reportable food using information from the Reportable Food 
     Registry as the Secretary deems necessary to protect the 
     public health.
       ``(2) Effect.--Paragraph (1) shall not affect the authority 
     of the Secretary to issue an alert or a notification under 
     any other provision of this Act.
       ``(d) Reporting and Notification.--
       ``(1) In general.--Except as provided in paragraph (2), as 
     soon as practicable, but in no case later than 24 hours after 
     a responsible party determines that an article of food

[[Page H10591]]

     is a reportable food, the responsible party shall--
       ``(A) submit a report to the Food and Drug Administration 
     through the electronic portal established under subsection 
     (b) that includes the data elements described in subsection 
     (e) (except the elements described in paragraphs (8), (9), 
     and (10) of such subsection); and
       ``(B) investigate the cause of the adulteration if the 
     adulteration of the article of food may have originated with 
     the responsible party.
       ``(2) No report required.--A responsible party is not 
     required to submit a report under paragraph (1) if--
       ``(A) the adulteration originated with the responsible 
     party;
       ``(B) the responsible party detected the adulteration prior 
     to any transfer to another person of such article of food; 
     and
       ``(C) the responsible party--
       ``(i) corrected such adulteration; or
       ``(ii) destroyed or caused the destruction of such article 
     of food.
       ``(3) Reports by public health officials.--A Federal, 
     State, or local public health official may submit a report 
     about a reportable food to the Food and Drug Administration 
     through the electronic portal established under subsection 
     (b) that includes the data elements described in subsection 
     (e) that the official is able to provide.
       ``(4) Report number.--The Secretary shall ensure that, upon 
     submission of a report under paragraph (1) or (3), a unique 
     number is issued through the electronic portal established 
     under subsection (b) to the person submitting such report, by 
     which the Secretary is able to link reports about the 
     reportable food submitted and amended under this subsection 
     and identify the supply chain for such reportable food.
       ``(5) Review.--The Secretary shall promptly review a report 
     submitted under paragraph (1) or (3).
       ``(6) Response to report submitted by a responsible 
     party.--After consultation with the responsible party that 
     submitted a report under paragraph (1), the Secretary may 
     require such responsible party to perform, as soon as 
     practicable, but in no case later than a time specified by 
     the Secretary, 1 or more of the following:
       ``(A) Amend the report submitted by the responsible party 
     under paragraph (1) to include the data element described in 
     subsection (e)(9).
       ``(B) Provide a notification--
       ``(i) to the immediate previous source of the article of 
     food, if the Secretary deems necessary;
       ``(ii) to the immediate subsequent recipient of the article 
     of food, if the Secretary deems necessary; and
       ``(iii) that includes--

       ``(I) the data elements described in subsection (e) that 
     the Secretary deems necessary;
       ``(II) the actions described under paragraph (7) that the 
     recipient of the notification shall perform, as required by 
     the Secretary; and
       ``(III) any other information that the Secretary may 
     require.

       ``(7) Subsequent reports and notifications.--Except as 
     provided in paragraph (8), the Secretary may require a 
     responsible party to perform, as soon as practicable, but in 
     no case later than a time specified by the Secretary, after 
     the responsible party receives a notification under 
     subparagraph (C) or paragraph (6)(B), 1 or more of the 
     following:
       ``(A) Submit a report to the Food and Drug Administration 
     through the electronic portal established under subsection 
     (b) that includes those data elements described in subsection 
     (e) and other information that the Secretary deems necessary.
       ``(B) Investigate the cause of the adulteration if the 
     adulteration of the article of food may have originated with 
     the responsible party.
       ``(C) Provide a notification--
       ``(i) to the immediate previous source of the article of 
     food, if the Secretary deems necessary;
       ``(ii) to the immediate subsequent recipient of the article 
     of food, if the Secretary deems necessary; and
       ``(iii) that includes--

       ``(I) the data elements described in subsection (e) that 
     the Secretary deems necessary;
       ``(II) the actions described under this paragraph that the 
     recipient of the notification shall perform, as required by 
     the Secretary; and
       ``(III) any other information that the Secretary may 
     require.

       ``(8) Amended report.--If a responsible party receives a 
     notification under paragraph (6)(B) or paragraph (7)(C) with 
     respect to an article of food after the responsible party has 
     submitted a report to the Food and Drug Administration under 
     paragraph (1) with respect to such article of food--
       ``(A) the responsible party is not required to submit an 
     additional report or make a notification under paragraph (7); 
     and
       ``(B) the responsible party shall amend the report 
     submitted by the responsible party under paragraph (1) to 
     include the data elements described in paragraph (9), and, 
     with respect to both such notification and such report, 
     paragraph (11) of subsection (e).
       ``(e) Data Elements.--The data elements described in this 
     subsection are the following:
       ``(1) The registration numbers of the responsible party 
     under section 415(a)(3).
       ``(2) The date on which an article of food was determined 
     to be a reportable food.
       ``(3) A description of the article of food including the 
     quantity or amount.
       ``(4) The extent and nature of the adulteration.
       ``(5) If the adulteration of the article of food may have 
     originated with the responsible party, the results of the 
     investigation required under paragraph (1)(B) or (7)(B) of 
     subsection (d), as applicable and when known.
       ``(6) The disposition of the article of food, when known.
       ``(7) Product information typically found on packaging 
     including product codes, use-by dates, and names of 
     manufacturers, packers, or distributors sufficient to 
     identify the article of food.
       ``(8) Contact information for the responsible party.
       ``(9) The contact information for parties directly linked 
     in the supply chain and notified under paragraph (6)(B) or 
     (7)(C) of subsection (d), as applicable.
       ``(10) The information required by the Secretary to be 
     included in a notification provided by the responsible party 
     involved under paragraph (6)(B) or (7)(C) of subsection (d) 
     or required in a report under subsection (d)(7)(A).
       ``(11) The unique number described in subsection (d)(4).
       ``(f) Coordination of Federal, State, and Local Efforts.--
       ``(1) Department of agriculture.--In implementing this 
     section, the Secretary shall--
       ``(A) share information and coordinate regulatory efforts 
     with the Department of Agriculture; and
       ``(B) if the Secretary receives a report submitted about a 
     food within the jurisdiction of the Department of 
     Agriculture, promptly provide such report to the Department 
     of Agriculture.
       ``(2) States and localities.--In implementing this section, 
     the Secretary shall work with the State and local public 
     health officials to share information and coordinate 
     regulatory efforts, in order to--
       ``(A) help to ensure coverage of the safety of the food 
     supply chain, including those food establishments regulated 
     by the States and localities that are not required to 
     register under section 415; and
       ``(B) reduce duplicative regulatory efforts.
       ``(g) Maintenance and Inspection of Records.--The 
     responsible party shall maintain records related to each 
     report received, notification made, and report submitted to 
     the Food and Drug Administration under this section for 2 
     years. A responsible party shall, at the request of the 
     Secretary, permit inspection of such records as provided for 
     section 414.
       ``(h) Request for Information.--Except as provided by 
     section 415(a)(4), section 552 of title 5, United States 
     Code, shall apply to any request for information regarding a 
     record in the Reportable Food Registry.
       ``(i) Safety Report.--A report or notification under 
     subsection (d) shall be considered to be a safety report 
     under section 756 and may be accompanied by a statement, 
     which shall be part of any report released for public 
     disclosure, that denies that the report or the notification 
     constitutes an admission that the product involved caused or 
     contributed to a death, serious injury, or serious illness.
       ``(j) Admission.--A report or notification under this 
     section shall not be considered an admission that the article 
     of food involved is adulterated or caused or contributed to a 
     death, serious injury, or serious illness.
       ``(k) Homeland Security Notification.--If, after receiving 
     a report under subsection (d), the Secretary believes such 
     food may have been deliberately adulterated, the Secretary 
     shall immediately notify the Secretary of Homeland Security. 
     The Secretary shall make relevant information from the 
     Reportable Food Registry available to the Secretary of 
     Homeland Security.''.
       (c) Definition.--Section 201(ff) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 321(ff)) is amended by striking 
     ``section 201(g)'' and inserting ``sections 201(g) and 417''.
       (d) Prohibited Acts.--Section 301 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 331), as amended by section 
     912, is further amended--
       (1) in subsection (e), by--
       (A) striking ``414,'' and inserting ``414, 417(g),''; and
       (B) striking ``414(b)'' and inserting ``414(b), 417''; and
       (2) by adding at the end the following:
       ``(mm) The failure to submit a report or provide a 
     notification required under section 417(d).
       ``(nn) The falsification of a report or notification 
     required under section 417(d).''.
       (e) Effective Date.--The requirements of section 417(d) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), shall become effective 1 year after the date 
     of the enactment of this Act.
       (f) Guidance.--Not later than 9 months after the date of 
     the enactment of this Act, the Secretary shall issue a 
     guidance to industry about submitting reports to the 
     electronic portal established under section 417 of the 
     Federal Food, Drug, and Cosmetic Act (as added by this 
     section) and providing notifications to other persons in the 
     supply chain of an article of food under such section 417.
       (g) Effect.--Nothing in this title, or an amendment made by 
     this title, shall be construed to alter the jurisdiction 
     between the

[[Page H10592]]

     Secretaries of Agriculture and of Health and Human Services, 
     under applicable statutes and regulations.

     SEC. 1006. ENHANCED AQUACULTURE AND SEAFOOD INSPECTION.

       (a) Findings.--Congress finds the following:
       (1) In 2007, there has been an overwhelming increase in the 
     volume of aquaculture and seafood that has been found to 
     contain substances that are not approved for use in food in 
     the United States.
       (2) As of May 2007, inspection programs are not able to 
     satisfactorily accomplish the goals of ensuring the food 
     safety of the United States.
       (3) To protect the health and safety of consumers in the 
     United States, the ability of the Secretary to perform 
     inspection functions must be enhanced.
       (b) Heightened Inspections.--The Secretary is authorized to 
     enhance, as necessary, the inspection regime of the Food and 
     Drug Administration for aquaculture and seafood, consistent 
     with obligations of the United States under international 
     agreements and United States law.
       (c) Report to Congress.--Not later than 180 days after the 
     date of the enactment of this Act, the Secretary shall submit 
     to Congress a report that--
       (1) describes the specifics of the aquaculture and seafood 
     inspection program;
       (2) describes the feasibility of developing a traceability 
     system for all catfish and seafood products, both domestic 
     and imported, for the purpose of identifying the processing 
     plant of origin of such products; and
       (3) provides for an assessment of the risks associated with 
     particular contaminants and banned substances.
       (d) Partnerships With States.--Upon the request by any 
     State, the Secretary may enter into partnership agreements, 
     as soon as practicable after the request is made, to 
     implement inspection programs to Federal standards regarding 
     the importation of aquaculture and seafood.

     SEC. 1007. CONSULTATION REGARDING GENETICALLY ENGINEERED 
                   SEAFOOD PRODUCTS.

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

     SEC. 1008. SENSE OF CONGRESS.

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

     SEC. 1009. ANNUAL REPORT TO CONGRESS.

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

     SEC. 1010. PUBLICATION OF ANNUAL REPORTS.

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

     SEC. 1011. RULE OF CONSTRUCTION.

       Nothing in this title (or an amendment made by this title) 
     shall be construed to affect--
       (1) the regulation of dietary supplements under the Dietary 
     Supplement Health and Education Act of 1994 (Public Law 103-
     417); or
       (2) the adverse event reporting system for dietary 
     supplements created under the Dietary Supplement and 
     Nonprescription Drug Consumer Protection Act (Public Law 109-
     462).

                       TITLE XI--OTHER PROVISIONS

                         Subtitle A--In General

     SEC. 1101. POLICY ON THE REVIEW AND CLEARANCE OF SCIENTIFIC 
                   ARTICLES PUBLISHED BY FDA EMPLOYEES.

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

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

       ``(a) Definition.--In this section, the term `article' 
     means a paper, poster, abstract, book, book chapter, or other 
     published writing.
       ``(b) Policies.--The Secretary, through the Commissioner of 
     Food and Drugs, shall establish and make publicly available 
     clear written policies to implement this section and govern 
     the timely submission, review, clearance, and disclaimer 
     requirements for articles.
       ``(c) Timing of Submission for Review.--If an officer or 
     employee, including a Staff Fellow and a contractor who 
     performs staff work, of the Food and Drug Administration is 
     directed by the policies established under subsection (b) to 
     submit an article to the supervisor of such officer or 
     employee, or to some other official of the Food and Drug 
     Administration, for review and clearance before such officer 
     or employee may seek to publish or present such an article at 
     a conference, such officer or employee shall submit such 
     article for such review and clearance not less than 30 days 
     before submitting the article for publication or 
     presentation.
       ``(d) Timing for Review and Clearance.--The supervisor or 
     other reviewing official shall review such article and 
     provide written clearance, or written clearance on the 
     condition of specified changes being made, to such officer or 
     employee not later than 30 days after such officer or 
     employee submitted such article for review.
       ``(e) Non-Timely Review.--If, 31 days after such submission 
     under subsection (c), the supervisor or other reviewing 
     official has not cleared or has not reviewed such article and 
     provided written clearance, such officer or employee may 
     consider such article not to have been cleared and may submit 
     the article for publication or presentation with an 
     appropriate disclaimer as specified in the policies 
     established under subsection (b).
       ``(f) Effect.--Nothing in this section shall be construed 
     as affecting any restrictions on such publication or 
     presentation provided by other provisions of law.''.

     SEC. 1102. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR 
                   TROPICAL DISEASES.

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

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

       ``(a)  Definitions.--In this section:
       ``(1) Priority review.--The term `priority review', with 
     respect to a human drug application as defined in section 
     735(1), means review and action by the Secretary on such 
     application not later than 6 months after receipt by the 
     Secretary of such application, as described in the Manual of 
     Policies and Procedures of the Food and Drug Administration 
     and goals identified in the letters described in section 
     101(c) of the Food and Drug Administration Amendments Act of 
     2007.

[[Page H10593]]

       ``(2) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a tropical disease product application that 
     entitles the holder of such voucher to priority review of a 
     single human drug application submitted under section 
     505(b)(1) or section 351 of the Public Health Service Act 
     after the date of approval of the tropical disease product 
     application.
       ``(3) Tropical disease.--The term `tropical disease' means 
     any of the following:
       ``(A) Tuberculosis.
       ``(B) Malaria.
       ``(C) Blinding trachoma.
       ``(D) Buruli Ulcer.
       ``(E) Cholera.
       ``(F) Dengue/dengue haemorrhagic fever.
       ``(G) Dracunculiasis (guinea-worm disease).
       ``(H) Fascioliasis.
       ``(I) Human African trypanosomiasis.
       ``(J) Leishmaniasis.
       ``(K) Leprosy.
       ``(L) Lymphatic filariasis.
       ``(M) Onchocerciasis.
       ``(N) Schistosomiasis.
       ``(O) Soil transmitted helmithiasis.
       ``(P) Yaws.
       ``(Q) Any other infectious disease for which there is no 
     significant market in developed nations and that 
     disproportionately affects poor and marginalized populations, 
     designated by regulation by the Secretary.
       ``(4) Tropical disease product application.--The term 
     `tropical disease product application' means an application 
     that--
       ``(A) is a human drug application as defined in section 
     735(1)--
       ``(i) for prevention or treatment of a tropical disease; 
     and
       ``(ii) the Secretary deems eligible for priority review;
       ``(B) is approved after the date of the enactment of the 
     Food and Drug Administration Amendments Act of 2007, by the 
     Secretary for use in the prevention, detection, or treatment 
     of a tropical disease; and
       ``(C) is for a human drug, no active ingredient (including 
     any ester or salt of the active ingredient) of which has been 
     approved in any other application under section 505(b)(1) or 
     section 351 of the Public Health Service Act.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a tropical disease product 
     application upon approval by the Secretary of such tropical 
     disease product application.
       ``(2) Transferability.--The sponsor of a tropical disease 
     product that receives a priority review voucher under this 
     section may transfer (including by sale) the entitlement to 
     such voucher to a sponsor of a human drug for which an 
     application under section 505(b)(1) or section 351 of the 
     Public Health Service Act will be submitted after the date of 
     the approval of the tropical disease product application.
       ``(3) Limitation.--
       ``(A) No award for prior approved application.--A sponsor 
     of a tropical disease product may not receive a priority 
     review voucher under this section if the tropical disease 
     product application was submitted to the Secretary prior to 
     the date of the enactment of this section.
       ``(B) One-year waiting period.--The Secretary shall issue a 
     priority review voucher to the sponsor of a tropical disease 
     product no earlier than the date that is 1 year after the 
     date of the enactment of the Food and Drug Administration 
     Amendments Act of 2007.
       ``(4) Notification.--The sponsor of a human drug 
     application shall notify the Secretary not later than 365 
     days prior to submission of the human drug application that 
     is the subject of a priority review voucher of an intent to 
     submit the human drug application, including the date on 
     which the sponsor intends to submit the application. Such 
     notification shall be a legally binding commitment to pay for 
     the user fee to be assessed in accordance with this section.
       ``(c) Priority Review User Fee.--
       ``(1) In general.--The Secretary shall establish a user fee 
     program under which a sponsor of a human drug application 
     that is the subject of a priority review voucher shall pay to 
     the Secretary a fee determined under paragraph (2). Such fee 
     shall be in addition to any fee required to be submitted by 
     the sponsor under chapter VII.
       ``(2) Fee amount.--The amount of the priority review user 
     fee shall be determined each fiscal year by the Secretary and 
     based on the average cost incurred by the agency in the 
     review of a human drug application subject to priority review 
     in the previous fiscal year.
       ``(3) Annual fee setting.--The Secretary shall establish, 
     before the beginning of each fiscal year beginning after 
     September 30, 2007, for that fiscal year, the amount of the 
     priority review user fee.
       ``(4) Payment.--
       ``(A) In general.--The priority review user fee required by 
     this subsection shall be due upon the submission of a human 
     drug application under section 505(b)(1) or section 351 of 
     the Public Health Services Act for which the priority review 
     voucher is used.
       ``(B) Complete application.--An application described under 
     subparagraph (A) for which the sponsor requests the use of a 
     priority review voucher shall be considered incomplete if the 
     fee required by this subsection and all other applicable user 
     fees are not paid in accordance with the Secretary's 
     procedures for paying such fees.
       ``(C) No waivers, exemptions, reductions, or refunds.--The 
     Secretary may not grant a waiver, exemption, reduction, or 
     refund of any fees due and payable under this section.
       ``(5) Offsetting collections.--Fees collected pursuant to 
     this subsection for any fiscal year--
       ``(A) shall be deposited and credited as offsetting 
     collections to the account providing appropriations to the 
     Food and Drug Administration; and
       ``(B) shall not be collected for any fiscal year except to 
     the extent provided in advance in appropriation Acts.''.

     SEC. 1103. IMPROVING GENETIC TEST SAFETY AND QUALITY.

       (a) Report.--If the Secretary's Advisory Committee on 
     Genetics, Health, and Society does not complete and submit 
     the Regulatory Oversight of Genetic/Genomic Testing Report & 
     Action Recommendations to the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     by July of 2008, the Secretary shall enter into a contract 
     with the Institute of Medicine to conduct a study to assess 
     the overall safety and quality of genetic tests and prepare a 
     report that includes recommendations to improve Federal 
     oversight and regulation of genetic tests. Such study shall 
     take into consideration relevant reports by the Secretary's 
     Advisory Committee on Genetics, Health, and Society and other 
     groups and shall be completed not later than 1 year after the 
     date on which the Secretary entered into such contract.
       (b) Rule of Construction.--Nothing in this section shall be 
     construed as requiring Federal efforts with respect to 
     regulatory oversight of genetic tests to cease or be limited 
     or delayed pending completion of the report by the 
     Secretary's Advisory Committee on Genetics, Health, and 
     Society or the Institute of Medicine.

     SEC. 1104. NIH TECHNICAL AMENDMENTS.

       The Public Health Service Act (42 U.S.C. 201 et seq.) is 
     amended--
       (1) in section 319C-2(j)(3)(B), by striking ``section 319C-
     1(h)'' and inserting ``section 319C-1(i)'';
       (2) in section 402(b)(4), by inserting ``minority and 
     other'' after ``reducing'';
       (3) in section 403(a)(4)(C)(iv)(III), by inserting ``and 
     postdoctoral training funded through research grants'' before 
     the semicolon;
       (4) by designating the second section 403C (relating to the 
     drug diethylstilbestrol) as section 403D; and
       (5) in section 403C(a)--
       (A) in the matter preceding paragraph (1)--
       (i) by inserting ``graduate students supported by the 
     National Institutes of Health'' after ``with respect to''; 
     and
       (ii) by deleting ``each degree-granting program'';
       (B) in paragraph (1), by inserting ``such'' after 
     ``percentage of''; and
       (C) in paragraph (2), by inserting ``(not including any 
     leaves of absence)'' after ``average time''.

     SEC. 1105. SEVERABILITY CLAUSE.

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

              Subtitle B--Antibiotic Access and Innovation

     SEC. 1111. IDENTIFICATION OF CLINICALLY SUSCEPTIBLE 
                   CONCENTRATIONS OF ANTIMICROBIALS.

       (a) Definition.--In this section, the term ``clinically 
     susceptible concentrations'' means specific values which 
     characterize bacteria as clinically susceptible, 
     intermediate, or resistant to the drug (or drugs) tested.
       (b) Identification.--The Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary''), 
     through the Commissioner of Food and Drugs, shall identify 
     (where such information is reasonably available) and 
     periodically update clinically susceptible concentrations.
       (c) Public Availability.--The Secretary, through the 
     Commissioner of Food and Drugs, shall make such clinically 
     susceptible concentrations publicly available, such as by 
     posting on the Internet, not later than 30 days after the 
     date of identification and any update under this section.
       (d) Effect.--Nothing in this section shall be construed to 
     restrict, in any manner, the prescribing of antibiotics by 
     physicians, or to limit the practice of medicine, including 
     for diseases such as Lyme and tick-borne diseases.

     SEC. 1112. 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. 1113. EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       Section 505 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355), as amended by

[[Page H10594]]

     section 920, is further amended by adding at the end the 
     following:
       ``(u) Certain Drugs Containing Single Enantiomers.--
       ``(1) In general.--For purposes of subsections 
     (c)(3)(E)(ii) and (j)(5)(F)(ii), if an application is 
     submitted under subsection (b) for a non-racemic drug 
     containing as an active ingredient (including any ester or 
     salt of the active ingredient) a single enantiomer that is 
     contained in a racemic drug approved in another application 
     under subsection (b), the applicant may, in the application 
     for such non-racemic drug, elect to have the single 
     enantiomer not be considered the same active ingredient as 
     that contained in the approved racemic drug, if--
       ``(A)(i) the single enantiomer has not been previously 
     approved except in the approved racemic drug; and
       ``(ii) the application submitted under subsection (b) for 
     such non-racemic drug--
       ``(I) includes full reports of new clinical investigations 
     (other than bioavailability studies)--

       ``(aa) necessary for the approval of the application under 
     subsections (c) and (d); and
       ``(bb) conducted or sponsored by the applicant; and

       ``(II) does not rely on any investigations that are part of 
     an application submitted under subsection (b) for approval of 
     the approved racemic drug; and
       ``(B) the application submitted under subsection (b) for 
     such non-racemic drug is not submitted for approval of a 
     condition of use--
       ``(i) in a therapeutic category in which the approved 
     racemic drug has been approved; or
       ``(ii) for which any other enantiomer of the racemic drug 
     has been approved.
       ``(2) Limitation.--
       ``(A) No approval in certain therapeutic categories.--Until 
     the date that is 10 years after the date of approval of a 
     non-racemic drug described in paragraph (1) and with respect 
     to which the applicant has made the election provided for by 
     such paragraph, the Secretary shall not approve such non-
     racemic drug for any condition of use in the therapeutic 
     category in which the racemic drug has been approved.
       ``(B) Labeling.--If applicable, the labeling of a non-
     racemic drug described in paragraph (1) and with respect to 
     which the applicant has made the election provided for by 
     such paragraph shall include a statement that the non-racemic 
     drug is not approved, and has not been shown to be safe and 
     effective, for any condition of use of the racemic drug.
       ``(3) Definition.--
       ``(A) In general.--For purposes of this subsection, the 
     term `therapeutic category' means a therapeutic category 
     identified in the list developed by the United States 
     Pharmacopeia pursuant to section 1860D-4(b)(3)(C)(ii) of the 
     Social Security Act and as in effect on the date of the 
     enactment of this subsection.
       ``(B) Publication by secretary.--The Secretary shall 
     publish the list described in subparagraph (A) and may amend 
     such list by regulation.
       ``(4) Availability.--The election referred to in paragraph 
     (1) may be made only in an application that is submitted to 
     the Secretary after the date of the enactment of this 
     subsection and before October 1, 2012.''.

     SEC. 1114. REPORT.

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

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Dingell) and the gentleman from Texas (Mr. Barton) each 
will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.


                             General Leave

  Mr. DINGELL. Mr. Speaker, I ask unanimous consent that all Members 
may have 5 legislative days in which to revise and extend their remarks 
and to include extraneous matter on the bill under consideration.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. DINGELL. Mr. Speaker, I yield myself 3 minutes.
  Mr. Speaker, I rise today to express strong support for H.R. 3580, 
the Food and Drug Administration Amendments Act of 2007. This is 
excellent legislation. It contains needed reforms to strengthen the 
safety of our Nation's drug, device, and food supply.
  I want to pay a word of compliment to my Republican colleagues and 
say that we have come to a compromise which I believe is satisfactory 
in the broad public interest and is an excellent piece of legislation. 
And I want to commend my friend Mr. Barton and our Republican 
colleagues for having worked with us well on this matter.
  On July 11, 2007, the House passed H.R. 2900, the Food and Drug 
Administration Amendments, by a bipartisan vote of 403-16. The bill was 
hailed by all as a strong bill that would improve the lives of 
Americans by ensuring that drugs and devices are reviewed in a 
competent and in a timely fashion.
  Earlier this year the Senate passed a similar bill. Since July, 
bipartisan meetings have been held frequently between the House Energy 
and Commerce Committee and the Senate Committee on Health, Education, 
Labor, and Pensions to reconcile the differences between the two bills.
  This bill includes two very different user-fee programs, both vital 
to the timely approval of lifesaving drugs and devices. The legislation 
would significantly improve our postmarket safety programs, thereby 
preventing many of the drug and device injuries and deaths that occur 
today. It fills an important gap in therapies available to one of our 
most vulnerable and important patient groups: our children. Finally, I 
note that the period of market exclusivity in the pediatric studies 
remains 6 months, as in current law.
  I want to thank all the members of the committee who have worked hard 
on this bill. They have endured long hours to ensure that this bill 
would be completed before the expiration of the two user-fee programs 
at the end of this month. And I want to pay particular tribute to the 
staff on both sides for their outstanding labors.
  Mr. Speaker, I want to point out that if this bill does not pass in 
the time limits which are imposed upon us by the September 30 
expiration of this statute, we will have significant problems here that 
we may not be able to address because, I would point out, that failure 
to do so will leave us with a situation where we are going to find that 
RIF notices will be going out at Food and Drug and the ability to 
approve new drugs will all of a sudden come to a screeching and 
unfortunate halt.

                              {time}  1500

  I urge my friends and colleagues to support this legislation; it is a 
good piece of legislation, it has the support of all who have worked 
with it, and I would commend it to the attention and the kindness of my 
colleagues.
  Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I yield myself such time as I may 
consume.
  (Mr. BARTON of Texas asked and was given permission to revise and 
extend his remarks.)
  Mr. BARTON of Texas. Mr. Speaker, most of us are too young to 
remember, but in the early days of the movies there was a series of 
movies based on the ``Perils of Pauline.'' Pauline was a heroine who 
always got tied to the railroad track, and just as the train was 
bearing down on her the hero would come out and rescue her for another 
adventure in the next movie reel.
  Well, this bill before us has kind of experienced the Perils of 
Pauline. It started out in a tremendous positive bipartisan spirit here 
in the House. Chairman Dingell and Subcommittee Chairman Pallone on the 
majority and Mr. Deal and myself on the minority side and our 
colleagues in the rank-and-file worked together. We reported a bill, 
and I don't remember how many votes it got on the House floor, but I 
believe it was over 400. It got over to the other body, and they 
modified it in some ways that were somewhat different than the House 
bill. The negotiations broke down, and it looked for a while this week 
that the Food and Drug Administration was going to have to send out 
reduction in force notices to over 2,000 employees at the Food and Drug 
Administration. But thanks to the tremendous leadership of Chairman 
Dingell and Subcommittee Chairman Pallone and the help of people like 
Congressman Waxman and others on the majority side, we've been able to 
come back together and create a unified House position and work with 
our friends in the other body. And they've accepted the compromise 
that's before us to say that here, at 3 o'clock on Wednesday afternoon, 
we're going to rescue Pauline and pass the PDUFA, I hope by unanimous 
consent on the suspension calendar, the PDUFA reauthorization bill, and 
lots of good things are going to happen.
  I am honored to be the ranking member on the Energy and Commerce 
Committee, along with Subcommittee

[[Page H10595]]

Ranking Member Deal, who has worked with the majority to put this 
compromise together.
  I want to stress the sensitivity of completing the reauthorization of 
the Prescription Drug User Fee Program and the Medical Device User Fee 
Program right now. As I said earlier, if we were not to have done that 
by the end of this week, over 2,000 employees at the FDA would probably 
have received a reduction in force notice sometime next week or the 
week after. These are dedicated experts who are responsible for 
reviewing and approving new drugs, biologics and medical devices. If we 
were to lose those individuals, we would probably never get them back. 
That would have severe negative repercussions for everybody in this 
country.
  The legislation before us will promote advancement in pediatric 
therapies both for pharmaceuticals and for medical devices. The 
Pediatric Rule and the Best Pharmaceuticals for Children Act have 
helped to fill a void in pediatric medicine. Prior to these acts, many 
children were not getting the best treatment because the information 
was simply not available to determine how a drug would act on them. 
Drugs do perform differently in different patients, which is especially 
true when that patient is a child. These acts have begun to provide 
physicians the information they need to make the best decisions for 
their pediatric patients. These two acts work together to ensure that 
accurate, timely pediatric use information is developed to ensure the 
best medical outcomes for the Nation's children.
  The bill preserves the 6-month incentive that companies receive to do 
additional testing in pediatric populations. I want to emphasize that. 
The bill before us preserves the 6-month pediatric exclusivity 
provision in current law, and I think that's a real accomplishment. 
Chairman Dingell should be commended for his leadership on that effort. 
I was glad to support him in that insistence on that particular 
provision. I would also like to thank Congresswoman Anna Eshoo for her 
work on that provision.
  Finally, the legislation addresses the issue of drug safety. No drug 
is completely safe. All drugs have some risk. The goal of the Food and 
Drug Administration is to ensure that the benefits of the drug outweigh 
any potential risks and ensure that patients have access to life-saving 
and life-improving medications.
  The legislation before us today strives to ensure that the FDA has 
the authority to monitor drugs to ensure that the balance between the 
benefit and the risk remains in equilibrium. The FDA will now have the 
authority to require that drug sponsors conduct postmarket clinical 
trials. The FDA will now have the authority to require that a drug make 
a label change. The FDA will also now have the authority to impose 
additional requirements on a drug in the form of a risk evaluation and 
mitigation strategy when it is needed to ensure that a drug's benefits 
outweigh its risk.
  Mr. Speaker, this bill is a bipartisan compromise that does 
strengthen the FDA, it will improve children's health, and it will 
reauthorize programs that are essential to ensuring that patients have 
timely access to drugs and medical devices.
  Before I reserve the balance of my time, I again want to thank 
Chairman Dingell, Subcommittee Chairman Pallone, Ranking Member Deal, 
and all the rank-and-file members. I also want to especially thank Ryan 
Long on the minority staff, the gentleman that is sitting to my left. 
He stayed up all last night working on these final nuances. I shouldn't 
say this, but I'm told that he has the same clothes on today that he 
had on yesterday because he has worked so hard on this bill. We do want 
to give him special commendation. And I would urge that he take the 
appropriate hygienic provisions as soon as possible.
  With that, Mr. Speaker, I reserve the balance of my time.
  Mr. DINGELL. Mr. Speaker, I ask unanimous consent that I be permitted 
to yield the remainder of my time to the distinguished gentleman from 
New Jersey (Mr. Pallone), the chairman of the subcommittee, and that he 
be permitted to control the time.
  The SPEAKER pro tempore. Without objection, the gentleman from New 
Jersey is recognized.
  There was no objection.
  Mr. PALLONE. Thank you, Mr. Speaker, and I yield myself such time as 
I may consume.
  Mr. Speaker, this is an important day for American consumers. Thanks 
to the legislation the House is about to pass, the Food and Drug 
Administration will have the financial resources and authorities 
necessary to ensure patients have timely access to safe and effective 
therapies.
  First and foremost, this bill is about drug safety. In order to 
empower the FDA to protect the public from harmful drugs, we are giving 
the agency new authority to compel important labeling changes. This is 
a significant improvement over current policy, where FDA must haggle 
with drug companies and protracted negotiations that put patients and 
consumers at risk.
  Under this bill, FDA will also be better equipped to force drug 
manufacturers to fulfill their responsibility to the American public 
and complete postmarket study commitments which are critical to 
ensuring a drug is safe.
  In addition to these important new authorities, this bill authorizes 
the collection of $225 million in new user fees, a significant increase 
in the amount of funds dedicated for the use of drug safety activities.
  The FDA Revitalization Act also provides for commonsense improvements 
to our Nation's food safety system, such as more stringent ingredient 
and labeling standards, establishment of an adulterated food registry, 
and improvements in public notifications.
  Patients will be happy to know that the bill before us also requires 
greater transparency of drug makers by calling for clinical trials to 
be registered in a database monitored by the National Institutes of 
Health, along with basic results data. As we saw with the case of 
Avandia, making this information available to patients, providers and 
researchers is critical to uncovering potential harmful effects of a 
drug. And under this legislation, the public will also have greater 
access to internal documents that FDA used in its review of a drug 
application.
  We also secure FDA scientists' right to publish by requiring the 
Secretary to establish clear policies on the timely clearance of 
articles written by FDA employees.
  And finally, Mr. Speaker, this bill would make significant progress 
in reducing the number of conflicted experts who serve on advisory 
committees.
  Mr. Speaker, I'm proud to say that this bill reauthorizes two very 
important programs for our Nation's children, the Best Pharmaceuticals 
for Children Act and the Pediatric Research and Equity Act. These 
programs have been crucial in the successful cultivation of important 
research used by doctors and parents to better determine what kinds of 
drug therapy is safest and most appropriate for a child patient.
  In addition to the two existing programs, we're creating a new 
program that would help provide device manufacturers with greater 
incentives to conduct research and development of pediatric devices. 
Combined, these three bills will strengthen the research being done on 
pediatric uses of drugs and devices, and will make sure that our 
Nation's children have access to the medicines and therapies they need 
to grow up healthy and strong.
  And finally, this bill reauthorizes two critically important user fee 
agreements with respect to prescription drugs and medical devices. 
These programs provide FDA with the necessary resources to review 
applications in a timely manner so patients who rely on new and 
improved drugs and devices don't have to go without. In addition to 
reauthorizing these existing user fee programs, this bill would 
establish a new user fee for the specific purpose of reviewing direct-
to-consumer advertising.
  I just want to commend Mr. Dingell, our ranking member Mr. Barton, 
Mr. Deal, and all of the members here, Mr. Waxman, Ms. Eshoo, Mr. 
Markey. Their leadership on these issues has been unwavering. It is to 
their credit that we have a bill on the floor today.
  This is a great victory for American consumers that will make 
tremendous strides in empowering the FDA and restoring public 
confidence in its ability to protect the public health, and I would 
urge my colleagues to vigorously support it.

[[Page H10596]]

  Mr. Speaker, I reserve the balance of my time.
  Mr. BARTON of Texas. Mr. Speaker, I would ask unanimous consent that 
the balance of the time on the minority side be yielded to Mr. Nathan 
Deal, the ranking member of the Health Subcommittee, for him to use and 
control as he sees fit.
  The SPEAKER pro tempore. Without objection, the gentleman from 
Georgia is recognized.
  There was no objection.
  Mr. DEAL of Georgia. Thank you, Mr. Speaker.
  I want to, first of all, thank Chairman Dingell and Chairman Pallone 
for working in a bipartisan fashion on this very important piece of 
legislation.
  As we all know, the work of the FDA is vital to the health and safety 
of the citizens of this country, and especially legislation such as 
this that enhances their ability to deal with the questions of drug 
safety and the monitoring capabilities and the continuing programs that 
are so vital both to the drugs and to medical devices which require 
review and approval by the FDA.
  The user fee programs that are being reauthorized by this legislation 
are very important to fulfilling their role in meeting their personnel 
needs to achieve a timely review of drugs and medical devices, and I 
believe that Congress should not and cannot afford to delay further 
action on this package. Certainly to do so would require FDA to begin 
to scale back their personnel, and none of us want to see that happen.
  Moreover, patients demand and deserve to know that the medications 
they are taking are safe and effective, and that the FDA has adequate 
resources, both pre- and postmarket, in order to ensure that the safety 
of the Nation's drug supply is intact.
  This legislation makes sensible bipartisan strides in that direction 
and balances the need to bring new life-saving medications to market, 
and at the same time provide the necessary protections for patient 
safety.
  Like all compromises, there was a necessary give-and-take from all 
sides to bring this bill to the floor today. I think it is through the 
responsible work of the leadership of our committee of Energy and 
Commerce and through the processes that the committee has followed that 
we were able to accomplish that on this very significant piece of 
legislation.
  I would urge my colleagues to vote in favor of the bill and hope that 
our colleagues across the rotunda would do likewise so that we can 
present a bill to the desk of the President for his signature which 
will keep this vital program and functions of FDA going forward and 
will not allow it to expire.
  Mr. Speaker, I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from 
California who has been a leader on this issue for so many years.
  Mr. WAXMAN. Mr. Speaker, the legislation we are considering provides 
FDA with critical tools the agency has been desperately lacking in its 
efforts to protect the American public from unsafe drugs. This 
legislation will provide FDA with the ability to require companies to 
update their drug label with new information, and FDA won't have to 
haggle with companies to get them to make those changes.
  It also says, in giving FDA this labeling change authority, Congress 
is making it clear that we do not intend to impact a drug company's 
responsibility to promptly update its label with safety information on 
its own accord.
  The legislation also gives FDA the authority to require companies to 
conduct postmarket studies and clinical trials of drugs. And it creates 
a mandatory clinical trial registry and results database to increase 
the transparency of those trials.

                              {time}  1515

  Mr. Speaker, before we break our arms trying to pat ourselves on the 
back, I want to express my deep disappointment that today we are 
walking away from a critical opportunity to make some reasonable 
adjustments to the windfall profits that drug companies receive for 
conducting pediatric studies under the Best Pharmaceuticals for 
Children Act. This is not about whether those pediatric studies should 
be done. We all agree about that. They are being done now. There is no 
question they will continue to be done. But if we were to cut back 
slightly on the term of exclusivity for only the blockbuster drugs, 
that would make a great deal of difference to people who are paying the 
high cost for pharmaceuticals.
  In my view, we lost that opportunity, and it is going to hurt a lot 
of our consumers. In my view, there is simply no justification for 
rewarding companies with incentives that are so far in excess of the 
actual cost of doing the studies themselves.
  I am also deeply disturbed the legislation fails to remove the sunset 
on FDA's authority to require pediatric studies under the Pediatric 
Research and Equity Act. There is absolutely no reason Congress needs 
to keep revisiting this commonsense measure that allows FDA to get 
essential information about whether new therapies are safe and 
effective for children.
  So although I am pleased that today will provide FDA with important 
new authorities and resources, I must express my deep regret that we 
fail to take this opportunity to help individuals, businesses, State 
governments and insurers who pay the bill for the higher prices that 
result when generic competition is delayed for these expensive 
blockbuster drugs. I think it is a shame. We are talking about drugs of 
$5 billion in sales a year. If they spend a couple million dollars for 
their studies, they are being overreimbursed at the consumer's expense.
  Mr. DEAL of Georgia. Mr. Speaker, I have no other requested time and 
would be prepared to close whenever the gentleman from New Jersey is 
prepared.
  Mr. PALLONE. Mr. Speaker, I yield 2\1/2\ minutes to the gentleman 
from Massachusetts who, again, had quite a bit to do with this 
legislation, particularly on the safety provisions.
  Mr. MARKEY. First of all, I want to commend you, Mr. Chairman, and 
Chairman Dingell, your staffs, Mr. Waxman, Ranking Member Barton and 
Mr. Deal, all the Members on the Republican side for the product that 
is here, all of the staff which has worked on it for so long. My own 
staff, Kate Bazinsky, who is sitting right here, just was married 2 
months ago, this has definitely affected those first 2 months of 
marriage, the incredible negotiations that have taken place to reach 
this point, along with Mark Bayer who was working on the privacy parts 
of this legislation with your staffs. I congratulate everyone.
  I am pleased that the final bill before us today retains the core 
drug safety and clinical trial provisions from the bill that 
Congressman Waxman and I introduced in March, which will improve 
transparency at the FDA and make drugs safer. Although I had hoped the 
sunset would be removed from the pediatric rule and less exclusivity 
given to blockbuster products under the pediatric incentive program, 
this bill is a historic achievement which will make drugs and medical 
devices safer for consumers around the world.
  The past several years have been marked by drug scandal after drug 
scandal, Vioxx, Ketek, Paxil and Avandia. These drugs have harmed 
families across the country and come to symbolize the urgent need for 
reform at the FDA. Taking drugs should not be a game of RX roulette, 
and yet the FDA's current system is broken, and thousands of American 
families have been harmed by drugs with dangerous side effects.
  Today, the House is responding to those failures. The bill is a 
victory for consumers and for patients. The bill will empower the FDA 
with important new authorities to mandate label changes and require 
postmarket studies. However, these new FDA authorities do not change 
the responsibility of companies to maintain drug labels and warn the 
public about risk.
  For the first time ever, the FDA will have the power to impose civil 
monetary penalties on companies that fail to conduct required 
postmarket studies. It will also establish a new postmarket risk 
identification and analysis system to identify harmful side effects 
without compromising patient privacy.
  Since 2004, I have been fighting for a mandatory clinical trial 
registry and results database which will ensure that the public has 
accurate and complete information about drugs and devices.

[[Page H10597]]

This bill will create that mandatory clinical trials database.
  I am also extremely pleased that the FDA package includes language 
from the Markey-Rogers pediatric devices bill which is a major step 
forward for getting better and better devices for kids.
  Mr. Speaker, again, I thank the chairman from New Jersey for all his 
great work.
  Mr. PALLONE. Mr. Speaker, I would yield 3 minutes to the gentlewoman 
from California (Ms. Eshoo) and point out, again, her leadership on 
this issue, particularly with regard to children and the pediatric 
issues.
  Ms. ESHOO. Mr. Speaker, I thank the distinguished chairman of the 
Health Subcommittee as well as all of my colleagues that have worked so 
hard to bring this bill forward. So I rise, obviously, in support of it 
because I think the bill is going to make an enormous difference in the 
safety and the effectiveness of drugs and medical devices used to treat 
adults and children.
  I think the bill also strengthens the FDA. I think the American 
people want the FDA to be an agency that is strong in its protection of 
consumers around the country. We know that there have been shortcomings 
that have had terrible effects on many families in our country. So, I 
think this bill is a victory in that arena.
  I am also pleased that the bill adopts much of my legislation 
relative to children and pharmaceutical drugs for children. The 
American Academy of Pediatrics has instructed us that only about 25 
percent of drugs administered to children have been appropriately 
tested and labeled for use in kids. Pediatricians often had to 
prescribe adult pharmaceuticals for children by telling parents, ``cut 
the pill in half, cut it in thirds, cut it in quarters.'' We understood 
that we had to do better. By every measurement, the reauthorization of 
this legislation, previous legislation, was supported because it was 
very, very successful. We know that children are not small adults, and 
the legislation recognizes that. We have reauthorized, and we are doing 
the right thing.
  I am pleased that the blockbuster provision is not a part of this 
legislation. The other body supported that. I didn't. This bill 
doesn't. In all negotiations, there is always give-and-take. There are 
items I supported that didn't make it into the package, including the 
permanent extension of the Pediatric Research Equity Act, which I 
championed, obviously, as part of my legislation in the original House 
bill. I hope that we can get to this at some point. I am sorry it is 
not in this bill.
  Overall, I want to thank all of my colleagues that made this possible 
and that we are here today; certainly, Chairman Dingell, Ranking Member 
Barton, most especially the professional staff, because they do so much 
work, no one more than John Ford of our staff, and Virgil Miller. I 
would like to also thank Jennifer Nieto Carey, formerly of my staff, 
who worked so hard and extensively to help bring us to this point.
  So this is a good bill. I think the whole House should support it. I 
think it is a tribute to the substance of it, that it is coming up 
under suspension. I salute everyone that made the effort a winning one. 
Most importantly, I think the bill is a winner for the people of our 
country, both children and adults.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Oregon (Ms. Hooley).
  Ms. HOOLEY. Mr. Speaker, I would like to thank my colleague from New 
Jersey who has done a fabulous job of chairing the subcommittee.
  Mr. Speaker, I rise today in strong support of H.R. 3580. Patients 
and consumers are the clear winners in this legislation today. This 
legislation will save lives by promoting the safe and quick approval of 
lifesaving medications and providing the FDA with vital new authority 
to protect consumers after a drug is on the market. This bill collects 
an additional $225 million over 5 years to enhance drug safety reviews 
and also promotes testing of pharmaceuticals and medical devices to 
ensure that they are safe for children.
  Revisions I crafted with my colleague, Mr. Doyle, the FDA and others 
require the creation of a unique device identification, or a UDI, 
system for medical devices that will help take important strides to 
improve the public health. Medical devices cannot easily be tracked or 
identified in any systemic fashion with current tools. A UDI system 
will enable the FDA to detect warning signs of a defective device 
earlier and quickly respond to recalls. Every person with an artificial 
knee, hip, pacemaker or any one of the thousands of other medical 
devices will benefit once this UDI system is in place.
  Mr. Speaker, I urge my colleagues to support this bipartisan and 
comprehensive drug and device safety bill.
  Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from 
Illinois (Ms. Schakowsky).
  Ms. SCHAKOWSKY. Mr. Speaker, I want to thank Chairman Dingell and 
Chairman Pallone, Mr. Waxman and Mr. Markey and Congresswoman Eshoo and 
all my colleagues on both sides of the aisle and their hardworking 
staffs for bringing this landmark bill to the floor today.
  This bill strikes to the heart of some of FDA's most troubling issues 
by granting additional authorities to the Food and Drug Administration 
that are critical to enhancing drug safety. This bill gives consumers a 
larger role in deciding how user fees are spent to enhance drug safety, 
a huge victory for consumer protection. It will take steps to enhance 
the kind of information that will be available to patients and their 
families as they make personal decisions regarding their health care.
  I am particularly pleased by the inclusion of an amendment I offered 
that will improve consumer's awareness of the MedWatch program, one of 
FDA's best but least known ways of monitoring adverse drug events once 
a product has been approved. Consumer reports of bad effects signal to 
FDA when prescription drugs pose a threat. The success of this program 
is crucial to postmarketing surveillance. Unfortunately, 9 out of 10 
Americans are unaware that the MedWatch program exists, yet adverse 
drug and device reactions account for as many as 100,000 deaths every 
year.
  My amendment requires that printed prescription drug ads include 
information on how to report side effects to the FDA's MedWatch 
program, both on the Internet and through a 1-800 number. It also 
requires the FDA to do a study on how we can best include this 
important information on the TV ads that have become so pervasive and 
influential in our society. So, again, I thank the chairman and staff 
for working with me to include this language.
  This bill makes a strong statement about the importance of protecting 
people who rely on prescription medications to get through their day 
and remain active members of society. I am encouraged by the steps it 
takes toward a safer, more transparent Food and Drug Administration.
  Mr. Speaker, I urge all my colleagues to support it.
  Mr. DEAL of Georgia. Mr. Speaker, I have no other requests for time.
  Mr. Speaker, I thank our staff and urge the adoption of this bill and 
I yield back the balance of our time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Mr. Speaker, I just want to thank everyone, particularly the staff 
that were involved in putting this legislation together and all the 
negotiations. I want to thank our legislative counsel, Warren Burke, 
Energy and Commerce Republicans, Ryan Long and Nandan Kenkeremath; Mr. 
Deal's staff, John Little; our Energy and Commerce Democrats, John 
Ford, Pete Goodloe, Virgil Miller, Bobby Clark; and Mr. Waxman's staff, 
Karen Nelson, Rachel Sher, Stephen Cha, Anne Witt; and also Mr. 
Markey's staffperson, Kate Bazinsky.
  Needless to say, this bill is a product of a lot of hard work here in 
the House on both sides of the aisle, and, of course, we are also 
expecting, since this is going to be a consensus bill passed on the 
suspension list today, that it will pass easily in the Senate hopefully 
tonight or tomorrow. And it really addresses the problems and the 
safety issues that have come to light in the last few years.

                              {time}  1530

  I think many of us know there has been a lot of media attention to 
the fact that oftentimes drugs in the postmarketing situation have been 
problems. People have died. People have gotten sick. This bill I think 
effectively addresses those issues. I hope

[[Page H10598]]

and expect that it will be noticed, because it will make a difference 
in people's lives.
  Mr. WAXMAN. Mr. Speaker, the legislation are poised to pass today 
provides FDA, for the first time, critical tools that the Agency has 
been desperately lacking in its efforts to protect the American public 
from unsafe drugs.
  This legislation will provide FDA with the ability to require 
companies to update their drug label with new safety information. Our 
goal here is to address tragic situations like Vioxx. In that case, 
because FDA could not compel the company to promptly make a labeling 
change, the Agency haggled with the company for 14 months before 
consumers were finally warned about serious cardiac risks in the drug 
label. This is simply unacceptable.
  However, this legislation will make clear that, in giving FDA this 
labeling change authority, Congress does not intend to impact, in any 
way, a drug company's responsibility to promptly update its label with 
safety information on its own accord. Under FDA's current regulations, 
companies are required to add new warnings to their labels as soon as 
they learn of new dangers, even if FDA has not yet required the change.
  In promulgating those regulations, FDA made a sensible policy choice. 
FDA recognized that the companies themselves are in the best position 
to know about risks associated with their own drugs. Logically, then, 
the companies should also be charged with the duty to make consumers 
aware of a drug's risk at the earliest possible moment. FDA recognized 
that drug safety is first and foremost a shared responsibility between 
the Agency and the company. And, today, Congress is making it clear 
that we do not mean to disrupt that balance.
  This legislation will also give FDA for the first time the authority 
to require companies to conduct post-market studies and clinical trials 
of drugs. Another section of the bill creates a mandatory clinical 
trial registry and results database to increase the transparency of 
those trials. Both of these provisions will make a critical 
contribution towards increasing the safety of our drugs once they are 
on the market.
  But I want to express my deep disappointment that this legislation 
failed to adopt a compromise that would have provided consumers with 
much-needed relief from the ever-increasing cost of drugs. Today, we 
are walking away from a critical and very rare opportunity to make some 
reasonable adjustments to the windfall profits drug companies receive 
for conducting pediatric studies under the Best Pharmaceuticals for 
Children Act.
  This is not about whether these pediatric studies should be done. We 
all agree about that. They are being done now. And there is no question 
that they would continue to be done if we were to cut back slightly on 
the term of exclusivity for just the blockbuster drugs that are 
realizing profits many times over the cost of doing pediatric studies. 
The Senate did this in its bill and I regret that the compromise 
agreement we are considering today did not reflect anything from the 
Senate approach on this issue.
  In my view, there simply is no justification for rewarding companies 
with incentives that are far in excess of the actual costs of the 
studies themselves--often hundreds of times over.
  I also am deeply disturbed that this legislation fails to remove what 
is an unprecedented sunset on FDA's statutory authority to require 
pediatric studies under the Pediatric Research and Equity Act. There is 
no reason Congress needs to keep revisiting this common sense measure 
that allows FDA to get critical information about whether new therapies 
are safe and effective for children--FDA quite obviously needs to have 
the ability to require that new treatments be tested in children. And 
there need not be any further discussion about that.
  So, although I am pleased that we will provide FDA with critical new 
authorities and resources in this bill today, I must express my deep 
regret that we failed to take this opportunity to help individuals, 
businesses, State governments, and insurers who pay the bill for the 
higher prices that result when generic competition is delayed for these 
expensive, blockbuster drugs.
  Mr. GENE GREEN of Texas. Mr. Speaker, I rise in strong support of 
this conference agreement 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 intense negotiations between the 
House and Senate, whose negotiators have worked tirelessly to reach 
consensus on this legislation. They did so with a looming deadline of 
September 31, after which the user fee program would expire and many 
hard-working FDA scientists would likely lose their jobs. To reach a 
compromise, all parties to the negotiation had to give and take, but I 
am pleased that the product before us represents something we can all 
support. I would like to congratulate the negotiators on their success.
  The FDA Amendments Act of 2007 makes important changes at the FDA to 
place a greater emphasis on post-market surveillance within the agency. 
The Risk, Evaluation, and Mitigation Strategy established by this bill 
would give the agency the authority to monitor drugs 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 5 
years for postmarket surveillance activities at the FDA. This 
additional funding represents an important investment by the 
pharmaceutical industry in the FDA's post-market safety activities, 
while also ensuring that pre-market user fees are adequate to bring 
potentially life-saving medicines to market in a reasonable time.
  There is no question that the labeling and liability language 
prompted a great deal of debate during conference negotiations, but one 
thing is clear: the Congress in no way intends to limit the ability of 
a patient injured by a drug to seek redress from our Nation's justice 
system. FDA should have the ability to require labeling changes, but 
that additional authority does not absolve the drug manufacturer of any 
duty to initiate labeling changes on their own when new data bears out 
the need for a change. The implementation of stronger drug safety 
authorities does not mean that drug companies get a free pass when 
their products harm consumers. I am pleased that the conference 
agreement makes this point perfectly clear.
  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, which help ensure that pharmaceuticals are tested 
for their effect on children. After all, we know that children are not 
simply smaller adults, and part of protecting America's children is 
knowing how best to treat them when they face health concerns.
  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. ESHOO. Mr. Speaker, I rise in support of H.R. 3580, the Food and 
Drug Administration Amendments Act.
  This bill will make an enormous difference in the safety and 
effectiveness of drugs and medical devices used to treat adults and 
children.
  I'm pleased that the bill adopts much of my legislation (H.R. 2589, 
Improving Pharmaceuticals for Children Act) to renew the Best 
Pharmaceuticals for Children Act (BPCA) and the Pediatric Research 
Equity Act (PREA). Together, BPCA and PREA represent two halves of a 
comprehensive effort to make sure that prescription drugs are 
appropriately tested and labeled for children.
  According to the American Academy of Pediatrics, about 25 percent of 
drugs administered to children have been appropriately tested and 
labeled 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 are not 
small adults; they 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.
  The bill helps improve drug safety for children in two ways. First, 
under BPCA, the bill provides an incentive, an extra 6 months of 
marketing exclusivity, for a drug if the innovator company agrees to 
undertake comprehensive pediatric studies requested by the FDA. Second, 
under PREA, FDA is granted authority to require studies when there is a 
demonstrated need and drug companies are required to submit a pediatric 
assessment each time they apply to market a new drug or change an 
existing drug's indication.
  I'm pleased this bill continues the BPCA incentive without the so-
called ``blockbuster provision'' adopted by the Senate. The Senate's 
proposal would have reduced the incentive for drugs with annual sales 
of $1 billion, and, I believe the Senate language had the potential to 
kill ``the goose that laid the golden egg.'' The 6-month incentive has 
worked. According to GAO, 81 percent of the time FDA has offered this 
incentive for a drug, drug companies have accepted, undertaking studies 
that have generated pediatric data that would otherwise not have been 
available. Scaling back the incentive for ``blockbusters'' would risk 
that proven record of success. That is a gamble on the

[[Page H10599]]

health of children, and I'm pleased it's not in the bill.
  In all negotiations there is give and take. There are items I 
supported that didn't make it into this package, including the 
permanent extension of PREA which I championed as part of my 
legislation and the original House bill. I hope we'll have a chance to 
revisit the issue in the next reauthorization, if not sooner.
  On balance, this bill will make a huge improvement in the safety of 
drugs and devices. We should pass it and send it to the President 
today.
  I want to commend Chairman Dingell, Ranking Member Barton and the 
professional staff of the House Energy and Commerce Committee, 
especially John Ford and Virgil Miller, as well as Jennifer Nieto Carey 
formerly of my staff, who worked extensively on this bill.
  Mr. PALLONE. Mr. Speaker, I want to thank everyone again, and I yield 
back the balance of my time.
  The SPEAKER pro tempore. The question is on the motion offered by the 
gentleman from Michigan (Mr. Dingell) that the House suspend the rules 
and pass the bill, H.R. 3580.
  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 vote was taken by electronic device, and there were--yeas 405, 
nays 7, not voting 20, as follows:

                             [Roll No. 885]

                               YEAS--405

     Abercrombie
     Ackerman
     Aderholt
     Akin
     Alexander
     Altmire
     Arcuri
     Baca
     Bachmann
     Bachus
     Baird
     Baker
     Baldwin
     Barrett (SC)
     Barrow
     Bartlett (MD)
     Barton (TX)
     Bean
     Becerra
     Berkley
     Berman
     Berry
     Biggert
     Bilbray
     Bilirakis
     Bishop (GA)
     Bishop (NY)
     Blackburn
     Blumenauer
     Bonner
     Bono
     Boozman
     Boren
     Boswell
     Boucher
     Boustany
     Boyd (FL)
     Boyda (KS)
     Brady (PA)
     Brady (TX)
     Braley (IA)
     Broun (GA)
     Brown (SC)
     Brown, Corrine
     Brown-Waite, Ginny
     Buchanan
     Burgess
     Burton (IN)
     Butterfield
     Buyer
     Calvert
     Camp (MI)
     Campbell (CA)
     Cannon
     Capito
     Capps
     Capuano
     Cardoza
     Carnahan
     Carson
     Castle
     Castor
     Chabot
     Chandler
     Clarke
     Clay
     Cleaver
     Clyburn
     Coble
     Cohen
     Conaway
     Conyers
     Cooper
     Costa
     Costello
     Courtney
     Cramer
     Crenshaw
     Crowley
     Cuellar
     Culberson
     Cummings
     Davis (AL)
     Davis (CA)
     Davis (IL)
     Davis (KY)
     Davis, David
     Davis, Lincoln
     Davis, Tom
     Deal (GA)
     DeFazio
     DeGette
     Delahunt
     DeLauro
     Dent
     Diaz-Balart, L.
     Diaz-Balart, M.
     Dingell
     Doggett
     Donnelly
     Doolittle
     Doyle
     Drake
     Dreier
     Edwards
     Ehlers
     Ellison
     Ellsworth
     Emanuel
     Engel
     English (PA)
     Eshoo
     Etheridge
     Everett
     Fallin
     Farr
     Fattah
     Feeney
     Ferguson
     Filner
     Forbes
     Fortenberry
     Fossella
     Foxx
     Frank (MA)
     Franks (AZ)
     Frelinghuysen
     Gallegly
     Garrett (NJ)
     Gerlach
     Giffords
     Gilchrest
     Gillibrand
     Gingrey
     Gohmert
     Gonzalez
     Goodlatte
     Gordon
     Graves
     Green, Al
     Green, Gene
     Grijalva
     Gutierrez
     Hall (NY)
     Hall (TX)
     Hare
     Harman
     Hastert
     Hastings (FL)
     Hastings (WA)
     Hayes
     Heller
     Hensarling
     Herger
     Herseth Sandlin
     Higgins
     Hill
     Hinojosa
     Hirono
     Hobson
     Hodes
     Hoekstra
     Holden
     Holt
     Honda
     Hooley
     Hoyer
     Hulshof
     Hunter
     Inglis (SC)
     Inslee
     Israel
     Issa
     Jackson (IL)
     Jackson-Lee (TX)
     Jefferson
     Johnson (IL)
     Johnson, E. B.
     Johnson, Sam
     Jones (NC)
     Jones (OH)
     Jordan
     Kagen
     Kanjorski
     Kaptur
     Keller
     Kennedy
     Kildee
     Kilpatrick
     Kind
     King (IA)
     King (NY)
     Kingston
     Kirk
     Klein (FL)
     Kline (MN)
     Knollenberg
     Kuhl (NY)
     LaHood
     Lamborn
     Lampson
     Langevin
     Lantos
     Larsen (WA)
     Larson (CT)
     Latham
     LaTourette
     Lee
     Levin
     Lewis (CA)
     Lewis (GA)
     Lewis (KY)
     Linder
     Lipinski
     LoBiondo
     Loebsack
     Lofgren, Zoe
     Lowey
     Lucas
     Lungren, Daniel E.
     Lynch
     Mack
     Mahoney (FL)
     Maloney (NY)
     Manzullo
     Marchant
     Markey
     Marshall
     Matheson
     Matsui
     McCarthy (CA)
     McCarthy (NY)
     McCaul (TX)
     McCollum (MN)
     McCrery
     McDermott
     McGovern
     McHenry
     McIntyre
     McKeon
     McMorris Rodgers
     McNerney
     McNulty
     Meek (FL)
     Meeks (NY)
     Melancon
     Mica
     Michaud
     Miller (FL)
     Miller (MI)
     Miller (NC)
     Miller, Gary
     Miller, George
     Mitchell
     Mollohan
     Moore (KS)
     Moore (WI)
     Moran (KS)
     Moran (VA)
     Murphy (CT)
     Murphy, Patrick
     Murphy, Tim
     Murtha
     Musgrave
     Myrick
     Nadler
     Napolitano
     Neal (MA)
     Neugebauer
     Nunes
     Oberstar
     Obey
     Olver
     Pallone
     Pascrell
     Pastor
     Payne
     Pearce
     Pence
     Perlmutter
     Peterson (MN)
     Peterson (PA)
     Petri
     Pickering
     Pitts
     Platts
     Poe
     Pomeroy
     Porter
     Price (GA)
     Price (NC)
     Pryce (OH)
     Radanovich
     Rahall
     Ramstad
     Rangel
     Regula
     Rehberg
     Reichert
     Renzi
     Reyes
     Reynolds
     Richardson
     Rodriguez
     Rogers (AL)
     Rogers (KY)
     Rogers (MI)
     Rohrabacher
     Ros-Lehtinen
     Roskam
     Ross
     Rothman
     Roybal-Allard
     Royce
     Ruppersberger
     Rush
     Ryan (OH)
     Ryan (WI)
     Salazar
     Sali
     Sanchez, Linda T.
     Sanchez, Loretta
     Sarbanes
     Saxton
     Schakowsky
     Schiff
     Schmidt
     Schwartz
     Scott (GA)
     Scott (VA)
     Sensenbrenner
     Serrano
     Sessions
     Sestak
     Shadegg
     Shays
     Shea-Porter
     Sherman
     Shimkus
     Shuler
     Shuster
     Simpson
     Sires
     Skelton
     Slaughter
     Smith (NE)
     Smith (NJ)
     Smith (TX)
     Smith (WA)
     Snyder
     Solis
     Souder
     Space
     Spratt
     Stark
     Stearns
     Stupak
     Sullivan
     Sutton
     Tancredo
     Tanner
     Tauscher
     Taylor
     Terry
     Thompson (CA)
     Thompson (MS)
     Thornberry
     Tiahrt
     Tiberi
     Tierney
     Towns
     Turner
     Udall (CO)
     Udall (NM)
     Upton
     Van Hollen
     Velazquez
     Visclosky
     Walberg
     Walden (OR)
     Walsh (NY)
     Walz (MN)
     Wamp
     Wasserman Schultz
     Watson
     Watt
     Waxman
     Weiner
     Welch (VT)
     Weldon (FL)
     Weller
     Westmoreland
     Wexler
     Whitfield
     Wicker
     Wilson (NM)
     Wilson (OH)
     Wilson (SC)
     Wolf
     Woolsey
     Wu
     Wynn
     Yarmuth
     Young (AK)
     Young (FL)

                                NAYS--7

     Duncan
     Emerson
     Flake
     Goode
     Hinchey
     Kucinich
     Paul

                             NOT VOTING--20

     Allen
     Andrews
     Bishop (UT)
     Blunt
     Boehner
     Cantor
     Carney
     Carter
     Cole (OK)
     Cubin
     Davis, Jo Ann
     Dicks
     Granger
     Jindal
     Johnson (GA)
     McCotter
     McHugh
     Ortiz
     Putnam
     Waters

                              {time}  1555

  Mr. GOODE changed his vote from ``yea'' to ``nay.''
  Mr. PRICE of North Carolina changed his vote from ``nay'' to ``yea.''
  So (two-thirds being in the affirmative) the rules were suspended and 
the bill was passed.
  The result of the vote was announced as above recorded.
  A motion to reconsider was laid on the table
  Stated for:
  Mr. COLE of Oklahoma. Mr. Speaker, on Wednesday, September 19, 2007, 
I was unavoidably detained due to a prior obligation.
  Had I been present and voting, I would have voted ``yea'' on rollcall 
No. 885.

                          ____________________