[Congressional Record (Bound Edition), Volume 158 (2012), Part 6]
[House]
[Pages 7907-7950]
[From the U.S. Government Publishing Office, www.gpo.gov]




            FOOD AND DRUG ADMINISTRATION REFORM ACT OF 2012

  Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill 
(H.R. 5651) 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 establish user-fee programs for generic drugs and 
biosimilars, and for other purposes, as amended.
  The Clerk read the title of the bill.
  The text of the bill is as follows:

                               H.R. 5651

       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 
     Reform Act of 2012''.

     SEC. 2. TABLE OF CONTENTS.

       The table of contents of this Act is as follows:

Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. References in Act.

                    TITLE I--FEES RELATING TO DRUGS

Sec. 101. Short title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Reauthorization; reporting requirements.
Sec. 105. Sunset dates.
Sec. 106. Effective date.
Sec. 107. Savings clause.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012

Sec. 201. Short title; findings.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Savings clause.
Sec. 206. Effective date.
Sec. 207. Sunset clause.
Sec. 208. Streamlined hiring authority to support activities related to 
              the process for the review of device applications.

               TITLE III--FEES RELATING TO GENERIC DRUGS

Sec. 301. Short title.
Sec. 302. Authority to assess and use human generic drug fees.
Sec. 303. Reauthorization; reporting requirements.
Sec. 304. Sunset dates.
Sec. 305. Effective date.
Sec. 306. Amendment with respect to misbranding.
Sec. 307. Streamlined hiring authority to support activities related to 
              human generic drugs.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Sec. 401. Short title; finding.
Sec. 402. Fees relating to biosimilar biological products.
Sec. 403. Reauthorization; reporting requirements.
Sec. 404. Sunset dates.
Sec. 405. Effective date.
Sec. 406. Savings clause.
Sec. 407. Conforming amendment.

 TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND 
                     PEDIATRIC RESEARCH EQUITY ACT

Sec. 501. Permanent extension of Best Pharmaceuticals for Children Act 
              and Pediatric Research Equity Act.
Sec. 502. Food and Drug Administration Report.
Sec. 503. Internal Committee for Review of Pediatric Plans, 
              Assessments, Deferrals, Deferral Extensions, and Waivers.
Sec. 504. Staff of Office of Pediatric Therapeutics.
Sec. 505. Continuation of operation of Pediatric Advisory Committee.
Sec. 506. Pediatric Subcommittee of the Oncologic Drugs Advisory 
              Committee.

     TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS

Sec. 601. Public participation in issuance of FDA guidance documents.
Sec. 602. Conflicts of interest.
Sec. 603. Electronic submission of applications.
Sec. 604. Notification of FDA intent to regulate laboratory-developed 
              tests.

           TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

Sec. 701. Investigational device exemptions.
Sec. 702. Clarification of least burdensome standard.
Sec. 703. Agency documentation and review of significant decisions.
Sec. 704. Transparency in clearance process.
Sec. 705. Device Modifications Requiring Premarket Notification Prior 
              to Marketing.

                    Subtitle B--Patients Come First

Sec. 711. Establishment of schedule and promulgation of regulation.
Sec. 712. Program to improve the device recall system.

               Subtitle C--Novel Device Regulatory Relief

Sec. 721. Modification of de novo application process.

     Subtitle D--Keeping America Competitive Through Harmonization

Sec. 731. Harmonization of device premarket review, inspection, and 
              labeling symbols; report.
Sec. 732. Participation in international fora.

  Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management

Sec. 741. Reauthorization of Third Party Review.
Sec. 742. Reauthorization of third party inspection.

                 Subtitle F--Humanitarian Device Reform

Sec. 751. Expanded access to humanitarian use devices.

               Subtitle G--Records and Reports on Devices

Sec. 761. Unique device identification system regulations.
Sec. 762. Effective device sentinel program.

                       Subtitle H--Miscellaneous

Sec. 771. Custom devices.
Sec. 772. Pediatric device reauthorization.
Sec. 773. Report on regulation of health information technology.

                TITLE VIII--DRUG REGULATORY IMPROVEMENTS

                     Subtitle A--Drug Supply Chain

Sec. 801. Registration of producers of drugs.
Sec. 802. Inspection of drugs.
Sec. 803. Drug supply quality and safety.
Sec. 804. Prohibition against delaying, denying, limiting, or refusing 
              inspection.
Sec. 805. Destruction of adulterated, misbranded, or counterfeit drugs 
              offered for import.
Sec. 806. Administrative detention.
Sec. 807. Enhanced criminal penalty for counterfeit drugs.
Sec. 808. Unique facility identification number.
Sec. 809. Documentation for admissibility of imports.
Sec. 810. Registration of commercial importers.
Sec. 811. Notification.
Sec. 812. Exchange of information.
Sec. 813. Extraterritorial jurisdiction.
Sec. 814. Protection against intentional adulteration.
Sec. 815. Records for inspection.

                     Subtitle B--Medical Gas Safety

Sec. 821. Regulation of medical gases.
Sec. 822. Changes to regulations.
Sec. 823. Rules of construction.

            Subtitle C--Generating Antibiotic Incentives Now

Sec. 831. Extension of exclusivity period for drugs.
Sec. 832. Study on incentives for qualified infectious disease 
              biological products.
Sec. 833. Clinical trials.
Sec. 834. Reassessment of qualified infectious disease product 
              incentives in 5 years.
Sec. 835. Guidance on pathogen-focused antibacterial drug development.

                    Subtitle D--Accelerated Approval

Sec. 841. Expedited approval of drugs for serious or life-threatening 
              diseases or conditions.
Sec. 842. Guidance; amended regulations.
Sec. 843. Independent review.

[[Page 7908]]

               Subtitle E--Critical Path Reauthorization

Sec. 851. Reauthorization of the critical path public-private 
              partnerships.

                       Subtitle F--Miscellaneous

Sec. 861. Reauthorization of provision relating to exclusivity of 
              certain drugs containing single enantiomers.
Sec. 862. Extension of period for first applicant To obtain tentative 
              approval without forfeiting 180-day exclusivity period.
Sec. 863. Final agency action relating to petitions and civil actions.
Sec. 864. Deadline for determination on certain petitions.
Sec. 865. Rare pediatric disease priority review voucher incentive 
              program.
Sec. 866. Combating prescription drug abuse.
Sec. 867. Assessment and modification of REMS.
Sec. 868. Consultation with external experts on rare diseases, targeted 
              therapies, and genetic targeting of treatments.
Sec. 869. Breakthrough therapies.
Sec. 870. Grants and Contracts for the Development of Orphan Drugs.

                        TITLE IX--DRUG SHORTAGES

Sec. 901. Discontinuance and interruptions of manufacturing of certain 
              drugs.
Sec. 902. Drug shortage list.
Sec. 903. Quotas applicable to drugs in shortage.
Sec. 904. Expedited review of major manufacturing changes for potential 
              and verified shortages of drugs that are life-supporting, 
              life-sustaining, or intended for use in the prevention of 
              a debilitating disease or condition.
Sec. 905. Study on drug shortages.
Sec. 906. Annual report on drug shortages.
Sec. 907. Attorney General report on drug shortages.
Sec. 908. Hospital repackaging of drugs in shortage.

     SEC. 3. REFERENCES IN ACT.

       Except as otherwise specified, amendments made by this Act 
     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.).

                    TITLE I--FEES RELATING TO DRUGS

     SEC. 101. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Prescription Drug User Fee Amendments of 2012''.
       (b) 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(7) (21 U.S.C. 379g) is amended by striking 
     ``expenses incurred in connection with'' and inserting 
     ``expenses in connection with''.

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

       Section 736 (21 U.S.C. 379h) is amended--
       (1) in subsection (a)--
       (A) in the matter preceding paragraph (1), by striking 
     ``fiscal year 2008'' and inserting ``fiscal year 2013'';
       (B) in paragraph (1)(A)--
       (i) in clause (i), by striking ``(c)(5)'' and inserting 
     ``(c)(4)''; and
       (ii) in clause (ii), by striking ``(c)(5)'' and inserting 
     ``(c)(4)'';
       (C) in the matter following clause (ii) in paragraph 
     (2)(A)--
       (i) by striking ``(c)(5)'' and inserting ``(c)(4)''; and
       (ii) by striking ``payable on or before October 1 of each 
     year'' and inserting ``due on the later of the first business 
     day on or after October 1 of such fiscal year or the first 
     business day after the enactment of an appropriations Act 
     providing for the collection and obligation of fees for such 
     fiscal year under this section'';
       (D) in paragraph (3)--
       (i) in subparagraph (A)--

       (I) by striking ``subsection (c)(5)'' and inserting 
     ``subsection (c)(4)''; and
       (II) by striking ``payable on or before October 1 of each 
     year.'' and inserting ``due on the later of the first 
     business day on or after October 1 of each such fiscal year 
     or the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for each such fiscal year under this 
     section.''; and

       (ii) by amending subparagraph (B) to read as follows:
       ``(B) Exception.--A prescription drug product shall not be 
     assessed a fee under subparagraph (A) if such product is--
       ``(i) identified on the list compiled under section 
     505(j)(7)(A) with a potency described in terms of per 100 mL;
       ``(ii) the same product as another product that--

       ``(I) was approved under an application filed under section 
     505(b) or 505(j); and
       ``(II) is not in the list of discontinued products compiled 
     under section 505(j)(7)(A);

       ``(iii) the same product as another product that was 
     approved under an abbreviated application filed under section 
     507 (as in effect on the day before the date of enactment of 
     the Food and Drug Administration Modernization Act of 1997); 
     or
       ``(iv) the same product as another product that was 
     approved under an abbreviated new drug application pursuant 
     to regulations in effect prior to the implementation of the 
     Drug Price Competition and Patent Term Restoration Act of 
     1984.'';
       (2) in subsection (b)--
       (A) in paragraph (1)--
       (i) in the language preceding subparagraph (A), by striking 
     ``fiscal years 2008 through 2012'' and inserting ``fiscal 
     years 2013 through 2017''; and
       (ii) in subparagraph (A), by striking ``$392,783,000; and'' 
     and inserting ``$693,099,000;''; and
       (iii) by striking subparagraph (B) and inserting the 
     following:
       ``(B) the dollar amount equal to the inflation adjustment 
     for fiscal year 2013 (as determined under paragraph (3)(A)); 
     and
       ``(C) the dollar amount equal to the workload adjustment 
     for fiscal year 2013 (as determined under paragraph 
     (3)(B)).''; and
       (B) by striking paragraphs (3) and (4) and inserting the 
     following:
       ``(3) Fiscal year 2013 inflation and workload 
     adjustments.--For purposes of paragraph (1), the dollar 
     amount of the inflation and workload adjustments for fiscal 
     year 2013 shall be determined as follows:
       ``(A) Inflation adjustment.--The inflation adjustment for 
     fiscal year 2013 shall be the sum of--
       ``(i) $652,709,000 multiplied by the result of an inflation 
     adjustment calculation determined using the methodology 
     described in subsection (c)(1)(B); and
       ``(ii) $652,709,000 multiplied by the result of an 
     inflation adjustment calculation determined using the 
     methodology described in subsection (c)(1)(C).
       ``(B) Workload adjustment.--Subject to subparagraph (C), 
     the workload adjustment for fiscal 2013 shall be--
       ``(i) $652,709,000 plus the amount of the inflation 
     adjustment calculated under subparagraph (A); multiplied by
       ``(ii) the amount (if any) by which a percentage workload 
     adjustment for fiscal year 2013, as determined using the 
     methodology described in subsection (c)(2)(A), would exceed 
     the percentage workload adjustment (as so determined) for 
     fiscal year 2012, if both such adjustment percentages were 
     calculated using the 5-year base period consisting of fiscal 
     years 2003 through 2007.
       ``(C) Limitation.--Under no circumstances shall the 
     adjustment under subparagraph (B) result in fee revenues for 
     fiscal year 2013 that are less than the sum of the amount 
     under paragraph (1)(A) and the amount under paragraph 
     (1)(B).'';
       (3) by striking subsection (c) and inserting the following:
       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year by the 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent 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 3 years of 
     the preceding 4 fiscal years, multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     the process for the review of human drug applications (as 
     defined in section 735(6)) for the first 3 years of the 
     preceding 4 fiscal years, and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of the process for the review of human drug 
     applications (as defined in section 735(6)) for the first 3 
     years of the preceding 4 fiscal years.

     The adjustment made each fiscal year under this paragraph 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this paragraph.
       ``(2) Workload adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, 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 for the process for 
     the review of human drug applications. With respect to such 
     adjustment:

[[Page 7909]]

       ``(A) The adjustment shall be determined by the Secretary 
     based on a weighted average of the change in the total number 
     of 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), efficacy supplements, and manufacturing 
     supplements submitted to the Secretary, 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. 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 sum of 
     the amount under subsection (b)(1)(A) and the amount under 
     subsection (b)(1)(B), as adjusted for inflation under 
     paragraph (1).
       ``(C) The Secretary shall contract with an independent 
     accounting or consulting firm to periodically review the 
     adequacy of the adjustment and publish the results of those 
     reviews. The first review shall be conducted and published by 
     the end of fiscal year 2013 (to examine the performance of 
     the adjustment since fiscal year 2009), and the second review 
     shall be conducted and published by the end of fiscal year 
     2015 (to examine the continued performance of the 
     adjustment). The reports shall evaluate whether the 
     adjustment reasonably represents actual changes in workload 
     volume and complexity and present options to discontinue, 
     retain, or modify any elements of the adjustment. The reports 
     shall be published for public comment. After review of the 
     reports and receipt of public comments, the Secretary shall, 
     if warranted, adopt appropriate changes to the methodology. 
     If the Secretary adopts changes to the methodology based on 
     the first report, the changes shall be effective for the 
     first fiscal year for which fees are set after the Secretary 
     adopts such changes and each subsequent fiscal year.
       ``(3) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under this 
     paragraph and paragraphs (1) and (2), 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 2018. If such an adjustment is 
     necessary, the rationale for the amount of the increase shall 
     be contained in the annual notice establishing fee revenues 
     and fees for fiscal year 2017. 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.
       ``(4) Annual fee setting.--The Secretary shall, not later 
     than 60 days before the start of each fiscal year that begins 
     after September 30, 2012, establish, for the next fiscal 
     year, application, product, and establishment fees under 
     subsection (a), based on the revenue amounts established 
     under subsection (b) and the adjustments provided under this 
     subsection.
       ``(5) Limit.--The total amount of fees charged, as adjusted 
     under this subsection, for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for the process for the review of human drug applications.''; 
     and
       (4) in subsection (g)--
       (A) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (B) in paragraph (2)--
       (i) in subparagraph (A)(i), by striking ``shall be 
     retained'' and inserting ``shall be collected and 
     available'';
       (ii) in subparagraph (A)(ii), by striking ``shall only be 
     collected and available'' and inserting ``shall be 
     available''; and
       (iii) by adding at the end the following new subparagraph:
       ``(C) Provision for early payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (C) in paragraph (3), by striking ``fiscal years 2008 
     through 2012'' and inserting ``fiscal years 2013 through 
     2017''; and
       (D) in paragraph (4)--
       (i) by striking ``fiscal years 2008 through 2010'' and 
     inserting ``fiscal years 2013 through 2015'';
       (ii) by striking ``fiscal year 2011'' and inserting 
     ``fiscal year 2016'';
       (iii) by striking ``fiscal years 2008 through 2011'' and 
     inserting ``fiscal years 2013 through 2016''; and
       (iv) by striking ``fiscal year 2012'' and inserting 
     ``fiscal year 2017''.

     SEC. 104. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Section 736B (21 U.S.C. 379h-2) is amended--
       (1) by amending subsection (a) to read as follows:
       ``(a) Performance Report.--
       ``(1) In general.--Beginning with fiscal year 2013, 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--
       ``(A) the progress of the Food and Drug Administration in 
     achieving the goals identified in the letters described in 
     section 101(b) of the Prescription Drug User Fee Amendments 
     of 2012 during such fiscal year and the future plans of the 
     Food and Drug Administration for meeting the goals, including 
     the status of the independent assessment described in such 
     letters; and
       ``(B) the progress of the Center for Drug Evaluation and 
     Research and the Center for Biologics Evaluation and Research 
     in achieving the goals, and future plans for meeting the 
     goals, including, for each review division--
       ``(i) the number of original standard new drug applications 
     and biologics license applications filed per fiscal year for 
     each review division;
       ``(ii) the number of original priority new drug 
     applications and biologics license applications filed per 
     fiscal year for each review division;
       ``(iii) the number of standard efficacy supplements filed 
     per fiscal year for each review division;
       ``(iv) the number of priority efficacy supplements filed 
     per fiscal year for each review division;
       ``(v) the number of applications filed for review under 
     accelerated approval per fiscal year for each review 
     division;
       ``(vi) the number of applications filed for review as fast 
     track products per fiscal year for each review division; and
       ``(vii) the number of applications filed for orphan-
     designated products per fiscal year for each review division.
       ``(2) Inclusion.--The report under this subsection for a 
     fiscal year shall include information on all previous cohorts 
     for which the Secretary has not given a complete response on 
     all human drug applications and supplements in the cohort.''.
       (2) in subsection (b), by striking ``2008'' and inserting 
     ``2013''; and
       (3) in subsection (d), by striking ``2012'' each place it 
     appears and inserting ``2017''.

     SEC. 105. SUNSET DATES.

       (a) Authorization.--Sections 735 and 736 (21 U.S.C. 379g; 
     379h) are repealed October 1, 2017.
       (b) Reporting Requirements.--Section 736B (21 U.S.C. 379h-
     2) is repealed January 31, 2018.
       (c) Previous Sunset Provision.--
       (1) In general.--Section 106 of the Prescription Drug User 
     Fee Amendments of 2007 (Title I of Public Law 110-85) is 
     repealed.
       (2) Conforming amendment.--The Food and Drug Administration 
     Amendments Act of 2007 (Public Law 110-85) is amended in the 
     table of contents in section 2, by striking the item relating 
     to section 106.
       (d) Technical Clarifications.--
       (1) Effective September 30, 2007--
       (A) section 509 of the Prescription Drug User Fee 
     Amendments Act of 2002 (Title V of Public Law 107-188) is 
     repealed; and
       (B) the Public Health Security and Bioterrorism 
     Preparedness and Response Act of 2002 (Public Law 107-188) is 
     amended in the table of contents in section 1(b), by striking 
     the item relating to section 509.
       (2) Effective September 30, 2002--
       (A) section 107 of the Food and Drug Administration 
     Modernization Act of 1997 (Public Law 105-115) is repealed; 
     and
       (B) the table of contents in section 1(c) of such Act is 
     amended by striking the item related to section 107.
       (3) Effective September 30, 1997, section 105 of the 
     Prescription Drug User Fee Act of 1992 (Public Law 102-571) 
     is repealed.

     SEC. 106. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, 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, 2012, regardless 
     of the date of the enactment of this Act.

     SEC. 107. SAVINGS CLAUSE.

       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, 2007, but before October 1, 2012, 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 2012.

          TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2012

     SEC. 201. SHORT TITLE; FINDINGS.

       (a) Short Title.--This Act may be cited as the ``Medical 
     Device User Fee Amendments of 2012''.
       (b) Findings.--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

[[Page 7910]]

     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.

     SEC. 202. DEFINITIONS.

       Section 737 (21 U.S.C. 379i) is amended--
       (1) in paragraph (9), by striking ``incurred'' after 
     ``expenses'';
       (2) in paragraph (10), by striking ``October 2001'' and 
     inserting ``October 2011''; and
       (3) in paragraph (13), by striking ``is required to 
     register'' and all that follows through the end of paragraph 
     (13) and inserting the following: ``is registered (or is 
     required to register) with the Secretary under section 510 
     because such establishment is engaged in the manufacture, 
     preparation, propagation, compounding, or processing of a 
     device.''.

     SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.

       (a) Types of Fees.--Section 738(a) (21 U.S.C. 379j(a)) is 
     amended--
       (1) in paragraph (1), by striking ``fiscal year 2008'' and 
     inserting ``fiscal year 2013'';
       (2) in paragraph (2)(A)--
       (A) in the matter preceding clause (i)--
       (i) by striking ``subsections (d) and (e)'' and inserting 
     ``subsections (d), (e), and (f)'';
       (ii) by striking ``October 1, 2002'' and inserting 
     ``October 1, 2012''; and
       (iii) by striking ``subsection (c)(1)'' and inserting 
     ``subsection (c)''; and
       (B) in clause (viii), by striking ``1.84'' and inserting 
     ``2''; and
       (3) in paragraph (3)--
       (A) in subparagraph (A), by inserting ``and subsection 
     (f)'' after ``subparagraph (B)''; and
       (B) in subparagraph (C), by striking ``initial 
     registration'' and all that follows through ``section 510.'' 
     and inserting ``later of--
       ``(i) the initial or annual registration (as applicable) of 
     the establishment under section 510; or
       ``(ii) the first business day after the date of enactment 
     of an appropriations Act providing for the collection and 
     obligation of fees for such year under this section.''.
       (b) Fee Amounts.--Section 738(b) (21 U.S.C. 379j(b)) is 
     amended to read as follows:
       ``(b) Fee Amounts.--
       ``(1) In general.--Subject to subsections (c), (d), (e), 
     (f), and (i), for each of fiscal years 2013 through 2017, 
     fees under subsection (a) shall be derived from the base fee 
     amounts specified in paragraph (2), to generate the total 
     revenue amounts specified in paragraph (3).
       ``(2) Base fee amounts specified.--For purposes of 
     paragraph (1), the base fee amounts specified in this 
     paragraph are as follows:

----------------------------------------------------------------------------------------------------------------
                                                 Fiscal Year  Fiscal Year  Fiscal Year  Fiscal Year  Fiscal Year
                   ``Fee Type                        2013         2014         2015         2016         2017
----------------------------------------------------------------------------------------------------------------
Premarket Application..........................     $248,000     $252,960     $258,019     $263,180     $268,443
Establishment Registration.....................       $2,575       $3,200       $3,750       $3,872       $3,872
----------------------------------------------------------------------------------------------------------------

       ``(3) Total revenue amounts.--For purposes of paragraph 
     (1), the total revenue amounts specified in this paragraph 
     are as follows:
       ``(A) $97,722,301 for fiscal year 2013.
       ``(B) $112,580,497 for fiscal year 2014.
       ``(C) $125,767,107 for fiscal year 2015.
       ``(D) $129,339,949 for fiscal year 2016.
       ``(E) $130,184,348 for fiscal year 2017.''.
       (c) Annual Fee Setting; Adjustments.--Section 738(c) (21 
     U.S.C. 379j(c)) is amended--
       (1) in the subsection heading, by inserting ``; 
     Adjustments'' after ``Setting'';
       (2) by striking paragraphs (1) and (2);
       (3) by redesignating paragraphs (3) and (4) as paragraphs 
     (4) and (5), respectively; and
       (4) by inserting before paragraph (4), as so redesignated, 
     the following:
       ``(1) In general.--The Secretary shall, 60 days before the 
     start of each fiscal year after September 30, 2012, establish 
     fees under subsection (a), based on amounts specified under 
     subsection (b) and the adjustments provided under this 
     subsection, and publish such fees, and the rationale for any 
     adjustments to such fees, in the Federal Register.
       ``(2) Inflation adjustments.--
       ``(A) Adjustment to total revenue amounts.--For fiscal year 
     2014 and each subsequent fiscal year, the Secretary shall 
     adjust the total revenue amount specified in subsection 
     (b)(3) for such fiscal year by multiplying such amount by the 
     applicable inflation adjustment under subparagraph (B) for 
     such year.
       ``(B) Applicable inflation adjustment to total revenue 
     amounts.--The applicable inflation adjustment for a fiscal 
     year is--
       ``(i) for fiscal year 2014, the base inflation adjustment 
     under subparagraph (C) for such fiscal year; and
       ``(ii) for fiscal year 2015 and each subsequent fiscal 
     year, the product of--

       ``(I) the base inflation adjustment under subparagraph (C) 
     for such fiscal year; and
       ``(II) the product of the base inflation adjustment under 
     subparagraph (C) for each of the fiscal years preceding such 
     fiscal year, beginning with fiscal year 2014.

       ``(C) Base inflation adjustment to total revenue amounts.--
       ``(i) In general.--Subject to further adjustment under 
     clause (ii), the base inflation adjustment for a fiscal year 
     is the sum of one plus--

       ``(I) the average annual percent 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 3 years of 
     the preceding 4 fiscal years, multiplied by 0.60; and
       ``(II) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by 0.40.

       ``(ii) Limitations.--For purposes of subparagraph (B), if 
     the base inflation adjustment for a fiscal year under clause 
     (i)--

       ``(I) is less than 1, such adjustment shall be considered 
     to be equal to 1; or
       ``(II) is greater than 1.04, such adjustment shall be 
     considered to be equal to 1.04.

       ``(D) Adjustment to base fee amounts.--For each of fiscal 
     years 2014 through 2017, the base fee amounts specified in 
     subsection (b)(2) shall be adjusted as needed, on a uniform 
     proportionate basis, to generate the total revenue amounts 
     under subsection (b)(3), as adjusted for inflation under 
     subparagraph (A).
       ``(3) Volume-based adjustments to establishment 
     registration base fees.--For each of fiscal years 2014 
     through 2017, after the base fee amounts specified in 
     subsection (b)(2) are adjusted under paragraph (2)(D), the 
     base establishment registration fee amounts specified in such 
     subsection shall be further adjusted, as the Secretary 
     estimates is necessary in order for total fee collections for 
     such fiscal year to generate the total revenue amounts, as 
     adjusted under paragraph (2).''.
       (d) Fee Waiver or Reduction.--Section 738 (21 U.S.C. 379j) 
     is amended by--
       (1) redesignating subsections (f) through (k) as 
     subsections (g) through (l), respectively; and
       (2) by inserting after subsection (e) the following new 
     subsection (f):
       ``(f) Fee Waiver or Reduction.--
       ``(1) In general.--The Secretary may, at the Secretary's 
     sole discretion, grant a waiver or reduction of fees under 
     subsection (a)(2) or (a)(3) if the Secretary finds that such 
     waiver or reduction is in the interest of public health.
       ``(2) Limitation.--The sum of all fee waivers or reductions 
     granted by the Secretary in any fiscal year under paragraph 
     (1) shall not exceed 2 percent of the total fee revenue 
     amounts established for such year under subsection (c).
       ``(3) Duration.--The authority provided by this subsection 
     terminates October 1, 2017.''.
       (e) Conditions.--Section 738(h)(1)(A) (21 U.S.C. 
     379j(h)(1)(A)), as redesignated by subsection (d)(1), is 
     amended by striking ``$205,720,000'' and inserting 
     ``$280,587,000''.
       (f) Crediting and Availability of Fees.--Section 738(i) (21 
     U.S.C. 379j(i)), as redesignated by subsection (d)(1), is 
     amended--
       (1) in paragraph (1), by striking ``Fees authorized'' and 
     inserting ``Subject to paragraph (2)(C), fees authorized'';
       (2) in paragraph (2)--
       (A) in subparagraph (A)--
       (i) in clause (i), by striking ``shall be retained'' and 
     inserting ``subject to subparagraph (C), shall be collected 
     and available''; and
       (ii) in clause (ii)--

       (I) by striking ``collected and'' after ``shall only be''; 
     and
       (II) by striking ``fiscal year 2002'' and inserting 
     ``fiscal year 2009''; and

       (B) by adding at the end, the following:
       ``(C) Provision for early year payments.--Payment of fees 
     authorized under this section for a fiscal year, prior to the 
     due date for such fees, may be accepted by the Secretary in 
     accordance with authority provided in advance in a prior year 
     appropriations Act.'';
       (3) in paragraph (3), by amending to read as follows:
       ``(3) Authorizations of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for

[[Page 7911]]

     fees under this section an amount equal to the total revenue 
     amount specified under subsection (b)(3) for the fiscal year, 
     as adjusted under subsection (c) and, for fiscal year 2017 
     only, as further adjusted under paragraph (4).''; and
       (4) in paragraph (4)--
       (A) by striking ``fiscal years 2008, 2009, and 2010'' and 
     inserting ``fiscal years 2013, 2014, and 2015'';
       (B) by striking ``fiscal year 2011'' and inserting ``fiscal 
     year 2016'';
       (C) by striking ``June 30, 2011'' and inserting ``June 30, 
     2016'';
       (D) by striking ``the amount of fees specified in aggregate 
     in'' and inserting ``the cumulative amount appropriated 
     pursuant to'';
       (E) by striking ``aggregate amount in'' before ``excess 
     shall be credited''; and
       (F) by striking ``fiscal year 2012'' and inserting ``fiscal 
     year 2017''.
       (g) Conforming Amendment.--Section 515(c)(4)(A) (21 U.S.C. 
     360e(c)(4)(A)) is amended by striking ``738(g)'' and 
     inserting ``738(h)''.

     SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.

       (a) Reauthorization.--Section 738A(b) (21 U.S.C. 379j-1(b)) 
     is amended--
       (1) in paragraph (1), by striking ``2012'' and inserting 
     ``2017''; and
       (2) in paragraph (5), by striking ``2012'' and inserting 
     ``2017''.
       (b) Performance Reports.--Section 738A(a) (21 U.S.C. 379j-
     1(a)) is amended--
       (1) by striking paragraph (1) and inserting the following:
       ``(1) Performance report.--
       ``(A) In general.--Beginning with fiscal year 2013, for 
     each fiscal year for 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 annual reports concerning the progress of the 
     Food and Drug Administration in achieving the goals 
     identified in the letters described in section 201(b) of the 
     Medical Device User Fee Amendments of 2012 during such fiscal 
     year and the future plans of the Food and Drug Administration 
     for meeting the goals.
       ``(B) Publication.--With regard to information to be 
     reported by the Food and Drug Administration to industry on a 
     quarterly and annual basis pursuant to the letters described 
     in section 201(b) of the Medical Device User Fee Amendments 
     Act of 2012, the Secretary shall make such information 
     publicly available on the Internet Website of the Food and 
     Drug Administration not later than 60 days after the end of 
     each quarter or 120 days after the end of each fiscal year, 
     respectively, to which such information applies. This 
     information shall include the status of the independent 
     assessment identified in the letters described in such 
     section 201(b).
       ``(C) Updates.--The Secretary shall include in each report 
     under subparagraph (A) 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.''; and
       (2) in paragraph (2), by striking ``2008 through 2012'' and 
     inserting ``2013 through 2017''.

     SEC. 205. SAVINGS CLAUSE.

       Notwithstanding the amendments made by this title, 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 title, shall 
     continue to be in effect with respect to the submissions 
     listed in section 738(a)(2)(A) of such Act (as defined in 
     such part as of such day) that on or after October 1, 2007, 
     but before October 1, 2012, 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 2013.

     SEC. 206. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, 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 submissions listed in 
     section 738(a)(2)(A) of such Act received on or after October 
     1, 2012, regardless of the date of the enactment of this Act.

     SEC. 207. SUNSET CLAUSE.

       (a) In General.--Sections 737 and 738 of the Federal Food, 
     Drug, and Cosmetic Act (21 U.S.C. 739i; 739j) shall cease to 
     be effective October 1, 2017. Section 738A (21 U.S.C. 739j-1) 
     of the Federal Food, Drug, and Cosmetic Act (regarding 
     reauthorization and reporting requirements) is repealed 
     January 31, 2018.
       (b) Previous Sunset Provision.--
       (1) In general.--Section 217 of the Medical Device User Fee 
     Amendments of 2007 (Title II of Public Law 110-85) is 
     repealed.
       (2) Conforming amendment.--The Food and Drug Administration 
     Amendments Act of 2007 (Public Law 110-85) is amended in the 
     table of contents in section 2, by striking the item relating 
     to section 217.
       (c) Technical Clarification.--Effective September 30, 
     2007--
       (1) section 107 of the Medical Device User Fee and 
     Modernization Act of 2002 (Public Law 107-250) is repealed; 
     and
       (2) the table of contents in section 1(b) of such Act is 
     amended by striking the item related to section 107.

     SEC. 208. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 
                   RELATED TO THE PROCESS FOR THE REVIEW OF DEVICE 
                   APPLICATIONS.

       Subchapter A of chapter VII (21 U.S.C. 371 et seq.) is 
     amended by inserting after section 713 the following new 
     section:

     ``SEC. 714. STREAMLINED HIRING AUTHORITY.

       ``(a) In General.--In addition to any other personnel 
     authorities under other provisions of law, the Secretary may, 
     without regard to the provisions of title 5, United States 
     Code, governing appointments in the competitive service, 
     appoint employees to positions in the Food and Drug 
     Administration to perform, administer, or support activities 
     described in subsection (b), if the Secretary determines that 
     such appointments are needed to achieve the objectives 
     specified in subsection (c).
       ``(b) Activities Described.--The activities described in 
     this subsection are activities under this Act related to the 
     process for the review of device applications (as defined in 
     section 737(8)).
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are with respect to the activities under 
     subsection (b)(1), the goals referred to in section 
     738A(a)(1).
       ``(d) Internal Controls.--The Secretary shall institute 
     appropriate internal controls for appointments under this 
     section.
       ``(e) Sunset.--The authority to appoint employees under 
     this section shall terminate on the date that is three years 
     after the date of enactment of this section.''.

               TITLE III--FEES RELATING TO GENERIC DRUGS

     SEC. 301. SHORT TITLE.

       (a) Short Title.--This title may be cited as the ``Generic 
     Drug User Fee Amendments of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     human generic drug activities, as set forth in the goals 
     identified for purposes of part 7 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. 302. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by adding at the end the following:

                ``PART 7--FEES RELATING TO GENERIC DRUGS

     ``SEC. 744A. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `abbreviated new drug application'--
       ``(A) means an application submitted under section 505(j), 
     an abbreviated application submitted under section 507 (as in 
     effect on the day before the date of enactment of the Food 
     and Drug Administration Modernization Act of 1997), or an 
     abbreviated new drug application submitted pursuant to 
     regulations in effect prior to the implementation of the Drug 
     Price Competition and Patent Term Restoration Act of 1984; 
     and
       ``(B) does not include an application for a positron 
     emission tomography drug.
       ``(2) The term `active pharmaceutical ingredient' means--
       ``(A) a substance, or a mixture when the substance is 
     unstable or cannot be transported on its own, intended--
       ``(i) to be used as a component of a drug; and
       ``(ii) to furnish pharmacological activity or other direct 
     effect in the diagnosis, cure, mitigation, treatment, or 
     prevention of disease, or to affect the structure or any 
     function of the human body; or
       ``(B) a substance intended for final crystallization, 
     purification, or salt formation, or any combination of those 
     activities, to become a substance or mixture described in 
     subparagraph (A).
       ``(3) The term `adjustment factor' means a factor 
     applicable to a fiscal year that is the Consumer Price Index 
     for all urban consumers (all items; United States city 
     average) for October of the preceding fiscal year divided by 
     such Index for October 2011.
       ``(4) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(5)(A) The term `facility'--
       ``(i) means a business or other entity--
       ``(I) under one management, either direct or indirect; and
       ``(II) at one geographic location or address engaged in 
     manufacturing or processing an active pharmaceutical 
     ingredient or a finished dosage form; and

[[Page 7912]]

       ``(ii) does not include a business or other entity whose 
     only manufacturing or processing activities are one or more 
     of the following: repackaging, relabeling, or testing.
       ``(B) For purposes of subparagraph (A), separate buildings 
     within close proximity are considered to be at one geographic 
     location or address if the activities in them are--
       ``(i) closely related to the same business enterprise;
       ``(ii) under the supervision of the same local management; 
     and
       ``(iii) capable of being inspected by the Food and Drug 
     Administration during a single inspection.
       ``(C) If a business or other entity would meet the 
     definition of a facility under this paragraph but for being 
     under multiple management, the business or other entity is 
     deemed to constitute multiple facilities, one per management 
     entity, for purposes of this paragraph.
       ``(6) The term `finished dosage form' means--
       ``(A) a drug product in the form in which it will be 
     administered to a patient, such as a tablet, capsule, 
     solution, or topical application;
       ``(B) a drug product in a form in which reconstitution is 
     necessary prior to administration to a patient, such as oral 
     suspensions or lyophilized powders; or
       ``(C) any combination of an active pharmaceutical 
     ingredient with another component of a drug product for 
     purposes of production of a drug product described in 
     subparagraph (A) or (B).
       ``(7) The term `generic drug submission' means an 
     abbreviated new drug application, an amendment to an 
     abbreviated new drug application, or a prior approval 
     supplement to an abbreviated new drug application.
       ``(8) The term `human generic drug activities' means the 
     following activities of the Secretary associated with generic 
     drugs and inspection of facilities associated with generic 
     drugs:
       ``(A) The activities necessary for the review of generic 
     drug submissions, including review of drug master files 
     referenced in such submissions.
       ``(B) The issuance of--
       ``(i) approval letters which approve abbreviated new drug 
     applications or supplements to such applications; or
       ``(ii) complete response letters which set forth in detail 
     the specific deficiencies in such applications and, where 
     appropriate, the actions necessary to place such applications 
     in condition for approval.
       ``(C) The issuance of letters related to Type II active 
     pharmaceutical drug master files which--
       ``(i) set forth in detail the specific deficiencies in such 
     submissions, and where appropriate, the actions necessary to 
     resolve those deficiencies; or
       ``(ii) document that no deficiencies need to be addressed.
       ``(D) Inspections related to generic drugs.
       ``(E) Monitoring of research conducted in connection with 
     the review of generic drug submissions and drug master files.
       ``(F) Postmarket safety activities with respect to drugs 
     approved under abbreviated new drug applications or 
     supplements, including the following activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on approved drugs, including adverse event 
     reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies) insofar as those activities relate to 
     abbreviated new drug applications.
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(G) Regulatory science activities related to generic 
     drugs.
       ``(9) 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.
       ``(10) The term `prior approval supplement' means a request 
     to the Secretary to approve a change in the drug substance, 
     drug product, production process, quality controls, 
     equipment, or facilities covered by an approved abbreviated 
     new drug application when that change has a substantial 
     potential to have an adverse effect on the identity, 
     strength, quality, purity, or potency of the drug product as 
     these factors may relate to the safety or effectiveness of 
     the drug product.
       ``(11) The term `resources allocated for human generic drug 
     activities' means the expenses 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 and employees 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; and
       ``(D) collecting fees under subsection (a) and accounting 
     for resources allocated for the review of abbreviated new 
     drug applications and supplements and inspection related to 
     generic drugs.
       ``(12) The term `Type II active pharmaceutical ingredient 
     drug master file' means a submission of information to the 
     Secretary by a person that intends to authorize the Food and 
     Drug Administration to reference the information to support 
     approval of a generic drug submission without the submitter 
     having to disclose the information to the generic drug 
     submission applicant.

     ``SEC. 744B. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG 
                   FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) One-time backlog fee for abbreviated new drug 
     applications pending on october 1, 2012.--
       ``(A) In general.--Each person that owns an abbreviated new 
     drug application that is pending on October 1, 2012, and that 
     has not received a tentative approval prior to that date, 
     shall be subject to a fee for each such application, as 
     calculated under subparagraph (B).
       ``(B) Method of fee amount calculation.--The amount of each 
     one-time backlog fee shall be calculated by dividing 
     $50,000,000 by the total number of abbreviated new drug 
     applications pending on October 1, 2012, that have not 
     received a tentative approval as of that date.
       ``(C) Notice.--Not later than October 31, 2012, the 
     Secretary shall cause to be published in the Federal Register 
     a notice announcing the amount of the fee required by 
     subparagraph (A).
       ``(D) Fee due date.--The fee required by subparagraph (A) 
     shall be due no later than 30 calendar days after the date of 
     the publication of the notice specified in subparagraph (C).
       ``(2) Drug master file fee.--
       ``(A) In general.--Each person that owns a Type II active 
     pharmaceutical ingredient drug master file that is referenced 
     on or after October 1, 2012, in a generic drug submission by 
     any initial letter of authorization shall be subject to a 
     drug master file fee.
       ``(B) One-time payment.--If a person has paid a drug master 
     file fee for a Type II active pharmaceutical ingredient drug 
     master file, the person shall not be required to pay a 
     subsequent drug master file fee when that Type II active 
     pharmaceutical ingredient drug master file is subsequently 
     referenced in generic drug submissions.
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall cause to be published in the Federal 
     Register a notice announcing the amount of the drug master 
     file fee for fiscal year 2013.
       ``(ii) Fiscal year 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall cause to be published in the 
     Federal Register the amount of the drug master file fee 
     established by this paragraph for such fiscal year.
       ``(D) Availability for reference.--
       ``(i) In general.--Subject to subsection (g)(2)(C), for a 
     generic drug submission to reference a Type II active 
     pharmaceutical ingredient drug master file, the drug master 
     file must be deemed available for reference by the Secretary.
       ``(ii) Conditions.--A drug master file shall be deemed 
     available for reference by the Secretary if--

       ``(I) the person that owns a Type II active pharmaceutical 
     ingredient drug master file has paid the fee required under 
     subparagraph (A) within 20 calendar days after the applicable 
     due date under subparagraph (E); and
       ``(II) the drug master file has not failed an initial 
     completeness assessment by the Secretary, in accordance with 
     criteria to be published by the Secretary.

       ``(iii) List.--The Secretary shall make publicly available 
     on the Internet Web site of the Food and Drug Administration 
     a list of the drug master file numbers that correspond to 
     drug master files that have successfully undergone an initial 
     completeness assessment, in accordance with criteria to be 
     published by the Secretary, and are available for reference.
       ``(E) Fee due date.--
       ``(i) In general.--Subject to clause (ii), a drug master 
     file fee shall be due no later than the date on which the 
     first generic drug submission is submitted that references 
     the associated Type II active pharmaceutical ingredient drug 
     master file.
       ``(ii) Limitation.--No fee shall be due under subparagraph 
     (A) for a fiscal year until the later of--

       ``(I) 30 calendar days after publication of the notice 
     provided for in clause (i) or (ii) of subparagraph (C), as 
     applicable; or
       ``(II) 30 calendar days after the date of enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section.

[[Page 7913]]

       ``(3) Abbreviated new drug application and prior approval 
     supplement filing fee.--
       ``(A) In general.--Each applicant that submits, on or after 
     October 1, 2012, an abbreviated new drug application or a 
     prior approval supplement to an abbreviated new drug 
     application shall be subject to a fee for each such 
     submission in the amount established under subsection (d).
       ``(B) Notice.--
       ``(i) Fiscal year 2013.--Not later than October 31, 2012, 
     the Secretary shall cause to be published in the Federal 
     Register a notice announcing the amount of the fees under 
     subparagraph (A) for fiscal year 2013.
       ``(ii) Fiscal years 2014 through 2017.--Not later than 60 
     days before the start of each of fiscal years 2014 through 
     2017, the Secretary shall cause to be published in the 
     Federal Register the amount of the fees under subparagraph 
     (A) for such fiscal year.
       ``(C) Fee due date.--
       ``(i) In general.--Except as provided in clause (ii), the 
     fees required by subparagraphs (A) and (F) shall be due no 
     later than the date of submission of the abbreviated new drug 
     application or prior approval supplement for which such fee 
     applies.
       ``(ii) Special rule for 2013.--For fiscal year 2013, such 
     fees shall be due on the later of--

       ``(I) the date on which the fee is due under clause (i);
       ``(II) 30 calendar days after publication of the notice 
     referred to in subparagraph (B)(i); or
       ``(III) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of submission of the application or prior 
     approval supplement for which the fees under subparagraphs 
     (A) and (F) apply, 30 calendar days after the date that such 
     an appropriations Act is enacted.

       ``(D) Refund of fee if abbreviated new drug application is 
     not considered to have been received.--The Secretary shall 
     refund 75 percent of the fee paid under subparagraph (A) for 
     any abbreviated new drug application or prior approval 
     supplement to an abbreviated new drug application that the 
     Secretary considers not to have been received within the 
     meaning of section 505(j)(5)(A) for a cause other than 
     failure to pay fees.
       ``(E) Fee for an application the secretary considers not to 
     have been received, or that has been withdrawn.--An 
     abbreviated new drug application or prior approval supplement 
     that was submitted on or after October 1, 2012, and that the 
     Secretary considers not to have been received, or that has 
     been withdrawn, shall, upon resubmission of the application 
     or a subsequent new submission following the applicant's 
     withdrawal of the application, be subject to a full fee under 
     subparagraph (A).
       ``(F) Additional fee for active pharmaceutical ingredient 
     information not included by reference to type ii active 
     pharmaceutical ingredient drug master file.--An applicant 
     that submits a generic drug submission on or after October 1, 
     2012, shall pay a fee, in the amount determined under 
     subsection (d)(3), in addition to the fee required under 
     subparagraph (A), if--
       ``(i) such submission contains information concerning the 
     manufacture of an active pharmaceutical ingredient at a 
     facility by means other than reference by a letter of 
     authorization to a Type II active pharmaceutical drug master 
     file; and
       ``(ii) a fee in the amount equal to the drug master file 
     fee established in paragraph (2) has not been previously paid 
     with respect to such information.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Facilities identified, or intended to be 
     identified, in at least one generic drug submission that is 
     pending or approved to produce a finished dosage form of a 
     human generic drug or an active pharmaceutical ingredient 
     contained in a human generic drug shall be subject to fees as 
     follows:
       ``(i) Generic drug facility.--Each person that owns a 
     facility which is identified or intended to be identified in 
     at least one generic drug submission that is pending or 
     approved to produce one or more finished dosage forms of a 
     human generic drug shall be assessed an annual fee for each 
     such facility.
       ``(ii) Active pharmaceutical ingredient facility.--Each 
     person that owns a facility which produces, or which is 
     pending review to produce, one or more active pharmaceutical 
     ingredients identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     or in a Type II active pharmaceutical ingredient drug master 
     file referenced in such a generic drug submission, shall be 
     assessed an annual fee for each such facility.
       ``(iii) Facilities producing both active pharmaceutical 
     ingredients and finished dosage forms.--Each person that owns 
     a facility identified, or intended to be identified, in at 
     least one generic drug submission that is pending or approved 
     to produce both one or more finished dosage forms subject to 
     clause (i) and one or more active pharmaceutical ingredients 
     subject to clause (ii) shall be subject to fees under both 
     such clauses for that facility.
       ``(B) Amount.--The amount of fees established under 
     subparagraph (A) shall be established under subsection (d).
       ``(C) Notice.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the 
     Secretary shall cause to be published in the Federal Register 
     a notice announcing the amount of the fees provided for in 
     subparagraph (A) within the timeframe specified in subsection 
     (d)(1)(B).
       ``(ii) Fiscal years 2014 through 2017.--Within the 
     timeframe specified in subsection (d)(2), the Secretary shall 
     cause to be published in the Federal Register the amount of 
     the fees under subparagraph (A) for such fiscal year.
       ``(D) Fee due date.--
       ``(i) Fiscal year 2013.--For fiscal year 2013, the fees 
     under subparagraph (A) shall be due on the later of--

       ``(I) not later than 45 days after the publication of the 
     notice under subparagraph (B); or
       ``(II) if an appropriations Act is not enacted providing 
     for the collection and obligation of fees under this section 
     by the date of the publication of such notice, 30 days after 
     the date that such an appropriations Act is enacted.

       ``(ii) Fiscal years 2014 through 2017.--For each of fiscal 
     years 2014 through 2017, the fees under subparagraph (A) for 
     such fiscal year shall be due on the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees under this section for such year.

       ``(5) Date of submission.--For purposes of this part, a 
     generic drug submission or Type II pharmaceutical master file 
     is deemed to be `submitted' to the Food and Drug 
     Administration--
       ``(A) if it is submitted via a Food and Drug Administration 
     electronic gateway, on the day when transmission to that 
     electronic gateway is completed, except that a submission or 
     master file that arrives on a weekend, Federal holiday, or 
     day when the Food and Drug Administration office that will 
     review that submission is not otherwise open for business 
     shall be deemed to be submitted on the next day when that 
     office is open for business; and
       ``(B) if it is submitted in physical media form, on the day 
     it arrives at the appropriate designated document room of the 
     Food and Drug Administration.
       ``(b) Fee Revenue Amounts.--
       ``(1) In general.--
       ``(A) Fiscal year 2013.--For fiscal year 2013, fees under 
     subsection (a) shall be established to generate a total 
     estimated revenue amount under such subsection of 
     $299,000,000. Of that amount--
       ``(i) $50,000,000 shall be generated by the one-time 
     backlog fee for generic drug applications pending on October 
     1, 2012, established in subsection (a)(1); and
       ``(ii) $249,000,000 shall be generated by the fees under 
     paragraphs (2) through (4) of subsection (a).
       ``(B) Fiscal years 2014 through 2017.--For each of the 
     fiscal years 2014 through 2017, fees under paragraphs (2) 
     through (4) of subsection (a) shall be established to 
     generate a total estimated revenue amount under such 
     subsection that is equal to $299,000,000, as adjusted 
     pursuant to subsection (c).
       ``(2) Types of fees.--In establishing fees under paragraph 
     (1) to generate the revenue amounts specified in paragraph 
     (1)(A)(ii) for fiscal year 2013 and paragraph (1)(B) for each 
     of fiscal years 2014 through 2017, such fees shall be derived 
     from the fees under paragraphs (2) through (4) of subsection 
     (a) as follows:
       ``(A) 6 percent shall be derived from fees under subsection 
     (a)(2) (relating to drug master files).
       ``(B) 24 percent shall be derived from fees under 
     subsection (a)(3) (relating to abbreviated new drug 
     applications and supplements). The amount of a fee for a 
     prior approval supplement shall be half the amount of the fee 
     for an abbreviated new drug application.
       ``(C) 56 percent shall be derived from fees under 
     subsection (a)(4)(A)(i) (relating to generic drug 
     facilities). The amount of the fee for a facility located 
     outside the United States and its territories and possessions 
     shall be not less than $15,000 and not more than $30,000 
     higher than the amount of the fee for a facility located in 
     the United States and its territories and possessions, as 
     determined by the Secretary on the basis of data concerning 
     the difference in cost between inspections of facilities 
     located in the United States, including its territories and 
     possessions, and those located outside of the United States 
     and its territories and possessions.
       ``(D) 14 percent shall be derived from fees under 
     subsection (a)(4)(A)(ii) (relating to active pharmaceutical 
     ingredient facilities). The amount of the fee for a facility 
     located outside the United States and its territories and 
     possessions shall be not less than $15,000 and not more than 
     $30,000 higher than the amount of the fee for a facility 
     located in the United States, including its territories and 
     possessions, as determined by the Secretary on the basis of 
     data concerning the difference in cost between inspections of 
     facilities located in the United States and its territories 
     and possessions and those located outside of the United 
     States and its territories and possessions.

[[Page 7914]]

       ``(c) Adjustments.--
       ``(1) Inflation adjustment.--For fiscal year 2014 and 
     subsequent fiscal years, the revenues established in 
     subsection (b) shall be adjusted by the Secretary by notice, 
     published in the Federal Register, for a fiscal year, by an 
     amount equal to the sum of--
       ``(A) one;
       ``(B) the average annual percent 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 3 years of 
     the preceding 4 fiscal years multiplied by the proportion of 
     personnel compensation and benefits costs to total costs of 
     human generic drug activities for the first 3 years of the 
     preceding 4 fiscal years; and
       ``(C) the average annual percent change that occurred in 
     the Consumer Price Index for urban consumers (Washington-
     Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; All items; 
     Annual Index) for the first 3 years of the preceding 4 years 
     of available data multiplied by the proportion of all costs 
     other than personnel compensation and benefits costs to total 
     costs of human generic drug activities for the first 3 years 
     of the preceding 4 fiscal years.

     The adjustment made each fiscal year under this subsection 
     shall be added on a compounded basis to the sum of all 
     adjustments made each fiscal year after fiscal year 2013 
     under this subsection.
       ``(2) Final year adjustment.--For fiscal year 2017, the 
     Secretary may, in addition to adjustments under paragraph 
     (1), 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 human generic drug activities for the 
     first 3 months of fiscal year 2018. Such fees may only be 
     used in fiscal year 2018. If such an adjustment is necessary, 
     the rationale for the amount of the increase shall be 
     contained in the annual notice establishing fee revenues and 
     fees for fiscal year 2017. If the Secretary has carryover 
     balances for such activities in excess of 3 months of such 
     operating reserves, the adjustment under this subparagraph 
     shall not be made.
       ``(d) Annual Fee Setting.--
       ``(1) Fiscal year 2013.--For fiscal year 2013--
       ``(A) the Secretary shall establish, by October 31, 2012, 
     the one-time generic drug backlog fee for generic drug 
     applications pending on October 1, 2012, the drug master file 
     fee, the abbreviated new drug application fee, and the prior 
     approval supplement fee under subsection (a), based on the 
     revenue amounts established under subsection (b); and
       ``(B) the Secretary shall establish, not later than 45 days 
     after the date to comply with the requirement for 
     identification of facilities in subsection (f)(2), the 
     generic drug facility fee and active pharmaceutical 
     ingredient facility fee under subsection (a) based on the 
     revenue amounts established under subsection (b).
       ``(2) Fiscal years 2014 through 2017.--Not more than 60 
     days before the first day of each of fiscal years 2014 
     through 2017, the Secretary shall establish the drug master 
     file fee, the abbreviated new drug application fee, the prior 
     approval supplement fee, the generic drug facility fee, and 
     the active pharmaceutical ingredient facility fee under 
     subsection (a) for such fiscal year, based on the revenue 
     amounts established under subsection (b) and the adjustments 
     provided under subsection (c).
       ``(3) Fee for active pharmaceutical ingredient information 
     not included by reference to type ii active pharmaceutical 
     ingredient drug master file.--In establishing the fees under 
     paragraphs (1) and (2), the amount of the fee under 
     subsection (a)(3)(F) shall be determined by multiplying--
       ``(A) the sum of--
       ``(i) the total number of such active pharmaceutical 
     ingredients in such submission; and
       ``(ii) for each such ingredient that is manufactured at 
     more than one such facility, the total number of such 
     additional facilities; and
       ``(B) the amount equal to the drug master file fee 
     established in subsection (a)(2) for such submission.
       ``(e) Limit.--The total amount of fees charged, as adjusted 
     under subsection (c), for a fiscal year may not exceed the 
     total costs for such fiscal year for the resources allocated 
     for human generic drug activities.
       ``(f) Identification of Facilities.--
       ``(1) Publication of notice; deadline for compliance.--Not 
     later than October 1, 2012, the Secretary shall cause to be 
     published in the Federal Register a notice requiring each 
     person that owns a facility described in subsection 
     (a)(4)(A), or a site or organization required to be 
     identified by paragraph (4), to submit to the Secretary 
     information on the identity of each such facility, site, or 
     organization. The notice required by this paragraph shall 
     specify the type of information to be submitted and the means 
     and format for submission of such information.
       ``(2) Required submission of facility identification.--Each 
     person that owns a facility described in subsection (a)(4)(A) 
     or a site or organization required to be identified by 
     paragraph (4) shall submit to the Secretary the information 
     required under this subsection each year. Such information 
     shall--
       ``(A) for fiscal year 2013, be submitted not later than 60 
     days after the publication of the notice under paragraph (1); 
     and
       ``(B) for each subsequent fiscal year, be submitted, 
     updated, or reconfirmed on or before June 1 of the previous 
     year.
       ``(3) Contents of notice.--At a minimum, the submission 
     required by paragraph (2) shall include for each such 
     facility--
       ``(A) identification of a facility identified or intended 
     to be identified in an approved or pending generic drug 
     submission;
       ``(B) whether the facility manufactures active 
     pharmaceutical ingredients or finished dosage forms, or both;
       ``(C) whether or not the facility is located within the 
     United States and its territories and possessions;
       ``(D) whether the facility manufactures positron emission 
     tomography drugs solely, or in addition to other drugs; and
       ``(E) whether the facility manufactures drugs that are not 
     generic drugs.
       ``(4) Certain sites and organizations.--
       ``(A) In general.--Any person that owns or operates a site 
     or organization described in subparagraph (B) shall submit to 
     the Secretary information concerning the ownership, name, and 
     address of the site or organization.
       ``(B) Sites and organizations.--A site or organization is 
     described in this subparagraph if it is identified in a 
     generic drug submission and is--
       ``(i) a site in which a bioanalytical study is conducted;
       ``(ii) a clinical research organization;
       ``(iii) a contract analytical testing site; or
       ``(iv) a contract repackager site.
       ``(C) Notice.--The Secretary may, by notice published in 
     the Federal Register, specify the means and format for 
     submission of the information under subparagraph (A) and may 
     specify, as necessary for purposes of this section, any 
     additional information to be submitted.
       ``(D) Inspection authority.--The Secretary's inspection 
     authority under section 704(a)(1) shall extend to all such 
     sites and organizations.
       ``(g) Effect of Failure To Pay Fees.--
       ``(1) Generic drug backlog fee.--Failure to pay the fee 
     under subsection (a)(1) shall result in the Secretary placing 
     the person that owns the abbreviated new drug application 
     subject to that fee on an arrears list, such that no new 
     abbreviated new drug applications or supplement submitted on 
     or after October 1, 2012, from that person, or any affiliate 
     of that person, will be received within the meaning of 
     section 505(j)(5)(A) until such outstanding fee is paid.
       ``(2) Drug master file fee.--
       ``(A) Failure to pay the fee under subsection (a)(2) within 
     20 calendar days after the applicable due date under 
     subparagraph (E) of such subsection (as described in 
     subsection (a)(2)(D)(ii)(I)) shall result in the Type II 
     active pharmaceutical ingredient drug master file not being 
     deemed available for reference.
       ``(B)(i) Any generic drug submission submitted on or after 
     October 1, 2012, that references, by a letter of 
     authorization, a Type II active pharmaceutical ingredient 
     drug master file that has not been deemed available for 
     reference shall not be received within the meaning of section 
     505(j)(5)(A) unless the condition specified in clause (ii) is 
     met.
       ``(ii) The condition specified in this clause is that the 
     fee established under subsection (a)(2) has been paid within 
     20 calendar days of the Secretary providing the notification 
     to the sponsor of the abbreviated new drug application or 
     supplement of the failure of the owner of the Type II active 
     pharmaceutical ingredient drug master file to pay the drug 
     master file fee as specified in subparagraph (C).
       ``(C)(i) If an abbreviated new drug application or 
     supplement to an abbreviated new drug application references 
     a Type II active pharmaceutical ingredient drug master file 
     for which a fee under subsection (a)(2)(A) has not been paid 
     by the applicable date under subsection (a)(2)(E), the 
     Secretary shall notify the sponsor of the abbreviated new 
     drug application or supplement of the failure of the owner of 
     the Type II active pharmaceutical ingredient drug master file 
     to pay the applicable fee.
       ``(ii) If such fee is not paid within 20 calendar days of 
     the Secretary providing the notification, the abbreviated new 
     drug application or supplement to an abbreviated new drug 
     application shall not be received within the meaning of 
     505(j)(5)(A).
       ``(3) Abbreviated new drug application fee and prior 
     approval supplement fee.--Failure to pay a fee under 
     subparagraph (A) or (F) of subsection (a)(3) within 20 
     calendar days of the applicable due date under subparagraph 
     (C) of such subsection shall result in the abbreviated new 
     drug application or the prior approval supplement to an 
     abbreviated new drug application not being received within 
     the meaning of section 505(j)(5)(A) until such outstanding 
     fee is paid.
       ``(4) Generic drug facility fee and active pharmaceutical 
     ingredient facility fee.--
       ``(A) In general.--Failure to pay the fee under subsection 
     (a)(4) within 20 calendar

[[Page 7915]]

     days of the due date as specified in subparagraph (D) of such 
     subsection shall result in the following:
       ``(i) The Secretary shall place the facility on a publicly 
     available arrears list, such that no new abbreviated new drug 
     application or supplement submitted on or after October 1, 
     2012, from the person that is responsible for paying such 
     fee, or any affiliate of that person, will be received within 
     the meaning of section 505(j)(5)(A).
       ``(ii) Any new generic drug submission submitted on or 
     after October 1, 2012, that references such a facility shall 
     not be received, within the meaning of section 505(j)(5)(A) 
     if the outstanding facility fee is not paid within 20 
     calendar days of the Secretary providing the notification to 
     the sponsor of the failure of the owner of the facility to 
     pay the facility fee under subsection (a)(4)(C).
       ``(iii) All drugs or active pharmaceutical ingredients 
     manufactured in such a facility or containing an ingredient 
     manufactured in such a facility shall be deemed misbranded 
     under section 502(aa).
       ``(B) Application of penalties.--The penalties under this 
     paragraph shall apply until the fee established by subsection 
     (a)(4) is paid or the facility is removed from all generic 
     drug submissions that refer to the facility.
       ``(C) Nonreceival for nonpayment.--
       ``(i) Notice.--If an abbreviated new drug application or 
     supplement to an abbreviated new drug application submitted 
     on or after October 1, 2012, references a facility for which 
     a facility fee has not been paid by the applicable date under 
     subsection (a)(4)(C), the Secretary shall notify the sponsor 
     of the generic drug submission of the failure of the owner of 
     the facility to pay the facility fee.
       ``(ii) Nonreceival.--If the facility fee is not paid within 
     20 calendar days of the Secretary providing the notification 
     under clause (i), the abbreviated new drug application or 
     supplement to an abbreviated new drug application shall not 
     be received within the meaning of section 505(j)(5)(A).
       ``(h) Limitations.--
       ``(1) In general.--Fees under subsection (a) shall be 
     refunded for a fiscal year beginning after fiscal year 2012, 
     unless appropriations for salaries and expenses of the Food 
     and Drug Administration for such fiscal year (excluding the 
     amount of fees appropriated for such fiscal year) are equal 
     to or greater than the amount of appropriations for the 
     salaries and expenses of the Food and Drug Administration for 
     the fiscal year 2009 (excluding the amount of fees 
     appropriated for such fiscal year) multiplied by the 
     adjustment factor (as defined in section 744A) applicable to 
     the fiscal year involved.
       ``(2) Authority.--If the Secretary does not assess fees 
     under subsection (a) during any portion of a fiscal year 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 Type II 
     active pharmaceutical ingredient drug master files, 
     abbreviated new drug applications and prior approval 
     supplements, and generic drug facilities and active 
     pharmaceutical ingredient facilities at any time in such 
     fiscal year notwithstanding the provisions of subsection (a) 
     relating to the date fees are to be paid.
       ``(i) 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, subject to paragraph (2). 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 human 
     generic drug activities.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--The fees authorized by this section--
       ``(i) subject to subparagraphs (C) and (D), shall be 
     collected and available 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 a fiscal year beginning after 
     fiscal year 2012 to defray the costs of human generic drug 
     activities (including such costs for an additional number of 
     full-time equivalent positions in the Department of Health 
     and Human Services to be engaged in such activities), only if 
     the Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $97,000,000 multiplied by the 
     adjustment factor defined in section 744A(3) applicable to 
     the fiscal year involved.
       ``(B) Compliance.--The Secretary shall be considered to 
     have met the requirements of subparagraph (A)(ii) in any 
     fiscal year if the costs funded by appropriations and 
     allocated for human generic activities are not more than 10 
     percent below the level specified in such subparagraph.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013 for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013, may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of the 
     fiscal years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total revenue amount determined under subsection (b) 
     for the fiscal year, as adjusted under subsection (c), if 
     applicable, or as otherwise affected under paragraph (2) of 
     this subsection.
       ``(j) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 calendar days after it is due, such 
     fee shall be treated as a claim of the United States 
     Government subject to subchapter II of chapter 37 of title 
     31, United States Code.
       ``(k) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employees, and advisory committees not engaged in human 
     generic drug activities, be reduced to offset the number of 
     officers, employees, and advisory committees so engaged.
       ``(l) Positron Emission Tomography Drugs.--
       ``(1) Exemption from fees.--Submission of an application 
     for a positron emission tomography drug or active 
     pharmaceutical ingredient for a positron emission tomography 
     drug shall not require the payment of any fee under this 
     section. Facilities that solely produce positron emission 
     tomography drugs shall not be required to pay a facility fee 
     as established in subsection (a)(4).
       ``(2) Identification requirement.--Facilities that produce 
     positron emission tomography drugs or active pharmaceutical 
     ingredients of such drugs are required to be identified 
     pursuant to subsection (f).
       ``(m) Disputes Concerning Fees.--To qualify for the return 
     of a fee claimed to have been paid in error under this 
     section, a person shall submit to the Secretary a written 
     request justifying such return within 180 calendar days after 
     such fee was paid.
       ``(n) Substantially Complete Applications.--An abbreviated 
     new drug application that is not considered to be received 
     within the meaning of section 505(j)(5)(A) because of failure 
     to pay an applicable fee under this provision within the time 
     period specified in subsection (g) shall be deemed not to 
     have been `substantially complete' on the date of its 
     submission within the meaning of section 
     505(j)(5)(B)(iv)(II)(cc). An abbreviated new drug application 
     that is not substantially complete on the date of its 
     submission solely because of failure to pay an applicable fee 
     under the preceding sentence shall be deemed substantially 
     complete and received within the meaning of section 
     505(j)(5)(A) as of the date such applicable fee is 
     received.''.

     SEC. 303. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 7 of subchapter C of chapter VII, as added by section 
     302 of this Act, is amended by inserting after section 744B 
     the following:

     ``SEC. 744C. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--
       ``(1) In general.--Beginning with fiscal year 2013, 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 301(b) of the Generic Drug User Fee Amendments of 
     2012 during such fiscal year and the future plans of the Food 
     and Drug Administration for meeting the goals.
       ``(2) Regulatory science accountability metrics.--The 
     report required by paragraph (1) shall describe the amounts 
     spent, data generated, and activities undertaken, including 
     any FDA Advisory Committee consideration, by the Secretary 
     for each of the local acting bioequivalence topics (Topics 1-
     3) in the Regulatory Science Plan described in the letters 
     described in section 301(b) of the Generic Drug User Fee 
     Amendments of 2012.
       ``(b) Fiscal Report.--Beginning with fiscal year 2013, 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.

[[Page 7916]]

       ``(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 human generic drug activities for 
     the first 5 fiscal years after fiscal year 2017, 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 generic drug industry.
       ``(2) Prior public input.--Prior to beginning negotiations 
     with the generic drug 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 generic drug 
     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 generic drug 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, 2017, 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 Internet 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 
     generic drug 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. 304. SUNSET DATES.

       (a) Authorization.--Sections 744A and 744B, as added by 
     section 302 of this Act, are repealed October 1, 2017.
       (b) Reporting Requirements.--Section 744C, as added by 
     section 303 of this Act, is repealed January 31, 2018.

     SEC. 305. EFFECTIVE DATE.

       The amendments made by this title shall take effect on 
     October 1, 2012, or the date of the enactment of this title, 
     whichever is later, except that fees under section 302 shall 
     be assessed for all human generic drug submissions and Type 
     II active pharmaceutical drug master files received on or 
     after October 1, 2012, regardless of the date of enactment of 
     this title.

     SEC. 306. AMENDMENT WITH RESPECT TO MISBRANDING.

       Section 502 (21 U.S.C. 352) is amended by adding at the end 
     the following:
       ``(aa) If it is a drug, or an active pharmaceutical 
     ingredient, and it was manufactured, prepared, propagated, 
     compounded, or processed in a facility for which fees have 
     not been paid as required by section 744A(a)(4) or for which 
     identifying information required by section 744B(f) has not 
     been submitted, or it contains an active pharmaceutical 
     ingredient that was manufactured, prepared, propagated, 
     compounded, or processed in such a facility.''.

     SEC. 307. STREAMLINED HIRING AUTHORITY TO SUPPORT ACTIVITIES 
                   RELATED TO HUMAN GENERIC DRUGS.

       Section 714, as added by section 208 of this Act, is 
     amended--
       (1) by amending subsection (b) to read as follows:
       ``(b) Activities Described.--The activities described in 
     this subsection are--
       ``(1) activities under this Act related to the process for 
     the review of device applications (as defined in section 
     737(8)); and
       ``(2) activities under this Act related to human generic 
     drug activities (as defined in section 744A).''; and
       (2) by amending subsection (c) to read as follows:
       ``(c) Objectives Specified.--The objectives specified in 
     this subsection are--
       ``(1) with respect to the activities under subsection 
     (b)(1), the goals referred to in section 738A(a)(1); and
       ``(2) with respect to the activities under subsection 
     (b)(2), the goals referred to in section 744C(a).''.

       TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     SEC. 401. SHORT TITLE; FINDING.

       (a) Short Title.--This title may be cited as the 
     ``Biosimilar User Fee Act of 2012''.
       (b) Finding.--The Congress finds that the fees authorized 
     by the amendments made in this title will be dedicated to 
     expediting the process for the review of biosimilar 
     biological product applications, including postmarket safety 
     activities, as set forth in the goals identified for purposes 
     of part 8 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. 402. FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS.

       Subchapter C of chapter VII (21 U.S.C. 379f et seq.) is 
     amended by inserting after part 7, as added by title III of 
     this Act, the following:

       ``PART 8--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

     ``SEC. 744G. DEFINITIONS.

       ``For purposes of this part:
       ``(1) The term `adjustment factor' applicable to a fiscal 
     year that is the Consumer Price Index for all urban consumers 
     (Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted; 
     All items) of the preceding fiscal year divided by such Index 
     for September 2011.
       ``(2) The term `affiliate' means a business entity that has 
     a relationship with a second business entity if, directly or 
     indirectly--
       ``(A) one business entity controls, or has the power to 
     control, the other business entity; or
       ``(B) a third party controls, or has power to control, both 
     of the business entities.
       ``(3) The term `biosimilar biological product' means a 
     product for which a biosimilar biological product application 
     has been approved.
       ``(4)(A) Subject to subparagraph (B), the term `biosimilar 
     biological product application' means an application for 
     licensure of a biological product under section 351(k) of the 
     Public Health Service Act.
       ``(B) Such term does not include--
       ``(i) a supplement to such an application;
       ``(ii) an application filed under section 351(k) of the 
     Public Health Service Act that cites as the reference product 
     a bovine blood product for topical application licensed 
     before September 1, 1992, or a large volume parenteral drug 
     product approved before such date;
       ``(iii) an application filed under section 351(k) of the 
     Public Health Service Act with respect to--
       ``(I) whole blood or a blood component for transfusion;
       ``(II) an allergenic extract product;
       ``(III) an in vitro diagnostic biological product; or
       ``(IV) a biological product for further manufacturing use 
     only; or
       ``(iv) an application for licensure under section 351(k) of 
     the Public Health Service Act that is submitted by a State or 
     Federal Government entity for a product that is not 
     distributed commercially.
       ``(5) The term `biosimilar biological product development 
     meeting' means any meeting, other than a biosimilar initial 
     advisory meeting, regarding the content of a development 
     program, including a proposed design for, or data from, a 
     study intended to support a biosimilar biological product 
     application.
       ``(6) The term `biosimilar biological product development 
     program' means the program under this part for expediting the 
     process for the review of submissions in connection with 
     biosimilar biological product development.
       ``(7)(A) The term `biosimilar biological product 
     establishment' means a foreign or domestic place of 
     business--
       ``(i) that is at one general physical location consisting 
     of one or more buildings, all of which are within five miles 
     of each other; and

[[Page 7917]]

       ``(ii) at which one or more biosimilar biological products 
     are manufactured in final dosage form.
       ``(B) For purposes of subparagraph (A)(ii), the term 
     `manufactured' does not include packaging.
       ``(8) The term `biosimilar initial advisory meeting'--
       ``(A) means a meeting, if requested, that is limited to--
       ``(i) a general discussion regarding whether licensure 
     under section 351(k) of the Public Health Service Act may be 
     feasible for a particular product; and
       ``(ii) if so, general advice on the expected content of the 
     development program; and
       ``(B) does not include any meeting that involves 
     substantive review of summary data or full study reports.
       ``(9) The term `costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications' means the expenses in connection with the 
     process for the review of biosimilar biological product 
     applications 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; and
       ``(D) collecting fees under section 744H and accounting for 
     resources allocated for the review of submissions in 
     connection with biosimilar biological product development, 
     biosimilar biological product applications, and supplements.
       ``(10) The term `final dosage form' means, with respect to 
     a biosimilar biological product, a finished dosage form which 
     is approved for administration to a patient without 
     substantial further manufacturing (such as lyophilized 
     products before reconstitution).
       ``(11) The term `financial hold'--
       ``(A) means an order issued by the Secretary to prohibit 
     the sponsor of a clinical investigation from continuing the 
     investigation if the Secretary determines that the 
     investigation is intended to support a biosimilar biological 
     product application and the sponsor has failed to pay any fee 
     for the product required under subparagraph (A), (B), or (D) 
     of section 744H(a)(1); and
       ``(B) does not mean that any of the bases for a `clinical 
     hold' under section 505(i)(3) have been determined by the 
     Secretary to exist concerning the investigation.
       ``(12) The term `person' includes an affiliate of such 
     person.
       ``(13) The term `process for the review of biosimilar 
     biological product applications' means the following 
     activities of the Secretary with respect to the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements:
       ``(A) The activities necessary for the review of 
     submissions in connection with biosimilar biological product 
     development, biosimilar biological product applications, and 
     supplements.
       ``(B) Actions related to submissions in connection with 
     biosimilar biological product development, the issuance of 
     action letters which approve biosimilar biological product 
     applications or which set forth in detail the specific 
     deficiencies in such applications, and where appropriate, the 
     actions necessary to place such applications in condition for 
     approval.
       ``(C) The inspection of biosimilar biological product 
     establishments and other facilities undertaken as part of the 
     Secretary's review of pending biosimilar biological product 
     applications and supplements.
       ``(D) Activities necessary for the release of lots of 
     biosimilar biological products under section 351(k) of the 
     Public Health Service Act.
       ``(E) Monitoring of research conducted in connection with 
     the review of biosimilar biological product applications.
       ``(F) Postmarket safety activities with respect to 
     biologics approved under biosimilar biological product 
     applications or supplements, including the following 
     activities:
       ``(i) Collecting, developing, and reviewing safety 
     information on biosimilar biological products, including 
     adverse-event reports.
       ``(ii) Developing and using improved adverse-event data-
     collection systems, including information technology systems.
       ``(iii) Developing and using improved analytical tools to 
     assess potential safety problems, including access to 
     external data bases.
       ``(iv) Implementing and enforcing section 505(o) (relating 
     to postapproval studies and clinical trials and labeling 
     changes) and section 505(p) (relating to risk evaluation and 
     mitigation strategies).
       ``(v) Carrying out section 505(k)(5) (relating to adverse-
     event reports and postmarket safety activities).
       ``(14) The term `supplement' means a request to the 
     Secretary to approve a change in a biosimilar biological 
     product application which has been approved, including a 
     supplement requesting that the Secretary determine that the 
     biosimilar biological product meets the standards for 
     interchangeability described in section 351(k)(4) of the 
     Public Health Service Act.

     ``SEC. 744H. AUTHORITY TO ASSESS AND USE BIOSIMILAR 
                   BIOLOGICAL PRODUCT FEES.

       ``(a) Types of Fees.--Beginning in fiscal year 2013, the 
     Secretary shall assess and collect fees in accordance with 
     this section as follows:
       ``(1) Biosimilar development program fees.--
       ``(A) Initial biosimilar biological product development 
     fee.--
       ``(i) In general.--Each person that submits to the 
     Secretary a meeting request described under clause (ii) or a 
     clinical protocol for an investigational new drug protocol 
     described under clause (iii) shall pay for the product named 
     in the meeting request or the investigational new drug 
     application the initial biosimilar biological product 
     development fee established under subsection (b)(1)(A).
       ``(ii) Meeting request.--The meeting request defined in 
     this clause is a request for a biosimilar biological product 
     development meeting for a product.
       ``(iii) Clinical protocol for ind.--A clinical protocol for 
     an investigational new drug protocol described in this clause 
     is a clinical protocol consistent with the provisions of 
     section 505(i), including any regulations promulgated under 
     section 505(i), (referred to in this section as 
     `investigational new drug application') describing an 
     investigation that the Secretary determines is intended to 
     support a biosimilar biological product application for a 
     product.
       ``(iv) Due date.--The initial biosimilar biological product 
     development fee shall be due by the earlier of the following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.
       ``(II) The date of submission of an investigational new 
     drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application.

       ``(v) Transition rule.--Each person that has submitted an 
     investigational new drug application prior to the date of 
     enactment of the Biosimilars User Fee Act of 2012 shall pay 
     the initial biosimilar biological product development fee by 
     the earlier of the following:

       ``(I) Not later than 60 days after the date of the 
     enactment of the Biosimilars User Fee Act of 2012, if the 
     Secretary determines that the investigational new drug 
     application describes an investigation that is intended to 
     support a biosimilar biological product application.
       ``(II) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting.

       ``(B) Annual biosimilar biological product development 
     fee.--
       ``(i) In general.--A person that pays an initial biosimilar 
     biological product development fee for a product shall pay 
     for such product, beginning in the fiscal year following the 
     fiscal year in which the initial biosimilar biological 
     product development fee was paid, an annual fee established 
     under subsection (b)(1)(B) for biosimilar biological product 
     development (referred to in this section as `annual 
     biosimilar biological product development fee').
       ``(ii) Due date.--The annual biosimilar biological product 
     development program fee for each fiscal year will be due on 
     the later of--

       ``(I) the first business day on or after October 1 of each 
     such year; or
       ``(II) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.

       ``(iii) Exception.--The annual biosimilar development 
     program fee for each fiscal year will be due on the date 
     specified in clause (ii), unless the person has--

       ``(I) submitted a marketing application for the biological 
     product that was accepted for filing; or
       ``(II) discontinued participation in the biosimilar 
     biological product development program for the product under 
     subparagraph (C).

       ``(C) Discontinuation of fee obligation.--A person may 
     discontinue participation in the biosimilar biological 
     product development program for a product effective October 1 
     of a fiscal year by, not later than August 1 of the preceding 
     fiscal year--
       ``(i) if no investigational new drug application concerning 
     the product has been submitted, submitting to the Secretary a 
     written declaration that the person has no present intention 
     of further developing the product as a biosimilar biological 
     product; or
       ``(ii) if an investigational new drug application 
     concerning the product has been submitted, by withdrawing the 
     investigational new drug application in accordance with part 
     312 of title 21, Code of Federal Regulations (or any 
     successor regulations).
       ``(D) Reactivation fee.--
       ``(i) In general.--A person that has discontinued 
     participation in the biosimilar biological product 
     development program for a

[[Page 7918]]

     product under subparagraph (C) shall pay a fee (referred to 
     in this section as `reactivation fee') by the earlier of the 
     following:

       ``(I) Not later than 5 days after the Secretary grants a 
     request for a biosimilar biological product development 
     meeting for the product (after the date on which such 
     participation was discontinued).
       ``(II) Upon the date of submission (after the date on which 
     such participation was discontinued) of an investigational 
     new drug application describing an investigation that the 
     Secretary determines is intended to support a biosimilar 
     biological product application for that product.

       ``(ii) Application of annual fee.--A person that pays a 
     reactivation fee for a product shall pay for such product, 
     beginning in the next fiscal year, the annual biosimilar 
     biological product development fee under subparagraph (B).
       ``(E) Effect of failure to pay biosimilar development 
     program fees.--
       ``(i) No biosimilar biological product development 
     meetings.--If a person has failed to pay an initial or annual 
     biosimilar biological product development fee as required 
     under subparagraph (A) or (B), or a reactivation fee as 
     required under subparagraph (D), the Secretary shall not 
     provide a biosimilar biological product development meeting 
     relating to the product for which fees are owed.
       ``(ii) No receipt of investigational new drug 
     applications.--Except in extraordinary circumstances, the 
     Secretary shall not consider an investigational new drug 
     application to have been received under section 505(i)(2) 
     if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee as required under subparagraph (D).

       ``(iii) Financial hold.--Notwithstanding section 505(i)(2), 
     except in extraordinary circumstances, the Secretary shall 
     prohibit the sponsor of a clinical investigation from 
     continuing the investigation if--

       ``(I) the Secretary determines that the investigation is 
     intended to support a biosimilar biological product 
     application; and
       ``(II) the sponsor has failed to pay an initial or annual 
     biosimilar biological product development fee for the product 
     as required under subparagraph (A) or (B), or a reactivation 
     fee for the product as required under subparagraph (D).

       ``(iv) No acceptance of biosimilar biological product 
     applications or supplements.--If a person has failed to pay 
     an initial or annual biosimilar biological product 
     development fee as required under subparagraph (A) or (B), or 
     a reactivation fee as required under subparagraph (D), any 
     biosimilar biological product application or supplement 
     submitted by that person shall be considered incomplete and 
     shall not be accepted for filing by the Secretary until all 
     such fees owed by such person have been paid.
       ``(F) Limits regarding biosimilar development program 
     fees.--
       ``(i) No refunds.--The Secretary shall not refund any 
     initial or annual biosimilar biological product development 
     fee paid under subparagraph (A) or (B), or any reactivation 
     fee paid under subparagraph (D).
       ``(ii) No waivers, exemptions, or reductions.--The 
     Secretary shall not grant a waiver, exemption, or reduction 
     of any initial or annual biosimilar biological product 
     development fee due or payable under subparagraph (A) or (B), 
     or any reactivation fee due or payable under subparagraph 
     (D).
       ``(2) Biosimilar biological product application and 
     supplement fee.--
       ``(A) In general.--Each person that submits, on or after 
     October 1, 2012, a biosimilar biological product application 
     or a supplement shall be subject to the following fees:
       ``(i) A fee for a biosimilar biological product application 
     that is equal to--

       ``(I) the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application for 
     which clinical data (other than comparative bioavailability 
     studies) with respect to safety or effectiveness are required 
     for approval; minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for the 
     product that is the subject of the application.

       ``(ii) A fee for a biosimilar biological product 
     application for which clinical data (other than comparative 
     bioavailability studies) with respect to safety or 
     effectiveness are not required, that is equal to--

       ``(I) half of the amount of the fee established under 
     subsection (b)(1)(D) for a biosimilar biological product 
     application; minus
       ``(II) the cumulative amount of fees paid, if any, under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.

       ``(iii) A fee for a supplement for which clinical data 
     (other than comparative bioavailability studies) with respect 
     to safety or effectiveness are required, that is equal to 
     half of the amount of the fee established under subsection 
     (b)(1)(D) for a biosimilar biological product application.
       ``(B) Reduction in fees.--Notwithstanding section 404 of 
     the Biosimilars User Fee Act of 2012, any person who pays a 
     fee under subparagraph (A), (B), or (D) of paragraph (1) for 
     a product before October 1, 2017, but submits a biosimilar 
     biological product application for that product after such 
     date, shall be entitled to the reduction of any biosimilar 
     biological product application fees that may be assessed at 
     the time when such biosimilar biological product application 
     is submitted, by the cumulative amount of fees paid under 
     subparagraphs (A), (B), and (D) of paragraph (1) for that 
     product.
       ``(C) Payment due date.--Any fee required by subparagraph 
     (A) shall be due upon submission of the application or 
     supplement for which such fee applies.
       ``(D) Exception for previously filed application or 
     supplement.--If a biosimilar biological product application 
     or supplement was submitted by a person that paid the fee for 
     such application or supplement, was accepted for filing, and 
     was not approved or was withdrawn (without a waiver), the 
     submission of a biosimilar biological product application or 
     a supplement for the same product by the same person (or the 
     person's licensee, assignee, or successor) shall not be 
     subject to a fee under subparagraph (A).
       ``(E) Refund of application fee if application refused for 
     filing or withdrawn before filing.--The Secretary shall 
     refund 75 percent of the fee paid under this paragraph for 
     any application or supplement which is refused for filing or 
     withdrawn without a waiver before filing.
       ``(F) Fees for applications previously refused for filing 
     or withdrawn before filing.--A biosimilar biological product 
     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 under subsection (c).
       ``(3) Biosimilar biological product establishment fee.--
       ``(A) In general.--Except as provided in subparagraph (E), 
     each person that is named as the applicant in a biosimilar 
     biological product application shall be assessed an annual 
     fee established under subsection (b)(1)(E) for each 
     biosimilar biological product establishment that is listed in 
     the approved biosimilar biological product application as an 
     establishment that manufactures the biosimilar biological 
     product named in such application.
       ``(B) Assessment in fiscal years.--The establishment fee 
     shall be assessed in each fiscal year for which the 
     biosimilar biological product named in the application is 
     assessed a fee under paragraph (4) unless the biosimilar 
     biological product establishment listed in the application 
     does not engage in the manufacture of the biosimilar 
     biological product during such fiscal year.
       ``(C) Due date.--The establishment fee for a fiscal year 
     shall be due on the later of--
       ``(i) the first business day on or after October 1 of such 
     fiscal year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such fiscal year under this section.
       ``(D) Application to establishment.--
       ``(i) Each biosimilar biological product establishment 
     shall be assessed only one fee per biosimilar biological 
     product establishment, notwithstanding the number of 
     biosimilar biological products manufactured at the 
     establishment, subject to clause (ii).
       ``(ii) In the event an establishment is listed in a 
     biosimilar biological product application by more than one 
     applicant, the establishment fee for the fiscal year shall be 
     divided equally and assessed among the applicants whose 
     biosimilar biological products are manufactured by the 
     establishment during the fiscal year and assessed biosimilar 
     biological product fees under paragraph (4).
       ``(E) Exception for new products.--If, during the fiscal 
     year, an applicant initiates or causes to be initiated the 
     manufacture of a biosimilar biological product at an 
     establishment listed in its biosimilar biological product 
     application--
       ``(i) that did not manufacture the biosimilar biological 
     product in the previous fiscal year; and
       ``(ii) for which the full biosimilar biological product 
     establishment fee has been assessed in the fiscal year at a 
     time before manufacture of the biosimilar biological product 
     was begun,

     the applicant shall not be assessed a share of the biosimilar 
     biological product establishment fee for the fiscal year in 
     which the manufacture of the product began.
       ``(4) Biosimilar biological product fee.--
       ``(A) In general.--Each person who is named as the 
     applicant in a biosimilar biological product application 
     shall pay for each such biosimilar biological product the 
     annual fee established under subsection (b)(1)(F).
       ``(B) Due date.--The biosimilar biological product fee for 
     a fiscal year shall be due on the later of--
       ``(i) the first business day on or after October 1 of each 
     such year; or
       ``(ii) the first business day after the enactment of an 
     appropriations Act providing for the collection and 
     obligation of fees for such year under this section.

[[Page 7919]]

       ``(C) One fee per product per year.--The biosimilar 
     biological product fee shall be paid only once for each 
     product for each fiscal year.
       ``(b) Fee Setting and Amounts.--
       ``(1) In general.--Subject to paragraph (2), the Secretary 
     shall, 60 days before the start of each fiscal year that 
     begins after September 30, 2012, establish, for the next 
     fiscal year, the fees under subsection (a). Except as 
     provided in subsection (c), such fees shall be in the 
     following amounts:
       ``(A) Initial biosimilar biological product development 
     fee.--The initial biosimilar biological product development 
     fee under subsection (a)(1)(A) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(B) Annual biosimilar biological product development 
     fee.--The annual biosimilar biological product development 
     fee under subsection (a)(1)(B) for a fiscal year shall be 
     equal to 10 percent of the amount established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(C) Reactivation fee.--The reactivation fee under 
     subsection (a)(1)(D) for a fiscal year shall be equal to 20 
     percent of the amount of the fee established under section 
     736(c)(4) for a human drug application described in section 
     736(a)(1)(A)(i) for that fiscal year.
       ``(D) Biosimilar biological product application fee.--The 
     biosimilar biological product application fee under 
     subsection (a)(2) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a human drug 
     application described in section 736(a)(1)(A)(i) for that 
     fiscal year.
       ``(E) Biosimilar biological product establishment fee.--The 
     biosimilar biological product establishment fee under 
     subsection (a)(3) for a fiscal year shall be equal to the 
     amount established under section 736(c)(4) for a prescription 
     drug establishment for that fiscal year.
       ``(F) Biosimilar biological product fee.--The biosimilar 
     biological product fee under subsection (a)(4) for a fiscal 
     year shall be equal to the amount established under section 
     736(c)(4) for a prescription drug product for that fiscal 
     year.
       ``(2) Limit.--The total amount of fees charged for a fiscal 
     year under this section may not exceed the total amount for 
     such fiscal year of the costs of resources allocated for the 
     process for the review of biosimilar biological product 
     applications.
       ``(c) Application Fee Waiver for Small Business.--
       ``(1) Waiver of application fee.--The Secretary shall grant 
     to a person who is named in a biosimilar biological product 
     application a waiver from the application fee assessed to 
     that person under subsection (a)(2)(A) for the first 
     biosimilar biological product application that a small 
     business or its affiliate submits to the Secretary for 
     review. After a small business or its affiliate is granted 
     such a waiver, the small business or its affiliate shall 
     pay--
       ``(A) application fees for all subsequent biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business; and
       ``(B) all supplement fees for all supplements to biosimilar 
     biological product applications submitted to the Secretary 
     for review in the same manner as an entity that is not a 
     small business.
       ``(2) Considerations.--In determining whether to grant a 
     waiver 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.
       ``(3) Small business defined.--In this subsection, the term 
     `small business' means an entity that has fewer than 500 
     employees, including employees of affiliates, and does not 
     have a drug product that has been approved under a human drug 
     application (as defined in section 735) or a biosimilar 
     biological product application (as defined in section 
     744G(4)) and introduced or delivered for introduction into 
     interstate commerce.
       ``(d) Effect of Failure To Pay Fees.--A biosimilar 
     biological product application or supplement submitted by a 
     person subject to fees under subsection (a) shall be 
     considered incomplete and shall not be accepted for filing by 
     the Secretary until all fees owed by such person have been 
     paid.
       ``(e) Crediting and Availability of Fees.--
       ``(1) In general.--Subject to paragraph (2), 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 review of biosimilar biological product 
     applications.
       ``(2) Collections and appropriation acts.--
       ``(A) In general.--Subject to subparagraphs (C) and (D), 
     the fees authorized by this section shall be collected and 
     available 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.
       ``(B) Use of fees and limitation.--The fees authorized by 
     this section shall be available for a fiscal year beginning 
     after fiscal year 2012 to defray the costs of the process for 
     the review of biosimilar biological product applications 
     (including such costs for an additional number of full-time 
     equivalent positions in the Department of Health and Human 
     Services to be engaged in such process), only if the 
     Secretary allocates for such purpose an amount for such 
     fiscal year (excluding amounts from fees collected under this 
     section) no less than $20,000,000, multiplied by the 
     adjustment factor applicable to the fiscal year involved.
       ``(C) Fee collection during first program year.--Until the 
     date of enactment of an Act making appropriations through 
     September 30, 2013, for the salaries and expenses account of 
     the Food and Drug Administration, fees authorized by this 
     section for fiscal year 2013 may be collected and shall be 
     credited to such account and remain available until expended.
       ``(D) Provision for early payments in subsequent years.--
     Payment of fees authorized under this section for a fiscal 
     year (after fiscal year 2013), prior to the due date for such 
     fees, may be accepted by the Secretary in accordance with 
     authority provided in advance in a prior year appropriations 
     Act.
       ``(3) Authorization of appropriations.--For each of fiscal 
     years 2013 through 2017, there is authorized to be 
     appropriated for fees under this section an amount equivalent 
     to the total amount of fees assessed for such fiscal year 
     under this section.
       ``(f) Collection of Unpaid Fees.--In any case where the 
     Secretary does not receive payment of a fee assessed under 
     subsection (a) within 30 days after it is due, such fee shall 
     be treated as a claim of the United States Government subject 
     to subchapter II of chapter 37 of title 31, United States 
     Code.
       ``(g) Written Requests for Waivers and Refunds.--To qualify 
     for consideration for a waiver under subsection (c), or for a 
     refund of any fee collected in accordance with subsection 
     (a)(2)(A), a person shall submit to the Secretary a written 
     request for such waiver or refund not later than 180 days 
     after such fee is due.
       ``(h) Construction.--This section may not be construed to 
     require that the number of full-time equivalent positions in 
     the Department of Health and Human Services, for officers, 
     employers, and advisory committees not engaged in the process 
     of the review of biosimilar biological product applications, 
     be reduced to offset the number of officers, employees, and 
     advisory committees so engaged.''.

     SEC. 403. REAUTHORIZATION; REPORTING REQUIREMENTS.

       Part 8 of subchapter C of chapter VII, as added by section 
     402 of this Act, is further amended by inserting after 
     section 744H the following:

     ``SEC. 744I. REAUTHORIZATION; REPORTING REQUIREMENTS.

       ``(a) Performance Report.--Beginning with fiscal year 2013, 
     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 401(b) of the Biosimilar User Fee Act of 2012 during 
     such fiscal year and the future plans of the Food and Drug 
     Administration for meeting such 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 biosimilar biological product applications and 
     supplements in the cohort.
       ``(b) Fiscal Report.--Not later than 120 days after the end 
     of fiscal year 2013 and each subsequent 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) Study.--
       ``(1) In general.--The Secretary shall contract with an 
     independent accounting or consulting firm to study the 
     workload volume and full costs associated with the process 
     for the review of biosimilar biological product applications.
       ``(2) Interim results.--Not later than June 1, 2015, the 
     Secretary shall publish, for public comment, interim results 
     of the study described under paragraph (1).

[[Page 7920]]

       ``(3) Final results.--Not later than September 30, 2016, 
     the Secretary shall publish, for public comment, the final 
     results of the study described under paragraph (1).
       ``(e) Reauthorization.--
       ``(1) Consultation.--In developing recommendations to 
     present to the Congress with respect to the goals described 
     in subsection (a), and plans for meeting the goals, for the 
     process for the review of biosimilar biological product 
     applications for the first 5 fiscal years after fiscal year 
     2017, and for the reauthorization of this part for such 
     fiscal years, the Secretary shall consult with--
       ``(A) the Committee on Energy and Commerce of the House of 
     Representatives;
       ``(B) the Committee on Health, Education, Labor, and 
     Pensions of the Senate;
       ``(C) scientific and academic experts;
       ``(D) health care professionals;
       ``(E) representatives of patient and consumer advocacy 
     groups; and
       ``(F) the regulated industry.
       ``(2) Public review of recommendations.--After negotiations 
     with the regulated industry, the Secretary shall--
       ``(A) present the recommendations developed under paragraph 
     (1) to the congressional committees specified in such 
     paragraph;
       ``(B) publish such recommendations in the Federal Register;
       ``(C) provide for a period of 30 days for the public to 
     provide written comments on such recommendations;
       ``(D) hold a meeting at which the public may present its 
     views on such recommendations; and
       ``(E) after consideration of such public views and 
     comments, revise such recommendations as necessary.
       ``(3) Transmittal of recommendations.--Not later than 
     January 15, 2017, the Secretary shall transmit to the 
     Congress the revised recommendations under paragraph (2), a 
     summary of the views and comments received under such 
     paragraph, and any changes made to the recommendations in 
     response to such views and comments.''.

     SEC. 404. SUNSET DATES.

       (a) Authorization.--Sections 744G and 744H, as added by 
     section 402 of this Act, are repealed October 1, 2017.
       (b) Reporting Requirements.--Section 744I, as added by 
     section 403 of this Act, is repealed January 31, 2018.

     SEC. 405. EFFECTIVE DATE.

       (a) In General.--Except as provided under subsection (b), 
     the amendments made by this title shall take effect on the 
     later of--
       (1) October 1, 2012; or
       (2) the date of the enactment of this title.
       (b) Exception.--Fees under part 8 of subchapter C of 
     chapter VII of the Federal Food, Drug, and Cosmetic Act, as 
     added by this title, shall be assessed for all biosimilar 
     biological product applications received on or after October 
     1, 2012, regardless of the date of the enactment of this 
     title.

     SEC. 406. SAVINGS CLAUSE.

       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 were accepted by 
     the Food and Drug Administration for filing on or after 
     October 1, 2007, but before October 1, 2012, with respect to 
     assessing and collecting any fee required by such part for a 
     fiscal year prior to fiscal year 2013.

     SEC. 407. CONFORMING AMENDMENT.

       Section 735(1)(B) (21 U.S.C. 379g(1)(B)) is amended by 
     striking ``or (k)''.

 TITLE V--REAUTHORIZATION OF BEST PHARMACEUTICALS FOR CHILDREN ACT AND 
                     PEDIATRIC RESEARCH EQUITY ACT

     SEC. 501. PERMANENT EXTENSION OF BEST PHARMACEUTICALS FOR 
                   CHILDREN ACT AND PEDIATRIC RESEARCH EQUITY ACT.

       (a) Program for Pediatric Studies of Drugs.--Section 
     409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) 
     is amended--
       (1) in subsection (c)(1)--
       (A) in the matter preceding subparagraph (A), by inserting 
     ``or section 351(m) of this Act,'' after ``Cosmetic Act,'';
       (B) in subparagraph (A)(i), by inserting ``or section 
     351(k) of this Act'' after ``Cosmetic Act''; and
       (C) by amending subparagraph (B) to read as follows:
       ``(B)(i) there remains no patent listed pursuant to section 
     505(b)(1) of the Federal Food, Drug, and Cosmetic Act; and
       ``(ii) every three-year and five-year period referred to in 
     subsection (c)(3)(E)(ii), (c)(3)(E)(iii), (c)(3)(E(iv), 
     (j)(5)(F)(ii), (j)(5)(F)(iii), or (j)(5)(F)(iv) of section 
     505 of the Federal Food, Drug and Cosmetic Act, or applicable 
     twelve-year period referred to in section 351(k)(7) of this 
     Act, and any seven-year period referred to in section 527 of 
     the Federal Food, Drug, and Cosmetic Act, has ended for at 
     least one form of the drug; and'';
       (2) in subsection (c)(2)--
       (A) in the heading of paragraph (2), by striking ``for 
     drugs lacking exclusivity'';
       (B) by striking ``under section 505 of the Federal Food, 
     Drug, and Cosmetic Act''; and
       (C) by striking ``505A of such Act'' and inserting ``505A 
     of the Federal Food, Drug, and Cosmetic Act or section 351(m) 
     of this Act''; and
       (3) in subsection (e)(1), by striking ``to carry out this 
     section'' and all that follows through the end of paragraph 
     (1) and inserting ``$25,000,000 for each of fiscal years 2013 
     through 2017.''.
       (b) Pediatric Studies of Drugs in FFDCA.--Section 505A (21 
     U.S.C. 355a) is amended--
       (1) in subsection (d)(1)(A), by adding at the end the 
     following: ``If a request under this subparagraph does not 
     request studies in neonates, such request shall include a 
     statement describing the rationale for not requesting studies 
     in neonates.'';
       (2) by amending subsection (h) to read as follows:
       ``(h) Relationship to Pediatric Research Requirements.--
     Exclusivity under this section shall only be granted for the 
     completion of a study or studies that are the subject of a 
     written request and for which reports are submitted and 
     accepted in accordance with subsection (d)(3). Written 
     requests under this section may consist of a study or studies 
     required under section 505B.'';
       (3) in subsection (k)(2), by striking ``subsection 
     (f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
       (4) in subsection (l)--
       (A) in paragraph (1)--
       (i) in the paragraph heading, by striking ``year one'' and 
     inserting ``first 18-month period''; and
       (ii) by striking ``one-year'' and inserting ``18-month'';
       (B) in paragraph (2)--
       (i) in the paragraph heading, by striking ``years'' and 
     inserting ``periods''; and
       (ii) by striking ``one-year period'' and inserting ``18-
     month period'';
       (C) by redesignating paragraph (3) as paragraph (4); and
       (D) by inserting after paragraph (2) the following:
       ``(3) Preservation of authority.--Nothing in this 
     subsection shall prohibit the Office of Pediatric 
     Therapeutics from providing for the review of adverse event 
     reports by the Pediatric Advisory Committee prior to the 18-
     month period referred to in paragraph (1), if such review is 
     necessary to ensure safe use of a drug in a pediatric 
     population.'';
       (5) in subsection (n)--
       (A) in the subsection heading, by striking ``Completed'' 
     and inserting ``Submitted''; and
       (B) in paragraph (1)--
       (i) in the text preceding subparagraph (A), by striking 
     ``have not been completed'' and inserting ``have not been 
     submitted by the date specified in the written request issued 
     and agreed upon''; and
       (ii) by revising subparagraphs (A) and (B) to read as 
     follows:
       ``(A) For a drug for which there remains any listed patent 
     or exclusivity protection eligible for extension under 
     subsection (b)(1) or (c)(1) of this section, or any 
     exclusivity protection eligible for extension under 
     subsection (m)(2) or (m)(3) of section 351 of the Public 
     Health Service Act, the Secretary shall make a determination 
     regarding whether an assessment shall be required to be 
     submitted under section 505B(b).
       ``(B) For a drug that has no remaining listed patents or 
     exclusivity protection eligible for extension under 
     subsection (b)(1) or (c)(1) of this section, or any 
     exclusivity protection eligible for extension under 
     subsection (m)(2) or (m)(3) of section 351 of the Public 
     Health Service Act, 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.'';
       (6) in subsection (o)(2), by amending subparagraph (B) to 
     read as follows:
       ``(B) a statement of any appropriate pediatric 
     contraindications, warnings, precautions, or other 
     information that the Secretary considers necessary to assure 
     safe use.''; and
       (7) by striking subsection (q) (relating to a sunset).
       (c) Research Into Pediatric Uses for Drugs and Biological 
     Projects in FFDCA.--Section 505B (21 U.S.C. 355c) is 
     amended--
       (1) in subsection (a)--
       (A) in paragraph (1), in the matter before subparagraph 
     (A), by inserting ``for a drug'' after ``(or supplement to an 
     application)'';
       (B) in paragraph (3)--
       (i) by redesignating subparagraph (B) as subparagraph (D); 
     and
       (ii) by inserting after subparagraph (A) the following:
       ``(B) Deferral extension.--On the initiative of the 
     Secretary or at the request of the applicant, the Secretary 
     may grant an extension of a deferral under subparagraph (A) 
     if--
       ``(i) the Secretary finds that the criteria specified in 
     subclause (II) or (III) of subparagraph (A)(i) continue to be 
     met; and
       ``(ii) the applicant submits the materials required under 
     subparagraph (A)(ii).
       ``(C) Consideration during deferral period.--If the 
     Secretary has under this paragraph deferred the date by which 
     an assessment must be submitted, then until the date 
     specified in the deferral under subparagraph (A) (including 
     any extension of such date under subparagraph (B))--
       ``(i) the assessment shall not be considered late or 
     delayed; and

[[Page 7921]]

       ``(ii) the Secretary shall not classify the assessment as 
     late or delayed in any report, database, or public 
     posting.''; and
       (iii) in subparagraph (D), as redesignated, by amending 
     clause (ii) to read as follows:
       ``(ii) Public availability.--Not later than 60 days after 
     the submission to the Secretary of the information submitted 
     through the annual review under clause (i), the Secretary 
     shall make available to the public in an easily accessible 
     manner, including through the Web site of the Food and Drug 
     Administration--

       ``(I) such information;
       ``(II) the name of the applicant for the product subject to 
     the assessment;
       ``(III) the date on which the product was approved; and
       ``(IV) the date of each deferral or deferral extension 
     under this paragraph for the product.''; and

       (C) in paragraph (4)(C)--
       (i) in the first sentence, by inserting ``partial'' before 
     ``waiver is granted''; and
       (ii) in the second sentence, by striking ``either a full or 
     partial waiver'' and inserting ``a partial waiver'';
       (2) in subsection (b)(1), by striking ``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'' and inserting ``The 
     Secretary'';
       (3) by amending subsection (d) to read as follows:
       ``(d) Failure To Meet Requirements.--If a person fails to 
     submit a required assessment described in subsection (a)(2), 
     fails to meet the applicable requirements in subsection 
     (a)(3), or fails to submit 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)(A) the Secretary shall issue a letter to such person 
     informing such person of such failure;
       ``(B) not later than 30 calendar days after the issuance of 
     a letter under subparagraph (A), the person who receives such 
     letter shall submit to the Secretary a written response to 
     such letter; and
       ``(C) not later than 45 calendar days after the issuance of 
     a letter under subparagraph (A), the Secretary shall make 
     such letter, and any response to such letter under 
     subparagraph (B), available to the public on the Web site of 
     the Food and Drug Administration, with appropriate redactions 
     made to protect trade secrets and confidential commercial 
     information, except that, if the Secretary determines that 
     the letter under subparagraph (A) was issued in error, the 
     requirements of this subparagraph shall not apply with 
     respect to such letter; and
       ``(2)(A) the drug or biological product that is the subject 
     of the required assessment, applicable requirements in 
     subsection (a)(3), or required request for approval of a 
     pediatric formulation 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
       ``(B) the failure to submit the required assessment, meet 
     the applicable requirements in subsection (a)(3), or submit 
     the required request for approval of a pediatric formulation 
     shall not be the basis for a proceeding--
       ``(i) to withdraw approval for a drug under section 505(e); 
     or
       ``(ii) to revoke the license for a biological product under 
     section 351 of the Public Health Service Act.'';
       (4) by amending subsection (e) to read as follows:
       ``(e) Initial Pediatric Plan.--
       ``(1) In general.--
       ``(A) Submission.--An applicant who is required to submit 
     an assessment under subsection (a)(1) shall submit an initial 
     pediatric plan.
       ``(B) Timing.--An applicant shall submit the initial 
     pediatric plan under paragraph (1)--
       ``(i) before the date on which the applicant submits the 
     assessments under subsection (a)(2); and
       ``(ii) not later than--

       ``(I) 60 calendar days after the date of end-of-Phase 2 
     meeting (as such term is used in section 312.47 of title 21, 
     Code of Federal Regulations, or successor regulations); or
       ``(II) such other time as may be agreed upon between the 
     Secretary and the applicant.

     Nothing in this section shall preclude the Secretary from 
     accepting the submission of an initial pediatric plan earlier 
     than the date otherwise applicable under this subparagraph.
       ``(C) Contents.--The initial pediatric plan shall include--
       ``(i) an outline of the pediatric studies that the 
     applicant plans to conduct;
       ``(ii) any request for a deferral, partial waiver, or 
     waiver under this section, along with supporting information; 
     and
       ``(iii) other information the Secretary determines 
     necessary, including any information specified in regulations 
     under paragraph (5).
       ``(2) Meeting.--
       ``(A) In general.--Subject to subparagraph (B), not later 
     than 90 calendar days after receiving an initial pediatric 
     plan under paragraph (1), the Secretary shall meet with the 
     applicant to discuss the plan.
       ``(B) Written response.--If the Secretary determines that a 
     written response to the initial pediatric plan is sufficient 
     to communicate comments on the initial pediatric plan, and 
     that no meeting is necessary the Secretary shall, not later 
     than 90 days after receiving an initial pediatric plan under 
     paragraph (1)--
       ``(i) notify the applicant of such determination; and
       ``(ii) provide to the applicant the Secretary's written 
     comments on the plan.
       ``(3) Agreed initial pediatric plan.--
       ``(A) Submission.--The applicant shall submit to the 
     Secretary a document reflecting the agreement between the 
     Secretary and the applicant on the initial pediatric plan 
     (referred to in this subsection as an `agreed initial 
     pediatric plan').
       ``(B) Confirmation.--Not later than 30 days after receiving 
     the agreed initial pediatric plan under subparagraph (A), the 
     Secretary shall provide written confirmation to the applicant 
     that such plan reflects the agreement of the Secretary.
       ``(C) Deferral and waiver.--If the agreed initial pediatric 
     plan contains a request from the applicant for a deferral, 
     partial waiver, or waiver under this section, the written 
     confirmation under subparagraph (B) shall include a 
     recommendation from the Secretary as to whether such request 
     meets the standards under paragraphs (3) or (4) of subsection 
     (a).
       ``(D) Amendments to the plan.--At the initiative of the 
     Secretary or the applicant, the agreed initial pediatric plan 
     may be amended at any time. The requirements of paragraph (2) 
     shall apply to any such proposed amendment in the same manner 
     and to the same extent as such requirements apply to an 
     initial pediatric plan under paragraph (1). The requirements 
     of subparagraphs (A) through (C) of this paragraph shall 
     apply to any agreement resulting from such proposed amendment 
     in the same manner and to the same extent as such 
     requirements apply to an agreed initial pediatric plan.
       ``(4) Internal committee.--The Secretary shall consult the 
     internal committee under section 505C on the review of the 
     initial pediatric plan, greed initial pediatric plan, and any 
     amendments to such plans.
       ``(5) Mandatory rulemaking.--Not later than one year after 
     the date of enactment of the Food and Drug Administration 
     Reform Act of 2012, the Secretary shall promulgate proposed 
     regulations and guidance to implement the provisions of this 
     subsection.
       ``(6) Effective date.--The provisions of this subsection 
     shall take effect 180 calendar days after the date of 
     enactment of the Food and Drug Administration Reform Act of 
     2012, irrespective of whether the Secretary has promulgated 
     final regulations to carry out this subsection by such 
     date.'';
       (5) in subsection (f)--
       (A) in the subsection heading, by inserting ``Deferral 
     Extensions,'' after ``Deferrals,'';
       (B) in paragraph (4)--
       (i) in the paragraph heading, by inserting ``deferral 
     extensions,'' after ``deferrals,''; and
       (ii) in the second sentence, by inserting ``, deferral 
     extensions,'' after ``deferrals''; and
       (C) in paragraph (6)(D)--
       (i) by inserting ``and deferral extensions'' before 
     ``requested and granted''; and
       (ii) by inserting ``and deferral extensions'' after ``the 
     reasons for such deferrals'';
       (6) in subsection (g)--
       (A) in paragraph (1)(A), by striking ``after the date of 
     the submission of the application or supplement'' and 
     inserting ``after the date of the submission of an 
     application or supplement that receives a priority review or 
     330 days after the date of the submission of an application 
     or supplement that receives a standard review''; and
       (B) in paragraph (2), by striking ``the label of such 
     product'' and inserting ``the labeling of such product'';
       (7) in subsection (h)(1)--
       (A) by inserting ``an application (or supplement to an 
     application) that contains'' after ``date of submission of''; 
     and
       (B) by inserting ``if the application (or supplement) 
     receives a priority review, or not later than 330 days after 
     the date of submission of an application (or supplement to an 
     application) that contains a pediatric assessment under this 
     section, if the application (or supplement) receives a 
     standard review,'' after ``under this section,'';
       (8) in subsection (i)--
       (A) in paragraph (1)--
       (i) in the paragraph heading, by striking ``year one'' and 
     inserting ``first 18-month period''; and
       (ii) by striking ``one-year'' and inserting ``18-month'';
       (B) in paragraph (2)--
       (i) in the paragraph heading, by striking ``years'' and 
     inserting ``periods''; and
       (ii) by striking ``one-year period'' and inserting ``18-
     month period'';
       (C) by redesignating paragraph (3) as paragraph (4); and
       (D) by inserting after paragraph (2) the following:

[[Page 7922]]

       ``(3) Preservation of authority.--Nothing in this 
     subsection shall prohibit the Office of Pediatric 
     Therapeutics from providing for the review of adverse event 
     reports by the Pediatric Advisory Committee prior to the 18-
     month period referred to in paragraph (1), if such review is 
     necessary to ensure safe use of a drug in a pediatric 
     population.'';
       (9) by striking subsection (m) (relating to integration 
     with other pediatric studies); and
       (10) by redesignating subsection (n) as subsection (m).
       (d) Pediatric Studies of Biological Products in PHSA.--
     Section 351(m)(1) of the Public Health Service Act (42 U.S.C. 
     262(m)(1)) is amended by striking ``(f), (i), (j), (k), (l), 
     (p), and (q)'' and inserting ``(f), (h), (i), (j), (k), (l), 
     (n), and (p)''.
       (e) Application; Transition Rule.--
       (1) Application.--Notwithstanding any provision of section 
     505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c) stating that a provision applies beginning 
     on the date of the enactment of the Best Pharmaceuticals for 
     Children Act of 2007 or the date of the enactment of the 
     Pediatric Research Equity Act of 2007, any amendment made by 
     this Act to such a provision applies beginning on the date of 
     the enactment of this Act.
       (2) Transitional rule for adverse event reporting.--With 
     respect to a drug for which a labeling change described under 
     section 505A(l)(1) or 505B(i)(1) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355a(l)(1); 355c(i)(1)) is 
     approved or made, respectively, during the one-year period 
     that ends on the day before the date of enactment of this 
     Act, the Secretary shall apply section 505A(l) and section 
     505B(i), as applicable, to such drug, as such sections were 
     in effect on such day.
       (f) Conforming Amendment.--Section 499(c)(1)(C) of the 
     Public Health Service Act (42 U.S.C. 290b(c)(1)(C)) is 
     amended by striking ``for which the Secretary issues a 
     certification in the affirmative under section 505A(n)(1)(A) 
     of the Federal Food, Drug, and Cosmetic Act''.
       (g) Public Meeting on Pediatric Cancers.--Not later than 
     December 31, 2013, the Secretary of Health and Human Services 
     shall hold a public meeting on the impact of sections 505A 
     and 505B of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 355a, 355c) on the development of new therapies for 
     children with cancer.

     SEC. 502. FOOD AND DRUG ADMINISTRATION REPORT.

       (a) In General.--Not later than four years after the date 
     of enactment of this Act and every five years thereafter, the 
     Secretary of Health and Human Services 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, and make publicly 
     available, including through posting on the Web site of the 
     Food and Drug Administration, a report on the implementation 
     of section 505A and 505B.
       (b) Contents.--The report described in paragraph (1) shall 
     include--
       (1) an assessment of the effectiveness of sections 505A and 
     505B in improving information about pediatric uses for 
     approved drugs and biologics, including the number and type 
     of labeling changes made since the date of enactment of this 
     Act;
       (2) the number of waivers and partial waivers granted under 
     section 505B since the date of enactment of this Act, and the 
     reasons such waivers and partial waivers were granted;
       (3) the number of deferrals and deferral extensions granted 
     under section 505B since the date of enactment of this Act, 
     and the reasons such deferrals and deferral extensions were 
     granted;
       (4) the number of letters issued under section 505B(d);
       (5) an assessment of the timeliness and effectiveness of 
     pediatric study planning since the date of enactment of this 
     Act, including the number of pediatric plans not submitted in 
     accordance with the requirements of section 505B(e) and any 
     resulting rulemaking;
       (6) the number of written requests issued, accepted, and 
     declined under section 505A since the date of enactment of 
     this Act, and a listing of any important gaps in pediatric 
     information as a result of such declined requests;
       (7) a description and current status of referrals made 
     under section 505A(n);
       (8) an assessment of the effectiveness of studying drugs 
     for rare diseases under 505A;
       (9) an assessment of the effectiveness of studying drugs 
     for children with cancer under 505A and 505B, and any 
     recommendations for modifications to the programs under such 
     sections that would lead to new and better therapies for 
     children with cancer;
       (10) an assessment of the effectiveness of studying drugs 
     in the neonate population under 505A and 505B;
       (11) an assessment of the effectiveness of studying 
     biological products in pediatric populations under 505A and 
     505B;
       (12) an assessment of the Secretary's efforts to address 
     the suggestions and options described in the report required 
     under 505A(p); and
       (13) any suggestions for modification to the programs that 
     would improve pediatric drug research and increase pediatric 
     labeling of drugs and biologics that the Secretary determines 
     to be appropriate.
       (c) Stakeholder Comment.--At least 180 days prior to the 
     submission of the report required in paragraph (1), the 
     Secretary shall consult with representatives of patient 
     groups, including pediatric patient groups, consumer groups, 
     regulated industry, academia, and other interested parties to 
     obtain any recommendations or information relevant to the 
     study and report including suggestions for modifications that 
     would improve pediatric drug research and pediatric labeling 
     of drugs and biologics.

     SEC. 503. INTERNAL COMMITTEE FOR REVIEW OF PEDIATRIC PLANS, 
                   ASSESSMENTS, DEFERRALS, DEFERRAL EXTENSIONS, 
                   AND WAIVERS.

       Section 505C (21 U.S.C. 355d) is amended--
       (1) in the section heading, by inserting ``DEFERRAL 
     EXTENSIONS,'' after ``DEFERRALS,''; and
       (2) by inserting ``neonatology'' after ``pediatric 
     ethics''.

     SEC. 504. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.

       Section 6(c) of the Best Pharmaceuticals for Children Act 
     (21 U.S.C. 393a(c)) is amended--
       (1) in paragraph (1), by striking ``and'' at the end;
       (2) by redesignating paragraph (2) as paragraph (4);
       (3) by inserting after paragraph (1) the following:
       ``(2) one or more additional individuals with expertise in 
     neonatology;
       ``(3) one or more additional individuals with expertise in 
     pediatric epidemiology; and''.

     SEC. 505. CONTINUATION OF OPERATION OF PEDIATRIC ADVISORY 
                   COMMITTEE.

       Section 14(d) of the Best Pharmaceuticals for Children Act 
     (42 U.S.C. 284m note) is amended by striking ``during the 
     five-year period beginning on the date of the enactment of 
     the Best Pharmaceuticals for Children Act of 2007'' and 
     inserting ``to carry out the advisory committee's 
     responsibilities under sections 505A, 505B, and 520(m) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c, 
     and 360j(m))''.

     SEC. 506. PEDIATRIC SUBCOMMITTEE OF THE ONCOLOGIC DRUGS 
                   ADVISORY COMMITTEE.

       Section 15(a) of the Best Pharmaceuticals for Children Act 
     (Public Law 107-109), as amended by section 502(e) of the 
     Food and Drug Administration Amendments Act of 2007 (Public 
     Law 110-85), is amended--
       (1) in paragraph (1)(D), by striking ``section 505B(f)'' 
     and inserting ``section 505C''; and
       (2) in paragraph (3), by striking ``during the five-year 
     period beginning on the date of the enactment of the Best 
     Pharmaceuticals for Children Act of 2007'' and inserting ``to 
     carry out the Subcommittee's responsibilities under this 
     section''.

     TITLE VI--FOOD AND DRUG ADMINISTRATION ADMINISTRATIVE REFORMS

     SEC. 601. PUBLIC PARTICIPATION IN ISSUANCE OF FDA GUIDANCE 
                   DOCUMENTS.

       Section 701(h)(1) (21 U.S.C. 371(h)(1)) is amended by 
     striking subparagraph (C) and inserting the following:
       ``(C) For any guidance document that sets forth initial 
     interpretations of a statute or regulation, sets forth 
     changes in interpretation or policy that are of more than a 
     minor nature, includes complex scientific issues, or covers 
     highly controversial issues--
       ``(i) the Secretary--
       ``(I) at least 30 days before issuance of a draft of such 
     guidance document, shall publish notice in the Federal 
     Register of the Secretary's intent to prepare such guidance 
     document; and
       ``(II) during preparation and before issuance of such 
     guidance document, may meet with interested stakeholders, 
     including industry, medical, and scientific experts and 
     others, and solicit public comment;
       ``(ii) if the Secretary for good cause finds that, with 
     respect to such guidance document, compliance with clause (i) 
     is impracticable, unnecessary, or contrary to the public 
     interest--
       ``(I) the Secretary shall publish such finding and a brief 
     statement of the reasons for such finding in the Federal 
     Register;
       ``(II) clause (i) shall not apply with respect to such 
     guidance document; and
       ``(III) during a 90-day period beginning not later than the 
     date of issuance of such guidance document, the Secretary may 
     meet with interested stakeholders, including industry, 
     medical, and scientific experts and others, and shall solicit 
     public comment;
       ``(iii) beginning on the date of enactment of the Food and 
     Drug Administration Reform Act of 2012, upon issuance of a 
     draft guidance document under clause (i) or (ii), the 
     Secretary shall--
       ``(I) designate the document as draft or final; and
       ``(II) not later than 18 months after the close of the 
     comment period for such guidance, issue a final version of 
     such guidance document in accordance with clauses (i) and 
     (ii);
       ``(iv) the Secretary may extend the deadline for issuing 
     final guidance under clause (iii)(II) by not more than 180 
     days upon submission by the Secretary of a notification of 
     such extension in the Federal Register;

[[Page 7923]]

       ``(v) if the Secretary issues a draft guidance document and 
     fails to finalize the draft by the deadline determined under 
     clause (iii)(II), as extended under clause (iv), the 
     Secretary shall, beginning on the date of such deadline, 
     treat the draft as null and void; and
       ``(vi) not less than every 5 years after the issuance of a 
     final guidance document in accordance with clause (iii), the 
     Secretary shall--
       ``(I) conduct a retrospective analysis of such guidance 
     document to ensure it is not outmoded, ineffective, 
     insufficient, or excessively burdensome; and
       ``(II) based on such analysis, modify, streamline, expand, 
     or repeal the guidance document in accordance with what has 
     been learned.
       ``(D) With respect to devices, a notice to industry 
     guidance letter, a notice to industry advisory letter, and 
     any similar notice that sets forth initial interpretations of 
     a statute or regulation or sets forth changes in 
     interpretation or policy shall be treated as a guidance 
     document for purposes of subparagraph (C).
       ``(E) The following shall not be treated as a guidance 
     document for purposes of subparagraph (C):
       ``(i) Any document that does not set forth an initial 
     interpretation or a reinterpretation of a statute or 
     regulation.
       ``(ii) Any document that sets forth or changes a policy 
     relating to internal procedures of the Food and Drug 
     Administration.
       ``(iii) Agency reports, general information documents 
     provided to consumers or health professionals, speeches, 
     journal articles and editorials, media interviews, press 
     materials, warning letters, memoranda of understanding, or 
     communications directed to individual persons or firms.''.

     SEC. 602. CONFLICTS OF INTEREST.

       (a) In General.--Section 712 (21 U.S.C. 379d-1) is 
     amended--
       (1) by striking subsections (b) and (c) and inserting the 
     following subsections:
       ``(b) Recruitment for Advisory Committees.--
       ``(1) In general.--The Secretary shall--
       ``(A) 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;
       ``(B) seek input from professional medical and scientific 
     societies to determine the most effective informational and 
     recruitment activities;
       ``(C) at least every 180 days, request referrals for 
     potential members of advisory committees from a variety of 
     stakeholders, including--
       ``(i) product developers, patient groups, and disease 
     advocacy organizations; and
       ``(ii) relevant--

       ``(I) professional societies;
       ``(II) medical societies;
       ``(III) academic organizations; and
       ``(IV) governmental organizations; and

       ``(D) in carrying out subparagraphs (A) and (B), take into 
     account the levels of activity (including the numbers of 
     annual meetings) and the numbers of vacancies of the advisory 
     committees.
       ``(2) Recruitment activities.--The recruitment activities 
     under paragraph (1) may include--
       ``(A) advertising the process for becoming an advisory 
     committee member at medical and scientific society 
     conferences;
       ``(B) 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
       ``(C) 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 whom the Food and Drug Administration 
     can contact regarding the nomination of individuals to serve 
     on advisory committees.
       ``(3) Expertise.--In carrying out this subsection, the 
     Secretary shall seek to ensure that the Secretary has access 
     to the most current expert advice.
       ``(c) Disclosure of Determinations and Certifications.--
     Notwithstanding section 107(a)(2) of the Ethics in Government 
     Act of 1978, the following shall apply:
       ``(1) 15 or more days in advance.--As soon as practicable, 
     but (except as provided in paragraph (2)) 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, or a written certification as 
     referred to in section 208(b)(3) of such title, applies, the 
     Secretary shall disclose (other than information exempted 
     from disclosure under section 552 or section 552a of title 5, 
     United States Code (popularly known as the Freedom of 
     Information Act and the Privacy Act of 1974, respectively)) 
     on the Internet Website of the Food and Drug Administration--
       ``(A) the type, nature, and magnitude of the financial 
     interests of the advisory committee member to which such 
     determination or certification applies; and
       ``(B) the reasons of the Secretary for such determination 
     or certification, including, as appropriate, the public 
     health interest in having the expertise of the member with 
     respect to the particular matter before the advisory 
     committee.
       ``(2) 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, or a written 
     certification as referred to in section 208(b)(3) of such 
     title applies, the Secretary shall disclose (other than 
     information exempted from disclosure under section 552 or 
     552a of title 5, United States Code) on the Internet Website 
     of the Food and Drug Administration, the information 
     described in subparagraphs (A) and (B) of paragraph (1) as 
     soon as practicable after the Secretary makes such 
     determination or certification, but in no case later than the 
     date of such meeting.'';
       (2) in subsection (d), by striking ``subsection (c)(3)'' 
     and inserting ``subsection (c)'';
       (3) by amending subsection (e) to read as follows:
       ``(e) Annual Report.--
       ``(1) In general.--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--
       ``(A) with respect to the fiscal year that ended on 
     September 30 of the previous year, the number of persons 
     nominated for participation at meetings for each advisory 
     committee, the number of persons so nominated, and willing to 
     serve, the number of vacancies on each advisory committee, 
     and the number of persons contacted for service as members on 
     each advisory committee meeting for each advisory committee 
     who did not participate because of the potential for such 
     participation to constitute a disqualifying financial 
     interest under section 208 of title 18, United States Code;
       ``(B) with respect to such year, the number of persons 
     contacted for services as members for each advisory committee 
     meeting for each advisory committee who did not participate 
     because of reasons other than the potential for such 
     participation to constitute a disqualifying financial 
     interest under section 208 of title 18, United States Code;
       ``(C) with respect to such year, the number of members 
     attending meetings for each advisory committee; and
       ``(D) with respect to such year, the aggregate number of 
     disclosures required under subsection (d) and the percentage 
     of individuals to whom such disclosures did not apply who 
     served on such committee.
       ``(2) Public availability.--Not later than 30 days after 
     submitting any report under paragraph (1) to the committees 
     specified in such paragraph, the Secretary shall make each 
     such report available to the public.''; and
       (4) in subsection (f), by striking ``shall review 
     guidance'' and all that follows through the end of the 
     subsection and inserting the following: ``shall--
       ``(1) review guidance of the Food and Drug Administration 
     with respect to advisory committees regarding disclosure of 
     conflicts of interest and the application of section 208 of 
     title 18, United States Code; and
       ``(2) update such guidance as necessary to ensure that the 
     Food and Drug Administration receives appropriate access to 
     needed scientific expertise, with due consideration of the 
     requirements of such section 208.''.
       (b) Applicability.--The amendments made by subsection (a) 
     apply beginning on October 1, 2012.

     SEC. 603. ELECTRONIC SUBMISSION OF APPLICATIONS.

       Subchapter D of chapter VII (21 U.S.C. 379k et seq.) is 
     amended by inserting after section 745 the following:

     ``SEC. 745A. ELECTRONIC FORMAT FOR SUBMISSIONS.

       ``(a) Drugs and Biologics.--
       ``(1) In general.--Beginning no earlier than 24 months 
     after the issuance of a final guidance issued after public 
     notice and opportunity for comment, submissions under 
     subsection (b), (i), or (j) of section 505 of this Act or 
     subsection (a) or (k) of section 351 of the Public Health 
     Service Act shall be submitted in such electronic format as 
     specified by the Secretary in such guidance.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide a timetable for establishment by the 
     Secretary of further standards for electronic submission as 
     required by such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.
       ``(3) Exception.--This subsection shall not apply to 
     submissions described in section 561.
       ``(b) Devices.--
       ``(1) In general.--Beginning after the issuance of final 
     guidance implementing this paragraph, pre-submissions and 
     submissions for devices under section 510(k), 513(f)(2)(A), 
     515(c), 515(d), 515(f), 520(g), 520(m), or 564 of this Act or 
     section 351 of the Public Health Service Act, and any 
     supplements to such

[[Page 7924]]

     pre-submissions or submissions, shall include an electronic 
     copy of such pre-submissions or submissions.
       ``(2) Guidance contents.--In the guidance under paragraph 
     (1), the Secretary may--
       ``(A) provide standards for the electronic copy required 
     under such paragraph; and
       ``(B) set forth criteria for waivers of and exemptions from 
     the requirements of this subsection.''.

     SEC. 604. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-
                   DEVELOPED TESTS.

       The Food and Drug Administration may not issue any draft or 
     final guidance on the regulation of laboratory-developed 
     tests under the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 301 et seq.) without, at least 60 days prior to such 
     issuance--
       (1) notifying the Committee on Energy and Commerce of the 
     House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate of the 
     Administration's intent to take such action; and
       (2) including in such notification the anticipated details 
     of such action.

           TITLE VII--MEDICAL DEVICE REGULATORY IMPROVEMENTS

                  Subtitle A--Premarket Predictability

     SEC. 701. INVESTIGATIONAL DEVICE EXEMPTIONS.

       Section 520(g) (21 U.S.C. 360j(g)) is amended--
       (1) in paragraph (2)(B)(ii), by inserting ``safety or 
     effectiveness'' before ``data obtained''; and
       (2) in paragraph (4), by adding at the end the following:
       ``(C) Consistent with paragraph (1), the Secretary shall 
     not disapprove an application under this subsection because 
     the Secretary determines that--
       ``(i) the investigation may not support a substantial 
     equivalence or de novo classification determination or 
     approval of the device;
       ``(ii) the investigation may not meet a requirement, 
     including a data requirement, relating to the approval or 
     clearance of a device; or
       ``(iii) an additional or different investigation may be 
     necessary to support clearance or approval of the device.''.

     SEC. 702. CLARIFICATION OF LEAST BURDENSOME STANDARD.

       (a) Premarket Approval.--Section 513(a)(3)(D) (21 U.S.C. 
     360c(a)(3)(D)) is amended--
       (1) by redesignating clause (iii) as clause (v); and
       (2) by inserting after clause (ii) the following:
       ``(iii) For purposes of clause (ii), the term `necessary' 
     means the minimum required information that would support a 
     determination by the Secretary that an application provides 
     reasonable assurance of the effectiveness of the device.
       ``(iv) Nothing in this subparagraph shall alter the 
     criteria for evaluating an application for premarket approval 
     of a device.''.
       (b) Premarket Notification Under Section 510(k).--Section 
     513(i)(1)(D) (21 U.S.C. 360c(i)(1)(D)) is amended--
       (1) by striking ``(D) Whenever'' and inserting ``(D)(i) 
     Whenever''; and
       (2) by adding at the end the following:
       ``(ii) For purposes of clause (i), the term `necessary' 
     means the minimum required information that would support a 
     determination of substantial equivalence between a new device 
     and a predicate device.
       ``(iii) Nothing in this subparagraph shall alter the 
     standard for determining substantial equivalence between a 
     new device and a predicate device.''.

     SEC. 703. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 
                   DECISIONS.

       Chapter V is amended by inserting after section 517 (21 
     U.S.C. 360g) the following:

     ``SEC. 517A. AGENCY DOCUMENTATION AND REVIEW OF SIGNIFICANT 
                   DECISIONS REGARDING DEVICES.

       ``(a) Documentation of Rationale for Significant 
     Decisions.--
       ``(1) In general.--The Secretary shall completely document 
     the scientific and regulatory rationale for any significant 
     decision of the Center for Devices and Radiological Health 
     regarding submission or review of a report under section 
     510(k), an application under section 515, or an application 
     for an exemption under section 520(g), including 
     documentation of significant controversies or differences of 
     opinion and the resolution of such controversies or 
     differences of opinion.
       ``(2) Provision of documentation.--Upon request, the 
     Secretary shall furnish such complete documentation to the 
     person who is seeking to submit, or who has submitted, such 
     report or application.
       ``(b) Review of Significant Decisions.--
       ``(1) Request for supervisory review of significant 
     decision.--Any person may request a supervisory review of the 
     significant decision described in subsection (a)(1). Such 
     review may be conducted at the next supervisory level or 
     higher above the individual who made the significant 
     decision.
       ``(2) Submission of request.--A person requesting a 
     supervisory review under paragraph (1) shall submit such 
     request to the Secretary not later than 30 days after such 
     decision and shall indicate in the request whether such 
     person seeks an in-person meeting or a teleconference review.
       ``(3) Timeframe.--
       ``(A) In general.--Except as provided in subparagraph (B), 
     the Secretary shall schedule an in-person or teleconference 
     review, if so requested, not later than 30 days after such 
     request is made. The Secretary shall issue a decision to the 
     person requesting a review under this subsection not later 
     than 45 days after the request is made under paragraph (1), 
     or, in the case of a person who requests an in-person meeting 
     or teleconference, 30 days after such meeting or 
     teleconference.
       ``(B) Exception.--Subparagraph (A) shall not apply in cases 
     that are referred to experts outside of the Food and Drug 
     Administration.''.

     SEC. 704. TRANSPARENCY IN CLEARANCE PROCESS.

       (a) Publication of Detailed Decision Summaries.--Section 
     520(h) (21 U.S.C. 360j(h)) is amended by adding at the end 
     the following:
       ``(5) Subject to subsection (c) and section 301(j), the 
     Secretary shall regularly publish detailed decision summaries 
     for each clearance of a device under section 510(k) requiring 
     clinical data.''.
       (b) Application.--The requirement of section 520(h)(5) of 
     the Federal Food, Drug, and Cosmetic Act, as added by 
     subsection (a), applies only with respect to clearance of a 
     device occurring after the date of the enactment of this Act.

     SEC. 705. DEVICE MODIFICATIONS REQUIRING PREMARKET 
                   NOTIFICATION PRIOR TO MARKETING.

       Section 510(n) (21 U.S.C. 360(n)) is amended by--
       (1) striking ``(n) The Secretary'' and inserting ``(n)(1) 
     The Secretary''; and
       (2) by adding at the end the following:
       ``(2)(A) Not later than 18 months after the enactment of 
     this paragraph, the Secretary shall 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 regarding when a premarket notification 
     under subsection (k) should be submitted for a modification 
     or change to a legally marketed device. The report shall 
     include the Secretary's interpretation of the following 
     terms: `could significantly affect the safety or 
     effectiveness of the device', `a significant change or 
     modification in design, material, chemical composition, 
     energy source, or manufacturing process,', and `major change 
     or modification in the intended use of the device'. The 
     report also shall discuss possible processes for industry to 
     use to determine whether a new submission under subsection 
     (k) is required and shall analyze how to leverage existing 
     quality system requirements to reduce premarket burden, 
     facilitate continual device improvement. and provide 
     reasonable assurance of safety and effectiveness of modified 
     devices. In developing such report, the Secretary shall 
     consider the input of interested stakeholders.
       ``(B) The Secretary shall withdraw the Food and Drug 
     Administration draft guidance entitled `Guidance for Industry 
     and FDA Staff--510(k) Device Modifications: Deciding When to 
     Submit a 510(k) for a Change to an Existing Device', dated 
     July 27, 2011, and shall not use this draft guidance as part 
     of, or for the basis of, any premarket review or any 
     compliance or enforcement decisions or actions. The Secretary 
     shall not issue--
       ``(i) any draft guidance or proposed regulation that 
     addresses when to submit a premarket notification submission 
     for changes and modifications made to a manufacturer's 
     previously cleared device before the receipt by the Committee 
     on Energy and Commerce of the House of Representatives and 
     the Committee on Health, Education, Labor, and Pensions of 
     the Senate of the report required in subparagraph (A); and
       ``(ii) any final guidance or regulation on that topic for 
     one year after date of receipt of such report by the 
     Committee on Energy and Commerce of the House of 
     Representatives and the Committee on Health, Education, 
     Labor, and Pensions of the Senate.
       ``(C) The Food and Drug Administration guidance entitled 
     `Deciding When to Submit a 510(k) for a Change to an Existing 
     Device', dated January 10, 1997, shall be in effect until the 
     subsequent issuance of guidance or promulgation, if 
     appropriate, of a regulation described in subparagraph (B), 
     and the Secretary shall interpret such guidance in a manner 
     that is consistent with the manner in which the Secretary has 
     interpreted such guidance since 1997.''.

                    Subtitle B--Patients Come First

     SEC. 711. ESTABLISHMENT OF SCHEDULE AND PROMULGATION OF 
                   REGULATION.

       (a) Establishment of Schedule.--Not later than 90 days 
     after the date of enactment of this Act, the Secretary of 
     Health and Human Services shall establish the schedule 
     referred to in section 515(i)(3) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360e(i)(3)).
       (b) Regulation.--Not later than one year after the date 
     that the schedule is established under such section 515(i)(3) 
     (as required by subsection (a)) the Secretary shall issue a 
     final regulation under section 515(b) of such Act for each 
     device that the Secretary requires to remain in class III

[[Page 7925]]

     through a determination under section 515(i)(2) of such Act.

     SEC. 712. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

       Chapter V is amended by inserting after section 518 (21 
     U.S.C. 360h) the following:

     ``SEC. 518A. PROGRAM TO IMPROVE THE DEVICE RECALL SYSTEM.

       ``(a) In General.--The Secretary shall--
       ``(1) establish a program to routinely and systematically 
     assess information relating to device recalls and use such 
     information to proactively identify strategies for mitigating 
     health risks presented by defective or unsafe devices;
       ``(2) clarify procedures for conducting device recall audit 
     checks to improve the ability of investigators to perform 
     those checks in a consistent manner;
       ``(3) develop detailed criteria for assessing whether a 
     person performing a device recall has performed an effective 
     correction or action plan for the recall; and
       ``(4) document the basis for each termination by the Food 
     and Drug Administration of a device recall.
       ``(b) Assessment Content.--The program established under 
     subsection (a)(1) shall, at a minimum, identify--
       ``(1) trends in the number and types of device recalls;
       ``(2) devices that are most frequently the subject of a 
     recall; and
       ``(3) underlying causes of device recalls.
       ``(c) Definition.--In this section, the term `recall' 
     means--
       ``(1) the removal from the market of a device pursuant to 
     an order of the Secretary under subsection (b) or (e) of 
     section 518; or
       ``(2) the correction or removal from the market of a device 
     at the initiative of the manufacturer or importer of the 
     device that is required to be reported to the Secretary under 
     section 519(g).''.

               Subtitle C--Novel Device Regulatory Relief

     SEC. 721. MODIFICATION OF DE NOVO APPLICATION PROCESS.

       (a) In General.--Section 513(f)(2) (21 U.S.C. 360c(f)(2)) 
     is amended--
       (1) by inserting ``(i)'' after ``(2)(A)'';
       (2) in subparagraph (A)(i), as so designated by paragraph 
     (1), by striking ``under the criteria set forth'' and all 
     that follows through the end of subparagraph (A) and 
     inserting a period;
       (3) by adding at the end of subparagraph (A) the following:
       ``(ii) In lieu of submitting a report under section 510(k) 
     and submitting a request for classification under clause (i) 
     for a device, if a person determines there is no legally 
     marketed device upon which to base a determination of 
     substantial equivalence (as defined in subsection (i)), a 
     person may submit a request under this clause for the 
     Secretary to classify the device.
       ``(iii) Upon receipt of a request under clause (i) or (ii), 
     the Secretary shall classify the device subject to the 
     request under the criteria set forth in subparagraphs (A) 
     through (C) of subsection (a)(1) within 120 days.
       ``(iv) Notwithstanding clause (iii), the Secretary may 
     decline to undertake a classification of a device pursuant to 
     a request under clause (ii) if the Secretary--
       ``(I) identifies a legally marketed device that would 
     permit a substantial equivalence determination under 
     paragraph (1) for the device; or
       ``(II) determines that the device submitted is not of low-
     moderate risk or special controls to mitigate the risks 
     cannot be developed for the device.
       ``(v) The person submitting the request for classification 
     under this subparagraph may recommend to the Secretary a 
     classification for the device and shall, if recommending 
     classification in class II, include in the request an initial 
     draft proposal for applicable special controls, as described 
     in subsection (a)(1)(B), that are necessary, in conjunction 
     with general controls, to provide reasonable assurance of 
     safety and effectiveness and a description of how the special 
     controls provide such assurance. Any such request shall 
     describe the device and provide detailed information and 
     reasons for the recommended classification.''; and
       (4) in subparagraph (B), by striking ``Not later than 60 
     days after the date of the submission of the request under 
     subparagraph (A), the Secretary'' and inserting ``The 
     Secretary''.
       (b) Conforming Amendments.--Section 513(f) of such Act (21 
     U.S.C. 360c(f)) is amended in paragraph (1)--
       (1) in subparagraph (A), by striking ``, or'' at the end 
     and inserting a semicolon;
       (2) in subparagraph (B), by striking the period and 
     inserting ``; or''; and
       (3) by inserting after subparagraph (B) the following:
       ``(C) the device is classified pursuant to a request 
     submitted under paragraph (2).''.

     Subtitle D--Keeping America Competitive Through Harmonization

     SEC. 731. HARMONIZATION OF DEVICE PREMARKET REVIEW, 
                   INSPECTION, AND LABELING SYMBOLS; REPORT.

       (a) In General.--Paragraph (4) of section 803(c) (21 U.S.C. 
     383(c)) is amended to read as follows:
       ``(4) With respect to devices, the Secretary may, when 
     appropriate, enter into arrangements with nations regarding 
     methods and approaches to harmonizing regulatory requirements 
     for activities, including inspections and common 
     international labeling symbols.''.
       (b) Report.--Not later than 3 years after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services 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 
     Food and Drug Administration's harmonization activities, 
     itemizing methods and approaches that have been harmonized 
     pursuant to section 803(c)(4) of the Federal Food, Drug, and 
     Cosmetic Act, as amended by subsection (a).

     SEC. 732. PARTICIPATION IN INTERNATIONAL FORA.

       Paragraph (3) of section 803(c) (21 U.S.C. 383(c)) is 
     amended--
       (1) by striking ``(3)'' and inserting ``(3)(A)''; and
       (2) by adding at the end the following:
       ``(B) In carrying out subparagraph (A), the Secretary may 
     participate in appropriate fora, including the International 
     Medical Device Regulators Forum, and may--
       ``(i) provide guidance to such fora on strategies, 
     policies, directions, membership, and other activities of a 
     forum as appropriate;
       ``(ii) to the extent appropriate, solicit, review, and 
     consider comments from industry, academia, health care 
     professionals, and patient groups regarding the activities of 
     such fora; and
       ``(iii) to the extent appropriate, inform the public of the 
     Secretary's activities within such fora, and share with the 
     public any documentation relating to a forum's strategies, 
     policies, and other activities of such fora.''.

  Subtitle E--FDA Renewing Efficiency From Outside Reviewer Management

     SEC. 741. REAUTHORIZATION OF THIRD PARTY REVIEW.

       (a) Periodic Reaccreditation.--Section 523(b)(2) (21 U.S.C. 
     360m(b)(2)) is amended by adding at the end of the following:
       ``(E) Periodic reaccreditation.--
       ``(i) Period.--Subject to suspension or withdrawal under 
     subparagraph (B), any accreditation under this section shall 
     be valid for a period of 3 years after its issuance.
       ``(ii) Response to reaccreditation request.--Upon the 
     submission of a request by an accredited person for 
     reaccreditation under this section, the Secretary shall 
     approve or deny such request not later than 60 days after 
     receipt of the request.
       ``(iii) Criteria.--Not later than 120 days after the date 
     of the enactment of this subparagraph, the Secretary shall 
     establish and publish in the Federal Register criteria to 
     reaccredit or deny reaccreditation to persons under this 
     section. The reaccreditation of persons under this section 
     shall specify the particular activities under subsection (a), 
     and the devices, for which such persons are reaccredited.''.
       (b) Duration of Authority.--Section 523(c) (21 U.S.C. 
     360m(c)) is amended by striking ``October 1, 2012'' and 
     inserting ``October 1, 2017''.

     SEC. 742. REAUTHORIZATION OF THIRD PARTY INSPECTION.

       Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by 
     striking ``October 1, 2012'' and inserting ``October 1, 
     2017''.

                 Subtitle F--Humanitarian Device Reform

     SEC. 751. EXPANDED ACCESS TO HUMANITARIAN USE DEVICES.

       (a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is 
     amended--
       (1) in paragraph (6)--
       (A) in subparagraph (A)--
       (i) in the matter preceding clause (i), by striking 
     ``subparagraph (D)'' and inserting ``subparagraph (C)'';
       (ii) by striking clause (i) and inserting the following:
       ``(i) The device with respect to which the exemption is 
     granted--
       ``(I) 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; or
       ``(II) is intended for the treatment or diagnosis of a 
     disease or condition that does not occur in pediatric 
     patients or that occurs in pediatric patients in such numbers 
     that the development of the device for such patients is 
     impossible, highly impracticable, or unsafe.'';
       (iii) by striking clause (ii) and inserting the following:
       ``(ii) During any calendar year, the number of such devices 
     distributed during that year under each exemption granted 
     under this subsection does not exceed the number of such 
     devices needed to treat, diagnose, or cure a population of 
     4,000 individuals in the United States (referred to in this 
     paragraph as the `annual distribution number').''; and
       (iv) in clause (iv), by striking ``2012'' and inserting 
     ``2017'';
       (B) by striking subparagraph (C);
       (C) by redesignating subparagraphs (D) and (E) as 
     subparagraphs (C) and (D), respectively; and
       (D) in subparagraph (C), as so redesignated, by striking 
     ``and modified under subparagraph (C), if applicable,'';

[[Page 7926]]

       (2) in paragraph (7), by striking ``regarding a device'' 
     and inserting ``regarding a device described in paragraph 
     (6)(A)(i)(I)''; and
       (3) in paragraph (8), by striking ``of all devices 
     described in paragraph (6)'' and inserting ``of all devices 
     described in paragraph (6)(A)(i)(I)''.
       (b) Applicability to Existing Devices.--A sponsor of a 
     device for which an exemption was approved under paragraph 
     (2) of section 520(m) of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 360j(m)) before the date of enactment of this 
     Act may seek a determination under subclause (I) or (II) of 
     paragraph (6)(A)(i) of such section 520(m) (as amended by 
     subsection (a)). If the Secretary determines that such 
     subclause (I) or (II) applies with respect to a device, then 
     clauses (ii), (iii), and (iv) of subparagraph (A) and 
     subparagraphs (B), (C), and (D) of paragraph (6) of such 
     section 520(m) shall apply to such device.
       (c) Report.--Not later than January 1, 2017, the 
     Comptroller General of the United States shall submit to 
     Congress a report that evaluates and describes--
       (1) the effectiveness of the amendments made by subsection 
     (a) in stimulating innovation with respect to medical 
     devices, including any favorable or adverse impact on 
     pediatric device development;
       (2) the impact of such amendments on pediatric device 
     approvals for devices that received a humanitarian use 
     designation under section 520(m) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 360j(m)) prior to the date of 
     enactment of this Act;
       (3) the status of public and private insurance coverage of 
     devices granted an exemption under paragraph (2) of such 
     section 520(m) and costs to patients of such devices;
       (4) the impact that paragraph (4) of such section 520(m) 
     has had on access to and insurance coverage of devices 
     granted an exemption under paragraph (2) of such section 
     520(m); and
       (5) the effect of the amendments made by subsection (a) on 
     patients described in such section 520(m).

               Subtitle G--Records and Reports on Devices

     SEC. 761. UNIQUE DEVICE IDENTIFICATION SYSTEM REGULATIONS.

       Not later than 120 days after the date of enactment of this 
     Act, the Secretary of Health and Human Services shall 
     promulgate the regulations required by section 519(f) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i(f)).

     SEC. 762. EFFECTIVE DEVICE SENTINEL PROGRAM.

       (a) Inclusion of Devices in Postmarket Risk Identification 
     and Analysis System.--Section 519 (21 U.S.C. 360i) is amended 
     by adding at the end the following:
       ``(h) Inclusion of Devices in Postmarket Risk 
     Identification and Analysis System.--
       ``(1) In general.--The Secretary shall amend the procedures 
     established and maintained under clauses (i), (ii), (iii), 
     and (v) of section 505(k)(3)(C) in order to expand the 
     postmarket risk identification and analysis system 
     established under such section to include and apply to 
     devices.
       ``(2) Data.--In expanding the system as described in 
     paragraph (1), the Secretary shall use relevant data with 
     respect to devices cleared under section 510(k) or approved 
     under section 515, which may include claims data, patient 
     survey data, and standardized analytic files that allow for 
     the pooling and analysis of data from disparate data 
     environments.
       ``(3) Stakeholder input.--To help ensure effective 
     implementation of the system as described in paragraph (1) 
     with respect to devices, the Secretary shall engage outside 
     stakeholders in development of the system, and gather 
     information from outside stakeholders regarding the content 
     of an effective sentinel program, through a public hearing, 
     advisory committee meeting, maintenance of a public docket, 
     or other similar public measures.
       ``(4) Voluntary surveys.--Chapter 35 of title 44, United 
     States Code, shall not apply to the collection of voluntary 
     information from health care providers, such as voluntary 
     surveys or questionnaires, initiated by the Secretary for 
     purposes of postmarket risk identification, mitigation, and 
     analysis for devices.''.
       (b) Amendments to Postmarket Risk Identification and 
     Analysis System.--Section 505(k)(3)(C)(i) (21 U.S.C. 
     355(k)(3)(C)(i)) is amended--
       (1) by striking subclause (II);
       (2) by redesignating subclauses (III) through (VI) as 
     subclauses (II) through (V), respectively; and
       (3) in item (bb) of subclause (II), as so redesignated, by 
     striking ``pharmaceutical purchase data and health insurance 
     claims data'' and inserting ``medical device utilization 
     data, health insurance claims data, and procedure and device 
     registries''.

                       Subtitle H--Miscellaneous

     SEC. 771. CUSTOM DEVICES.

       Section 520(b) (21 U.S.C. 360j) is amended to read as 
     follows:
       ``(b) Custom Devices.--
       ``(1) In general.--The requirements of sections 514 and 515 
     shall not apply to a device that--
       ``(A) is created or modified in order to comply with the 
     order of an individual physician or dentist (or any other 
     specially qualified person designated under regulations 
     promulgated by the Secretary after an opportunity for an oral 
     hearing);
       ``(B) in order to comply with an order described in 
     subparagraph (A), necessarily deviates from an otherwise 
     applicable performance standard under section 514 or 
     requirement under section 515;
       ``(C) is not generally available in the United States in 
     finished form through labeling or advertising by the 
     manufacturer, importer, or distributor for commercial 
     distribution;
       ``(D) is designed to treat a unique pathology or 
     physiological condition that no other device is domestically 
     available to treat;
       ``(E)(i) is intended to meet the special needs of such 
     physician or dentist (or other specially qualified person so 
     designated) in the course of the professional practice of 
     such physician or dentist (or other specially qualified 
     person so designated); or
       ``(ii) is intended for use by an individual patient named 
     in such order of such physician or dentist (or other 
     specially qualified person so designated);
       ``(F) is assembled from components or manufactured and 
     finished on a case-by-case basis to accommodate the unique 
     needs of individuals described in clause (i) or (ii) of 
     subparagraph (E); and
       ``(G) may have common, standardized design characteristics, 
     chemical and material compositions, and manufacturing 
     processes as commercially distributed devices.
       ``(2) Limitations.--Paragraph (1) shall apply to a device 
     only if--
       ``(A) such device is for the purpose of treating a 
     sufficiently rare condition, such that conducting clinical 
     investigations on such device would be impractical;
       ``(B) production of such device under paragraph (1) is 
     limited to no more than 5 units per year of a particular 
     device type, provided that such replication otherwise 
     complies with this section; and
       ``(C) the manufacturer of such device notifies the 
     Secretary on an annual basis, in a manner prescribed by the 
     Secretary, of the manufacture of such device.
       ``(3) Guidance.--Not later than 2 years after the date of 
     enactment of this section, the Secretary shall issue final 
     guidance on replication of multiple devices described in 
     paragraph (2)(B).''.

     SEC. 772. PEDIATRIC DEVICE REAUTHORIZATION.

       (a) Final Rule Relating To Tracking of Pediatric Uses of 
     Devices.--The Secretary of Health and Human Services shall 
     issue--
       (1) a proposed rule implementing section 515A(a)(2) of the 
     Federal Food, Drug and Cosmetic Act (21 U.S.C. 360e-1(a)(2)) 
     not later than December 31, 2012; and
       (2) a final rule implementing such section not later than 
     December 31, 2013.
       (b) Demonstration Grants To Improve Pediatric Device 
     Availability.--Section 305(e) of the Pediatric Medical Device 
     Safety and Improvement Act of 2007 (Title III of Public Law 
     110-85) is amended by striking ``2008 through 2012'' and 
     inserting ``2013 through 2017''.

     SEC. 773. REPORT ON REGULATION OF HEALTH INFORMATION 
                   TECHNOLOGY.

       (a) Report.--Not later than 18 months after the date of the 
     enactment of this Act, the Secretary of Health and Human 
     Services, in consultation with the Commissioner of Food and 
     Drugs, the National Coordinator for Health Information 
     Technology, and the Chairman of the Federal Communications 
     Commission, shall submit to the Committee on Energy and 
     Commerce of the House of Representatives and the appropriate 
     committees of the Senate a report that contains--
       (1) a strategy for coordinating the regulation of health 
     information technology in order to avoid regulatory 
     duplication; and
       (2) recommendations on an appropriate regulatory framework 
     for health information technology, including a risk-based 
     framework.
       (b) Definition.--In this section, the terms ``health 
     information technology'' has the meaning given such term in 
     section 3000(5) of the Public Health Service Act and includes 
     technologies such as electronic health records, personal 
     health records, mobile medical applications, computerized 
     health care provider order entry systems, and clinical 
     decision support.

                TITLE VIII--DRUG REGULATORY IMPROVEMENTS

                     Subtitle A--Drug Supply Chain

     SEC. 801. REGISTRATION OF PRODUCERS OF DRUGS.

       (a) Timing.--Section 510 (21 U.S.C. 360) is amended--
       (1) in subsection (b)(1), by striking ``On or before'' and 
     inserting ``During the period beginning on October 1 and 
     ending on''; and
       (2) in subsection (i)(1)(B)(i), by striking ``on or 
     before'' and inserting ``during the period beginning on 
     October 1 and ending on''.
       (b) Establishments Not Duly Registered; Misbranding.--
     Section 502(o) (21 U.S.C. 352(o)) is amended by striking ``in 
     any State''.

     SEC. 802. INSPECTION OF DRUGS.

       Subsection (h) of section 510 (21 U.S.C. 360) is amended--
       (1) by striking ``(h)'' and inserting ``(h)(1)'';
       (2) by inserting ``with respect to the manufacture, 
     preparation, propagation,

[[Page 7927]]

     compounding, or processing of a device'' after ``registered 
     with the Secretary pursuant to this section'';
       (3) by striking ``of a drug or drugs or''; and
       (4) by adding at the end the following:
       ``(2) Inspections With Respect to Drug Establishments.--
     With respect to the manufacture, preparation, propagation, 
     compounding, or processing of a drug:
       ``(A) In general.--Every establishment that is required to 
     be registered with the Secretary under this section shall be 
     subject to inspection pursuant to section 704.
       ``(B) Risk-based schedule.--In the case of an establishment 
     that is engaged in the manufacture, preparation, propagation, 
     compounding, or processing of a drug or drugs (referred to in 
     this subsection as a `drug establishment'), the inspections 
     required under subparagraph (A) shall be conducted by 
     officers or employees duly designated by the Secretary, on a 
     risk-based schedule established by the Secretary.
       ``(C) Risk factors.--In establishing the risk-based 
     schedule under subparagraph (B), the Secretary shall allocate 
     resources to inspect establishments according to the known 
     safety risks of such establishments, based on the following 
     factors:
       ``(i) The compliance history of the establishment.
       ``(ii) The inspection frequency and history of the 
     establishment, including whether it has been inspected 
     pursuant to section 704 within the last four years.
       ``(iii) The record, history, and nature of recalls linked 
     to the establishment.
       ``(iv) The inherent risk of the drug manufactured, 
     prepared, propagated, compounded, or processed at the 
     establishment.
       ``(v) Any other criteria deemed necessary and appropriate 
     by the Secretary for purposes of allocating inspection 
     resources.
       ``(D) Effect of status.--In determining the risk associated 
     with an establishment for purposes of establishing a risk-
     based schedule under subparagraph (B), the Secretary shall 
     not consider whether the drugs manufactured, prepared, 
     propagated, compounded, or processed by such establishment 
     are drugs described in section 503(b)(1).
       ``(E) Annual report on inspections of establishments.--Not 
     later than February 1 of each year, the Secretary shall 
     submit to Congress a report that contains the following:
       ``(i) The number of domestic and foreign establishments 
     registered pursuant to this section in the previous calendar 
     year.
       ``(ii) The number of such registered domestic and foreign 
     establishments that the Secretary inspected in the previous 
     calendar year.
       ``(iii) The number of such registered establishments that 
     list one or more drugs approved pursuant to an application 
     filed under section 505(j).
       ``(iv) The number of such registered establishments that 
     list one or more drugs approved pursuant to an application 
     filed under section 505(b).
       ``(v) The number of registered establishments that list 
     both drug products approved pursuant to an application filed 
     under section 505(j) and drug products approved pursuant to 
     an application filed under section 505(b).
       ``(vi) A description of how the Secretary implemented the 
     risk-based schedule under subparagraph (B) utilizing the 
     factors under subparagraph (C).
       ``(F) Public availability of annual reports.--The Secretary 
     shall make the report required under subparagraph (E) 
     available to the public on the Internet Web site of the Food 
     and Drug Administration.''.

     SEC. 803. DRUG SUPPLY QUALITY AND SAFETY.

       Paragraph (a) of section 501 (21 U.S.C. 351) is amended by 
     adding at the end the following: ``For purposes of 
     subparagraph (2)(B), the term `current good manufacturing 
     practice' includes the implementation of oversight and 
     controls over the manufacture of drugs to ensure quality, 
     including managing the risk of and establishing the safety of 
     raw materials, materials used in the manufacturing of drugs, 
     and finished drug products.''.

     SEC. 804. PROHIBITION AGAINST DELAYING, DENYING, LIMITING, OR 
                   REFUSING INSPECTION.

       (a) In General.--Section 501 (21 U.S.C. 351) is amended by 
     adding at the end the following:
       ``(j) If it is a drug and it has been manufactured, 
     processed, packed, or held in any factory, warehouse, or 
     establishment and the owner, operator, or agent of such 
     factory, warehouse, or establishment delays, denies, or 
     limits an inspection, or refuses to permit entry or 
     inspection.''.
       (b) Guidance.--Not later than 1 year after the date of 
     enactment of this section, the Secretary of Health and Human 
     Services shall issue guidance that defines the circumstances 
     that would constitute delaying, denying, or limiting 
     inspection, or refusing to permit entry or inspection, for 
     purposes of section 501(j) of the Federal Food, Drug, and 
     Cosmetic Act (as added by subsection (a)).

     SEC. 805. DESTRUCTION OF ADULTERATED, MISBRANDED, OR 
                   COUNTERFEIT DRUGS OFFERED FOR IMPORT.

       (a) In General.--The sixth sentence of section 801(a) (21 
     U.S.C. 381(a)) is amended by inserting before the period at 
     the end the following: ``, except that the Secretary of 
     Health and Human Services, in consultation with the Secretary 
     of Homeland Security, may cause the destruction, without the 
     opportunity for export, of any drug refused admission that 
     has reasonable probability of causing serious adverse health 
     consequences or death, as determined by the Secretary of 
     Health and Human Services, or that is valued at an amount 
     that is $2,000 or less (or such higher amount as the 
     Secretary of Homeland Security may set by regulation pursuant 
     to section 498 of the Tariff Act of 1930 (19 U.S.C. 1498))''.
       (b) Notice.--Section 801(a) (21 U.S.C. 381(a)), as amended 
     by subsection (a), is further amended by inserting after the 
     sixth sentence the following: ``The Secretary of Health and 
     Human Services shall issue regulations providing for notice 
     and an opportunity for a hearing on the destruction of a drug 
     under the previous sentence. For a drug with a value less 
     than and or equal to $2,000 (or, as described in the sixth 
     sentence of this subsection, such higher amount as the 
     Secretary of Homeland Security may set by regulation pursuant 
     to section 498 of the Tariff Act of 1930 (19 U.S.C. 1498)) 
     the regulations under the previous sentence shall provide for 
     prompt notice and an opportunity for a hearing for the owner 
     or consignee before or after the destruction has occurred. 
     For a drug with a value greater than $2,000 (or, as described 
     in the sixth sentence of this subsection, such higher amount 
     as the Secretary of Homeland Security may set by regulation 
     pursuant to section 498 of the Tariff Act of 1930 (19 U.S.C. 
     1498)) that has reasonable probability of causing serious 
     adverse health consequences or death as determined by the 
     Secretary of Health and Human Services, the regulations under 
     the seventh sentence of this subsection shall provide for 
     notice and an opportunity for a hearing to the owner or 
     consignee before the destruction occurs.''.
       (c) Restitution.--In the regulations described in the 
     seventh sentence of section 801(a) of the Federal Food, Drug, 
     and Cosmetic Act (as added by subsection (b)), the Secretary 
     of Health and Human Services shall establish an 
     administrative process whereby an owner or consignee of a 
     drug destroyed without an opportunity for a hearing on 
     destruction may obtain restitution for the value of the drug 
     destroyed under the sixth sentence of such section upon 
     demonstration that such drug was wrongfully destroyed.
       (d) Conforming Amendment.--The first sentence of section 
     801(a) (21 U.S.C. 381(a)) is amended by inserting ``, except 
     as otherwise described in the sixth and seventh sentences of 
     this subsection,'' after ``giving notice thereof''.

     SEC. 806. ADMINISTRATIVE DETENTION.

       (a) In General.--Section 304(g) (21 U.S.C. 335a(g)) is 
     amended--
       (1) in paragraph (1), by inserting ``, drug,'' after 
     ``device'', each place it appears;
       (2) in paragraph (2)(A), by inserting ``, drug,'' after 
     ``(B), a device''; and
       (3) in paragraph (2)(B), by inserting ``or drug'' after 
     ``device'' each place it appears.
       (b) Regulation.--Not later than 2 years after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services shall promulgate regulations to implement 
     administrative detention authority with respect to drugs, as 
     authorized by the amendments made by subsection (a). Before 
     promulgating such regulations, the Secretary shall consult 
     with stakeholders, including manufacturers of drugs.
       (c) Effective Date.--The amendments made by subsection (a) 
     shall not take effect until the Secretary has issued a final 
     regulation under subsection (b).

     SEC. 807. ENHANCED CRIMINAL PENALTY FOR COUNTERFEIT DRUGS.

       (a) In General.--Section 303(a) (21 U.S.C. 333(a)) is 
     amended by adding at the end the following:
       ``(3) Notwithstanding paragraph (2), any person who engages 
     in any conduct described in section 301(i)(2) knowing or 
     having reason to know that the conduct concerns the rendering 
     of a drug as a counterfeit drug, or who engages in conduct 
     described in section 301(i)(3) knowing or having reason to 
     know that the conduct will cause a drug to be a counterfeit 
     drug or knowing or having reason to know that a drug held, 
     sold, or dispensed is a counterfeit drug, shall be fined in 
     accordance with title 18, United States Code, or imprisoned 
     not more than 20 years, or both, except that if the use of 
     the counterfeit drug by a consumer is the proximate cause of 
     the death of the consumer, the term of imprisonment shall be 
     any term of years or for life.''.
       (b) Conforming Amendment.--Section 201(g)(2) (21 U.S.C. 
     321(g)(2)) is amended by adding at the end the following 
     sentence: ``The term `counterfeit drug' shall not include a 
     drug or placebo intended for use in a clinical trial that is 
     intentionally labeled or marked to maintain proper blinding 
     of the study.''.

     SEC. 808. UNIQUE FACILITY IDENTIFICATION NUMBER.

       (a) Domestic Establishments.--Section 510 (21 U.S.C. 360) 
     is amended--
       (1) in subsection (b)(1), by striking ``and all such 
     establishments'' and inserting ``all such establishments, and 
     the unique facility identifier of each such establishment''; 
     and

[[Page 7928]]

       (2) in subsection (c), by striking ``and such 
     establishment'' and inserting ``such establishment, and the 
     unique facility identifier of such establishment''.
       (b) Foreign Establishments.--Subparagraph (A) of section 
     510(i)(1) (21 U.S.C. 360(i)(1)) is amended by inserting ``the 
     unique facility identifier of the establishment,'' after 
     ``the name and place of business of the establishment,''.
       (c) Guidance.--Section 510 (21 U.S.C. 360) is amended by 
     adding at the end the following:
       ``(q) Guidance on Submission of Unique Facility 
     Identifiers.--
       ``(1) In general.--Not later than 2 years after the date of 
     the enactment of this subsection, the Secretary shall, by 
     guidance, specify--
       ``(A) the unique facility identifier system to be used to 
     meet the requirements of--
       ``(i) subsections (b)(1), (c), and (i)(1)(A) of this 
     section; and
       ``(ii) section 801(s) (relating to registration of 
     commercial importers); and
       ``(B) the form, manner, and timing of submissions of unique 
     facility identifiers under the provisions specified in 
     subparagraph (A).
       ``(2) Consideration.--In developing the guidance under 
     paragraph (1), the Secretary shall take into account the 
     utilization of existing unique identification schemes and 
     compatibility with customs automated systems.''.
       (d) Importation.--Section 801(a) (21 U.S.C. 381(a)) is 
     amended by inserting ``or (5) for an article that is a drug, 
     the appropriate unique facility identifiers under subsection 
     (s) (relating to commercial importers) and section 510(i) 
     (relating to foreign establishments), as specified by the 
     Secretary, are not provided,'' before ``then such article 
     shall be refused admission''.

     SEC. 809. DOCUMENTATION FOR ADMISSIBILITY OF IMPORTS.

       Section 801 (21 U.S.C. 381) is amended by adding at the end 
     the following:
       ``(r) Documentation.--
       ``(1) Submission.--The Secretary may require, in 
     consultation with the Secretary of Homeland Security acting 
     through U.S. Customs and Border Protection as determined 
     appropriate by the Secretary, the submission of documentation 
     or other information for a drug that is imported or offered 
     for import into the United States.
       ``(2) Refusal of admission.--A drug imported or offered for 
     import into the United States shall be refused admission 
     unless all documentation and information the Secretary 
     requires under this Act, the Public Health Service Act, or 
     both, as appropriate, for such article is submitted.
       ``(3) Regulations.--
       ``(A) Documents and information.--The Secretary shall issue 
     a regulation to specify the documentation or other 
     information that is described in paragraph (1). Such 
     information may include--
       ``(i) information demonstrating the regulatory status of 
     the drug, such as the new drug application, abbreviated new 
     drug application, or investigational new drug or Drug Master 
     File number;
       ``(ii) facility information, such as proof of registration 
     and the unique facility identifier; and
       ``(iii) indication of compliance with current good 
     manufacturing practice, such as satisfactory testing results, 
     certifications relating to satisfactory inspections, and 
     compliance with the country of export regulations.
       ``(B) Exemption.--The Secretary may, by regulation, exempt 
     drugs imported for research purposes only and other types of 
     drug imports from some or all of the requirements of this 
     subsection.
       ``(4) Effective date.--The final rule under paragraph 
     (3)(A) shall take effect not less than 180 days after the 
     Secretary promulgates such final rule.''.

     SEC. 810. REGISTRATION OF COMMERCIAL IMPORTERS.

       (a) Prohibitions.--Section 301 (21 U.S.C. 331) is amended 
     by adding at the end the following:
       ``(aaa) The failure to register in accordance with section 
     801(s).''.
       (b) Registration.--Section 801 (21 U.S.C. 381), as amended 
     by section 809, is further amended by adding at the end the 
     following:
       ``(s) Registration of Commercial Importers.--
       ``(1) Registration.--The Secretary shall require a 
     commercial importer of drugs--
       ``(A) to be registered with the Secretary in a form and 
     manner specified by the Secretary; and
       ``(B) consistent with the guidance under section 510(q), to 
     submit, at the time of registration, a unique identifier for 
     the principal place of business for which the importer is 
     required to register under this subsection.
       ``(2) Regulations.--
       ``(A) In general.--The Secretary, in consultation with the 
     Secretary of Homeland Security acting through U.S. Customs 
     and Border Protection, shall promulgate regulations to 
     establish good importer practices that specify the measures 
     an importer shall take to ensure imported drugs are in 
     compliance with the requirements of this Act and the Public 
     Health Service Act.
       ``(B) Expedited clearance for certain importers.--In 
     promulgating good importer practice regulations under 
     subparagraph (A), the Secretary may, as appropriate, take 
     into account differences among importers and types of 
     imports, and, based on the level of risk posed by the 
     imported drug, provide for expedited clearance for those 
     importers that volunteer to participate in partnership 
     programs for highly compliant companies.
       ``(3) Discontinuance of registration.--The Secretary shall 
     discontinue the registration of any commercial importer of 
     drugs that fails to comply with the regulations promulgated 
     under this subsection.
       ``(4) Exemptions.--The Secretary, by notice in the Federal 
     Register, may establish exemptions from the requirements of 
     this subsection.''.
       (c) Misbranding.--Section 502(o) (21 U.S.C. 352) is amended 
     by inserting ``if it is a drug and was imported or offered 
     for import by a commercial importer of drugs not duly 
     registered under section 801(s),'' after ``not duly 
     registered under section 510,''.
       (d) Regulations.--
       (1) In general.--Not later than 36 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services, in consultation with the Secretary of Homeland 
     Security acting through U.S. Customs and Border Protection, 
     shall promulgate the regulations required to carry out 
     section 801(s) of the Federal Food, Drug, and Cosmetic Act, 
     as added by subsection (b).
       (2) Effective date.--In establishing the effective date of 
     the regulations under paragraph (1), the Secretary of Health 
     and Human Services shall, in consultation with the Secretary 
     of Homeland Security acting through U.S. Customs and Border 
     Protection, as determined appropriate by the Secretary of 
     Health and Human Services, provide a reasonable period of 
     time for an importer of a drug to comply with good importer 
     practices, taking into account differences among importers 
     and types of imports, including based on the level of risk 
     posed by the imported product.

     SEC. 811. NOTIFICATION.

       (a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as 
     amended by section 810, is further amended by adding at the 
     end the following:
       ``(bbb) The failure to notify the Secretary in violation of 
     section 568.''.
       (b) Notification.--Subchapter E of chapter V (21 U.S.C. 
     360bbb et seq.) is amended by adding at the end the 
     following:

     ``SEC. 568. NOTIFICATION.

       ``(a) Notification to Secretary.--With respect to a drug, 
     the Secretary may require notification to the Secretary by a 
     regulated person if the regulated person knows--
       ``(1) that the use of such drug in the United States may 
     result in serious injury or death;
       ``(2) of a significant loss or known theft of such drug 
     intended for use in the United States; or
       ``(3) that--
       ``(A) such drug has been or is being counterfeited; and
       ``(B)(i) the counterfeit product is in commerce in the 
     United States or could be reasonably expected to be 
     introduced into commerce; or
       ``(ii) such drug has been or is being imported into the 
     United States or may reasonably be expected to be offered for 
     import into the United States.
       ``(b) Manner of Notification.--Notification under this 
     section shall be made in such manner and by such means as the 
     Secretary may specify by regulation or guidance.
       ``(c) Savings Clause.--Nothing in this section shall be 
     construed as limiting any other authority of the Secretary to 
     require notifications related to a drug under any other 
     provision of this Act or the Public Health Service Act.
       ``(d) Definition.--In this section, the term `regulated 
     person' means--
       ``(1) a person who is required to register under section 
     510 or 801(s);
       ``(2) a wholesale distributor of a drug product; or
       ``(3) any other person that distributes drugs except a 
     person that distributes drugs exclusively for retail sale.''.

     SEC. 812. EXCHANGE OF INFORMATION.

       Section 708 (21 U.S.C. 379) is amended--
       (1) by striking ``The Secretary may provide'' and inserting 
     the following:
       ``(a) Contractors.--The Secretary may provide''; and
       (2) by adding at the end the following:
       ``(b) Ability To Receive and Protect Confidential 
     Information.--Except pursuant to an order of a court of the 
     United States, the Secretary shall not be required to 
     disclose under section 552 of title 5, United States Code, or 
     any other provision of law, any information relating to drugs 
     obtained from a Federal, State, or local government agency, 
     or from a foreign government agency, if the agency has 
     requested that the information be kept confidential. For 
     purposes of section 552 of title 5, United States Code, this 
     subsection shall be considered a statute described in section 
     552(b)(3)(B).
       ``(c) Authority To Enter Into Memoranda of Understanding 
     for Purposes of Information Exchange.--The Secretary may 
     enter into written agreements regarding the exchange of 
     information referenced in section 301(j) subject to the 
     following criteria:
       ``(1) Certification.--The Secretary may only enter into 
     written agreements under

[[Page 7929]]

     this subsection with foreign governments that the Secretary 
     has certified as having the authority and demonstrated 
     ability to protect trade secret information from disclosure. 
     Responsibility for this certification shall not be delegated 
     to any officer or employee other than the Commissioner of 
     Food and Drugs.
       ``(2) Written agreement.--The written agreement under this 
     subsection shall include a commitment by the foreign 
     government to protect information exchanged under this 
     subsection from disclosure unless and until the sponsor gives 
     written permission for disclosure or the Secretary makes a 
     declaration of a public health emergency pursuant to section 
     319 of the Public Health Service Act that is relevant to the 
     information.
       ``(3) Information exchange.--The Secretary may provide to a 
     foreign government that has been certified under paragraph 
     (1), and that has executed a written agreement under 
     paragraph (2), information referenced in section 301(j) in 
     the following circumstances:
       ``(A) Information concerning the inspection of a facility 
     may be provided if--
       ``(i) the Secretary reasonably believes, or the written 
     agreement described in paragraph (2) establishes, that the 
     government has authority to otherwise obtain such 
     information; and
       ``(ii) the written agreement executed under paragraph (2) 
     limits the recipient's use of the information to the 
     recipient's civil regulatory purposes.
       ``(B) Information not described in subparagraph (A) may be 
     provided as part of an investigation, or to alert the foreign 
     government to the potential need for an investigation, if the 
     Secretary has reasonable grounds to believe that a drug has a 
     reasonable probability of causing serious adverse health 
     consequences or death.
       ``(d) No Limitation on Authority.--This section shall not 
     affect the authority of the Secretary to provide or disclose 
     information under any other provision of law.''.

     SEC. 813. EXTRATERRITORIAL JURISDICTION.

       Chapter III (21 U.S.C. 331 et seq.) is amended by adding at 
     the end the following:

     ``SEC. 311. EXTRATERRITORIAL JURISDICTION.

       ``There is extraterritorial jurisdiction over any violation 
     of this Act relating to any article regulated under this Act 
     if such article was intended for import into the United 
     States or if any act in furtherance of the violation was 
     committed in the United States.''.

     SEC. 814. PROTECTION AGAINST INTENTIONAL ADULTERATION.

       Section 303(b) (21 U.S.C. 333(b)) is amended by adding at 
     the end the following:
       ``(7) Notwithstanding subsection (a)(2), any person that 
     knowingly and intentionally engages in an activity that 
     results in a drug becoming adulterated under subsection 
     (a)(1), (b), (c), or (d) of section 501 and having a 
     reasonable probability of causing serious adverse health 
     consequences or death shall be imprisoned for not more than 
     20 years or fined not more than $1,000,000, or both.''.

     SEC. 815. RECORDS FOR INSPECTION.

       Section 704(a) (21 U.S.C. 374(a)) is amended by adding at 
     the end the following:
       ``(4)(A) Any records or other information that the 
     Secretary may inspect under this section from a person that 
     owns or operates an establishment that is engaged in the 
     manufacture, preparation, propagation, compounding, or 
     processing of a drug shall, upon the request of the 
     Secretary, be provided to the Secretary by such person, in 
     advance of or in lieu of an inspection, within a reasonable 
     timeframe, within reasonable limits, and in a reasonable 
     manner, and in either electronic or physical form, at the 
     expense of such person. The Secretary's request shall include 
     a sufficient description of the records requested.
       ``(B) Upon receipt of the records requested under 
     subparagraph (A), the Secretary shall provide to the person 
     confirmation of receipt.
       ``(C) Nothing in this paragraph supplants the authority of 
     the Secretary to conduct inspections otherwise permitted 
     under this Act in order to ensure compliance with this 
     Act.''.

                     Subtitle B--Medical Gas Safety

     SEC. 821. REGULATION OF MEDICAL GASES.

       Chapter V (21 U.S.C. 351 et seq.) is amended by adding at 
     the end the following:

                     ``Subchapter G--Medical Gases

     ``SEC. 575. DEFINITIONS.

       ``In this subchapter:
       ``(1) The term `designated medical gas' means any of the 
     following:
       ``(A) Oxygen that meets the standards set forth in an 
     official compendium.
       ``(B) Nitrogen that meets the standards set forth in an 
     official compendium.
       ``(C) Nitrous oxide that meets the standards set forth in 
     an official compendium.
       ``(D) Carbon dioxide that meets the standards set forth in 
     an official compendium.
       ``(E) Helium that meets the standards set forth in an 
     official compendium.
       ``(F) Carbon monoxide that meets the standards set forth in 
     an official compendium.
       ``(G) Medical air that meets the standards set forth in an 
     official compendium.
       ``(H) Any other medical gas deemed appropriate by the 
     Secretary, after taking into account any investigational new 
     drug application or investigational new animal drug 
     application for the same medical gas submitted in accordance 
     with regulations applicable to such applications in title 21 
     of the Code of Federal Regulations, unless any period of 
     exclusivity under section 505(c)(3)(E)(ii) or section 
     505(j)(5)(F)(ii), or the extension of any such period under 
     section 505A, applicable to such medical gas has not expired.
       ``(2) The term `medical gas' means a drug that--
       ``(A) is manufactured or stored in a liquefied, 
     nonliquefied, or cryogenic state; and
       ``(B) is administered as a gas.

     ``SEC. 576. REGULATION OF MEDICAL GASES.

       ``(a) Certification of Designated Medical Gases.--
       ``(1) Submission.--Beginning 180 days after the date of 
     enactment of this section, any person may file with the 
     Secretary a request for certification of a medical gas as a 
     designated medical gas. Any such request shall contain the 
     following information:
       ``(A) A description of the medical gas.
       ``(B) The name and address of the sponsor.
       ``(C) The name and address of the facility or facilities 
     where the medical gas is or will be manufactured.
       ``(D) Any other information deemed appropriate by the 
     Secretary to determine whether the medical gas is a 
     designated medical gas.
       ``(2) Grant of certification.--The certification requested 
     under paragraph (1) is deemed to be granted unless, within 60 
     days of the filing of such request, the Secretary finds 
     that--
       ``(A) the medical gas subject to the certification is not a 
     designated medical gas;
       ``(B) the request does not contain the information required 
     under paragraph (1) or otherwise lacks sufficient information 
     to permit the Secretary to determine that the medical gas is 
     a designated medical gas; or
       ``(C) denying the request is necessary to protect the 
     public health.
       ``(3) Effect of certification.--
       ``(A) In general.--
       ``(i) Approved uses.--A designated medical gas for which a 
     certification is granted under paragraph (2) is deemed, alone 
     or in combination, as medically appropriate, with another 
     designated medical gas or gases for which a certification or 
     certifications have been granted, to have in effect an 
     approved application under section 505 or 512, subject to all 
     applicable post-approval requirements, for the following 
     indications for use:

       ``(I) In the case of oxygen, the treatment or prevention of 
     hypoxemia or hypoxia.
       ``(II) In the case of nitrogen, use in hypoxic challenge 
     testing.
       ``(III) In the case of nitrous oxide, analgesia.
       ``(IV) In the case of carbon dioxide, use in extracorporeal 
     membrane oxygenation therapy or respiratory stimulation.
       ``(V) In the case of helium, the treatment of upper airway 
     obstruction or increased airway resistance.
       ``(VI) In the case of medical air, to reduce the risk of 
     hyperoxia.
       ``(VII) In the case of carbon monoxide, use in lung 
     diffusion testing.
       ``(VIII) Any other indication for use for a designated 
     medical gas or combination of designated medical gases deemed 
     appropriate by the Secretary, unless any period of 
     exclusivity under clause (iii) or (iv) of section 
     505(c)(3)(E), clause (iii) or (iv) of section 505(j)(5)(F), 
     or section 527, or the extension of any such period under 
     section 505A, applicable to such indication for use for such 
     gas or combination of gases has not expired.

       ``(ii) Labeling.--The requirements of sections 503(b)(4) 
     and 502(f) are deemed to have been met for a designated 
     medical gas if the labeling on final use container for such 
     medical gas bears--

       ``(I) the information required by section 503(b)(4);
       ``(II) a warning statement concerning the use of the 
     medical gas as determined by the Secretary by regulation; and
       ``(III) appropriate directions and warnings concerning 
     storage and handling.

       ``(B) Inapplicability of exclusivity provisions.--
       ``(i) No exclusivity for a certified medical gas.--No 
     designated medical gas deemed under subparagraph (A)(i) to 
     have in effect an approved application is eligible for any 
     period of exclusivity under section 505(c), 505(j), or 527, 
     or the extension of any such period under section 505A, on 
     the basis of such deemed approval.
       ``(ii) Effect on certification.--No period of exclusivity 
     under section 505(c), 505(j), or section 527, or the 
     extension of any such period under section 505A, with respect 
     to an application for a drug product shall prohibit, limit, 
     or otherwise affect the submission, grant, or effect of a 
     certification under this section, except as provided in 
     subsection (a)(3)(A)(i)(VIII) and section 575(1)(H).
       ``(4) Withdrawal, suspension, or revocation of approval.--
       ``(A) Withdrawal, suspension of approval.--Nothing in this 
     subchapter limits the Secretary's authority to withdraw or 
     suspend approval of a drug product, including a designated 
     medical gas deemed under this section to have in effect an 
     approved application under section 505 or section 512 of this 
     Act.

[[Page 7930]]

       ``(B) Revocation of certification.--The Secretary may 
     revoke the grant of a certification under paragraph (2) if 
     the Secretary determines that the request for certification 
     contains any material omission or falsification.
       ``(b) Prescription Requirement.--
       ``(1) In general.--A designated medical gas shall be 
     subject to the requirements of section 503(b)(1) unless the 
     Secretary exercises the authority provided in section 
     503(b)(3) to remove such medical gas from the requirements of 
     section 503(b)(1), the gas is approved for use without a 
     prescription pursuant to an application under section 505 or 
     512, or the use in question is authorized pursuant to another 
     provision of this Act relating to use of medical products in 
     emergencies.
       ``(2) Oxygen.--
       ``(A) No prescription required for certain uses.--
     Notwithstanding paragraph (1), oxygen may be provided without 
     a prescription for the following uses:
       ``(i) For use in the event of depressurization or other 
     environmental oxygen deficiency.
       ``(ii) For oxygen deficiency or for use in emergency 
     resuscitation, when administered by properly trained 
     personnel.
       ``(B) Labeling.--For oxygen provided pursuant to 
     subparagraph (A), the requirements of section 503(b)(4) shall 
     be deemed to have been met if its labeling bears a warning 
     that the oxygen can be used for emergency use only and for 
     all other medical applications a prescription is required.

     ``SEC. 577. INAPPLICABILITY OF DRUG FEES TO DESIGNATED 
                   MEDICAL GASES.

       ``A designated medical gas, alone or in combination with 
     another designated gas or gases (as medically appropriate) 
     deemed under section 576 to have in effect an approved 
     application shall not be assessed fees under section 736(a) 
     on the basis of such deemed approval.''.

     SEC. 822. CHANGES TO REGULATIONS.

       (a) Report.--Not later than 18 months after the date of the 
     enactment of this Act, the Secretary, after obtaining input 
     from medical gas manufacturers and any other interested 
     members of the public, shall--
       (1) determine whether any changes to the Federal drug 
     regulations are necessary for medical gases; and
       (2) 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 regarding 
     any such changes.
       (b) Regulations.--If the Secretary determines under 
     subsection (a) that changes to the Federal drug regulations 
     are necessary for medical gases, the Secretary shall issue 
     final regulations revising the Federal drug regulations with 
     respect to medical gases not later than 48 months after the 
     date of the enactment of this Act.
       (c) Definitions.--In this section:
       (1) The term ``Federal drug regulations'' means regulations 
     in title 21 of the Code of Federal Regulations pertaining to 
     drugs.
       (2) The term ``medical gas'' has the meaning given to such 
     term in section 575 of the Federal Food, Drug, and Cosmetic 
     Act, as added by section 821 of this Act.
       (3) The term ``Secretary'' means the Secretary of Health 
     and Human Services, acting through the Commissioner of Food 
     and Drugs.

     SEC. 823. RULES OF CONSTRUCTION.

       Nothing in this subtitle and the amendments made by this 
     subtitle applies with respect to--
       (1) a drug that is approved prior to May 1, 2012, pursuant 
     to an application submitted under section 505 or 512 of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355, 360b);
       (2) any gas listed in subparagraphs (A) through (G) of 
     section 575(1) of the Federal Food, Drug, and Cosmetic Act, 
     as added by section 821 of this Act, or any combination of 
     any such gases, for an indication that--
       (A) is not included in, or is different from, those 
     specified in subclauses (I) through (VII) of section 
     576(a)(3)(A)(i) of such Act; and
       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under Section 505 or 512; or
       (3) any designated medical gas added pursuant to 
     subparagraph (H) of section 575(1) of such Act for an 
     indication that--
       (A) is not included in, or is different from, those 
     originally added pursuant to subparagraph (H) of section 
     575(1) and section 576(a)(3)(A)(i)(VIII); and
       (B) is approved on or after May 1, 2012, pursuant to an 
     application submitted under section 505 or 512 of such Act.

            Subtitle C--Generating Antibiotic Incentives Now

     SEC. 831. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.

       (a) In General.--The Federal Food, Drug, and Cosmetic Act 
     is amended by inserting after section 505D (21 U.S.C. 355e) 
     the following:

     ``SEC. 505E. EXTENSION OF EXCLUSIVITY PERIOD FOR NEW 
                   QUALIFIED INFECTIOUS DISEASE PRODUCTS.

       ``(a) Extension.--If the Secretary approves an application 
     pursuant to section 505 for a drug that has been determined 
     to be a qualified infectious disease product under subsection 
     (d), then the four- and five-year periods described in 
     subsections (c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, 
     the three-year periods described in clauses (iii) and (iv) of 
     subsection (c)(3)(E) and clauses (iii) and (iv) of subsection 
     (j)(5)(F) of section 505, or the seven year period described 
     in section 527, as applicable, shall be extended by five 
     years.
       ``(b) Relation to Pediatric Exclusivity.--Any extension 
     under subsection (a) of a period shall be in addition to any 
     extension of the period under section 505A with respect to 
     the drug.
       ``(c) Limitations.--Subsection (a) does not apply to the 
     approval of--
       ``(1) a supplement to an application under section 505(b) 
     for any qualified infectious disease product for which an 
     extension described in subsection (a) is in effect or has 
     expired;
       ``(2) a subsequent application filed by the same sponsor or 
     manufacturer of a qualified infectious disease product 
     described in paragraph (1) (or a licensor, predecessor in 
     interest, or other related entity) for--
       ``(A) a change (not including a modification to the active 
     moiety of the qualified infectious disease product) that 
     results in a new indication, route of administration, dosing 
     schedule, dosage form, delivery system, delivery device, or 
     strength; or
       ``(B) a modification to the active moiety of the qualified 
     infectious disease product that does not result in a change 
     in safety or effectiveness; or
       ``(3) a product that does not meet the definition of a 
     qualified infectious disease product under subsection (f) 
     based upon its approved uses.
       ``(d) Determination.--The manufacturer or sponsor of a drug 
     may request that the Secretary designate a drug as a 
     qualified infectious disease product at any time in the drug 
     development process prior to the submission of an application 
     under section 505(b) for the drug, but not later than 45 days 
     before the submission of such application. The Secretary 
     shall, not later than 30 days after the submission of such 
     request, determine whether the drug is a qualified infectious 
     disease product.
       ``(e) Regulations.--The Secretary shall promulgate 
     regulations for carrying out this section. The Secretary 
     shall promulgate the initial regulations for carrying out 
     this section not later than 12 months after the date of the 
     enactment of this section.
       ``(f) Definitions.--In this section:
       ``(1) Qualified infectious disease product.--The term 
     `qualified infectious disease product' means an antibacterial 
     or antifungal drug for human use that treats or prevents an 
     infection caused by a qualifying pathogen.
       ``(2) Qualifying pathogen.--The term `qualifying pathogen' 
     means--
       ``(A) resistant gram-positive pathogens, including 
     methicillin-resistant Staphylococcus aureus (MRSA), 
     vancomycin-resistant Staphylococcus aureus (VRSA), and 
     vancomycin-resistant enterococcus (VRE);
       ``(B) multidrug resistant gram-negative bacteria, including 
     Acinetobacter, Klebsiella, Pseudomonas, and E. coli species;
       ``(C) multi-drug resistant tuberculosis; or
       ``(D) any other infectious pathogen identified for purposes 
     of this section by the Secretary.''.
       (b) Application.--Section 505E of the Federal Food, Drug, 
     and Cosmetic Act, as added by subsection (a), applies only 
     with respect to a drug that is first approved under section 
     505(c) of such Act (21 U.S.C. 355(c)) on or after the date of 
     the enactment of this Act.

     SEC. 832. STUDY ON INCENTIVES FOR QUALIFIED INFECTIOUS 
                   DISEASE BIOLOGICAL PRODUCTS.

       (a) In General.--The Comptroller General of the United 
     States shall--
       (1) conduct a study on the need for incentives to encourage 
     research on and development and marketing of qualified 
     infectious disease biological products; and
       (2) not later than 1 year after the date of the enactment 
     of this Act, submit a report to the Congress on the results 
     of such study, including any recommendations of the 
     Comptroller General on appropriate incentives for addressing 
     such need.
       (b) Definitions.--In this section:
       (1) The term ``biological product'' has the meaning given 
     to such term in section 351 of the Public Health Service Act 
     (42 U.S.C. 262).
       (2) The term ``qualified infectious disease biological 
     product'' means a biological product for human use that 
     treats or prevents an infection caused by a qualifying 
     pathogen.
       (3) The term ``qualifying pathogen'' has the meaning given 
     to such term in section 505E of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 831 of this Act.

     SEC. 833. CLINICAL TRIALS.

       (a) Review and Revision of Guidelines.--
       (1) In general.--Not later than 1 year after the date of 
     the enactment of this Act, and not later than 4 years 
     thereafter, the Secretary shall--
       (A) review the guidance of the Food and Drug Administration 
     for the conduct of clinical trials with respect to 
     antibacterial and antifungal drugs; and
       (B) as appropriate, revise such guidance to reflect 
     developments in scientific and medical information and 
     technology and to ensure clarity regarding the procedures and 
     requirements for approval of an antibiotic and antifungal 
     drug under chapter V of the Federal Food, Drug, and Cosmetic 
     Act (21 U.S.C. 351 et seq.).

[[Page 7931]]

       (2) Issues for review.--At a minimum, the review under 
     paragraph (1) shall address the appropriate animal models of 
     infection, in vitro techniques, valid microbiological 
     surrogate markers, the use of noninferiority versus 
     superiority trials, and appropriate delta values for 
     noninferiority trials.
       (3) Rule of construction.--Except to the extent to which 
     the Secretary of Health and Human Services makes revisions 
     under paragraph (1)(B), nothing in this section shall be 
     construed to repeal or otherwise affect the guidance of the 
     Food and Drug Administration.
       (b) Recommendations for Investigations.--
       (1) Request.--The sponsor of a drug intended to be used to 
     treat or prevent a qualifying pathogen may request that the 
     Secretary provide written recommendations for nonclinical and 
     clinical investigations which may be conducted with the drug 
     before it may be approved for such use under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
       (2) Recommendations.--If the Secretary has reason to 
     believe that a drug for which a request is made under this 
     subsection is a qualified infectious disease product, the 
     Secretary shall provide the person making the request written 
     recommendations for the nonclinical and clinical 
     investigations which the Secretary believes, on the basis of 
     information available to the Secretary at the time of the 
     request, would be necessary for approval under section 505 of 
     the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) of 
     such drug for the use described in paragraph (1).
       (c) Definitions.--In this section:
       (1) The term ``drug'' has the meaning given to such term in 
     section 201 of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 321).
       (2) The term ``qualified infectious disease product'' has 
     the meaning given to such term in section 505E of the Federal 
     Food, Drug, and Cosmetic Act, as added by section 831 of this 
     Act.
       (3) The term ``qualifying pathogen'' has the meaning given 
     to such term in section 505E of the Federal Food, Drug, and 
     Cosmetic Act, as added by section 831 of this Act.
       (4) The term ``Secretary'' means the Secretary of Health 
     and Human Services, acting through the Commissioner of Food 
     and Drugs.

     SEC. 834. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE 
                   PRODUCT INCENTIVES IN 5 YEARS.

       Not later than five years after the date of enactment of 
     this Act, the Secretary of Health and Human Services shall, 
     in consultation with the Food and Drug Administration, 
     Centers for Disease Control and Prevention and other 
     appropriate agencies, 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 
     that contains the following:
       (1)(A) The number of initial designations of drugs as 
     qualified infectious disease products under section 505E of 
     the Federal Food, Drug, and Cosmetic Act;
       (B) the number of qualified infectious disease products 
     approved under this program; and
       (C) whether such products address the need for 
     antibacterial and antifungal drugs to treat serious and life-
     threatening infections.
       (2) Recommendations--
       (A) based on the information in paragraph (1) and any other 
     relevant data, on any changes that should be made to the list 
     of pathogens that are defined as qualifying pathogens under 
     section 505E(f)(2) of the Federal Food, Drug, and Cosmetic 
     Act, as added by section 831; and
       (B) on whether any additional program (such as the 
     development of public-private collaborations to advance 
     antibacterial drug innovation) or changes to the incentives 
     under this subtitle may be needed to promote the development 
     of antibacterial drugs.
       (3) An examination of--
       (A) the adoption of programs to measure the use of 
     antibacterial drugs in health care settings; and
       (B) the implementation and effectiveness of antimicrobial 
     stewardship protocols across all health care settings.
       (4) Any recommendations for ways to encourage further 
     development and establishment of stewardship programs.

     SEC. 835. GUIDANCE ON PATHOGEN-FOCUSED ANTIBACTERIAL DRUG 
                   DEVELOPMENT.

       (a) Draft Guidance.--Not later than June 30, 2013, in order 
     to facilitate the development of antibacterial drugs for 
     serious or life-threatening bacterial infections, 
     particularly in areas of unmet need, the Secretary of Health 
     and Human Services shall publish draft guidance that--
       (1) specifies how preclinical and clinical data can be 
     utilized to inform an efficient and streamlined pathogen-
     focused antibacterial drug development program that meets the 
     approval standards of the Food and Drug Administration; and
       (2) provides advice on approaches for the development of 
     antibacterial drugs that target a more limited spectrum of 
     pathogens.
       (b) Final Guidance.--Not later than December 31, 2014, 
     after notice and opportunity for public comment on the draft 
     guidance under subsection (a), the Secretary of Health and 
     Human Services shall publish final guidance consistent with 
     this section.

                    Subtitle D--Accelerated Approval

     SEC. 841. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
                   THREATENING DISEASES OR CONDITIONS.

       (a) Findings; Sense of Congress.--
       (1) Findings.--The Congress finds as follows:
       (A) The Food and Drug Administration (referred to in this 
     subsection as the ``FDA'') serves a critical role in helping 
     to assure that new medicines are safe and effective. 
     Regulatory innovation is 1 element of the Nation's strategy 
     to address serious and life-threatening diseases or 
     conditions by promoting investment in and development of 
     innovative treatments for unmet medical needs.
       (B) During the 2 decades following the establishment of the 
     accelerated approval mechanism, advances in medical sciences, 
     including genomics, molecular biology, and bioinformatics, 
     have provided an unprecedented understanding of the 
     underlying biological mechanism and pathogenesis of disease. 
     A new generation of modern, targeted medicines is under 
     development to treat serious and life-threatening diseases, 
     some applying drug development strategies based on biomarkers 
     or pharmacogenomics, predictive toxicology, clinical trial 
     enrichment techniques, and novel clinical trial designs, such 
     as adaptive clinical trials.
       (C) As a result of these remarkable scientific and medical 
     advances, the FDA should be encouraged to implement more 
     broadly effective processes for the expedited development and 
     review of innovative new medicines intended to address unmet 
     medical needs for serious or life-threatening diseases or 
     conditions, including those for rare diseases or conditions, 
     using a broad range of surrogate or clinical endpoints and 
     modern scientific tools earlier in the drug development cycle 
     when appropriate. This may result in fewer, smaller, or 
     shorter clinical trials for the intended patient population 
     or targeted subpopulation without compromising or altering 
     the high standards of the FDA for the approval of drugs.
       (D) Patients benefit from expedited access to safe and 
     effective innovative therapies to treat unmet medical needs 
     for serious or life-threatening diseases or conditions.
       (E) For these reasons, the statutory authority in effect on 
     the day before the date of enactment of this Act governing 
     expedited approval of drugs for serious or life-threatening 
     diseases or conditions should be amended in order to enhance 
     the authority of the FDA to consider appropriate scientific 
     data, methods, and tools, and to expedite development and 
     access to novel treatments for patients with a broad range of 
     serious or life-threatening diseases or conditions.
       (2) Sense of congress.--It is the sense of the Congress 
     that the FDA should apply the accelerated approval and fast 
     track provisions set forth in section 506 of the Federal 
     Food, Drug, and Cosmetic Act (21 U.S.C. 356), as amended by 
     this section, to help expedite the development and 
     availability to patients of treatments for serious or life-
     threatening diseases or conditions while maintaining safety 
     and effectiveness standards for such treatments.
       (b) Expedited Approval.--Section 506 (21 U.S.C. 356) is 
     amended to read as follows:

     ``SEC. 506. EXPEDITED APPROVAL OF DRUGS FOR SERIOUS OR LIFE-
                   THREATENING DISEASES OR CONDITIONS.

       ``(a) Designation of Drug as a Fast Track Product.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a new drug, facilitate the development and 
     expedite the review of such drug if it is intended, whether 
     alone or in combination with one or more other drugs, for the 
     treatment of a serious or life-threatening disease or 
     condition, and it demonstrates the potential to address unmet 
     medical needs for such a disease or condition. In this 
     section, such a drug is referred to as a `fast track 
     product'.
       ``(2) Request for designation.--The sponsor of a new drug 
     may request the Secretary to designate the drug as a fast 
     track product. A request for the designation may be made 
     concurrently with, or at any time after, submission of an 
     application for the investigation of the drug under section 
     505(i) of this Act or section 351(a)(3) of the Public Health 
     Service Act.
       ``(3) Designation.--Within 60 calendar days after the 
     receipt of a request under paragraph (2), the Secretary shall 
     determine whether the drug that is the subject of the request 
     meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a fast track product 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such product.
       ``(b) Accelerated Approval of a Drug for a Serious or Life-
     Threatening Disease or Condition, Including a Fast Track 
     Product.--
       ``(1) In general.--The Secretary may approve an application 
     for approval of a product for a serious or life-threatening 
     disease or condition, including a fast track product, under 
     section 505(c) of this Act or section

[[Page 7932]]

     351(a) of the Public Health Service Act upon making a 
     determination that the product has an effect on--
       ``(A) a surrogate endpoint that is reasonably likely to 
     predict clinical benefit; or
       ``(B) a clinical endpoint that can be measured earlier than 
     irreversible morbidity or mortality, that is reasonably 
     likely to predict an effect on irreversible morbidity or 
     mortality or other clinical benefit,

     taking into account the severity or rarity of the disease or 
     condition and the availability of alternative treatments. The 
     evidence to support that an endpoint is reasonably likely to 
     predict clinical benefit may include epidemiological, 
     pathophysiologic, pharmacologic, therapeutic or other 
     evidence developed using, for example, biomarkers, or other 
     scientific methods or tools.
       ``(2) Limitation.--Approval of a product under this 
     subsection may, as determined by the Secretary, be subject to 
     the following requirements--
       ``(A) that the sponsor conduct appropriate post-approval 
     studies to verify and describe the predicted effect of the 
     product on irreversible morbidity or mortality or other 
     clinical benefit; and
       ``(B) that the sponsor submit copies of all promotional 
     materials related to the product, at least 30 days prior to 
     dissemination of the materials--
       ``(i) during the preapproval review period; and
       ``(ii) following approval, for a period that the Secretary 
     determines to be appropriate.
       ``(3) Expedited withdrawal of approval.--The Secretary may 
     withdraw approval of a product approved pursuant to this 
     subsection using expedited procedures (as prescribed by the 
     Secretary in regulations, which shall include an opportunity 
     for an informal hearing) if--
       ``(A) the sponsor fails to conduct any required post-
     approval study of the product with due diligence;
       ``(B) a study required to verify and describe the predicted 
     effect on irreversible morbidity or mortality or other 
     clinical benefit of the product fails to verify and describe 
     such effect or benefit;
       ``(C) other evidence demonstrates that the product is not 
     safe or effective under the conditions of use; or
       ``(D) the sponsor disseminates false or misleading 
     promotional materials with respect to the product.
       ``(c) Review of Incomplete Applications for Approval of a 
     Fast Track Product.--
       ``(1) In general.--If the Secretary determines, after 
     preliminary evaluation of clinical data submitted by the 
     sponsor, that a fast track product may be effective, the 
     Secretary shall evaluate for filing, and may commence review 
     of portions of, an application for the approval of the 
     product before the sponsor submits a complete application. 
     The Secretary shall commence such review only if the 
     applicant--
       ``(A) provides a schedule for submission of information 
     necessary to make the application complete; and
       ``(B) pays any fee that may be required under section 736.
       ``(2) Exception.--Any time period for review of human drug 
     applications that has been agreed to by the Secretary and 
     that has been set forth in goals identified in letters of the 
     Secretary (relating to the use of fees collected under 
     section 736 to expedite the drug development process and the 
     review of human drug applications) shall not apply to an 
     application submitted under paragraph (1) until the date on 
     which the application is complete.
       ``(d) Awareness Efforts.--The Secretary shall--
       ``(1) develop and disseminate to physicians, patient 
     organizations, pharmaceutical and biotechnology companies, 
     and other appropriate persons a description of the provisions 
     of this section applicable to accelerated approval and fast 
     track products; and
       ``(2) establish a program to encourage the development of 
     surrogate and clinical endpoints, including biomarkers, and 
     other scientific methods and tools that can assist the 
     Secretary in determining whether the evidence submitted in an 
     application is reasonably likely to predict clinical benefit 
     for serious or life-threatening conditions for which there 
     exist significant unmet medical needs.''.

     SEC. 842. GUIDANCE; AMENDED REGULATIONS.

       (a) Initial Guidance.--Not later than one year after the 
     date of enactment of this Act, the Secretary of Health and 
     Human Services (in this subtitle referred to as the 
     ``Secretary'') shall issue draft guidance to implement the 
     amendment made by section 841.
       (b) Final Guidance.--Not later than one year after the 
     issuance of draft guidance under subsection (a), after an 
     opportunity for public comment, the Secretary shall--
       (1) issue final guidance to implement the amendment made by 
     section 841; and
       (2) amend the regulations governing accelerated approval in 
     parts 314 and 601 of title 21, Code of Federal Regulations, 
     as necessary to conform such regulations with the amendments 
     made by section 841.
       (c) Considerations.--In developing the guidance under 
     subsections (a) and (b)(1) and the amendments under 
     subsection (b)(2), the Secretary shall consider--
       (1) issues arising under the accelerated approval and fast 
     track processes under section 506 of the Federal Food, Drug, 
     and Cosmetic Act (as amended by section 841) for drugs 
     designated for a rare disease or condition under section 526 
     of the Federal, Food, Drug, and Cosmetic Act; and
       (2) how to incorporate novel approaches to the review of 
     surrogate endpoints based on pathophysiologic and 
     pharmacologic evidence in such guidance, especially in 
     instances where the low prevalence of a disease renders the 
     existence or collection of other types of data unlikely or 
     impractical.
       (d) No Delay in Review or Approval.--The issuance (or non-
     issuance) of guidance or conforming regulations implementing 
     the amendments made by section 841 shall not preclude the 
     review of, or action on, a request for designation or an 
     application for approval submitted pursuant to section 506 of 
     the Federal Food, Drug, and Cosmetic Act, as amended by 
     section 841.

     SEC. 843. INDEPENDENT REVIEW.

       (a) In General.--The Secretary may, in conjunction with 
     other planned reviews of the new drug review process, 
     contract with an independent entity with expertise in 
     assessing the quality and efficiency of biopharmaceutical 
     development and regulatory review programs, to evaluate the 
     Food and Drug Administration's application of the processes 
     described in section 506 of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 841, and the impact of 
     such processes on the development and timely availability of 
     innovative treatments for patients suffering from serious or 
     life-threatening conditions.
       (b) Consultation.--Any evaluation under subsection (a) 
     shall include consultation with regulated industries, patient 
     advocacy and disease research foundations, and relevant 
     academic medical centers.

               Subtitle E--Critical Path Reauthorization

     SEC. 851. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE 
                   PARTNERSHIPS.

       Subsection (f) of section 566 (21 U.S.C. 360bbb-5) is 
     amended to read as follows:
       ``(f) Authorization of Appropriations.--To carry out this 
     section, there is authorized to be appropriated $6,000,000 
     for each of fiscal years 2013 through 2017.''.

                       Subtitle F--Miscellaneous

     SEC. 861. REAUTHORIZATION OF PROVISION RELATING TO 
                   EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE 
                   ENANTIOMERS.

       Section 505(u)(4) (21 U.S.C. 355(u)(4)) is amended by 
     striking ``2012'' and inserting ``2017''.

     SEC. 862. EXTENSION OF PERIOD FOR FIRST APPLICANT TO OBTAIN 
                   TENTATIVE APPROVAL WITHOUT FORFEITING 180-DAY 
                   EXCLUSIVITY PERIOD.

       (a) Extension.--
       (1) In general.--If a first applicant files an application 
     during the 30-month period ending on the date of enactment of 
     this Act and such application initially contains a 
     certification described in paragraph (2)(A)(vii)(IV) of 
     section 505(j) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355(j)), or if a first applicant files an 
     application and the application is amended during such period 
     to first contain such a certification, the phrase ``30 
     months'' in paragraph (5)(D)(i)(IV) of such section shall, 
     with respect to such application, be read as meaning--
       (A) during the period beginning on the date of enactment of 
     this Act, and ending on September 30, 2013, ``45 months'';
       (B) during the period beginning on October 1, 2013, and 
     ending on September 30, 2014, ``42 months'';
       (C) during the period beginning on October 1, 2014, and 
     ending on September 30, 2015, ``39 months''; and
       (D) during the period beginning on October 1, 2015, and 
     ending on September 30, 2016, ``36 months''.
       (2) Conforming amendment.--In the case of an application to 
     which an extended period under paragraph (1) applies, the 
     reference to the 30-month period under section 505(q)(1)(G) 
     of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
     355(q)(1)(G)) shall be read to be the applicable period under 
     paragraph (1).
       (b) Period for Obtaining Tentative Approval of Certain 
     Applications.--If an application is filed on or before the 
     date of enactment of this Act and such application is amended 
     during the period beginning on the day after the date of 
     enactment of this Act and ending on September 30, 2017, to 
     first contain a certification described in paragraph 
     (2)(A)(vii)(IV) of section 505(j) of the Federal Food, Drug, 
     and Cosmetic Act (21 U.S.C. 355(j)), the date of the filing 
     of such amendment (rather than the date of the filing of such 
     application) shall be treated as the beginning of the 30-
     month period described in paragraph (5)(D)(i)(IV) of such 
     section 505(j).
       (c) Definitions.--For the purposes of this section, the 
     terms ``application'' and ``first applicant'' mean 
     application and first applicant, as such terms are used in 
     section 505(j)(5)(D)(i)(IV) of the Federal Food, Drug, and 
     Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(IV)).

     SEC. 863. FINAL AGENCY ACTION RELATING TO PETITIONS AND CIVIL 
                   ACTIONS.

       Section 505(q) (21 U.S.C. 355(q)) is amended--

[[Page 7933]]

       (1) in paragraph (1)--
       (A) in subparagraph (A), by striking ``subsection (b)(2) or 
     (j)'' inserting ``subsection (b)(2) or (j) of the Act or 
     351(k) of the Public Health Service Act''; and
       (B) in subparagraph (F), by striking ``180 days'' and 
     inserting ``150 days'';
       (2) in paragraph (2)(A)--
       (A) in the subparagraph heading, by striking ``180'' and 
     inserting ``150''; and
       (B) in clause (i), by striking ``180-day'' and inserting 
     ``150-day''; and
       (3) in paragraph (5), by striking ``subsection (b)(2) or 
     (j)'' inserting ``subsection (b)(2) or (j) of the Act or 
     351(k) of the Public Health Service Act''.

     SEC. 864. DEADLINE FOR DETERMINATION ON CERTAIN PETITIONS.

       (a) In General.--Section 505 (21 U.S.C. 355) is amended by 
     adding at the end the following:
       ``(w) Deadline for Determination on Certain Petitions.--The 
     Secretary shall issue a final, substantive determination on a 
     petition submitted pursuant to subsection (b) of section 
     314.161 of title 21, Code of Federal Regulations (or any 
     successor regulations), no later than 270 days after the date 
     the petition is submitted.''.
       (b) Application.--The amendment made by subsection (a) 
     shall apply to any petition that is submitted pursuant to 
     subsection (b) of section 314.161 of title 21, Code of 
     Federal Regulations (or any successor regulations), on or 
     after the date of enactment of this Act.

     SEC. 865. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER 
                   INCENTIVE PROGRAM.

       Subchapter B of Chapter V (21 U.S.C. 360aa et seq.) is 
     amended by adding at the end the following:

     ``SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE 
                   PEDIATRIC 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(b) of the Prescription Drug User Fee Amendments of 2012.
       ``(2) Priority review voucher.--The term `priority review 
     voucher' means a voucher issued by the Secretary to the 
     sponsor of a rare pediatric 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(a) of the Public Health Service Act 
     after the date of approval of the rare pediatric disease 
     product application.
       ``(3) Rare pediatric disease.--The term `rare pediatric 
     disease' means a disease that meets each of the following 
     criteria:
       ``(A) The disease primarily affects individuals aged from 
     birth to 18 years, including age groups often called 
     neonates, infants, children, and adolescents.
       ``(B) The disease is a rare disease or condition, within 
     the meaning of section 526.
       ``(4) Rare pediatric disease product application.--The term 
     `rare pediatric disease product application' means a human 
     drug application, as defined in section 735(1), that--
       ``(A) is for a drug or biological product--
       ``(i) that is for the prevention or treatment of a rare 
     pediatric disease; and
       ``(ii) that contains no active ingredient (including any 
     ester or salt of the active ingredient) that has been 
     previously approved in any other application under section 
     505(b)(1), 505(b)(2), or 505(j) of this Act or section 351(a) 
     or 351(k) of the Public Health Service Act;
       ``(B) is submitted under section 505(b)(1) of this Act or 
     section 351(a) of the Public Health Service Act;
       ``(C) the Secretary deems eligible for priority review;
       ``(D) that relies on clinical data derived from studies 
     examining a pediatric population and dosages of the drug 
     intended for that population;
       ``(E) that does not seek approval for an adult indication 
     in the original rare pediatric disease product application; 
     and
       ``(F) is approved after the date of the enactment of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(b) Priority Review Voucher.--
       ``(1) In general.--The Secretary shall award a priority 
     review voucher to the sponsor of a rare pediatric disease 
     product application upon approval by the Secretary of such 
     rare pediatric disease product application.
       ``(2) Transferability.--
       ``(A) In general.--The sponsor of a rare pediatric disease 
     product application that receives a priority review voucher 
     under this section may transfer (including by sale) the 
     entitlement to such voucher. There is no limit on the number 
     of times a priority review voucher may be transferred before 
     such voucher is used.
       ``(B) Notification of transfer.--Each person to whom a 
     voucher is transferred shall notify the Secretary of such 
     change in ownership of the voucher not later than 30 days 
     after such transfer.
       ``(3) Limitation.--A sponsor of a rare pediatric disease 
     product application may not receive a priority review voucher 
     under this section if the rare pediatric disease product 
     application was submitted to the Secretary prior to the date 
     that is 90 days after the date of enactment of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(4) Notification.--
       ``(A) In general.--The sponsor of a human drug application 
     shall notify the Secretary not later than 90 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.
       ``(B) Transfer after notice.--The sponsor of a human drug 
     application that provides notification of the intent of such 
     sponsor to use the voucher for the human drug application 
     under subparagraph (A) may transfer the voucher after such 
     notification is provided, if such sponsor has not yet 
     submitted the human drug application described in the 
     notification.
       ``(5) Termination of authority.--The Secretary may not 
     award any priority review vouchers under paragraph (1) after 
     the last day of the 1-year period that begins on the date 
     that the Secretary awards the third rare pediatric disease 
     priority voucher under 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, 
     based on the difference between--
       ``(A) the average cost incurred by the Food and Drug 
     Administration in the review of a human drug application 
     subject to priority review in the previous fiscal year; and
       ``(B) the average cost incurred by the Food and Drug 
     Administration in the review of a human drug application that 
     is not 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, 2012, the amount of the priority review user 
     fee for that fiscal year.
       ``(4) Payment.--
       ``(A) In general.--The priority review user fee required by 
     this subsection shall be due upon the notification by a 
     sponsor of the intent of such sponsor to use the voucher, as 
     specified in subsection (b)(4)(A). All other user fees 
     associated with the human drug application shall be due as 
     required by the Secretary or under applicable law.
       ``(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.
       ``(d) Designation Process.--
       ``(1) In general.--Upon the request of the manufacturer or 
     the sponsor of a new drug, the Secretary may designate--
       ``(A) the new drug as a drug for a rare pediatric disease; 
     and
       ``(B) the application for the new drug as a rare pediatric 
     disease product application.
       ``(2) Request for designation.--The request for a 
     designation under paragraph (1), shall be made at the same 
     time a request for designation of orphan disease status under 
     section 526 or fast-track designation under section 506 is 
     made. Requesting designation under this subsection is not a 
     prerequisite to receiving a priority review voucher under 
     this section.
       ``(3) Determination by secretary.--Not later than 60 days 
     after a request is submitted under paragraph (1), the 
     Secretary shall determine whether--
       ``(A) the disease or condition that is the subject of such 
     request is a rare pediatric disease; and
       ``(B) the application for the new drug is a rare pediatric 
     disease product application.
       ``(e) Marketing of Rare Pediatric Disease Products.--
       ``(1) In general.--The Secretary shall deem a rare 
     pediatric disease product application incomplete if such 
     application does not contain a description of the plan of the 
     sponsor of such application to market the product in the 
     United States.
       ``(2) Revocation.--The Secretary may revoke any priority 
     review voucher awarded

[[Page 7934]]

     under subsection (b) if the rare pediatric disease product 
     for which such voucher was awarded is not marketed in the 
     United States within the 365 day period beginning on the date 
     of the approval of such drug under section 505 of this Act or 
     section 351 of the Public Health Service Act.
       ``(3) Postapproval production report.--The sponsor of an 
     approved rare pediatric disease product shall submit a report 
     to the Secretary not later than 5 years after the approval of 
     the applicable rare pediatric disease product application. 
     Such report shall provide the following information, with 
     respect to each of the first 4 years after approval of such 
     product:
       ``(A) The estimated population in the United States 
     suffering from the rare pediatric disease.
       ``(B) The estimated demand in the United States for such 
     rare pediatric disease product.
       ``(C) The actual amount of such rare pediatric disease 
     product distributed in the United States.
       ``(f) Notice and Report.--
       ``(1) Notice of issuance of voucher and approval of 
     products under voucher.--The Secretary shall publish a notice 
     in the Federal Register and on the Web site of the Food and 
     Drug Administration not later than 30 days after the 
     occurrence of each of the following:
       ``(A) The Secretary issues a priority review voucher under 
     this section.
       ``(B) The Secretary approves a drug pursuant to an 
     application submitted under section 505(b) of this Act or 
     section 351(a) of the Public Health Service Act for which the 
     sponsor of the application used a priority review voucher 
     under this section.
       ``(2) Report.--If, after the last day of the 1-year period 
     that begins on the date that the Secretary awards the third 
     rare pediatric disease priority voucher under this section, a 
     sponsor of an application submitted under section 505(b) of 
     this Act or section 351(a) of the Public Health Service Act 
     for a drug uses a priority review voucher under this section 
     for such application, the Secretary shall 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 document--
       ``(A) notifying such Committees of the use of such voucher; 
     and
       ``(B) identifying the drug for which such priority review 
     voucher is used.
       ``(g) Eligibility for Other Programs.--Nothing in this 
     section precludes a sponsor who seeks a priority review 
     voucher under this section from participating in any other 
     incentive program, including under this Act.
       ``(h) Relation to Other Provisions.--The provisions of this 
     section shall supplement, not supplant, any other provisions 
     of this Act or the Public Health Service Act that encourage 
     the development of drugs for tropical diseases and rare 
     pediatric diseases.
       ``(i) GAO Study and Report.--
       ``(1) Study.--
       ``(A) In general.--Beginning on the date that the Secretary 
     awards the third rare pediatric disease priority voucher 
     under this section, the Comptroller General of the United 
     States shall conduct a study of the effectiveness of awarding 
     rare pediatric disease priority vouchers under this section 
     in the development of on human drug products that treat or 
     prevent such diseases.
       ``(B) Contents of study.--In conducting the study under 
     subparagraph (A), the Comptroller General shall examine the 
     following:
       ``(i) The indications for which each rare disease product 
     for which a priority review voucher was awarded was approved 
     under section 505 or section 351 of the Public Health Service 
     Act.
       ``(ii) Whether, and to what extent, an unmet need related 
     to the treatment or prevention of a rare pediatric disease 
     was met through the approval of such a rare disease product.
       ``(iii) The value of the priority review voucher if 
     transferred.
       ``(iv) Identification of each drug for which a priority 
     review voucher was used.
       ``(v) The length of the period of time between the date on 
     which a priority review voucher was awarded and the date on 
     which it was used.
       ``(2) Report.--Not later than 1 year after the date under 
     paragraph (1)(A), the Comptroller General shall 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 containing the 
     results of the study under paragraph (1).''.

     SEC. 866. COMBATING PRESCRIPTION DRUG ABUSE.

       (a) In General.--To combat the significant rise in 
     prescription drug abuse and the consequences of such abuse, 
     the Secretary of Health and Human Services (referred to in 
     this section as the ``Secretary''), acting through the 
     Commissioner of Food and Drugs (referred to in this section 
     as the ``Commissioner'') and in coordination with other 
     Federal agencies, as appropriate, shall review current 
     Federal initiatives and identify gaps and opportunities with 
     respect to ensuring the safe use of prescription drugs with 
     the potential for abuse.
       (b) Report.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary shall issue a report to 
     Congress on the findings of the review under subsection (a). 
     Such report shall include recommendations on--
       (1) how best to leverage and build upon existing Federal 
     and federally funded data sources, such as prescription drug 
     monitoring program data and the sentinel initiative of the 
     Food and Drug Administration under section 505(k)(3) of the 
     Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351(k)(3)), 
     as it relates to collection of information relevant to 
     adverse events, patient safety, and patient outcomes, to 
     create a centralized data clearinghouse and early warning 
     tool;
       (2) how best to develop and disseminate widely best 
     practices models and suggested standard requirements to 
     States for achieving greater interoperability and 
     effectiveness of prescription drug monitoring programs, 
     especially with respect to producing standardized data on 
     adverse events, patient safety, and patient outcomes; and
       (3) how best to develop provider and patient education 
     tools and a strategy to widely disseminate such tools and 
     assess the efficacy of such tools.
       (c) Guidance on Tamper-Deterrent Products.--Not later than 
     6 months after the date of enactment of this Act, the 
     Secretary, acting through the Commissioner, shall promulgate 
     guidance on the development of tamper-deterrent drug 
     products.

     SEC. 867. ASSESSMENT AND MODIFICATION OF REMS.

       (a) Assessment and Modification of Approved Strategy.--
     Section 505-1(g) (21 U.S.C. 355-1(g)) is amended--
       (1) in paragraph (1), by striking ``, and propose a 
     modification to,'';
       (2) in paragraph (2)--
       (A) in the matter before subparagraph (A)--
       (i) by striking ``, subject to paragraph (5),''; and
       (ii) by striking ``, and may propose a modification to,'';
       (B) in subparagraph (C), by striking ``new safety or 
     effectiveness information indicates that'' and all that 
     follows and inserting the following: ``an assessment is 
     needed to evaluate whether the approved strategy should be 
     modified to--
       ``(i) ensure the benefits of the drug outweigh the risks of 
     the drug; or
       ``(ii) minimize the burden on the health care delivery 
     system of complying with the strategy.''; and
       (C) by striking subparagraph (D);
       (3) in paragraph (3), by striking ``for a drug shall 
     include--'' and all that follows and inserting the following 
     ``for a drug shall include, with respect to each goal 
     included in the strategy, an assessment of the extent to 
     which the approved strategy, including each element of the 
     strategy, is meeting the goal or whether 1 or more such goals 
     or such elements should be modified.''; and
       (4) by amending paragraph (4) to read as follows:
       ``(4) Modification.--
       ``(A) On initiative of responsible person.--After the 
     approval of a risk evaluation and mitigation strategy by the 
     Secretary, the responsible person may, at any time, submit to 
     the Secretary a proposal to modify the approved strategy. 
     Such proposal may propose the addition, modification, or 
     removal of any goal or element of the approved strategy and 
     shall include an adequate rationale to support such proposed 
     addition, modification, or removal of any goal or element of 
     the strategy.
       ``(B) On initiative of secretary.--After the approval of a 
     risk evaluation and mitigation strategy by the Secretary, the 
     Secretary may, at any time, require a responsible person to 
     submit a proposed modification to the strategy within 120 
     days or within such reasonable time as the Secretary 
     specifies, if the Secretary, in consultation with the offices 
     described in subsection (c)(2), determines that 1 or more 
     goals or elements should be added, modified, or removed from 
     the approved strategy to--
       ``(i) ensure the benefits of the drug outweigh the risks of 
     the drug; or
       ``(ii) minimize the burden on the health care delivery 
     system of complying with the strategy.''.
       (b) Review of Proposed Strategies; Review of Assessments 
     and Modifications of Approved Strategies.--Section 505-1(h) 
     (21 U.S.C. 355-1(h)) is amended--
       (1) in the subsection heading by inserting ``and 
     Modifications'' after ``Review of Assessments'';
       (2) in paragraph (1)--
       (A) by inserting ``and proposed modification to'' after 
     ``under subsection (a) and each assessment of''; and
       (B) by inserting ``, and, if necessary, promptly initiate 
     discussions with the responsible person about such proposed 
     strategy, assessment, or modification'' after ``subsection 
     (g)'';
       (3) by striking paragraph (2);
       (4) by redesignating paragraphs (3) through (9) as 
     paragraphs (2) through (8), respectively;
       (5) in paragraph (2), as redesignated by paragraph (4)--
       (A) by amending subparagraph (A) to read as follows:
       ``(A) In general.--
       ``(i) Timeframe.--Unless the dispute resolution process 
     described under paragraph (3)

[[Page 7935]]

     or (4) applies, and, except as provided in clause (ii) or 
     clause (iii) below, the Secretary, in consultation with the 
     offices described in subsection (c)(2), shall review and act 
     on the proposed risk evaluation and mitigation strategy for a 
     drug or any proposed modification to any required strategy 
     within 180 days of receipt of the proposed strategy or 
     modification.
       ``(ii) Minor modifications.--The Secretary shall review and 
     act on a proposed minor modification, as defined by the 
     Secretary in guidance, within 60 days of receipt of such 
     modification.
       ``(iii) REMS modification due to safety label changes.--Not 
     later than 60 days after the Secretary receives a proposed 
     modification to an approved risk evaluation and mitigation 
     strategy to conform the strategy to approved safety label 
     changes, including safety labeling changes initiated by the 
     sponsor in accordance with FDA regulatory requirements, or to 
     a safety label change that the Secretary has directed the 
     holder of the application to make pursuant to section 
     505(o)(4), the Secretary shall review and act on such 
     proposed modification to the approved strategy.
       ``(iv) Guidance.--The Secretary shall establish, through 
     guidance, that responsible persons may implement certain 
     modifications to an approved risk evaluation and mitigation 
     strategy following notification to the Secretary.''; and
       (B) by amending subparagraph (C) to read as follows:
       ``(C) Public availability.--Upon acting on a proposed risk 
     evaluation and mitigation strategy or proposed modification 
     to a risk evaluation and mitigation strategy under 
     subparagraph (A), the Secretary shall make publicly available 
     an action letter describing the actions taken by the 
     Secretary under such subparagraph (A).''.
       (6) in paragraph (4), as redesignated by paragraph (4)--
       (A) in subparagraph (A)(i)--
       (i) by striking ``Not earlier than 15 days, and not later 
     than 35 days, after discussions under paragraph (2) have 
     begun, the'' and inserting ``The''; and
       (ii) by inserting ``, after the sponsor is required to make 
     a submission under subsection (a)(2) or (g),'' before 
     ``request in writing''; and
       (B) in subparagraph (I)--
       (i) by striking clauses (i) and (ii); and
       (ii) by striking ``if the Secretary--'' and inserting ``if 
     the Secretary 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.'';
       (7) in paragraph (5), as redesignated by paragraph (4)--
       (A) in subparagraph (A), by striking ``any of subparagraphs 
     (B) through (D)'' and inserting ``subparagraph (B) or (C)''; 
     and
       (B) in subparagraph (C), by striking ``paragraph (4) or 
     (5)'' and inserting ``paragraph (3) or (4)''; and
       (8) in paragraph (8), as redesignated by paragraph (4), by 
     striking ``paragraphs (7) and (8)'' and inserting 
     ``paragraphs (6) and (7).''.
       (c) Guidance.--Not later than 1 year after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services shall issue guidance that, for purposes of section 
     505-1(h)(2)(A) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 355-1(h)(2)(A)), describes the types of 
     modifications to approved risk evaluation and mitigation 
     strategies that shall be considered to be minor modifications 
     of such strategies.

     SEC. 868. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as 
     amended by section 811(b), is further amended by adding at 
     the end the following:

     ``SEC. 569. CONSULTATION WITH EXTERNAL EXPERTS ON RARE 
                   DISEASES, TARGETED THERAPIES, AND GENETIC 
                   TARGETING OF TREATMENTS.

       ``(a) In General.--For the purpose of promoting the 
     efficiency of and informing the review by the Food and Drug 
     Administration of new drugs and biological products for rare 
     diseases and drugs and biological products that are 
     genetically targeted, the following shall apply:
       ``(1) Consultation with stakeholders.--Consistent with 
     sections X.C and IX.E.4 of the PDUFA Reauthorization 
     Performance Goals and Procedures Fiscal Years 2013 through 
     2017, as referenced in the letters described in section 
     101(b) of the Prescription Drug User Fee Amendments of 2012, 
     the Secretary shall ensure that opportunities exist, at a 
     time the Secretary determines appropriate, for consultations 
     with stakeholders on the topics described in subsection (b).
       ``(2) Consultation with external experts.--
       ``(A) In general.--The Secretary shall develop and maintain 
     a list of external experts who, because of their special 
     expertise, are qualified to provide advice on rare disease 
     issues, including topics described in subsection (c). The 
     Secretary may, when appropriate to address a specific 
     regulatory question, consult such external experts on issues 
     related to the review of new drugs and biological products 
     for rare diseases and drugs and biological products that are 
     genetically targeted, including the topics described in 
     subsection (b), when such consultation is necessary because 
     the Secretary lacks the specific scientific, medical, or 
     technical expertise necessary for the performance of the 
     Secretary's regulatory responsibilities and the necessary 
     expertise can be provided by the external experts.
       ``(B) External experts.--For purposes of subparagraph (A), 
     external experts are individuals who possess scientific or 
     medical training that the Secretary lacks with respect to one 
     or more rare diseases.
       ``(b) Topics for Consultation.--Topics for consultation 
     pursuant to this section may include--
       ``(1) rare diseases;
       ``(2) the severity of rare diseases;
       ``(3) the unmet medical need associated with rare diseases;
       ``(4) the willingness and ability of individuals with a 
     rare disease to participate in clinical trials;
       ``(5) an assessment of the benefits and risks of therapies 
     to treat rare diseases;
       ``(6) the general design of clinical trials for rare 
     disease populations and subpopulations; and
       ``(7) the demographics and the clinical description of 
     patient populations.
       ``(c) Classification as Special Government Employees.--The 
     external experts who are consulted under this section may be 
     considered special government employees, as defined under 
     section 202 of title 18, United States Code.
       ``(d) Protection of Confidential Information and Trade 
     Secrets.--
       ``(1) Rule of construction.--Nothing in this section shall 
     be construed to alter the protections offered by laws, 
     regulations, and policies governing disclosure of 
     confidential commercial or trade secret information, and any 
     other information exempt from disclosure pursuant to section 
     552(b) of title 5, United States Code, as such provisions 
     would be applied to consultation with individuals and 
     organizations prior to the date of enactment of this section.
       ``(2) Consent required for disclosure.--The Secretary shall 
     not disclose confidential commercial or trade secret 
     information to an expert consulted under this section without 
     the written consent of the sponsor unless the expert is a 
     special government employee (as defined under section 202 of 
     title 18, United States Code) or the disclosure is otherwise 
     authorized by law.
       ``(e) Other Consultation.--Nothing in this section shall be 
     construed to limit the ability of the Secretary to consult 
     with individuals and organizations as authorized prior to the 
     date of enactment of this section.
       ``(f) No Right or Obligation.--
       ``(1) No right to consultation.--Nothing in this section 
     shall be construed to create a legal right for a consultation 
     on any matter or require the Secretary to meet with any 
     particular expert or stakeholder.
       ``(2) No altering of goals.--Nothing in this section shall 
     be construed to alter agreed upon goals and procedures 
     identified in the letters described in section 101(b) of the 
     Prescription Drug User Fee Amendments of 2012.
       ``(3) No change to number of review cycles.--Nothing in 
     this section is intended to increase the number of review 
     cycles as in effect before the date of enactment of this 
     section.
       ``(g) No Delay in Product Review.--Prior to a consultation 
     with an external expert, as described in this section, 
     relating to an investigational new drug application under 
     section 505(i), a new drug application under section 505(b), 
     or a biologics license application under section 351 of the 
     Public Health Service Act, the Director of the Center for 
     Drug Evaluation and Research or the Director of the Center 
     for Biologics Evaluation and Research (or appropriate 
     Division Director), as appropriate, shall determine that--
       ``(1) such consultation will--
       ``(A) facilitate the Secretary's ability to complete the 
     Secretary's review;
       ``(B) address outstanding deficiencies in the application; 
     and
       ``(C) increase the likelihood of an approval decision in 
     the current review cycle; or
       ``(2) the sponsor authorized such consultation.''.

     SEC. 869. BREAKTHROUGH THERAPIES.

       (a) In General.--Section 506 (21 U.S.C. 356), as amended by 
     section 841, is further amended--
       (1) by redesignating subsection (d) as subsection (e);
       (2) by redesignating subsections (a) through (c) as 
     subsections (b) through (d), respectively;
       (3) by inserting before subsection (b), as so redesignated, 
     the following:
       ``(a) Designation of a Drug as a Breakthrough Therapy.--
       ``(1) In general.--The Secretary shall, at the request of 
     the sponsor of a drug, expedite the development and review of 
     such drug if the drug is intended, alone or in combination 
     with 1 or more other drugs, to treat a serious or life-
     threatening disease or condition and preliminary clinical 
     evidence indicates that the drug may demonstrate substantial 
     improvement over existing therapies on 1 or more clinically 
     significant endpoints, such

[[Page 7936]]

     as substantial treatment effects observed early in clinical 
     development. In this section, such a drug is referred to as a 
     `breakthrough therapy'.
       ``(2) Request for designation.--The sponsor of a drug may 
     request the Secretary to designate the drug as a breakthrough 
     therapy. A request for the designation may be made 
     concurrently with, or at any time after, the submission of an 
     application for the investigation of the drug under section 
     505(i) or section 351(a)(3) of the Public Health Service Act.
       ``(3) Designation.--
       ``(A) In general.--Not later than 60 calendar days after 
     the receipt of a request under paragraph (2), the Secretary 
     shall determine whether the drug that is the subject of the 
     request meets the criteria described in paragraph (1). If the 
     Secretary finds that the drug meets the criteria, the 
     Secretary shall designate the drug as a breakthrough therapy 
     and shall take such actions as are appropriate to expedite 
     the development and review of the application for approval of 
     such drug.
       ``(B) Actions.--The actions to expedite the development and 
     review of an application under subparagraph (A) may include, 
     as appropriate--
       ``(i) holding meetings with the sponsor and the review team 
     throughout the development of the drug;
       ``(ii) providing timely advice to, and interactive 
     communication with, the sponsor regarding the development of 
     the drug to ensure that the development program to gather the 
     non-clinical and clinical data necessary for approval is as 
     efficient as practicable;
       ``(iii) involving senior managers and experienced review 
     staff, as appropriate, in a collaborative, cross-disciplinary 
     review;
       ``(iv) assigning a cross-disciplinary project lead for the 
     Food and Drug Administration review team to facilitate an 
     efficient review of the development program and to serve as a 
     scientific liaison between the review team and the sponsor; 
     and
       ``(v) taking steps to ensure that the design of the 
     clinical trials is as efficient as practicable, when 
     scientifically appropriate, such as by minimizing the number 
     of patients exposed to a potentially less efficacious 
     treatment.'';
       (4) in subsection (e)(1), as so redesignated, by striking 
     ``applicable to accelerated approval'' and inserting 
     ``applicable to breakthrough therapies, accelerated 
     approval,''; and
       (5) by adding at the end the following:
       ``(f) Report.--Beginning in fiscal year 2013, the Secretary 
     shall annually 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, and make publicly available, with respect to 
     this section for the previous fiscal year--
       ``(1) the number of drugs for which a sponsor requested 
     designation as a breakthrough therapy;
       ``(2) the number of products designated as a breakthrough 
     therapy; and
       ``(3) for each product designated as a breakthrough 
     therapy, a summary of the actions taken under subsection 
     (a)(3).''.
       (b) Guidance; Amended Regulations.--
       (1) In general.--
       (A) Guidance.--Not later than 18 months after the date of 
     enactment of this Act, the Secretary of Health and Human 
     Services (referred to in this section as the ``Secretary'') 
     shall issue draft guidance on implementing the requirements 
     with respect to breakthrough therapies, as set forth in 
     section 506(a) of the Federal Food, Drug, and Cosmetic Act 
     (21 U.S.C. 356(a)), as amended by this section. The Secretary 
     shall issue final guidance not later than 1 year after the 
     close of the comment period for the draft guidance.
       (B) Amended regulations.--
       (i) In general.--If the Secretary determines that it is 
     necessary to amend the regulations under title 21, Code of 
     Federal Regulations in order to implement the amendments made 
     by this section to section 506(a) of the Federal Food, Drug, 
     and Cosmetic Act, the Secretary shall amend such regulations 
     not later than 2 years after the date of enactment of this 
     Act.
       (ii) Procedure.--In amending regulations under clause (i), 
     the Secretary shall--

       (I) issue a notice of proposed rulemaking that includes the 
     proposed regulation;
       (II) provide a period of not less than 60 days for comments 
     on the proposed regulation; and
       (III) publish the final regulation not less than 30 days 
     before the effective date of the regulation.

       (iii) Restrictions.--Notwithstanding any other provision of 
     law, the Secretary shall promulgate regulations implementing 
     the amendments made by section only as described in clause 
     (ii).
       (2) Requirements.--Guidance issued under this section 
     shall--
       (A) specify the process and criteria by which the Secretary 
     makes a designation under section 506(a)(3) of the Federal 
     Food, Drug, and Cosmetic Act; and
       (B) specify the actions the Secretary shall take to 
     expedite the development and review of a breakthrough therapy 
     pursuant to such designation under such section 506(a)(3), 
     including updating good review management practices to 
     reflect breakthrough therapies.
       (c) Independent Review.--Not later than 3 years after the 
     date of enactment of this Act, the Comptroller General of the 
     United States, in consultation with appropriate experts, 
     shall assess the manner by which the Food and Drug 
     Administration has applied the processes described in section 
     506(a) of the Federal Food, Drug, and Cosmetic Act, as 
     amended by this section, and the impact of such processes on 
     the development and timely availability of innovative 
     treatments for patients affected by serious or life-
     threatening conditions. Such assessment shall be made 
     publicly available upon completion.
       (d) Conforming Amendments.--Section 506B(e) (21 U.S.C. 
     356b) is amended by striking ``section 506(b)(2)(A)'' each 
     place such term appears and inserting ``section 
     506(c)(2)(A)''.

     SEC. 870. GRANTS AND CONTRACTS FOR THE DEVELOPMENT OF ORPHAN 
                   DRUGS.

       (a) Qualified Testing Definition.--Section 5(b)(1)(A)(ii) 
     of the Orphan Drug Act (21 U.S.C. 360ee(b)(1)(A)(ii)) is 
     amended by striking ``after the date such drug is designated 
     under section 526 of such Act and''.
       (b) Authorization of Appropriations.--Section 5(c) of the 
     Orphan Drug Act (21 U.S.C. 360ee(c)) is amended to read as 
     follows:
       ``(c) Authorization of Appropriations.--For grants and 
     contracts under subsection (a), there is authorized to be 
     appropriated $30,000,000 for each of fiscal years 2013 
     through 2017.''.

                        TITLE IX--DRUG SHORTAGES

     SEC. 901. DISCONTINUANCE AND INTERRUPTIONS OF MANUFACTURING 
                   OF CERTAIN DRUGS.

       (a) In General.--Section 506C (21 U.S.C. 356c) is amended 
     to read as follows:

     ``SEC. 506C. DISCONTINUANCE AND INTERRUPTIONS OF 
                   MANUFACTURING OF CERTAIN DRUGS.

       ``(a) In General.--A manufacturer of a drug subject to 
     section 503(b)(1)--
       ``(1) that is--
       ``(A) life-supporting;
       ``(B) life-sustaining; or
       ``(C) intended for use in the prevention or treatment of a 
     debilitating disease or condition; and
       ``(2) that is not a radio pharmaceutical drug product, a 
     product derived from human plasma protein and their 
     recombinant analogs, or any other product as designated by 
     the Secretary,

     shall notify the Secretary of a discontinuance of the 
     manufacture of the drug, or an interruption of the 
     manufacture of the drug that is likely to lead to a 
     meaningful disruption in the manufacturer's supply of the 
     drug, and the reason for such discontinuance or interruption, 
     in accordance with subsection (b).
       ``(b) Timing.--A notice required by subsection (a) shall be 
     submitted to the Secretary--
       ``(1) at least 6 months prior to the date of the 
     discontinuance or interruption; or
       ``(2) if compliance with paragraph (1) is not possible, as 
     soon as practicable.
       ``(c) Distribution.--To the maximum extent practicable, the 
     Secretary shall distribute information on the discontinuation 
     or interruption of the manufacture of the drugs described in 
     subsection (a) to appropriate organizations, including 
     physician, health provider, and patient organizations, as 
     described in section 506D.
       ``(d) Confidentiality.--Nothing in this section shall be 
     construed as authorizing the Secretary to disclose any 
     information that is a trade secret or confidential 
     information subject to section 552(b)(4) of title 5, United 
     States Code, or section 1905 of title 18, United States Code.
       ``(e) Coordination With Attorney General.--Not later than 
     30 days after the receipt of a notification described in 
     subsection (a), the Secretary shall--
       ``(1) determine whether the notification pertains to a 
     controlled substance subject to a production quota under 
     section 306 of the Controlled Substances Act; and
       ``(2) if necessary, as determined by the Secretary--
       ``(A) notify the Attorney General that the Secretary has 
     received such a notification;
       ``(B) request that the Attorney General increase the 
     aggregate and individual production quotas under section 306 
     of the Controlled Substances Act applicable to such 
     controlled substance and any ingredient therein to a level 
     the Secretary deems necessary to address a shortage of a 
     controlled substance based on the best available market data; 
     and
       ``(C) if the Attorney General determines that the level 
     requested is not necessary to address a shortage of a 
     controlled substance, the Attorney General shall provide to 
     the Secretary a written response detailing the basis for the 
     Attorney General's determination.

     The Secretary shall make the written response provided under 
     subparagraph (C) available to the public on the Web site of 
     the Food and Drug Administration.

[[Page 7937]]

       ``(f) Failure To Meet Requirements.--If a person fails to 
     submit information required under subsection (a) in 
     accordance with subsection (b)--
       ``(1) the Secretary shall issue a letter to such person 
     informing such person of such failure;
       ``(2) not later than 30 calendar days after the issuance of 
     a letter under paragraph (1), the person who receives such 
     letter shall submit to the Secretary a written response to 
     such letter setting forth the basis for noncompliance and 
     providing information required under subsection (a); and
       ``(3) not later than 45 calendar days after the issuance of 
     a letter under paragraph (1), the Secretary shall make such 
     letter and any response to such letter under paragraph (2) 
     available to the public on the Web site of the Food and Drug 
     Administration, with appropriate redactions made to protect 
     information described in subsection (d), except that, if the 
     Secretary determines that the letter under paragraph (1) was 
     issued in error or, after review of such response, the person 
     had a reasonable basis for not notifying as required under 
     subsection (a), the requirements of this paragraph shall not 
     apply.''.
       (b) Regulations.--
       (1) In general.--Not later than 18 months after the date of 
     the enactment of this Act, the Secretary of Health and Human 
     Services, after issuing a notice of proposed rule and holding 
     a public hearing, shall promulgate final regulations that 
     implement the amendment made by subsection (a).
       (2) Contents.--Such regulations shall, for purposes of 
     section 506C of the Federal Food, Drug, and Cosmetic Act (21 
     U.S.C. 356c)--
       (A) define the terms ``life-supporting'', ``life-
     sustaining'', and ``intended for use in the prevention or 
     treatment of a debilitating disease or condition''; and
       (B) define the term ``interruption of the manufacture of 
     the drug that is likely to lead to a meaningful disruption in 
     the manufacturer's supply of the drug'' to mean a change in 
     production that is highly likely to lead to more than a 
     negligible reduction in the supply of the drug and affects 
     the ability of the manufacturer to meet demand for such drug, 
     but not to include a change in production due to matters such 
     as routine maintenance or insignificant changes in 
     manufacturing so long as the manufacturer expects to resume 
     operations in a short period of time.

     SEC. 902. DRUG SHORTAGE LIST.

       Title V (21 U.S.C. 351 et seq.) is amended by inserting 
     after section 506C the following new section:

     ``SEC. 506D. DRUG SHORTAGE LIST.

       ``(a) Establishment.--The Secretary shall maintain an up-
     to-date list of drugs that are determined by the Secretary to 
     be in shortage in the United States.
       ``(b) Contents.--For each drug on such list, the Secretary 
     shall include the following information:
       ``(1) The name of the drug in shortage.
       ``(2) The name of each manufacturer of such drug.
       ``(3) The reason for the shortage, as determined by the 
     Secretary, selecting from the following categories:
       ``(A) Requirements related to complying with good 
     manufacturing practices.
       ``(B) Regulatory delay.
       ``(C) Shortage of an active ingredient.
       ``(D) Shortage of an inactive ingredient component.
       ``(E) Discontinuation of the manufacture of the drug.
       ``(F) Delay in shipping of the drug.
       ``(G) Demand increase for the drug.
       ``(4) The estimated duration of the shortage as determined 
     by the Secretary.
       ``(c) Public Availability.--
       ``(1) In general.--Subject to paragraphs (2) and (3), the 
     Secretary shall make the information in such list publicly 
     available.
       ``(2) Trade secrets and confidential information.--Nothing 
     in this section alters or amends section 1905 of title 18, 
     United States Code, or section 552(b)(4) of title 5 of such 
     Code.
       ``(3) Public health exception.--The Secretary may choose 
     not to make information collected under this section publicly 
     available under paragraph (1) if the Secretary determines 
     that disclosure of such information would adversely affect 
     the public health (such as by increasing the possibility of 
     hoarding or other disruption of the availability of drug 
     products to patients).''.

     SEC. 903. QUOTAS APPLICABLE TO DRUGS IN SHORTAGE.

       Section 306 of the Controlled Substances Act (21 U.S.C. 
     826) is amended by adding at the end the following:
       ``(h)(1) Not later than 30 days after the receipt of a 
     request described in paragraph (2), the Attorney General 
     shall--
       ``(A) complete review of such request; and
       ``(B)(i) as necessary to address a shortage of a controlled 
     substance, increase the aggregate and individual production 
     quotas under this section applicable to such controlled 
     substance and any ingredient therein to the level requested; 
     or
       ``(ii) if the Attorney General determines that the level 
     requested is not necessary to address a shortage of a 
     controlled substance, the Attorney General shall provide a 
     written response detailing the basis for the Attorney 
     General's determination.
     The Secretary shall make the written response provided under 
     subparagraph (B)(ii) available to the public on the Web site 
     of the Food and Drug Administration.
       ``(2) A request is described in this paragraph if--
       ``(A) the request pertains to a controlled substance on the 
     list of drugs in shortage maintained under section 506D of 
     the Federal Food, Drug, and Cosmetic Act;
       ``(B) the request is submitted by the manufacturer of the 
     controlled substance; and
       ``(C) the controlled substance is in schedule II.''.

     SEC. 904. EXPEDITED REVIEW OF MAJOR MANUFACTURING CHANGES FOR 
                   POTENTIAL AND VERIFIED SHORTAGES OF DRUGS THAT 
                   ARE LIFE-SUPPORTING, LIFE-SUSTAINING, OR 
                   INTENDED FOR USE IN THE PREVENTION OF A 
                   DEBILITATING DISEASE OR CONDITION.

       Subsection (c) of section 506A (21 U.S.C. 356a) is amended 
     by adding at the end the following new paragraph:
       ``(3) Changes addressing a drug shortage.--
       ``(A) Certification.--
       ``(i) Description.--A certification is described in this 
     subparagraph if the manufacturer, having notified the 
     Secretary of an interruption or discontinuance of a drug in 
     accordance with Section 506C, certifies (in such 
     certification) that the major manufacturing change for which 
     approval is being sought may prevent or alleviate a 
     discontinuance or interruption of such drug.
       ``(ii) Bad faith exception.--Subparagraphs (B) and (C) do 
     not apply in the case of a certification which the Secretary 
     determines to be made in bad faith.
       ``(B) Expedited review.--If a certification described in 
     subparagraph (A) is submitted in connection with a 
     supplemental application for a major manufacturing change, 
     the Secretary shall--
       ``(i) expedite any technical review or inspection necessary 
     for consideration of the supplemental application;
       ``(ii) provide any technical assistance necessary to 
     facilitate approval of the supplemental application; and
       ``(iii) not later than 60 days after receipt of the 
     certification, complete review of the supplemental 
     application.''.

     SEC. 905. STUDY ON DRUG SHORTAGES.

       (a) Study.--The Comptroller General of the United States 
     shall conduct a study to examine the cause of drug shortages 
     and formulate recommendations on how to prevent or alleviate 
     such shortages.
       (b) Consideration.--In conducting the study under this 
     section, the Comptroller General shall consider the following 
     questions:
       (1) What are the dominant characteristics of drugs that 
     have gone into actual shortage over the preceding three 
     years?
       (2) Are there systemic high-risk factors (such as drug 
     pricing structure, including Federal reimbursements, or the 
     number of manufacturers producing a drug product) that have 
     led to the concentration of drug shortages in certain drug 
     products that have made such products vulnerable to drug 
     shortages?
       (3) Is there a reason why drug shortages have occurred 
     primarily in the sterile injectable market and in certain 
     therapeutic areas?
       (4) How have regulations, guidance documents, regulatory 
     practices, and other actions of Federal departments and 
     agencies (including the effectiveness of interagency and 
     intraagency coordination, communication, strategic planning, 
     and decision-making) affected drug shortages?
       (5) How does hoarding affect drug shortages?
       (6) How would incentives alleviate or prevent drug 
     shortages?
       (7) How are healthcare providers, including hospitals and 
     physicians responding to drug shortages, to what extent are 
     such providers able to adjust care effectively to compensate 
     for such shortages, and what impediments exist that hinder 
     provider ability to adjust to such shortages?
       (c) Consultation With Stakeholders.--In conducting the 
     study under this section, the Comptroller General shall 
     consult with relevant stakeholders, including physicians, 
     pharmacists, hospitals, patients, drug manufacturers, and 
     other health providers.
       (d) Report.--Note later than 18 months after the date of 
     the enactment of this Act, the Comptroller General shall 
     submit a report to the Committee on Energy and Commerce of 
     the House of Representatives and the Committee on Health, 
     Education, Labor, and Pensions of the Senate on the results 
     of the study under this section.

     SEC. 906. ANNUAL REPORT ON DRUG SHORTAGES.

       Not later than 18 months after the date of the enactment of 
     this Act, and annually thereafter, the Secretary of Health 
     and Human Services shall 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 drug shortages that--
       (1) describes the communication between the field 
     investigators of the Food and Drug Administration and the 
     staff of the Center for Drug Evaluation and Research's Office 
     of Compliance and Drug Shortage Program, including the Food 
     and Drug Administration's

[[Page 7938]]

     procedures for enabling and ensuring such communication;
       (2) describes the Food and Drug Administration's efforts to 
     expedite the review of new manufacturing sites, new 
     suppliers, and specification changes to prevent or alleviate 
     a drug shortage;
       (3) describes the coordination between the Food and Drug 
     Administration and the Drug Enforcement Administration on 
     efforts to prevent or alleviate drug shortages;
       (4) identifies the number of, and describes the instances 
     in which the Food and Drug Administration exercised 
     regulatory flexibility and discretion to prevent or alleviate 
     a drug shortage;
       (5) identifies the number of instances in which the Food 
     and Drug Administration asked firms to increase production to 
     prevent or alleviate a shortage;
       (6) identifies the number of notifications submitted to the 
     Secretary under section 506C of the Federal Food, Drug, and 
     Cosmetic Act, as amended by section 901 of this Act, 
     including the percentage of such notifications for a drug 
     that is a sterile injectable;
       (7) describes the Food and Drug Administration's 
     implementation of section 506D of the Federal Food, Drug, and 
     Cosmetic Act (relating to a drug shortage list), as added by 
     section 902 of this Act, and identifies--
       (A) the name of each drug on the list under such section 
     506D at any point during the period covered by the report;
       (B) the name of each manufacturer of each such drug;
       (C) the reason for the shortage of each such drug; and
       (D) the anticipated or, if known, actual duration of the 
     shortage of each such drug;
       (8) identifies whether, and how, the Food and Drug 
     Administration expedited the review of regulatory submissions 
     to prevent or alleviate shortages, including how the 
     Administration utilized the authority in section 506A(c)(3) 
     of the Federal Food, Drug, and Cosmetic Act, as added by 
     section 904 of this Act;
       (9) identifies the number of certifications submitted under 
     such section 506A(c)(3) and, for each such certification, 
     whether the Food and Drug Administration completed expedited 
     review within 60 days as required by subparagraph (B) of such 
     section 506A(c)(3);
       (10) describes the Secretary's public engagement on drug 
     shortages with stakeholders, including physicians, 
     pharmacists, patients, hospitals, drug manufacturers, and 
     other health providers; and
       (11) contains the Secretary's plan for addressing drug 
     shortages in the upcoming year, including with respect to the 
     issues described in paragraphs (1) through (10).

     SEC. 907. ATTORNEY GENERAL REPORT ON DRUG SHORTAGES.

       Not later than 6 months after the date of the enactment of 
     this Act, and annually thereafter, the Attorney General shall 
     submit to the Committee on Energy and Commerce of the House 
     of Representatives and the Committee on the Judiciary of the 
     Senate a report on drug shortages that--
       (1) identifies the number of requests received under 
     section 306(h) of the Controlled Substances Act (as added by 
     section 903 of this Act), the average review time for such 
     requests, the number of requests granted and denied under 
     such section, and, for each of the requests denied under such 
     section, the basis for such denial;
       (2) describes the coordination between the Drug Enforcement 
     Administration and Food and Drug Administration on efforts to 
     prevent or alleviate drug shortages; and
       (3) identifies drugs containing a controlled substance 
     subject to section 306 of the Controlled Substances Act when 
     such a drug is determined by the Secretary of Health and 
     Human Services to be in shortage.

     SEC. 908. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

       Chapter V (21 U.S.C. 351 et seq.), as amended by section 
     902 of this Act, is further amended by inserting after 
     section 506D the following:

     ``SEC. 506E. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.

       ``(a) Definitions.--In this section:
       ``(1) Drug.--The term `drug' excludes any controlled 
     substance (as such term is defined in section 102 of the 
     Controlled Substances Act).
       ``(2) Health system.--The term `health system' means a 
     collection of hospitals that are owned and operated by the 
     same entity and that share access to databases with drug 
     order information for their patients.
       ``(3) Repackage.--For the purposes of this section only, 
     the term `repackage', with respect to a drug, means to divide 
     the volume of a drug into smaller amounts in order to--
       ``(A) extend the supply of a drug in response to the 
     placement of the drug on a drug shortage list described in 
     subsection (b); and
       ``(B) facilitate access to the drug by hospitals within the 
     same health system.
       ``(b) Exclusion From Registration.--Notwithstanding any 
     other provision of this Act, a hospital shall not be 
     considered an establishment for which registration is 
     required under section 510 solely because it repackages a 
     drug and transfers it to another hospital within the same 
     health system in accordance with the conditions in subsection 
     (c)--
       ``(1) during any period in which the drug is listed on the 
     Drug Shortage List of the Food and Drug Administration; or
       ``(2) during the 60-day period following any period 
     described in paragraph (1).
       ``(c) Conditions.--Subsection (b) shall only apply to a 
     hospital, with respect to the repackaging of a drug for 
     transfers to another hospital within the same health system, 
     if the following conditions are met:
       ``(1) Drug for intrasystem use only.--In no case may a drug 
     that has been repackaged in accordance with this section be 
     sold or otherwise distributed by the health system or a 
     hospital within the system to an entity or individual that is 
     not a hospital within such health system.
       ``(2) Compliance with state rules.--Repackaging of a drug 
     under this section shall be done in compliance with 
     applicable State requirements in which the health system is 
     located.
       ``(d) Termination.--This section shall not apply on or 
     after the date on which the Secretary issues final guidance 
     that clarifies the policy of the Food and Drug Administration 
     regarding hospital pharmacies repackaging and safely 
     transferring repackaged drugs to other hospitals within the 
     same health system during a drug shortage.''.

  The SPEAKER pro tempore. Pursuant to the rule, the gentleman from 
Michigan (Mr. Upton) and the gentleman from New Jersey (Mr. Pallone) 
each will control 20 minutes.
  The Chair recognizes the gentleman from Michigan.


                             General Leave

  Mr. UPTON. Mr. Speaker, I ask unanimous consent that all Members may 
have 5 legislative days in which to revise and extend their remarks and 
insert extraneous materials into the Record.
  The SPEAKER pro tempore. Is there objection to the request of the 
gentleman from Michigan?
  There was no objection.
  Mr. UPTON. Mr. Speaker, I yield myself 2 minutes.
  Mr. Speaker, I want to thank, first of all, Chairman Pitts, Dr. 
Burgess, Mr. Barton, Mr. Waxman, Mr. Pallone, Mr. Dingell, and other 
committee members on both sides of the aisle for their bipartisanship 
through this process. H.R. 5651 is a reflection of their hard work, 
dedication, and willingness to work together. And because of that 
outstanding work, we have a bill today that will help American patients 
and innovators, and it will support millions of jobs, believe it or 
not, millions of jobs in an important sector of our economy.
  As I've said since the beginning of this Congress, we need to enact 
this user fee by the end of June, and I believe that we're on track to 
accomplish that goal.
  And as we put this user-fee package together, I wanted to ensure that 
it fostered American innovation by improving the predictability, 
consistency, transparency, and efficiency of FDA regulation. Fostering 
innovation is essential in getting new treatments to patients and 
creating American jobs.
  This bill will foster American innovation because it includes 
significant accountability and reform measures designed to hold the FDA 
responsible for its performance. The measures include independent 
assessments of FDA's drug-and-device review process. It also requires 
quarterly reporting from the device center so that we don't have to 
wait a year to find out their progress.
  I commit today that our committee will continue its vigorous 
oversight of the FDA. For example, we're going to use the independent 
assessments to determine where the review process can be improved, and 
we will ensure FDA fixes the problems. Also, we'll use the quarterly 
data on device reviews and bring the FDA before our committee to 
explain how it's doing.
  This bill will give us the information that we need to understand how 
the FDA is performing. It is up to us to ensure that we use that 
information to hold the FDA accountable for their performance.
  Together, the committee members have produced a bill that will help 
American patients, while supporting innovation and job creators. I 
thank the committee for their participation.
  I reserve the balance of my time.
  Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
  Today marks a very exceptional day in this body, one that deserves 
great

[[Page 7939]]

praise. The bill before us, H.R. 5651, the FDA Reform Act of 2012, is 
the product of bipartisanship, collaboration, and compromise that I'm 
very proud of. The bill is a result of more than a year of negotiations 
between industry, FDA, and Congress.
  In the Energy and Commerce Committee, we held a number of hearings on 
the critical issues within the bill, and earlier this month it passed 
unanimously in both subcommittee and full committee. The bill is 
slightly modified from the bill reported by committee, as it now 
includes a bipartisan provision which results in the bill reducing the 
deficit by $370 million over the next 10 years.
  The FDA Reform Act will ensure that Americans have access to safe and 
effective new medicines and medical devices by reauthorizing the user-
fee programs for prescription drugs and medical devices. It will reduce 
drug costs for consumers by speeding the approval of lower-cost generic 
drugs with the establishment of new user-fee programs for generic drugs 
and for lower-cost versions of biotech drugs.
  The bill will also reform and revitalize many FDA programs to improve 
its regulatory scheme to facilitate a more efficient and predictable 
review process.
  Mr. Speaker, the bill also makes permanent two complementary 
programs, the Best Pharmaceuticals for Children Act and the Pediatric 
Research Equity Act, which both help to foster the development and safe 
use of prescription drugs for children.
  In addition, a significant improvement was made to the FDA's ability 
to police an ever-growing global drug supply chain to improve patient 
safety, and these provisions will give the FDA critical tools it needs 
to keep our medicine safer.
  It also includes important provisions to help prevent and mitigate 
drug shortages by requiring that drugmakers notify the FDA in advance 
of any expected disruption in the supply of certain critical drugs, and 
for the FDA to inform health care providers of the potential drug 
shortage.
  I want to thank Chairman Upton and Chairman Pitts, Ranking Member 
Waxman, Mr. Dingell, and my other colleagues on the committee for their 
leadership and dedication to this important piece of legislation, a 
special thanks to the staffs, in particular my staff person, Tiffany 
Guarascio, who's to my right. But on both sides of the aisle, the staff 
worked hard, and they should be very proud of what we've accomplished.
  Reauthorizing and revitalizing the FDA user-fee system is a critical 
investment to our Nation's public health.
  Mr. Speaker, I urge all Members of the House to vote ``aye.''
  I reserve the balance of my time.
  Mr. UPTON. Mr. Speaker, I yield 3 minutes to the gentleman from 
Pennsylvania (Mr. Pitts), chairman of the Health Subcommittee on the 
Energy and Commerce Committee.
  Mr. PITTS. Mr. Speaker, the Food and Drug Administration Reform Act 
of 2012 is a product of nearly a year and a half of work in the Energy 
and Commerce Health Subcommittee. H.R. 5651 is the result of bipartisan 
negotiations. The bill passed out of the Health Subcommittee by a 
unanimous voice vote and passed out of the full committee 46-0.
  I would especially like to thank Clay Alspach, Ryan Long, and Paul 
Edattel and the other staffers for their dedication and hard work in 
making this bill possible. I know they've put in a lot of hours; and 
because of that work, we have brought this bill to the floor in a 
timely manner.
  The FDA Reform Act is critical to saving lives and sustaining a 
dynamic American industry. American companies are the leading 
developers of new medical devices and drugs to save and sustain life.
  To ensure that products are both safe and effective, we've tasked the 
Food and Drug Administration with reviewing products before they make 
their way into the market. This is a big job. The device and drug 
industries are dynamic and innovative. Companies spend tens of millions 
of dollars and years of work to develop products.
  The review stage is a critical time for any company. Inconsistent 
reviews mean that the true cost of developing a new product is hidden, 
making it difficult to properly prepare.

                              {time}  1640

  When we began considering this legislation last year, we heard from a 
number of individuals involved in the medical device industry about the 
increasing difficulty of working through the review process. American 
patients were waiting almost 4 years longer for new devices that had 
already been approved in Europe, and despite the slow review process, 
the safety outcomes were comparable.
  The FDA Reform Act contains critical reforms to the Medical Device 
User Fee Act which will hold the FDA accountable and keep the reviews 
on schedule. Under the fourth version of the Prescription Drug User Fee 
Act, the median time of approval was 9 months. With the 
reauthorization, we set the goal of reducing the review time to 8 
months. Currently, generic drugs have an average approval time of 32 
months. Included in this legislation is a new user-fee program that 
should be able to gradually reduce review times to 10 months for most 
products. A separate user-fee program for biosimilars has the goal of 
10-month approval times for most products. Finally, we also include 
language to help patients, doctors, and hospitals to deal with drug 
shortages.
  Mr. Speaker, I am proud of the work we have done here. I would like 
especially to thank full committee Chairman Upton as well as Health 
Subcommittee Ranking Member Frank Pallone, full committee Ranking 
Member Henry Waxman, and their staffs for patiently working with us on 
the FDA Reform Act.
  This is legislation to help save lives and create jobs, which are two 
goals that we can all agree on. It is a bipartisan effort, and I urge 
all Members to support the legislation.
  Mr. PALLONE. Mr. Speaker, I would like to yield 3 minutes to our 
chairman emeritus, Mr. Dingell, who has worked so hard and who has been 
so much a part of this legislation.
  Mr. DINGELL. I thank the gentleman from New Jersey.
  Mr. Speaker, I rise in strong support of H.R. 5651, to reauthorize 
the prescription drug and medical device user-fee programs, to 
establish new user-fee programs for generic drugs and biosimilars, and 
also to give substantial new authorities to the Food and Drug 
Administration, with the support of the industry, to provide broad 
additional protections to American consumers.
  H.R. 5651 is an excellent example of the great good that can be done 
when both parties come together in the spirit of bipartisanship, 
cooperation, and compromise, and when they work with consumers and the 
industry to achieve a bill supported by all.
  This legislation will ensure the timely access to safe and effective 
drugs and medical devices, encourage the development of the innovative 
drug treatments for our children, and improve the Food and Drug 
Administration's current authority to deal with drug shortages. More 
importantly, this legislation will provide FDA with much-needed new 
authorities to secure the safety of our drug supply and to help prevent 
another incident like that unfortunate one involving heparin, in which 
over 80 people died from a blood thinner which was contaminated from 
where it came, in China, and which also sickened over 100 people of 
whom we know.
  H.R. 5651's drug supply chain provisions will improve information FDA 
has about domestic and foreign drug manufacturers. It will, for the 
first time in history, provide FDA with information about importers and 
will enable FDA to control imported pharmaceuticals and devices. It 
will also allow FDA to detain or to destroy counterfeit or adulterated 
drugs, prohibit the entry of imported drugs that have been delayed or 
been denied inspection by FDA, and will encourage parity in the 
inspections of the domestic and foreign drug establishments. It will 
permit, for the first time, the real inspection of foreign producers, 
and it will treat all manufacturers alike.

[[Page 7940]]

  These provisions mirror those in drug legislation which I authored 
earlier. The new authorities provided to FDA for our drug supply will 
enable the leveling of the playing field for our domestic drug 
manufacturers and will give American families the peace of mind that 
FDA can and will--and will have the authority to--respond to unsafe, 
misbranded, counterfeit, or contaminated drugs.
  I want to thank my colleagues on the committee for the fine way this 
legislation was worked on, particularly Energy and Commerce Committee 
Chairman Upton, Ranking Member Waxman, Subcommittee on Health Chairman 
Pitts, Ranking Member Pallone, and their staffs--Clay Alspach, Ryan 
Long, Rachel Sher, Eric Flamm, Arun Patel, and Tiffany Guarascio, as 
well as Kimberlee Trzeciak of my staff--for their hard work and their 
commitment through this process to producing a bipartisan bill.
  Mr. Speaker, I am pleased to be a coauthor of this important 
legislation. We have built upon the good work that FDA is already doing 
as well as the strong agreements negotiated by industry and FDA, and I 
urge the House to pass this bill.
  I look forward to working with my colleagues in the Senate to swiftly 
pass legislation this summer that can be signed into law by the 
President.
  Mr. UPTON. I yield myself 1\1/2\ minutes for the purpose of a 
colloquy, and I yield to the gentleman from Florida (Mr. Buchanan).
  Mr. BUCHANAN. Mr. Chairman, I would like to thank you for working 
with me to advance my pill mill crackdown legislation and for your 
commitment to curbing prescription drug abuse. This crisis has created 
enormous pain and suffering on our families and communities, killing 
tens of thousands of Americans every year--tens of thousands.
  I am pleased that the Senate FDA bill contains the central component 
of my bill to reschedule hydrocodone combination drugs--one of the most 
addictive and deadly drug mixtures. By reclassifying these drugs from a 
schedule III to a schedule II drug, we will be making them much more 
difficult to obtain and abuse. This provision has the support of the 
medical and the law enforcement communities as well.
  I look forward to working with you, Mr. Chairman, to ensure that the 
final bill addresses this critical issue and contains the Buchanan pill 
mill provision.
  Mr. UPTON. I appreciate your constant leadership on the national 
problem of prescription drug abuse. I appreciated your input during 
your phone call to me last week back in Michigan when the Senate passed 
this amendment. Our committee has focused on this issue, and you have 
been an outstanding partner with Congressman Ed Whitfield and 
Congresswoman Bono Mack on this.
  When used properly, we know that these medications provide needed 
therapies for those suffering from pain. However, the abuse of some of 
those products has devastated communities and destroyed families across 
the country. So, as we move forward on this bill in our discussions 
with the Senate, I hope that we can continue the partnership and be 
able to work this issue out.
  At this point, Mr. Speaker, I ask unanimous consent that the balance 
of my time be controlled by the gentleman from Pennsylvania (Mr. 
Pitts).
  The SPEAKER pro tempore. Without objection, the gentleman from 
Pennsylvania (Mr. Pitts) will control the remainder of the time.
  There was no objection.
  Mr. PALLONE. I yield 3 minutes to the gentlewoman from California 
(Mrs. Capps).
  Mrs. CAPPS. I thank my colleague for yielding me time.
  I rise today in strong support of the FDA Reform Act of 2012. I must 
say it is an honor to associate myself with the remarks of our chairman 
emeritus, Mr. Dingell, who worked tirelessly over the years with regard 
to the Food and Drug Administration in making it a good institution 
that can only become better.
  This bill represents the spirit of compromise--compromise across the 
aisle and also among the many stakeholders that work toward innovations 
to improve our health. It demonstrates that at a time when most of the 
country believes that we in Congress can't work together at all or pass 
a piece of legislation without a long and bitter fight, we can come 
together to improve health, protect the safety of the American people 
and, at the same time, to support good jobs and innovation in our 
health care industry.
  I am especially pleased that two of my provisions have been included 
in this legislation. For example, the SAFE Devices Act will improve the 
postmarket surveillance of medical devices and the implementation of 
the unique device identifier program. This is an essential provision 
that will let us know that our devices work, and it will allow us to 
identify potential problems early on, protecting patients and 
identifying issues when they are easier and less costly to address. 
Additionally, the bill includes the simplification of FDA's de novo 
process--an important step to helping both medical devices 
manufacturers and patients.
  I thank Chairmen Upton and Pitts and Ranking Members Pallone and 
Waxman for their leadership on this bill. I also thank the numerous 
advocates, the many patients and other stakeholders who came together 
and contributed to this bill so that it would come to fruition today.
  Of course, there is more work in front of us that remains to be done, 
but this bill before us is an important step in ensuring that our drug 
and device pipelines continue to produce needed cures and treatments in 
order to keep us all healthy, which is why I urge my colleagues to 
support it.

                              {time}  1650

  Mr. PITTS. Mr. Speaker, I yield 2 minutes to a gentleman who showed 
great leadership in the development of this legislation, in the 
negotiations, and has been a very integral part, the vice-chair of the 
Health Subcommittee, the gentleman from Texas, Dr. Burgess.
  Mr. BURGESS. I thank the gentleman for yielding.
  Mr. Speaker, this is not a perfect bill, but it's a good bill, and 
it's a solid bill. It is worthy of the support of everyone on this 
floor. This bill reauthorizes the FDA's user-fee programs for 
prescription drugs and medical devices and, in fact, authorizes two new 
programs for generic devices and what are known as biosimilars. 
Together, all of these products provide powerful tools to prevent and 
alleviate human suffering.
  The Food and Drug Administration must have the infrastructure and the 
resources to ensure patient safety and to approve new products in a 
straightforward and predictable fashion. Delayed reviews increase 
costs, hurt innovation, cost jobs, and deny patients potentially 
lifesaving products. These agreements present the tremendous 
opportunity to ensure that we have a strong and efficient FDA, and the 
committee responded appropriately and seized that opportunity. This 
bill will help the FDA build on what's working, address what isn't, and 
provide resources to meet future goals.
  With the ranking member on the subcommittee, Mr. Pallone, we crafted 
new guidelines for how the Food and Drug Administration recruits, 
approaches, and accesses relative scientific and medical expertise. I'm 
also pleased that we require the Food and Drug Administration to now 
notify Congress before issuing guidance regarding the regulation of 
laboratory-developed tests. We still need to strengthen and improve the 
oversight of laboratory-developed tests instead of promoting 
duplicative regulation that delays access to lifesaving diagnostics, 
but it's a good first step. Additionally, the bill takes good first 
steps to address critical drug shortages. No physician wants to tell a 
patient they can't receive the care that they need because the product 
is unavailable.
  The process was respectful and resulted from hundreds of hours of 
negotiation. Certainly, Chairman Pitts and Ranking Members Waxman and 
Pallone and Chairman Emeritus Dingell and their staffs should be given 
tremendous credit, along with Ryan Long and Clay Alspach for the work 
they did on the majority staff, and my personal

[[Page 7941]]

staff, J.P. Paluskiewicz, who put in long hours to get this product to 
the floor.
  This vote is about patients. We need to get it right for them, and I 
think we've come awfully close to getting it right.
  Mr. PALLONE. Mr. Speaker, I want to make a special thanks to another 
staff person for the committee, Rachel Sher, who is on my right here, 
as well. Thank you, Rachel.
  I would now like to yield 3 minutes to the gentleman from 
Massachusetts (Mr. Markey).
  Mr. MARKEY. I thank Chairman Upton and Chairman Pitts and I thank 
Ranking Member Pallone and Ranking Member Waxman for their work in 
bringing to the floor a bipartisan bill that provides FDA additional 
resources to bring new drugs and medical devices to market. But today's 
bill is also a huge missed opportunity. It would be a disservice to 
patient safety to ignore the bill's major shortfall.
  Many Americans would be surprised to learn that 90 percent of medical 
devices are not required to undergo clinical testing in human beings 
prior to being sold. Under current law, the FDA is required to clear 
certain medical devices as long as they demonstrate their similarity to 
an earlier product, even if the new device is modeled after a similar 
defective device that caused serious injury or even death. Today's bill 
offered an important opportunity to address this device-safety 
loophole, but it doesn't. The loophole remains in place, and patients 
are still, and will remain, at grave risk.
  Four years ago, Jaye Nevarez, a 50-year-old mother of three, was a 
healthy truck driver who earned a decent living, played in a band, and 
paid her bills on time. Then her doctor implanted a bladder mesh, a 
device that traces its origin back to a previous product that was 
recalled for causing serious injury and in some cases death. Jaye now 
lives in constant pain. She was forced to quit her job. She can't walk 
without a cane. She lost her insurance and faces a growing mountain of 
medical debt. The bank recently began foreclosure proceedings on her 
home where she lives with her 79-year-old mother.
  Jaye isn't the first to be harmed by this loophole. If we fail to fix 
it, she won't be the last. There will be tens of thousands of others 
who fall into this loophole who will suffer serious injury.
  I introduced the SOUND Devices Act providing FDA the ability to 
protect the public from these unsafe devices, but this was not included 
in the bill. The bill we are voting on today is critically important, 
however. It includes the EXPERRT Act, a bill that I authored to improve 
communication between FDA and experts in rare diseases. It includes 
bipartisan provisions that I'm proud to have worked with other Members 
to promote, especially in pediatric-device development.
  This bill must not be the last word on medical-device safety. I hope 
that my colleagues will join with me to close this loophole so that we 
can keep the American public safe from harmful medical practices.
  Mr. PITTS. Mr. Speaker, at this time I am happy to yield 1\1/2\ 
minutes to the subcommittee chairman of O&I, the gentleman from Florida 
(Mr. Stearns).
  Mr. STEARNS. Mr. Speaker, the authorization of the FDA user fees will 
simply provide stability at FDA's new product review as companies 
submit new and innovative devices and drugs for their approval.
  I'm especially proud that in this bill I had a piece of legislation 
called the Faster Access to Specialized Treatments--FAST--Act, which is 
H.R. 4132. It was included in the FDA Reform Act. This act modernizes 
the FDA accelerated approval pathways to reflect the 20 years of 
science developed since accelerated approval was first established in 
1992. So think of that: since 1992, with this bill that I've included 
in our FDA bill, it will accelerate approval through the FDA. It will 
simply allow new drugs to get to market faster for people who are 
suffering from rare diseases. There are 30 million Americans suffering 
from one of over 7,000 rare diseases, but only 250 currently have any 
treatment. This act will save lives.
  I would like to enter, Mr. Speaker, this letter of support for FAST 
signed by over 150 rare-disease groups into the Record.
  I'm also glad that the FDA Reform Act includes the Expanding and 
Promoting Expertise in Review of Rare Treatments Act, EXPERRT Act, H.R. 
4156. This will help FDA consult with medical experts when evaluating 
drugs dealing with rare disease such as cystic fibrosis. As the 
cofounder of the Cystic Fibrosis Caucus, I'm glad we're giving this 
tool to the FDA.
  Mr. Speaker, I support passage of the FDA Reform Act.

                                                   March 23, 2012.
     Hon. Cliff Stearns,
     U.S. House of Representatives,
     Washington, DC.
     Hon. Edolphus Towns,
     U.S. House of Representatives,
     Washington, DC.
       Dear Congressmen Stearns & Towns: On behalf of patients, 
     physicians, and other members of the health advocacy 
     community we are writing to express our support for H.R. 
     4132, the Faster Access to Specialized Treatments (FAST) Act. 
     This legislation will modernize and expand the FDA's 
     Accelerated Approval pathway to encompass a broader range of 
     diseases and leverage 21st century drug development tools and 
     strategies. This reform will speed the approval of much-
     needed therapies and cures to patients who are facing serious 
     and life-threatening conditions, including Alzheimer's 
     disease, autoimmune diseases, multiple sclerosis, Parkinson's 
     disease, neuromuscular disease and hundreds of rare diseases 
     that remain untreated.
       We commend you for championing legislation that maintains 
     the FDA's high standard for approval while at the same time 
     ensuring the Agency can help facilitate the development of 
     new and novel therapies to patients in a more timely manner. 
     In many cases our patients have no available treatment for 
     their diseases, or they are using a therapy that is older and 
     may not work as effectively and safely. This is not 
     acceptable. We believe that this legislation will ensure 
     patients receive the best, modern treatment as soon as 
     possible and we applaud your efforts on their behalf.
       Thank you for your leadership on this important bill and we 
     look forward to working with you as it moves forward.
           Sincerely,
         Abigail Alliance for Better Access to Developmental 
           Drugs; Advocacy for Patients with Chronic Illness, 
           Inc.; Affiliated American CSA Foundation; Alliance for 
           Aging Research; Alliance for Patient Access; American 
           Autoimmune Related Diseases Association; American Brain 
           Tumor Association; American Childhood Cancer 
           Organization; American College of Medical Genetics; 
           American Institute for Medical and Biological 
           Engineering; American Society of Clinical 
           Psychopharmacology; Batten Disease Support and Research 
           Association; Break Through Cancer Coalition; 
           Californians for Cures; Celiac Disease Center at 
           Columbia University; Celiac Sprue Association; Charcot-
           Marie-Tooth Association (CMTA); Children's 
           Cardiomyopathy Foundation, Inc.; Chinese American 
           Association of Greater Chicago; Coalition Duchenne; 
           Coalition for Pulmonary Fibrosis; Colon Cancer 
           Alliance; Cooleys Anemia Foundation; Crohn's and 
           Colitis Foundation of America; Cryoglobulinemia 
           Vasculitis Organization; CureDuchenne; CurePSP; 
           Digestive Disease National Coalition; Erik Metzler 
           Foundation; EveryLife Foundation for Rare Diseases; 
           Fabry Support & Information Group; Georgia PKU Connect; 
           GIST Support International; Hadley Hope Fund; Hannah's 
           Hope Fund; Hayden's Batten Disease Foundation Inc.; 
           HealthHIV; Hope4Bridget Foundation; ICE Epilepsy 
           Alliance; I Have IIH; In Need of Diagnosis, Inc. 
           (INOD); Inspire; International Cancer Advocacy Network 
           (ICAN); Jacob's Cure, Inc.; Jain Foundation Inc.; 
           Jonah's Just Begun-Foundation to Cure Sanfilippo Inc.; 
           LAM Treatment Alliance; LGS Foundation; Liddy Shriver 
           Sarcoma Initiative; Little Miss Hannah Foundation; Lung 
           Cancer Alliance; Lupus Foundation of America; 
           Lymphangiomatosis & Gorham's Disease Alliance (LGDA); 
           Lymphatic Malformation Institute (LMI); Macular 
           Degeneration Support, Inc.; Madisons Foundation; 
           Midwest Asian Health Association (MAHA); MLD 
           Foundation; Mpdsupport.org--Myeloproliferative Disease 
           Support; Muscular Dystrophy Association; National 
           Family Caregivers Association; National MPS Society; 
           National MS Society; National Niemann-Pick Disease 
           Foundation, Inc.; National PKU Alliance; National Tay-
           Sachs & Allied Diseases Association; National Venture 
           Capital Association; NBIA Disorders Association; New 
           Jersey Association for Biomedical Research; NKH 
           International Family Network; Noah's Hope--Batten 
           Disease Fund; Oxalosis and Hyperoxaluria Foundation;

[[Page 7942]]

           Pachyonychia Congenita Project; Parkinson's Action 
           Network; Parry-Romberg Syndrome Resource, Inc.; 
           Partnership for Cures; Polycystic Kidney Disease 
           Foundation; RARE Project; Russell-Silver Syndrome 
           Support; Scleroderma Research Foundation; Sickle Cell 
           Disease Association of America, Inc.; Society for 
           Women's Health Research; Solving Kids' Cancer; Student 
           Society for Stem Cell Research; Sudden Arrhythmia Death 
           Syndromes (SADS) Foundation; Taylor's Tale; The 
           Association for Frontotemporal Degeneration (AFTD); The 
           Children's Medical Research Foundation, Inc.; The 
           Erythromelalgia Association; The Focus Foundation; The 
           Manton Center for Orphan Disease Research, Children's 
           Hospital Boston; The Reflex Sympathetic Dystrophy 
           Syndrome Association (RSDSA); The Stop ALD Foundation; 
           Tuberous Sclerosis Alliance; Veterans Health Council; 
           VHL Family Alliance; Vietnam Veterans of America; 
           ZERO--The Project to End Prostate Cancer.

  Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from 
North Carolina (Mr. Butterfield).
  Mr. BUTTERFIELD. I thank the gentleman for yielding, and I thank him 
for his leadership on our committee.
  Mr. Speaker, I rise today in support of H.R. 5651, the Food and Drug 
Administration Reform Act, and want to simply highlight section 865, 
the Rare Pediatric Disease Priority Review Voucher Incentive program. 
I'm so pleased this section was included in the base text of the bill. 
I want to thank my colleagues on the committee and my good friend 
Congressman Mike McCaul of Texas for joining with me to see to its 
inclusion. Actually, we joined together in seeing to its inclusion. 
Also, let me give a strong thank you to Nancy Goodman with Kids vs. 
Cancer, who was a strong advocate on this issue.
  The program will incentivize pharmaceutical companies to develop new 
drugs for children with rare pediatric diseases such as childhood 
cancers and sickle cell disease by expanding the cost-neutral priority 
review voucher program. Expanding the voucher program will allow 
pharmaceutical companies to expedite FDA review of more profitable 
drugs in return for developing treatments for rare pediatric disease.
  Since 1980, the FDA has approved only one new drug for treatment of 
childhood cancer while having approved 50 new cancer-fighting drugs for 
adults. Children living with life-threatening conditions need access to 
newly developed drugs that can treat these rare diseases.

                              {time}  1700

  Whether a disease is rare or common, the need for effective care and 
potential cures is the same. Therefore, I strongly urge its inclusion 
in the final bill that will go to the President for his signature.
  Mr. Speaker, on a slightly different note, I would also like to 
discuss another issue of equal importance. My colleagues and I have 
worked closely with the Pharmaceutical Distribution Security Alliance 
to craft a consensus proposal that has the support of manufacturers, 
distributors, wholesalers, and both the community and chain pharmacists 
in dealing with traceability of prescription medication.
  The proposal, known as RxTEC, would establish a national standard to 
address the serious issue of drug traceability and pedigree. I commend 
PDSA for their commitment to consumer and patient safety by working so 
diligently with both Chambers on this very important issue, ultimately 
securing placeholder language in the Senate FDA reform bill.
  I am very supportive of this proposal, as RxTEC increases patient 
access to safe medicines, improves security of the pharmaceutical 
distribution chain, and lowers costs and regulatory burdens. Given the 
seriousness of this issue, and to avoid additional injuries and 
potential deaths from counterfeit drugs, I urge the FDA and all parties 
involved in these talks to find common ground so that we can include 
final supply chain integrity language into the final draft similar to 
section 865.
  I ask my colleagues on the committee to also voice their support for 
inclusion.
  Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Pennsylvania (Mr. Murphy), a member of the Health Subcommittee, really 
the author of the sections on generic drug user fees and biosimilars in 
the bill.
  Mr. MURPHY of Pennsylvania. I thank the chairman.
  This year a typical senior will spend 15 percent of their household 
income on health care, including $620 plus on prescriptions.
  But that sum would be much higher if there were no FDA-approved 
generic pharmaceuticals. Without generics, that same senior might pay 
$1,000 for medicine, and Medicare would spend some $67 billion more.
  We must always assure that any medication, brand name or generic, is 
of the highest quality. But currently the Food and Drug Administration 
cannot assure that medicines coming in from overseas factories such as 
those in China are pure.
  This bill includes my legislation, the Generic Drug and Biosimilar 
User Fee Act, to authorize for the first time an FDA program that will 
expedite approval of generics and clear a backlog of over 2,800 generic 
applications. Currently, the FDA is supposed to make a decision on the 
application within 16 months.
  But the agency is taking twice that time because it lacks resources 
for conducting reviews and inspecting factories. U.S. factories are 
inspected perhaps once every 2 years, and more often if the FDA 
decides; foreign factories perhaps 7 to 9 years. That means millions of 
dosages of drugs coming in from overseas without any inspection.
  Recall what happened when heparin ended up killing perhaps 100 to 200 
people and causing other complications for many people. Ninety percent 
of pharmaceutical ingredients are made in foreign factories, but we 
cannot remain dependent on drugs from other countries that are below 
U.S. standards.
  People of all ages deserve peace of mind, and we all want to have the 
highest trust for all medicines, either brand name or generic. This 
bill will restore and support that trust for American consumers.
  Mr. PALLONE. Mr. Speaker, I am not expecting any more speakers, and I 
reserve the balance of my time.
  Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from 
Georgia (Mr. Gingrey), another valued member of the Health 
Subcommittee, the author of the GAIN Act, the section dealing with 
antibiotics, and a valued participant in all these negotiations.
  Mr. GINGREY of Georgia. I thank subcommittee Chairman Pitts, Chairman 
Upton, subcommittee Ranking Member Pallone. The bill that we are 
passing today in the House of Representatives, H.R. 5651, is an 
opportunity to come to the well in support of something that we have 
done in a bipartisan way. I really relish that fairly rare opportunity. 
Mr. Speaker, once again we are showing the American people that we can, 
when we have a need, a need and good ideas. Months and months and 
months went into working on this bill, staffs on both side. I commend 
them all and, of course, Ranking Member Waxman as well.
  Let me just say this. Other Members are talking about the many 
aspects of the bill, talking about the user-fee aspect of prescription 
drugs, generic drugs, biologic, biosimilars, the drug safety chain 
aspect, addressing this problem of shortage of drugs. Emeritus Member 
Dingell is a big part of that aspect of the bill.
  Let me just say one thing about something that I had a lot of input 
into, and I am very proud of, and that is a specific drug, antibiotics, 
where we have a tremendous shortage. That inclusion of my bill, the 
GAIN Act, Generating Antibiotic Incentives Now, in this bill, I think, 
is hugely important. We have a lack of antibiotics in this country. We 
need to incentivize manufacturers to come forward with new and better 
antibiotics.
  Mr. Speaker, I want to just mention very briefly anecdotally, in my 
district, the 11th District of Georgia, northwest Georgia, a young 
college student fell recently in a stream, the

[[Page 7943]]

little Tallapoosa River, deeply gashed her leg. Bacteria got in that 
leg, which normally 99 out of a 100 times, Mr. Speaker, would cause no 
problems whatsoever.
  In this instance, I guess maybe because of the depth of the wound and 
the amount of the trauma to the tissue, it resulted in something called 
necrotizing fasciitis. This young student, 24 years old, has been 
struggling for months in an Augusta hospital to recover from these 
injuries. She is on the way to recovery, thank God, but not without 
significant long-term disabilities. That's why things like the GAIN 
aspect of the bill is so important so that we can get new and better 
antibiotics to the market.
  I support this bill tremendously in a bipartisan way.
  Mr. PITTS. Mr. Speaker, I yield 2 minutes to the gentleman from Ohio 
(Mr. LaTourette).
  Mr. LaTOURETTE. I thank the gentleman very much for yielding.
  I commend the Energy and Commerce Committee for producing a good 
piece of legislation. I also want to applaud the efforts to enhance the 
safety of America's pharmaceutical supply chain. While we are fortunate 
in America to not yet have a widespread problem, counterfeit drugs pose 
a serious health risk to all consumers.
  The current patchwork of State requirements and licensing, however, 
makes supply chain compliance and safety inconsistent and challenging, 
which potentially jeopardizes the safety and welfare of millions of 
Americans. Unless a uniform Federal policy covering all pharmaceutical 
supply chain stakeholders is enacted, the U.S. will fail to provide the 
visibility and leverage technology that will provide a superior cost-
effective consumer protection.
  Third party logistic providers, or 3PLs, are playing a growing and 
important role in making sure that safe medicines reach their 
destinations. The term ``third party logistics provider'' refers to an 
entity that provides or coordinates warehousing, distribution, or other 
services on behalf of a manufacturer.
  Currently, Federal law does not recognize the role of a 3PL. Only one 
State today offers a license for 3PLs. Other States require a 3PL to 
apply for a wholesale distributor license, even though 3PLs don't buy 
or sell drugs.
  The varying patchwork of inconsistent State requirements does not 
provide for optimum law enforcement, and there is an added cost without 
a safety benefit. 3PLs need to be defined in Federal legislation and 
properly licensed. Including a 3PL definition in Federal language is a 
strong first step towards the development of uniform Federal standards 
and 3PL licenses.
  I want to thank my colleagues on the Energy and Commerce Committee in 
advance for a successful and constructive conference process, and I am 
confident that we can enhance the supply chain safety in a reasonable 
and cost-effective manner.
  Mr. PALLONE. Mr. Speaker, I just want to say in closing that I think 
it's a great example with this bill of what we can do, not only in the 
Energy and Commerce Committee but in general in this House, on a 
bipartisan basis when everyone works together for a common goal.

                              {time}  1710

  This is actually a very important piece of legislation. It's 
important for the pharmaceutical industry. It's important in terms of 
job creation. It's important in terms of innovation and also bringing 
low-cost drugs to the American people. Without the type of bipartisan 
cooperation we had, we would not have been able to get here with this 
time schedule, which is truly amazing. So I want to thank everyone. I 
would like to say that I hope that we can do similar good work in the 
remainder of this Congress, and I would urge my colleagues to vote 
``aye.''
  I yield back the balance of my time.
  Mr. PITTS. Mr. Speaker, in conclusion, I want to again commend 
leadership on both sides of the aisle: Ranking Member Emeritus Mr. 
Dingell and Ranking Member Mr. Pallone and Mr. Waxman and Chairman 
Upton and staff of both sides. They have done a terrific job and spent 
countless hours. I especially want to mention Clay Alspach and Ryan 
Long on our side, as well as our personal staff. They have been 
absolutely terrific. Because of this, this legislation is going to save 
many lives. It's going to help the United States continue to be the 
world leader in the pharmaceutical and medical device industries and 
mean a lot to our economy as well.
  I urge all Members to support this very important legislation, and I 
yield back the balance of my time.
  Mr. BILBRAY. Mr. Speaker, I want to indicate my strong support of 
H.R. 5651, the Food and Drug Administration Reform Act of 2012, which 
we are addressing on the House floor today. This bipartisan legislation 
is not only good for the health of the American public; it is also a 
key component to restoring the health of our economy.
  Nowhere will the impacts of this legislation be felt more than in 
Southern California and the San Diego region. According to BIOCOM, 
Southern California's life sciences cluster employs just over 97,000 in 
five sectors: biopharmaceuticals, industrial biotechnology and 
biofuels, life sciences trade, medical devices and diagnostics, and 
research and lab services. Medical devices and diagnostics is the 
region's largest life sciences sector, employing 33,871, followed by 
research and lab services with 31,878 jobs. These two sectors account 
for 68 percent of the total employment in the cluster, with over 65,000 
jobs in the region. These innovative companies are on the forefront for 
discoveries from everything from Cancer therapies to the latest medical 
device that will prolong life.
  The Food and Drug Administration Reform Act of 2012 will provide 
timely and necessary improvements to the user fee programs for drugs, 
medical devices, generics and biologics. Through this legislation, FDA 
will now be committed to meeting their performance goals for the review 
of life saving drugs--thus expediting these products to patients who 
need them, create an independent review entity to hold FDA accountable 
for the approval and clearance process for devices, as well as the 
creation of a new user fee program for generic drug and biologics 
approval all the while ensuring the safety of U.S. patients.
  H.R. 5651 contains many provisions that will improve the lives of 
American patients and promote the competitiveness of the U.S. life 
science enterprise. However, there are two provisions in this 
legislation that I am most proud of including. Included in the final 
House draft were two pieces of bipartisan legislation that I sponsored 
and worked with my colleagues on both sides of the aisle to get 
included. They are:
  H.R. 3203, the Novel Device Regulatory Relief Act, coauthored with 
Representative Lois Capps (D-Santa Barbara) improves the FDA's third 
party review and inspection of medical devices by making the process 
more efficient, transparent, and beneficial to the life science 
industry seeking approval.
  H.R. 5334, the Breakthroughs Therapy Act, coauthored with 
Representative Diana DeGette (D-Denver) expedites the review of 
breakthrough drugs for patients with serious or life-threatening 
disease or a condition where preliminary clinical evidence shows an 
improvement over existing therapies.
  As we move forward in reconciling our legislation with the Senate it 
is my hope that we can address another national crisis that was not 
included in the House bill--the need for a reliable track and trace 
system for pharmaceutical products. For years, Congress has attempted 
to craft legislation that would secure the distribution chain for 
pharmaceuticals. Either due to lack of consensus from industry and 
patient participants or poor timing, this was never accomplished. This 
lack of action has resulted in a patchwork of State laws which create 
opportunities for bad actors to shop for States with the lowest safety 
requirements in order to introduce unsafe products into the legitimate 
supply chain. This patchwork also creates regulatory uncertainty in the 
supply chain, which adds increased costs and burden to the health care 
system.
  But this year is different. For the first time, we have seen industry 
stakeholders put aside differences and come to a consensus on a 
language that is supported by me and my friend Mr. Matheson that will 
create a national pedigree system which will replace a patchwork of 
State laws that are currently in place. While not a perfect solution, 
this legislation is a first step in creating a secure supply chain 
system that will protect the U.S. public from counterfeit drugs while 
preventing unwanted regulatory burden on American businesses. It is my 
goal to work with my colleagues to include track and trace language in 
the final legislation which will secure the drug supply

[[Page 7944]]

chain and address the concerns of the large pharmaceutical 
distributors, secondary pharmaceutical distributors, local pharmacists, 
third party logistical providers and the large scale pharmacies.
  In closing, I wish to thank Full Committee Chairman Fred Upton and 
Health Subcommittee Chairman Joe Pitts for their commitment to this 
issue. Without their guidance and hard work, this legislation would 
never have seen the light of day. I look forward to casting my vote in 
support of H.R. 5651 and urge my colleagues to do the same.
  Mrs. EMERSON. Mr. Speaker, I want to express my support for the 
reauthorization of the Food and Drug Administration (FDA) under 
consideration today. The FDA provides essential safeguards for patients 
in America and around the world, while making possible new treatments 
and therapies for diseases and conditions which affect millions. This 
bill supports greater speed of generic medications to market and 
assures much needed drugs to treat cancer will get to the patients who 
need them.
  However, one provision (Section 805) in this legislation causes me 
special concern. The section includes the new authority for the 
Secretary of Health and Human Services to consult with the Department 
of Homeland Security to cause the destruction of any drug ``that has 
reasonable probability of causing serious adverse health consequences 
or death . . . or that is valued at an amount that is $2,000 or less.'' 
This section poses a serious concern to hundreds of thousands of 
Americans who receive their drugs by mail from licensed and regulated 
pharmacies in Canada and other foreign countries. For these patients, 
these American consumers, there is often only one choice beyond a 
Canadian pharmacy, and that is to not purchase the medicines they need 
at all.
  Patients expecting receipt of legitimate prescriptions, written by 
their doctor and filled by a licensed pharmacy in Canada, could have 
their shipment of medication destroyed without receiving any 
notification either before or after the Federal Government takes that 
action. A bus full of senior citizens which crosses the border into 
Canada to visit a pharmacy where they can fill their prescriptions for 
one-third the price of the same medications in the United States could 
have their pill bottles seized at the border, their meager budget for 
their monthly health care expenses already exhausted. This is not good 
policy, nor is it what Americans expect from a free market.
  This language threatens a critical, cost-effective supply of 
medications and pharmaceuticals. These drugs are exactly the same as 
their counterparts sold in America. I urge further discussion of this 
critical issue in conference and a full examination of the consequences 
of passing this provision into law.
  Mr. WAXMAN. Mr. Speaker, today, the House considers a bill that 
represents a significant bipartisan achievement. Our work to find a 
common approach to legislation to support and strengthen the FDA is 
truly remarkable. It has been a pleasure to work with Mr. Upton, Mr. 
Pitts, Mr. Pallone, Mr. Dingell, and other members of the Committee to 
achieve this result.
  When we began this process, there were wildly divergent views on the 
various issues contained in this bill. But we worked together and found 
ways to address those issues in a way that protects both innovation and 
patients.
  This legislation contains several provisions that are critical to the 
functioning of major parts of FDA. Our reauthorization of FDA's drug 
and medical device user fee programs will provide resources to enable 
the efficient review of applications and give patients access to 
therapies at the earliest possible time. We are also reauthorizing two 
pediatric programs which foster the development and safe use of 
prescription drugs in children.
  This year we will be establishing two new programs to help speed 
FDA's review of new generics and biosimilars. These provisions 
illustrate our bipartisan commitment to ensuring a vibrant generic 
marketplace. All of us will see the benefits when more low-cost 
generics are on the market as a result of this legislation.
  The bill also includes provisions to modernize FDA's authorities with 
respect to the drug supply chain. FDA has been trying to keep pace with 
our increasingly globalized drug supply chain using an outdated 
statute. This legislation will give FDA critical new tools to police 
this dramatically different marketplace.
  We also have included some important provisions that will go a long 
way toward addressing drug shortages, which have unfortunately now 
become an all-too-frequent occurrence.
  When we began this process, I had concerns about many of the 
Republican proposals relating to medical devices. But we worked 
together to address those concerns and to assure that nothing in this 
bill will take us backwards in terms of patient safety.
  Our bipartisan work has truly paid off.
  I support this bill, but I also think we can continue to improve it 
in the area of antibiotics. I agree that we need to look at ways to 
incentivize the development of new antibiotics. But we would more 
effectively address this need if we narrowed the provisions of the GAIN 
Act to target only drugs that treat serious and life-threatening 
infections. Additionally, mandating that steps be taken to preserve the 
effectiveness of antibiotics would strengthen the bill, in my view.
  I want to thank my colleagues on both sides of the aisle, and their 
staffs, for the hard work they have put into making this a strong, 
bipartisan bill. I particularly want to thank Mr. Pallone's and Mr. 
Dingell's staff members Tiffany Guarascio and Kim Trzeciak as well as 
Mr. Upton's and Mr. Pitts' staff, Ryan Long and Clay Alspach. And, 
finally, my own staff, Karen Nelson, Rachel Sher, Eric Flamm, and Arun 
Patel.
  I expect the same level of bipartisan cooperation will continue as we 
work together with our colleagues in the Senate to get this to the 
President before the 4th of July recess.
  Ms. KAPTUR. Mr. Speaker, I reluctantly rise today in support of H.R. 
5651, the Food and Drug Administration Reform Act of 2012.
  First, I would like to commend Chairman Upton and Ranking Member 
Waxman for putting together a bipartisan bill. Bipartisan bills are a 
rarity in this Congress and I hope we can use the goodwill gained in 
this bill to come together on additional measures, such as those that 
create jobs and promote economic growth.
  While this bill has support from both sides of the aisle, from my 
perspective, it does not go far enough.
  The Food and Drug Administration (FDA) is tasked with ensuring the 
safety of $2 trillion in products produced by industry. The FDA's 
approval of a company's products all but guarantees profits for that 
company.
  Companies that benefit from the FDA's approval should significantly 
contribute to the FDA's budget to reduce the burden on taxpayers who 
are already paying for tax cuts for millionaires and billionaires and 
two unpaid wars. In FY 12, user fees comprised a mere 35 percent of the 
FDA's budget.
  The FDA is facing many challenges. Approximately half of medical 
devices used in the United States come from abroad. Nearly 40 percent 
of the drugs Americans take are made overseas and about 80 percent of 
the active pharmaceutical ingredients are imported. Several years ago, 
contaminated heparin from China caused a number of deaths and illnesses 
in my Congressional District.
  Additional resources are needed to properly investigate, inspect, and 
police foreign products like heparin to ensure American consumers are 
fully protected. Industry should be contributing more.
  Despite my reservations, this bill is a step in the right direction. 
It reauthorizes user fees for prescription drug and medical devices at 
levels that should provide the FDA with sufficient resources to give 
patients access to therapies at the earliest possible time.
  In addition, this legislation authorizes a new user fee for generic 
drug reviews. In the last decade, the use of generic drugs saved the 
U.S. health care system more than $931 billion. Consequently, I'm glad 
to see the underlying bill provides resources to improve review times 
to ensure safe generic drugs come into the market as quickly as 
possible.
  Finally, the bill addresses some of my concerns regarding foreign 
products. I strongly support the provisions that require drug importers 
to register with the FDA, requiring sufficient information from 
importers to allow the FDA to implement a risk-based approach to import 
screening and barring the entry of imported drugs if deemed to have 
been delayed, limited or denied a full safety inspection.
  I also strongly support the section of the bill that provides 
extraterritorial Federal jurisdiction to enable United States law 
enforcement to hold those accountable who violate our safety laws, such 
as those who are responsible for the heparin-related deaths in my 
Congressional District.
  Mr. TOWNS. Mr. Speaker, I rise today in support of H.R. 5651, The FDA 
Reform Act of 2012. I would like to thank my colleagues for working 
with me and my staff on this important piece of legislation. As we move 
forward in the legislative process I would like to state the importance 
of maintaining the provision in the accelerated approval section that 
requests guidance from the FDA on how to implement reforms to the drug 
approval process enacted by Congress. During our discussion in 
subcommittee I submitted letters in support of this language from NORD, 
BIO, and fifty other patient groups. I hope that we maintain this 
guidance language as we continue to move through the legislative 
process.

[[Page 7945]]

  I have only a few remaining concerns that I hope we can work through 
together before the bill is signed into law. One issue is regarding our 
drug supply chain security and the second is regarding medical device 
technologies which potentiate drugs.
  For many years, creating a national standard on drug traceability, or 
pedigree, has eluded Congress. Realizing that the U.S. pharmaceutical 
supply chain has many safeguards in place and companies spend 
significant amounts of money to ensure the integrity of their 
products--criminals, thieves and other bad actors will stop at nothing 
to make profit off of the high value prescription drugs that are 
manufactured and sent throughout the distribution chain down to our 
pharmacies, and ultimately to patients and consumers. I support efforts 
to create consensus language on this issue that has the backing of 
stakeholders--from manufacturers, to distributors, wholesalers on down 
to pharmacists--all involved in various aspects of the U.S. supply 
chain.
  We know that the other chamber was able to include ``placeholder'' 
language in its version of the FDA bill to ensure that conversations 
can continue to play out between FDA, supply chain stakeholders and 
Congressional stakeholders to come to a final consensus over the course 
of the coming weeks. Given the seriousness of this issue--to avoid 
additional injuries and potential deaths from counterfeit and 
adulterated product, and to avoid a patchwork of individual state laws 
to address an issue which clearly requires a federal solution--I would 
urge the FDA and all parties involved in these talks to find common 
ground so that we can include final supply chain integrity language 
into the final FDA user fee bill that is agreed upon between the two 
chambers. I would ask my colleagues on the committee to also support 
this request and signal their support as well.
  My final concern is regarding medical device technologies. The 
Centers for Disease Control and Prevention (CDC) estimates that more 
than 70% of bacterial and fungal pathogens resist at least one of the 
drugs typically used to eradicate them. The CDC estimates that these 
infections are responsible for over 90,000 deaths annually and cost the 
U.S. an excess of $4 billion. These life-threatening infections also 
prolong hospital stays and create substantial additional costs in the 
fighting of these infections.
  With such knowledge, the importance of innovative treatments such as 
patented laser technology that combat resistant organisms such as MRSA 
is pivotal. One section of this bill addresses the critical need to 
improve the pipeline of medical drugs identified as qualified 
infectious disease products (QIDPs). It has been brought to my 
attention that new peer-reviewed and patented laser technology is 
emerging that has the potential to eradicate drug resistant bacteria 
and fungus by potentiation of existing generic antimicrobial drugs 
while preserving human tissue. The standard definition of 
``potentiation'' is when one drug enhances a second drug so that the 
combined effect is greater than the sum of the effects of each one 
alone.
  With these innovative technologies, we can improve post-surgical and 
inpatient outcomes. Furthermore, these technologies have shown the 
potential to successfully treat over 2.7 million patients annually 
suffering from diabetic ulcers and lower limb and amputations. I hope 
the FDA will consider medical device technology which potentiate drugs 
as well QlDPs which have already been identified in this legislation in 
taking steps toward eradicating bacterial and fungal infections.
  Mr. Speaker, this legislation has been the model of bipartisanship. I 
hope that we can continue our important work together to have these 
critical provisions affecting patients included in the final bill 
before it is signed into law.
  Ms. DeLAURO. Mr. Speaker, while I have serious reservations, I rise 
in support of the Food and Drug Administration Reform Act of 2012 that 
we are considering under suspension of the rules today.
  As we all know, this bill is critical to patients, consumers, and 
industry across the country. It will ensure that Americans continue to 
have access to safe, affordable, and effective medications and medical 
devices.
  And there are several positive things in this legislation. For 
example, it will help to prevent drug shortages by requiring that 
companies notify the FDA if certain drugs are expected to experience 
manufacturing interruptions or discontinuances. Between 2005 and 2010, 
the number of reported drug shortages nearly tripled--so we must act, 
and the provisions in this bill are a step forward in addressing this 
issue.
  The bill also permanently reauthorizes pediatric drug programs, 
including those originally created because of the Best Pharmaceuticals 
for Children's Act. It requires the electronic submission of new drug 
applications and issuance of regulations supporting a unique device 
identification system. It authorizes new efforts to prevent 
prescription drug abuse.
  Unlike the Senate bill passed last week, this bill includes a clause 
that may result in the destruction of drugs valuing less than $2,000 
entering this country before notifying the individual receiving the 
package--simply put, some Americans may order medications that never 
arrive, placing their health at risk as they wait for their affordable 
medication. We should move to the Senate position on this issue.
  Unfortunately, this bill also represents a missed opportunity. We 
should be going much further to ensure that medications and medical 
devices are safe and effective, and to improve consumer and patient 
protections. For example, the bill does not strengthen the premarket 
review of medical devices, improve the agency's ability to 
appropriately reclassify medical devices, or even authorize an 
independent review of the drug approval process. It authorizes changes 
to the agency's conflict of interest policy for Advisory Committees, 
but does not strengthen them. And it does not reform the medical device 
clearance process.
  The bill we consider today should not be an end point. American 
consumers need access to products that are safe and effective, and 
numerous independent organizations have found the current system 
lacking. Just last year, the Institute of Medicine found that the 
510(k) clearance process is not ``a reliable premarket screen of the 
safety and effectiveness'' of some devices. In sum, we should pass this 
bill, but we must also do more to strengthen the pre-market and post-
market oversight of drugs and devices.
  Mrs. CHRISTENSEN. Mr. Speaker, there are so many reasons that I rise 
in strong support of this bipartisen legislation. Not only will it 
modernize the FDA review process of new and generic prescription drugs, 
biosimilars and medical devices, and ensure that Americans have 
reliable access to new, safe and innovative medicines and devices, as 
well as to affordable generic drugs, but it also promotes greater 
equity and safety in the development and use of prescription drugs for 
children--a level of importance that cannot be stressed enough.
  I strongly support this legislation because it prioritizes and 
protects the health and welfare of consumers, while also being fair and 
just to the prescription drug and medical device industries. And, this 
legislation includes incentives for the development of new antibiotics 
to treat both life-threatening infections as well as those that if not 
treated, snowball into life-threatening situations.
  Finally, I rise in strong support of this legislation because it will 
take significant steps forward to address our nation's ever-growing 
challenge with drug shortages. And so, Mr. Speaker, I urge my 
colleagues to join me with their strong support of this legislation so 
that we may achieve what we have long hoped to accomplish: reforming 
and strengthening many of the Food and Drug Administration's key 
programs which--together--will ensure that Americans have greater and 
more timely access to safe, affordable therapies and medical devices to 
treat and manage their conditions, and improve their overall health, 
quality of life and thus life opportunities.
  Ms. McCOLLUM. Mr. Speaker, I rise today in strong support of the Food 
and Drug Administration Reform Act of 2012 (H.R. 5651), which will 
strengthen Minnesota's health care system and economy.
  The Food and Drug Administration Reform Act reauthorizes the FDA's 
drug and medical device user fee programs at a critical time. If these 
user fees are not reauthorized before the end of June, the FDA will not 
have the funding it needs to ensure life-saving drugs and medical 
devices are available to patients in a timely fashion. This bill also 
accelerates approval of treatments to address rare diseases, 
reauthorizes two successful pediatric programs, and helps to prevent 
drug shortages that are affecting families across the country. Overall, 
the reforms in H.R. 5651 bring the FDA into the 21st century by making 
the agency more responsive to changes in the U.S. health care system 
and better equipped to oversee a globalized market for medical 
products. This legislation will deliver safer treatments, faster 
innovation and better care for millions of American patients and 
families.
  This legislation is especially important for America's medical device 
sector. The approval process for medical devices at the FDA slowed by 
as much as 60 percent since 2005, according to the General 
Accountability Office. While longer approval times do not contribute to 
patient safety, they have delayed or even denied life-saving treatments 
to patients and undermined the international competitiveness of the 
U.S. medical device industry. There is

[[Page 7946]]

general agreement that the broken approval process for medical devices 
is doing real harm to patients and workers. This is especially 
concerning for Minnesota because our state is a hub of medical device 
innovation; the sector employs thousands of highly-skilled workers in 
our state. H.R. 5651 reforms and reauthorizes the medical device user 
fee program through fiscal year 2017, providing years of stability and 
increased regulatory certainty for companies that range from local 
small business start-ups to global Fortune 500 enterprises. Moreover, 
the bill will foster innovation in the sector by speeding market access 
for new and improved medical devices without compromising patient 
safety.
  The Food and Drug Administration Reform Act is a rare bipartisan 
success story. This legislation comes to the House floor after months 
of close bipartisan collaboration. The Senate approved a bill very 
similar to H.R. 5651 by a vote of 96 to 1. The House Energy and 
Commerce Committee voted 46 to 0 to move H.R. 5651 to the floor. Both 
Democratic and Republican members of Congress understand that a high-
quality health care system requires a strong and effective FDA. Today's 
bill is a major step forward for the FDA and a demonstration of 
legislative compromise for the good of the American people.
  I urge all my colleagues to support H.R. 5651.
  Mr. CHANDLER. Mr. Speaker, I rise today to address the significant 
bipartisan effort to reauthorize FDA user fee legislation. This 
reauthorization provides an opportunity to update the relevant FDA laws 
to reflect changes and challenges in the important area of prescription 
drugs and medical devices.
  One critical area that Congress must continue to focus on is the 
safety and security of the pharmaceutical supply chain. Counterfeit 
drugs are a growing problem and put patient safety and health at risk. 
Patients who rely on certain medications should not have to live in 
fear they are not receiving the treatment they need because their 
medicine has been compromised.
  This is unacceptable, and we must work to find a national solution to 
this growing problem of counterfeit drugs. Because so much of the 
pharmaceutical supply chain relies on interstate commerce, I believe 
our federal government must ensure that properly licensed entities are 
involved in our national pharmaceutical supply chain, particularly 
third-party logistics providers (3PLs).
  The way prescription drugs are moved from the manufacturer to the 
consumer has changed over the past several years with the emerging role 
of 3PLs. These providers are not in the business of manufacturing, 
buying, selling, or dispensing prescription drugs; they provide or 
coordinate warehousing, distribution, or other services on behalf of 
the manufacturer, wholesaler, or dispenser. We cannot realistically 
expect to have a thorough and comprehensive national supply chain 
track-and-trace system without providing for a clear and accurate 
definition of third party logistics providers. Our federal laws need to 
reflect this new reality.
  I applaud the Chairman and Ranking Member of the Energy & Commerce 
Committee for their leadership and diligent work on this bill, and I 
encourage them to ensure that the final product from the House-Senate 
conference implements a uniform federal serialization policy covering 
all pharmaceutical supply chain participants.
  Mr. PASCRELL. Mr. Speaker, I stand today to support H.R. 5651--Food 
and Drug Administration Reform Act of 2012, which reauthorizes the 
Federal Drug Administration's (FDA) prescription drug and medical 
device user fee programs through 2017. This legislation will provide 
the FDA the ability to collect user fees from drug and medical device 
companies to help fund its reviews of their products. These user fee 
programs provide the FDA the resources to enable the efficient review 
of applications and give patients access to therapies at the earliest 
possible time, and most importantly, help prevent drug shortages that 
threaten public health.
  I am supportive of the legislation because it will authorize a new 
user fee program for generic drugs, resulting in decreased review 
times, and it authorizes user fee program for biosimilars, thus 
ensuring parity. Additionally, the legislation reauthorizes and makes 
permanent two complementary pediatric drug programs, which foster the 
development and safe use of prescription drugs for children.
  Further, the legislation will assist in the modernization of the 
FDA's global drug supply chain authority, resulting in improved safety 
of our prescription drugs The legislation will also provide new 
incentives for the development of antibiotics to address the public 
health threat of antibiotic resistance. Finally, the bill includes 
important provisions to help prevent and mitigate drug shortages, which 
have unfortunately now become an all-too-frequent occurrence.
  Ultimately, the legislation will ensure that Americans have access to 
crucial medicines and medical devices, improves access to new and 
innovative medicines and devices, helps prevent and mitigate drug 
shortages and reduces drug costs for consumers by speeding the approval 
of lower-cost generic drugs.
  Mr. PAULSEN. Mr. Speaker, I rise today in strong support of H.R. 
5651, the Food and Drug Administration Reform Act.
  The United States has led the global medical device industry for 
decades. This leadership has brought hundreds of thousands of high-
paying jobs to our country and life-saving, life-improving devices to 
our nation's patients. U.S. medical device-related employment totals 
over 2 million jobs, and these are good, rewarding jobs.
  This legislation will streamline and modernize the medical device 
approval process to make it more transparent, more consistent, and more 
predictable. This much needed reform will help companies bring their 
products to market quicker and cheaper, ultimately increasing patient 
access to life improving and life saving technologies.
  I would like to highlight one portion of the bill that was taken from 
my legislation, the FDA REFORM Act. This provision would expand and 
clarify the FDA's ability to use accredited third party reviewers for 
low risk devices.
  This will free up valuable resources and allow the FDA to function 
more effectively while still focusing on protecting patient safety.
  I want to thank Chairman Upton and his staff for their continued 
support and effort on this matter. I urge adoption of this crucial 
legislation that will help bring new products to market.
  Mr. BASS of New Hampshire. Mr. Speaker, I rise in strong support of 
H.R. 5651, the Food and Drug Administration (FDA) Reform Act of 2012. 
The user fee process at the FDA is a vital element in maintaining 
operations at the FDA to bring valuable drugs and devices through the 
approval pathway and to market. I am optimistic that, with the enhanced 
financial incentives and resources available to the FDA included in the 
user fee agreements, we will see shorter approval times and more 
successful products available to patients. Additionally, there are 
significant drug and device regulatory improvements that will, I 
believe, increase transparency, market involvement, and the development 
of innovative and life-saving drugs and devices.
  Consistent throughout this process has been a commitment to bringing 
the need of the rare disease community to the forefront of this debate, 
both through medical device legislation as well as a focus on drug 
development for rare diseases. I am proud to have my bill, the 
Humanitarian Device Reform Act (H.R. 3211), included as a provision in 
the device regulatory section. This language will make it easier for 
device manufacturers to create Humanitarian Use Devices (HUDs) to treat 
individuals, both children and adults, who suffer from diseases that 
affect communities of 4,000 or fewer each year. Current law prevents 
companies who manufacture HUDs from recouping beyond the research and 
development costs, subsequently restricting entry into this field, 
particularly for smaller device companies, such as those found in New 
Hampshire. This provision would lift this outdated profit cap 
restriction and would do so in a way that maintains incentives for 
devices developed for both children and adults and keeps in place the 
necessary product safeguards. It would maintain FDA's current oversight 
of HUDs but, by allowing manufacturers to generate a profit from the 
sale of these devices, allow for further development, improvements, and 
incentives to make it possible for new device developers to enter the 
marketplace, many of which cannot afford to do so under current 
statute.
  During this debate I have made clear my support for rare diseases and 
the focus on drug development and expedited approval pathways for drugs 
to treat rare diseases. With this increased focus on providing 
incentives to manufacturers to invest in the development of these 
drugs, it can be an attainable goal for an individual and family 
affected by rare diseases to not only improve the quality of life but 
possibly even find a cure. By working together, the FDA and drug 
developers will be able to maintain the high standards of safety but 
also fast-track the approval process in order to bring these important 
drugs to the patient.
  While H.R. 5651 makes a number of important reforms, more work needs 
to be done to strengthen the integrity of the drug supply chain. 
Congress must maintain its commitment to keeping the American people 
safe and protect the integrity of drugs, from the manufacturing floor 
to the medicine cabinet. We need

[[Page 7947]]

more than the prospect of a patchwork of state regulations that would 
prove to be costly and ineffective, and more importantly, would fail to 
get the job done. Instead, we need a common sense national tracking 
system that will provide a consistent and workable solution for all 
parties in the supply chain.
  At the beginning of May, I joined a bipartisan group of my colleagues 
in writing a letter to Chairmen Upton and Pitts and Ranking Members 
Waxman and Pallone stressing the importance of the pharmaceutical 
distribution chain and urging the inclusion of legislative language to 
establish a prescription drug traceability platform. While I had hoped 
an agreement would have been included in the bill we are considering 
today, I am encouraged that a compromise can be reached during a House 
and Senate conference.
  Mr. Speaker, I would like to thank my colleagues on the Energy and 
Commerce Committee for the work they have done on this user fee 
agreement and urge its swift passage.
  Mr. MARKEY. Mr. Speaker, I want to thank Chairmen Upton and Pitts and 
Ranking Members Waxman and Pallone for their work in bringing to the 
floor a bipartisan bill that provides FDA additional resources to bring 
new drugs and medical devices to market. These new resources will 
enable FDA to improve review times for new product applications and 
provide companies greater clarity about compliance requirements and 
their responsibilities.
  There are many important policy improvements in this bill. They 
include:
  A reauthorization of the user fee programs for prescription drugs and 
medical devices, as well as the creation of a new generic user fee 
program that will help slash current review times for these products.
  A reauthorization of two programs that foster the development and 
safe use of prescription drugs for children.
  New incentives for the development of antibiotics, which are needed 
to increase the number of products in the development pipeline.
  Today's bill also includes the reauthorization of legislation I 
authored in 2007 that has helped spur the development of medical 
devices for children. The Pediatric Medical Device Safety and 
Improvement Act, PMDSIA, creates grants that bridge the gap between the 
people who understand the medical need--doctors and innovators--with 
the people who can help turn their ideas into devices on the shelves, 
like manufacturers and federal regulators. Since the grant program's 
inception, the five Pediatric Device Consortia established as a result 
of this language have assisted in advancing the development of 135 
pediatric medical devices. Currently the consortia are managing 80 
active pediatric medical device products.
  The FDA Reform Act also extends a provision of PMDSIA that provided 
profit incentives for companies to develop devices for rare pediatric 
diseases. The original incentive passed in 2007 solely for pediatric 
diseases proved immensely successful. Today's bill strikes a compromise 
to extend this incentive for devices used to treat rare diseases in 
adults as well, while still retaining the incentive for pediatric 
devices. I urge Congress does not negatively impact the development of 
devices for children.
  In addition, we will need to ensure that companies using this 
incentive and making a profit on their device because they got 
pediatric labeling actually continue to sell their device for use in 
children and not only for adults. The Pediatric Advisory Committee at 
the FDA will need to play a vital role in this oversight and in 
monitoring the number of devices sold for adult use as opposed to the 
number sold for pediatric use.
  PMDSIA also included a requirement that device companies provide FDA 
with information on the pediatric populations that could benefit from a 
new device they are looking to sell. This was supposed to help FDA 
track what devices are available for children and where gaps remain. 
FDA put out a proposed rule and a direct to final rule simultaneously 
to implement the provision, but it withdrew the direct to final rule 
after industry voiced opposition. The regulation has languished ever 
since.
  The failure to implement this provision of the law has made it 
difficult for FDA to provide Congress information about the 
availability of pediatric medical devices and to identify unmet medical 
device needs, according to a GAO report. I am disappointed that this 
important tracking provision has gone unimplemented for nearly five 
years, and I hope that FDA will comply with the timeframe included in 
the legislation to issue a final rule implementing the law no later 
than December 31, 2013.
  Despite these advances, today's bill is a missed opportunity because 
it fails to address a glaring patient safety issue that affects 
patients around the country.
  Many Americans would be surprised to learn that ninety percent of 
medical devices are not required to undergo clinical testing in humans 
prior to being sold. Instead, most devices, including brain stents and 
hip implants, need only to show similarity to an earlier product to 
make their way to market.
  Under current law, the FDA is required to clear certain medical 
devices as long as they demonstrate their similarity to an earlier 
product. This is true even if the new device is modeled after a 
defective device that caused serious injury or even death.
  If the device is indeed similar to the earlier model, flaw and all, 
FDA's hands are tied. The agency does not have the legal authority to 
deny approval.
  This makes no sense.
  We wouldn't fast-track approval of a new drug that was based on one 
that had been recalled.
  We shouldn't do it here, either, with medical devices.
  This legislation was an important opportunity to address this medical 
device safety loophole, but it doesn't. The loophole remains in place 
and patients are still at grave risk.
  Thousands of patients have already been seriously harmed by this 
loophole. Four years ago, Jaye Nevarez, a 50 year-old mother of three, 
was a healthy truck driver who earned a decent living, played in a 
band, and paid her bills on time. Then her doctor implanted bladder 
mesh, a device that traces its origins back to an older product that 
had to be recalled for causing serious injury and even death.
  Jaye now lives in constant pain. She was forced to quit her job. She 
can't walk without a cane. She lost her insurance and faces a growing 
mountain of medical debt. The bank recently began foreclosure 
proceedings on her home where she lives with her 79 year-old mother.
  Jaye isn't the first to be harmed by this loophole. If we fail to fix 
it, she won't be the last.
  As documented in the accompanying report prepared by my staff--
``Defective Devices, Destroyed Lives'', several medical devices that 
have been recalled because they severely injured patients continue to 
be used as models for new devices--many of these are on the market and 
being implanted in patients today.
  I introduced the Sound Devices Act, providing FDA the ability to 
protect the public from these unsafe devices, but this was not included 
in the bill.
  The definition of insanity is doing the same thing over and over 
again and expecting a different result. When it comes to medical 
devices we have an insane policy that makes no sense.
  Despite repeated testimony from the FDA that the current law 
restricts their ability to assure the safety of medical devices, 
Republicans have refused to acknowledge and address this very dangerous 
loophole.
  This bill must not be the last word on medical device safety. I hope 
my colleagues will join me to close this medical device loophole so 
that we can keep the American public safe from harm.
  Lastly, I remained concerned about the mandatory clinical trials 
database that was created in the 2007 FDA Amendments. This registry and 
results database was meant to directly address issues stemming from a 
lack of transparency of clinical trials. Several high profile examples, 
including the drugs Paxil and Vioxx, gained national attention when 
their manufacturers were found to have suppressed clinical trial data 
that demonstrated safety and efficacy concerns.
  Today, the website requires information about certain clinical trials 
to be publically posted on the database, but loopholes in the 
underlying law still allow researchers and companies to avoid 
publishing unfavorable data, putting human subjects of clinical trials 
at grave risk. To protect the public from potentially dangerous drugs 
and medical devices these loopholes must be closed to provide 
equivalent transparency of all clinical trials. I hope I can work with 
my colleagues to address this serious issue in the very near future.
  Mr. GENE GREEN of Texas. Mr. Speaker, this bill is the result of hard 
work by our committee. I especially want to thank Chairmen Upton and 
Pitts and Ranking Members Waxman and Pallone and I am proud that our 
committee is setting an example for bipartisan compromise and 
productive governing.
  Contained in the FDA Reform Act is the GAIN Act, a bill introduced by 
Congressman Gingrey and myself, which is aimed at incentivizing the 
development of new antibiotics that will fight the serious and life 
threatening infections that mankind will face in the coming years.
  The GAIN Act provisions of this bill represent a careful bipartisan 
balance that appropriately protects patient safety and responsibly

[[Page 7948]]

offers incentives to innovative drug companies seeking the cures to our 
world's most deadly bacterial pathogens such as extensively drug 
resistant tuberculosis, MRSA, and others that we are currently ill-
equipped to treat. Currently, we are unable to manage many significant 
public health threats posed by these pathogens.
  While a widespread public health threat is in our future, some people 
in this country are dying today as a result of drug resistance and 
super bugs. We hear a lot about the challenges of South East Asia, but 
our health professionals are confronting bacterial infections that are 
resistant to all currently available antibiotics.
  Recently, the World Health Organization Director-General said 
``things as common as strep throat or a child's scratched knee could 
once again kill. Hip replacements, organ transplants, cancer 
chemotherapy and care of preterm infants would become far more 
difficult or even too dangerous to undertake'' due to the rising threat 
of super bugs.
  According to providers I've heard from, drug resistance is already a 
distinct problem in the front lines of our nation's health delivery.
  For example, in one instance, a 15 year old girl got her ears 
pierced. Her earlobes swelled and got red. She went to the emergency 
room and was admitted for IV antibiotics. The infection was resistant 
to the usual antibiotics and she became septic and died.
  There are many other cases in which minor injuries and simple 
procedures produce unexpected complications because of the emerging 
threat of drug resistance.
  Because of the nature of this threat, I urge my colleagues as this 
heads to the floor and hopefully to conference, that no changes are 
made to the GAIN provisions to further limit incentives or reduce the 
list of pathogens. The truth is we do not know what the specific public 
health threat will be and once it is on top of us it is too late. We 
have to be prepared and part of this preparedness is getting our drug 
companies to develop drugs that may not be profit blockbusters but are 
necessary to help protect us from public health crises.
  With the help of Chairman Upton and Ranking Member Waxman, we have 
struck a careful balance. I strongly oppose any changes to the GAIN Act 
in an eventual conference with the Senate. I am concerned that any 
changes could create lopsided incentives that lead to unnecessary drugs 
or, alternatively, remove incentives and result in too few, if any, 
drugs.
  I believe the GAIN Act as included in this bill, as well as the 
entire bill, are good policy. The FDA Reform Act deserves to be passed 
by the House and I strongly urge my colleagues to support it.
  Mr. BILBRAY. Mr. Speaker, I rise today to bring to the attention of 
my colleagues an issue of great importance to the patient and provider 
community--the availability of critical diagnostic tests. On June 1, 
2011, the Food and Drug Administration issued a draft guidance titled, 
``Draft Guidance for Industry and FDA Staff--Commercially Distributed 
In Vitro Diagnostic Products Labeled for Research Use Only or 
Investigational Use Only: Frequently Asked Questions.''
  As written, this draft guidance could jeopardize the future of 
personalized medicine and individualized treatment options for 
patients. I also want to note that when the FDA sought public comment 
on this draft guidance, the agency received correspondence from 54 
organizations and individuals. Every comment received by the FDA 
expressed concerns about the draft guidance, and not one endorsed the 
approach.
  For example, the Johns Hopkins University department of pathology 
surveyed laboratories at the university, and found that dozens of tests 
could be impacted by the guidance, including diagnostics for viral 
meningitis, and diagnosis of HIV infection in infants with infected 
mothers. Mayo Clinic indicated that certain important cancer 
diagnostics could disappear if this guidance is implemented as 
currently written. Public health laboratories, including those in my 
home state of California would lose their ability to identify and 
provide laboratory-based surveillance for diseases such as measles, 
West Nile virus, eastern equine encephalitis virus, and multidrug-
resistant tuberculosis.
  When the academic community expresses such serious reservations, I 
believe it is important that FDA review and address these concerns. It 
is important for the Agency to work with all stakeholders, including 
the patient and provider communities, on a balanced approach before 
issuing its final guidance.
  Ms. SPEIER. Mr. Speaker, I rise today to share my additional thoughts 
on the Food and Drug Administration (FDA) issue raised by my colleagues 
Mr. Bilbray and Mr. Towns.
  The Research Use Only (RUO) and Investigational Use Only (IUO) 
products draft guidance issued by the FDA last June could result in 
serious consequences for the future of health care. Patients and 
doctors want access to validated tests that will guide and improve 
their medical care. The development of tests by laboratories and their 
validation and regulation under the Clinical Laboratory Improvements 
Act (CLIA) are part of a long-standing regulatory framework. I am 
concerned that this draft guidance, should it be finalized in its 
current form, could seriously disrupt this process and the development 
of new technologies and diagnostics.
  Another concern about the FDA draft guidance is that manufacturers 
could be held accountable for the activities of their customers who 
purchase these RUO and IUO products. It is quite possible that the 
draft guidance will cause manufacturers to stop offering important 
components for diagnostic tests. And what would be the end result? 
Commercial, academic, and public health laboratories may not be able to 
continue current tests or develop new tests to help diagnose or prevent 
the progression of diseases and conditions such as cystic fibrosis, 
ovarian cancer, organ failure and transplantation, and identifying new 
infectious organisms.
  The FDA must consider the potential impact of this guidance on the 
practice of medicine and patient access to new and existing 
diagnostics. The concerns raised by the health care community, 
including the American Hospital Association and the Association of 
Public Health Laboratories, should be addressed before finalizing this 
guidance.
  Mr. TOWNS. Mr. Speaker, I rise today to echo the comments of my 
colleagues, Representative Bilbray and Representative Speier, and share 
my concerns about the Food and Drug Administration's draft guidance on 
Research Use Only and Investigational Use Only products.
  This guidance provides no flexibility for tests used infrequently, 
for example, to identify rare disorders. Rare diseases, such as Gaucher 
Disease and Fragile X, can be hard to diagnose, but genetic tests 
developed and validated by laboratories have made them much easier to 
identify. In some instances, these tests can point the way to 
successful treatment of the underlying condition.
  Emerging public health threats are another key area that could be 
impacted by this guidance. Three years ago, this country dealt with the 
H1N1 flu virus, an emerging infectious disease. If another such public 
health threat became a serious concern, this draft guidance could block 
the development and deployment of new diagnostics urgently needed 
during a national crisis.
  It is critical that the FDA consider these serious and valid concerns 
before issuing a final guidance on Research Use Only or Investigational 
Use Only products.
  Ms. ESHOO. Mr. Speaker, I rise today to speak in support of H.R. 
5651, the Food and Drug Administration Reform Act of 2012, to 
reauthorize the Prescription Drug User Fee Act and the Medical Device 
User Fee Act. These critically important laws have improved patient 
access to important therapies and expedited the FDA's approval times 
while upholding the most rigorous standards for patient safety.
  The Prescription Drug User Fee Act, PDUFA, was enacted in 1992 when 
drug review times were lagging and FDA simply couldn't keep up with the 
flood of new drug applications. Through user fees paid by applicants, 
PDUFA gave FDA the resources it needed to hire and support more staff. 
The program has been successful at reducing review-time backlogs and 
expediting safe and effective therapies to patients.
  Along with faster drug approvals, Congress also recognized the need 
to study drugs in children. As the original author of the Best 
Pharmaceuticals for Children Act, BPCA, and the Pediatric Research 
Equity Act, PREA, I'm proud of how successful these programs have been 
in treating children, resulting in new dosing information, new 
indications of use, new safety information, and new data on 
effectiveness. Before BPCA and PREA, the vast majority of drugs (more 
than 80 percent) used in children were used off-label, without data for 
their safety and efficacy. Today, that number has been reduced to 50 
percent.
  We know that children are not just small adults--they have unique 
medical needs and drugs react differently in their bodies. That's why 
in this year's reauthorization, it was important for us to look at 
areas in need of improvement. The bipartisan legislation gives FDA the 
tools it needs to ensure companies are thinking about pediatric 
populations as early as possible in the drug development process, and 
that they're able to enforce timelines that are routinely missed. The 
language encourages further study into untested age groups, like 
neonates, and clarifies any confusion over what some see as 
``loopholes'' to allow companies to access the market exclusivity 
incentive without completing additional studies.

[[Page 7949]]

  The legislation ensures that companies routinely submit their 
pediatric plans earlier in the process by establishing a clear timeline 
and expectations. I will be closely monitoring the regulation that will 
implement the pediatric plan content, as it was my intention that the 
regulation closely mirror the 1998 Pediatric Rule.
  I thank my colleagues, Rep. Mike Rogers and Rep. Edward Markey who 
worked tirelessly with me to improve these programs, and the American 
Academy of Pediatrics, along with 20 other pediatric advocacy groups 
who provided expert guidance and recommendations throughout the 
process. Together we've improved BPCA and PREA to benefit medical care 
for children for generations to come.
  Ms. RICHARDSON. Mr. Speaker, I rise in support of H.R. 5651, The 
Bipartisan Food and Drug Administration Act of 2012, which modifies the 
Food and Drug Administration's (FDA) policies and procedures to enhance 
Americans' access to effective healthcare. This bill improves the 
safety, development, and distribution of medications and medical 
devices to patients and medical providers.
  This bill reauthorizes the FDA's user fee program for prescription 
drugs and medical devices through fiscal year 2017. Further, it 
introduces a new user fee program for generic medications. These fees, 
collected from drug and medical device companies, will give the FDA the 
funding it requires to grant patients rapid access to the treatments 
they need. This will improve the accessibility of vital medicines to 
patients throughout the U.S.
  Mr. Speaker, this bill permanently reauthorizes two beneficial 
pediatric drug programs. The first, the Best Pharmaceuticals for 
Children Act, enhances the safety and availability of prescription 
drugs for children. It does this by providing mechanisms through which 
drug companies can test their products for use in pediatrics, and 
offering a six month patent extension as an incentive to companies who 
do so.
  The second pediatric drug program that is permanently reauthorized is 
the Pediatric Research Equity Act. This act increases the safety of 
prescription drugs for children by requiring pediatric testing of 
certain medications intended for adults in order to fully understand 
their effects. This will ensure that physicians have a clearer grasp of 
the effects these medications have before prescribing small dosages to 
children.
  This bill also provides for a vital update of the FDA's global drug 
supply chain authority, requiring drug importers to register with the 
FDA, and disallowing the import of medicines from organizations that 
have limited or denied inspections.
  Most importantly, the bill expands the jurisdiction of the Federal 
Food, Drug, and Cosmetic Act. This allows for the FDA to prosecute 
foreign violators of the act, and thus discourages such violations in 
the future. These updates will improve the safety of the prescription 
drugs that are provided to American patients.
  Finally, Mr. Speaker, this bill will implement new FDA requirements 
that will help to prevent drug shortages. The bill does this by 
updating the FDA's reporting policies for manufacturers, and ensuring 
that the agency maintains a drug shortage list that is made available 
to healthcare providers. Additionally, should a shortage still occur, 
this bill outlines steps to be taken to mitigate the problem. If 
enacted, these new policies will help protect the country's 
prescription drug supply, ensuring that Americans always have access to 
the medication they need.
  Mr. Speaker, it is for these reasons that I support H.R. 5651.
  Mr. STEARNS. Mr. Speaker, the Food and Drug Administration Reform 
Act, H.R. 5651, is based on user fee negotiations between FDA and the 
prescription drug, generic drug, biologic, and medical device industry. 
This reauthorization of the FDA user fees will provide stability with 
FDA's new product review as companies submit new and innovative devices 
and drugs for approval.
  In codifying the User Fee Agreement, this committee has included 
additional provisions designed to address some of the defects of the 
regulatory structure and overreach by the FDA. Under my Chairmanship of 
the Oversight and Investigation Subcommittee, we held a hearing into 
FDA's regulatory efforts in the medical device space. During our 
hearing, many of the witnesses talked about the reluctance of FDA to 
approve devices and how FDA continually moved the goalposts for 
approval. I am glad that Title VII of this bill includes a significant 
number of reform provisions designed to bring certainty to the medical 
device field.
  In addition to reforming approaches to medical devices through Title 
VII, the FDA's approach to rare diseases must also be modernized. I'm 
happy the Committee included the Faster Access to Specialized 
Treatments Act, FAST Act, H.R. 4132, which I introduced with my friend 
and colleague, Representative Ed Towns. FAST updates and modernizes 
Section 506 of the Food, Drug & Cosmetic Act, and updates the 
Accelerated Approval statute to reflect two decades worth of medical 
sciences that has occurred since Accelerated Approval was first 
created. FAST will help FDA implement broadly effective processes for 
the expedited development and review of innovative new medicines 
intended to address unmet medical needs for serious or life-threatening 
diseases by using modern scientific tools.
  The use of surrogate endpoints may result in fewer, smaller or 
shorter clinical trials without compromising FDA's existing high 
standards for safety or efficacy. Surrogate and clinical endpoints only 
need to be reasonable predictors of clinical benefit to support 
accelerated approval. They do not need to be validated or proven first. 
The changes made to current law permitting the Secretary to require 
validation of surrogates following accelerated approval is not intended 
to change FDA's long history of granting accelerated approval based on 
unvalidated, but predictive, surrogate endpoints.
  Additionally, FAST includes explicit language for FDA to think about 
the challenges of rare diseases when developing their guidance and 
gives the rare disease community an opportunity to publically comment 
on FDA's draft guidance. FAST ensures that the voices of the 30 million 
Americans with a rare disease will be heard by FDA. There are about 
7,000 rare diseases and only about 250 have any treatment. FAST will 
save lives, and give a voice to the voiceless; and I am glad it is in 
the bill.
  Lastly, the committee included the Expanding and Promoting Expertise 
in Review of Rare Treatments, EXPERRT Act, H.R. 4156, a bill my fellow 
Co-Chairs of the Cystic Fibrosis Caucus and I introduced. EXPERRT will 
have the FDA consult with experts in rare diseases. This will ensure 
that FDA has access to the knowledge needed when dealing with drug 
approvals for diseases where FDA may lack subject matter expertise. As 
one of the Co-Founders of the Cystic Fibrosis Caucus, I am glad that we 
are giving this tool to the FDA.
  I'd like to submit this letter of support for FAST signed by over 150 
rare disease groups into the Record.
  H.R. 5651 is a good bill that will help new drugs and new medicines 
get into the market and be available to patients. I support passage of 
the FDA Reform Act.
                                                   March 23, 2012.
     Hon. Cliff Stearns,
     House of Representatives, Rayburn House Office Building, 
         Washington, DC.
     Hon. Edolphus Towns,
     House of Representatives, Rayburn House Office Building, 
         Washington, DC.
       Dear Congressmen Stearns & Towns: On behalf of patients, 
     physicians, and other members of the health advocacy 
     community we are writing to express our support for H.R. 
     4132, the Faster Access to Specialized Treatments (FAST) Act. 
     This legislation will modernize and expand the FDA's 
     Accelerated Approval pathway to encompass a broader range of 
     diseases and leverage 21st century drug development tools and 
     strategies. This reform will speed the approval of much-
     needed therapies and cures to patients who are facing serious 
     and life-threatening conditions, including Alzheimer's 
     disease, autoimmune diseases, multiple sclerosis, Parkinson's 
     disease, neuromuscular disease and hundreds of rare diseases 
     that remain untreated.
       We commend you for championing legislation that maintains 
     the FDA's high standard for approval while at the same time 
     ensuring the Agency can help facilitate the development of 
     new and novel therapies to patients in a more timely manner. 
     In many cases our patients have no available treatment for 
     their diseases, or they are using a therapy that is older and 
     may not work as effectively and safely. This is not 
     acceptable. We believe that this legislation will ensure 
     patients receive the best, modern treatment as soon as 
     possible and we applaud your efforts on their behalf.
       Thank you for your leadership on this important bill and we 
     look forward to working with you as it moves forward.
           Sincerely,
         Abigail Alliance for Better Access to Developmental 
           Drugs; Advocacy for Patients with Chronic Illness, 
           Inc.; Affiliated American CSA Foundation; Alliance for 
           Aging Research; Alliance for Patient Access; American 
           Autoimmune Related Diseases Association; American Brain 
           Tumor Association; American Childhood Cancer 
           Organization; American College of Medical Genetics; 
           American Institute for Medical and Biological 
           Engineering; American Society of Clinical 
           Psychopharmacology; Batten Disease Support and Research 
           Association; Break Through Cancer Coalition; 
           Californians for Cures.

[[Page 7950]]

         Celiac Disease Center at Columbia University; Celiac 
           Sprue Association; Charcot-Marie-Tooth Association 
           (CMTA); Children's Cardiomyopathy Foundation, Inc.; 
           Chinese American Association of Greater Chicago; 
           Coalition Duchenne; Coalition for Pulmonary Fibrosis; 
           Colon Cancer Alliance; Cooleys Anemia Foundation; 
           Crohn's and Colitis Foundation of America; 
           Cryoglobulinemia Vasculitis Organization; CureDuchenne; 
           CurePSP; Digestive Disease National Coalition; Erik 
           Metzler Foundation.
         EveryLife Foundation for Rare Diseases; Fabry Support & 
           Information Group; Georgia PKU Connect; GIST Support 
           International; Hadley Hope Fund; Hannah's Hope Fund; 
           Hayden's Batten Disease Foundation Inc.; HealthHIV; 
           Hope4Bridget Foundation; ICE Epilepsy Alliance; I Have 
           IIH; In Need of Diagnosis, Inc. (INOD); Inspire; 
           International Cancer Advocacy Network (ICAN); Jacob's 
           Cure, Inc.
         Jain Foundation Inc.; Jonah's Just Begun--Foundation to 
           Cure Sanfilippo Inc. LAM Treatment Alliance; LGS 
           Foundation; Liddy Shriver Sarcoma Initiative; Little 
           Miss Hannah Foundation; Lung Cancer Alliance; Lupus 
           Foundation of America; Lymphangiomatosis & Gorham's 
           Disease Alliance (LGDA); Lymphatic Malformation 
           Institute (LMI); Macular Degeneration Support, Inc. 
           Madisons Foundation; Midwest Asian Health Association 
           (MAHA); MLD Foundation; Mpdsupport.org--
           Myeloproliferative Disease Support; Muscular Dystrophy 
           Association.
         National Family Caregivers Association; National MPS 
           Society; National MS Society; National Niemann-Pick 
           Disease Foundation, Inc.; National PKU Alliance; 
           National Tay-Sachs & Allied Diseases Association; 
           National Venture Capital Association; NBIA Disorders 
           Association; New Jersey Association for Biomedical 
           Research; NKH International Family Network; Noah's 
           Hope--Batten Disease Fund; Oxalosis and Hyperoxaluria 
           Foundation; Pachyonychia Congenita Project.
         Parkinson's Action Network; Parry-Romberg Syndrome 
           Resource, Inc.; Partnership for Cures; Polycystic 
           Kidney Disease Foundation; RARE Project; Russell-Silver 
           Syndrome Support; Scleroderma Research Foundation; 
           Sickle Cell Disease Association of America, Inc.; 
           Society for Women's Health Research; Solving Kids' 
           Cancer; Student Society for Stem Cell Research; Sudden 
           Arrhythmia Death Syndromes (SADS) Foundation; Taylor's 
           Tale.
         The Association for Frontotemporal Degeneration (AFTD); 
           The Children's Medical Research Foundation, Inc.; The 
           Erythromelalgia Association; The Focus Foundation; The 
           Manton Center for Orphan Disease Research, Children's 
           Hospital Boston; The Reflex Sympathetic Dystrophy 
           Syndrome Association (RSDSA); The Stop ALD Foundation; 
           Tuberous Sclerosis Alliance; Veterans Health Council; 
           VHL Family Alliance; Vietnam Veterans of America; 
           ZERO--The Project to End Prostate Cancer.

  The SPEAKER pro tempore (Mr. Simpson). The question is on the motion 
offered by the gentleman from Michigan (Mr. Upton) that the House 
suspend the rules and pass the bill, H.R. 5651, as amended.
  The question was taken.
  The SPEAKER pro tempore. In the opinion of the Chair, two-thirds 
being in the affirmative, the ayes have it.
  Mr. PITTS. Mr. Speaker, on that I demand the yeas and nays.
  The yeas and nays were ordered.
  The SPEAKER pro tempore. Pursuant to clause 8 of rule XX, further 
proceedings on this question will be postponed.

                          ____________________