[Congressional Record Volume 158, Number 94 (Wednesday, June 20, 2012)]
[House]
[Pages H3825-H3868]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FOOD AND DRUG ADMINISTRATION SAFETY AND INNOVATION ACT
Mr. UPTON. Mr. Speaker, I move to suspend the rules and pass the bill
(S. 3187) to amend the Federal Food, Drug, and Cosmetic Act to revise
and extend the user-fee programs for prescription drugs and 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 amendment is as follows:
Amendment:
Strike out all after the enacting clause and insert:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Safety and Innovation Act''.
SEC. 2. TABLE OF CONTENTS; REFERENCES IN ACT.
(a) Table of Contents.--The table of contents of this Act
is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents; 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--FEES RELATING TO DEVICES
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.
Sec. 308. Additional reporting requirements.
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.
Sec. 408. Additional reporting requirements.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Permanence.
Sec. 502. Written requests.
Sec. 503. Communication with Pediatric Review Committee.
Sec. 504. Access to data.
Sec. 505. Ensuring the completion of pediatric studies.
Sec. 506. Pediatric study plans.
Sec. 507. Reauthorizations.
Sec. 508. Report.
Sec. 509. Technical amendments.
Sec. 510. Pediatric rare diseases.
Sec. 511. Staff of Office of Pediatric Therapeutics.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
Sec. 601. Investigational device exemptions.
Sec. 602. Clarification of least burdensome standard.
Sec. 603. Agency documentation and review of significant decisions.
Sec. 604. Device modifications requiring premarket notification prior
to marketing.
Sec. 605. Program to improve the device recall system.
Sec. 606. Clinical holds on investigational device exemptions.
Sec. 607. Modification of de novo application process.
Sec. 608. Reclassification procedures.
Sec. 609. Harmonization of device premarket review, inspection, and
labeling symbols.
Sec. 610. Participation in international fora.
Sec. 611. Reauthorization of third-party review.
Sec. 612. Reauthorization of third-party inspection.
Sec. 613. Humanitarian device exemptions.
Sec. 614. Unique device identifier.
Sec. 615. Sentinel.
Sec. 616. Postmarket surveillance.
Sec. 617. Custom devices.
Sec. 618. Health information technology.
Sec. 619. Good guidance practices relating to devices.
Sec. 620. Pediatric device consortia.
TITLE VII--DRUG SUPPLY CHAIN
Sec. 701. Registration of domestic drug establishments.
Sec. 702. Registration of foreign establishments.
Sec. 703. Identification of drug excipient information with product
listing.
Sec. 704. Electronic system for registration and listing.
Sec. 705. Risk-based inspection frequency.
Sec. 706. Records for inspection.
Sec. 707. Prohibition against delaying, denying, limiting, or refusing
inspection.
Sec. 708. Destruction of adulterated, misbranded, or counterfeit drugs
offered for import.
Sec. 709. Administrative detention.
Sec. 710. Exchange of information.
Sec. 711. Enhancing the safety and quality of the drug supply.
Sec. 712. Recognition of foreign government inspections.
Sec. 713. Standards for admission of imported drugs.
Sec. 714. Registration of commercial importers.
Sec. 715. Notification.
Sec. 716. Protection against intentional adulteration.
Sec. 717. Penalties for counterfeiting drugs.
Sec. 718. Extraterritorial jurisdiction.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
Sec. 801. Extension of exclusivity period for drugs.
Sec. 802. Priority review.
Sec. 803. Fast track product.
Sec. 804. Clinical trials.
Sec. 805. Reassessment of qualified infectious disease product
incentives in 5 years.
Sec. 806. Guidance on pathogen-focused antibacterial drug development.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
Sec. 901. Enhancement of accelerated patient access to new medical
treatments.
Sec. 902. Breakthrough therapies.
Sec. 903. Consultation with external experts on rare diseases, targeted
therapies, and genetic targeting of treatments.
Sec. 904. Accessibility of information on prescription drug container
labels by visually impaired and blind consumers.
Sec. 905. Risk-benefit framework.
Sec. 906. Grants and Contracts for the Development of Orphan Drugs.
Sec. 907. Reporting of inclusion of demographic subgroups in clinical
trials and data analysis in applications for drugs,
biologics, and devices.
Sec. 908. Rare pediatric disease priority review voucher incentive
program.
TITLE X--DRUG SHORTAGES
Sec. 1001. Discontinuance or interruption in the production of life-
saving drugs.
Sec. 1002. Annual reporting on drug shortages.
Sec. 1003. Coordination; task force and strategic plan.
Sec. 1004. Drug shortage list.
Sec. 1005. Quotas applicable to drugs in shortage.
Sec. 1006. Attorney General report on drug shortages.
Sec. 1007. Hospital repackaging of drugs in shortage.
Sec. 1008. Study on drug shortages.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
Sec. 1101. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 1102. Reauthorization of the critical path public-private
partnerships.
Subtitle B--Medical Gas Product Regulation
Sec. 1111. Regulation of medical gases.
Sec. 1112. Changes to regulations.
Sec. 1113. Rules of construction.
Subtitle C--Miscellaneous Provisions
Sec. 1121. Guidance document regarding product promotion using the
Internet.
Sec. 1122. Combating prescription drug abuse.
Sec. 1123. Optimizing global clinical trials.
Sec. 1124. Advancing regulatory science to promote public health
innovation.
Sec. 1125. Information technology.
Sec. 1126. Nanotechnology.
Sec. 1127. Online pharmacy report to Congress.
Sec. 1128. Report on small businesses.
Sec. 1129. Protections for the commissioned corps of the public health
service act.
Sec. 1130. Compliance date for rule relating to sunscreen drug products
for over-the-counter human use.
Sec. 1131. Strategic integrated management plan.
Sec. 1132. Assessment and modification of REMS.
Sec. 1133. Extension of period for first applicant to obtain tentative
approval without forfeiting 180-day-exclusivity period.
Sec. 1134. Deadline for determination on certain petitions.
Sec. 1135. Final agency action relating to petitions and civil actions.
Sec. 1136. Electronic submission of applications.
Sec. 1137. Patient participation in medical product discussions.
Sec. 1138. Ensuring adequate information regarding pharmaceuticals for
all populations, particularly underrepresented
subpopulations, including racial subgroups.
[[Page H3826]]
Sec. 1139. Scheduling of hydrocodone.
Sec. 1140. Study on Drug Labeling by Electronic Means.
Sec. 1141. Recommendations on interoperability standards.
Sec. 1142. Conflicts of interest.
Sec. 1143. Notification of FDA intent to regulate laboratory-developed
tests.
Subtitle D--Synthetic Drugs
Sec. 1151. Short title.
Sec. 1152. Addition of synthetic drugs to schedule I of the Controlled
Substances Act.
Sec. 1153. Temporary scheduling to avoid imminent hazards to public
safety expansion.
(b) 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 each 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 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.''; 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) 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);
``(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 matter preceding subparagraph (A), by striking
``fiscal years 2008 through 2012'' and inserting ``fiscal
years 2013 through 2017'';
(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:
``(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,
[[Page H3827]]
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 paragraph 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 ``subject to subparagraph (C), 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;
``(vii) the number of applications filed for orphan-
designated products per fiscal year for each review division;
and
``(viii) the number of breakthrough designations for a
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 of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379g; 379h) shall
cease to be effective October 1, 2017.
(b) Reporting Requirements.--Section 736B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h 2) shall cease
to be effective January 31, 2018.
(c) Previous Sunset Provision.--
(1) In general.--Section 106 of the Food and Drug
Administration Amendments Act of 2007 (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--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDINGS.
(a) Short Title.--This title 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
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:
[[Page H3828]]
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2013 Year 2014 Year 2015 Year 2016 Year 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 specified.--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) 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 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) by amending paragraph (3) to read as follows:
``(3) Authorizations of appropriations.--For each of the
fiscal years 2013 through 2017, there is authorized to be
appropriated for 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 Web site 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 (in effect 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.
[[Page H3829]]
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) shall cease to be
effective January 31, 2018.
(b) Previous Sunset Provision.--
(1) In general.--Section 217 of the Food and Drug
Administration Amendments Act 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), 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 3 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
``(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.
[[Page H3830]]
``(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 publish 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 publish 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 publish 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.
``(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 publish 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 publish 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 publish 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
publish 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 Act, 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
[[Page H3831]]
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; or
``(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) Six percent shall be derived from fees under
subsection (a)(2) (relating to drug master files).
``(B) Twenty-four 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) Fifty-six 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) Fourteen 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.
``(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 publish 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 a publicly available 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
[[Page H3832]]
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 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
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.--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.
``(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
[[Page H3833]]
under this part, the Secretary shall prepare and submit to
the Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a report on the
implementation of the authority for such fees during such
fiscal year and the use, by the Food and Drug Administration,
of the fees collected for such fiscal year.
``(c) Public Availability.--The Secretary shall make the
reports required under subsections (a) and (b) available to
the public on the Internet Web site of the Food and Drug
Administration.
``(d) Reauthorization.--
``(1) Consultation.--In developing recommendations to
present to the Congress with respect to the goals, and plans
for meeting the goals, for 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 of the Federal
Food, Drug, and Cosmetic Act, as added by section 302 of this
Act, shall cease to be effective October 1, 2017.
(b) Reporting Requirements.--Section 744C of the Federal
Food, Drug, and Cosmetic Act, as added by section 303 of this
Act, shall cease to be effective 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).''.
SEC. 308. ADDITIONAL REPORTING REQUIREMENTS.
Subchapter A of chapter VII (21 U.S.C. 371 et seq.), as
amended by section 208, is further amended by adding at the
end the following:
``SEC. 715. REPORTING REQUIREMENTS.
``(a) Generic Drugs.--Beginning with fiscal year 2013 and
ending after fiscal year 2017, not later than 120 days after
the end of each fiscal year for which fees are collected
under part 7 of subchapter C, the Secretary shall prepare and
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report concerning,
for all applications for approval of a generic drug under
section 505(j), amendments to such applications, and prior
approval supplements with respect to such applications filed
in the previous fiscal year--
``(1) the number of such applications that met the goals
identified for purposes of part 7 of subchapter C, 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;
``(2) the average total time to decision by the Secretary
for applications for approval of a generic drug under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications filed in the
previous fiscal year, including the number of calendar days
spent during the review by the Food and Drug Administration
and the number of calendar days spent by the sponsor
responding to a complete response letter;
``(3) the total number of applications under section
505(j), amendments to such applications, and prior approval
supplements with respect to such applications that were
pending with the Secretary for more than 10 months on the
date of enactment of the Food and Drug Administration Safety
and Innovation Act; and
``(4) the number of applications described in paragraph (3)
on which the Food and Drug Administration took final
regulatory action in the previous fiscal year.''.
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--
[[Page H3834]]
``(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 5 miles of
each other; and
``(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 described 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, 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
[[Page H3835]]
product development program for a 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.
``(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
[[Page H3836]]
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, 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).
``(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 of the Federal
Food, Drug, and Cosmetic Act, as added by section 402 of this
Act, shall cease to be effective October 1, 2017.
[[Page H3837]]
(b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act, as added by section 403 of this
Act, shall cease to be effective 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)''.
SEC. 408. ADDITIONAL REPORTING REQUIREMENTS.
Section 715, as added by section 308 of this Act, is
amended by adding at the end the following:
``(b) Biosimilar Biological Products.--
``(1) In general.--Beginning with fiscal year 2014, not
later than 120 days after the end of each fiscal year for
which fees are collected under part 8 of subchapter C, the
Secretary shall prepare and submit to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives a report concerning--
``(A) the number of applications for approval filed under
section 351(k) of the Public Health Service Act; and
``(B) the percentage of applications described in
subparagraph (A) that were approved by the Secretary.
``(2) Additional information.--As part of the performance
report described in paragraph (1), the Secretary shall
include an explanation of how the Food and Drug
Administration is managing the biological product review
program to ensure that the user fees collected under part 2
are not used to review an application under section 351(k) of
the Public Health Service Act.''.
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. PERMANENCE.
(a) Pediatric Studies of Drugs.--Section 505A (21 U.S.C.
355a) is amended by striking subsection (q) (relating to a
sunset).
(b) Research Into Pediatric Uses for Drugs and Biological
Products.--Section 505B (21 U.S.C. 355c) is amended--
(1) by striking subsection (m); and
(2) by redesignating subsection (n) as subsection (m).
SEC. 502. WRITTEN REQUESTS.
(a) In General.--
(1) Federal food, drug, and cosmetic act.--Subsection (h)
of section 505A (21 U.S.C. 355a) is amended 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.''.
(2) Public health service act.--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)''.
(b) Neonates.--Subparagraph (A) of section 505A(d)(1) is
amended 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.''.
SEC. 503. COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.
Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services (referred to
in this title as the ``Secretary'') shall issue internal
standard operating procedures that provide for the review by
the internal review committee established under section 505C
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d)
of any significant modifications to initial pediatric study
plans, agreed initial pediatric study plans, and written
requests under sections 505A and 505B of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). Such internal
standard operating procedures shall be made publicly
available on the Internet Web site of the Food and Drug
Administration.
SEC. 504. ACCESS TO DATA.
Not later than 3 years after the date of enactment of this
Act, the Secretary shall make available to the public,
including through posting on the Internet Web site of the
Food and Drug Administration, the medical, statistical, and
clinical pharmacology reviews of, and corresponding written
requests issued to an applicant, sponsor, or holder for,
pediatric studies submitted between January 4, 2002, and
September 27, 2007, under subsection (b) or (c) of section
505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a) for which 6 months of market exclusivity was granted
and that resulted in a labeling change. The Secretary shall
make public the information described in the preceding
sentence in a manner consistent with how the Secretary
releases information under section 505A(k) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a(k)).
SEC. 505. ENSURING THE COMPLETION OF PEDIATRIC STUDIES.
(a) Extension of Deadline for Deferred Studies.--Section
505B (21 U.S.C. 355c) is amended--
(1) in subsection (a)(3)--
(A) by redesignating subparagraph (B) as subparagraph (C);
(B) by inserting after subparagraph (A) the following:
``(B) Deferral extension.--
``(i) In general.--On the initiative of the Secretary or at
the request of the applicant, the Secretary may grant an
extension of a deferral approved under subparagraph (A) for
submission of some or all assessments required under
paragraph (1) if--
``(I) the Secretary determines that the conditions
described in subclause (II) or (III) of subparagraph (A)(i)
continue to be met; and
``(II) the applicant submits a new timeline under
subparagraph (A)(ii)(IV) and any significant updates to the
information required under subparagraph (A)(ii).
``(ii) Timing and information.--If the deferral extension
under this subparagraph is requested by the applicant, the
applicant shall submit the deferral extension request
containing the information described in this subparagraph not
less than 90 days prior to the date that the deferral would
expire. The Secretary shall respond to such request not later
than 45 days after the receipt of such letter. If the
Secretary grants such an extension, the specified date shall
be the extended date. The sponsor of the required assessment
under paragraph (1) shall not be issued a letter described in
subsection (d) unless the specified or extended date of
submission for such required studies has passed or if the
request for an extension is pending. For a deferral that has
expired prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act or that will expire
prior to 270 days after the date of enactment of such Act, a
deferral extension shall be requested by an applicant not
later than 180 days after the date of enactment of such Act.
The Secretary shall respond to any such request as soon as
practicable, but not later than 1 year after the date of
enactment of such Act. Nothing in this clause shall prevent
the Secretary from updating the status of a study or studies
publicly if components of such study or studies are late or
delayed.''; and
(C) in subparagraph (C), as so redesignated--
(i) in clause (i), by adding at the end the following:
``(III) Projected completion date for pediatric studies.
``(IV) The reason or reasons why a deferral or deferral
extension continues to be necessary.''; and
(ii) by amending clause (ii) to read as follows:
``(ii) Public availability.--Not later than 90 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 Internet 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
(2) in subsection (f)--
(A) in the subsection heading, by inserting ``Deferral
Extensions,'' after ``Deferrals,'';
(B) in paragraph (1), by inserting ``, deferral
extension,'' after ``deferral''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by inserting ``deferral
extensions,'' after ``deferrals,''; and
(ii) by inserting ``, deferral extensions,'' after
``deferrals''.
(b) Tracking of Extensions; Annual Information.--Section
505B(f)(6)(D) (21 U.S.C. 355c(f)(6)(D)) is amended to read as
follows:
``(D) aggregated on an annual basis--
``(i) the total number of deferrals and deferral extensions
requested and granted under this section and, if granted, the
reasons for each such deferral or deferral extension;
``(ii) the timeline for completion of the assessments; and
``(iii) the number of assessments completed and pending;''.
(c) Action on Failure To Complete Studies.--
(1) Issuance of letter.--Subsection (d) of section 505B (21
U.S.C. 355c) is amended to read as follows:
``(d) Submission of Assessments.--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), the following shall apply:
``(1) Beginning 270 days after the date of enactment of the
Food and Drug Administration Safety and Innovation Act, the
Secretary shall issue a non-compliance letter to such person
informing them of such failure to submit or meet the
requirements of the applicable subsection.
[[Page H3838]]
Such letter shall require the person to respond in writing
within 45 calendar days of issuance of such letter. Such
response may include the person's request for a deferral
extension if applicable. Such letter and the person's written
response to such letter shall be made publicly available on
the Internet Web site of the Food and Drug Administration 60
calendar days after issuance, with redactions for any trade
secrets and confidential commercial information. If the
Secretary determines that the letter was issued in error, the
requirements of this paragraph shall not apply.
``(2) The drug or biological product that is the subject of
an assessment described in subsection (a)(2), applicable
requirements in subsection (a)(3), or 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 such failure
shall not be the basis for a proceeding--
``(A) to withdraw approval for a drug under section 505(e);
or
``(B) to revoke the license for a biological product under
section 351 of the Public Health Service Act.''.
(2) Tracking of letters issued.--Subparagraph (D) of
section 505B(f)(6) (21 U.S.C. 355c(f)(6)), as amended by
subsection (b), is further amended--
(A) in clause (ii), by striking ``; and'' and inserting a
semicolon;
(B) in clause (iii), by adding ``and'' at the end; and
(C) by adding at the end the following:
``(iv) the number of postmarket non-compliance letters
issued pursuant to subsection (d), and the recipients of such
letters;''.
SEC. 506. PEDIATRIC STUDY PLANS.
(a) In General.--Subsection (e) of section 505B (21 U.S.C.
355c) is amended to read as follows:
``(e) Pediatric Study Plans.--
``(1) In general.--An applicant subject to subsection (a)
shall submit to the Secretary an initial pediatric study plan
prior to the submission of the assessments described under
subsection (a)(2).
``(2) Timing; content; meeting.--
``(A) 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 the 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.
``(B) Content of initial plan.--The initial pediatric study
plan shall include--
``(i) an outline of the pediatric study or studies that the
applicant plans to conduct (including, to the extent
practicable study objectives and design, age groups, relevant
endpoints, and statistical approach);
``(ii) any request for a deferral, partial waiver, or
waiver under this section, if applicable, along with any
supporting information; and
``(iii) other information specified in the regulations
promulgated under paragraph (7).
``(C) Meeting.--The Secretary--
``(i) shall meet with the applicant to discuss the initial
pediatric study plan as soon as practicable, but not later
than 90 calendar days after the receipt of such plan under
subparagraph (A);
``(ii) may determine that a written response to the initial
pediatric study plan is sufficient to communicate comments on
the initial pediatric study plan, and that no meeting is
necessary; and
``(iii) if the Secretary determines that no meeting is
necessary, shall so notify the applicant and provide written
comments of the Secretary as soon as practicable, but not
later than 90 calendar days after the receipt of the initial
pediatric study plan.
``(3) Agreed initial pediatric study plan.--Not later than
90 calendar days following the meeting under paragraph
(2)(C)(i) or the receipt of a written response from the
Secretary under paragraph (2)(C)(iii), the applicant shall
document agreement on the initial pediatric study plan in a
submission to the Secretary marked `Agreed Initial Pediatric
Study Plan', and the Secretary shall confirm such agreement
to the applicant in writing not later than 30 calendar days
of receipt of such agreed initial pediatric study plan.
``(4) Deferral and waiver.--If the agreed initial pediatric
study plan contains a request from the applicant for a
deferral, partial waiver, or waiver under this section, the
written confirmation under paragraph (3) shall include a
recommendation from the Secretary as to whether such request
meets the standards under paragraphs (3) or (4) of subsection
(a).
``(5) Amendments to the plan.--At the initiative of the
Secretary or the applicant, the agreed initial pediatric
study plan may be amended at any time. The requirements of
paragraph (2)(C) shall apply to any such proposed amendment
in the same manner and to the same extent as such
requirements apply to an initial pediatric study plan under
paragraph (1). The requirements of paragraphs (3) and (4)
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 study plan.
``(6) Internal committee.--The Secretary shall consult the
internal committee under section 505C on the review of the
initial pediatric study plan, agreed initial pediatric plan,
and any significant amendments to such plans.
``(7) Required rulemaking.--Not later than 1 year after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, the Secretary shall promulgate proposed
regulations and issue guidance to implement the provisions of
this subsection.''.
(b) Conforming Amendments.--Section 505B (21 U.S.C. 355c)
is amended--
(1) by amending subclause (II) of subsection (a)(3)(A)(ii)
to read as follows:
``(II) a pediatric study plan as described in subsection
(e);''; and
(2) in subsection (f)--
(A) in the subsection heading, by striking ``Pediatric
Plans,'' and inserting ``Pediatric Study Plans,'';
(B) in paragraph (1), by striking ``all pediatric plans''
and inserting ``initial pediatric study plans, agreed initial
pediatric study plans,''; and
(C) in paragraph (4)--
(i) in the paragraph heading, by striking ``Pediatric
Plans,'' and inserting ``Pediatric Study Plans,''; and
(ii) by striking ``pediatric plans'' and inserting
``initial pediatric study plans, agreed initial pediatric
study plans,''.
(c) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect 180 calendar days
after the date of enactment of this Act, irrespective of
whether the Secretary has promulgated final regulations to
carry out such amendments.
(2) Rule of construction.--Paragraph (1) shall not be
construed to affect the deadline for promulgation of proposed
regulations under section 505B(e)(7) of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a) of this
section.
SEC. 507. REAUTHORIZATIONS.
(a) 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))''.
(b) Pediatric Subcommittee of the Oncologic Drugs Advisory
Committee.--Section 15(a)(3) 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 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 ``for the duration of the operation of the
Oncologic Drugs Advisory Committee''.
(c) Humanitarian Device Exemption Extension.--Section
520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking ``2012''
and inserting ``2017''.
(d) Program for Pediatric Study of Drugs in PHSA.--Section
409I(e)(1) of the Public Health Service Act (42 U.S.C.
284m(e)(1)) is amended by striking ``to carry out this
section'' and all that follows through the end of paragraph
(1) and inserting ``to carry out this section, $25,000,000
for each of fiscal years 2013 through 2017.''.
SEC. 508. REPORT.
(a) In General.--Not later than four years after the date
of enactment of this Act and every five years thereafter, 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, and make publicly available, including
through posting on the Internet Web site of the Food and Drug
Administration, a report on the implementation of sections
505A and 505B of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355a, 355c).
(b) Contents.--Each report under subsection (a) shall
include--
(1) an assessment of the effectiveness of sections 505A and
505B of the Federal Food, Drug, and Cosmetic Act in improving
information about pediatric uses for approved drugs and
biological products, including the number and type of
labeling changes made since the date of enactment of this Act
and the importance of such uses in the improvement of the
health of children;
(2) the number of required studies under such section 505B
that have not met the initial deadline provided under such
section 505B, including--
(A) the number of deferrals and deferral extensions granted
and the reasons such extensions were granted;
(B) the number of waivers and partial waivers granted; and
(C) the number of letters issued under subsection (d) of
such section 505B;
(3) an assessment of the timeliness and effectiveness of
pediatric study planning since the date of enactment of this
Act, including the number of initial pediatric study plans
not submitted in accordance with the requirements of
subsection (e) of such section 505B and any resulting
rulemaking;
(4) the number of written requests issued, accepted, and
declined under such 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;
(5) a description and current status of referrals made
under subsection (n) of such section 505A;
(6) an assessment of the effectiveness of studying
biological products in pediatric populations
[[Page H3839]]
under such sections 505A and 505B and section 409I of the
Public Health Service Act (42 U.S.C. 284m);
(7)(A) the efforts made by the Secretary to increase the
number of studies conducted in the neonatal population
(including efforts made to encourage the conduct of
appropriate studies in neonates by companies with products
that have sufficient safety and other information to make the
conduct of the studies ethical and safe); and
(B) the results of such efforts;
(8)(A) the number and importance of drugs and biological
products for children with cancer that are being tested as a
result of the programs under such sections 505A and 505B and
under section 409I of the Public Health Service Act; and
(B) any recommendations for modifications to such programs
that would lead to new and better therapies for children with
cancer, including a detailed rationale for each
recommendation;
(9) any recommendations for modification to such programs
that would improve pediatric drug research and increase
pediatric labeling of drugs and biological products;
(10) an assessment of the successes of and limitations to
studying drugs for rare diseases under such sections 505A and
505B; and
(11) an assessment of the Secretary's efforts to address
the suggestions and options described in any prior report
issued by the Comptroller General, Institute of Medicine, or
the Secretary, and any subsequent reports, including
recommendations therein, regarding the topics addressed in
the reports under this section, including with respect to--
(A) improving public access to information from pediatric
studies conducted under such sections 505A and 505B; and
(B) improving the timeliness of pediatric studies and
pediatric study planning under such sections 505A and 505B.
(c) Stakeholder Comment.--At least 180 days prior to the
submission of each report under subsection (a), 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
report including suggestions for modifications that would
improve pediatric drug research and pediatric labeling of
drugs and biological products.
SEC. 509. TECHNICAL AMENDMENTS.
(a) Pediatric Studies of Drugs in FFDCA.--Section 505A (21
U.S.C. 355a) is amended--
(1) in subsection (k)(2), by striking ``subsection
(f)(3)(F)'' and inserting ``subsection (f)(6)(F)'';
(2) 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.'';
(3) in subsection (n)--
(A) in the subsection heading, by striking ``Completed''
and inserting ``Submitted''; and
(B) in paragraph (1)--
(i) in the matter preceding subparagraph (A), by striking
``have not been completed'' and inserting ``have not been
submitted by the date specified in the written request issued
or if the applicant or holder does not agree to the
request'';
(ii) in subparagraph (A)--
(I) in the first sentence, by inserting ``, or for which a
period of exclusivity eligible for extension under subsection
(b)(1) or (c)(1) of this section or under subsection (m)(2)
or (m)(3) of section 351 of the Public Health Service Act has
not ended'' after ``expired''; and
(II) by striking ``Prior to'' and all that follows through
the period at the end; and
(iii) in subparagraph (B), by striking ``no listed patents
or has 1 or more listed patents that have expired,'' and
inserting ``no unexpired listed patents and for which no
unexpired periods of exclusivity eligible for extension under
subsection (b)(1) or (c)(1) of this section or under
subsection (m)(2) or (m)(3) of section 351 of the Public
Health Service Act apply,''; and
(4) 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.''.
(b) 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)''; and
(B) 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'' and inserting ``such a'';
(2) in subsection (b)(1), in the matter preceding
subparagraph (A), by striking ``After providing notice'' and
all that follows through ``studies), the'' and inserting
``The'';
(3) in subsection (g)--
(A) in paragraph (1)(A), by inserting ``that receives a
priority review or 330 days after the date of the submission
of an application or supplement that receives a standard
review'' after ``after the date of the submission of the
application or supplement''; and
(B) in paragraph (2), by striking ``the label of such
product'' and inserting ``the labeling of such product'';
(4) 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,''; and
(5) 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:
``(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.''.
(c) 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,''.
(d) 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 paragraph (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) there remains no patent listed pursuant to section
505(b)(1) of the Federal Food, Drug, and Cosmetic Act, and
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''; and
(2) in paragraph (2)--
(A) in the paragraph heading, 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''.
(e) Pediatric Subcommittee of the Oncologic 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 in paragraph (1)(D), by
striking ``section 505B(f)'' and inserting ``section 505C''.
(f) Foundation of National Institutes of Health.--Section
499(c)(1)(C) of the Public Health Service Act (42 U.S.C.
290b(c)(1)(C)) is amended by striking ``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) 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.
SEC. 510. PEDIATRIC RARE DISEASES.
(a) Public Meeting.--Not later than 18 months after the
date of enactment of this Act, the Secretary shall hold at
least one public
[[Page H3840]]
meeting to discuss ways to encourage and accelerate the
development of new therapies for pediatric rare diseases.
(b) Report.--Not later than 180 days after the date of the
public meeting under subsection (a), the Secretary shall
issue a report that includes a strategic plan for encouraging
and accelerating the development of new therapies for
treating pediatric rare diseases.
SEC. 511. STAFF OF OFFICE OF PEDIATRIC THERAPEUTICS.
Section 6 of the Best Pharmaceuticals for Children Act (21
U.S.C. 393a) is amended--
(1) in subsection (c)--
(A) in paragraph (1), by striking ``and'' at the end;
(B) by redesignating paragraph (2) as paragraph (4); and
(C) by inserting after paragraph (1) the following:
``(2) subject to subsection (d), one or more additional
individuals with necessary expertise in a pediatric
subpopulation that is, as determined through consideration of
the reports and recommendations issued by the Institute of
Medicine and the Comptroller General of the United States,
less likely to be studied as a part of a written request
issued under section 505A of the Federal Food, Drug, and
Cosmetic Act or an assessment under section 505B of such Act;
``(3) one or more additional individuals with expertise in
pediatric epidemiology; and''; and
(2) by adding at the end the following:
``(d) Neonatology Expertise.--For the 5-year period
beginning on the date of enactment of this subsection, at
least one of the individuals described in subsection (c)(2)
shall have expertise in neonatology.''.
TITLE VI--MEDICAL DEVICE REGULATORY IMPROVEMENTS
SEC. 601. 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. 602. 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. 603. 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 provide a
substantive summary of 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 substantive summary 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. 604. 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 date of
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.''.
SEC. 605. 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) Termination of Recalls.--The Secretary shall document
the basis for the termination by the Food and Drug
Administration of a device recall.
``(d) 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).''.
SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE
EXEMPTIONS.
Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at
the end the following:
[[Page H3841]]
``(8)(A) At any time, the Secretary may prohibit the
sponsor of an investigation from conducting the investigation
(referred to in this paragraph as a `clinical hold') if the
Secretary makes a determination described in subparagraph
(B). The Secretary shall specify the basis for the clinical
hold, including the specific information available to the
Secretary which served as the basis for such clinical hold,
and confirm such determination in writing.
``(B) For purposes of subparagraph (A), a determination
described in this subparagraph with respect to a clinical
hold is a determination that--
``(i) the device involved represents an unreasonable risk
to the safety of the persons who are the subjects of the
clinical investigation, taking into account the
qualifications of the clinical investigators, information
about the device, the design of the clinical investigation,
the condition for which the device is to be investigated, and
the health status of the subjects involved; or
``(ii) the clinical hold should be issued for such other
reasons as the Secretary may by regulation establish.
``(C) Any written request to the Secretary from the sponsor
of an investigation that a clinical hold be removed shall
receive a decision, in writing and specifying the reasons
therefor, within 30 days after receipt of such request. Any
such request shall include sufficient information to support
the removal of such clinical hold.''.
SEC. 607. 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 request submitted under
clause (ii) if the Secretary identifies a legally marketed
device that could provide a reasonable basis for review of
substantial equivalence under paragraph (1), or when the
Secretary determines that the device submitted is not of low-
moderate risk or that general controls would be inadequate to
control the risks and special controls to mitigate the risks
cannot be developed.
``(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) (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).''.
SEC. 608. RECLASSIFICATION PROCEDURES.
(a) Classification Changes.--
(1) In general.--Section 513(e)(1) (21 U.S.C. 360c(e)(1))
is amended to read as follows:
``(e)(1)(A)(i) Based on new information respecting a
device, the Secretary may, upon the initiative of the
Secretary or upon petition of an interested person, change
the classification of such device, and revoke, on account of
the change in classification, any regulation or requirement
in effect under section 514 or 515 with respect to such
device, by administrative order published in the Federal
Register following publication of a proposed reclassification
order in the Federal Register, a meeting of a device
classification panel described in subsection (b), and
consideration of comments to a public docket, notwithstanding
subchapter II of chapter 5 of title 5, United States Code.
The proposed reclassification order published in the Federal
Register shall set forth the proposed reclassification, and a
substantive summary of the valid scientific evidence
concerning the proposed reclassification, including--
``(I) the public health benefit of the use of the device,
and the nature and, if known, incidence of the risk of the
device;
``(II) in the case of a reclassification from class II to
class III, why general controls pursuant to subsection
(a)(1)(A) and special controls pursuant to subsection
(a)(1)(B) together are not sufficient to provide a reasonable
assurance of safety and effectiveness for such device; and
``(III) in the case of reclassification from class III to
class II, why general controls pursuant to subsection
(a)(1)(A) and special controls pursuant to subsection
(a)(1)(B) together are sufficient to provide a reasonable
assurance of safety and effectiveness for such device.
``(ii) An order under this subsection changing the
classification of a device from class III to class II may
provide that such classification shall not take effect until
the effective date of a performance standard established
under section 514 for such device.
``(B) Authority to issue such administrative order shall
not be delegated below the Director of the Center for Devices
and Radiological Health, acting in consultation with the
Commissioner.''.
(2) Technical and conforming amendments.--
(A) Section 513(e)(2) (21 U.S.C. 360c(e)(2)) is amended by
striking ``regulation promulgated'' and inserting ``an order
issued''.
(B) Section 514(a)(1) (21 U.S.C. 360d(a)(1)) is amended by
striking ``under a regulation under section 513(e) but such
regulation'' and inserting ``under an administrative order
under section 513(e) (or a regulation promulgated under such
section prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act) but such order (or
regulation)''.
(C) Section 517(a)(1) (21 U.S.C. 360g(a)(1)) is amended by
striking ``or changing the classification of a device to
class I'' and inserting ``, an administrative order changing
the classification of a device to class I,''.
(3) Devices reclassified prior to the date of enactment of
this act.--
(A) In general.--The amendments made by this subsection
shall have no effect on a regulation promulgated with respect
to the classification of a device under section 513(e) of the
Federal Food, Drug, and Cosmetic Act prior to the date of
enactment of this Act.
(B) Applicability of other provisions.--In the case of a
device reclassified under section 513(e) of the Federal Food,
Drug, and Cosmetic Act by regulation prior to the date of
enactment of this Act, section 517(a)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360g(a)(1)) shall apply to
such regulation promulgated under section 513(e) of such Act
with respect to such device in the same manner such section
517(a)(1) applies to an administrative order issued with
respect to a device reclassified after the date of enactment
of this Act.
(b) Devices Marketed Before May 28, 1976.--
(1) Premarket approval.--Section 515 (21 U.S.C. 360e) is
amended--
(A) in subsection (a), by striking ``regulation promulgated
under subsection (b)'' and inserting ``an order issued under
subsection (b) (or a regulation promulgated under such
subsection prior to the date of enactment of the Food and
Drug Administration Safety and Innovation Act)'';
(B) in subsection (b)--
(i) in paragraph (1)--
(I) in the heading, by striking ``Regulation'' and
inserting ``Order''; and
(II) in the matter following subparagraph (B)--
(aa) by striking ``by regulation, promulgated in accordance
with this subsection'' and inserting ``by administrative
order following publication of a proposed order in the
Federal Register, a meeting of a device classification panel
described in section 513(b), and consideration of comments
from all affected stakeholders, including patients, payors,
and providers, notwithstanding subchapter II of chapter 5 of
title 5, United States Code''; and
(bb) by adding at the end the following: ``Authority to
issue such administrative order shall not be delegated below
the Director of the Center for Devices and Radiological
Health, acting in consultation with the Commissioner.'';
(ii) in paragraph (2)--
(I) by striking subparagraph (B); and
(II) in subparagraph (A)--
(aa) by striking ``(2)(A) A proceeding for the promulgation
of a regulation under paragraph (1) respecting a device shall
be initiated by the publication in the Federal Register of a
notice of proposed rulemaking. Such notice shall contain--''
and inserting ``(2) A proposed order required under paragraph
(1) shall contain--'';
(bb) by redesignating clauses (i) through (iv) as
subparagraphs (A) through (D), respectively;
(cc) in subparagraph (A), as so redesignated, by striking
``regulation'' and inserting ``order''; and
(dd) in subparagraph (C), as so redesignated, by striking
``regulation'' and inserting ``order'';
(iii) in paragraph (3)--
(I) by striking ``proposed regulation'' each place such
term appears and inserting ``proposed order'';
(II) by striking ``paragraph (2) and after'' and inserting
``paragraph (2),'';
(III) by inserting ``and a meeting of a device
classification panel described in section 513(b),'' after
``such proposed regulation and findings,'';
(IV) by striking ``(A) promulgate such regulation'' and
inserting ``(A) issue an administrative order under paragraph
(1)'';
(V) by striking ``paragraph (2)(A)(ii)'' and inserting
``paragraph (2)(B)''; and
(VI) by striking ``promulgation of the regulation'' and
inserting ``issuance of the administrative order''; and
(iv) by striking paragraph (4); and
(C) in subsection (i)--
(i) in paragraph (2)--
(I) in the matter preceding subparagraph (A)--
(aa) by striking ``December 1, 1995'' and inserting ``the
date that is 2 years after the date of enactment of the Food
and Drug Administration Safety and Innovation Act''; and
(bb) by striking ``publish a regulation in the Federal
Register'' and inserting ``issue an administrative order
following publication of a proposed order in the Federal
Register, a meeting of a device classification panel
described in
[[Page H3842]]
section 513(b), and consideration of comments from all
affected stakeholders, including patients, payors, and
providers, notwithstanding subchapter II of chapter 5 of
title 5, United States Code,'';
(II) in subparagraph (B), by striking ``final regulation
has been promulgated under section 515(b)'' and inserting
``administrative order has been issued under subsection (b)
(or no regulation has been promulgated under such subsection
prior to the date of enactment of the Food and Drug
Administration Safety and Innovation Act)'';
(III) in the matter following subparagraph (B), by striking
``regulation requires'' and inserting ``administrative order
issued under this paragraph requires''; and
(IV) by striking the third and fourth sentences; and
(ii) in paragraph (3)--
(I) by striking ``regulation requiring'' each place such
term appears and inserting ``order requiring''; and
(II) by striking ``promulgation of a section 515(b)
regulation'' and inserting ``issuance of an administrative
order under subsection (b)''.
(2) Technical and conforming amendments.--Section 501(f)
(21 U.S.C. 351(f)) is amended--
(A) in subparagraph (1)(A)--
(i) in subclause (i), by striking ``a regulation
promulgated'' and inserting ``an order issued''; and
(ii) in subclause (ii), by striking ``promulgation of such
regulation'' and inserting ``issuance of such order'';
(B) in subparagraph (2)(B)--
(i) by striking ``a regulation promulgated'' and inserting
``an order issued''; and
(ii) by striking ``promulgation of such regulation'' and
inserting ``issuance of such order''; and
(C) by adding at the end the following:
``(3) In the case of a device with respect to which a
regulation was promulgated under section 515(b) prior to the
date of enactment of the Food and Drug Administration Safety
and Innovation Act, a reference in this subsection to an
order issued under section 515(b) shall be deemed to include
such regulation.''.
(3) Approval by regulation prior to the date of enactment
of this act.--The amendments made by this subsection shall
have no effect on a regulation that was promulgated prior to
the date of enactment of this Act requiring that a device
have an approval under section 515 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360e) of an application for
premarket approval.
(c) Reporting.--The Secretary of Health and Human Services
shall annually post on the Internet Web site of the Food and
Drug Administration--
(1) the number and type of class I and class II devices
reclassified as class II or class III in the previous
calendar year under section 513(e)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(e)(1));
(2) the number and type of class II and class III devices
reclassified as class I or class II in the previous calendar
year under such section 513(e)(1); and
(3) the number and type of devices reclassified in the
previous calendar year under section 515 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360e).
SEC. 609. HARMONIZATION OF DEVICE PREMARKET REVIEW,
INSPECTION, AND LABELING SYMBOLS.
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.''.
SEC. 610. 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.''.
SEC. 611. 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. 612. 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''.
SEC. 613. HUMANITARIAN DEVICE EXEMPTIONS.
(a) In General.--Section 520(m) (21 U.S.C. 360j(m)) is
amended--
(1) in paragraph (6)--
(A) in subparagraph (A)--
(i) 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.''; and
(ii) 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 annual distribution
number for such device. In this paragraph, the term `annual
distribution number' means the number of such devices
reasonably needed to treat, diagnose, or cure a population of
4,000 individuals in the United States. The Secretary shall
determine the annual distribution number when the Secretary
grants such exemption.''; and
(B) by amending subparagraph (C) to read as follows:
``(C) A person may petition the Secretary to modify the
annual distribution number determined by the Secretary under
subparagraph (A)(ii) with respect to a device if additional
information arises, and the Secretary may modify such annual
distribution number.'';
(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
section 520(m)(6)(A)(i) (as amended by subsection (a)). If
the Secretary of Health and Human Services determines that
such subclause (I) or (II) applies with respect to a device,
clauses (ii), (iii), and (iv) of subparagraph (A) and
subparagraphs (B), (C), (D), and (E) of paragraph (6) of such
section 520(m) shall apply to such device, and the Secretary
shall determine the annual distribution number for purposes
of clause (ii) of such subparagraph (A) when making the
determination under this subsection.
SEC. 614. UNIQUE DEVICE IDENTIFIER.
Section 519(f) (21 U.S.C. 360i(f)) is amended--
(1) by striking ``The Secretary shall promulgate'' and
inserting ``Not later than December 31, 2012, the Secretary
shall issue proposed''; and
(2) by adding at the end the following: ``The Secretary
shall finalize the proposed regulations not later than 6
months after the close of the comment period and shall
implement the final regulations with respect to devices that
are implantable, life-saving, and life sustaining not later
than 2 years after the regulations are finalized, taking into
account patient access to medical devices and therapies.''.
SEC. 615. SENTINEL.
Section 519 (21 U.S.C. 360i) is amended by adding at the
end the following:
``(h) Inclusion of Devices in the Postmarket Risk
Identification and Analysis System.--
``(1) In general.--
``(A) Application to devices.--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.
``(B) Exception.--Subclause (II) of clause (i) of section
505(k)(3)(C) shall not apply to devices.
``(C) Clarification.--With respect to devices, the private
sector health-related electronic data provided under section
505(k)(3)(C)(i)(III)(bb) may include medical device
utilization data, health insurance claims data, and procedure
and device registries.
``(2) Data.--In expanding the system as described in
paragraph (1)(A), the Secretary shall use relevant data with
respect to devices cleared under section 510(k) or approved
under section 515, including claims data, patient survey
data, and any other data deemed appropriate by the Secretary.
``(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,
[[Page H3843]]
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.''.
SEC. 616. POSTMARKET SURVEILLANCE.
Section 522 (21 U.S.C. 360l) is amended--
(1) in subsection (a)(1)(A), in the matter preceding clause
(i), by inserting ``, at the time of approval or clearance of
a device or at any time thereafter,'' after ``by order''; and
(2) in subsection (b)(1), by inserting ``The manufacturer
shall commence surveillance under this section not later than
15 months after the day on which the Secretary issues an
order under this section.'' after the second sentence.
SEC. 617. CUSTOM DEVICES.
Section 520(b) (21 U.S.C. 360j(b)) 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. 618. HEALTH INFORMATION TECHNOLOGY.
(a) Report.--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''),
acting through the Commissioner of Food and Drugs, and in
consultation with the National Coordinator for Health
Information Technology and the Chairman of the Federal
Communications Commission, shall post on the Internet Web
sites of the Food and Drug Administration, the Federal
Communications Commission, and the Office of the National
Coordinator for Health Information Technology, a report that
contains a proposed strategy and recommendations on an
appropriate, risk-based regulatory framework pertaining to
health information technology, including mobile medical
applications, that promotes innovation, protects patient
safety, and avoids regulatory duplication.
(b) Working Group.--
(1) In general.--In carrying out subsection (a), the
Secretary may convene a working group of external
stakeholders and experts to provide appropriate input on the
strategy and recommendations required for the report under
subsection (a).
(2) Representatives.--If the Secretary convenes the working
group under paragraph (1), the Secretary, 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
determine the number of representatives participating in the
working group, and shall, to the extent practicable, ensure
that the working group is geographically diverse and includes
representatives of patients, consumers, health care
providers, startup companies, health plans or other third-
party payers, venture capital investors, information
technology vendors, health information technology vendors,
small businesses, purchasers, employers, and other
stakeholders with relevant expertise, as determined by the
Secretary.
SEC. 619. GOOD GUIDANCE PRACTICES RELATING TO DEVICES.
Subparagraph (C) of section 701(h)(1) (21 U.S.C. 371(h)(1))
is amended--
(1) by striking ``(C) For guidance documents'' and
inserting ``(C)(i) For guidance documents''; and
(2) by adding at the end the following:
``(ii) With respect to devices, if a notice to industry
guidance letter, a notice to industry advisory letter, or any
similar notice sets forth initial interpretations of a
regulation or policy or sets forth changes in interpretation
or policy, such notice shall be treated as a guidance
document for purposes of this subparagraph.''.
SEC. 620. PEDIATRIC DEVICE CONSORTIA.
(a) In General.--Section 305(e) of Pediatric Medical Device
Safety and Improvement Act (Public Law 110 85; 42 U.S.C. 282
note)) is amended by striking ``$6,000,000 for each of fiscal
years 2008 through 2012'' and inserting ``$5,250,000 for each
of fiscal years 2013 through 2017''.
(b) 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.
TITLE VII--DRUG SUPPLY CHAIN
SEC. 701. REGISTRATION OF DOMESTIC DRUG ESTABLISHMENTS.
Section 510 (21 U.S.C. 360) is amended--
(1) in subsection (b)--
(A) in paragraph (1), by striking ``On or before'' and all
that follows through the period at the end and inserting the
following: ``During the period beginning on October 1 and
ending on December 31 of each year, every person who owns or
operates any establishment in any State engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or drugs shall register with the
Secretary the name of such person, places of business of such
person, all such establishments, the unique facility
identifier of each such establishment, and a point of contact
e-mail address.; and
(B) by adding at the end the following:
``(3) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1). The requirement to include a unique facility
identifier in a registration under paragraph (1) shall not
apply until the date that the identifier system is specified
by the Secretary under the preceding sentence.''; and
(2) in subsection (c), by striking ``with the Secretary his
name, place of business, and such establishment'' and
inserting ``with the Secretary--
``(1) with respect to drugs, the information described
under subsection (b)(1); and
``(2) with respect to devices, the information described
under subsection (b)(2).''.
SEC. 702. REGISTRATION OF FOREIGN ESTABLISHMENTS.
(a) Enforcement of Registration of Foreign
Establishments.--Section 502(o) (21 U.S.C. 352(o)) is amended
by striking ``in any State''.
(b) Registration of Foreign Drug Establishments.--Section
510(i) (U.S.C. 360(i)) is amended--
(1) in paragraph (1)--
(A) by amending the matter preceding subparagraph (A) to
read as follows: ``Every person who owns or operates any
establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or
processing of a drug or device that is imported or offered
for import into the United States shall, through electronic
means in accordance with the criteria of the Secretary--'';
(B) by amending subparagraph (A) to read as follows:
``(A) upon first engaging in any such activity, immediately
submit a registration to the Secretary that includes--
``(i) with respect to drugs, the name and place of business
of such person, all such establishments, the unique facility
identifier of each such establishment, a point of contact e-
mail address, the name of the United States agent of each
such establishment, the name of each importer of such drug in
the United States that is known to the establishment, and the
name of each person who imports or offers for import such
drug to the United States for purposes of importation; and
``(ii) with respect to devices, the name and place of
business of the establishment, the name of the United States
agent for the establishment, the name of each importer of
such device in the United States that is known to the
establishment, and the name of each person who imports or
offers for import such device to the United States for
purposes of importation; and''; and
(C) by amending subparagraph (B) to read as follows:
``(B) each establishment subject to the requirements of
subparagraph (A) shall thereafter register with the Secretary
during the period beginning on October 1 and ending on
December 31 of each year.''; and
(2) by adding at the end the following:
``(4) The Secretary shall specify the unique facility
identifier system that shall be used by registrants under
paragraph (1) with respect to drugs. The requirement to
include a unique facility identifier in a registration under
paragraph (1) with respect to drugs shall not apply until the
date that the identifier system is specified by the Secretary
under the preceding sentence.''.
SEC. 703. IDENTIFICATION OF DRUG EXCIPIENT INFORMATION WITH
PRODUCT LISTING.
Section 510(j) (21 U.S.C. 360(j)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (C), by striking ``; and'' and
inserting a semicolon;
[[Page H3844]]
(B) in subparagraph (D), by striking the period at the end
and inserting ``; and''; and
(C) by adding at the end the following:
``(E) in the case of a drug contained in the applicable
list, the name and place of business of each manufacturer of
an excipient of the listed drug with which the person listing
the drug conducts business, including all establishments used
in the production of such excipient, the unique facility
identifier of each such establishment, and a point of contact
e-mail address for each such excipient manufacturer.''; and
(2) by adding at the end the following:
``(4) The Secretary shall require persons subject to this
subsection to use, for purposes of this subsection, the
unique facility identifier systems specified under
subsections (b)(3) and (i)(4) with respect to drugs. Such
requirement shall not apply until the date that the
identifier system under subsection (b)(3) or (i)(4), as
applicable, is specified by the Secretary.''.
SEC. 704. ELECTRONIC SYSTEM FOR REGISTRATION AND LISTING.
Section 510(p) (21 U.S.C. 360(p)) is amended--
(1) by striking ``(p) Registrations and listings'' and
inserting the following:
``(p) Electronic Registration and Listing.--
``(1) In general.--Registrations and listings''; and
(2) by adding at the end the following:
``(2) Electronic database.--Not later than 2 years after
the Secretary specifies a unique facility identifier system
under subsections (b) and (i), the Secretary shall maintain
an electronic database, which shall not be subject to
inspection under subsection (f), populated with the
information submitted as described under paragraph (1) that--
``(A) enables personnel of the Food and Drug Administration
to search the database by any field of information submitted
in a registration described under paragraph (1), or
combination of such fields; and
``(B) uses the unique facility identifier system to link
with other relevant databases within the Food and Drug
Administration, including the database for submission of
information under section 801(r).
``(3) Risk-based information and coordination.--The
Secretary shall ensure the accuracy and coordination of
relevant Food and Drug Administration databases in order to
identify and inform risk-based inspections under section
510(h).''.
SEC. 705. RISK-BASED INSPECTION FREQUENCY.
Section 510(h) (21 U.S.C. 360(h)) is amended to read as
follows:
``(h) Inspections.--
``(1) 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.
``(2) Biennial inspections for devices.--Every
establishment described in paragraph (1), in any State, that
is engaged in the manufacture, propagation, compounding, or
processing of a device or devices classified in class II or
III shall be so inspected by one or more officers or
employees duly designated by the Secretary, or by persons
accredited to conduct inspections under section 704(g), at
least once in the 2-year period beginning with the date of
registration of such establishment pursuant to this section
and at least once in every successive 2-year period
thereafter.
``(3) Risk-based schedule for drugs.--The Secretary, acting
through one or more officers or employees duly designated by
the Secretary, shall inspect establishments described in
paragraph (1) that are engaged in the manufacture,
preparation, propagation, compounding, or processing of a
drug or drugs (referred to in this subsection as `drug
establishments') in accordance with a risk-based schedule
established by the Secretary.
``(4) Risk factors.--In establishing the risk-based
scheduled under paragraph (3), the Secretary shall inspect
establishments according to the known safety risks of such
establishments, which shall be based on the following
factors:
``(A) The compliance history of the establishment.
``(B) The record, history, and nature of recalls linked to
the establishment.
``(C) The inherent risk of the drug manufactured, prepared,
propagated, compounded, or processed at the establishment.
``(D) The inspection frequency and history of the
establishment, including whether the establishment has been
inspected pursuant to section 704 within the last 4 years.
``(E) Whether the establishment has been inspected by a
foreign government or an agency of a foreign government
recognized under section 809.
``(F) Any other criteria deemed necessary and appropriate
by the Secretary for purposes of allocating inspection
resources.
``(5) Effect of status.--In determining the risk associated
with an establishment for purposes of establishing a risk-
based schedule under paragraph (3), the Secretary shall not
consider whether the drugs manufactured, prepared,
propagated, compounded, or processed by such establishment
are drugs described in section 503(b).
``(6) Annual report on inspections of establishments.--
Beginning in 2014, not later than February 1 of each year,
the Secretary shall make available on the Internet Web site
of the Food and Drug Administration a report regarding--
``(A)(i) the number of domestic and foreign establishments
registered pursuant to this section in the previous fiscal
year; and
``(ii) the number of such domestic establishments and the
number of such foreign establishments that the Secretary
inspected in the previous fiscal year;
``(B) with respect to establishments that manufacture,
prepare, propagate, compound, or process an active ingredient
of a drug, a finished drug product, or an excipient of a
drug, the number of each such type of establishment; and
``(C) the percentage of the budget of the Food and Drug
Administration used to fund the inspections described under
subparagraph (A).''.
SEC. 706. 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.''.
SEC. 707. 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. 708. 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 may destroy, without the
opportunity for export, any drug refused admission under this
section, if such drug is valued at an amount that is $2,500
or less (or such higher amount as the Secretary of the
Treasury may set by regulation pursuant to section 498(a)(1)
of the Tariff Act of 1930 (19 U.S.C. 1498(a)(1)) and was not
brought into compliance as described under subsection (b).''.
(b) Notice.--Subsection (a) of section 801 (21 U.S.C. 381),
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 to appear before the Secretary
of Health and Human Services and introduce testimony, as
described in the first sentence of this subsection, on
destruction of a drug under the sixth sentence of this
subsection. The regulations shall provide that prior to
destruction, appropriate due process is available to the
owner or consignee seeking to challenge the decision to
destroy the drug. Where the Secretary of Health and Human
Services provides notice and an opportunity to appear and
introduce testimony on the destruction of a drug, the
Secretary of Health and Human Services shall store and, as
applicable, dispose of the drug after the issuance of the
notice, except that the owner and consignee shall remain
liable for costs pursuant to subsection (c). Such process may
be combined with the notice and opportunity to appear before
the Secretary and introduce testimony, as described in the
first sentence of this subsection, as long as appropriate
notice is provided to the owner or consignee.''.
(c) Applicability.--The amendment made by subsection (a)
shall apply beginning on the effective date of the
regulations promulgated pursuant to the amendment made by
subsection (b).
(d) Regulations.--
(1) In general.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human
Services shall adopt final regulations implementing the
amendments made this section.
(2) Procedure.--In promulgating a regulation implementing
the amendments made by this section, the Secretary of Health
and Human Services shall--
(A) issue a notice of proposed rulemaking that includes a
copy of the proposed regulation;
(B) provide a period of not less than 60 days for comments
on the proposed regulation; and
(C) publish the final regulation not less than 30 days
before the effective date of the regulation.
(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services shall
promulgate regulations implementing the amendments made by
this section only as described in paragraph (2).
SEC. 709. 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) Regulations.--
[[Page H3845]]
(1) In general.--Not later than 2 years after the date of
the enactment of this Act, the Secretary of Health and Human
Services shall promulgate regulations in accordance with
section 304(i) of the Federal Food, Drug, and Cosmetic Act,
as added by paragraph (2) of this subsection, 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.
(2) In general.--Section 304 (21 U.S.C. 334) is amended by
adding at the end the following:
``(i) Procedures for Promulgating Regulations.--
``(1) In general.--In promulgating a regulation
implementing this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the regulation's effective date.
``(2) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary
shall only promulgate regulations as described in paragraph
(1).''.
(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. 710. EXCHANGE OF INFORMATION.
Section 708 (21 U.S.C. 379) is amended--
(1) by striking ``confidential information'' and all that
follows through ``The Secretary may provide'' and inserting
the following:
``SEC. 708. CONFIDENTIAL INFORMATION.
``(a) Contractors.--The Secretary may provide''; and
(2) by adding at the end the following:
``(b) Ability To Receive and Protect Confidential
Information Obtained From Foreign Governments.--
``(1) In general.--The Secretary shall not be required to
disclose under section 552 of title 5, United States Code
(commonly referred to as the `Freedom of Information Act'),
or any other provision of law, any information relating to
drugs obtained from a foreign government agency, if--
``(A) the information concerns the inspection of a
facility, is part of an investigation, alerts the United
States to the potential need for an investigation, or
concerns a drug that has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals;
``(B) the information is provided or made available to the
United States Government voluntarily on the condition that it
not be released to the public; and
``(C) the information is covered by, and subject to, a
written agreement between the Secretary and the foreign
government.
``(2) Time limitations.--The written agreement described in
paragraph (1)(C) shall specify the time period for which
paragraph (1) shall apply to the voluntarily disclosed
information. Paragraph (1) shall not apply with respect to
such information after the date specified in such agreement,
but all other applicable legal protections, including the
provisions of section 552 of title 5, United States Code, and
section 319L(e)(1) of the Public Health Service Act, as
applicable, shall continue to apply to such information. If
no date is specified in the written agreement, paragraph (1)
shall not apply with respect to such information for a period
of more than 36 months.
``(3) Disclosures not affected.--Nothing in this section
authorizes any official to withhold, or to authorize the
withholding of, information from Congress or information
required to be disclosed pursuant to an order of a court of
the United States.
``(4) Relation to other law.--For purposes of section 552
of title 5, United States Code, this subsection shall be
considered a statute described in subsection (b)(3)(B) of
such section 552.
``(c) Authority To Enter Into Memoranda of Understanding
for Purposes of Information Exchange.--The Secretary may
enter into written agreements to provide information
referenced in section 301(j) to foreign governments subject
to the following criteria:
``(1) Certification.--The Secretary may enter into a
written agreement to provide information under this
subsection to a foreign government only if the Secretary has
certified such government 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 to provide
information to the foreign government 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 only the
following circumstances:
``(A) Information concerning the inspection of a facility
may be provided to a foreign government 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 to humans or animals.
``(4) Effect of subsection.--Nothing in this subsection
affects the ability of the Secretary to enter into any
written agreement authorized by other provisions of law to
share confidential information.''.
SEC. 711. ENHANCING THE SAFETY AND QUALITY OF THE DRUG
SUPPLY.
Section 501 (21 U.S.C. 351) is amended by adding at the end
the following flush text:
``For purposes of paragraph (a)(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. 712. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
Chapter VIII (21 U.S.C. 381 et seq.) is amended by adding
at the end the following:
``SEC. 809. RECOGNITION OF FOREIGN GOVERNMENT INSPECTIONS.
``(a) Inspection.--The Secretary--
``(1) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government to
recognize the inspection of foreign establishments registered
under section 510(i) in order to facilitate risk-based
inspections in accordance with the schedule established in
section 510(h)(3);
``(2) may enter into arrangements and agreements with a
foreign government or an agency of a foreign government under
this section only with a foreign government or an agency of a
foreign government that the Secretary has determined as
having the capability of conduction inspections that meet the
applicable requirements of this Act; and
``(3) shall perform such reviews and audits of drug safety
programs, systems, and standards of a foreign government or
agency for the foreign government as the Secretary deems
necessary to determine that the foreign government or agency
of the foreign government is capable of conducting
inspections that meet the applicable requirements of this
Act.
``(b) Results of Inspection.--The results of inspections
performed by a foreign government or an agency of a foreign
government under this section may be used as--
``(1) evidence of compliance with section 501(a)(2)(B) or
section 801(r); and
``(2) for any other purposes as determined appropriate by
the Secretary.''.
SEC. 713. STANDARDS FOR ADMISSION OF IMPORTED DRUGS.
Section 801 (21 U.S.C. 381) is amended--
(1) in subsection (o), by striking ``drug or''; and
(2) by adding at the end the following:
``(r)(1) The Secretary may require, pursuant to the
regulations promulgated under paragraph (4)(A), as a
condition of granting admission to a drug imported or offered
for import into the United States, that the importer
electronically submit information demonstrating that the drug
complies with applicable requirements of this Act.
``(2) The information described under paragraph (1) may
include--
``(A) 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;
``(B) facility information, such as proof of registration
and the unique facility identifier;
``(C) indication of compliance with current good
manufacturing practice, testing results, certifications
relating to satisfactory inspections, and compliance with the
country of export regulations; and
``(D) any other information deemed necessary and
appropriate by the Secretary to assess compliance of the
article being offered for import.
``(3) Information requirements referred to in paragraph
(2)(C) may, at the discretion of the Secretary, be
satisfied--
``(A) through representation by a foreign government, if an
inspection is conducted by a foreign government using
standards and practices as determined appropriate by the
Secretary;
``(B) through representation by a foreign government or an
agency of a foreign government recognized under section 809;
or
``(C) other appropriate documentation or evidence as
described by the Secretary.
``(4)(A) Not later than 18 months after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this subsection. Such requirements shall be
appropriate for the type of import, such as whether the drug
is for import into the United States for use in preclinical
research or in a clinical investigation under an
investigational new drug exemption under 505(i).
``(B) In promulgating the regulations under subparagraph
(A), the Secretary--
``(i) 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 and
pass a review of internal controls, including sourcing of
foreign manufacturing inputs, and plant inspections; and
``(ii) shall--
``(I) issue a notice of proposed rulemaking that includes
the proposed regulation;
[[Page H3846]]
``(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.
``(C) Notwithstanding any other provision of law, the
Secretary shall promulgate regulations implementing this
subsection only as described in subparagraph (B).''.
SEC. 714. 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 713 of this Act, 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) subject to paragraph (4), 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) Procedure.--In promulgating a regulation under
subparagraph (A), 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 regulation's effective date.
``(C) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this subsection, the Secretary
shall only promulgate regulations as described in
subparagraph (B).
``(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) Unique facility identifier.--The Secretary shall
specify the unique facility identifier system that shall be
used by registrants under paragraph (1). The requirement to
include a unique facility identifier in a registration under
paragraph (1) shall not apply until the date that the
identifier system is specified by the Secretary under the
preceding sentence.
``(5) 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) Procedures for promulgating regulations.--
(A) In general.--In promulgating a regulation under
paragraph (1), 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 regulation's effective date.
(B) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing section 801(s) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (b), the
Secretary shall promulgate regulations only as described in
subparagraph (A).
(3) 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. 715. NOTIFICATION.
(a) Prohibited Acts.--Section 301 (21 U.S.C. 331), as
amended by section 714 of this Act, 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 in the United States; 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. 716. 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 adulterates a drug such that the
drug is adulterated under subsection (a)(1), (b), (c), or (d)
of section 501 and has a reasonable probability of causing
serious adverse health consequences or death to humans or
animals shall be imprisoned for not more than 20 years or
fined not more than $1,000,000, or both.''.
SEC. 717. PENALTIES FOR COUNTERFEITING DRUGS.
(a) Counterfeit Drug Penalty Enhancement.--
(1) Offense.--Section 2320(a) of title 18, United States
Code, is amended--
(A) by striking ``or'' at the end of paragraph (2);
(B) by inserting ``or'' at the end of paragraph (3);
(C) by inserting after paragraph (3) the following:
``(4) traffics in a counterfeit drug,''; and
(D) by striking ``through (3)'' and inserting ``through
(4)''.
(2) Penalties.--Section 2320(b)(3) of title 18, United
States Code, is amended--
(A) in the heading, by inserting ``and counterfeit drugs''
after ``services''; and
(B) by inserting ``or counterfeit drug'' after ``service''.
(3) Definition.--Section 2320(f) of title 18, United States
Code, is amended--
(A) by striking ``and'' at the end of paragraph (4);
(B) by striking the period at the end of paragraph (5) and
inserting ``; and''; and
(C) by adding at the end the following:
``(6) the term `counterfeit drug' means a drug, as defined
by section 201 of the Federal Food, Drug, and Cosmetic Act,
that uses a counterfeit mark on or in connection with the
drug.''.
(4) Priority given to certain investigations and
prosecutions.--The Attorney General shall give increased
priority to efforts to investigate and prosecute offenses
under section 2320 of title 18, United States Code, that
involve counterfeit drugs.
(b) Sentencing Commission Directive.--
(1) Directive to sentencing commission.--Pursuant to its
authority under section 994(p) of title 28, United States
Code, and in accordance with this subsection, the United
States Sentencing Commission shall review and amend, if
appropriate, its guidelines and its policy statements
applicable to persons convicted of an offense described in
section 2320(a)(4) of title 18, United States Code, as
amended by subsection (a), in order to reflect the intent of
Congress that such penalties be increased in comparison to
those currently provided by the guidelines and policy
statements.
(2) Requirements.--In carrying out this subsection, the
Commission shall--
(A) ensure that the sentencing guidelines and policy
statements reflect the intent of Congress that the guidelines
and policy statements reflect the serious nature of the
offenses described in paragraph (1) and the need for an
effective deterrent and appropriate punishment to prevent
such offenses;
(B) consider the extent to which the guidelines may or may
not appropriately account for the potential and actual harm
to the public resulting from the offense;
(C) assure reasonable consistency with other relevant
directives and with other sentencing guidelines;
(D) account for any additional aggravating or mitigating
circumstances that might justify exceptions to the generally
applicable sentencing ranges;
(E) make any necessary conforming changes to the sentencing
guidelines; and
(F) assure that the guidelines adequately meet the purposes
of sentencing as set forth in section 3553(a)(2) of title 18,
United States Code.
SEC. 718. 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
[[Page H3847]]
in furtherance of the violation was committed in the United
States.''.
TITLE VIII--GENERATING ANTIBIOTIC INCENTIVES NOW
SEC. 801. EXTENSION OF EXCLUSIVITY PERIOD FOR DRUGS.
(a) In General.--Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 505D 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 designated
as a qualified infectious disease product under subsection
(d), the 4- and 5-year periods described in subsections
(c)(3)(E)(ii) and (j)(5)(F)(ii) of section 505, the 3-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 7-year period described in section
527, as applicable, shall be extended by 5 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 with respect to a
product approved under section 505 for a change that results
in a new indication, route of administration, dosing
schedule, dosage form, delivery system, delivery device, or
strength; or
``(3) a product that does not meet the definition of a
qualified infectious disease product under subsection (g)
based upon its approved uses.
``(d) Designation.--
``(1) In general.--The manufacturer or sponsor of a drug
may request the Secretary to designate a drug as a qualified
infectious disease product at any time before the submission
of an application under section 505(b) for such drug. The
Secretary shall, not later than 60 days after the submission
of such a request, determine whether the drug is a qualified
infectious disease product.
``(2) Limitation.--Except as provided in paragraph (3), a
designation under this subsection shall not be withdrawn for
any reason, including modifications to the list of qualifying
pathogens under subsection (f)(2)(C).
``(3) Revocation of designation.--The Secretary may revoke
a designation of a drug as a qualified infectious disease
product if the Secretary finds that the request for such
designation contained an untrue statement of material fact.
``(e) Regulations.--
``(1) In general.--Not later than 2 years after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt final regulations
implementing this section, including developing the list of
qualifying pathogens described in subsection (f).
``(2) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the effective date of the regulation.
``(3) Restrictions.--Notwithstanding any other provision of
law, the Secretary shall promulgate regulations implementing
this section only as described in paragraph (2), except that
the Secretary may issue interim guidance for sponsors seeking
designation under subsection (d) prior to the promulgation of
such regulations.
``(4) Designation prior to regulations.--The Secretary
shall designate drugs as qualified infectious disease
products under subsection (d) prior to the promulgation of
regulations under this subsection, if such drugs meet the
definition of a qualified infectious disease product
described in subsection (g).
``(f) Qualifying Pathogen.--
``(1) Definition.--In this section, the term `qualifying
pathogen' means a pathogen identified and listed by the
Secretary under paragraph (2) that has the potential to pose
a serious threat to public health, such as--
``(A) resistant gram positive pathogens, including
methicillin-resistant Staphylococcus aureus, vancomycin-
resistant Staphylococcus aureus, and vancomycin-resistant
enterococcus;
``(B) multi-drug resistant gram negative bacteria,
including Acinetobacter, Klebsiella, Pseudomonas, and E. coli
species;
``(C) multi-drug resistant tuberculosis; and
``(D) Clostridium difficile.
``(2) List of qualifying pathogens.--
``(A) In general.--The Secretary shall establish and
maintain a list of qualifying pathogens, and shall make
public the methodology for developing such list.
``(B) Considerations.--In establishing and maintaining the
list of pathogens described under this section, the Secretary
shall--
``(i) consider--
``(I) the impact on the public health due to drug-resistant
organisms in humans;
``(II) the rate of growth of drug-resistant organisms in
humans;
``(III) the increase in resistance rates in humans; and
``(IV) the morbidity and mortality in humans; and
``(ii) consult with experts in infectious diseases and
antibiotic resistance, including the Centers for Disease
Control and Prevention, the Food and Drug Administration,
medical professionals, and the clinical research community.
``(C) Review.--Every 5 years, or more often as needed, the
Secretary shall review, provide modifications to, and publish
the list of qualifying pathogens under subparagraph (A) and
shall by regulation revise the list as necessary, in
accordance with subsection (e).
``(g) Qualified Infectious Disease Product.--The term
`qualified infectious disease product' means an antibacterial
or antifungal drug for human use intended to treat serious or
life-threatening infections, including those caused by--
``(1) an antibacterial or antifungal resistant pathogen,
including novel or emerging infectious pathogens; or
``(2) qualifying pathogens listed by the Secretary under
subsection (f).''.
(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. 802. PRIORITY REVIEW.
(a) Amendment.--Chapter V (21 U.S.C. 351 et seq.) is
amended by inserting after section 524 the following:
``SEC. 524A. PRIORITY REVIEW FOR QUALIFIED INFECTIOUS DISEASE
PRODUCTS.
``If the Secretary designates a drug under section 505E(d)
as a qualified infectious disease product, then the Secretary
shall give priority review to any application submitted for
approval for such drug under section 505(b).''.
(b) Application.--Section 524A of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies only
with respect to an application that is submitted under
section 505(b) of such Act (21 U.S.C. 355(b)) on or after the
date of the enactment of this Act.
SEC. 803. FAST TRACK PRODUCT.
Section 506(a)(1) (21 U.S.C. 356(a)(1)), as amended by
section 901(b) of this Act, is amended by inserting ``, or if
the Secretary designates the drug as a qualified infectious
disease product under section 505E(d)'' before the period at
the end of the first sentence.
SEC. 804. CLINICAL TRIALS.
(a) Review and Revision of Guidance Documents.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
review and, as appropriate, revise not fewer than 3 guidance
documents per year, which shall include--
(A) reviewing the guidance documents of the Food and Drug
Administration for the conduct of clinical trials with
respect to antibacterial and antifungal drugs; and
(B) as appropriate, revising such guidance documents to
reflect developments in scientific and medical information
and technology and to ensure clarity regarding the procedures
and requirements for approval of antibacterial and antifungal
drugs under chapter V of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 351 et seq.).
(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, trial enrollment, data requirements, and
appropriate delta values for noninferiority trials.
(3) Rule of construction.--Except to the extent to which
the Secretary makes revisions under paragraph (1)(B), nothing
in this section shall be construed to repeal or otherwise
effect the guidance documents of the Food and Drug
Administration.
(b) Recommendations for Investigations.--
(1) Request.--The sponsor of a drug intended to be
designated as a qualified infectious disease product may
request that the Secretary provide written recommendations
for nonclinical and clinical investigations which the
Secretary believes may be necessary to be conducted with the
drug before such drug may be approved under section 505 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) for
use in treating, detecting, preventing, or identifying a
qualifying pathogen, as defined in section 505E of such Act.
(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) Qualified Infectious Disease Product.--For purposes of
this section, the term ``qualified infectious disease
product'' has the meaning given such term in section 505E(g)
of the Federal Food, Drug, and Cosmetic Act, as added by
section 801 of this Act.
SEC. 805. REASSESSMENT OF QUALIFIED INFECTIOUS DISEASE
PRODUCT INCENTIVES IN 5 YEARS.
(a) In General.--Not later than 5 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, the 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
[[Page H3848]]
under section 505E of the Federal Food, Drug, and Cosmetic
Act.
(B) The number of qualified infectious disease products
approved under such section 505E.
(C) Whether such products address the need for
antibacterial and antifungal drugs to treat serious and life-
threatening infections.
(D) A list of qualified infectious disease products with
information on the types of exclusivity granted for each
product, consistent with the information published under
section 505(j)(7)(A)(iii) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(7)(A)(iii)).
(E) The progress made regarding the review and revision of
the clinical trial guidance documents required under section
804 and the impact such review and revision has had on the
review and approval of qualified infectious disease products.
(F) The Federal contribution, if any, to funding of the
clinical trials for each qualified infectious disease product
for each phase.
(2) Recommendations--
(A) based on the information under 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 801 of this Act; 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.
(5) A description of the regulatory challenges and
impediments to clinical development, approval, and licensure
of qualified infectious disease products, and the steps the
Secretary has taken and will take to address such challenges
and ensure regulatory certainty and predictability with
respect to qualified infectious disease products.
(b) Definition.--For purposes of this section, the term
``qualified infectious disease product'' has the meaning
given such term in section 505E(g) of the Federal Food, Drug,
and Cosmetic Act, as added by section 801 of this Act.
SEC. 806. 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.
TITLE IX--DRUG APPROVAL AND PATIENT ACCESS
SEC. 901. ENHANCEMENT OF ACCELERATED PATIENT ACCESS TO NEW
MEDICAL TREATMENTS.
(a) Findings; Sense of Congress.--
(1) Findings.--Congress finds as follows:
(A) The Food and Drug Administration (referred to in this
section 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 Congress that
the Food and Drug Administration 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 of Drugs for Serious or Life-
Threatening Diseases or Conditions.--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 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) 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.--
``(A) Accelerated approval.--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) or section 351(a) of the Public
Health Service Act upon a determination that the product has
an effect on a surrogate endpoint that is reasonably likely
to predict clinical benefit, or on 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, rarity, or
prevalence of the condition and the availability or lack of
alternative treatments. The approval described in the
preceding sentence is referred to in this section as
`accelerated approval'.
``(B) Evidence.--The evidence to support that an endpoint
is reasonably likely to predict clinical benefit under
subparagraph (A) may include epidemiological,
pathophysiological, therapeutic, pharmacologic, or other
evidence developed using biomarkers, for example, or other
scientific methods or tools.
``(2) Limitation.--Approval of a product under this
subsection may be subject to 1 or both of the following
requirements:
``(A) That the sponsor conduct appropriate postapproval
studies to verify and describe the predicted effect on
irreversible morbidity or mortality or other clinical
benefit.
``(B) That the sponsor submit copies of all promotional
materials related to the product during the preapproval
review period and, following approval and for such period
thereafter as the Secretary determines to be appropriate, at
least 30 days prior to dissemination of the materials.
``(3) Expedited withdrawal of approval.--The Secretary may
withdraw approval of a product approved under accelerated
approval 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
postapproval study of the drug 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
[[Page H3849]]
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
significant unmet medical needs exist.
``(e) Construction.--
``(1) Purpose.--The amendments made by the Food and Drug
Administration Safety and Innovation Act to this section are
intended to encourage the Secretary to utilize innovative and
flexible approaches to the assessment of products under
accelerated approval for treatments for patients with serious
or life-threatening diseases or conditions and unmet medical
needs.
``(2) Construction.--Nothing in this section shall be
construed to alter the standards of evidence under subsection
(c) or (d) of section 505 (including the substantial evidence
standard in section 505(d)) of this Act or under section
351(a) of the Public Health Service Act. Such sections and
standards of evidence apply to the review and approval of
products under this section, including whether a product is
safe and effective. Nothing in this section alters the
ability of the Secretary to rely on evidence that does not
come from adequate and well-controlled investigations for the
purpose of determining whether an endpoint is reasonably
likely to predict clinical benefit as described in subsection
(b)(1)(B).''.
(c) Guidance; Amended Regulations.--
(1) Draft guidance.--Not later than 1 year 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 to implement the amendments made
by this section. In developing such guidance, the Secretary
shall specifically consider issues arising under the
accelerated approval and fast track processes under section
506 of the Federal Food, Drug, and Cosmetic Act, as amended
by subsection (b), for drugs designated for a rare disease or
condition under section 526 of such Act (21 U.S.C. 360bb) and
shall also consider any unique issues associated with very
rare diseases.
(2) Final guidance.--Not later than 1 year after the
issuance of draft guidance under paragraph (1), and after an
opportunity for public comment, the Secretary shall--
(A) issue final guidance; and
(B) 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 amendment
made by subsection (b).
(3) Consideration.--In developing the guidance under
paragraphs (1) and (2)(A) and the amendments under paragraph
(2)(B), the Secretary shall consider 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.
(4) Conforming changes.--The Secretary shall issue, as
necessary, conforming amendments to the applicable
regulations under title 21, Code of Federal Regulations,
governing accelerated approval.
(5) No effect of inaction on requests.--The issuance (or
nonissuance) of guidance or conforming regulations
implementing the amendment made by subsection (b) 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 subsection (b).
(d) Independent Review.--The Secretary may, in conjunction
with other planned reviews, 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
subsection (b), and the impact of such processes on the
development and timely availability of innovative treatments
for patients suffering from serious or life-threatening
conditions. Any such evaluation shall include consultation
with regulated industries, patient advocacy and disease
research foundations, and relevant academic medical centers.
SEC. 902. BREAKTHROUGH THERAPIES.
(a) In General.--Section 506 (21 U.S.C. 356), as amended by
section 901 of this Act, is further amended--
(1) by redesignating subsections (a) through (c) as
subsections (b) through (d), respectively;
(2) by redesignating subsection (d) as subsection (f);
(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 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
nonclinical 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.''; and
(4) in subsection (f)(1), as so redesignated, by striking
``applicable to accelerated approval'' and inserting
``applicable to breakthrough therapies, accelerated approval,
and''.
(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 this 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) 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. 903. 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 715 of this Act,
[[Page H3850]]
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.--
``(1) In general.--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--
``(A) such consultation will--
``(i) facilitate the Secretary's ability to complete the
Secretary's review; and
``(ii) address outstanding deficiencies in the application;
or
``(B) the sponsor authorized such consultation.
``(2) Limitation.--The requirements of this subsection
shall apply only in instances where the consultation is
undertaken solely under the authority of this section. The
requirements of this subsection shall not apply to any
consultation initiated under any other authority.''.
SEC. 904. ACCESSIBILITY OF INFORMATION ON PRESCRIPTION DRUG
CONTAINER LABELS BY VISUALLY IMPAIRED AND BLIND
CONSUMERS.
(a) Establishment of Working Group.--
(1) In general.--The Architectural and Transportation
Barriers Compliance Board (referred to in this section as the
``Access Board'') shall convene a stakeholder working group
(referred to in this section as the ``working group'') to
develop best practices on access to information on
prescription drug container labels for individuals who are
blind or visually impaired.
(2) Members.--The working group shall be comprised of
representatives of national organizations representing blind
and visually impaired individuals, national organizations
representing the elderly, and industry groups representing
stakeholders, including retail, mail-order, and independent
community pharmacies, who would be impacted by such best
practices. Representation within the working group shall be
divided equally between consumer and industry advocates.
(3) Best practices.--
(A) In general.--The working group shall develop, not later
than 1 year after the date of the enactment of this Act, best
practices for pharmacies to ensure that blind and visually
impaired individuals have safe, consistent, reliable, and
independent access to the information on prescription drug
container labels.
(B) Public availability.--The best practices developed
under subparagraph (A) may be made publicly available,
including through the Internet Web sites of the working group
participant organizations, and through other means, in a
manner that provides access to interested individuals,
including individuals with disabilities.
(C) Limitations.--The best practices developed under
subparagraph (A) shall not be construed as accessibility
guidelines or standards of the Access Board, and shall not
confer any rights or impose any obligations on working group
participants or other persons. Nothing in this section shall
be construed to limit or condition any right, obligation, or
remedy available under the Americans with Disabilities Act of
1990 (42 U.S.C. 12101 et seq.) or any other Federal or State
law requiring effective communication, barrier removal, or
nondiscrimination on the basis of disability.
(4) Considerations.--In developing and issuing the best
practices under paragraph (3)(A), the working group shall
consider--
(A) the use of--
(i) Braille;
(ii) auditory means, such as--
(I) ``talking bottles'' that provide audible container
label information;
(II) digital voice recorders attached to the prescription
drug container; and
(III) radio frequency identification tags;
(iii) enhanced visual means, such as--
(I) large font labels or large font ``duplicate'' labels
that are affixed or matched to a prescription drug container;
(II) high-contrast printing; and
(III) sans-serf font; and
(iv) other relevant alternatives as determined by the
working group;
(B) whether there are technical, financial, manpower, or
other factors unique to pharmacies with 20 or fewer retail
locations which may pose significant challenges to the
adoption of the best practices; and
(C) such other factors as the working group determines to
be appropriate.
(5) Information campaign.--Upon completion of development
of the best practices under subsection (a)(3), the National
Council on Disability, in consultation with the working
group, shall conduct an informational and educational
campaign designed to inform individuals with disabilities,
pharmacists, and the public about such best practices.
(6) FACA waiver.--The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the working group.
(b) GAO Study.--
(1) In general.--Beginning 18 months after the completion
of the development of best practices under subsection
(a)(3)(A), the Comptroller General of the United States shall
conduct a review of the extent to which pharmacies are
utilizing such best practices, and the extent to which
barriers to accessible information on prescription drug
container labels for blind and visually impaired individuals
continue.
(2) Report.--Not later than September 30, 2016, the
Comptroller General of the United States shall submit to
Congress a report on the review conducted under paragraph
(1). Such report shall include recommendations about how best
to reduce the barriers experienced by blind and visually
impaired individuals to independently accessing information
on prescription drug container labels.
(c) Definitions.--In this section--
(1) the term ``pharmacy'' includes a pharmacy that receives
prescriptions and dispenses prescription drugs through an
Internet Web site or by mail;
(2) the term ``prescription drug'' means a drug subject to
section 503(b)(1) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 353(b)(1)); and
(3) the term ``prescription drug container label'' means
the label with the directions for use that is affixed to the
prescription drug container by the pharmacist and dispensed
to the consumer.
SEC. 905. RISK-BENEFIT FRAMEWORK.
Section 505(d) (21 U.S.C. 355(d)) is amended by adding at
the end the following: ``The Secretary shall implement a
structured risk-benefit assessment framework in the new drug
approval process to facilitate the balanced consideration of
[[Page H3851]]
benefits and risks, a consistent and systematic approach to
the discussion and regulatory decisionmaking, and the
communication of the benefits and risks of new drugs. Nothing
in the preceding sentence shall alter the criteria for
evaluating an application for premarket approval of a
drug.''.
SEC. 906. 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.''.
SEC. 907. REPORTING OF INCLUSION OF DEMOGRAPHIC SUBGROUPS IN
CLINICAL TRIALS AND DATA ANALYSIS IN
APPLICATIONS FOR DRUGS, BIOLOGICS, AND DEVICES.
(a) Report.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary, acting through the
Commissioner, shall publish on the Internet Web site of the
Food and Drug Administration a report, consistent with the
regulations of the Food and Drug Administration pertaining to
the protection of sponsors' confidential commercial
information as of the date of enactment of this Act,
addressing the extent to which clinical trial participation
and the inclusion of safety and effectiveness data by
demographic subgroups including sex, age, race, and
ethnicity, is included in applications submitted to the Food
and Drug Administration, and shall provide such publication
to Congress.
(2) Contents of report.--The report described in paragraph
(1) shall contain the following:
(A) A description of existing tools to ensure that data to
support demographic analyses are submitted in applications
for drugs, biological products, and devices, and that these
analyses are conducted by applicants consistent with
applicable Food and Drug Administration requirements and
Guidance for Industry. The report shall address how the Food
and Drug Administration makes available information about
differences in safety and effectiveness of medical products
according to demographic subgroups, such as sex, age, racial,
and ethnic subgroups, to health care providers, researchers,
and patients.
(B) An analysis of the extent to which demographic data
subset analyses on sex, age, race, and ethnicity is presented
in applications for new drug applications for new molecular
entities under section 505 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355), in biologics license
applications under section 351 of the Public Health Service
Act (42 U.S.C. 262), and in premarket approval applications
under section 515 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360e) for products approved or licensed by the
Food and Drug Administration, consistent with applicable
requirements and Guidance for Industry, and consistent with
the regulations of the Food and Drug Administration
pertaining to the protection of sponsors' confidential
commercial information as of the date of enactment of this
Act.
(C) An analysis of the extent to which demographic
subgroups, including sex, age, racial, and ethnic subgroups,
are represented in clinical studies to support applications
for approved or licensed new molecular entities, biological
products, and devices.
(D) An analysis of the extent to which a summary of product
safety and effectiveness data by demographic subgroups
including sex, age, race, and ethnicity is readily available
to the public in a timely manner by means of the product
labeling or the Food and Drug Administration's Internet Web
site.
(b) Action Plan.--
(1) In general.--Not later than 1 year after the
publication of the report described in subsection (a), the
Secretary, acting through the Commissioner, shall publish an
action plan on the Internet Web site of the Food and Drug
Administration, and provide such publication to Congress.
(2) Content of action plan.--The plan described in
paragraph (1) shall include--
(A) recommendations, as appropriate, to improve the
completeness and quality of analyses of data on demographic
subgroups in summaries of product safety and effectiveness
data and in labeling;
(B) recommendations, as appropriate, on the inclusion of
such data, or the lack of availability of such data in
labeling;
(C) recommendations, as appropriate, to otherwise improve
the public availability of such data to patients, health care
providers, and researchers; and
(D) a determination with respect to each recommendation
identified in subparagraphs (A) through (C) that
distinguishes between product types referenced in subsection
(a)(2)(B) insofar as the applicability of each such
recommendation to each type of product.
(c) Definitions.--In this section:
(1) The term ``Commissioner'' means the Commissioner of
Food and Drugs.
(2) The term ``device'' has the meaning given such term in
section 201(h) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(h)).
(3) The term ``drug'' has the meaning given such term in
section 201(g) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321(g)).
(4) The term ``biological product'' has the meaning given
such term in section 351(i) of the Public Health Service Act
(42 U.S.C. 262(i)).
(5) The term ``Secretary'' means the Secretary of Health
and Human Services.
SEC. 908. 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--
[[Page H3852]]
``(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 appropriations 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) Revocation.--The Secretary may revoke any priority
review voucher awarded 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.
``(2) 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 Internet 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) Notification.--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 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).''.
TITLE X--DRUG SHORTAGES
SEC. 1001. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION
OF LIFE-SAVING DRUGS.
(a) In General.--Section 506C (21 U.S.C. 356c) is amended
to read as follows:
``SEC. 506C. DISCONTINUANCE OR INTERRUPTION IN THE PRODUCTION
OF LIFE-SAVING DRUGS.
``(a) In General.--A manufacturer of a drug--
``(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, including any such drug
used in emergency medical care or during surgery; and
``(2) that is not a radio pharmaceutical drug product or
any other product as designated by the Secretary,
shall notify the Secretary, in accordance with subsection
(b), of a permanent discontinuance in 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 supply of
that drug in the United States, and the reasons for such
discontinuance or interruption.
``(b) Timing.--A notice required under 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, through such means as the
Secretary deems appropriate, 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 506E.
``(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 Internet Web
site of the Food and Drug Administration.
``(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
[[Page H3853]]
Secretary shall make such letter and any response to such
letter under paragraph (2) available to the public on the
Internet 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.
``(g) Expedited Inspections and Reviews.--If, based on
notifications described in subsection (a) or any other
relevant information, the Secretary concludes that there is,
or is likely to be, a drug shortage of a drug described in
subsection (a), the Secretary may--
``(1) expedite the review of a supplement to a new drug
application submitted under section 505(b), an abbreviated
new drug application submitted under section 505(j), or a
supplement to such an application submitted under section
505(j) that could help mitigate or prevent such shortage; or
``(2) expedite an inspection or reinspection of an
establishment that could help mitigate or prevent such drug
shortage.
``(h) Definitions.--For purposes of this section--
``(1) the term `drug'--
``(A) means a drug (as defined in section 201(g)) that is
intended for human use and that is subject to section
503(b)(1); and
``(B) does not include biological products (as defined in
section 351 of the Public Health Service Act), unless
otherwise provided by the Secretary in the regulations
promulgated under subsection (i);
``(2) the term `drug shortage' or `shortage', with respect
to a drug, means a period of time when the demand or
projected demand for the drug within the United States
exceeds the supply of the drug; and
``(3) the term `meaningful disruption'--
``(A) means a change in production that is reasonably
likely to lead to a reduction in the supply of a drug by a
manufacturer that is more than negligible and affects the
ability of the manufacturer to fill orders or meet expected
demand for its product; and
``(B) does not include interruptions in manufacturing 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.
``(i) Regulations.--
``(1) In general.--Not later than 18 months after the date
of enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall adopt a final regulation
implementing this section.
``(2) Contents.--Such regulation shall define, for purposes
of this section, the terms `life-supporting', `life-
sustaining', and `intended for use in the prevention or
treatment of a debilitating disease or condition'.
``(3) Inclusion of biological products.--
``(A) In general.--The Secretary may by regulation apply
this section to biological products (as defined in section
351 of the Public Health Service Act), including plasma
products derived from human plasma protein and their
recombinant analogs, if the Secretary determines such
inclusion would benefit the public health. Such regulation
shall take into account any supply reporting programs and
shall aim to reduce duplicative notification.
``(B) Rule for vaccines.--If the Secretary applies this
section to vaccines pursuant to subparagraph (A), the
Secretary shall--
``(i) consider whether the notification requirement under
subsection (a) may be satisfied by submitting a notification
to the Centers for Disease Control and Prevention under the
vaccine shortage notification program of such Centers; and
``(ii) explain the determination made by the Secretary
under clause (i) in the regulation.
``(4) Procedure.--In promulgating a regulation implementing
this section, the Secretary shall--
``(A) issue a notice of proposed rulemaking that includes
the proposed regulation;
``(B) provide a period of not less than 60 days for
comments on the proposed regulation; and
``(C) publish the final regulation not less than 30 days
before the regulation's effective date.
``(5) Restrictions.--Notwithstanding any other provision of
Federal law, in implementing this section, the Secretary
shall only promulgate regulations as described in paragraph
(4).''.
(b) Effect of Notification.--The submission of a
notification to the Secretary of Health and Human Services
(referred to in this title as the ``Secretary'') for purposes
of complying with the requirement in section 506C(a) of the
Federal Food, Drug, and Cosmetic Act (as amended by
subsection (a)) shall not be construed--
(1) as an admission that any product that is the subject of
such notification violates any provision of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 301 et seq.); or
(2) as evidence of an intention to promote or market the
product for an indication or use for which the product has
not been approved by the Secretary.
SEC. 1002. ANNUAL REPORTING ON DRUG SHORTAGES.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C, as amended by section 1001 of this Act,
the following:
``SEC. 506C 1. ANNUAL REPORTING ON DRUG SHORTAGES.
``(a) Annual Reports to Congress.--Not later than the end
of calendar year 2013, and not later than the end of each
calendar year thereafter, 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 on drug shortages
that--
``(1) specifies the number of manufacturers that submitted
a notification to the Secretary under section 506C(a) during
such calendar year;
``(2) 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 procedures for enabling and
ensuring such communication;
``(3)(A) lists the major actions taken by the Secretary to
prevent or mitigate the drug shortages described in paragraph
(7);
``(B) in the list under subparagraph (A), includes--
``(i) the number of applications and supplements for which
the Secretary expedited review under section 506C(g)(1)
during such calendar year; and
``(ii) the number of establishment inspections or
reinspections that the Secretary expedited under section
506C(g)(2) during such calendar year;
``(4) describes the coordination between the Food and Drug
Administration and the Drug Enforcement Administration on
efforts to prevent or alleviate drug shortages;
``(5) 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;
``(6) lists the names of manufacturers that were issued
letters under section 506C(f); and
``(7) specifies the number of drug shortages occurring
during such calendar year, as identified by the Secretary.
``(b) Trend Analysis.--The Secretary is authorized to
retain a third party to conduct a study, if the Secretary
believes such a study would help clarify the causes, trends,
or solutions related to drug shortages.
``(c) Definition.--In this section, the term `drug
shortage' or `shortage' has the meaning given such term in
section 506C.''.
SEC. 1003. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506C 1, as added by section 1002 of this Act,
the following:
``SEC. 506D. COORDINATION; TASK FORCE AND STRATEGIC PLAN.
``(a) Task Force and Strategic Plan.--
``(1) In general.--
``(A) Task force.--As soon as practicable after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the Secretary shall establish a task force to
develop and implement a strategic plan for enhancing the
Secretary's response to preventing and mitigating drug
shortages.
``(B) Strategic plan.--The strategic plan described in
subparagraph (A) shall include--
``(i) plans for enhanced interagency and intra-agency
coordination, communication, and decisionmaking;
``(ii) plans for ensuring that drug shortages are
considered when the Secretary initiates a regulatory action
that could precipitate a drug shortage or exacerbate an
existing drug shortage;
``(iii) plans for effective communication with outside
stakeholders, including who the Secretary should alert about
potential or actual drug shortages, how the communication
should occur, and what types of information should be shared;
``(iv) plans for considering the impact of drug shortages
on research and clinical trials; and
``(v) an examination of whether to establish a `qualified
manufacturing partner program', as described in subparagraph
(C).
``(C) Description of program.--In conducting the
examination of a `qualified manufacturing partner program'
under subparagraph (B)(v), the Secretary--
``(i) shall take into account that--
``(I) a `qualified manufacturer', for purposes of such
program, would need to have the capability and capacity to
supply products determined or anticipated to be in shortage;
and
``(II) in examining the capability and capacity to supply
products in shortage, the `qualified manufacturer' could have
a site that manufactures a drug listed under section 506E or
have the capacity to produce drugs in response to a shortage
within a rapid timeframe; and
``(ii) shall examine whether incentives are necessary to
encourage the participation of `qualified manufacturers' in
such a program.
``(D) Consultation.--In carrying out this paragraph, the
task force shall ensure consultation with the appropriate
offices within the Food and Drug Administration, including
the Office of the Commissioner, the Center for Drug
Evaluation and Research, the Office of Regulatory Affairs,
and employees within the Department of Health and Human
Services with expertise regarding drug shortages. The
Secretary shall engage external stakeholders and experts as
appropriate.
``(2) Timing.--Not later than 1 year after the date of
enactment of the Food and Drug Administration Safety and
Innovation Act, the task force shall--
``(A) publish the strategic plan described in paragraph
(1); and
``(B) submit such plan to Congress.
``(b) Communication.--The Secretary shall ensure that,
prior to any enforcement action or issuance of a warning
letter that the Secretary determines could reasonably be
anticipated to lead to a meaningful disruption in the supply
in the United States of a drug described under section
506C(a), there is communication with the appropriate office
of the Food and Drug Administration with expertise regarding
drug shortages regarding whether the action or letter could
cause, or exacerbate, a shortage of the drug.
``(c) Action.--If the Secretary determines, after the
communication described in subsection (b), that an
enforcement action or a warning
[[Page H3854]]
letter could reasonably cause or exacerbate a shortage of a
drug described under section 506C(a), then the Secretary
shall evaluate the risks associated with the impact of such
shortage upon patients and those risks associated with the
violation involved before taking such action or issuing such
letter, unless there is imminent risk of serious adverse
health consequences or death to humans.
``(d) Reporting by Other Entities.--The Secretary shall
identify or establish a mechanism by which health care
providers and other third-party organizations may report to
the Secretary evidence of a drug shortage.
``(e) Review and Construction.--No determination, finding,
action, or omission of the Secretary under this section
shall--
``(1) be subject to judicial review; or
``(2) be construed to establish a defense to an enforcement
action by the Secretary.
``(f) Sunset.--Subsections (a), (b), (c), and (e) shall
cease to be effective on the date that is 5 years after the
date of enactment of the Food and Drug Administration Safety
and Innovation Act.''.
SEC. 1004. DRUG SHORTAGE LIST.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506D, as added by section 1003 of this Act, the
following:
``SEC. 506E. 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, including the
National Drug Code number for such drug.
``(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) or section 506C(c) 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. 1005. 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 Internet
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 506E 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. 1006. 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 1005 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 to be in shortage.
SEC. 1007. HOSPITAL REPACKAGING OF DRUGS IN SHORTAGE.
Chapter V (21 U.S.C. 351 et seq.) is amended by inserting
after section 506E, as added by section 1004 of this Act, the
following:
``SEC. 506F. 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 under section
506E; 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 under section 506E; 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
transfer 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 of each State in which the drug
is repackaged and received.
``(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.''.
SEC. 1008. 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 a drug shortage over the preceding 3 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)(A) How have regulations, guidance documents, regulatory
practices, policies, and other actions of Federal departments
and agencies (including the effectiveness of interagency and
intra-agency coordination, communication, strategic planning,
and decisionmaking), including those used to enforce
statutory requirements, affected drug shortages?
(B) Do any such regulations, guidances, policies, or
practices cause, exacerbate, prevent, or mitigate drug
shortages?
(C) How can regulations, guidances, policies, or practices
be modified, streamlined, expanded, or discontinued in order
to reduce or prevent such drug shortages?
(D) What effect would the changes described in subparagraph
(C) have on the public health?
(5) How does hoarding affect drug shortages?
(6) How would incentives alleviate or prevent drug
shortages?
(7) To what extent are health care providers, including
hospitals and physicians responding to drug shortages, able
to adjust care effectively to compensate for such shortages,
and what impediments exist that hinder provider ability to
adjust to such shortages?
(8)(A) Have drug shortages led market participants to
stockpile affected drugs or sell such drugs at inflated
prices?
(B) What has been the impact of any such activities
described in subparagraph (A) on Federal revenue, and are
there any economic factors that have exacerbated or created a
market for such activities?
(C) Is there a need for any additional reporting or
enforcement actions to address such activities?
(9)(A) How have the activities under section 506D of the
Federal Food, Drug, and Cosmetic Act (as added by section
1003 of this Act) improved the efforts of the Food and Drug
Administration to mitigate and prevent drug shortages?
[[Page H3855]]
(B) Is there a need to continue the task force and
strategic plan under such section 506D, or are there any
other recommendations to increase communication and
coordination inside the Food and Drug Administration, between
the Food and Drug Administration and other agencies, and
between the Food and Drug Administration and stakeholders?
(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.--Not 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.
TITLE XI--OTHER PROVISIONS
Subtitle A--Reauthorizations
SEC. 1101. REAUTHORIZATION OF PROVISION RELATING TO
EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.
(a) In General.--Section 505(u)(4) (21 U.S.C. 355(u)(4)) is
amended by striking ``2012'' and inserting ``2017''.
(b) Amendment.--Section 505(u)(1)(A)(ii)(II) (21 U.S.C.
355(u)(1)(A)(ii)(II)) is amended by inserting ``clinical''
after ``any''.
SEC. 1102. 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 B--Medical Gas Product Regulation
SEC. 1111. 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 postapproval 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.
``(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. 1112. 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 1111 of this Act.
(3) The term ``Secretary'' means the Secretary of Health
and Human Services, acting through the Commissioner of Food
and Drugs.
SEC. 1113. RULES OF CONSTRUCTION.
Nothing in this subtitle and the amendments made by this
subtitle applies with respect to--
[[Page H3856]]
(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 1111 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--Miscellaneous Provisions
SEC. 1121. GUIDANCE DOCUMENT REGARDING PRODUCT PROMOTION
USING THE INTERNET.
Not later than 2 years after the date of enactment of this
Act, the Secretary of Health and Human Services shall issue
guidance that describes Food and Drug Administration policy
regarding the promotion, using the Internet (including social
media), of medical products that are regulated by such
Administration.
SEC. 1122. 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''), in coordination with
other Federal agencies, as appropriate, shall review current
Federal initiatives and identify gaps and opportunities with
respect to--
(1) ensuring the safe use of prescription drugs with the
potential for abuse; and
(2) the treatment of prescription drug dependance.
(b) Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary shall post on the
Department of Health and Human Service's Internet Web site a
report on the findings of the review under subsection (a).
Such report shall include findings and 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 provider participation, producing
standardized data on adverse events, patient safety, and
patient outcomes; and
(3) how best to develop provider, pharmacist, and patient
education tools and a strategy to widely disseminate such
tools and assess the efficacy of such tools.
(c) Guidance on Abuse-Deterrent Products.--Not later than 6
months after the date of enactment of this Act, the Secretary
shall promulgate guidance on the development of abuse-
deterrent drug products.
SEC. 1123. OPTIMIZING GLOBAL CLINICAL TRIALS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 903 of this Act, is further amended by
adding at the end the following:
``SEC. 569A. OPTIMIZING GLOBAL CLINICAL TRIALS.
``(a) In General.--The Secretary shall--
``(1) work with other regulatory authorities of similar
standing, medical research companies, and international
organizations to foster and encourage uniform, scientifically
driven clinical trial standards with respect to medical
products around the world; and
``(2) enhance the commitment to provide consistent parallel
scientific advice to manufacturers seeking simultaneous
global development of new medical products in order to--
``(A) enhance medical product development;
``(B) facilitate the use of foreign data; and
``(C) minimize the need to conduct duplicative clinical
studies, preclinical studies, or nonclinical studies.
``(b) Medical Product.--In this section, the term `medical
product' means a drug, as defined in subsection (g) of
section 201, a device, as defined in subsection (h) of such
section, or a biological product, as defined in section
351(i) of the Public Health Service Act.
``(c) Savings Clause.--Nothing in this section shall alter
the criteria for evaluating the safety or effectiveness of a
medical product under this Act.
``SEC. 569B. USE OF CLINICAL INVESTIGATION DATA FROM OUTSIDE
THE UNITED STATES.
``(a) In General.--In determining whether to approve,
license, or clear a drug or device pursuant to an application
submitted under this chapter, the Secretary shall accept data
from clinical investigations conducted outside of the United
States, including the European Union, if the applicant
demonstrates that such data are adequate under applicable
standards to support approval, licensure, or clearance of the
drug or device in the United States.
``(b) Notice to Sponsor.--If the Secretary finds under
subsection (a) that the data from clinical investigations
conducted outside the United States, including in the
European Union, are inadequate for the purpose of making a
determination on approval, clearance, or licensure of a drug
or device pursuant to an application submitted under this
chapter, the Secretary shall provide written notice to the
sponsor of the application of such finding and include the
rationale for such finding.''.
SEC. 1124. ADVANCING REGULATORY SCIENCE TO PROMOTE PUBLIC
HEALTH INNOVATION.
(a) In General.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services (referred to in this section as the ``Secretary'')
shall develop a strategy and implementation plan for
advancing regulatory science for medical products in order to
promote the public health and advance innovation in
regulatory decisionmaking.
(b) Requirements.--The strategy and implementation plan
developed under subsection (a) shall be consistent with the
user fee performance goals in the Prescription Drug User Fee
Agreement commitment letter, the Generic Drug User Fee
Agreement commitment letter, and the Biosimilar User Fee
Agreement commitment letter transmitted by the Secretary to
Congress on January 13, 2012, and the Medical Device User Fee
Agreement commitment letter transmitted by the Secretary to
Congress on April 20, 2012, and shall--
(1) identify a clear vision of the fundamental role of
efficient, consistent, and predictable, science-based
decisions throughout regulatory decisionmaking of the Food
and Drug Administration with respect to medical products;
(2) identify the regulatory science priorities of the Food
and Drug Administration directly related to fulfilling the
mission of the agency with respect to decisionmaking
concerning medical products and allocation of resources
toward such regulatory science priorities;
(3) identify regulatory and scientific gaps that impede the
timely development and review of, and regulatory certainty
with respect to, the approval, licensure, or clearance of
medical products, including with respect to companion
products and new technologies, and facilitating the timely
introduction and adoption of new technologies and
methodologies in a safe and effective manner;
(4) identify clear, measurable metrics by which progress on
the priorities identified under paragraph (2) and gaps
identified under paragraph (3) will be measured by the Food
and Drug Administration, including metrics specific to the
integration and adoption of advances in regulatory science
described in paragraph (5) and improving medical product
decisionmaking, in a predictable and science-based manner;
and
(5) set forth how the Food and Drug Administration will
ensure that advances in regulatory science for medical
products are adopted, as appropriate, on an ongoing basis and
in an manner integrated across centers, divisions, and
branches of the Food and Drug Administration, including by
senior managers and reviewers, including through the--
(A) development, updating, and consistent application of
guidance documents that support medical product
decisionmaking; and
(B) adoption of the tools, methods, and processes under
section 566 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb 5).
(c) Performance Reports.--The annual performance reports
submitted to Congress under sections 736B(a) (as amended by
section 104 of this Act), 738A(a) (as amended by section 204
of this Act), 744C(a) (as added by section 303 of this Act),
and 744I(a) (as added by section 403 of this Act) of the
Federal Food, Drug, and Cosmetic Act for each of fiscal years
2014 and 2016, shall include a report from the Secretary on
the progress made with respect to--
(1) advancing the regulatory science priorities identified
under paragraph (2) of subsection (b) and resolving the gaps
identified under paragraph (3) of such subsection, including
reporting on specific metrics identified under paragraph (4)
of such subsection;
(2) the integration and adoption of advances in regulatory
science as set forth in paragraph (5) of such subsection; and
(3) the progress made in advancing the regulatory science
goals outlined in the Prescription Drug User Fee Agreement
commitment letter, the Generic Drug User Fee Agreement
commitment letter, and the Biosimilar User Fee Agreement
commitment letter transmitted by the Secretary to Congress on
January 13, 2012, and the Medical Device User Fee Agreement
transmitted by the Secretary to Congress on April 20, 2012.
(d) Medical Product.--In this section, the term ``medical
product'' means a drug, as defined in subsection (g) of
section 201 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321), a device, as defined in subsection (h) of such
section, or a biological product, as defined in section
351(i) of the Public Health Service Act.
SEC. 1125. INFORMATION TECHNOLOGY.
(a) HHS Report.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall--
(1) report to Congress on--
(A) the milestones and a completion date for developing and
implementing a comprehensive information technology strategic
plan to align the information technology systems
modernization projects with the strategic goals of the Food
and Drug Administration, including results-oriented goals,
strategies, milestones, performance measures;
(B) efforts to finalize and approve a comprehensive
inventory of the information technology systems of the Food
and Drug Administration that includes information describing
each system, such as costs, system function or
[[Page H3857]]
purpose, and status information, and incorporate use of the
system portfolio into the information investment management
process of the Food and Drug Administration;
(C) the ways in which the Food and Drug Administration uses
the plan described in subparagraph (A) to guide and
coordinate the modernization projects and activities of the
Food and Drug Administration, including the interdependencies
among projects and activities; and
(D) the extent to which the Food and Drug Administration
has fulfilled or is implementing recommendations of the
Government Accountability Office with respect to the Food and
Drug Administration and information technology; and
(2) develop--
(A) a documented enterprise architecture program management
plan that includes the tasks, activities, and timeframes
associated with developing and using the architecture and
addresses how the enterprise architecture program management
will be performed in coordination with other management
disciplines, such as organizational strategic planning,
capital planning and investment control, and performance
management; and
(B) a skills inventory, needs assessment, gap analysis, and
initiatives to address skills gaps as part of a strategic
approach to information technology human capital planning.
(b) GAO Report.--Not later than January 1, 2016, the
Comptroller General of the United States shall issue a report
regarding the strategic plan described in subsection
(a)(1)(A) and related actions carried out by the Food and
Drug Administration. Such report shall assess the progress
the Food and Drug Administration has made on--
(1) the development and implementation of a comprehensive
information technology strategic plan, including the results-
oriented goals, strategies, milestones, and performance
measures identified in subsection (a)(1)(A);
(2) the effectiveness of the comprehensive information
technology strategic plan described in subsection (a)(1)(A),
including the results-oriented goals and performance
measures; and
(3) the extent to which the Food and Drug Administration
has fulfilled recommendations of the Government
Accountability Office with respect to such agency and
information technology.
SEC. 1126. NANOTECHNOLOGY.
(a) In General.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary'') shall
intensify and expand activities related to enhancing
scientific knowledge regarding nanomaterials included or
intended for inclusion in products regulated under the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)
or other statutes administered by the Food and Drug
Administration, to address issues relevant to the regulation
of those products, including the potential toxicology of such
nanomaterials, the potential benefit of new therapies derived
from nanotechnology, the effects of such nanomaterials on
biological systems, and the interaction of such nanomaterials
with biological systems.
(b) Activities.--In conducting activities related to
nanotechnology, the Secretary may--
(1) assess scientific literature and data on general
nanomaterials interactions with biological systems and on
specific nanomaterials of concern to the Food and Drug
Administration;
(2) in cooperation with other Federal agencies, develop and
organize information using databases and models that will
facilitate the identification of generalized principles and
characteristics regarding the behavior of classes of
nanomaterials with biological systems;
(3) promote Food and Drug Administration programs and
participate in collaborative efforts, to further the
understanding of the science of novel properties of
nanomaterials that might contribute to toxicity;
(4) promote and participate in collaborative efforts to
further the understanding of measurement and detection
methods for nanomaterials;
(5) collect, synthesize, interpret, and disseminate
scientific information and data related to the interactions
of nanomaterials with biological systems;
(6) build scientific expertise on nanomaterials within the
Food and Drug Administration, including field and laboratory
expertise, for monitoring the production and presence of
nanomaterials in domestic and imported products regulated
under this Act;
(7) ensure ongoing training, as well as dissemination of
new information within the centers of the Food and Drug
Administration, and more broadly across the Food and Drug
Administration, to ensure timely, informed consideration of
the most current science pertaining to nanomaterials;
(8) encourage the Food and Drug Administration to
participate in international and national consensus standards
activities pertaining to nanomaterials; and
(9) carry out other activities that the Secretary
determines are necessary and consistent with the purposes
described in paragraphs (1) through (8).
SEC. 1127. ONLINE PHARMACY REPORT TO CONGRESS.
Not later than 1 year after the date of enactment of this
Act, the Comptroller General of the United States shall
submit to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives a report that
describes any problems posed by pharmacy Internet Web sites
that violate Federal or State law, including--
(1) the methods by which Internet Web sites are used to
sell prescription drugs in violation of Federal or State law
or established industry standards;
(2) the harmful health effects that patients experience
when they consume prescription drugs purchased through such
pharmacy Internet Web sites;
(3) efforts by the Federal Government and State and local
governments to investigate and prosecute the owners or
operators of pharmacy Internet Web sites, to address the
threats such Web sites pose, and to protect patients;
(4) the level of success that Federal, State, and local
governments have experienced in investigating and prosecuting
such cases;
(5) whether the law, as in effect on the date of the
report, provides sufficient authorities to Federal, State,
and local governments to investigate and prosecute the owners
and operators of pharmacy Internet Web sites that violate
Federal or State law or established industry standards;
(6) additional authorities that could assist Federal,
State, and local governments in investigating and prosecuting
the owners and operators of pharmacy Internet Web sites that
violate Federal or State law or established industry
standards;
(7) laws, policies, and activities that would educate
consumers about how to distinguish pharmacy Internet Web
sites that comply with Federal and State laws and established
industry standards from those pharmacy Internet Web sites
that do not comply with such laws and standards; and
(8) activities that private sector actors are taking to
address the prevalence of illegitimate pharmacy Internet Web
sites, and any policies to encourage further activities.
SEC. 1128. REPORT ON SMALL BUSINESSES.
Not later than 1 year after the date of enactment of this
Act, the Commissioner of Food and Drugs shall submit a report
to Congress that includes--
(1) a listing of and staffing levels of all small business
offices at the Food and Drug Administration, including the
small business liaison program;
(2) the status of partnership efforts between the Food and
Drug Administration and the Small Business Administration;
(3) a summary of outreach efforts to small businesses and
small business associations, including availability of toll-
free telephone help lines;
(4) with respect to the program under the Orphan Drug Act
(Public Law 97 414), the number of applications made by small
businesses and number of applications approved for research
grants and the number of companies receiving protocol
assistance for the development of drugs for rare diseases and
disorders;
(5) the number of small businesses submitting applications
and receiving approval for unsolicited grant applications
from the Food and Drug Administration;
(6) the number of small businesses submitting applications
and receiving approval for solicited grant applications from
the Food and Drug Administration; and
(7) barriers small businesses encounter in the drug and
medical device approval process.
SEC. 1129. PROTECTIONS FOR THE COMMISSIONED CORPS OF THE
PUBLIC HEALTH SERVICE ACT.
(a) In General.--Section 221(a) of the Public Health
Service Act (42 U.S.C. 213a(a)) is amended by adding at the
end the following:
``(18) Section 1034, Protected Communications; Prohibition
of Retaliatory Personnel Actions.''.
(b) Conforming Amendment.--Section 221(b) of the Public
Health Service Act (42 U.S.C. 213a(b)) is amended by adding
at the end the following: ``For purposes of paragraph (18) of
subsection (a), the term `Inspector General' in section 1034
of such title 10 shall mean the Inspector General of the
Department of Health and Human Services.''.
SEC. 1130. COMPLIANCE DATE FOR RULE RELATING TO SUNSCREEN
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE.
In accordance with the final rule issued by the
Commissioner of Food and Drug entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-
Counter Human Use; Delay of Compliance Dates'' (77 Fed. Reg.
27591 (May 11, 2012)), a product subject to the final rule
issued by the Commissioner entitled ``Labeling and
Effectiveness Testing; Sunscreen Drug Products for Over-the-
Counter Human Use'' (76 Fed. Reg. 35620 (June 17, 2011)),
shall comply with such rule not later than--
(1) December 17, 2013, for products subject to such rule
with annual sales of less than $25,000 and
(2) December 17, 2012, for all other products subject to
such rule.
SEC. 1131. STRATEGIC INTEGRATED MANAGEMENT PLAN.
Not later than 1 year after the date of enactment of this
Act, the Secretary of Health and Human Services shall submit
to Congress a strategic integrated management plan for the
Center for Drug Evaluation and Research, the Center for
Biologics Evaluation and Research, and the Center for Devices
and Radiological Health. Such strategic management plan
shall--
(1) identify strategic institutional goals, priorities, and
mechanisms to improve efficiency, for the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, and the Center for Devices and Radiological
Health;
(2) describe the actions the Secretary will take to
recruit, retain, train, and continue to develop the workforce
at the Center for Drug Evaluation and Research, the Center
for Biologics Evaluation and Research, and the Center for
Devices and Radiological Health to fulfill the public health
mission of the Food and Drug Administration; and
(3) identify results-oriented, outcome-based measures that
the Secretary will use to measure the progress of achieving
the strategic goals, priorities, and mechanisms identified
under paragraph (1) and the effectiveness of the actions
[[Page H3858]]
identified under paragraph (2), including metrics to ensure
that managers and reviewers of the Center for Drug Evaluation
and Research, the Center for Biologics Evaluation and
Research, and the Center for Devices and Radiological Health
are familiar with and appropriately and consistently apply
the requirements under the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 301 et seq.), including new requirements under
parts 2, 3, 7, and 8 of subchapter C of title VII of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379f et
seq.).
SEC. 1132. 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) 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. 1133. 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, 2015, ``40 months'';
and
(B) 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. 1134. 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. 1135. FINAL AGENCY ACTION RELATING TO PETITIONS AND
CIVIL ACTIONS.
Section 505(q) (21 U.S.C. 355(q)) is amended--
(1) in paragraph (1)--
(A) in subparagraph (A), by striking ``subsection (b)(2) or
(j)'' and inserting ``subsection (b)(2) or (j) of this
section or section 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'';
(3) in paragraph (4)--
[[Page H3859]]
(A) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and moving such clauses, as so
redesignated, 2 ems to the right;
(B) by striking ``This subsection does not apply to--'' and
inserting the following:
``(A) This subsection does not apply to--''; and
(C) by adding at the end the following:
``(B) Paragraph (2) does not apply to a petition addressing
issues concerning an application submitted pursuant to
section 351(k) of the Public Health Service Act.''; and
(4) 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. 1136. 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, presubmissions 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 presubmissions or submissions, shall
include an electronic copy of such presubmissions 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. 1137. PATIENT PARTICIPATION IN MEDICAL PRODUCT
DISCUSSIONS.
Subchapter E of chapter V (21 U.S.C. 360bbb et seq.), as
amended by section 1123 of this Act, is further amended by
adding at the end the following:
``SEC. 569C. PATIENT PARTICIPATION IN MEDICAL PRODUCT
DISCUSSION.
``(a) In General.--The Secretary shall develop and
implement strategies to solicit the views of patients during
the medical product development process and consider the
perspectives of patients during regulatory discussions,
including by--
``(1) fostering participation of a patient representative
who may serve as a special government employee in appropriate
agency meetings with medical product sponsors and
investigators; and
``(2) exploring means to provide for identification of
patient representatives who do not have any, or have minimal,
financial interests in the medical products industry.
``(b) Protection of Proprietary Information.--Nothing in
this section shall be construed to alter the protections
offered by laws, regulations, or 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 laws, regulations, or policies would apply to
consultation with individuals and organizations prior to the
date of enactment of this section.
``(c) 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.
``(d) No Right or Obligation.--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. 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. Nothing in
this section is intended to increase the number of review
cycles as in effect before the date of enactment of this
section.
``(e) Financial Interest.--In this section, the term
`financial interest' means a financial interest under section
208(a) of title 18, United States Code.''.
SEC. 1138. ENSURING ADEQUATE INFORMATION REGARDING
PHARMACEUTICALS FOR ALL POPULATIONS,
PARTICULARLY UNDERREPRESENTED SUBPOPULATIONS,
INCLUDING RACIAL SUBGROUPS.
(a) Communication Plan.--The Secretary of Health and Human
Services (referred to in this section as the ``Secretary''),
acting through the Commissioner of Food and Drugs, shall
review and modify, as necessary, the Food and Drug
Administration's communication plan to inform and educate
health care providers and patients on the benefits and risks
of medical products, with particular focus on
underrepresented subpopulations, including racial subgroups.
(b) Content.--The communication plan described under
subsection (a)--
(1) shall take into account--
(A) the goals and principles set forth in the Strategic
Action Plan to Reduce Racial and Ethnic Health Disparities
issued by the Department of Health and Human Services;
(B) the nature of the medical product; and
(C) health and disease information available from other
agencies within such Department, as well as any new means of
communicating health and safety benefits and risks related to
medical products;
(2) taking into account the nature of the medical product,
shall address the best strategy for communicating safety
alerts, labeled indications for the medical products, changes
to the label or labeling of medical products (including
black-box warnings, health advisories, health and safety
benefits and risks), particular actions to be taken by health
care professionals and patients, any information identifying
particular subpopulations, and any other relevant information
as determined appropriate to enhance communication, including
varied means of electronic communication; and
(3) shall include a process for implementation of any
improvements or other modifications determined to be
necessary.
(c) Issuance and Posting of Communication Plan.--
(1) Communication plan.--Not later than 1 year after the
date of enactment of this Act, the Secretary, acting through
the Commissioner of Food and Drugs, shall issue the
communication plan described under this section.
(2) Posting of communication plan on the office of minority
health web site.--The Secretary, acting through the
Commissioner of Food and Drugs, shall publicly post the
communication plan on the Internet Web site of the Office of
Minority Health of the Food and Drug Administration, and
provide links to any other appropriate Internet Web site, and
seek public comment on the communication plan.
SEC. 1139. SCHEDULING OF HYDROCODONE.
(a) In General.--Not later than 60 days after the date of
enactment of this Act, if practicable, the Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') shall hold a public meeting to solicit advice
and recommendations to assist in conducting a scientific and
medical evaluation in connection with a scheduling
recommendation to the Drug Enforcement Administration
regarding drug products containing hydrocodone, combined with
other analgesics or as an antitussive.
(b) Stakeholder Input.--In conducting the evaluation under
subsection (a), the Secretary shall solicit input from a
variety of stakeholders including patients, health care
providers, harm prevention experts, the National Institute on
Drug Abuse, the Centers for Disease Control and Prevention,
and the Drug Enforcement Administration regarding the health
benefits and risks, including the potential for abuse and the
impact of up-scheduling of these products.
(c) Transcript.--The transcript of any public meeting
conducted pursuant to this section shall be published on the
Internet Web site of the Food and Drug Administration.
SEC. 1140. STUDY ON DRUG LABELING BY ELECTRONIC MEANS.
(a) Study.--The Comptroller General of the United States
shall conduct a study on the benefits and efficiencies of
electronic patient labeling of prescription drugs, as a
complete or partial substitute for patient labeling in paper
form. The study shall address the implementation costs to the
different levels of the distribution system, logistical
barriers to utilizing a system of electronic patient
labeling, and any anticipated public health impact of
movement to electronic labeling.
(b) Report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General shall submit
to Congress a report on the results of the study under
subsection (a).
SEC. 1141. RECOMMENDATIONS ON INTEROPERABILITY STANDARDS.
(a) In General.--The Secretary of Health and Human Services
may facilitate, and, as appropriate, may consult with the
Attorney General to facilitate, the development of
recommendations on interoperability standards to inform and
facilitate the exchange of prescription drug information
across State lines by States receiving grant funds under--
(1) the Harold Rogers Prescription Drug Monitoring Program
established under the Departments of Commerce, Justice, and
State, the Judiciary, and Related Agencies Appropriations
Act, 2002 (Public Law 107 77; 115 Stat. 748); and
(2) the Controlled Substance Monitoring Program established
under section 399O of the Public Health Service Act (42
U.S.C. 280g 3).
(b) Requirements.--The Secretary of Health and Human
Services shall consider the following in facilitating the
development of recommendations on interoperability of
prescription drug monitoring programs under subsection (a)--
(1) open standards that are freely available, without cost
and without restriction, in order to promote broad
implementation;
(2) the use of exchange intermediaries, or hubs, as
necessary to facilitate interstate interoperability by
accommodating State-to-hub, hub-to-hub, and direct State-to-
State communication;
(3) the support of transmissions that are fully secured as
required, using industry standard methods of encryption, to
ensure that protected health information and personally
identifiable information are not compromised at any point
during such transmission;
(4) access control methodologies to share protected
information solely in accordance with State laws and
regulations; and
(5) consider model interoperability standards developed by
the Alliance of States with Prescription Monitoring Programs.
(c) Report.--
[[Page H3860]]
(1) In general.--Not later than 1 year 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
enhancing the interoperability of State prescription drug
monitoring programs with other technologies and databases
used for detecting and reducing fraud, diversion, and abuse
of prescription drugs.
(2) Contents.--The report required under paragraph (1)
shall include--
(A) an assessment of legal, technical, fiscal, privacy, or
security challenges that have an impact on interoperability;
(B) a discussion of how State prescription drug monitoring
programs could increase the production and distribution of
unsolicited reports to prescribers and dispensers of
prescription drugs, law enforcement officials, and health
professional licensing agencies, including the enhancement of
such reporting through interoperability with other States and
relevant technology and databases;
(C) any recommendations for addressing challenges that
impact interoperability of State prescription drug monitoring
programs in order to reduce fraud, diversion, and abuse of
prescription drugs; and
(D) an assessment of the extent to which providers use
prescription drug management programs in delivering care and
preventing prescription drug abuse.
SEC. 1142. 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 Web site 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 Web site
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.'';
(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.''; and
(5) by adding at the end the following:
``(g) Guidance on Reported Disclosed Financial Interest or
Involvement.--The Secretary shall issue guidance that
describes how the Secretary reviews the financial interests
and involvement of advisory committee members that are
disclosed under subsection (c) but that the Secretary
determines not to meet the definition of a disqualifying
interest under section 208 of title 18, United States Code
for the purposes of participating in a particular matter.''.
(b) Applicability.--The amendments made by subsection (a)
apply beginning on October 1, 2012.
SEC. 1143. NOTIFICATION OF FDA INTENT TO REGULATE LABORATORY-
DEVELOPED TESTS.
(a) In General.--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.
(b) Sunset.--Subsection (a) shall cease to have force or
effect on the date that is 5 years after the date of
enactment of this Act.
Subtitle D--Synthetic Drugs
SEC. 1151. SHORT TITLE.
This subtitle may be cited as the ``Synthetic Drug Abuse
Prevention Act of 2012''.
SEC. 1152. ADDITION OF SYNTHETIC DRUGS TO SCHEDULE I OF THE
CONTROLLED SUBSTANCES ACT.
(a) Cannabimimetic Agents.--Schedule I, as set forth in
section 202(c) of the Controlled Substances Act (21 U.S.C.
812(c)) is amended by adding at the end the following:
``(d)(1) Unless specifically exempted or unless listed in
another schedule, any material, compound, mixture, or
preparation which contains any quantity of cannabimimetic
agents, or which contains their salts, isomers, and salts of
isomers whenever the existence of such salts, isomers, and
salts of isomers is possible within the specific chemical
designation.
``(2) In paragraph (1):
``(A) The term `cannabimimetic agents' means any substance
that is a cannabinoid receptor type 1 (CB1 receptor) agonist
as demonstrated by binding studies and functional assays
within any of the following structural classes:
``(i) 2-(3-hydroxycyclohexyl)phenol with substitution at
the 5-position of the phenolic ring by alkyl or alkenyl,
whether or not substituted on the cyclohexyl ring to any
extent.
``(ii) 3-(1-naphthoyl)indole or 3-(1-naphthylmethane)indole
by substitution at the nitrogen atom of the indole ring,
whether or not further substituted on the indole ring to any
extent, whether or not substituted on the naphthoyl or
naphthyl ring to any extent.
[[Page H3861]]
``(iii) 3-(1-naphthoyl)pyrrole by substitution at the
nitrogen atom of the pyrrole ring, whether or not further
substituted in the pyrrole ring to any extent, whether or not
substituted on the naphthoyl ring to any extent.
``(iv) 1-(1-naphthylmethylene)indene by substitution of the
3-position of the indene ring, whether or not further
substituted in the indene ring to any extent, whether or not
substituted on the naphthyl ring to any extent.
``(v) 3-phenylacetylindole or 3-benzoylindole by
substitution at the nitrogen atom of the indole ring, whether
or not further substituted in the indole ring to any extent,
whether or not substituted on the phenyl ring to any extent.
``(B) Such term includes--
``(i) 5-(1,1-dimethylheptyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (CP 47,497);
``(ii) 5-(1,1-dimethyloctyl)-2-[(1R,3S)-3-
hydroxycyclohexyl]-phenol (cannabicyclohexanol or CP 47,497
C8-homolog);
``(iii) 1-pentyl-3-(1-naphthoyl)indole (JWH 018 and AM678);
``(iv) 1-butyl-3-(1-naphthoyl)indole (JWH 073);
``(v) 1-hexyl-3-(1-naphthoyl)indole (JWH 019);
``(vi) 1-[2-(4-morpholinyl)ethyl]-3-(1-naphthoyl)indole
(JWH 200);
``(vii) 1-pentyl-3-(2-methoxyphenylacetyl)indole (JWH 250);
``(viii) 1-pentyl-3-[1-(4-methoxynaphthoyl)]indole (JWH
081);
``(ix) 1-pentyl-3-(4-methyl-1-naphthoyl)indole (JWH 122);
``(x) 1-pentyl-3-(4-chloro-1-naphthoyl)indole (JWH 398);
``(xi) 1-(5-fluoropentyl)-3-(1-naphthoyl)indole (AM2201);
``(xii) 1-(5-fluoropentyl)-3-(2-iodobenzoyl)indole (AM694);
``(xiii) 1-pentyl-3-[(4-methoxy)-benzoyl]indole (SR 19 and
RCS 4);
``(xiv) 1-cyclohexylethyl-3-(2-methoxyphenylacetyl)indole
(SR 18 and RCS 8); and
``(xv) 1-pentyl-3-(2-chlorophenylacetyl)indole (JWH
203).''.
(b) Other Drugs.--Schedule I of section 202(c) of the
Controlled Substances Act (21 U.S.C. 812(c)) is amended in
subsection (c) by adding at the end the following:
``(18) 4-methylmethcathinone (Mephedrone).
``(19) 3,4-methylenedioxypyrovalerone (MDPV).
``(20) 2-(2,5-Dimethoxy-4-ethylphenyl)ethanamine (2C E).
``(21) 2-(2,5-Dimethoxy-4-methylphenyl)ethanamine (2C D).
``(22) 2-(4-Chloro-2,5-dimethoxyphenyl)ethanamine (2C C).
``(23) 2-(4-Iodo-2,5-dimethoxyphenyl)ethanamine (2C I).
``(24) 2-[4-(Ethylthio)-2,5-dimethoxyphenyl]ethanamine (2C
T 2).
``(25) 2-[4-(Isopropylthio)-2,5-dimethoxyphenyl]ethanamine
(2C T 4).
``(26) 2-(2,5-Dimethoxyphenyl)ethanamine (2C H).
``(27) 2-(2,5-Dimethoxy-4-nitro-phenyl)ethanamine (2C N).
``(28) 2-(2,5-Dimethoxy-4-(n)-propylphenyl)ethanamine (2C
P).''.
SEC. 1153. TEMPORARY SCHEDULING TO AVOID IMMINENT HAZARDS TO
PUBLIC SAFETY EXPANSION.
Section 201(h)(2) of the Controlled Substances Act (21
U.S.C. 811(h)(2)) is amended--
(1) by striking ``one year'' and inserting ``2 years''; and
(2) by striking ``six months'' and inserting ``1 year''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Michigan (Mr. Upton) and the gentleman from California (Mr. Waxman)
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 material in the Record.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from California?
There was no objection.
Mr. UPTON. Mr. Speaker, I yield myself 2 minutes.
Mr. Speaker, I want to thank Mr. Waxman, Chairman Harkin, Senator
Enzi, and Members on both sides of the aisle in both the House and the
Senate who played a role in this process. S. 3187 is a reflection of
the hard work put in by both Members and staff, and of everyone's
willingness to put partisanship aside to look at the issues together.
Because of that outstanding dedication, we have a bill today that will
make a real difference in the lives of so many patients and provide
much-needed support for innovators across our great country.
At the outset of this Congress, I set a goal of enacting this bill by
the end of June--and here we are, well before the clock expires for
this month--in order to provide certainty for American patients and
innovators. I never lost confidence that we could deliver the
bipartisan reforms we needed, and I am so proud that we will accomplish
that goal.
Mr. Speaker, this is a jobs bill, and it's a medical innovation bill.
And as we put this package together, our goal was to improve the
predictability, consistency, transparency, and efficiency of FDA
regulation. These reforms will help get new treatments to patients more
quickly. They will help us not only keep jobs in Michigan and all
across the country, but also to create new ones. In order to get it
right, we turned to patients, innovators, and job creators who provided
firsthand experience of how the current system is broken. And we
included many of their suggestions in the bill.
This bill includes significant accountability and reform measures
designed to hold the FDA responsible for its performance. The measure
includes independent assessments of FDA's drug and device review
process. It also includes requiring quarterly reporting from the device
center so we don't have to wait a year to find out FDA's progress. The
bill is about patients, and that's why so many patient advocates have
spoken out in support of these reforms. Whether it is steps that we
took to support treatments for rare diseases or mitigate drug shortages
or speed up the approval of devices that will improve a patient's
quality of life, these are steps that will make a real and significant
difference.
{time} 1430
They're going to keep the U.S. at the forefront of medical innovation
where we belong.
This bill is just the first step. This bill provides the resources
and the game plans so that FDA can improve its performance.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. UPTON. I yield myself an additional minute.
It is now up to the FDA to execute that game plan. And I give my
commitment today that our committee will continue to monitor and hold
the FDA accountable for its performance. So, together, the Members of
the House and the Senate have produced a bill that is a win for
American patients, innovation, and job creation.
Before I conclude, I would like to recognize Warren Burke and Megan
Renfrew from the Legislative Counsel's Office for their tireless work.
The role of Legislative Counsel often goes unnoticed. I also want to
appreciate our staff, starting with our staff director, Gary Andres,
for pushing this legislation over the finish line; Clay Alspach, on the
majority staff; Rachel Sher, on the minority staff; and in particular,
Ryan Long, the chief counsel for the Health Subcommittee.
This bill, when it becomes law, patients will benefit from faster,
newer, and better treatments, and American workers will keep us on the
cutting edge of medical innovation.
I reserve the balance of my time.
Mr. WAXMAN. Mr. Speaker, I yield myself 3 minutes.
Today, the House considers a bill that represents a significant
bipartisan and bicameral achievement.
On May 30 of this year, the House passed its user fee legislation by
a dramatic vote of 387 5. That bill was a strong one, but through our
collaborative process with the Senate, we have made it even better.
It has been a pleasure to work not only with Mr. Upton, Mr. Pitts,
Mr. Pallone, and Mr. Dingell, among many involved House colleagues, but
also with our Senate colleagues, Senators Harkin and Enzi.
When we began this process, there were divergent views on the various
issues contained in this bill. But we worked together and found ways to
bridge our differences in a fashion that protects patients and fosters
innovation.
This legislation contains many provisions that are critical to the
functioning of major parts of the FDA. We reauthorize the FDA's drug
and medical device user fee programs which will provide resources to
enable the efficient review of applications and give patients rapid
access to new therapies. We're also reauthorizing two pediatric
programs which foster the development and safe use of prescription
drugs in children.
This year, we're establishing two new programs to help the FDA speed
up their review of new generics and biosimilars. These provisions
illustrate our bipartisan commitment to ensuring a vibrant generic
marketplace. All
[[Page H3862]]
of us will see the benefits when more low-cost generics are on the
market.
One of the most important improvements to the House-passed bill is in
the area of antibiotics. We accepted the Senate language that directs
incentives for the development of antibiotics toward serious and life-
threatening infections.
This bill also includes provisions to modernize FDA's authorities
with respect to the drug supply chain. Today, 80 percent of active
ingredients and bulk chemicals used in U.S. drugs come from abroad and
40 percent of finished drugs are manufactured abroad. FDA has been
trying to keep pace with this increasingly globalized drug supply
change using an outdated statute. This legislation will give the FDA
critical new tools to police this dramatically different marketplace.
We have also worked to address the area of drug shortages, which is a
complex and multifaceted problem, but this legislation takes some
sensible first steps.
I want to thank my colleagues on both sides of the aisle and their
staffs for the hard work they've put into making this a strong
bipartisan bill. I particularly want to thank Mr. Pallone and Mr.
Dingell's staff members, Tiffany Guarascio and Kim Trzeciak, as well as
Mr. Upton and Mr. Pitt's staff, Ryan Long and Clay Alspach.
The SPEAKER pro tempore. The time of the gentleman has expired.
Mr. WAXMAN. I yield myself an additional 30 seconds.
Warren Burke and Megan Renfrew have done tremendous work on this
bill. I'd like to express my appreciation for their efforts. I want to
thank my own staff: Karen Nelson, Rachel Sher, Eric Flamm, and Arun
Patel.
The American public will benefit from the provisions of this bill.
The FDA will have the resources to remain the gold standard for the
future. This is an important bill, a good one. I urge its support.
I reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the chairman emeritus of
the Energy and Commerce Committee, the gentleman from Texas (Mr.
Barton).
(Mr. BARTON of Texas asked and was given permission to revise and
extend his remarks.)
Mr. BARTON of Texas. I thank the distinguished chairman.
Mr. Speaker, I rise in strong support of this bill. When the American
public asks, ``Why can't Congress just work together?'' we should hold
this bill up as Exhibit A that it is possible.
As the ranking member just pointed out, this is a bipartisan,
bicameral preconference agreement for a very complicated bill. We
reauthorize the Food and Drug Administration user fee program for 5
years. We also reauthorize the medical device user fee program for 5
years, and, I believe for the first time, do one for generic and
biosimilars. This is a complicated, complex piece of legislation, but
it has been worked out in a bipartisan agreement.
I have had some concerns about the extent and the cost of the user
fees. I will continue to monitor that, Mr. Speaker. But this is a good
piece of legislation. The chairman and ranking member and the
subcommittee chairman and ranking member and all the others who have
worked on this should be commended. This is an excellent bill, and I
hope that the Congress will unanimously support it and the Senate will
agree when we send it to the other body.
Mr. WAXMAN. Mr. Speaker, at this time, I'd like to yield 3 minutes to
the gentleman from New Jersey (Mr. Pallone), the ranking member of the
Health Subcommittee, the subcommittee that was responsible for this
legislation in its first instance.
I ask unanimous consent that Mr. Pallone be permitted to manage the
rest of the time on our side of the aisle.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from California?
There was no objection.
Mr. PALLONE. Thank you, Chairman Waxman.
I want to say I'm very proud to support the bill before us, which
would reauthorize and revitalize a number of different programs at the
FDA.
This bill really represents a great compromise between the House and
the Senate and strikes the right balance by including strong provisions
that will be good for both innovation and patient safety.
When we passed the House version of this bill, I spoke highly of a
great cordial process, and I'm happy to be able to echo those
sentiments again here today. This process should be a model for
congressional bipartisan cooperation in the future. Not only did we all
work so well together, staffs were able to rectify the differences
among the two Chambers' versions of the bill in a matter of 2 weeks.
That's commendable. It's a clear indication that Congress is certainly
capable of greatness if we just allow ourselves to set politics aside
and simply legislate.
I want to thank Chairman Upton and Ranking Member Waxman for your
leadership. And to all the staff who worked around the clock--and of
course particularly Tiffany Guarascio, who is my staff person--they
were all dedicated to achieving a comprehensive and consensus product,
and they've done just that.
The bill before us today provides the FDA with more than $6 billion
over 5 years to pay for the timely and efficient reviews of medical
products. Together, these agreements will ensure that Americans have
access to safe and effective new medicines and medical devices. It will
reduce the drug costs for consumers by speeding the approval of lower
cost generic drugs with the establishment of a new user fee program for
generic drugs and for lower cost versions of biotech drugs as well.
It also includes promising provisions that address the safety of the
supply chain, help to foster the development and safe use of
prescription drugs for children, increase efforts to address drug
shortages, change conflict of interest rules so that the FDA has access
to the best expertise on their advisory panels, and other provisions
which are important to the pubic health of our Nation.
This bill is good for the FDA; it's good for industry; it's good for
patients alike. I'm confident we will pass this critical bill
overwhelmingly today and that the Senate will act early next week so we
can send it to the President for his signature as soon as possible.
I urge all Members to support this bill, and I reserve the balance of
my time.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the distinguished
chairman of the Health Subcommittee, the gentleman from Pennsylvania
(Mr. Pitts).
Mr. PITTS. Mr. Speaker, I stand to strongly support this legislation.
This bipartisan agreement represents over 18 months of work from the
Energy and Commerce Health Subcommittee, and I'm especially proud and
appreciative of the hard work of Ryan Long and Clay Alspach for their
diligent and tireless efforts in helping to make this bill possible.
The FDA Safety and Innovation Act is critical to saving lives,
improving regulatory operations, and sustaining a vital and dynamic
American industry.
{time} 1440
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, and this
is a critical responsibility.
The device and drug industries are dynamic and innovative. Companies
spend hundreds of millions of dollars and years of research and work to
develop products. The review stage is a critical time for any company.
Inconsistent reviews mean that the true cost of developing new products
is hidden, making it difficult to properly prepare.
When our Health Subcommittee began considering this legislation last
year, we heard from a number of individuals 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 slower U.S. review process,
the safety outcomes were comparable.
The FDA Safety and Innovation Act contains important reforms to the
Medical Device User Fee Act and will hold the FDA accountable and keep
reviews on schedule. There are many reforms in this bill.
Finally, we include language to help patients and doctors and
hospitals deal with drug shortages. Mr. Speaker, I'm
[[Page H3863]]
proud of the work we've done. I'm proud that we have such a bipartisan
effort.
I'd like to especially thank Ranking Member Frank Pallone and his
staff for patiently working with us, for Mr. Dingell, Mr. Waxman. We've
accomplished much with this legislation, and it will help save lives,
create jobs--two goals that we can all agree on. Thanks to our
chairman, Mr. Upton.
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to our chairman emeritus,
the gentleman from Michigan (Mr. Dingell), who worked so hard on this
bill, particularly with regard to the safety provisions.
(Mr. DINGELL asked and was given permission to revise and extend his
remarks.)
Mr. DINGELL. Mr. Speaker, this is a good bill. I urge my colleagues
to support it. I rise in strong support of it, and I urge my colleagues
to join.
This legislation enjoys broad bipartisan support on both sides of the
Capitol and from industry and patient groups. We should also be proud
of the work we have done to get it here today.
I would observe that it has been done because the Members worked
together in the finest traditions of this body. And I'm also proud of
the work that my colleagues on the committee and the staff have done on
this matter. I was pleased to work with them to include strong upstream
drug supply chain provisions, something that's been a long priority of
mine.
I'm also pleased that, for the first time, commercial importers will
be required to register, so we'll know who's bringing what in and
whether it's safe or not. There will also be parity between inspections
of domestic and foreign drug facilities, something which is a major
problem because foreign facilities and foreign manufacturers now import
much into this country, much of which is unsafe and improperly
inspected.
FDA will be able to maintain a practice in which they will detain and
destruct counterfeit drugs and those which are unsafe or intentionally
or otherwise adulterated, and they will be able to impose increased
penalties on those who adulterate these drugs and pharmaceuticals.
These provisions, which mirror safety provisions in my drug safety
bill, will equip FDA with the authorities it needs to better oversee
our increasingly globalized drug supply chain and will give American
families comfort that the pharmaceuticals that they are taking are
safe, and help to deter and to respond to any future heparin-like
incidents which killed some 80 Americans and hurt thousands more.
While I am disappointed we were unable to come forward with a
consensus on a national track-and-trace standard, it's my hope that we
will continue to work on this in coming days. And I want to commend my
colleagues, Mr. Matheson and Mr. Bilbray, for the fine work they have
done on this matter.
I've also been working on this issue for many years, and we've come
closer than ever before to finding a consensus. Given additional time,
I think we could have resolved this issue; but because of time
pressures, we were not able to.
I also want to thank my friends, Mr. Upton, Mr. Harkin, Ranking
Members Waxman and Enzi, and their staff for the hard work they did to
send this critical bill to the President before July 4. I also want to
thank Kimberly Trzeciak of my staff for her diligence on the supply
chain provisions and other matters.
I urge my colleagues to support this bill. It will be something of
which we will be proud. It will confer much safety on the American
people in areas of very substantial danger; and it will see to it that,
to a modest degree at least, the industry-supported provisions,
including those which involved the collection of fees, will begin to
work for the benefit of the American people.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the gentleman from Texas
(Mr. Burgess), the distinguished vice chair of the Health Subcommittee.
Mr. BURGESS. I thank the chairman for yielding and the Speaker for
the recognition.
Today, we are considering the Food and Drug Administration's Safety
Innovation Act, and I urge my colleagues to support it. This bill
reauthorizes Food and Drug Administration's user fee programs. The bill
will allow industry to continue to partner in providing our physicians
the tools they need to prevent and alleviate human suffering.
The legislation retains significant reforms that were made in our
House bill and enhances other provisions, such as those on drug
shortages. The bill will ensure that the Food and Drug Administration
has the scientific and medical expertise they need when reviewing
products utilizing emerging science, or for those populations with very
rare diseases.
This bill will spur innovation for antibiotics, will help those with
rare diseases, and be particularly helpful to the community of
physicians that takes care of our pediatric cancer patients.
The Food and Drug Administration is now required to notify Congress
before issuing guidance regarding the regulation of laboratory-
developed tests. I still believe we should strengthen and improve
CLIA's oversight of laboratory-developed tests, instead of even
contemplating any type of duplicative regulation.
The bill avoids provisions added by the other Chamber that I thought
crossed the line into the practice of medicine by Congress and actually
threatened patient treatment. It will address numerous other issues to
enhance the work of the FDA, while correcting missteps of the Agency in
such areas as public input, good guidance practices, and the
manufacture of custom devices.
The process to this vote from the very beginning was respectful and
resulted from hundreds of hours of negotiations. Chairman Upton, thank
you, and Chairman Pitts, Ranking Members Waxman and Pallone. I
specifically want to thank Ryan Long and Clay Alspach on the staff of
the majority who sacrificed much to get this product to the floor
today.
This vote is really about patients who will be served by the passage
of this bill, and I urge its expeditious passage.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentlewoman from
Colorado (Ms. DeGette), who worked very hard on the drug shortage
provisions of the legislation.
Ms. DeGETTE. Mr. Speaker, I'm delighted to support this bipartisan
legislation which addresses critical problems affecting the safety of
drugs and medical devices in this country. There are several highlights
I'd like to talk about, like Dr. Gingrey's incentives for antibiotic
development, or the supply chain legislation that Mr. Dingell has
worked on tirelessly for years.
But there's one issue that I've been working on on a bipartisan basis
throughout this Congress that I want to discuss briefly. Drug shortages
have rattled our hospitals, our doctors, and our families. Figures
recently released by the University of Utah show there were 56 more
newly reported drug shortages in the U.S. last year than in 2010 when
there were 211.
So, again, let me say 211 drugs in shortage. How can this be
happening, and what can we do about it?
Representative Tom Rooney from Florida and I introduced the
bipartisan Preserving Access to Life-Saving Medications Act, which
eventually had 85 cosponsors. The bill creates an early warning system
between the FDA, drug companies, and providers so a community can
respond to a drug shortage quickly and efficiently. It won't solve the
root problems of the drug shortage crisis, but it will help providers
and doctors and hospitals identify those crises and help with the
patient.
This February, for example, under a voluntary program, the FDA
stepped in to allow for temporary emergency importation of the cancer
drug, Doxil, which was in shortage. And at the same time, the FDA
prioritized the review of a new manufacturer of the same drug when the
cancer drug went into shortage.
So what our bill will do is make this program mandatory. What we
think it will do is it will help patients across the spectrum get the
drugs they need. It will help the hospitals and the providers identify
potential shortages, and it will help the manufacturers better make
sure that they get the drugs to the patients that need them.
I'm thrilled that this is contained, and I want to thank the
chairman.
{time} 1450
Mr. UPTON. Mr. Speaker, I yield 1 minute to the distinguished
gentleman from Florida (Mr. Stearns).
[[Page H3864]]
Mr. STEARNS. My colleagues, this reauthorization of the FDA's user
fees will provide stability for the FDA's new product review as
companies submit new and innovative drugs, medical devices, and
biologics for approval.
I am especially proud that my bill, the Faster Access to Specialized
Treatments, H.R. 4132, FAST, was included in the FDA Reform Act. FAST
modernizes the FDA's accelerated approval pathway to reflect scientific
developments that have occurred over the past 20 years. This will allow
for new drugs for people 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. FAST will save lives.
I am pleased also that the bill includes the EXPERRT Act, H.R. 4156.
This will help the FDA consult with medical experts when evaluating
drugs designed for rare diseases, such as cystic fibrosis. As the
cofounder of the Cystic Fibrosis Caucus, I am glad we are finally
providing this tool to the FDA.
I obviously support the passage of this bill.
Mr. Speaker, the Food and Drug Administration Safety and Innovation
Act (S. 3187) 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.
This bill is the result of hard work and negotiations between
industry and FDA, and the hard work between Republicans and Democrats,
and between the House and the Senate. This bill is a true bipartisan,
bicameral bill that will serve the American people well.
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 VI 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
VI, the FDA's approach to rare diseases must also be modernized.
I want to take this opportunity to thank Dr. Emil Kakkis, Julia
Jenkins, Harry Sporidis, Tim Perrin, Steve Stranne, everyone at the
EveryLife Foundation for Rare Diseases, Pat Furlong, Nick Manetto,
everyone at the Parent Project Muscular Dystrophy, and the other 150
rare disease groups that supported FAST and ULTRA. In 2011, I met with
Dr. Kakkis who introduced me to two parents who had children with rare
diseases and limited options as most rare diseases do not have
treatments. One parent talked about his frustration at not having any
treatments, except for a drug trial happening in Europe, not the United
States. We talked about how we need FDA to properly address the issue
of drug approval for the rare disease community, which led to examining
the Accelerated Approval pathway and trying to modernize it. We
developed the Unlocking Lifesaving Treatments for Rare-Diseases Act
(ULTRA, H.R. 3737), which I introduced with my friend and colleague,
Rep. Ed Towns, to nudge the FDA into using Accelerated Approval for
rare diseases.
However, after further review of the law, FDA's history of usage of
Accelerated Approval and the feedback we received from stakeholders, we
realized that amending the law was not sufficient. Instead, we worked
with all the stakeholders to rewrite the entirety of the Accelerated
Approval statute. In March, Representative Towns and I introduced the
Faster Access to Specialized Treatments Act (FAST, H.R. 4132). 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 final 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 also want to thank
Stephanie Krenrich and the Cystic Fibrosis Foundation for all their
hard work in developing EXPERRT.
I would like to submit these letters from the EveryLife Foundation
for Rare Diseases and the Parent Project Muscular Dystrophy into the
Record.
S. 3187 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 Safety and Innovation Act.
Parent Project
Muscular Dystrophy,
Hackensack, NJ, June 20, 2012.
Hon. Cliff Stearns,
U.S. Congress, Washington, DC.
Rayburn House Office Building,
Dear Representative Stearns: On behalf of all patients and
families living with Duchenne muscular dystrophy--the most
common form of muscular dystrophy and the most common lethal
genetic condition diagnosed in childhood--Parent Project
Muscular Dystrophy (PPMD) would like to express its deep
gratitude for your efforts to include provisions of deep
interest to the rare disease community in S. 3187, the Food
and Drug Administration Safety and Innovation Act. The final
user fee reconciliation package between the House of
Representatives and Senate includes a number of measures that
will accelerate the Food and Drug Administration (FDA)
process of reviewing potential therapies for serious life-
threatening conditions like Duchenne, will ensure that the
patient voice has a seat at the table when key decisions are
made, and will incent industry to develop treatments for
pediatric rare diseases.
As you know, Duchenne muscular dystrophy exemplifies the
challenges faced by many patients and families afflicted by
rare diseases. It is a fatal condition with most patients not
living past their late 20s, and the only approved therapies
are steroids, which cause significant complications long-
term. With nearly 20 potential therapies in various stages of
clinical trials, our community is hopeful that better times
are ahead, and we recognize that a more efficient FDA attuned
to the needs of the rare disease patient population is
critical to our success. Again, we are most appreciative of
your efforts to ensure that the above mentioned provisions
were included in the final legislation. On behalf of Duchenne
and the broader rare disease community, thank you for your
leadership and support.
Sincerely,
Pat Furlong,
Founding President and CEO.
____
EveryLife Foundation
for Rare Diseases,
Novato, CA, June 19, 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 Representatives Stearns and Towns: On behalf of the
EveryLife Foundation for Rare Diseases and our 180 patient
organization partners, thank you for championing the FAST Act
which is included in The Food and Drug Administration Safety
and Innovation Act, S. 3187. This essential legislation will
improve access to the Accelerated Approval pathway for rare
diseases and spur the development of lifesaving treatments.
Currently, there are fewer than 400 approved treatments for
7,000 rare diseases affecting more than 30 million Americans.
Without a treatment, diagnosis of a rare disease can be a
death sentence for these patients, many of whom are young
children. The science exists for many of these diseases to be
treated, and the inclusion of this legislation will provide a
more predictable development and regulatory pathway to unlock
the investment potential for rare disease treatments.
The language from the FAST Act will fix a ``catch 22'' that
prevents very rare diseases
[[Page H3865]]
from accessing the Accelerated Approval pathway. We applaud
you both for your tremendous leadership in ensuring that this
essential provision be included in the FDA user fee
legislation. This provision provides FDA the ability to
utilize all the tools available to them to help bring new
drugs to market to treat rare and ultra-rare diseases while
maintaining the FDA's strong safety and efficacy standards.
Access to the Accelerated Approval pathway will significantly
decrease the time and cost to develop a treatment and has
been extremely successful in getting treatments approved for
cancer and AIDS patients. Additionally, this provision has an
added benefit of promoting private investment in new
biotechnology companies and job growth in the United States.
We thank you for your strong commitment to accelerating the
delivery of safe and effective therapies to patients in need.
We also would like to thank the more than 200 patient
organizations including Parent Project Muscular Dystrophy,
and the thousands of patient advocates who worked to support
this legislation. Passage of this legislation is testament of
perseverance of the rare disease community and the commitment
of the Congress to promote the development of lifesaving
treatments.
Sincerely,
Emil Kakkis,
President.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from California (Mrs. Capps).
Mrs. CAPPS. I thank my colleague for yielding.
Mr. Speaker, I rise today in strong support of the FDA Safety and
Innovation Act. This bipartisan effort will improve the health and
safety of the American people; and at the same time, it will support
good jobs and innovation in the health care industry. I am especially
pleased that this bill includes two provisions which I authored:
The first is modeled on my SAFE Devices Act, which will improve the
post-market surveillance of medical devices and the implementation of
the unique device identifier program. This essential provision will
allow us to identify potential device problems early, thereby
protecting patients and identifying issues when they are easier and
less costly to address;
The second provision I authored comes from my bipartisan HEART for
Women Act, which the House has passed two times. It requires the FDA to
report on the availability of new drug and device safety and efficacy
data by sex, age, and racial and ethnic subgroups. Drugs and devices
can have dissimilar effects among various populations, and this
provision will help reduce substantial disparities in health care,
especially for women and minorities.
So I thank the chairmen and ranking members for their leadership on
the FDA Safety and Innovation Act and for their support of these two
provisions. I urge my colleagues to support this bipartisan bill.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the distinguished
gentlewoman from North Carolina, the vice chair of the Energy and
Commerce Committee, Mrs. Myrick.
Mrs. MYRICK. Thank you, Mr. Chairman.
The bill before us contains critical improvements to the current law.
Among them is the creation of a priority review voucher program for
companies that develop treatments for rare pediatric diseases. I am
pleased with this and other advances.
Yet the long-term success or failure of crucial drug and device
approvals doesn't just depend on approving new funds and guidelines for
the FDA. It also depends on instilling a culture at the FDA that seeks
out practical solutions to the diseases that our constituents face. The
FDA must recognize that patients, especially those with fatal
illnesses, deserve to have potential treatments made available.
Whenever possible, the FDA should use all the tools it has available
to appropriately warn doctors and patients of risks associated with a
treatment without removing patient access. Patients facing fatal
diagnoses, whether it's metastatic cancer, ALS or others, should be
given the benefit of the doubt unless treatments are very risky. This
should be a guiding principle of the FDA and not simply a
consideration.
I urge the support of the bill.
Mr. PALLONE. Mr. Speaker, I yield 1 minute to the gentleman from New
York (Mr. Engel).
Mr. ENGEL. I thank my friend for yielding to me.
I rise in strong support of S. 3187, the Food and Drug Administration
Safety and Innovation Act of 2012.
This is one of these rare occasions these days when Congress is
working in a bipartisan manner to get good things done. This
bipartisan, bicameral agreement is something of which we can all be
proud; and it is a prime example, again, of the good legislative work
that can be done by this body when compromises are accepted.
In particular, I would like to thank the chairmen and ranking members
of the full Energy and Commerce Committee and of the Health
Subcommittee for their hard work to finalize this bill in such a timely
manner. I would also like to thank them for including the
reauthorization of the Critical Path Public-Private Partnerships in
this legislation, something for which I pushed for a long time so that
needed improvements in regulatory science can continue.
I believe this bill will help meet the needs of the FDA industry and,
most importantly, of the patients. I look forward to its passage.
Mr. UPTON. I yield 1 minute to the distinguished gentleman from
Pennsylvania, Dr. Murphy.
Mr. MURPHY of Pennsylvania. Mr. Speaker, what good are life-saving
drugs if you can't afford them?
That's why real reform of the Nation's health care system begins with
promoting quality and affordability. I am excited this legislation is
moving forward because the FDA will finally have a system for bringing
more life-saving generic drugs to market.
Today's bill authorizes the first generic drug user-fee program in
order to expedite the approval of generics, which are only a fraction
of the cost of brand-name drugs. Generic medications can save a patient
$1,000 a year on medication alone, but it may well yield billions in
savings across our Nation when affordable generic drugs are used to
treat acute and chronic illness. Right now, consumers are spending
millions, if not billions, more in out-of-pocket costs because the FDA
doesn't have the resources to tackle 2,800 generic applications
awaiting review.
There will be fewer strokes, heart attacks, and cases of
cardiovascular disease when this bill moves forward into law, and we
will be assured the medicines our families take are of the highest
quality. Under this bill, regulators will no longer be able to look
past China's history of tainted drugs, like the 2007 heparin scare that
killed 200 people.
I would like to thank Congressmen Dingell and Waxman and Chairman
Upton for moving forward with this bipartisan bill. I urge its
adoption.
Mr. PALLONE. Mr. Speaker, I inquire of how much time remains on both
sides.
The SPEAKER pro tempore. The gentleman from New Jersey has 6\1/2\
minutes remaining, and the gentleman from Michigan has 9 minutes
remaining.
Mr. PALLONE. I now yield 1\1/2\ minutes to the gentleman from North
Carolina (Mr. Butterfield).
Mr. BUTTERFIELD. Let me thank you, Mr. Pallone, for yielding the
time, and I thank you so very much for your leadership on the Health
Subcommittee. You do extraordinary work on our committee.
Mr. Speaker, I rise today in support of S. 3187, the amended version
of the Food and Drug Administration Safety and Innovation Act. I
strongly support this bill, and I am particularly pleased that the
intent of H.R. 3059, the Creating Hope Act, sponsored by my good friend
from Texas (Mr. McCaul) and myself, was included in the final bill.
I am thrilled to highlight section 908, the Rare Pediatric Disease
Priority Review Voucher Incentive program. 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 the FDA review of more profitable drugs in return for
developing treatments for rare pediatric diseases. I think that is a
good trade-off.
I would like to thank Mr. McCaul, Mr. Waxman, Mrs. Myrick, and all of
those who have worked on this bill with us. I want to thank our Senate
colleagues, Messrs. Casey and Brown, for working diligently with me and
our
[[Page H3866]]
colleagues to see to its inclusion. Finally, I want to recognize Nancy
Goodman, with Kids Versus Cancer, who continues to be a tireless
advocate for this issue.
Mr. UPTON. Mr. Speaker, I yield 1 minute to a member of the
committee, the distinguished gentleman from California (Mr. Bilbray).
Mr. BILBRAY. Mr. Speaker, I stand in support of this bill.
I want to thank Chairman Upton and the leadership on both sides of
the aisle for getting together and doing what's right for the American
people.
In this time that we talk about economic strife, we've got to
remember that the FDA can be a friend or an enemy of not only our
health but also of our jobs and our economic opportunities. In
California alone, Mr. Speaker, we have over 267 people working in the
pharmaceutical industry.
{time} 1500
We have over 42,000 just working in San Diego County.
This bill will not only help to protect jobs, but this bill is a
bipartisan bill to save lives. What better message can we send to the
American people than Washington is listening to the fact that they want
bipartisan support and bipartisan efforts and bipartisan successes on
things that matter?
This bill is something that matters. We're talking about preserving
the economic opportunities of our fellow citizens, and we're talking
about saving the lives of our family members and our neighbors.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Massachusetts (Mr. Markey).
Mr. MARKEY. I would like to thank Chairman Upton and Chairman Pitts
and Ranking Member Waxman and Ranking Member Pallone and their staffs
for their work in bringing the FDA Safety and Innovation Act to the
floor today.
Passing this bill will allow the FDA to continue its critical mission
of bringing safe and effective drugs and medical devices to the
patients who need them. Reviewing drug and device applications has
become increasingly challenging. Medical breakthroughs of today often
target rare diseases or genetic subsets of those diseases. FDA
reviewers must now assess a growing pipeline of very specialized
treatments.
I'm pleased that this bill includes language I helped author to
improve collaboration between FDA and external experts in rare diseases
like cystic fibrosis and sickle cell disease.
The bill before us today also includes an important provision I
helped author to ensure that the millions of Americans who are blind or
visually impaired have safe and independent access to the information
on prescription drug labels. No one should have to sacrifice their
privacy or independence to access the vital information on these
bottles, and I'm glad we're taking steps to address that here today.
Finally, this bill helps increase the availability of pediatric
medical devices and ensures that medications are tested and labeled
appropriately for children. I was proud to work on these provisions
with my colleagues, Congresswoman Eshoo and Congressman Rogers.
I would have liked to have seen additional measures included in this
bill to ensure the safety of medical devices based on defective models
that have already been approved by the FDA, that unfortunately continue
to be sold and jeopardize patients' health all across this country. I
am going to continue to work on this critical issue. I believe it's a
problem that we must solve. Once the FDA approves a device and then it
turns out that there's a defect, there should be no excuse for allowing
new companies to build their devices based upon the old approved
defective model that the FDA had approved. Tens of thousands of
Americans are put in jeopardy, and I would like to work to solve that
problem.
Nonetheless, this is an excellent piece of legislation, and I hope
that the House gives it its overwhelming approval.
Mr. UPTON. Mr. Speaker, I yield 2 minutes to the distinguished
gentleman from Georgia, Dr. Gingrey, a member of the committee.
Mr. GINGREY of Georgia. Mr. Speaker, I thank the gentleman for
yielding.
The FDA Safety and Innovation Act of 2012 may not be a great bill,
but it is a darn good bill. And as a physician and a member of the
Energy and Commerce Committee, I strongly support it.
As my colleagues have said on both sides, this is a bicameral,
bipartisan piece of legislation, and yes, we can get our work done. I
want to particularly thank Chairman Upton, Ranking Member Waxman,
Health Subcommittee Chairman Pitts, Ranking Member Pallone, and all of
the Members that have worked so hard on this really vast, huge bill
that covers a lot of things, not the least of which, of course, is to
provide 65 percent of the funding for the FDA so they can, indeed, hire
the best and brightest scientists so they get their work done in a
timely manner, get new drugs to the market, medical devices, and bottom
line, keep the health care system in this country the best in the world
for our constituents and our patients.
Mr. Speaker, I want to mention one particular aspect of the bill that
I was very much involved in, and that's this issue of antibiotic
shortage. The bill as it stood alone was called the GAIN Act, and I had
a tremendous amount of help on both sides of the aisle. On the
Democratic side, there was Congresswoman Eshoo, Congresswoman DeGette,
and Congressman Gene Green. On my side of the aisle, there was Mike
Rogers of Michigan, Mr. Shimkus, and Mr. Whitfield. What we do with
that portion of the bill is to provide an opportunity for the
manufacturers of antibiotics to have an additional 5 years of
exclusivity so they can bring these innovative fifth- and sixth-
generation antibiotics to the market and still have an opportunity to
recoup the investment and the expense of doing so.
I want to just say to my colleagues on both sides of the aisle, it's
a proud day, I think, for all of us, for Chairman Emeritus Dingell, the
former chairman on our side of the aisle, Mr. Barton, and everybody
involved in this bill. I thank all of you. Let's all unanimously
support this bill.
Mr. PALLONE. Mr. Speaker, I have no additional speakers, so I will
reserve the balance of my time.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New
Jersey (Mr. Lance), a member of the committee.
Mr. LANCE. Thank you, Mr. Chairman.
Mr. Speaker, such legislation will ensure that patients get improved
access to innovative, lifesaving therapies and medical devices while
protecting and creating U.S. jobs. The bill is critically important to
New Jersey, where we have a high concentration of medical device,
pharmaceutical, and life science employees.
I'm pleased that the conference report contains provisions important
to streamline and modernize FDA regulations while promoting patient
safety. Just as important, today's measure is fiscally responsible,
reducing the deficit by $311 billion over the next 10 years according
to the CBO.
I thank Chairman Upton, Chairman Pitts, Ranking Member Waxman,
Ranking Member Pallone, and members of the Energy and Commerce
Committee for working together in a bipartisan capacity on a final bill
that protects patients and brings much needed certainty to the medical
and biopharmaceutical industries. This is the way Congress should work.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Kentucky (Mr. Guthrie).
Mr. GUTHRIE. Mr. Speaker, I appreciate the gentleman for yielding.
I rise today in support of the legislation to reauthorize the
Prescription Drug and Medical Device User Fee Act and authorize new
user fee programs for generic drugs and biosimilars. The legislation
also includes important reforms to grant patients improved access to
new therapies and promotes innovation and job creation.
Jobs and the economy are top issues for most Americans, and this bill
focuses on that. As a manufacturer, I've heard many stories from many
device manufacturers across the country about problems they face with
the FDA and how those struggles are making it harder for them to
manufacture in America.
This bill includes important changes, including one that I
championed, to reform the FDA's guidance process that will inject
certainty into the process and create more American jobs.
[[Page H3867]]
This bill is an example of working in a bipartisan way to achieve a
quality product that creates jobs. I thank the chairman and the ranking
member for their work. And, Mr. Speaker, I urge my colleagues to
support this bill.
The SPEAKER pro tempore (Mr. Daniel E. Lungren of California). The
gentleman from New Jersey has 3 minutes remaining, and the gentleman
from Michigan has 4 minutes remaining.
Mr. PALLONE. Mr. Speaker, I yield 30 seconds to the gentleman from
Virginia (Mr. Moran).
Mr. MORAN. Mr. Speaker, I don't oppose the bill, but I do have
concerns about one element of this bill, and that is the provision that
affects whistleblowers in the Public Health Service.
The law that would apply to these employees is that of the military,
the Defense Department, which, frankly, is weaker than that which
applies to protecting whistleblowers who are in the civil service,
civilian whistleblowers.
I do think protection of whistleblowers needs to be a priority. In
this case, I would hope that we could work in subsequent legislation to
protect the rights of whistleblowers who are essential to our being
able to do our job, as well as those people in the executive branch. I
just wanted to make note of that point.
{time} 1510
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from New
Hampshire (Mr. Bass), a member of the committee.
Mr. BASS of New Hampshire. I thank the distinguished chairman of the
committee for recognizing me for 1 minute.
Mr. Speaker, I rise in strong support of the Food and Drug
Administration Safety and Innovation Act.
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
products available to patients.
Throughout this process, there has been a commitment to addressing
the unique issues associated with the rare disease community and
bringing it to the forefront of this debate. And I am proud to have had
my bill, the Humanitarian Device Reform Act, included as a provision in
this device regulatory section. This language will make it easier for
medical device manufacturers to create devices specifically for the
treatment of individuals, both children and adults, who are afflicted
with very rare diseases.
With this increased focus on providing incentives to manufacturers to
invest in the development of these devices and 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.
Mr. UPTON. Mr. Speaker, I yield 1 minute to the gentleman from
Minnesota (Mr. Paulsen).
Mr. PAULSEN. Mr. Speaker, I want to applaud, first of all, the
chairman, the subcommittee chairman, and the ranking members for their
leadership in bringing this bipartisan package to the floor.
Mr. Speaker, nearly every week, I get a chance to tour a medical
device company in my district. And almost every week, I hear a similar
story from these companies that talk about how the FDA has become so
burdensome and bureaucratic and inefficient that they move the goalpost
in the process of the device approval process. As a result, some of
these companies are closing their doors. Some of these companies are
investing overseas and moving jobs, as opposed to keeping them in their
home State of Minnesota or here in the United States.
Unfortunately, it seems that Washington tends to thrive on these
types of bureaucracies and inefficiencies. And I think the package that
is before us today is designed to help correct that. The FDA review
process needs to be rigorous, but it also needs to be relevant. You
have heard that message time and time again: We have to find ways to
streamline and modernize the FDA so that the United States can remain
the leader in global medical innovation.
This package absolutely moves us closer to meeting all of those
goals. These reforms will make the device approval process much more
transparent, much more consistent, and much more predictable. And
specifically, I'm happy that my provisions to streamline the third-
party review process were included as well.
I want to thank the chairman and Members for their bipartisan
support, and I urge the support of my colleagues.
Mr. UPTON. Mr. Speaker, may I ask how much time remains on each side?
The SPEAKER pro tempore. The gentleman from Michigan has 2 minutes
remaining, and the gentleman from New Jersey has 2\1/2\ minutes
remaining.
Mr. UPTON. Mr. Speaker, I have no further requests for time. So if
the gentleman wants to close, then I will close.
The SPEAKER pro tempore. The gentleman from New Jersey is recognized
for 2\1/2\ minutes.
Mr. PALLONE. Thank you, Mr. Speaker. I won't use all the time.
I just want to stress, again, that the process of getting this bill
passed and moved both here and in the Senate has been just a great
model, if you will, for what we can do when we want to get together and
work together on a bipartisan, bicameral basis. So I can't say enough
about everyone who was involved on both sides of the aisle and staff
for making this happen today.
I also want to reiterate some of the things that some of my
colleagues have said about how important this is. Because it's on a
suspension, some people may say, Well, how important is it? It is
extremely important. And some of those sentiments have been echoed by
those who talk about the drug and medical device industry, which is
really so important to this country.
We pride ourselves on innovation. As some of you know, many of these
companies are in my district. And we pride ourselves on the fact that
Thomas Edison had his lab at Menlo Park, in my district, and that we
are an innovative area in New Jersey, and New Jersey as a whole. But
innovation can't continue to happen in this industry unless we continue
to have an FDA process that runs smoothly and effectively.
The fact of the matter is that this legislation is designed to make
sure that that continues to happen, that the money is available so we
can have an efficient process that continues to make the United States
the innovator in the area of pharmaceuticals and medical devices.
I'm very proud to have been part of this today. I urge everyone to
support the bill. I thank my colleagues.
I yield back the balance of my time.
The SPEAKER pro tempore. The gentleman from Michigan is recognized
for 2 minutes.
Mr. UPTON. Thank you, Mr. Speaker.
Mr. Speaker, I just want to say that with all of the positive
comments here, this bill was not a piece of cake. There was a lot of
hard work on both sides of the aisle, particularly by the staff on both
sides of the aisle. Again, I want to cite Clay and Ryan on our staff.
But let's face it: All of us particularly involved on the health side
of the issues, as we meet with different folks afflicted with different
diseases, we want to find a cure. And it would be great to find that
cure here in America because we have outstanding pharmaceutical
industries that have the talent and the staff to work with the
different departments, whether it be the NIH, the CDC, certainly the
FDA.
So we really did set out last summer to embark on a good listening
session to find out what it is that we needed to do not only to find
the cures and the prescriptions but the right process for them to be
approved so that those companies that are willing to make that
investment would stay here in America and not go overseas. Because we
really do want it made in America. We have the best folks here. And
that's what this bill does.
The hard work in so many of the hearings that Joe Pitts led with Mr.
Pallone, the work, the amendments, the subcommittee, the full
committee, that whole process to get it done before it really expired
later on this year is so important not only to the workers but, more
importantly, to the patients.
So dealing with the drug shortages and working with Mr. McCaul and
the different rare diseases, all of those different elements, we were
able to weave
[[Page H3868]]
into what I think is a mighty fine, strong bill. And to then, of
course, work with our counterparts in the Senate, whom we often bash
here, but they actually stayed with us, and we were able to work in a
very strong bipartisan way to get our two bills refined and done in
order to bring up on the House floor this afternoon.
I want to compliment everyone--and certainly Mr. Waxman, who is back
on the floor--our leadership, the team that we had on both sides of the
aisle and, again, our hardworking staff that really worked so hard to
get this done, which impacts millions of lives.
I urge my colleagues to support this bill, and I yield back the
balance of my time.
Mr. RAHALL. Mr. Speaker, I support the passage of the Food and Drug
Administration Reform Act, which reauthorizes vital programs that will
ensure the FDA continues to study and approve life-saving drugs and
medical devices and work to prevent drug shortages of much needed
medications.
I am concerned, however, that the Congress is not doing more to fight
prescription drug abuse. Members of the House were not permitted to
offer amendments to address prescription drug addiction when this
measure came before us last month, even though the FDA has a vital role
in regulating the addictive qualities of drugs that are manufactured
and ensuring sufficient education and awareness for health care
providers and the general public.
This conference report is a bittersweet pill to swallow. While it
includes a provision that will ban the sale of dangerous synthetic
drugs, which I support and the House of Representatives passed late
last year, the FDA's programs could have been strengthened
significantly to address substance abuse and its impact on our Nation's
economic and security needs.
If one reads any newspaper in southern West Virginia, you will
undoubtedly find downright scary stories of families, children and
seniors devastated by prescription drug abuse, and the crime that it
engenders. As many of my colleagues know, fighting back against this
unending wave of abuse will take the action of all--local, state and
federal governments. I have introduced legislation, as have a number of
my colleagues who serve in the Prescription Drug Abuse Caucus, which
would arm our law enforcement, physicians, and local communities in
this fight--making it harder for pills to get into the wrong hands and
be misused, and ensuring that all prescriptions are properly monitored.
Though this bill mentions the need to combat abuse of prescription
drugs, it is not nearly strong enough, nor should we consider it
sufficient, in addressing what has become a crisis in too many
Appalachian communities. Our families and communities need more than
recommendations--they need action, and they simply cannot wait any
longer for help.
I urge House leadership to work with members of this body who are
committed to fighting back against this plague and saving our
communities to consider legislation that will stop this scourge.
Mr. DENT. Mr. Speaker, I rise in support of the Food and Drug
Administration Safety and Innovation Act and particularly the
provisions related to synthetic drugs.
I introduced H.R. 1254, the Synthetic Drug Control Act, after the
issue of synthetic or designer drugs was first brought to my attention
by a constituent whose son had been abusing legal substitutes for
marijuana.
H.R. 1254 passed the House by a strong, bipartisan vote of 317 to 98
this past December.
After months of hard work, I am glad to see that similar language has
been included in the House Amendment to the Senate-passed FDA reform
bill. I would like to thank Chairmen Upton and Smith for their diligent
efforts in advancing this legislation.
This legislation will finally add a long list of dangerous drugs to
Schedule I of the Controlled Substances Act.
It covers synthetic cannabinoids, which affect the brain in a manner
similar to marijuana but can actually be even more harmful, as well as
many of the chemicals used in so-called ``bath salts,'' which have
properties similar to cocaine, methamphetamine, LSD, and other hard
street drugs.
It will also double the amount of time that DEA may temporarily ban a
new substance while working to prove that the drug in question should
be banned permanently.
As we speak, the proliferators of these deadly chemicals are working
on new formulas to circumvent Federal law.
This additional time will enhance DEA's ability to combat new and
emerging substances.
This legislation is especially timely given the recent reports of
inhuman and psychotic acts committed by individuals high on bath salts.
Last month, we all heard the horrifying story of a Miami man who
stripped naked, assaulted another individual, and chewed his face off
before being shot dead by the police.
Last year, a man in my district was arrested after injecting himself
with bath salts and firing a gun out of his window in a university
neighborhood. He later attributed his actions to a drug-induced state
of paranoia.
Poison control centers nationwide have reported exponential increases
in calls related to synthetic drugs, and far too many deaths have
resulted both from overdoses and the Psychotic behavior that the drugs
induce.
For the inclusion of this important public safety language and for
the many ways this legislation will spur economic growth and medical
innovation, I urge all of my colleagues to vote in favor of the
underlying bill.
The SPEAKER pro tempore. The question is on the motion offered by the
gentleman from Michigan (Mr. Upton) that the House suspend the rules
and pass the bill, S. 3187, as amended.
The question was taken; and (two-thirds being in the affirmative) the
rules were suspended and the bill, as amended, was passed.
A motion to reconsider was laid on the table.
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