[Congressional Record Volume 163, Number 117 (Wednesday, July 12, 2017)]
[House]
[Pages H5454-H5483]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
FDA REAUTHORIZATION ACT OF 2017
Mr. WALDEN. Mr. Speaker, I move to suspend the rules and pass the
bill (H.R. 2430) to amend the Federal Food, Drug, and Cosmetic Act to
revise and extend the user-fee programs for prescription drugs, medical
devices, generic drugs, and biosimilar biological products, and for
other purposes, as amended.
The Clerk read the title of the bill.
The text of the bill is as follows:
H.R. 2430
Be it enacted by the Senate and House of Representatives of
the United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``FDA Reauthorization Act of
2017''.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--FEES RELATING TO DRUGS
Sec. 101. Short title; finding.
Sec. 102. Authority to assess and use drug fees.
Sec. 103. Reauthorization; reporting requirements.
Sec. 104. Sunset dates.
Sec. 105. Effective date.
Sec. 106. Savings clause.
TITLE II--FEES RELATING TO DEVICES
Sec. 201. Short title; finding.
Sec. 202. Definitions.
Sec. 203. Authority to assess and use device fees.
Sec. 204. Reauthorization; reporting requirements.
Sec. 205. Conformity assessment pilot program.
Sec. 206. Reauthorization of review.
Sec. 207. Electronic format for submissions.
Sec. 208. Savings clause.
Sec. 209. Effective date.
Sec. 210. Sunset dates.
TITLE III--FEES RELATING TO GENERIC DRUGS
Sec. 301. Short title; finding.
Sec. 302. Definitions.
Sec. 303. Authority to assess and use human generic drug fees.
Sec. 304. Reauthorization; reporting requirements.
Sec. 305. Sunset dates.
Sec. 306. Effective date.
Sec. 307. Savings clause.
TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS
Sec. 401. Short title; finding.
Sec. 402. Definitions.
Sec. 403. Authority to assess and use biosimilar fees.
Sec. 404. Reauthorization; reporting requirements.
Sec. 405. Sunset dates.
Sec. 406. Effective date.
Sec. 407. Savings clause.
TITLE V--PEDIATRIC DRUGS AND DEVICES
Sec. 501. Best pharmaceuticals for children.
Sec. 502. Pediatric devices.
Sec. 503. Early meeting on pediatric study plan.
Sec. 504. Development of drugs and biological products for pediatric
cancers.
Sec. 505. Additional provisions on development of drugs and biological
products for pediatric use.
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
Sec. 601. Reauthorization of provision relating to exclusivity of
certain drugs containing single enantiomers.
Sec. 602. Reauthorization of the critical path public-private
partnerships.
Sec. 603. Reauthorization of orphan grants program.
Sec. 604. Protecting and strengthening the drug supply chain.
Sec. 605. Patient experience data.
Sec. 606. Communication plans.
Sec. 607. Orphan drugs.
Sec. 608. Pediatric information added to labeling.
Sec. 609. Sense of Congress on lowering the cost of prescription drugs.
Sec. 610. Expanded access.
Sec. 611. Tropical disease product application.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
Sec. 701. Risk-based inspections for devices.
Sec. 702. Improvements to inspections process for device
establishments.
Sec. 703. Reauthorization of inspection program.
Sec. 704. Certificates to foreign governments for devices.
Sec. 705. Facilitating international harmonization.
Sec. 706. Fostering innovation in medical imaging.
Sec. 707. Risk-based classification of accessories.
Sec. 708. Device pilot projects.
Sec. 709. Regulation of over-the-counter hearing aids.
Sec. 710. Report on servicing of devices.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
Sec. 801. Priority review of generic drugs.
Sec. 802. Enhancing regulatory transparency to enhance generic
competition.
Sec. 803. Competitive generic therapies.
Sec. 804. Accurate information about drugs with limited competition.
Sec. 805. Suitability petitions.
Sec. 806. Inspections.
Sec. 807. Reporting on pending generic drug applications and priority
review applications.
Sec. 808. Incentivizing competitive generic drug development.
Sec. 809. GAO study of issues regarding first cycle approvals of
generic medicines.
TITLE IX--ADDITIONAL PROVISIONS
Sec. 901. Technical corrections.
Sec. 902. Annual report on inspections.
Sec. 903. Streamlining and improving consistency in performance
reporting.
Sec. 904. Analysis of use of funds.
Sec. 905. Facilities management.
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 2017''.
(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. AUTHORITY TO ASSESS AND USE DRUG FEES.
(a) Types of Fees.--
(1) In general.--Section 736(a) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379h(a)) is amended--
(A) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(B) in the heading of paragraph (1), by striking ``and
supplement'';
(C) in paragraph (1), by striking ``or a supplement'' and
``or supplement'' each place either appears;
(D) in paragraph (1)(A)--
(i) in clause (i), by striking ``(c)(4)'' and inserting
``(c)(5)''; and
(ii) in clause (ii), by striking ``A fee established'' and
all that follows through ``are required.'' and inserting the
following: ``A fee established under subsection (c)(5) for a
human drug application for which clinical data (other than
bioavailability or bioequivalence studies) with respect to
safety or effectiveness are not required for approval.'';
(E) in the heading of paragraph (1)(C), by striking ``or
supplement'';
(F) in paragraph (1)(F)--
(i) in the heading, by striking ``or indication''; and
(ii) by striking the second sentence;
(G) by striking paragraph (2) (relating to a prescription
drug establishment fee);
(H) by redesignating paragraph (3) as paragraph (2);
(I) in the heading of paragraph (2), as so redesignated, by
striking ``Prescription drug product fee'' and inserting
``Prescription drug program fee'';
(J) in subparagraph (A) of such paragraph (2), by amending
the first sentence to read as follows: ``Except as provided
in subparagraphs (B) and (C), each person who is named as the
applicant in a human drug application, and who, after
September 1, 1992, had pending before the Secretary a human
drug application or supplement, shall pay the annual
prescription drug program fee established for a fiscal year
under subsection (c)(5) for each prescription drug product
that is identified in such a human drug application approved
as of October 1 of such fiscal year.'';
(K) in subparagraph (B) of such paragraph (2)--
(i) in the heading of subparagraph (B), by inserting after
``Exception'' the following: ``for certain prescription drug
products''; and
(ii) by striking ``A prescription drug product shall not be
assessed a fee'' and inserting ``A prescription drug program
fee shall not be assessed for a prescription drug product'';
and
(L) by adding at the end of such paragraph (2) the
following:
``(C) Limitation.--A person who is named as the applicant
in an approved human drug application shall not be assessed
more than 5 prescription drug program fees for a fiscal
[[Page H5455]]
year for prescription drug products identified in such
approved human drug application.''.
(2) Conforming amendment.--Subparagraph (C) of section
740(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-12(a)(3)) is amended to read as follows:
``(C) Limitation.--An establishment shall be assessed only
one fee per fiscal year under this section.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 736 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h) is
amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) In general.--For each of the fiscal years 2018
through 2022, fees under subsection (a) shall, except as
provided in subsections (c), (d), (f), and (g), be
established to generate a total revenue amount under such
subsection that is equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (3));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the capacity planning
adjustment for the fiscal year (as determined under
subsection (c)(2));
``(D) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(3));
``(E) the dollar amount equal to the additional direct cost
adjustment for the fiscal year (as determined under
subsection (c)(4)); and
``(F) additional dollar amounts for each fiscal year as
follows:
``(i) $20,077,793 for fiscal year 2018.
``(ii) $21,317,472 for fiscal year 2019.
``(iii) $16,953,329 for fiscal year 2020.
``(iv) $5,426,896 for fiscal year 2021.
``(v) $2,769,609 for fiscal year 2022.
``(2) Types of fees.--Of the total revenue amount
determined for a fiscal year under paragraph (1)--
``(A) 20 percent shall be derived from human drug
application fees under subsection (a)(1); and
``(B) 80 percent shall be derived from prescription drug
program fees under subsection (a)(2).
``(3) Annual base revenue.--For purposes of paragraph (1),
the dollar amount of the annual base revenue for a fiscal
year shall be--
``(A) for fiscal year 2018, $878,590,000; and
``(B) for fiscal years 2019 through 2022, the dollar amount
of the total revenue amount established under paragraph (1)
for the previous fiscal year, not including any adjustments
made under subsection (c)(3) or (c)(4).''.
(c) Adjustments; Annual Fee Setting.--Subsection (c) of
section 736 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379h) is amended to read as follows:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection (b)(1)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for each fiscal year shall be equal to the
product of--
``(i) such annual base revenue for the fiscal year under
subsection (b)(1)(A); and
``(ii) the inflation adjustment percentage under
subparagraph (B).
``(B) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal
year is equal to the sum of--
``(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 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
``(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 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.
``(2) Capacity planning adjustment.--
``(A) In general.--For each fiscal year, after the annual
base revenue established in subsection (b)(1)(A) is adjusted
for inflation in accordance with paragraph (1), such revenue
shall be adjusted further for such fiscal year, in accordance
with this paragraph, to reflect changes in the resource
capacity needs of the Secretary for the process for the
review of human drug applications.
``(B) Interim methodology.--
``(i) In general.--Until the capacity planning methodology
described in subparagraph (C) is effective, the adjustment
under this paragraph for a fiscal year shall be based on the
product of--
``(I) the annual base revenue for such year, as adjusted
for inflation under paragraph (1); and
``(II) the adjustment percentage under clause (ii).
``(ii) Adjustment percentage.--The adjustment percentage
under this clause for a fiscal year is the weighted change in
the 3-year average ending in the most recent year for which
data are available, over the 3-year average ending in the
previous year, for--
``(I) the total number of human drug applications, efficacy
supplements, and manufacturing supplements submitted to the
Secretary;
``(II) the total number of active commercial
investigational new drug applications; and
``(III) the total number of formal meetings scheduled by
the Secretary, and written responses issued by the Secretary
in lieu of such formal meetings, as identified in section I.H
of the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2017.
``(C) Capacity planning methodology.--
``(i) Development; evaluation and report.--The Secretary
shall obtain, through a contract with an independent
accounting or consulting firm, a report evaluating options
and recommendations for a new methodology to accurately
assess changes in the resource and capacity needs of the
process for the review of human drug applications. The
capacity planning methodological options and recommendations
presented in such report shall utilize and be informed by
personnel time reporting data as an input. The report shall
be published for public comment no later than the end of
fiscal year 2020.
``(ii) Establishment and implementation.--After review of
the report described in clause (i) and any public comments
thereon, the Secretary shall establish a capacity planning
methodology for purposes of this paragraph, which shall--
``(I) replace the interim methodology under subparagraph
(B);
``(II) incorporate such approaches and attributes as the
Secretary determines appropriate; and
``(III) be effective beginning with the first fiscal year
for which fees are set after such capacity planning
methodology is established.
``(D) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue for a
fiscal year that is less than the sum of the amounts under
subsections (b)(1)(A) (the annual base revenue for the fiscal
year) and (b)(1)(B) (the dollar amount of the inflation
adjustment for the fiscal year).
``(E) Publication in federal register.--The Secretary shall
publish in the Federal Register notice under paragraph (5) of
the fee revenue and fees resulting from the adjustment and
the methodologies under this paragraph.
``(3) Operating reserve adjustment.--
``(A) Increase.--For fiscal year 2018 and subsequent fiscal
years, the Secretary may, in addition to adjustments under
paragraphs (1) and (2), further increase the fee revenue and
fees if such an adjustment is necessary to provide for not
more than 14 weeks of operating reserves of carryover user
fees for the process for the review of human drug
applications.
``(B) Decrease.--If the Secretary has carryover balances
for such process in excess of 14 weeks of such operating
reserves, the Secretary shall decrease such fee revenue and
fees to provide for not more than 14 weeks of such operating
reserves.
``(C) Notice of rationale.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the amount
of the increase or decrease (as applicable) in fee revenue
and fees shall be contained in the annual Federal Register
notice under paragraph (5) establishing fee revenue and fees
for the fiscal year involved.
``(4) Additional direct cost adjustment.--
``(A) In general.--The Secretary shall, in addition to
adjustments under paragraphs (1), (2), and (3), further
increase the fee revenue and fees--
``(i) for fiscal year 2018, by $8,730,000; and
``(ii) for fiscal year 2019 and subsequent fiscal years, by
the amount determined under subparagraph (B).
``(B) Amount.--The amount determined under this
subparagraph is--
``(i) $8,730,000, multiplied by
``(ii) the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted;
All Items; Annual Index) for the most recent year of
available data, divided by such Index for 2016.
``(5) Annual fee setting.--The Secretary shall, not later
than 60 days before the start of each fiscal year that begins
after September 30, 2017--
``(A) establish, for each such fiscal year, human drug
application fees and prescription drug program fees under
subsection (a), based on the revenue amounts established
under subsection (b) and the adjustments provided under this
subsection; and
``(B) publish such fee revenue and fees in the Federal
Register.
``(6) 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.''.
(d) Fee Waiver or Reduction.--Section 736(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379h(d)) is amended--
(1) in paragraph (1)--
(A) by inserting ``or'' at the end of subparagraph (B);
(B) by striking subparagraph (C); and
(C) by redesignating subparagraph (D) as subparagraph (C);
(2) by striking paragraph (3) (relating to use of standard
costs);
(3) by redesignating paragraph (4) as paragraph (3); and
[[Page H5456]]
(4) in paragraph (3), as so redesignated--
(A) in subparagraphs (A) and (B), by striking ``paragraph
(1)(D)'' and inserting ``paragraph (1)(C)''; and
(B) in subparagraph (B)--
(i) by striking clause (ii);
(ii) by striking ``shall pay'' through ``(i) application
fees'' and inserting ``shall pay application fees''; and
(iii) by striking ``; and'' at the end and inserting a
period.
(e) Effect of Failure To Pay Fees.--Section 736(e) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(e)) is
amended by striking ``all fees'' and inserting ``all such
fees''.
(f) Limitations.--Section 736(f)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(f)(2)) is amended by
striking ``supplements, prescription drug establishments, and
prescription drug products'' and inserting ``prescription
drug program fees''.
(g) Crediting and Availability of Fees.--Section 736(g) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h(g))
is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting ``2018
through 2022''; and
(B) by striking ``and paragraph (4) of this subsection'';
and
(2) by striking paragraph (4).
(h) Orphan Drugs.--Section 736(k) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379h(k)) is amended by
striking ``product and establishment fees'' each place it
appears and inserting ``prescription drug program fees''.
SEC. 103. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 736B of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379h-2) is amended--
(1) in subsection (a)(1)--
(A) in the matter before subparagraph (A), by striking
``2013'' and inserting ``2018''; and
(B) in subparagraph (A), by striking ``Prescription Drug
User Fee Amendments of 2012'' and inserting ``Prescription
Drug User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 104. 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, 2022.
(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, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
subsections (a) and (b) of section 105 of the Food and Drug
Administration Safety and Innovation Act (Public Law 112-144)
are repealed.
SEC. 105. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2017, 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, 2017, regardless
of the date of the enactment of this Act.
SEC. 106. 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, 2012, but before October 1, 2017, 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 2018.
TITLE II--FEES RELATING TO DEVICES
SEC. 201. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Medical
Device User Fee Amendments of 2017''.
(b) Finding.--The Congress finds that the fees authorized
under the amendments made by this title will be dedicated
toward expediting the process for the review of device
applications and for assuring the safety and effectiveness of
devices, as set forth in the goals identified for purposes of
part 3 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act in the letters from the Secretary of
Health and Human Services to the Chairman of the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Chairman of the Committee on Energy and Commerce of the House
of Representatives, as set forth in the Congressional Record.
SEC. 202. DEFINITIONS.
(a) In General.--Section 737 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i) is amended--
(1) by redesignating paragraphs (8) through (13) as
paragraphs (9) through (14), respectively;
(2) by inserting after paragraph (7) the following new
paragraph:
``(8) The term `de novo classification request' means a
request made under section 513(f)(2)(A) with respect to the
classification of a device.'';
(3) in subparagraph (D) of paragraph (10) (as redesignated
by paragraph (1)), by striking ``and submissions'' and
inserting ``submissions, and de novo classification
requests''; and
(4) in paragraph (11) (as redesignated by paragraph (1)),
by striking ``2011'' and inserting ``2016''.
(b) Conforming Amendment.--Section 714(b)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379d-3(b)(1)) is
amended by striking ``737(8)'' and inserting ``737(9)''.
SEC. 203. AUTHORITY TO ASSESS AND USE DEVICE FEES.
(a) Types of Fees.--Section 738(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j(a)) is amended--
(1) in paragraph (1), by striking ``fiscal year 2013'' and
inserting ``fiscal year 2018''; and
(2) in paragraph (2)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i), by striking
``October 1, 2012'' and inserting ``October 1, 2017'';
(ii) in clause (viii), by striking ``2'' and inserting
``3.4''; and
(iii) by adding at the end the following new clause:
``(xi) For a de novo classification request, a fee equal to
30 percent of the fee that applies under clause (i).''; and
(B) in subparagraph (B)(v)(I), by striking ``or premarket
notification submission'' and inserting ``premarket
notification submission, or de novo classification request''.
(b) Fee Amounts.--Section 738(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j(b)) is amended to read as
follows:
``(b) Fee Amounts.--
``(1) In general.--Subject to subsections (c), (d), (e),
and (h), for each of fiscal years 2018 through 2022, fees
under subsection (a) shall be derived from the base fee
amounts specified in paragraph (2), to generate the total
revenue amounts specified in paragraph (3).
``(2) Base fee amounts specified.--For purposes of
paragraph (1), the base fee amounts specified in this
paragraph are as follows:
----------------------------------------------------------------------------------------------------------------
Fiscal Fiscal Fiscal Fiscal Fiscal
``Fee Type Year 2018 Year 2019 Year 2020 Year 2021 Year 2022
----------------------------------------------------------------------------------------------------------------
Premarket Application.................................... $294,000 $300,000 $310,000 $328,000 $329,000
Establishment Registration............................... $4,375 $4,548 $4,760 $4,975 $4,978
----------------------------------------------------------------------------------------------------------------
``(3) Total revenue amounts specified.--For purposes of
paragraph (1), the total revenue amounts specified in this
paragraph are as follows:
``(A) $183,280,756 for fiscal year 2018.
``(B) $190,654,875 for fiscal year 2019.
``(C) $200,132,014 for fiscal year 2020.
``(D) $211,748,789 for fiscal year 2021.
``(E) $213,687,660 for fiscal year 2022.''.
(c) Annual Fee Setting; Adjustments.--Section 738(c) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(c)) is
amended--
(1) in paragraph (1), by striking ``2012'' and inserting
``2017'';
(2) in paragraph (2)--
(A) in subparagraph (A), by striking ``2014'' and inserting
``2018'';
(B) by striking subparagraph (B) and inserting the
following new subparagraph:
``(B) Applicable inflation adjustment.--The applicable
inflation adjustment for fiscal year 2018 and each subsequent
fiscal year is 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 2016.'';
(C) in subparagraph (C), in the heading, by striking ``to
total revenue amounts''; and
(D) by amending subparagraph (D) to read as follows:
``(D) Adjustment to base fee amounts.--For each of fiscal
years 2018 through 2022, the Secretary shall--
``(i) adjust the base fee amounts specified in subsection
(b)(2) for such fiscal year by multiplying such amounts by
the applicable inflation adjustment under subparagraph (B)
for such year; and
``(ii) if the Secretary determines necessary, increase (in
addition to the adjustment under clause (i)) such base fee
amounts, on a uniform proportionate basis, to generate the
total revenue amounts under subsection (b)(3), as adjusted
for inflation under subparagraph (A).''; and
(3) in paragraph (3)--
(A) by striking ``2014 through 2017'' and inserting ``2018
through 2022''; and
[[Page H5457]]
(B) by striking ``further adjusted'' and inserting
``increased''.
(d) Small Businesses; Fee Waiver and Fee Reduction
Regarding Premarket Approval Fees.--Section 738(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(d)) is
amended--
(1) in paragraph (1), by striking ``specified in clauses
(i) through (v) and clauses (vii), (ix), and (x)'' and
inserting ``specified in clauses (i) through (vii) and
clauses (ix), (x), and (xi)''; and
(2) in paragraph (2)(C)--
(A) by striking ``supplement, or'' and inserting
``supplement,''; and
(B) by inserting ``, or a de novo classification request''
after ``class III device''.
(e) Small Businesses; Fee Reduction Regarding Premarket
Notification Submissions.--Section 738(e)(2)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
379j(e)(2)(C)) is amended by striking ``50'' and inserting
``25''.
(f) Fee Waiver or Reduction.--
(1) Repeal.--Section 738 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j) is amended by striking
subsection (f).
(2) Conforming amendments.--
(A) Section 515(c)(4)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e(c)(4)(A)) is amended by striking
``738(h)'' and inserting ``738(g)''.
(B) Section 738 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j), as amended by paragraph (1), is further
amended--
(i) by redesignating subsections (g) through (l) as
subsections (f) through (k);
(ii) in subsection (a)(2)(A), by striking ``(d), (e), and
(f)'' and inserting ``(d) and (e)''; and
(iii) in subsection (a)(3)(A), by striking ``and subsection
(f)''.
(g) Effect of Failure To Pay Fees.--Subsection (f)(1), as
so redesignated, of section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j) is amended--
(1) by striking ``or periodic reporting concerning a class
III device'' and inserting ``periodic reporting concerning a
class III device, or de novo classification request''; and
(2) by striking ``all fees'' and inserting ``all such
fees''.
(h) Conditions.--Subsection (g)(1)(A), as so redesignated,
of section 738 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j) is amended by striking ``$280,587,000'' and
inserting ``$320,825,000''.
(i) Crediting and Availability of Fees.--Subsection (h), as
so redesignated, of section 738 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 379j) is amended--
(1) in paragraph (3)--
(A) by striking ``2013 through 2017'' and inserting ``2018
through 2022''; and
(B) by striking ``subsection (c)'' and all that follows
through the period at the end and inserting ``subsection
(c).''; and
(2) by striking paragraph (4).
SEC. 204. REAUTHORIZATION; REPORTING REQUIREMENTS.
(a) Performance Reports.--Section 738A(a) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) by striking ``2013'' and inserting ``2018''; and
(ii) by striking ``the Medical Device User Fee Amendments
of 2012'' and inserting ``the Medical Device User Fee
Amendments of 2017''; and
(B) in subparagraph (B), by striking ``the Medical Device
User Fee Amendments Act of 2012'' and inserting ``the Medical
Device User Fee Amendments of 2017''; and
(2) in paragraph (2), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
(b) Reauthorization.--Section 738A(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(b)) is amended--
(1) in paragraph (1), by striking ``2017'' and inserting
``2022''; and
(2) in paragraph (5), by striking ``2017'' and inserting
``2022''.
SEC. 205. CONFORMITY ASSESSMENT PILOT PROGRAM.
(a) In General.--Section 514 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360d) is amended by adding at the end
the following:
``(d) Pilot Accreditation Scheme for Conformity
Assessment.--
``(1) In general.--The Secretary shall establish a pilot
program under which--
``(A) testing laboratories may be accredited, by
accreditation bodies meeting criteria specified by the
Secretary, to assess the conformance of a device with certain
standards recognized under this section; and
``(B) subject to paragraph (2), determinations by testing
laboratories so accredited that a device conforms with such
standard or standards shall be accepted by the Secretary for
purposes of demonstrating such conformity under this section
unless the Secretary finds that a particular such
determination shall not be so accepted.
``(2) Secretarial review of accredited laboratory
determinations.--The Secretary may--
``(A) review determinations by testing laboratories
accredited pursuant to this subsection, including by
conducting periodic audits of such determinations or
processes of accredited bodies or testing laboratories and,
following such review, taking additional measures under this
Act, such as suspension or withdrawal of accreditation of
such testing laboratory under paragraph (1)(A) or requesting
additional information with respect to such device, as the
Secretary determines appropriate; and
``(B) if the Secretary becomes aware of information
materially bearing on safety or effectiveness of a device
assessed for conformity by a testing laboratory so
accredited, take such additional measures under this Act as
the Secretary determines appropriate, such as suspension or
withdrawal of accreditation of such testing laboratory under
paragraph (1)(A), or requesting additional information with
regard to such device.
``(3) Implementation and reporting.--
``(A) Public meeting.--The Secretary shall publish in the
Federal Register a notice of a public meeting to be held no
later than September 30, 2018, to discuss and obtain input
and recommendations from stakeholders regarding the goals and
scope of, and a suitable framework and procedures and
requirements for, the pilot program under this subsection.
``(B) Pilot program guidance.--The Secretary shall--
``(i) not later than September 30, 2019, issue draft
guidance regarding the goals and implementation of the pilot
program under this subsection; and
``(ii) not later than September 30, 2021, issue final
guidance with respect to the implementation of such program.
``(C) Pilot program initiation.--Not later than September
30, 2020, the Secretary shall initiate the pilot program
under this subsection.
``(D) Report.--The Secretary shall make available on the
internet website of the Food and Drug Administration an
annual report on the progress of the pilot program under this
subsection.
``(4) Sunset.--As of October 1, 2022--
``(A) the authority for accreditation bodies to accredit
testing laboratories pursuant to paragraph (1)(A) shall cease
to have force or effect;
``(B) the Secretary--
``(i) may not accept a determination pursuant to paragraph
(1)(B) made by a testing laboratory after such date; and
``(ii) may accept such a determination made prior to such
date;
``(C) except for purposes of accepting a determination
described in subparagraph (B)(ii), the Secretary shall not
continue to recognize the accreditation of testing
laboratories accredited under paragraph (1)(A); and
``(D) the Secretary may take actions in accordance with
paragraph (2) with respect to the determinations made prior
to such date and recognition of the accreditation of testing
laboratories pursuant to determinations made prior to such
date.''.
SEC. 206. REAUTHORIZATION OF REVIEW.
Section 523 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360m) is amended--
(1) in subsection (a)(3)--
(A) in subparagraph (A), by striking clauses (ii) and (iii)
and inserting the following:
``(ii) a device classified under section 513(f)(2) or
designated under section 515C(d);
``(iii) a device that is intended to be permanently
implantable, life sustaining, or life supporting, unless
otherwise determined by the Secretary in accordance with
subparagraph (B)(i)(II) and listed as eligible for review
under subparagraph (B)(iii); or
``(iv) a device that is of a type, or subset of a type,
listed as not eligible for review under subparagraph
(B)(iii).'';
(B) by striking subparagraph (B) and inserting the
following:
``(B) Designation for review.--The Secretary shall--
``(i) issue draft guidance on the factors the Secretary
will use in determining whether a class I or class II device
type, or subset of such device types, is eligible for review
by an accredited person, including--
``(I) the risk of the device type, or subset of such device
type; and
``(II) whether the device type, or subset of such device
type, is permanently implantable, life sustaining, or life
supporting, and whether there is a detailed public health
justification for permitting the review by an accredited
person of such device type or subset;
``(ii) not later than 24 months after the date on which the
Secretary issues such draft guidance, finalize such guidance;
and
``(iii) beginning on the date such guidance is finalized,
designate and post on the internet website of the Food and
Drug Administration, an updated list of class I and class II
device types, or subsets of such device types, and the
Secretary's determination with respect to whether each such
device type, or subset of a device type, is eligible or not
eligible for review by an accredited person under this
section based on the factors described in clause (i).''; and
(C) by adding at the end the following:
``(C) Interim rule.--Until the date on which the updated
list is designated and posted in accordance with subparagraph
(B)(iii), the list in effect on the date of enactment the
Medical Device User Fee Amendments of 2017 shall be in
effect.'';
(2) in subsection (b)--
(A) in paragraph (2)--
(i) by striking subparagraph (D); and
(ii) by redesignating subparagraph (E) as subparagraph (D);
and
(B) in paragraph (3)--
(i) by redesignating subparagraph (E) as subparagraph (F);
(ii) in subparagraph (F) (as so redesignated), by striking
``The operations of'' and
[[Page H5458]]
all that follows through ``it will--'' and inserting ``Such
person shall agree, at a minimum, to include in its request
for accreditation a commitment to, at the time of
accreditation, and at any time it is performing any review
pursuant to this section--''; and
(iii) by inserting after subparagraph (D) the following new
subparagraph:
``(E) The operations of such person shall be in accordance
with generally accepted professional and ethical business
practices.''; and
(3) in subsection (c), by striking ``2017'' and inserting
``2022''.
SEC. 207. ELECTRONIC FORMAT FOR SUBMISSIONS.
Section 745A(b) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379k-1(b)) is amended by adding at the end the
following new paragraph:
``(3) Presubmissions and submissions solely in electronic
format.--
``(A) In general.--Beginning on such date as the Secretary
specifies in final guidance issued under subparagraph (C),
presubmissions and submissions for devices described in
paragraph (1) (and any appeals of action taken by the
Secretary with respect to such presubmissions or submissions)
shall be submitted solely in such electronic format as
specified by the Secretary in such guidance.
``(B) Draft guidance.--The Secretary shall, not later than
October 1, 2019, issue draft guidance providing for--
``(i) any further standards for the submission by
electronic format required under subparagraph (A);
``(ii) a timetable for the establishment by the Secretary
of such further standards; and
``(iii) criteria for waivers of and exemptions from the
requirements of this subsection.
``(C) Final guidance.--The Secretary shall, not later than
1 year after the close of the public comment period on the
draft guidance issued under subparagraph (B), issue final
guidance.''.
SEC. 208. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 3
of subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379i et seq.), as in effect on the
day before the date of the enactment of this title, shall
continue to be in effect with respect to the submissions
listed in section 738(a)(2)(A) of such Act (as defined in
such part as of such day) that on or after October 1, 2012,
but before October 1, 2017, 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 2018.
SEC. 209. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2017, 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, 2017, regardless of the date of the enactment of this Act.
SEC. 210. SUNSET DATES.
(a) Authorization.--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, 2022.
(b) Reporting Requirements.--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, 2023.
(c) Previous Sunset Provision.--Effective October 1, 2017,
section 207(a) of the Food and Drug Administration Safety and
Innovation Act (Public Law 112-144) is repealed.
TITLE III--FEES RELATING TO GENERIC DRUGS
SEC. 301. SHORT TITLE; FINDING.
(a) Short Title.--This title may be cited as the ``Generic
Drug User Fee Amendments of 2017''.
(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. DEFINITIONS.
Section 744A of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-41) is amended--
(1) in paragraph (1)(B), by striking ``application for a
positron emission tomography drug.'' and inserting
``application--
``(i) for a positron emission tomography drug; or
``(ii) submitted by a State or Federal governmental entity
for a drug that is not distributed commercially.'';
(2) by redesignating paragraphs (5) through (12) as
paragraphs (6) through (13), respectively; and
(3) by inserting after paragraph (4) the following:
``(5) The term `contract manufacturing organization
facility' means a manufacturing facility of a finished dosage
form of a drug approved pursuant to an abbreviated new drug
application, where such manufacturing facility is not
identified in an approved abbreviated new drug application
held by the owner of such facility or an affiliate of such
owner or facility.''.
SEC. 303. AUTHORITY TO ASSESS AND USE HUMAN GENERIC DRUG
FEES.
(a) Types of Fees.--Section 744B(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in paragraph (1), by adding at the end the following:
``(E) Sunset.--This paragraph shall cease to be effective
October 1, 2022.'';
(3) in paragraph (2)--
(A) by amending subparagraph (C) to read as follows:
``(C) Notice.--Not later than 60 days before the start of
each of fiscal years 2018 through 2022, the Secretary shall
publish in the Federal Register the amount of the drug master
file fee established by this paragraph for such fiscal
year.''; and
(B) in subparagraph (E)--
(i) in clause (i)--
(I) by striking ``no later than the date'' and inserting
``on the earlier of--
``(I) the date'';
(II) by striking the period and inserting ``; or''; and
(III) by adding at the end the following:
``(II) the date on which the drug master file holder
requests the initial completeness assessment.''; and
(ii) in clause (ii), by striking ``notice provided for in
clause (i) or (ii) of subparagraph (C), as applicable'' and
inserting ``notice provided for in subparagraph (C)'';
(4) in paragraph (3)--
(A) in the heading, by striking ``and prior approval
supplement'';
(B) in subparagraph (A), by striking ``or a prior approval
supplement to an abbreviated new drug application'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) Notice.--Not later than 60 days before the start of
each of fiscal years 2018 through 2022, the Secretary shall
publish in the Federal Register the amount of the fees under
subparagraph (A) for such fiscal year.
``(C) Fee due date.--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.'';
(D) in subparagraph (D)--
(i) in the heading, by inserting ``, is withdrawn prior to
being received, or is no longer received'' after
``received''; and
(ii) by striking ``The Secretary shall'' and all that
follows through the period and inserting the following:
``(i) Applications not considered to have been received and
applications withdrawn prior to being received.--The
Secretary shall refund 75 percent of the fee paid under
subparagraph (A) for any 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, or that has been withdrawn prior to
being received within the meaning of section 505(j)(5)(A).
``(ii) Applications no longer received.--The Secretary
shall refund 100 percent of the fee paid under subparagraph
(A) for any abbreviated new drug application if the Secretary
initially receives the application under section 505(j)(5)(A)
and subsequently determines that an exclusivity period for a
listed drug should have prevented the Secretary from
receiving such application, such that the abbreviated new
drug application is no longer received within the meaning of
section 505(j)(5)(A).'';
(E) in subparagraph (E), by striking ``or prior approval
supplement''; and
(F) in the matter preceding clause (i) of subparagraph
(F)--
(i) by striking ``2012'' and inserting ``2017''; and
(ii) by striking ``subsection (d)(3)'' and inserting
``subsection (d)(2)'';
(5) in paragraph (4)--
(A) in subparagraph (A)--
(i) in the matter preceding clause (i) and in clause (iii),
by striking ``, or intended to be identified, in at least one
generic drug submission that is pending or'' and inserting
``in at least one generic drug submission that is'';
(ii) in clause (i), by striking ``or intended to be
identified in at least one generic drug submission that is
pending or'' and inserting ``in at least one generic drug
submission that is'';
(iii) in clause (ii), by striking ``produces,'' and all
that follows through ``such a'' and inserting ``is identified
in at least one generic drug submission in which the facility
is approved to produce one or more active pharmaceutical
ingredients or in a Type II active pharmaceutical ingredient
drug master file referenced in at least one such''; and
(iv) in clause (iii), by striking ``to fees under both such
clauses'' and inserting ``only to the fee attributable to the
manufacture of the finished dosage forms''; and
(B) by amending subparagraphs (C) and (D) to read as
follows:
``(C) Notice.--Within the timeframe specified in subsection
(d)(1), the Secretary shall publish in the Federal Register
the amount of the fees under subparagraph (A) for such fiscal
year.
``(D) Fee due date.--For each of fiscal years 2018 through
2022, the fees under subparagraph (A) for such fiscal year
shall be due on the later of--
[[Page H5459]]
``(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 for such
year.'';
(6) by redesignating paragraph (5) as paragraph (6); and
(7) by inserting after paragraph (4) the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A generic drug applicant program fee
shall be assessed annually as described in subsection
(b)(2)(E).
``(B) Amount.--The amount of fees established under
subparagraph (A) shall be established under subsection (d).
``(C) Notice.--Within the timeframe specified in subsection
(d)(1), the Secretary shall publish in the Federal Register
the amount of the fees under subparagraph (A) for such fiscal
year.
``(D) Fee due date.--For each of fiscal years 2018 through
2022, 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 fiscal year; 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 fiscal year under this section
for such fiscal year.''.
(b) Fee Revenue Amounts.--Section 744B(b) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(b)) is
amended--
(1) in paragraph (1)--
(A) in subparagraph (A)--
(i) in the heading, by striking ``2013'' and inserting
``2018'';
(ii) by striking ``2013'' and inserting ``2018'';
(iii) by striking ``$299,000,000'' and inserting
``$493,600,000''; and
(iv) by striking ``Of that amount'' and all that follows
through the end of clause (ii); and
(B) in subparagraph (B)--
(i) in the heading, by striking ``2014 through 2017'' and
inserting ``2019 through 2022'';
(ii) by striking ``2014 through 2017'' and inserting ``2019
through 2022'';
(iii) by striking ``paragraphs (2) through (4)'' and
inserting ``paragraphs (2) through (5)''; and
(iv) by striking ``$299,000,000'' and inserting
``$493,600,000''; and
(2) in paragraph (2)--
(A) in the matter preceding subparagraph (A)--
(i) by striking ``paragraph (1)(A)(ii) for fiscal year 2013
and paragraph (1)(B) for each of fiscal years 2014 through
2017'' and inserting ``such paragraph for a fiscal year'';
and
(ii) by striking ``through (4)'' and inserting ``through
(5)'';
(B) in subparagraph (A), by striking ``Six percent'' and
inserting ``Five percent'';
(C) by amending subparagraphs (B) and (C) to read as
follows:
``(B) Thirty-three percent shall be derived from fees under
subsection (a)(3) (relating to abbreviated new drug
applications).
``(C) Twenty percent shall be derived from fees under
subsection (a)(4)(A)(i) (relating to generic drug
facilities). The amount of the fee for a contract
manufacturing organization facility shall be equal to one-
third the amount of the fee for a facility that is not a
contract manufacturing organization facility. The amount of
the fee for a facility located outside the United States and
its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United
States and its territories and possessions.'';
(D) in subparagraph (D)--
(i) by striking ``Fourteen percent'' and inserting ``Seven
percent'';
(ii) by striking ``not less than $15,000 and not more than
$30,000'' and inserting ``$15,000''; and
(iii) by striking ``, as determined'' and all that follows
through the period at the end and inserting a period; and
(E) by adding at the end the following:
``(E)(i) Thirty-five percent shall be derived from fees
under subsection (a)(5) (relating to generic drug applicant
program fees). For purposes of this subparagraph, if a person
has affiliates, a single program fee shall be assessed with
respect to that person, including its affiliates, and may be
paid by that person or any one of its affiliates. The
Secretary shall determine the fees as follows:
``(I) If a person (including its affiliates) owns at least
one but not more than 5 approved abbreviated new drug
applications on the due date for the fee under this
subsection, the person (including its affiliates) shall be
assessed a small business generic drug applicant program fee
equal to one-tenth of the large size operation generic drug
applicant program fee.
``(II) If a person (including its affiliates) owns at least
6 but not more than 19 approved abbreviated new drug
applications on the due date for the fee under this
subsection, the person (including its affiliates) shall be
assessed a medium size operation generic drug applicant
program fee equal to two-fifths of the large size operation
generic drug applicant program fee.
``(III) If a person (including its affiliates) owns 20 or
more approved abbreviated new drug applications on the due
date for the fee under this subsection, the person (including
its affiliates) shall be assessed a large size operation
generic drug applicant program fee.
``(ii) For purposes of this subparagraph, an abbreviated
new drug application shall be deemed not to be approved if
the applicant has submitted a written request for withdrawal
of approval of such abbreviated new drug application by April
1 of the previous fiscal year.''.
(c) Adjustments.--Section 744B(c) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(c)) is amended--
(1) in paragraph (1)--
(A) by striking ``2014'' and inserting ``2019'';
(B) by inserting ``to equal the product of the total
revenues established in such notice for the prior fiscal year
multiplied'' after ``a fiscal year,''; and
(C) by striking the flush text following subparagraph (C);
and
(2) in paragraph (2)--
(A) by striking ``2017'' each place it appears and
inserting ``2022'';
(B) by striking ``the first 3 months of fiscal year 2018''
and inserting ``the first 3 months of fiscal year 2023''; and
(C) by striking ``Such fees may only be used in fiscal year
2018.''.
(d) Annual Fee Setting.--Section 744B(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(d)) is
amended--
(1) by striking paragraphs (1) and (2) and inserting the
following:
``(1) Fiscal years 2018 through 2022.--Not more than 60
days before the first day of each of fiscal years 2018
through 2022, the Secretary shall establish the fees
described in paragraphs (2) through (5) of subsection (a),
based on the revenue amounts established under subsection (b)
and the adjustments provided under subsection (c).'';
(2) by redesignating paragraph (3) as paragraph (2); and
(3) in paragraph (2) (as so redesignated), in the matter
preceding subparagraph (A), by striking ``fees under
paragraphs (1) and (2)'' and inserting ``fee under paragraph
(1)''.
(e) Identification of Facilities.--Section 744B(f) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(f))
is amended--
(1) by striking paragraph (1);
(2) by redesignating paragraphs (2) through (4) as
paragraphs (1) through (3), respectively;
(3) in paragraph (1) (as so redesignated)--
(A) by striking ``paragraph (4)'' and inserting ``paragraph
(3)''; and
(B) by striking ``Such information shall'' and all that
follows through the end of subparagraph (B) and inserting
``Such information shall, for each fiscal year, be submitted,
updated, or reconfirmed on or before June 1 of the previous
fiscal year.''; and
(4) in paragraph (2), as so redesignated--
(A) in the heading, by striking ``Contents of notice'' and
inserting ``Information required to be submitted'';
(B) in the matter preceding subparagraph (A), by striking
``paragraph (2)'' and inserting ``paragraph (1)'';
(C) in subparagraph (A), by striking ``or intended to be
identified'';
(D) in subparagraph (D), by striking ``and'' at the end;
(E) in subparagraph (E), by striking the period and
inserting ``; and''; and
(F) by adding at the end the following:
``(F) whether the facility is a contract manufacturing
organization facility.''.
(f) Effect of Failure To Pay Fees.--Section 744B(g) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42(g))
is amended--
(1) in paragraph (1), by adding at the end the following:
``This paragraph shall cease to be effective on October 1,
2022.'';
(2) in paragraph (2)(C)(ii), by striking ``of
505(j)(5)(A)'' and inserting ``of section 505(j)(5)(A)''; and
(3) by adding at the end the following:
``(5) Generic drug applicant program fee.--
``(A) In general.--A person who fails to pay a fee as
required under subsection (a)(5) by the date that is 20
calendar days after the due date, as specified in
subparagraph (D) of such subsection, shall be subject to the
following:
``(i) The Secretary shall place the person on a publicly
available arrears list.
``(ii) Any abbreviated new drug application submitted by
the generic drug applicant or an affiliate of such applicant
shall not be received, within the meaning of section
505(j)(5)(A).
``(iii) All drugs marketed pursuant to any abbreviated new
drug application held by such applicant or an affiliate of
such applicant shall be deemed misbranded under section
502(aa).
``(B) Application of penalties.--The penalties under
subparagraph (A) shall apply until the fee required under
subsection (a)(5) is paid.''.
(g) Limitations.--Section 744B(h)(2) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-42(h)(2)) is amended
by striking ``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''.
(h) Crediting and Availability of Fees.--Section 744B(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
42(i)) is amended--
(1) in paragraph (2)--
(A) in subparagraph (A), by striking ``subparagraphs (C)
and (D)'' and inserting ``subparagraph (C)'';
(B) by striking subparagraph (C) (relating to fee
collection during first program year);
(C) in subparagraph (D)--
(i) in the heading, by striking ``in subsequent years'';
and
[[Page H5460]]
(ii) by striking ``(after fiscal year 2013)''; and
(D) by redesignating subparagraph (D) as subparagraph (C);
and
(2) in paragraph (3), by striking ``fiscal years 2013
through 2017'' and inserting ``fiscal years 2018 through
2022''.
(i) Information on Abbreviated New Drug Applications Owned
by Applicants and Their Affiliates.--Section 744B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-42) is
amended by adding at the end the following:
``(o) Information on Abbreviated New Drug Applications
Owned by Applicants and Their Affiliates.--
``(1) In general.--By April 1 of each year, each person
that owns an abbreviated new drug application, or a
designated affiliate of such person, shall submit, on behalf
of the person and the affiliates of such person, to the
Secretary a list of--
``(A) all approved abbreviated new drug applications owned
by such person; and
``(B) if any affiliate of such person also owns an
abbreviated new drug application, all affiliates that own any
such abbreviated new drug application and all approved
abbreviated new drug applications owned by any such
affiliate.
``(2) Format and method.--The Secretary shall specify in
guidance the format and method for submission of lists under
this subsection.''.
SEC. 304. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744C of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-43) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Generic Drug User Fee Amendments of
2012'' and inserting ``Generic Drug User Fee Amendments of
2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018''; and
(3) in subsection (d), by striking ``2017'' each place it
appears and inserting ``2022''.
SEC. 305. SUNSET DATES.
(a) Authorization.--Sections 744A and 744B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-41; 379j-42)
shall cease to be effective October 1, 2022.
(b) Reporting Requirements.--Section 744C of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43) shall cease
to be effective January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 304 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 304.
SEC. 306. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2017, or the date of the enactment of this Act,
whichever is later, except that fees under part 7 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all abbreviated new drug
applications received on or after October 1, 2017, regardless
of the date of the enactment of this Act.
SEC. 307. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 7
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 abbreviated new drug applications (as defined in
such part as of such day) that were received by the Food and
Drug Administration within the meaning of section
505(j)(5)(A) of such Act (21 U.S.C. 355(j)(5)(A)), prior
approval supplements that were submitted, and drug master
files for Type II active pharmaceutical ingredients that were
first referenced on or after October 1, 2012, but before
October 1, 2017, with respect to assessing and collecting any
fee required by such part for a fiscal year prior to fiscal
year 2018.
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 Amendments of 2017''.
(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. DEFINITIONS.
(a) Adjustment Factor.--Section 744G(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(1)) is
amended to read as follows:
``(1) The term `adjustment factor' applicable to a fiscal
year is the Consumer Price Index for urban consumers
(Washington-Baltimore, DC-MD-VA-WV; Not Seasonally Adjusted;
All items) for October of the preceding fiscal year divided
by such Index for October 2011.''.
(b) Biosimilar Biological Product.--Section 744G(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-51(3))
is amended by striking ``means a product'' and inserting
``means a specific strength of a biological product in final
dosage form''.
SEC. 403. AUTHORITY TO ASSESS AND USE BIOSIMILAR FEES.
(a) Types of Fees.--Section 744H(a) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-52(a)) is amended--
(1) in the matter preceding paragraph (1), by striking
``fiscal year 2013'' and inserting ``fiscal year 2018'';
(2) in the heading of paragraph (1), by striking
``Biosimilar'' and inserting ``Biosimilar biological
product'';
(3) in paragraph (1)(A)(i), by striking ``(b)(1)(A)'' and
inserting ``(c)(5)'';
(4) in paragraph (1)(B)(i), by striking ``(b)(1)(B) for
biosimilar biological product development'' and inserting
``(c)(5) for the biosimilar biological product development
program'';
(5) in paragraph (1)(B)(ii), by striking ``annual
biosimilar biological product development program fee'' and
inserting ``annual biosimilar biological product development
fee'';
(6) in paragraph (1)(B)(iii), by striking ``annual
biosimilar development program fee'' and inserting ``annual
biosimilar biological product development fee'';
(7) in paragraph (1)(B), by adding at the end the
following:
``(iv) Refund.--If a person submits a marketing application
for a biosimilar biological product before October 1 of a
fiscal year and such application is accepted for filing on or
after October 1 of such fiscal year, the person may request a
refund equal to the annual biosimilar biological product
development fee paid by the person for the product for such
fiscal year. To qualify for consideration for a refund under
this clause, a person shall submit to the Secretary a written
request for such refund not later than 180 days after the
marketing application is accepted for filing.'';
(8) in paragraph (1)(C), by striking ``for a product
effective October 1 of a fiscal year by,'' and inserting
``for a product, effective October 1 of a fiscal year, by,'';
(9) in paragraph (1)(D)--
(A) in clause (i) in the matter preceding subclause (I), by
inserting ``, if the person seeks to resume participation in
such program,'' before ``pay a fee'';
(B) in clause (i)(I), by inserting after ``grants a
request'' the following: ``by such person''; and
(C) in clause (i)(II), by inserting after ``discontinued)''
the following: ``by such person'';
(10) in the heading of paragraph (1)(E), by striking
``biosimilar development program'';
(11) in paragraph (1)(F)--
(A) in the subparagraph heading, by striking ``biosimilar
development program''; and
(B) by amending clause (i) to read as follows:
``(i) Refunds.--Except as provided in subparagraph (B)(iv),
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).'';
(12) in paragraph (2)--
(A) in the paragraph heading, by striking ``and
supplement'';
(B) by amending subparagraphs (A) and (B) to read as
follows:
``(A) In general.--Each person that submits, on or after
October 1, 2017, a biosimilar biological product application
shall be subject to the following fees:
``(i) A fee established under subsection (c)(5) 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.
``(ii) A fee established under subsection (c)(5) for a
biosimilar biological product application for which clinical
data (other than comparative bioavailability studies) with
respect to safety or effectiveness are not required for
approval. Such fee shall be equal to half of the amount of
the fee described in clause (i).
``(B) Rule of applicability; treatment of certain
previously paid fees.--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--
``(i) be subject to any biosimilar biological product
application fees that may be assessed at the time when such
biosimilar biological product application is submitted; and
``(ii) be entitled to no reduction of such application fees
based on the amount of fees paid for that product before
October 1, 2017, under such subparagraph (A), (B), or (D).'';
(C) in the heading of subparagraph (D), by striking ``or
supplement'';
(D) in subparagraphs (C) through (F), by striking ``or
supplement'' each place it appears; and
(E) in subparagraph (D), by striking ``or a supplement'';
(13) by amending paragraph (3) to read as follows:
``(3) Biosimilar biological product program fee.--
``(A) In general.--Each person who is named as the
applicant in a biosimilar biological product application
shall pay the annual biosimilar biological product program
[[Page H5461]]
fee established for a fiscal year under subsection (c)(5) for
each biosimilar biological product that--
``(i) is identified in such a biosimilar biological product
application approved as of October 1 of such fiscal year; and
``(ii) as of October 1 of such fiscal year, does not appear
on a list, developed and maintained by the Secretary, of
discontinued biosimilar biological products.
``(B) Due date.--The biosimilar biological product program
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 program fee shall be paid only once for
each product for each fiscal year.
``(D) Limitation.--A person who is named as the applicant
in a biosimilar biological product application shall not be
assessed more than 5 biosimilar biological product program
fees for a fiscal year for biosimilar biological products
identified in such biosimilar biological product
application.''.
(b) Fee Revenue Amounts.--Subsection (b) of section 744H of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52)
is amended to read as follows:
``(b) Fee Revenue Amounts.--
``(1) Fiscal year 2018.--For fiscal year 2018, fees under
subsection (a) shall be established to generate a total
revenue amount equal to the sum of--
``(A) $45,000,000; and
``(B) the dollar amount equal to the fiscal year 2018
adjustment (as determined under subsection (c)(4)).
``(2) Subsequent fiscal years.--For each of the fiscal
years 2019 through 2022, fees under subsection (a) shall,
except as provided in subsection (c), be established to
generate a total revenue amount equal to the sum of--
``(A) the annual base revenue for the fiscal year (as
determined under paragraph (4));
``(B) the dollar amount equal to the inflation adjustment
for the fiscal year (as determined under subsection (c)(1));
``(C) the dollar amount equal to the capacity planning
adjustment for the fiscal year (as determined under
subsection (c)(2)); and
``(D) the dollar amount equal to the operating reserve
adjustment for the fiscal year, if applicable (as determined
under subsection (c)(3)).
``(3) Allocation of revenue amount among fees; limitations
on fee amounts.--
``(A) Allocation.--The Secretary shall determine the
percentage of the total revenue amount for a fiscal year to
be derived from, respectively--
``(i) initial and annual biosimilar biological product
development fees and reactivation fees under subsection
(a)(1);
``(ii) biosimilar biological product application fees under
subsection (a)(2); and
``(iii) biosimilar biological product program fees under
subsection (a)(3).
``(B) Limitations on fee amounts.--Until the first fiscal
year for which the capacity planning adjustment under
subsection (c)(2) is effective, the amount of any fee under
subsection (a) for a fiscal year after fiscal year 2018 shall
not exceed 125 percent of the amount of such fee for fiscal
year 2018.
``(C) Biosimilar biological product development fees.--The
initial biosimilar biological product development fee under
subsection (a)(1)(A) for a fiscal year shall be equal to the
annual biosimilar biological product development fee under
subsection (a)(1)(B) for that fiscal year.
``(D) Reactivation fee.--The reactivation fee under
subsection (a)(1)(D) for a fiscal year shall be equal to
twice the amount of the annual biosimilar biological product
development fee under subsection (a)(1)(B) for that fiscal
year.
``(4) Annual base revenue.--For purposes of paragraph (2),
the dollar amount of the annual base revenue for a fiscal
year shall be the dollar amount of the total revenue amount
for the previous fiscal year, excluding any adjustments to
such revenue amount under subsection (c)(3).''.
(c) Adjustments; Annual Fee Setting.--Section 744H of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-52) is
amended--
(1) by redesignating subsections (c) through (h) as
subsections (d) through (i), respectively;
(2) in subsections (a)(2)(F) and (h) (as redesignated by
paragraph (1)), by striking ``subsection (c)'' and inserting
``subsection (d)'';
(3) in subsection (a)(4)(A), by striking ``subsection
(b)(1)(F)'' and inserting ``subsection (c)(5)''; and
(4) by inserting after subsection (b) the following:
``(c) Adjustments; Annual Fee Setting.--
``(1) Inflation adjustment.--
``(A) In general.--For purposes of subsection (b)(2)(B),
the dollar amount of the inflation adjustment to the annual
base revenue for each fiscal year shall be equal to the
product of--
``(i) such annual base revenue for the fiscal year under
subsection (b); and
``(ii) the inflation adjustment percentage under
subparagraph (B).
``(B) Inflation adjustment percentage.--The inflation
adjustment percentage under this subparagraph for a fiscal
year is equal to the sum of--
``(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 the proportion of
personnel compensation and benefits costs to total costs of
the process for the review of biosimilar biological product
applications (as defined in section 744G(13)) for the first 3
years of the preceding 4 fiscal years; 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 the proportion of all costs
other than personnel compensation and benefits costs to total
costs of the process for the review of biosimilar biological
product applications (as defined in section 744G(13)) for the
first 3 years of the preceding 4 fiscal years.
``(2) Capacity planning adjustment.--
``(A) In general.--Beginning with the fiscal year described
in subparagraph (B)(ii)(II), the Secretary shall, in addition
to the adjustment under paragraph (1), further increase the
fee revenue and fees under this section for a fiscal year to
reflect changes in the resource capacity needs of the
Secretary for the process for the review of biosimilar
biological product applications.
``(B) Capacity planning methodology.--
``(i) Development; evaluation and report.--The Secretary
shall obtain, through a contract with an independent
accounting or consulting firm, a report evaluating options
and recommendations for a new methodology to accurately
assess changes in the resource and capacity needs of the
process for the review of biosimilar biological product
applications. The capacity planning methodological options
and recommendations presented in such report shall utilize
and be informed by personnel time reporting data as an input.
The report shall be published for public comment not later
than September 30, 2020.
``(ii) Establishment and implementation.--After review of
the report described in clause (i) and receipt and review of
public comments thereon, the Secretary shall establish a
capacity planning methodology for purposes of this paragraph,
which shall--
``(I) incorporate such approaches and attributes as the
Secretary determines appropriate; and
``(II) be effective beginning with the first fiscal year
for which fees are set after such capacity planning
methodology is established.
``(C) Limitation.--Under no circumstances shall an
adjustment under this paragraph result in fee revenue for a
fiscal year that is less than the sum of the amounts under
subsections (b)(2)(A) (the annual base revenue for the fiscal
year) and (b)(2)(B) (the dollar amount of the inflation
adjustment for the fiscal year).
``(D) Publication in federal register.--The Secretary shall
publish in the Federal Register notice under paragraph (5)
the fee revenue and fees resulting from the adjustment and
the methodologies under this paragraph.
``(3) Operating reserve adjustment.--
``(A) Interim application; fee reduction.--Until the first
fiscal year for which the capacity planning adjustment under
paragraph (2) is effective, the Secretary may, in addition to
the adjustment under paragraph (1), reduce the fee revenue
and fees under this section for a fiscal year as the
Secretary determines appropriate for long-term financial
planning purposes.
``(B) General application and methodology.--Beginning with
the first fiscal year for which the capacity planning
adjustment under paragraph (2) is effective, the Secretary
may, in addition to the adjustments under paragraphs (1) and
(2)--
``(i) reduce the fee revenue and fees under this section as
the Secretary determines appropriate for long-term financial
planning purposes; or
``(ii) increase the fee revenue and fees under this section
if such an adjustment is necessary to provide for not more
than 21 weeks of operating reserves of carryover user fees
for the process for the review of biosimilar biological
product applications.
``(C) Federal register notice.--If an adjustment under
subparagraph (A) or (B) is made, the rationale for the amount
of the increase or decrease (as applicable) in fee revenue
and fees shall be contained in the annual Federal Register
notice under paragraph (5)(B) establishing fee revenue and
fees for the fiscal year involved.
``(4) Fiscal year 2018 adjustment.--
``(A) In general.--For fiscal year 2018, the Secretary
shall adjust the fee revenue and fees under this section in
such amount (if any) as needed to reflect an updated
assessment of the workload for the process for the review of
biosimilar biological product applications.
``(B) Methodology.--The Secretary shall publish under
paragraph (5)(B) a description of the methodology used to
calculate the fiscal year 2018 adjustment under this
paragraph in the Federal Register notice establishing fee
revenue and fees for fiscal year 2018.
``(C) Limitation.--No adjustment under this paragraph shall
result in an increase in fee revenue and fees under this
section in excess of $9,000,000.
[[Page H5462]]
``(5) Annual fee setting.--For fiscal year 2018 and each
subsequent fiscal year, the Secretary shall, not later than
60 days before the start of each such fiscal year--
``(A) establish, for the fiscal year, initial and annual
biosimilar biological product development fees and
reactivation fees under subsection (a)(1), biosimilar
biological product application fees under subsection (a)(2),
and biosimilar biological product program fees under
subsection (a)(3), based on the revenue amounts established
under subsection (b) and the adjustments provided under this
subsection; and
``(B) publish such fee revenue and fees in the Federal
Register.
``(6) Limit.--The total amount of fees assessed for a
fiscal year under this section may not exceed the total costs
for such fiscal year for the resources allocated for the
process for the review of biosimilar biological product
applications.''.
(d) Application Fee Waiver for Small Business.--Subsection
(d)(1) of section 744H of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-52), as redesignated by
subsection (c)(1), is amended--
(1) by striking subparagraph (B);
(2) by striking ``; and'' at the end of subparagraph (A)
and inserting a period; and
(3) by striking ``shall pay--'' and all that follows
through ``application fees'' and inserting ``shall pay
application fees''.
(e) Effect of Failure To Pay Fees.--Subsection (e) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52), as redesignated by subsection (c)(1), is
amended by striking ``all fees'' and inserting ``all such
fees''.
(f) Crediting and Availability of Fees.--Subsection (f) of
section 744H of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-52), as redesignated by subsection (c)(1), is
amended--
(1) in paragraph (2)--
(A) by striking subparagraph (C) (relating to fee
collection during first program year) and inserting the
following:
``(C) Compliance.--The Secretary shall be considered to
have met the requirements of subparagraph (B) in any fiscal
year if the costs described in such subparagraph are not more
than 15 percent below the level specified in such
subparagraph.''; and
(B) in subparagraph (D)--
(i) in the heading, by striking ``in subsequent years'';
and
(ii) by striking ``(after fiscal year 2013)''; and
(2) in paragraph (3), by striking ``2013 through 2017'' and
inserting ``2018 through 2022''.
SEC. 404. REAUTHORIZATION; REPORTING REQUIREMENTS.
Section 744I of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 379j-53) is amended--
(1) in subsection (a)--
(A) by striking ``2013'' and inserting ``2018''; and
(B) by striking ``Biosimilar User Fee Act of 2012'' and
inserting ``Biosimilar User Fee Amendments of 2017'';
(2) in subsection (b), by striking ``2013'' and inserting
``2018'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in subsection (d), as so redesignated, by striking
``2017'' each place it appears and inserting ``2022''.
SEC. 405. SUNSET DATES.
(a) Authorization.--Sections 744G and 744H of the Federal
Food, Drug, and Cosmetic Act shall cease to be effective
October 1, 2022.
(b) Reporting Requirements.--Section 744I of the Federal
Food, Drug, and Cosmetic Act shall cease to be effective
January 31, 2023.
(c) Previous Sunset Provision.--
(1) In general.--Effective October 1, 2017, section 404 of
the Food and Drug Administration Safety and Innovation Act
(Public Law 112-144) is repealed.
(2) Conforming amendment.--The Food and Drug Administration
Safety and Innovation Act (Public Law 112-144) is amended in
the table of contents in section 2 by striking the item
relating to section 404.
SEC. 406. EFFECTIVE DATE.
The amendments made by this title shall take effect on
October 1, 2017, or the date of the enactment of this Act,
whichever is later, except that fees under part 8 of
subchapter C of chapter VII of the Federal Food, Drug, and
Cosmetic Act shall be assessed for all biosimilar biological
product applications received on or after October 1, 2017,
regardless of the date of the enactment of this Act.
SEC. 407. SAVINGS CLAUSE.
Notwithstanding the amendments made by this title, part 8
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 biosimilar biological product 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, 2012, but before October 1, 2017, with
respect to assessing and collecting any fee required by such
part for a fiscal year prior to fiscal year 2018.
TITLE V--PEDIATRIC DRUGS AND DEVICES
SEC. 501. BEST PHARMACEUTICALS FOR CHILDREN.
Section 409I of the Public Health Service Act (42 U.S.C.
284m) is amended--
(1) in subsection (a)(2)(A)(ii), by inserting ``and
identification of biomarkers for such diseases, disorders, or
conditions,'' after ``biologics,'';
(2) in subsection (c)--
(A) in paragraph (6)--
(i) by amending subparagraph (B) to read as follows:
``(B) Availability of reports.--
``(i) In general.--Each report submitted under subparagraph
(A) shall be considered to be in the public domain (subject
to section 505A(d)(4) of the Federal Food, Drug, and Cosmetic
Act) and not later than 90 days after submission of such
report, shall be--
``(I) posted on the internet website of the National
Institutes of Health in a manner that is accessible and
consistent with all applicable Federal laws and regulations,
including such laws and regulations for the protection of--
``(aa) human research participants, including with respect
to privacy, security, informed consent, and protected health
information; and
``(bb) proprietary interests, confidential commercial
information, and intellectual property rights; and
``(II) assigned a docket number by the Commissioner of Food
and Drugs and made available for the submission of public
comments.
``(ii) Submission of comments.--An interested person may
submit written comments concerning such pediatric studies to
the Commissioner of Food and Drugs, and the submitted
comments shall become part of the docket file with respect to
each of the drugs.''; and
(ii) in subparagraph (C), by striking ``appropriate
action'' and all that follows through the period and
inserting ``action in a timely and appropriate manner in
response to the reports submitted under subparagraph (A), and
shall begin such action upon receipt of the report under
subparagraph (A), in accordance with paragraph (7).''; and
(B) in paragraph (7)--
(i) in the matter preceding subparagraph (A), by striking
``During'' and inserting ``Within'';
(ii) in subparagraph (C)(i), by striking ``place'' and all
that follows through ``and of'' and inserting ``include in
the public docket file a reference to the location of the
report on the internet website of the National Institutes of
Health and a copy of''; and
(iii) in clause (ii), by striking ``in the Federal Register
and'';
(3) by striking subsection (d);
(4) by redesignating subsection (e) as subsection (d); and
(5) in paragraph (1) of subsection (d), as so redesignated,
by striking ``2013 through 2017'' and inserting ``2018
through 2022''.
SEC. 502. PEDIATRIC DEVICES.
(a) Pediatric Use of Devices.--Section 515A(a)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-1(a)(3))
is amended--
(1) by redesignating subparagraphs (B) through (D) as
subparagraphs (D) through (F), respectively;
(2) by inserting after subparagraph (A) the following:
``(B) any information, based on a review of data available
to the Secretary, regarding devices used in pediatric
patients but not labeled for such use for which the Secretary
determines that approved pediatric labeling could confer a
benefit to pediatric patients;
``(C) the number of pediatric devices that receive a
humanitarian use exemption under section 520(m);'';
(3) in subparagraph (E), as so redesignated, by striking
``; and'' and inserting ``;'';
(4) in subparagraph (F) (as so redesignated), by striking
``(B), and (C).'' and inserting ``(C), (D), and (E);''; and
(5) by adding at the end the following:
``(G) the number of devices for which the Secretary relied
on data with respect to adults to support a determination of
a reasonable assurance of safety and effectiveness in
pediatric patients; and
``(H) the number of devices for which the Secretary relied
on data from one pediatric subpopulation to support a
determination of a reasonable assurance of safety and
effectiveness in another pediatric subpopulation.
For the items described in this paragraph, such report shall
disaggregate the number of devices by pediatric
subpopulation.''.
(b) Humanitarian Device Exemption.--Section 520(m) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)) is
amended--
(1) in paragraph (4)--
(A) in subparagraph (B), by inserting ``or an appropriate
local committee'' after ``review committee'' each place such
term appears; and
(B) in the matter following subparagraph (B), by inserting
``or an appropriate local committee'' after ``review
committee'' each place such term appears; and
(2) in paragraph (6)(A)(iv), by striking ``2017'' and
inserting ``2022''.
(c) Demonstration Grants for Improving Pediatric
Availability.--Section 305 of the Pediatric Medical Device
Safety and Improvement Act of 2007 (Public Law 110-85; 42
U.S.C. 282 note)) is amended--
(1) in subsection (c)--
(A) in paragraph (4), by striking ``and'' at the end;
(B) in paragraph (5), by striking the period and inserting
``; and''; and
(C) by adding at the end the following:
``(6) providing regulatory consultation to device sponsors
in support of the submission
[[Page H5463]]
of an application for a pediatric device, where
appropriate.''; and
(2) in subsection (e), by striking ``2013 through 2017''
and inserting ``2018 through 2022''.
(d) Meeting on Pediatric Device Development.--
(1) In general.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall convene a public meeting on the development,
approval or clearance, and labeling of pediatric medical
devices. The Secretary shall invite to such meeting
representatives from the medical device industry, academia,
recipients of funding under section 305 of the Pediatric
Medical Device Safety and Improvement Act of 2007 (Public Law
110-85; 42 U.S.C. 282 note), medical provider organizations,
and organizations representing patients and consumers.
(2) Topics.--The meeting described in paragraph (1) shall
include consideration of ways to--
(A) improve research infrastructure and research networks
to facilitate the conduct of clinical studies of devices for
pediatric populations that would result in the approval or
clearance, and labeling, of medical devices for such
populations;
(B) appropriately use extrapolation under section 515A(b)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
1(b));
(C) enhance the appropriate use of postmarket registries
and data to increase pediatric medical device labeling;
(D) increase Food and Drug Administration assistance to
medical device manufacturers in developing devices for
pediatric populations that are approved or cleared, and
labeled, for their use; and
(E) identify current barriers to pediatric device
development and incentives to address such barriers.
(3) Report.--The report submitted under section 515A(a)(3)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e-
1(a)(3)) with respect to the calendar year in which the
meeting described in paragraph (1) is held shall include a
summary of, and responses to, recommendations raised in such
meeting.
SEC. 503. EARLY MEETING ON PEDIATRIC STUDY PLAN.
(a) In General.--Clause (i) of section 505B(e)(2)(C) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(e)(2)(C)) is amended to read as follows:
``(i) shall meet with the applicant--
``(I) if requested by the applicant with respect to a drug
or biological product that is intended to treat a serious or
life-threatening disease or condition, to discuss preparation
of the initial pediatric study plan, not later than the end-
of-Phase 1 meeting (as such term is used in section 312.82(b)
of title 21, Code of Federal Regulations, or successor
regulations) or within 30 calendar days of receipt of such
request, whichever is later;
``(II) 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); and
``(III) to discuss the bases for the deferral under
subsection (a)(4) or a full or partial waiver under
subsection (a)(5);''.
(b) Conforming Changes.--Section 505B(e) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c(e)) is amended--
(1) in the heading of paragraph (2), by striking
``meeting'' and inserting ``meetings'';
(2) in the heading of paragraph (2)(C), by striking
``Meeting'' and inserting ``Meetings'';
(3) in clauses (ii) and (iii) of paragraph (2)(C), by
striking ``no meeting'' each place it appears and inserting
``no meeting under clause (i)(II)''; and
(4) in paragraph (3) by striking ``meeting under paragraph
(2)(C)(i)'' and inserting ``meeting under paragraph
(2)(C)(i)(II)''.
SEC. 504. DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS FOR
PEDIATRIC CANCERS.
(a) Molecular Targets Regarding Cancer Drugs and Biological
Products.--Section 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c) is amended--
(1) in subsection (a)--
(A) in paragraph (1)--
(i) by redesignating subparagraphs (A) and (B) as clauses
(i) and (ii), respectively, and adjusting the margins
accordingly;
(ii) by striking ``A person'' and inserting the following:
``(A) General requirements.--Except with respect to an
application for which subparagraph (B) applies, a person'';
(iii) in clause (i), as so redesignated, by striking ``,
or'' at the end and inserting ``; or''; and
(iv) by adding after subparagraph (A), as so designated by
clause (ii), the following:
``(B) Certain molecularly targeted cancer indications.--A
person that submits, on or after the date that is 3 years
after the date of enactment of the FDA Reauthorization Act of
2017, an original application for a new active ingredient
under section 505 of this Act or section 351 of the Public
Health Service Act, shall submit with the application reports
on the investigation described in paragraph (3) if the drug
or biological product that is the subject of the application
is--
``(i) intended for the treatment of an adult cancer; and
``(ii) directed at a molecular target that the Secretary
determines to be substantially relevant to the growth or
progression of a pediatric cancer.'';
(B) in paragraph (2)(A), by striking ``paragraph (1)'' and
inserting ``paragraph (1)(A)'';
(C) by redesignating paragraphs (3) and (4) as paragraphs
(4) and (5), respectively;
(D) by inserting after paragraph (2) the following:
``(3) Molecularly targeted pediatric cancer
investigation.--
``(A) In general.--With respect to a drug or biological
product described in paragraph (1)(B), the investigation
described in this paragraph is a molecularly targeted
pediatric cancer investigation, which shall be designed to
yield clinically meaningful pediatric study data, gathered
using appropriate formulations for each age group for which
the study is required, regarding dosing, safety, and
preliminary efficacy to inform potential pediatric labeling.
``(B) Extrapolation of data.--Paragraph (2)(B) shall apply
to investigations described in this paragraph to the same
extent and in the same manner as paragraph (2)(B) applies
with respect to the assessments required under paragraph
(1)(A).
``(C) Deferrals and waivers.--Deferrals and waivers under
paragraphs (4) and (5) shall apply to investigations
described in this paragraph to the same extent and in the
same manner as such deferrals and waivers apply with respect
to the assessments under paragraph (2)(B).'';
(E) in paragraph (4), as so redesignated--
(i) by striking ``assessments required under paragraph
(1)'' each place it appears and inserting ``assessments
required under paragraph (1)(A) or reports on the
investigation required under paragraph (1)(B)'';
(ii) in subparagraph (A)(ii)(I), by inserting ``or reports
on the investigation'' after ``assessments'';
(iii) in subparagraph (B)(ii), by striking ``assessment
under paragraph (1)'' and inserting ``assessment under
paragraph (1)(A) or reports on the investigation under
paragraph (1)(B)''; and
(iv) in subparagraph (C)(ii)(II), by inserting ``or
investigation'' after ``assessment''; and
(F) in paragraph (5), as so redesignated, by inserting ``or
reports on the investigation'' after ``assessments'' each
place it appears;
(2) in subsection (d)--
(A) by striking ``subsection (a)(3)'' each place it appears
and inserting ``subsection (a)(4)'';
(B) by inserting ``and Reports on the Investigation'' after
``Submission of Assessments'' in the heading; and
(C) by inserting ``or the investigation described in
subsection (a)(3)'' after ``assessment described in
subsection (a)(2)'' each place it appears;
(3) in subsection (e)--
(A) in paragraph (1), by inserting ``or the investigation
described in subsection (a)(3)'' after ``under subsection
(a)(2)''; and
(B) in paragraph (2)(A)(i), by inserting ``or the
investigation described in subsection (a)(3)'' after ``under
subsection (a)(2)''; and
(4) by adding at the end the following:
``(m) List of Primary Molecular Targets.--
``(1) In general.--Within one year of the date of enactment
of the FDA Reauthorization Act of 2017, the Secretary shall
establish and update regularly, and shall publish on the
internet website of the Food and Drug Administration--
``(A) a list of molecular targets considered, on the basis
of data the Secretary determines to be adequate, to be
substantially relevant to the growth and progression of a
pediatric cancer, and that may trigger the requirements under
this section; and
``(B) a list of molecular targets of new cancer drugs and
biological products in development for which pediatric cancer
study requirements under this section will be automatically
waived.
``(2) Consultation.--In establishing the lists described in
paragraph (1), the Secretary shall consult the National
Cancer Institute, members of the internal committee under
section 505C, and the Pediatric Oncology Subcommittee of the
Oncologic Drugs Advisory Committee, and shall take into
account comments from the meeting under subsection (c).
``(3) Rule of construction.--Nothing in paragraph (1) shall
be construed--
``(A) to require the inclusion of a molecular target on the
list published under such paragraph as a condition for
triggering the requirements under subsection (a)(1)(B) with
respect to a drug or biological product directed at such
molecular target; or
``(B) to authorize the disclosure of confidential
commercial information, as prohibited under section 301(j) of
this Act or section 1905 of title 18, United States Code.''.
(b) Orphan Drugs.--Section 505B(k) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355c(k)) is amended to read
as follows:
``(k) Relation to Orphan Drugs.--
``(1) In general; exemption for orphan indications.--Unless
the Secretary requires otherwise by regulation and except as
provided in paragraph (2), this section does not apply to any
drug or biological product for an indication for which orphan
designation has been granted under section 526.
``(2) Applicability despite orphan designation of certain
indications.--This section shall apply with respect to a drug
or biological product for which an indication has been
granted orphan designation under 526 if the investigation
described in subsection (a)(3) applies to the drug or
biological product as described in subsection (a)(1)(B).''.
(c) Meeting, Consultation, and Guidance.--
(1) Meeting.--The Secretary of Health and Human Services
(referred to in this subsection as the ``Secretary''), acting
through
[[Page H5464]]
the Commissioner of Food and Drugs and in collaboration with
the Director of the National Cancer Institute, shall convene
a public meeting not later than 1 year after the date of
enactment of this Act to solicit feedback from physicians and
researchers (including pediatric oncologists and rare disease
specialists), patients, and other stakeholders to provide
input on development of the guidance under paragraph (2) and
the list under subsection (m) of section 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355c), as added by
subsection (a). The Secretary shall seek input at such
meeting on--
(A) the data necessary to determine that there is
scientific evidence that a drug or biological product is
directed at a molecular target that is considered to be
substantially relevant to the growth or progression of a
pediatric cancer;
(B) the data necessary to determine that there is
scientific evidence that a molecular target is considered to
be substantially relevant to the growth or progression of a
pediatric cancer;
(C) the data needed to meet the requirement of conducting
an investigation described in section 505B(a)(3) of the
Federal Food, Drug, and Cosmetic Act, as amended by
subsection (a);
(D) considerations when developing the list under section
505B(m) of the Federal Food, Drug, and Cosmetic Act that
contains molecular targets shared between different tumor
types;
(E) the process the Secretary shall utilize to update
regularly a list of molecular targets that may trigger a
pediatric study under section 505B of the Federal Food, Drug,
and Cosmetic Act, as so amended, and how often such updates
shall occur;
(F) how to overcome the challenges related to pediatric
cancer drug and biological product development, including
issues related to the ethical, practical, and other barriers
to conducting clinical trials in pediatric cancer with small
patient populations;
(G) scientific or operational challenges associated with
performing an investigation described in section
505B(a)(1)(B) of the Federal Food, Drug, and Cosmetic Act,
including the effect on pediatric studies currently underway
in a pediatric patient population, treatment of a pediatric
patient population, and the ability to complete adult
clinical trials;
(H) the advantages and disadvantages of innovative clinical
trial designs in addressing the development of cancer drugs
or biological products directed at molecular targets in
pediatric cancer patients;
(I) the ways in which the Secretary can improve the current
process outlined under sections 505A and 505B of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) to
encourage additional research and development of pediatric
cancer treatments;
(J) the ways in which the Secretary might streamline and
improve the written request process, including when studies
contained in a request under such section 505A are not
feasible due to the ethical, practical, or other barriers to
conducting clinical trials in pediatric cancer populations;
(K) how the Secretary will facilitate collaboration among
pediatric networks, academic centers and experts in pediatric
cancer to conduct an investigation described in such section
505B(a)(3);
(L) how the Secretary may facilitate collaboration among
sponsors of same-in-class drugs and biological products that
would be subject to the requirements for an investigation
under such section 505B based on shared molecular targets;
and
(M) the ways in which the Secretary will help to mitigate
the risks, if any, of discouraging the research and
development of orphan drugs when implementing such section
505B as amended.
(2) Guidance.--Not later than 2 years after the date of
enactment of this Act, the Secretary, acting through the
Commissioner of Food and Drugs, shall issue final guidance on
implementation of the amendments to section 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c)
regarding molecularly targeted cancer drugs made by this
section, including--
(A) the scientific criteria, types of data, and regulatory
considerations for determining whether a molecular target is
substantially relevant to the growth or progression of a
pediatric cancer and would trigger an investigation under
section 505B of the Federal Food, Drug, and Cosmetic Act, as
amended;
(B) the process by which the Secretary will engage with
sponsors to discuss determinations, investigation
requirements, deferrals, waivers, and any other issues that
need to be resolved to ensure that any required investigation
based on a molecular target can be reasonably conducted;
(C) the scientific or operational challenges for which the
Secretary may issue deferrals or waivers for an investigation
described in subsection (a)(3) of such section 505B,
including adverse impacts on current pediatric studies
underway in a pediatric patient population, studies involving
drugs designated as orphan drugs, treatment of a pediatric
patient population, or the ability to complete adult clinical
trials;
(D) how the Secretary and sponsors will facilitate
collaboration among pediatric networks, academic centers, and
experts in pediatric cancer to conduct an investigation
described in subsection (a)(3) of such section 505B;
(E) scientific and regulatory considerations for study
designs, including the applicability of innovative clinical
trial designs for pediatric cancer drug and biological
product developments under sections 505A and 505B of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c);
(F) approaches to streamline and improve the amendment
process, including when studies contained in a request under
such section 505A are not feasible due to the ethical,
practical, or other barriers to conducting clinical trials in
pediatric cancer populations;
(G) the process for submission of an initial pediatric
study plan for the investigation described in section
505B(a)(3) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355c(a)(3)), including the process for a sponsor to
meet and reach agreement with the Secretary on the initial
pediatric study plan; and
(H) considerations for implementation of such section 505B,
as so amended, and waivers of the requirements of such
section 505B with regard to molecular targets for which
several drugs or biological products may be under
investigation.
(d) Report to Congress.--Section 508(b) of the Food and
Drug Administration Safety and Innovation Act (21 U.S.C.
355c-1(b)) is amended--
(1) in paragraph (10), by striking ``; and'' and inserting
``;''; and
(2) by striking paragraph (11) and inserting the following:
``(11) an assessment of the impact of the amendments to
such section 505B made by the FDA Reauthorization Act of 2017
on pediatric research and labeling of drugs and biological
products and pediatric labeling of molecularly targeted drugs
and biological products for the treatment of cancer;
``(12) an assessment of the efforts of the Secretary to
implement the plan developed under section 505C-1 of the
Federal Food, Drug, and Cosmetic Act, regarding earlier
submission of pediatric studies under sections 505A and 505B
of such Act and section 351(m) of the Public Health Service
Act, including--
``(A) the average length of time after the approval of an
application under section 505(b)(1) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) or section
351(a) of the Public Health Service Act (42 U.S.C. 262(a))
before studies conducted pursuant to such section 505A, 505B,
or section 351(m) are completed, submitted, and incorporated
into labeling;
``(B) the average length of time after the receipt of a
proposed pediatric study request before the Secretary
responds to such request;
``(C) the average length of time after the submission of a
proposed pediatric study request before the Secretary issues
a written request for such studies;
``(D) the number of written requests issued for each
investigational new drug or biological product prior to the
submission of an application under section 505(b)(1) of the
Federal Food, Drug, and Cosmetic Act or section 351(a) of the
Public Health Service Act; and
``(E) the average number, and range of numbers, of
amendments to written requests issued, and the time the
Secretary requires to review and act on proposed amendments
to written requests;
``(13) a list of sponsors of applications or holders of
approved applications who received exclusivity under such
section 505A or such section 351(m) after receiving a letter
issued under such section 505B(d)(1) for any drug or
biological product before the studies referred to in such
letter were completed and submitted;
``(14) a list of assessments and investigations required
under such section 505B;
``(15) how many requests under such section 505A for
molecular targeted cancer drugs, as defined by subsection
(a)(1)(B) of such section 505B, approved prior to 3 years
after the date of enactment of the FDA Reauthorization Act of
2017, have been issued by the Food and Drug Administration,
and how many such requests have been completed; and
``(16) the Secretary's assessment of the overall impact of
the amendments made by section 504 of the FDA Reauthorization
Act of 2017 on the conduct and effectiveness of pediatric
cancer research and the orphan drug program, as well any
subsequent recommendations.''.
(e) Rule of Construction.--Nothing in this section,
including the amendments made by this section, shall limit
the authority of the Secretary of Health and Human Services
to issue written requests under section 505A of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355a) or section
351(m) of the Public Health Service Act (42 U.S.C. 262(m)),
or to negotiate or implement amendments to such requests
proposed by the an applicant.
(f) GAO Report.--
(1) In general.--Beginning on the date that is 5 years
after the date of enactment of this Act, the Comptroller
General of the United States shall conduct a study of the
effectiveness of requiring assessments and investigations
described in section 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c), as amended by this section, in
the development of drugs and biological products for
pediatric cancer indications. The Comptroller General shall
examine--
(A) the indications and associated molecular targets
studied in assessments and investigations required for drugs
or biological products intended for the treatment of an adult
cancer;
[[Page H5465]]
(B) the indication for which the study was requested as
compared to the indication requested under the new drug
application filed by the sponsor;
(C) the number of pediatric cancer indications for which
assessments and investigations have been required under such
section 505B;
(D) the number of requests for deferral and waiver of
pediatric assessments and investigations required under such
section and the number of such deferral and waiver requests
granted and denied;
(E) the number of orphan-designated indications for drugs
and biological products for which assessments and
investigations were required under such section;
(F) the number of drugs and biological products approved
for the treatment of cancer in the pediatric population for
which the supportive studies were required to be conducted
under such section;
(G) the number of written requests made under section 505A
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a)
relating to investigations required under subsection
(a)(1)(B) of such section 505B; and
(H) any additional considerations by the Secretary
regarding the effectiveness of requiring pediatric
assessments described in such section 505B in the development
of drugs and biological products for pediatric cancer
indications.
(2) Review.--The study under paragraph (1) shall include a
review of the Food and Drug Administration's use of the
authority under section 505B of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355c), as amended by this section,
including the amendments to the deferral and waiver criteria
under such section and how such criteria have been applied.
(3) Consultation.--In conducting the study under paragraph
(1), the Comptroller General of the United States shall
consult with appropriate stakeholders that may be required to
conduct the trials under section 505B of the Federal Food,
Drug, and Cosmetic Act, and the ability of such stakeholders
to adhere to the requests issued by the Food and Drug
Administration.
(4) Report.--Not later than the date that is 6 years after
the date of enactment of this Act, the Comptroller General of
the United States shall submit a report containing the
results of the study under paragraph (1) to the Secretary of
Health and Human Services, the Committee on Health,
Education, Labor, and Pensions of the Senate, and the
Committee on Energy and Commerce of the House of
Representatives.
SEC. 505. ADDITIONAL PROVISIONS ON DEVELOPMENT OF DRUGS AND
BIOLOGICAL PRODUCTS FOR PEDIATRIC USE.
(a) Informing Internal Review Committee.--Section 505A(f)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355a(f)) is amended by adding at the end the following:
``(7) Informing internal review committee.--The Secretary
shall provide to the committee referred to in paragraph (1)
any response issued to an applicant or holder with respect to
a proposed pediatric study request.''.
(b) Action on Submissions.--
(1) In general.--Section 505A(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355a(d)) is amended--
(A) by redesignating paragraphs (3) through (5) as
paragraphs (4) through (6), respectively; and
(B) by inserting after paragraph (2) the following:
``(3) Action on submissions.--The Secretary shall review
and act upon a submission by a sponsor or holder of a
proposed pediatric study request or a proposed amendment to a
written request for pediatric studies within 120 calendar
days of the submission.''.
(2) Conforming amendments.--
(A) Federal food, drug, and cosmetic act.--Section 505A of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a), as
amended by paragraph (1), is further amended by striking
subsection ``(d)(3)'' each place it appears and inserting
``(d)(4)''.
(B) Public health service act.--Paragraphs (2), (3), and
(4) of section 351(m) of the Public Health Service Act (42
U.S.C. 262(m)) are amended by striking ``section 505A(d)(3)''
each place it appears and inserting ``section 505A(d)(4)''.
(c) Plan.--The Secretary of Health and Human Services,
acting through the internal review committee established
under section 505C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355d) shall, not later than one year after the
date of enactment of this Act, develop and implement a plan
to achieve, when appropriate, earlier submission of pediatric
studies under section 505A of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355a) or section 351(m) of the Public
Health Service Act (42 U.S.C. 262(m)). Such plan shall
include recommendations to achieve--
(1) earlier discussion of proposed pediatric study requests
and written requests with sponsors, and if appropriate,
discussion of such requests at the meeting required under
section 505B(e)(2)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355c(e)(2)(C)), as amended by section 503(a);
(2) earlier issuance of written requests for a pediatric
study under such section 505A, including for investigational
new drugs prior to the submission of an application under
section 505(b)(1) of such Act (21 U.S.C. 355(b)(1)); and
(3) shorter timelines, when appropriate, for the completion
of studies pursuant to a written request under such section
505A or such section 351(m).
(d) Neonatology Expertise.--
(1) In general.--Section 6(d) of the Best Pharmaceuticals
for Children Act (21 U.S.C. 393a(d)) is amended by striking
``For the 5-year period beginning on the date of enactment of
this subsection, at'' and inserting ``At''.
(2) Draft guidance.--Not later than 2 years after the date
of enactment of this Act, the Secretary shall issue draft
guidance on clinical pharmacology considerations for neonatal
studies for drugs and biological products.
(e) Submission of Assessments.--Section 505B(d)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355c(d)(1))
is amended by adding at the end the following: ``The
Secretary shall inform the Pediatric Advisory Committee of
letters issued under this paragraph and responses to such
letters.''.
(f) Internal Committee.--Section 505C of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355d) is amended by
inserting ``or pediatric rare diseases'' after
``psychiatry''.
(g) Report on Labeling of Orphan Drugs.--
(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 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
website of the Food and Drug Administration, a report on the
lack of information in the labeling of drugs for indications
that have received an orphan designation under section 526 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb)
with respect to the use of such drugs pediatric populations.
(2) Contents.--The report described in paragraph (1) shall
include--
(A) a list of drugs for which--
(i) an indication was granted an orphan designation under
section 526 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360bbb);
(ii) an application described under section 505B(a)(1) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355c(a)(1)) for such indication was submitted to the
Secretary of Health and Human Services on or after April 1,
1999; and
(iii) the labeling for such indication lacks important
pediatric information, including information related to
safety, dosing, and effectiveness;
(B) a description of the lack of information referred to in
subparagraph (A)(iii) for each drug for an indication on such
list; and
(C) Federal policy recommendations to improve the labeling
of drugs for indications that have received an orphan
designation under such section 526 with respect to the use of
such drugs pediatric populations.''
TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS
SEC. 601. REAUTHORIZATION OF PROVISION RELATING TO
EXCLUSIVITY OF CERTAIN DRUGS CONTAINING SINGLE
ENANTIOMERS.
Section 505(u)(4) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(u)(4)) is amended by striking ``2017'' and
inserting ``2022''.
SEC. 602. REAUTHORIZATION OF THE CRITICAL PATH PUBLIC-PRIVATE
PARTNERSHIPS.
Section 566(f) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360bbb-5(f)) is amended by striking ``2013 through
2017'' and inserting ``2018 through 2022''.
SEC. 603. REAUTHORIZATION OF ORPHAN GRANTS PROGRAM.
Section 5(c) of the Orphan Drug Act (21 U.S.C. 360ee(c)) is
amended by striking ``2013 through 2017'' and inserting
``2018 through 2022''.
SEC. 604. PROTECTING AND STRENGTHENING THE DRUG SUPPLY CHAIN.
(a) Diverted Drugs.--Paragraph (1) of section 801(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(d)) is
amended--
(1) by striking ``(d)(1) Except as'' and inserting
``(d)(1)(A) Except as''; and
(2) by adding at the end the following:
``(B) Except as authorized by the Secretary in the case of
a drug that appears on the drug shortage list under section
506E or in the case of importation pursuant to section 804,
no drug that is subject to section 503(b)(1) may be imported
into the United States for commercial use if such drug is
manufactured outside the United States, unless the
manufacturer has authorized the drug to be marketed in the
United States and has caused the drug to be labeled to be
marketed in the United States.''.
(b) Counterfeit Drugs.--Subsection (b) of section 303 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 333) is
amended by adding at the end the following:
``(8) Notwithstanding subsection (a), any person who
violates section 301(i)(3) by knowingly making, selling or
dispensing, or holding for sale or dispensing, a counterfeit
drug shall be imprisoned for not more than 10 years or fined
in accordance with title 18, United States Code, or both.''.
SEC. 605. PATIENT EXPERIENCE DATA.
Section 569C(c)(2)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb-8c(c)(2)(A)) is amended by
striking ``impact of such disease or condition, or a related
therapy,'' and inserting ``impact (including physical and
psychosocial impacts) of such disease or condition, or a
related therapy or clinical investigation''.
[[Page H5466]]
SEC. 606. COMMUNICATION PLANS.
Section 505-1(e)(3) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355-1(e)(3)) is amended--
(1) in subparagraph (B), by striking ``; or'';
(2) in subparagraph (C), by striking the period and
inserting ``; or''; and
(3) by adding at the end the following:
``(D) disseminating information to health care providers
about drug formulations or properties, including information
about the limitations or patient care implications of such
formulations or properties, and how such formulations or
properties may be related to serious adverse drug events
associated with use of the drug.''.
SEC. 607. ORPHAN DRUGS.
(a) In General.--Section 527 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360cc) is amended--
(1) in subsection (a), in the matter following paragraph
(2), by striking ``such drug for such disease or condition''
and inserting ``the same drug for the same disease or
condition'';
(2) in subsection (b)--
(A) in the matter preceding paragraph (1), by striking ``If
an application'' and all that follows through ``such license
if'' and inserting ``During the 7-year period described in
subsection (a) for an approved application under section 505
or license under section 351 of the Public Health Service
Act, the Secretary may approve an application or issue a
license for a drug that is otherwise the same, as determined
by the Secretary, as the already approved drug for the same
rare disease or condition if'';
(B) in paragraph (1), by striking ``notice'' and all that
follows through ``assure'' and inserting ``of exclusive
approval or licensure notice and opportunity for the
submission of views, that during such period the holder of
the exclusive approval or licensure cannot ensure''; and
(C) in paragraph (2), by striking ``such holder provides''
and inserting ``the holder provides''; and
(3) by adding at the end the following:
``(c) Condition of Clinical Superiority.--
``(1) In general.--If a sponsor of a drug that is
designated under section 526 and is otherwise the same, as
determined by the Secretary, as an already approved or
licensed drug is seeking exclusive approval or exclusive
licensure described in subsection (a) for the same rare
disease or condition as the already approved drug, the
Secretary shall require such sponsor, as a condition of such
exclusive approval or licensure, to demonstrate that such
drug is clinically superior to any already approved or
licensed drug that is the same drug.
``(2) Definition.--For purposes of paragraph (1), the term
`clinically superior' with respect to a drug means that the
drug provides a significant therapeutic advantage over and
above an already approved or licensed drug in terms of
greater efficacy, greater safety, or by providing a major
contribution to patient care.
``(d) Regulations.--The Secretary may promulgate
regulations for the implementation of subsection (c).
Beginning on the date of enactment of the FDA Reauthorization
Act of 2017, until such time as the Secretary promulgates
regulations in accordance with this subsection, the Secretary
may apply any definitions set forth in regulations that were
promulgated prior to such date of enactment, to the extent
such definitions are not inconsistent with the terms of this
section, as amended by such Act.
``(e) Demonstration of Clinical Superiority Standard.--To
assist sponsors in demonstrating clinical superiority as
described in subsection (c), the Secretary--
``(1) upon the designation of any drug under section 526,
shall notify the sponsor of such drug in writing of the basis
for the designation, including, as applicable, any plausible
hypothesis offered by the sponsor and relied upon by the
Secretary that the drug is clinically superior to a
previously approved drug; and
``(2) upon granting exclusive approval or licensure under
subsection (a) on the basis of a demonstration of clinical
superiority as described in subsection (c), shall publish a
summary of the clinical superiority findings.''.
(b) Rule of Construction.--Nothing in the amendments made
by subsection (a) shall affect any determination under
sections 526 and 527 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360bb, 360cc) made prior to the date of
enactment of the FDA Reauthorization Act of 2017.
SEC. 608. PEDIATRIC INFORMATION ADDED TO LABELING.
Section 505A(o) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355a(o)) is amended--
(1) in the subsection heading, by striking ``UNDER SECTION
505(j)'';
(2) in paragraph (1)--
(A) by striking ``under section 505(j)'' and inserting
``under subsection (b)(2) or (j) of section 505''; and
(B) by striking ``or by exclusivity under clause (iii) or
(iv) of section 505(j)(5)(F)'' and inserting ``, or by
exclusivity under clause (iii) or (iv) of section
505(j)(5)(F), clause (iii) or (iv) of section 505(c)(3)(E),
or section 527(a), or by an extension of such exclusivity
under this section or section 505E'';
(3) in paragraph (2), in the matter preceding subparagraph
(A)--
(A) by inserting ``clauses (iii) and (iv) of section
505(c)(3)(E), or section 527,'' after ``section
505(j)(5)(F),''; and
(B) by striking ``drug approved under section 505(j)'' and
inserting ``drug approved pursuant to an application
submitted under subsection (b)(2) or (j) of section 505'';
and
(4) by amending paragraph (3) to read as follows:
``(3) Preservation of pediatric exclusivity and
extensions.--This subsection does not affect--
``(A) the availability or scope of exclusivity under--
``(i) this section;
``(ii) section 505 for pediatric formulations; or
``(iii) section 527;
``(B) the availability or scope of an extension to any such
exclusivity, including an extension under this section or
section 505E;
``(C) the question of the eligibility for approval under
section 505 of any application described in subsection (b)(2)
or (j) of such section that omits any other aspect of
labeling protected by exclusivity under--
``(i) clause (iii) or (iv) of section 505(j)(5)(F);
``(ii) clause (iii) or (iv) of section 505(c)(3)(E); or
``(iii) section 527(a); or
``(D) except as expressly provided in paragraphs (1) and
(2), the operation of section 505 or section 527.''.
SEC. 609. SENSE OF CONGRESS ON LOWERING THE COST OF
PRESCRIPTION DRUGS.
It is the sense of the Congress that the Secretary of
Health and Human Services should commit to engaging with the
House of Representatives and the Senate to take
administrative actions and enact legislative changes that--
(1) will lower the cost of prescription drugs for consumers
and reduce the burden of such cost on taxpayers; and
(2) in lowering such cost, will--
(A) balance the need to encourage innovation with the need
to improve affordability; and
(B) strive to increase competition in the pharmaceutical
market, prevent anticompetitive behavior, and promote the
timely availability of affordable, high-quality generic drugs
and biosimilars.
SEC. 610. EXPANDED ACCESS.
(a) Patient Access to Investigational Drugs.--
(1) Public meeting.--
(A) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), acting
through the Commissioner of Food and Drugs, in coordination
with the Director of the National Institutes of Health, and
in consultation with patients, health care providers, drug
sponsors, bioethicists, and other stakeholders, shall, not
later than 270 days after the date of enactment of this Act,
convene a public meeting to discuss clinical trial inclusion
and exclusion criteria to inform the guidance under paragraph
(3). The Secretary shall inform the Comptroller General of
the United States of the date when the public meeting will
take place.
(B) Topics.--The Secretary shall make available on the
internet website of the Food and Drug Administration a report
on the topics discussed at the meeting described in
subparagraph (A) within 90 days of such meeting. Such topics
shall include discussion of--
(i) the rationale for, and potential barriers for patients
created by, research clinical trial inclusion and exclusion
criteria;
(ii) how appropriate patient populations can benefit from
the results of trials that employ alternative designs;
(iii) barriers to participation in clinical trials,
including--
(I) information regarding any potential risks and benefits
of participation;
(II) regulatory, geographical, and socioeconomic barriers;
and
(III) the impact of exclusion criteria on the enrollment in
clinical trials of particular populations, including infants
and children, pregnant and lactating women, seniors,
individuals with advanced disease, and individuals with co-
morbid conditions;
(iv) clinical trial designs and methods, including expanded
access trials, that increase enrollment of more diverse
patient populations, when appropriate, while facilitating the
collection of data to establish safe use and support
substantial evidence of effectiveness, including data
obtained from expanded access trials; and
(v) how changes to clinical trial inclusion and exclusion
criteria may impact the complexity and length of clinical
trials, the data necessary to demonstrate safety and
effectiveness, and potential approaches to mitigating those
impacts.
(2) Report.--Not later than 1 year after the Secretary
issues the report under paragraph (1)(B), the Comptroller
General of the United States shall report to the Committee on
Health, Education, Labor, and Pensions of the Senate and the
Committee on Energy and Commerce of the House of
Representatives on individual access to investigational drugs
through the expanded access program under section 561(b) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb(b)). The report shall include--
(A) a description of actions taken by manufacturers and
distributors under section 561A of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb-0);
(B) consideration of whether Form FDA 3926 and the guidance
documents titled ``Expanded Access to Investigational Drugs
for Treatment Use--Questions and Answers'' and
[[Page H5467]]
``Individual Patient Expanded Access Applications: Form FDA
3926'', issued by the Food and Drug Administration in June
2016, have reduced application burden with respect to
individuals and physicians seeking access to investigational
new drugs pursuant to section 561(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360bbb) and improved
clarity for patients, physicians, and drug manufacturers
about such process;
(C) consideration of whether the guidance or regulations
issued to implement section 561 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360bbb) have improved access for
individual patients to investigational drugs who do not
qualify for clinical trials of such investigational drugs,
and what barriers to such access remain;
(D) an assessment of methods patients and health care
providers use to engage with the Food and Drug Administration
or drug sponsors on expanded access; and
(E) an analysis of the Secretary's report under paragraph
(1)(B).
(3) Guidance.--
(A) In general.--Not later than 1 year after the
publication of the report under paragraph (1)(B), the
Secretary, acting through the Commissioner of Food and Drugs,
shall issue one or more draft guidances regarding eligibility
criteria for clinical trials. Not later than 1 year after the
public comment period on each such draft guidance ends, the
Secretary shall issue a revised draft guidance or final
guidance.
(B) Contents.--The guidance documents described in
subparagraph (A) shall address methodological approaches that
a manufacturer or sponsor of an investigation of a new drug
may take to--
(i) broaden eligibility criteria for clinical trials and
expanded access trials, especially with respect to drugs for
the treatment of serious and life-threatening conditions or
diseases for which there is an unmet medical need;
(ii) develop eligibility criteria for, and increase trial
recruitment to, clinical trials so that enrollment in such
trials more accurately reflects the patients most likely to
receive the drug, as applicable and as appropriate, while
establishing safe use and supporting findings of substantial
evidence of effectiveness; and
(iii) use the criteria described in clauses (i) and (ii) in
a manner that is appropriate for drugs intended for the
treatment of rare diseases or conditions.
(b) Improving Institutional Review Board Review of Single
Patient Expanded Access Protocol.--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 guidance or regulations, or revise existing guidance or
regulations, to streamline the institutional review board
review of individual patient expanded access protocols
submitted under 561(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360bbb(b)). To facilitate the use of
expanded access protocols, any guidance or regulations so
issued or revised may include a description of the process
for any person acting through a physician licensed in
accordance with State law to request that an institutional
review board chair (or designated member of the institutional
review board) review a single patient expanded access
protocol submitted under such section 561(b) for a drug. The
Secretary shall update any relevant forms associated with
individual patient expanded access requests under such
section 561(b) as necessary.
(c) Expanded Access Policy Transparency.--Section 561A(f)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360bbb-0(f)) is amended--
(1) in the matter preceding paragraph (1), by striking
``later'' and inserting ``earlier'';
(2) by striking paragraph (1);
(3) by redesignating paragraph (2) as paragraph (1);
(4) in paragraph (1) as so redesignated, by striking the
period at the end and inserting ``; or''; and
(5) by adding at the end the following:
``(2) as applicable, 15 days after the drug receives a
designation as a breakthrough therapy, fast track product, or
regenerative advanced therapy under subsection (a), (b), or
(g), respectively, of section 506.''.
SEC. 611. TROPICAL DISEASE PRODUCT APPLICATION.
(a) In General.--Subparagraph (A) of section 524(a)(4) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360n(a)(4)) is amended--
(1) in clause (i), by striking ``and'' at the end; and
(2) by adding at the end the following:
``(iii) that contains reports of one or more new clinical
investigations (other than bioavailability studies) that are
essential to the approval of the application and conducted or
sponsored by the sponsor of such application; and
``(iv) that contains an attestation from the sponsor of the
application that such reports were not submitted as part of
an application for marketing approval or licensure by a
regulatory authority in India, Brazil, Thailand, or any
country that is a member of the Pharmaceutical Inspection
Convention or the Pharmaceutical Inspection Cooperation
Scheme prior to September 27, 2007.''.
(b) Effective Date.--The amendments made by subsection (a)
shall apply to human drug applications submitted after
September 30, 2017.
TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS
SEC. 701. RISK-BASED INSPECTIONS FOR DEVICES.
(a) In General.--Section 510(h) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360(h)) is amended--
(1) by striking paragraph (2) and inserting the following:
``(2) Risk-based schedule for devices.--
``(A) In general.--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, propagation, compounding, or
processing of a device or devices (referred to in this
subsection as `device establishments') in accordance with a
risk-based schedule established by the Secretary.
``(B) Factors and considerations.--In establishing the
risk-based schedule under subparagraph (A), the Secretary
shall--
``(i) apply, to the extent applicable for device
establishments, the factors identified in paragraph (4); and
``(ii) consider the participation of the device
establishment, as applicable, in international device audit
programs in which the United States participates or the
United States recognizes for purposes of inspecting device
establishments.''; and
(2) in paragraph (4)--
(A) in the matter preceding subparagraph (A), by striking
``paragraph (3)'' and inserting ``paragraph (2) or (3)''; and
(B) in subparagraph (C), by inserting ``or device'' after
``drug''.
(b) Foreign Inspections.--Section 809(a)(1) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 384e(a)(1)) is
amended by striking ``section 510(h)(3)'' and inserting
``paragraph (2) or (3) of section 510(h)''.
SEC. 702. IMPROVEMENTS TO INSPECTIONS PROCESS FOR DEVICE
ESTABLISHMENTS.
(a) In General.--Section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374) is amended by adding at the end
the following:
``(h)(1) In the case of inspections other than for-cause
inspections, the Secretary shall review processes and
standards applicable to inspections of domestic and foreign
device establishments in effect as of the date of the
enactment of this subsection, and update such processes and
standards through the adoption of uniform processes and
standards applicable to such inspections. Such uniform
processes and standards shall provide for--
``(A) exceptions to such processes and standards, as
appropriate;
``(B) announcing the inspection of the establishment within
a reasonable time before such inspection occurs, including by
providing to the owner, operator, or agent in charge of the
establishment a notification regarding the type and nature of
the inspection;
``(C) a reasonable estimate of the timeframe for the
inspection, an opportunity for advance communications between
the officers or employees carrying out the inspection under
subsection (a)(1) and the owner, operator, or agent in charge
of the establishment concerning appropriate working hours
during the inspection, and, to the extent feasible, advance
notice of some records that will be requested; and
``(D) regular communications during the inspection with the
owner, operator, or agent in charge of the establishment
regarding inspection status, which may be recorded by either
party with advance notice and mutual consent.
``(2)(A) The Secretary shall, with respect to a request
described in subparagraph (B), provide nonbinding feedback
with respect to such request not later than 45 days after the
Secretary receives such request.
``(B) A request described in this subparagraph is a request
for feedback--
``(i) that is made by the owner, operator, or agent in
charge of such establishment in a timely manner; and
``(ii) with respect to actions proposed to be taken by a
device establishment in a response to a report received by
such establishment pursuant to subsection (b) that involve a
public health priority, that implicate systemic or major
actions, or relate to emerging safety issues (as determined
by the Secretary).
``(3) Nothing in this subsection affects the authority of
the Secretary to conduct inspections otherwise permitted
under this Act in order to ensure compliance with this
Act.''.
(b) Guidance.--
(1) Draft guidance.--Not later than 18 months after the
date of enactment of this Act, the Secretary of Health and
Human Services, acting through the Commissioner of Food and
Drugs, shall issue draft guidance that--
(A) specifies how the Food and Drug Administration will
implement the processes and standards described in paragraph
(1) of subsection (h) of section 704 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 374), as added by
subsection (a), and the requirements described in paragraph
(2) of such subsection (h);
(B) provides for standardized methods for communications
described in such paragraphs;
(C) establishes, with respect to inspections of both
domestic and foreign device establishments (as referred to in
section 510(h)(2) of the Federal Food, Drug, and Cosmetic
Act, as amended by subsection (a)), a standard timeframe for
such inspections--
[[Page H5468]]
(i) that occurs over consecutive days; and
(ii) to which each investigator conducting such an
inspection shall adhere unless the investigator identifies to
the establishment involved a reason that more time is needed
to conduct such investigation; and
(D) identifies practices for investigators and device
establishments to facilitate the continuity of inspections of
such establishments.
(2) Final guidance.--Not later than 1 year after providing
notice and opportunity for public comment on the draft
guidance issued under paragraph (1), the Secretary of Health
and Human Services shall issue final guidance to implement
subsection (h) of section 704 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 374), as added by subsection (a).
(c) Adulterated Devices.--Subsection (j) of section 501 of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351) is
amended by inserting ``or device'' after ``drug''.
SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.
Section 704(g)(11) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 374(g)(11)) is amended by striking ``October
1, 2017'' and inserting ``October 1, 2022''.
SEC. 704. CERTIFICATES TO FOREIGN GOVERNMENTS FOR DEVICES.
Subsection (e)(4) of section 801 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 381(e)(4)) is amended--
(1) by adding at the end the following:
``(E)(i)(I) If the Secretary denies a request for
certification under subparagraph (A)(ii) with respect to a
device manufactured in an establishment (foreign or domestic)
registered under section 510, the Secretary shall provide in
writing to the person seeking such certification the basis
for such denial, and specifically identify the finding upon
which such denial is based.
``(II) If the denial of a request as described in subclause
(I) is based on grounds other than an injunction proceeding
pursuant to section 302, seizure action pursuant to section
304, or a recall designated Class I or Class II pursuant to
part 7, title 21, Code of Federal Regulations, and is based
on the facility being out of compliance with part 820 of
title 21, Code of Federal Regulations, the Secretary shall
provide a substantive summary of the specific grounds for
noncompliance identified by the Secretary.
``(III) With respect to a device manufactured in an
establishment that has received a report under section
704(b), the Secretary shall not deny a request for
certification as described in subclause (I) with respect to a
device based solely on the issuance of that report if the
owner, operator, or agent in charge of such establishment has
agreed to a plan of correction in response to such report.
``(ii)(I) The Secretary shall provide a process for a
person who is denied a certification as described in clause
(i)(I) to request a review that conforms to the standards of
section 517A(b).
``(II) Notwithstanding any previous review conducted
pursuant to subclause (I), a person who has been denied a
certification as described in clause (i)(I) may at any time
request a review in order to present new information relating
to actions taken by such person to address the reasons
identified by the Secretary for the denial of certification,
including evidence that corrective actions are being or have
been implemented to address grounds for noncompliance
identified by the Secretary.
``(III) Not later than 1 year after the date of enactment
of the FDA Reauthorization Act of 2017, the Secretary shall
issue guidance providing for a process to carry out this
subparagraph. Not later than 1 year after the close of the
comment period for such guidance, the Secretary shall issue
final guidance.
``(iii)(I) Subject to subclause (II), this subparagraph
applies to requests for certification on behalf of any device
establishment registered under section 510, whether the
establishment is located inside or outside of the United
States, and regardless of whether such devices are to be
exported from the United States.
``(II) If an establishment described in subclause (I) is
not located within the United States and does not demonstrate
that the devices manufactured, prepared, propagated,
compounded, or processed at such establishment are to be
exported from the United States, this subparagraph shall
apply only if--
``(aa) the establishment has been inspected by the
Secretary within 3 years of the date of the request; or
``(bb) the establishment participates in an audit program
in which the United States participates or the United States
recognizes, an audit under such program has been conducted,
and the findings of such audit are provided to the Secretary
within 3 years of the date of the request.''; and
(2) by moving the margins of subparagraphs (C) and (D) 4
ems to the left.
SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.
Section 704(g) of the Federal Food, Drug and Cosmetic Act
(21 U.S.C. 374) is amended by adding at the end the
following:
``(15)(A) Notwithstanding any other provision of this
subsection, the Secretary may recognize auditing
organizations that are recognized by organizations
established by governments to facilitate international
harmonization for purposes of conducting inspections of--
``(i) establishments that manufacture, prepare, propagate,
compound, or process devices (other than types of devices
licensed under section 351 of the Public Health Service Act),
as required under section 510(h); or
``(ii) establishments required to register pursuant to
section 510(i).
``(B) Nothing in this paragraph affects--
``(i) the authority of the Secretary to inspect any device
establishment pursuant to this Act; or
``(ii) the authority of the Secretary to determine the
official classification of an inspection.''.
SEC. 706. FOSTERING INNOVATION IN MEDICAL IMAGING.
(a) Approval of Applications for Certain Diagnostic Medical
Imaging Devices.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (42 U.S.C. 360j) is amended by adding at the end
the following:
``(p) Diagnostic Imaging Devices Intended for Use With
Contrast Agents.--
``(1) In general.--The Secretary may, subject to the
succeeding provisions of this subsection, approve an
application (or a supplement to such an application)
submitted under section 515 with respect to an applicable
medical imaging device, or, in the case of an applicable
medical imaging device for which a notification is submitted
under section 510(k), may make a substantial equivalence
determination with respect to an applicable medical imaging
device, or may grant a request submitted under section
513(f)(2) for an applicable medical imaging device, if such
application, notification, or request involves the use of a
contrast agent that is not--
``(A) in a concentration, rate of administration, or route
of administration that is different from those described in
the approved labeling of the contrast agent, except that the
Secretary may approve such application, make such substantial
equivalence determination, or grant such request if the
Secretary determines that such differences in concentration,
rate of administration, or route of administration exist but
do not adversely affect the safety and effectiveness of the
contrast agent when used with the device;
``(B) in a region, organ, or system of the body that is
different from those described in the approved labeling of
the contrast agent, except that the Secretary may approve
such application, make such substantial equivalence
determination, or grant such request if the Secretary
determines that such differences in region, organ, or system
of the body exist but do not adversely affect the safety and
effectiveness of the contrast agent when used with the
device;
``(C) in a patient population that is different from those
described in the approved labeling of the contrast agent,
except that the Secretary may approve such application, make
such substantial equivalence determination, or grant such
request if the Secretary determines such differences in
patient population exist but do not adversely affect the
safety and effectiveness of the contrast agent when used with
the device; or
``(D) in an imaging modality that is different from those
described in the approved labeling of the contrast agent.
``(2) Premarket review.--The agency center charged with
premarket review of devices shall have primary jurisdiction
with respect to the review of an application, notification,
or request described in paragraph (1). In conducting such
review, such agency center may--
``(A) consult with the agency center charged with the
premarket review of drugs or biological products; and
``(B) review information and data provided to the Secretary
by the sponsor of a contrast agent in an application
submitted under section 505 of this Act or section 351 of the
Public Health Service Act, so long as the sponsor of such
contrast agent has provided to the sponsor of the applicable
medical imaging device that is the subject of such review a
right of reference and the application is submitted in
accordance with this subsection.
``(3) Applicable requirements.--An application submitted
under section 515, a notification submitted under section
510(k), or a request submitted under section 513(f)(2), as
described in paragraph (1), with respect to an applicable
medical imaging device shall be subject to the requirements
of such respective section. Such application, notification,
or request shall only be subject to the requirements of this
Act applicable to devices.
``(4) Definitions.--For purposes of this subsection--
``(A) the term `applicable medical imaging device' means a
device intended to be used in conjunction with a contrast
agent (or class of contrast agents) for an imaging use that
is not described in the approved labeling of such contrast
agent (or the approved labeling of any contrast agent in the
same class as such contrast agent); and
``(B) the term `contrast agent' means a drug that is
approved under section 505 or licensed under section 351 of
the Public Health Service Act, is intended for use in
conjunction with an applicable medical imaging device, and--
``(i) is a diagnostic radiopharmaceutical, as defined in
section 315.2 and 601.31 of title 21, Code of Federal
Regulations (or any successor regulations); or
``(ii) is a diagnostic agent that improves the
visualization of structure or function within the body by
increasing the relative difference in signal intensity within
the target tissue, structure, or fluid.''.
[[Page H5469]]
(b) Applications for Approval of Contrast Agents Intended
for Use With Certain Diagnostic Medical Imaging Devices.--
Section 505 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355) is amended by adding at the end the following:
``(y) Contrast Agents Intended for Use With Applicable
Medical Imaging Devices.--
``(1) In general.--The sponsor of a contrast agent for
which an application has been approved under this section may
submit a supplement to the application seeking approval for a
new use following the authorization of a premarket submission
for an applicable medical imaging device for that use with
the contrast agent pursuant to section 520(p)(1).
``(2) Review of supplement.--In reviewing a supplement
submitted under this subsection, the agency center charged
with the premarket review of drugs may--
``(A) consult with the center charged with the premarket
review of devices; and
``(B) review information and data submitted to the
Secretary by the sponsor of an applicable medical imaging
device pursuant to section 515, 510(k), or 513(f)(2) so long
as the sponsor of such applicable medical imaging device has
provided to the sponsor of the contrast agent a right of
reference.
``(3) Definitions.--For purposes of this subsection--
``(A) the term `new use' means a use of a contrast agent
that is described in the approved labeling of an applicable
medical imaging device described in section 520(p), but that
is not described in the approved labeling of the contrast
agent; and
``(B) the terms `applicable medical imaging device' and
`contrast agent' have the meanings given such terms in
section 520(p).''.
SEC. 707. RISK-BASED CLASSIFICATION OF ACCESSORIES.
(a) In General.--Subsection (f) of section 513 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360c) is
amended by adding at the end the following new paragraph:
``(6)(A) Subject to the succeeding subparagraphs of this
paragraph, the Secretary shall, by written order, classify an
accessory under this section based on the risks of the
accessory when used as intended and the level of regulatory
controls necessary to provide a reasonable assurance of
safety and effectiveness of the accessory, notwithstanding
the classification of any other device with which such
accessory is intended to be used.
``(B) The classification of any accessory distinct from
another device by regulation or written order issued prior to
December 13, 2016, shall continue to apply unless and until
the accessory is reclassified by the Secretary,
notwithstanding the classification of any other device with
which such accessory is intended to be used. Nothing in this
paragraph shall preclude the Secretary's authority to
initiate the classification of an accessory through
regulation or written order, as appropriate.
``(C)(i) In the case of a device intended to be used with
an accessory, where the accessory has been included in an
application for premarket approval of such device under
section 515 or a report under section 510(k) for clearance of
such device and the Secretary has not classified such
accessory distinctly from another device in accordance with
subparagraph (A), the person filing the application or report
(as applicable) at the time such application or report is
filed--
``(I) may include a written request for the proper
classification of the accessory pursuant to subparagraph (A);
``(II) shall include in any such request such information
as may be necessary for the Secretary to evaluate, based on
the least burdensome approach, the appropriate class for the
accessory under subsection (a); and
``(III) shall, if the request under subclause (I) is
requesting classification of the accessory in class II,
include in the application an initial draft proposal for
special controls, if special controls would be required
pursuant to subsection (a)(1)(B).
``(ii) The Secretary's response under section 515(d) or
section 510(n) (as applicable) to an application or report
described in clause (i) shall also contain the Secretary's
granting or denial of the request for classification of the
accessory involved.
``(iii) The Secretary's evaluation of an accessory under
clause (i) shall constitute an order establishing a new
classification for such accessory for the specified intended
use or uses of such accessory and for any accessory with the
same intended use or uses as such accessory.
``(D) For accessories that have been granted marketing
authorization as part of a submission for another device with
which the accessory involved is intended to be used, through
an application for such other device under section 515(c), a
report under section 510(k), or a request for classification
under paragraph (2) of this subsection, the following shall
apply:
``(i) Not later than the date that is one year after the
date of enactment of the FDA Reauthorization Act of 2017 and
at least once every 5 years thereafter, and as the Secretary
otherwise determines appropriate, pursuant to this paragraph,
the Secretary shall publish in the Federal Register a notice
proposing a list of such accessories that the Secretary
determines may be suitable for a distinct classification in
class I and the proposed regulations for such
classifications. In developing such list, the Secretary shall
consider recommendations from sponsors of device submissions
and other stakeholders for accessories to be included on such
list. The notices shall provide for a period of not less than
60 calendar days for public comment. Within 180 days after
the end of the comment period, the Secretary shall publish in
the Federal Register a final action classifying such suitable
accessories into class I.
``(ii) A manufacturer or importer of an accessory that has
been granted such marketing authorization may submit to the
Secretary a written request for the appropriate
classification of the accessory based on the risks and
appropriate level of regulatory controls as described in
subparagraph (A), and shall, if the request is requesting
classification of the accessory in class II, include in the
submission an initial draft proposal for special controls, if
special controls would be required pursuant to subsection
(a)(1)(B). Such request shall include such information as may
be necessary for the Secretary to evaluate, based on the
least burdensome approach, the appropriate class for the
accessory under subsection (a). The Secretary shall provide
an opportunity for a manufacturer or importer to meet with
appropriate personnel of the Food and Drug Administration to
discuss the appropriate classification of such accessory
prior to submitting a written request under this clause for
classification of the accessory.
``(iii) The Secretary shall respond to a request made under
clause (ii) not later than 85 calendar days after receiving
such request by issuing a written order classifying the
accessory or denying the request. If the Secretary does not
agree with the recommendation for classification submitted by
the manufacturer or importer, the response shall include a
detailed description and justification for such
determination. Within 30 calendar days after granting such a
request, the Secretary shall publish a notice in the Federal
Register announcing such response.
``(E) Nothing in this paragraph may be construed as
precluding a manufacturer of an accessory of a new type from
using the classification process described in subsection
(f)(2) to obtain classification of such accessory in
accordance with the criteria and requirements set forth in
that subsection.''.
(b) Conforming Change.--Section 513(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360c(b)) is amended by
striking paragraph (9) (relating to classification of an
accessory).
(c) Effective Date.--The amendments made by subsections (a)
and (b) shall take effect on the date that is 60 days after
the date of enactment of this Act.
SEC. 708. DEVICE PILOT PROJECTS.
(a) Postmarket Pilot.--Section 519 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 360i) is amended by adding
at the end the following:
``(i) Postmarket Pilot.--
``(1) In general.--In order to provide timely and reliable
information on the safety and effectiveness of devices
approved under section 515, cleared under section 510(k), or
classified under section 513(f)(2), including responses to
adverse events and malfunctions, and to advance the
objectives of part 803 of title 21, Code of Federal
Regulations (or successor regulations), and advance the
objectives of, and evaluate innovative new methods of
compliance with, this section and section 522, the Secretary
shall, within one year of the date of enactment of the FDA
Reauthorization Act of 2017, initiate one or more pilot
projects for voluntary participation by a manufacturer or
manufacturers of a device or device type, or continue
existing projects, in accordance with paragraph (3), that--
``(A) are designed to efficiently generate reliable and
timely safety and active surveillance data for use by the
Secretary or manufacturers of the devices that are involved
in the pilot project;
``(B) inform the development of methods, systems, data
criteria, and programs that could be used to support safety
and active surveillance activities for devices included or
not included in such project;
``(C) may be designed and conducted in coordination with a
comprehensive system for evaluating medical device technology
that operates under a governing board with appropriate
representation of stakeholders, including patient groups and
device manufacturers;
``(D) use electronic health data including claims data,
patient survey data, or any other data, as the Secretary
determines appropriate; and
``(E) prioritize devices and device types that meet one or
more of the following criteria:
``(i) Devices and device types for which the collection and
analysis of real world evidence regarding a device's safety
and effectiveness is likely to advance public health.
``(ii) Devices and device types that are widely used.
``(iii) Devices and device types, the failure of which has
significant health consequences.
``(iv) Devices and device types for which the Secretary--
``(I) has received public recommendations in accordance
with paragraph (2)(B); and
``(II) has determined to meet one or more of the criteria
under clause (i), (ii), or (iii) and is appropriate for such
a pilot project.
``(2) Participation.--The Secretary shall establish the
conditions and processes--
``(A) under which a manufacturer of a device may
voluntarily participate in a pilot project described in
paragraph (1); and
``(B) for facilitating public recommendations for devices
to be prioritized under such
[[Page H5470]]
a pilot project, including requirements for the data
necessary to support such a recommendation.
``(3) Continuation of ongoing projects.--The Secretary may
continue or expand projects, with respect to providing timely
and reliable information on the safety and effectiveness of
devices approved under section 515, cleared under section
510(k), or classified under section 513(f)(2), that are being
carried out as of the date of the enactment of the FDA
Reauthorization Act of 2017. The Secretary shall, beginning
on such date of enactment, take such steps as may be
necessary--
``(A) to ensure such projects meet the requirements of
subparagraphs (A) through (E) of paragraph (1); and
``(B) to increase the voluntary participation in such
projects of manufacturers of devices and facilitate public
recommendations for any devices prioritized under such a
project.
``(4) Implementation.--
``(A) Contracting authority.--The Secretary may carry out a
pilot project meeting the criteria specified in subparagraphs
(A) through (E) of paragraph (1) or a project continued or
expanded under paragraph (3) by entering into contracts,
cooperative agreements, grants, or other appropriate
agreements with public or private entities that have a
significant presence in the United States and meet the
following conditions:
``(i) If such an entity is a component of another
organization, the entity and the organization have
established an agreement under which appropriate security
measures are implemented to maintain the confidentiality and
privacy of the data described in paragraph (1)(D) and such
agreement ensures that the entity will not make an
unauthorized disclosure of such data to the other components
of the organization in breach of requirements with respect to
confidentiality and privacy of such data established under
such security measures.
``(ii) In the case of the termination or nonrenewal of such
a contract, cooperative agreement, grant, or other
appropriate agreement, the entity or entities involved shall
comply with each of the following:
``(I) The entity or entities shall continue to comply with
the requirements with respect to confidentiality and privacy
referred to in clause (i) with respect to all data disclosed
to the entity under such an agreement.
``(II) The entity or entities shall return any data
disclosed to such entity pursuant to this subsection and to
which it would not otherwise have access or, if returning
such data is not practicable, destroy the data.
``(iii) The entity or entities shall have one or more
qualifications with respect to--
``(I) research, statistical, epidemiologic, or clinical
capability and expertise to conduct and complete the
activities under this subsection, including the capability
and expertise to provide the Secretary access to de-
identified data consistent with the requirements of this
subsection;
``(II) an information technology infrastructure to support
electronic data and operational standards to provide security
for such data, as appropriate;
``(III) experience with, and expertise on, the development
of research on, and surveillance of, device safety and
effectiveness using electronic health data; or
``(IV) such other expertise which the Secretary determines
necessary to carry out such a project.
``(B) Review of contract in the event of a merger or
acquisition.--The Secretary shall review any contract,
cooperative agreement, grant, or other appropriate agreement
entered into under this paragraph with an entity meeting the
conditions specified in subparagraph (A) in the event of a
merger or acquisition of the entity in order to ensure that
the requirements specified in this subsection will continue
to be met.
``(5) Compliance with requirements for records or reports
on devices.--The participation of a manufacturer in pilot
projects under this subsection or a project continued or
expanded under paragraph (3) shall not affect the eligibility
of such manufacturer to participate in any quarterly
reporting program with respect to devices carried out under
this section 519 or section 522. The Secretary may determine
that, for a specified time period to be determined by the
Secretary, a manufacturer's participation in a pilot project
under this subsection or a project continued or expanded
under paragraph (3) may meet the applicable requirements of
this section or section 522, if--
``(A) the project has demonstrated success in capturing
relevant adverse event information; and
``(B) the Secretary has established procedures for making
adverse event and safety information collected from such
project public, to the extent possible.
``(6) Privacy requirements.--With respect to the disclosure
of any health information collected through a project
conducted under this subsection--
``(A) individually identifiable health information so
collected shall not be disclosed when presenting any
information from such project; and
``(B) any such disclosure shall be made in compliance with
regulations issued pursuant to section 264(c) of the Health
Insurance Portability and Accountability Act of 1996 (42
U.S.C. 1320d-2 note) and sections 552 and 552a of title 5,
United States Code.
``(7) Limitations.--No pilot project under this subsection,
or in coordination with the comprehensive system described in
paragraph (1)(C), may allow for an entity participating in
such project, other than the Secretary, to make
determinations of safety or effectiveness, or substantial
equivalence, for purposes of this Act.
``(8) Other projects required to comply.--Paragraphs
(1)(B), (4)(A)(i), (4)(A)(ii), (5), (6), and (7) shall apply
with respect to any pilot project undertaken in coordination
with the comprehensive system described in paragraph (1)(C)
that relates to the use of real world evidence for devices in
the same manner and to the same extent as such paragraphs
apply with respect to pilot projects conducted under this
subsection.
``(9) Report to congress.--Not later than 18 months after
the date of enactment of this Act, and annually 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
containing a description of the pilot projects being
conducted under this subsection and projects continued or
expanded pursuant to paragraph (3), including for each such
project--
``(A) how the project is being implemented in accordance
with paragraph (4), including how such project is being
implemented through a contract, cooperative agreement, grant,
or other appropriate agreement, if applicable;
``(B) the number of manufacturers that have agreed to
participate in such project;
``(C) the data sources used to conduct such project;
``(D) the devices or device categories involved in such
project;
``(E) the number of patients involved in such project; and
``(F) the findings of the project in relation to device
safety, including adverse events, malfunctions, and other
safety information.
``(10) Sunset.--The Secretary may not carry out a pilot
project initiated by the Secretary under this subsection
after October 1, 2022.''.
(b) Report.--Not later than January 31, 2021, the Secretary
of Health and Human Services, acting through the Commissioner
of Food and Drugs, shall conduct a review through an
independent third party to evaluate the strengths,
limitations, and appropriate use of evidence collected
pursuant to real world evidence pilot projects described in
the letters described in section 201(b) of the Medical Device
User Fee Amendments of 2017 and subsection (i) of section 519
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i),
as amended by subsection (a), for informing premarket and
postmarket decisionmaking for multiple device types, and to
determine whether the methods, systems, and programs in such
pilot projects efficiently generate reliable and timely
evidence about the effectiveness or safety surveillance of
devices.
SEC. 709. REGULATION OF OVER-THE-COUNTER HEARING AIDS.
(a) In General.--Section 520 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is
further amended by adding at the end the following:
``(q) Regulation of Over-the-Counter Hearing Aids.--
``(1) Definition.--
``(A) In general.--In this subsection, the term `over-the-
counter hearing aid' means a device that--
``(i) uses the same fundamental scientific technology as
air conduction hearing aids (as defined in section 874.3300
of title 21, Code of Federal Regulations) (or any successor
regulation) or wireless air conduction hearing aids (as
defined in section 874.3305 of title 21, Code of Federal
Regulations) (or any successor regulation);
``(ii) is intended to be used by adults age 18 and older to
compensate for perceived mild to moderate hearing impairment;
``(iii) through tools, tests, or software, allows the user
to control the over-the-counter hearing aid and customize it
to the user's hearing needs;
``(iv) may--
``(I) use wireless technology; or
``(II) include tests for self-assessment of hearing loss;
and
``(v) is available over-the-counter, without the
supervision, prescription, or other order, involvement, or
intervention of a licensed person, to consumers through in-
person transactions, by mail, or online.
``(B) Exception.--Such term does not include a personal
sound amplification product intended to amplify sound for
nonhearing impaired consumers in situations including hunting
and bird-watching.
``(2) Regulation.--An over-the-counter hearing aid shall be
subject to the regulations promulgated in accordance with
section 709(b) of the FDA Reauthorization Act of 2017 and
shall be exempt from sections 801.420 and 801.421 of title
21, Code of Federal Regulations (or any successor
regulations).''.
(b) Regulations To Establish Category.--
(1) In general.--The Secretary of Health and Human Services
(referred to in this section as the ``Secretary''), not later
than 3 years after the date of enactment of this Act, shall
promulgate proposed regulations to establish a category of
over-the-counter hearing aids, as defined in subsection (q)
of section 520 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j) as amended by subsection (a), and, not later
than 180 days after the date on which the public comment
[[Page H5471]]
period on the proposed regulations closes, shall issue such
final regulations.
(2) Requirements.--In promulgating the regulations under
paragraph (1), the Secretary shall--
(A) include requirements that provide reasonable assurances
of the safety and effectiveness of over-the-counter hearing
aids;
(B) include requirements that establish or adopt output
limits appropriate for over-the-counter hearing aids;
(C) include requirements for appropriate labeling of over-
the-counter hearing aids, including requirements that such
labeling include a conspicuous statement that the device is
only intended for adults age 18 and older, information on how
consumers may report adverse events, information on any
contraindications, conditions, or symptoms of medically
treatable causes of hearing loss, and advisements to consult
promptly with a licensed health care practitioner; and
(D) describe the requirements under which the sale of over-
the-counter hearing aids is permitted, without the
supervision, prescription, or other order, involvement, or
intervention of a licensed person, to consumers through in-
person transactions, by mail, or online.
(3) Premarket notification.--The Secretary shall make
findings under section 510(m) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(m)) to determine whether over-
the-counter hearing aids (as defined in section 520(q) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as
amended by subsection (a)) require a report under section
510(k) to provide reasonable assurance of safety and
effectiveness.
(4) Effect on state law.--No State or local government
shall establish or continue in effect any law, regulation,
order, or other requirement specifically related to hearing
products that would restrict or interfere with the servicing,
marketing, sale, dispensing, use, customer support, or
distribution of over-the-counter hearing aids (as defined in
section 520(q) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360j), as amended by subsection (a)) through in-
person transactions, by mail, or online, that is different
from, in addition to, or otherwise not identical to, the
regulations promulgated under this subsection, including any
State or local requirement for the supervision, prescription,
or other order, involvement, or intervention of a licensed
person for consumers to access over-the-counter hearing aids.
(5) No effect on private remedies.--Nothing in this section
shall be construed to modify or otherwise affect the ability
of any person to exercise a private right of action under any
State or Federal product liability, tort, warranty, contract,
or consumer protection law.
(c) New Guidance Issued.--Not later than the date on which
final regulations are issued under subsection (b), the
Secretary shall update and finalize the draft guidance of the
Department of Health and Human Services entitled ``Regulatory
Requirements for Hearing Aid Devices and Personal Sound
Amplification Products'', issued on November 7, 2013. Such
updated and finalized guidance shall clarify which products,
on the basis of claims or other marketing, advertising, or
labeling material, meet the definition of a device in section
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321) and which products meet the definition of a personal
sound amplification product, as set forth in such guidance.
(d) Report.--Not later than 2 years after the date on which
the final regulations described in subsection (b)(1) are
issued, the Secretary of Health and Human Services shall
submit to Congress a report analyzing any adverse events
relating to over-the-counter hearing aids (as defined in
subsection (q)(1) of section 520 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 360j)).
SEC. 710. REPORT ON SERVICING OF DEVICES.
(a) In General.--Not later than 270 days after the date of
enactment of this Act, the Secretary of Health and Human
Services, acting through the Commissioner of Food and Drugs,
shall post on the internet website of the Food and Drug
Administration a report on the continued quality, safety, and
effectiveness of devices (as defined in section 201(h) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))) with
respect to servicing (as defined in subsection (c)).
(b) Contents.--The report submitted under subsection (a)
shall contain--
(1) the status of, and findings to date, with respect to,
the proposed rule entitled ``Refurbishing, Reconditioning,
Rebuilding, Remarketing, Remanufacturing, and Servicing of
Medical Devices Performed by Third-Party Entities and
Original Equipment Manufacturers; Request for Comments''
published in the Federal Register by the Food and Drug
Administration on March 4, 2016 (81 Fed. Reg. 11477);
(2) information presented during the October 2016 public
workshop entitled ``Refurbishing, Reconditioning, Rebuilding,
Remarketing, Remanufacturing, and Servicing of Medical
Devices Performed by Third-Party Entities and Original
Equipment Manufacturers'';
(3) a description of the statutory and regulatory authority
of the Food and Drug Administration with respect to the
servicing of devices conducted by any entity, including
original equipment manufacturers and third party entities;
(4) details regarding how the Food and Drug Administration
currently regulates devices with respect to servicing to
ensure safety and effectiveness, how the agency could improve
such regulation using the authority described in paragraph
(3), and whether additional authority is recommended;
(5) information on actions the Food and Drug Administration
could take under the authority described in paragraphs (3)
and (4) to assess the servicing of devices, including the
size, scope, location, and composition of third party
entities;
(6) information on actions the Food and Drug Administration
could take to track adverse events caused by servicing errors
performed by any entity, including original equipment
manufacturers and third party entities;
(7) information regarding the regulation by States, the
Joint Commission, or other regulatory bodies of device
servicing performed by any entity, including original
equipment manufacturers and third party entities; and
(8) any additional information determined by the Secretary
(acting through the Commissioner) to be relevant to ensuring
the quality, safety, and effectiveness of devices with
respect to servicing.
(c) Servicing Defined.--In this section, the term
``servicing'' includes, with respect to a device,
refurbishing, reconditioning, rebuilding, remarketing,
repairing, remanufacturing, or other servicing of the device.
TITLE VIII--IMPROVING GENERIC DRUG ACCESS
SEC. 801. PRIORITY REVIEW OF GENERIC DRUGS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j)) is amended by adding at the end the
following:
``(11)(A) Subject to subparagraph (B), the Secretary shall
prioritize the review of, and act within 8 months of the date
of the submission of, an original abbreviated new drug
application submitted for review under this subsection that
is for a drug--
``(i) for which there are not more than 3 approved drug
products listed under paragraph (7) and for which there are
no blocking patents and exclusivities; or
``(ii) that has been included on the list under section
506E.
``(B) To qualify for priority review under this paragraph,
not later than 60 days prior to the submission of an
application described in subparagraph (A) or that the
Secretary may prioritize pursuant to subparagraph (D), the
applicant shall provide complete, accurate information
regarding facilities involved in manufacturing processes and
testing of the drug that is the subject of the application,
including facilities in corresponding Type II active
pharmaceutical ingredients drug master files referenced in an
application and sites or organizations involved in
bioequivalence and clinical studies used to support the
application, to enable the Secretary to make a determination
regarding whether an inspection of a facility is necessary.
Such information shall include the relevant (as determined by
the Secretary) sections of such application, which shall be
unchanged relative to the date of the submission of such
application, except to the extent that a change is made to
such information to exclude a facility that was not used to
generate data to meet any application requirements for such
submission and that is not the only facility intended to
conduct one or more unit operations in commercial production.
Information provided by an applicant under this subparagraph
shall not be considered the submission of an application
under this subsection.
``(C) The Secretary may expedite an inspection or
reinspection under section 704 of an establishment that
proposes to manufacture a drug described in subparagraph (A).
``(D) Nothing in this paragraph shall prevent the Secretary
from prioritizing the review of other applications as the
Secretary determines appropriate.
``(12) The Secretary shall publish on the internet website
of the Food and Drug Administration, and update at least once
every 6 months, a list of all drugs approved under subsection
(c) for which all patents and periods of exclusivity under
this Act have expired and for which no application has been
approved under this subsection.''.
SEC. 802. ENHANCING REGULATORY TRANSPARENCY TO ENHANCE
GENERIC COMPETITION.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355), as amended by section 801, is further
amended by adding at the end the following:
``(13) Upon the request of an applicant regarding one or
more specified pending applications under this subsection,
the Secretary shall, as appropriate, provide review status
updates indicating the categorical status of the applications
by each relevant review discipline.''.
SEC. 803. COMPETITIVE GENERIC THERAPIES.
(a) In General.--Chapter V of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 351 et seq.) is amended by inserting
after section 506G the following:
``SEC. 506H. COMPETITIVE GENERIC THERAPIES.
``(a) In General.--The Secretary may, at the request of an
applicant of a drug that is designated as a competitive
generic therapy pursuant to subsection (b), expedite the
development and review of an abbreviated new drug application
under section 505(j) for such drug.
``(b) Designation Process.--
``(1) Request.--The applicant may request the Secretary to
designate the drug as a competitive generic therapy.
[[Page H5472]]
``(2) Timing.--A request under paragraph (1) may be made
concurrently with, or at any time prior to, the submission of
an abbreviated new drug application for the drug under
section 505(j).
``(3) Criteria.--A drug is eligible for designation as a
competitive generic therapy under this section if the
Secretary determines that there is inadequate generic
competition.
``(4) Designation.--Not later than 60 calendar days after
the receipt of a request under paragraph (1), the Secretary
may--
``(A) determine whether the drug that is the subject of the
request meets the criteria described in paragraph (3); and
``(B) if the Secretary finds that the drug meets such
criteria, designate the drug as a competitive generic
therapy.
``(c) Actions.--In expediting the development and review of
an application under subsection (a), the Secretary may, as
requested by the applicant, take actions including the
following:
``(1) Hold meetings with the applicant and the review team
throughout the development of the drug prior to submission of
the application for such drug under section 505(j).
``(2) Provide timely advice to, and interactive
communication with, the applicant regarding the development
of the drug to ensure that the development program to gather
the data necessary for approval is as efficient as
practicable.
``(3) Involve senior managers and experienced review staff,
as appropriate, in a collaborative, coordinated review of
such application, including with respect to drug-device
combination products and other complex products.
``(4) Assign a cross-disciplinary project lead--
``(A) to facilitate an efficient review of the development
program and application, including manufacturing inspections;
and
``(B) to serve as a scientific liaison between the review
team and the applicant.
``(d) Reporting Requirement.--Not later than one year after
the date of the approval of an application under section
505(j) with respect to a drug for which the development and
review is expedited under this section, the sponsor of such
drug shall report to the Secretary on whether the drug has
been marketed in interstate commerce since the date of such
approval.
``(e) Definitions.--In this section:
``(1) The term `generic drug' means a drug that is approved
pursuant to section 505(j).
``(2) The term `inadequate generic competition' means, with
respect to a drug, there is not more than one approved drugs
on the list of drugs described in section 505(j)(7)(A) (not
including drugs on the discontinued section of such list)
that is--
``(A) the reference listed drug; or
``(B) a generic drug with the same reference listed drug as
the drug for which designation as a competitive generic
therapy is sought.
``(3) The term `reference listed drug' means the listed
drug (as such term is used in section 505(j)) for the drug
involved.''.
(b) Guidance; Amended Regulations.--
(1) In general.--
(A) Issuance.--The Secretary of Health and Human Services
shall--
(i) not later than 18 months after the date of enactment of
this Act, issue draft guidance on section 506H of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a); and
(ii) not later than 1 year after the close of the comment
period for the draft guidance, issue final guidance on such
section 506H.
(B) Contents.--The guidance issued under this paragraph
shall--
(i) specify the process and criteria by which the Secretary
makes a designation under section 506H of the Federal Food,
Drug, and Cosmetic Act, as added by subsection (a);
(ii) specify the actions the Secretary may take to expedite
the development and review of a competitive generic therapy
pursuant to such a designation; and
(iii) include good review management practices for
competitive generic therapies.
(2) Amended regulations.--The Secretary of Health and Human
Services shall issue or revise any regulations as may be
necessary to carry out this section not later than 2 years
after the date of enactment of this Act.
SEC. 804. ACCURATE INFORMATION ABOUT DRUGS WITH LIMITED
COMPETITION.
Chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) is amended by inserting after section
506H, as added by section 803, the following:
``SEC. 506I. PROMPT REPORTS OF MARKETING STATUS.
``(a) Notification of Withdrawal.--The holder of an
application approved under subsection (c) or (j) of section
505 shall notify the Secretary in writing 180 days prior to
withdrawing the approved drug from sale, or if 180 days is
not practicable as soon as practicable but not later than the
date of withdrawal. The holder shall include with such notice
the--
``(1) National Drug Code;
``(2) identity of the drug by established name and by
proprietary name, if any;
``(3) new drug application number or abbreviated
application number;
``(4) strength of the drug;
``(5) date on which the drug is expected to no longer be
available for sale; and
``(6) reason for withdrawal of the drug.
``(b) Notification of Drug Not Available for Sale.--The
holder of an application approved under subsection (c) or (j)
shall notify the Secretary in writing within 180 calendar
days of the date of approval of the drug if the drug will not
be available for sale within 180 calendar days of such date
of approval. The holder shall include with such notice the--
``(1) identity of the drug by established name and by
proprietary name, if any;
``(2) new drug application number or abbreviated
application number;
``(3) strength of the drug;
``(4) date on which the drug will be available for sale, if
known; and
``(5) reason for not marketing the drug after approval.
``(c) Additional One-time Report.--Within 180 days of the
date of enactment of this section, all holders of
applications approved under subsection (c) or (j) of section
505 shall review the information in the list published under
subsection 505(j)(7)(A) and shall notify the Secretary in
writing that--
``(1) all of the application holder's drugs in the active
section of the list published under subsection 505(j)(7)(A)
are available for sale; or
``(2) one or more of the application holder's drugs in the
active section of the list published under subsection
505(j)(7)(A) have been withdrawn from sale or have never been
available for sale, and include with such notice the
information required pursuant to subsection (a) or (b), as
applicable.
``(d) Failure to Meet Requirements.--If a holder of an
approved application fails to submit the information required
under subsection (a), (b), or (c), the Secretary may move the
application holder's drugs from the active section of the
list published under subsection 505(j)(7)(A) to the
discontinued section of the list, except that the Secretary
shall remove from the list in accordance with subsection
505(j)(7)(C) drugs the Secretary determines have been
withdrawn from sale for reasons of safety of effectiveness.
``(e) Updates.--The Secretary shall update the list
published under subsection 505(j)(7)(A) based on the
information provided under subsections (a), (b), and (c) by
moving drugs that are not available for sale from the active
section to the discontinued section of the list, except that
drugs the Secretary determines have been withdrawn from sale
for reasons of safety or effectiveness shall be removed from
the list in accordance with subsection 505(j)(7)(C). The
Secretary shall make monthly updates to the list based on the
information provided pursuant to subsections (a) and (b), and
shall update the list based on the information provided under
subsection (c) as soon as practicable.
``(f) Limitation on Use of Notices.--Any notice submitted
under this section shall not be made public by the Secretary
and shall be used solely for the purpose of the updates
described in subsection (e).''.
SEC. 805. SUITABILITY PETITIONS.
(a) In General.--It is the sense of Congress that the Food
and Drug Administration shall meet the requirement under
section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(2)(C)) and section 314.93(e) of title
21, Code of Federal Regulations, of responding to suitability
petitions within 90 days of submission.
(b) Report.--The Secretary of Health and Human Services
shall include in the annual reports under section 807--
(1) the number of pending petitions under section
505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)(2)(C)); and
(2) the number of such petitions pending a substantive
response for more than 180 days from the date of receipt.
SEC. 806. INSPECTIONS.
Within 6 months of the date of enactment of this Act, the
Secretary of Health and Human Services shall develop and
implement a protocol for expediting review of timely
responses to reports of observations from an inspection under
section 704 of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 374). Such protocol shall--
(1) apply to responses to such reports pertaining to
applications submitted under section 505 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355)--
(A) for which the approval is dependent upon remediation of
conditions identified in the report;
(B) for which concerns related to observations from an
inspection under such section 704 are the only barrier to
approval; and
(C) where the drug that is the subject of the application
is a drug--
(i) for which there are not more than 3 other approved
applications under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)) that reference the same
listed drug and for which there are less than 6 abbreviated
new drug applications tentatively approved; or
(ii) that is included on the list under section 506E of
such Act (21 U.S.C. 356e);
(2) address expedited re-inspection of facilities, as
appropriate; and
(3) establish a 6-month timeline for completion of review
of such responses to such reports.
SEC. 807. REPORTING ON PENDING GENERIC DRUG APPLICATIONS AND
PRIORITY REVIEW APPLICATIONS.
Not later than 180 calendar days after the date of
enactment of this Act, and quarterly thereafter until October
1, 2022, the Secretary of Health and Human Services shall
post on the internet website of the Food and Drug
Administration a report that provides, with respect to the
months covered by the report--
[[Page H5473]]
(1) with respect to applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) that, during the most recent calendar year, were
subject to priority review under paragraph (11) of such
section 505(j) (as added by section 801) or expedited
development and review under section 506H of the Federal
Food, Drug, and Cosmetic Act (as added by section 803), the
numbers of such applications (with denotation of such
applications that were filed prior to October 1, 2014) that
are--
(A) awaiting action by the applicant;
(B) awaiting action by the Secretary; and
(C) approved by the Secretary;
(2) the number of applications filed under section 505(j)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
355(j)) and prior approval supplements withdrawn in each
month;
(3) the mean and median approval and tentative approval
times and the number of review cycles for such applications;
(4) the number and type of meetings requested and held
under such section 506H (as added by section 803); and
(5) the number of such applications on which the Secretary
has taken action pursuant to subsection (c) of such section
506H (as added by section 803) and any effect such section
506H may have on the length of time for approval of
applications under such section 505(j) and the number of
review cycles for such approvals.
SEC. 808. INCENTIVIZING COMPETITIVE GENERIC DRUG DEVELOPMENT.
Section 505(j)(5) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)(5)) is amended--
(1) in subparagraph (B), by adding at the end the
following:
``(v) 180-day exclusivity period for competitive generic
therapies.--
``(I) Effectiveness of application.--Subject to
subparagraph (D)(iv), if the application is for a drug that
is the same as a competitive generic therapy for which any
first approved applicant has commenced commercial marketing,
the application shall be made effective on the date that is
180 days after the date of the first commercial marketing of
the competitive generic therapy (including the commercial
marketing of the listed drug) by any first approved
applicant.
``(II) Limitation.--The exclusivity period under subclause
(I) shall not apply with respect to a competitive generic
therapy that has previously received an exclusivity period
under subclause (I).
``(III) Definitions.--In this clause and subparagraph
(D)(iv):
``(aa) The term `competitive generic therapy' means a
drug--
``(AA) that is designated as a competitive generic therapy
under section 506H; and
``(BB) for which there are no unexpired patents or
exclusivities on the list of products described in section
505(j)(7)(A) at the time of submission.
``(bb) The term `first approved applicant' means any
applicant that has submitted an application that--
``(AA) is for a competitive generic therapy that is
approved on the first day on which any application for such
competitive generic therapy is approved;
``(BB) is not eligible for a 180-day exclusivity period
under clause (iv) for the drug that is the subject of the
application for the competitive generic therapy; and
``(CC) is not for a drug for which all drug versions have
forfeited eligibility for a 180-day exclusivity period under
clause (iv) pursuant to subparagraph (D).''; and
(2) in subparagraph (D), by adding at the end the
following:
``(iv) Special forfeiture rule for competitive generic
therapy.--The 180-day exclusivity period described in
subparagraph (B)(v) shall be forfeited by a first approved
applicant if the applicant fails to market the competitive
generic therapy within 75 days after the date on which the
approval of the first approved applicant's application for
the competitive generic therapy is made effective.''.
SEC. 809. GAO STUDY OF ISSUES REGARDING FIRST CYCLE APPROVALS
OF GENERIC MEDICINES.
(a) Study by GAO.--The Comptroller General of the United
States shall conduct a study to determine the following:
(1) The rate of first cycle approvals and tentative
approvals for applications submitted under section 505(j) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j))
during the period beginning on October 1, 2012, and ending on
September 30, 2017. The rate of first cycle approvals and
tentative approvals shall be determined and reported per each
GDUFA cohort year during this period.
(2) If the rate determined pursuant to paragraph (1) for
any GDUFA cohort year is lower than 20 percent, the reasons
contributing to the relatively low rate of first cycle
approvals and tentative approvals for generic drug
applications shall be itemized, assessed, and reported. In
making the assessment required by this paragraph, the
Comptroller General shall consider, among other things, the
role played by--
(A) the Food and Drug Administration's implementation of
approval standards for generic drug applications;
(B) the extent to which those approval standards are
communicated clearly to industry and applied consistently
during the review process;
(C) the procedures for reviewing generic drug applications,
including timelines for review activities by the Food and
Drug Administration;
(D) the extent to which those procedures are followed
consistently (and those timelines are met) by the Food and
Drug Administration;
(E) the processes and practices for communication between
the Food and Drug Administration and sponsors of generic drug
applications; and
(F) the completeness and quality of original generic drug
applications submitted to the Food and Drug Administration.
(3) Taking into account the determinations made pursuant to
paragraphs (1) and (2) and any review process improvements
implemented pursuant to this Act, whether there are ways the
review process for generic drugs could be improved to
increase the rate of first cycle approvals and tentative
approvals for generic drug applications. In making this
determination, the Comptroller General shall consider, among
other things, options for increasing review efficiency and
communication effectiveness.
(b) Completion Date.--Not later than the expiration of the
2-year period beginning on the date of enactment of this Act,
the Comptroller General shall complete the study under
subsection (a) and submit a report describing the findings
and conclusions of the study to the Secretary, the Committee
on Energy and Commerce of the House of Representatives, and
the Committee on Health, Education, Labor, and Pensions of
the Senate.
(c) Definitions.--For purposes of this section:
(1) The term ``GDUFA cohort year'' means a fiscal year.
(2) The term ``generic drug'' means a drug that is approved
or is seeking approval under section 505(j) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)).
(3) The term ``generic drug application'' means an
abbreviated new drug application for the approval of a
generic drug under section 505(j) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(j)).
(4) The term ``Secretary'' means the Secretary of Health
and Human Services.
(5)(A) The term ``first cycle approvals and tentative
approvals'' means the approval or tentative approval of a
generic drug application after the Food and Drug
Administration's complete review of the application and
without issuance of one or more complete response letters.
(B) For purposes of this paragraph, the term ``complete
response letter'' means a written communication to the
sponsor of a generic drug application or holder of a drug
master file from the Food and Drug Administration describing
all of the deficiencies that the Administration has
identified in the generic drug application (including pending
amendments) or drug master file that must be satisfactorily
addressed before the generic drug application can be
approved.
TITLE IX--ADDITIONAL PROVISIONS
SEC. 901. TECHNICAL CORRECTIONS.
(a) Section 3075(a) of the 21st Century Cures Act (Public
Law 114-255) is amended--
(1) in the matter preceding paragraph (1), by striking ``as
amended by section 2074'' and inserting ``as amended by
section 3102''; and
(2) in paragraph (2), by striking ``section 2074(1)(C)''
and inserting ``section 3102(1)(C)''.
(b) Section 506G(b)(1)(A) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 356g(b)(1)(A)) is amended by striking
``identity'' and inserting ``identify''.
(c) Section 505F(b) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355g(b)) is amended by striking ``randomized''
and inserting ``traditional''.
(d) Section 505F(d) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355g(d)) is amended by striking ``2'' and
inserting ``3''.
(e) Section 510(h)(6) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360(h)(6)) is amended by striking
``February 1'' and replacing with ``May 1''.
(f) Effective as of the enactment of the 21st Century Cures
Act (Public Law 114-255)--
(1) section 3051(a) of such Act is amended by striking ``by
inserting after section 515B'' and inserting ``by inserting
after section 515A''; and
(2) section 515C of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 360e-3), as inserted by such section 3051(a),
is redesignated as section 515B.
(g) Section 515B(f)(2) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360e-3(f)(2)), as redesignated by
subsection (e)(2) of this section, is amended by striking ``a
proposed guidance'' and inserting ``a draft version of that
guidance''.
(h) Section 513(b)(5)(D) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360c(b)(5)(D)) is amended by striking
``medical device submissions'' and inserting ``medical
devices that may be specifically the subject of a review by a
classification panel''.
SEC. 902. ANNUAL REPORT ON INSPECTIONS.
Not later than March 1 of each year, the Secretary of
Health and Human Services shall post on the internet website
of the Food and Drug Administration information related to
inspections of facilities necessary for approval of a drug
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355), approval of a device under section 515 of
such Act (21 U.S.C. 360e), or clearance of a device under
section 510(k) of such Act (21 U.S.C. 360(k)) that were
conducted during the previous calendar year. Such information
shall include the following:
[[Page H5474]]
(1) The median time following a request from staff of the
Food and Drug Administration reviewing an application or
report to the beginning of the inspection, and the median
time from the beginning of an inspection to the issuance of a
report pursuant to section 704(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 374(b)).
(2) The median time from the issuance of a report pursuant
to such section 704(b) to the sending of a warning letter,
issuance of an import alert, or holding of a regulatory
meeting for inspections for which the Secretary concluded
that regulatory or enforcement action was indicated.
(3) The median time from the sending of a warning letter,
issuance of an import alert, or holding of a regulatory
meeting to resolution of the regulatory or enforcement action
indicated for inspections for which the Secretary concluded
that such action was indicated.
(4) The number of times that a facility was issued a report
pursuant to such section 704(b) and approval of an
application was delayed due to the issuance of a withhold
recommendation.
SEC. 903. STREAMLINING AND IMPROVING CONSISTENCY IN
PERFORMANCE REPORTING.
(a) PDUFA.--Section 736B(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h-2(a)), as amended by section
103, is further amended by inserting after paragraph (2) the
following:
``(3) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the
data described in subparagraph (B) on the internet website of
the Food and Drug Administration for such quarter and on a
cumulative basis for such fiscal year, and may remove
duplicative data from the annual performance report under
this subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance on
topics related to the process for the review of human drug
applications, and whether such guidances were issued as
required by statute or pursuant to a commitment under the
letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017.
``(ii) The number and titles of public meetings held on
topics related to the process for the review of human drug
applications, and whether such meetings were required by
statute or pursuant to a commitment under the letters
described in section 101(b) of the Prescription Drug User Fee
Amendments of 2017.
``(iii) The number of new drug applications and biological
licensing applications approved.
``(iv) The number of new drug applications and biological
licensing applications filed.
``(4) Rationale for pdufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food and Drug
Administration by each division within the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs, and the
Office of the Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for the process for the review
of human drugs, including identifying drivers of such
changes; and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research,
the Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time
reporting is not required.''.
(b) MDUFA.--Section 738A(a)(1)(A) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-1(a)(1)(A)), as
amended by section 204, is further amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(i) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(ii) Additional information.--Beginning with fiscal year
2018, the annual report under this subparagraph shall include
the progress of the Center for Devices and Radiological
Health in achieving the goals, and future plans for meeting
the goals, including--
``(I) the number of premarket applications filed under
section 515 per fiscal year for each review division;
``(II) the number of reports submitted under section 510(k)
per fiscal year for each review division; and
``(III) the number of expedited development and priority
review designations under section 515C per fiscal year.
``(iii) Real time reporting.--
``(I) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the
data described in subclause (II) on the internet website of
the Food and Drug Administration for such quarter and on a
cumulative basis for such fiscal year, and may remove
duplicative data from the annual report under this
subparagraph.
``(II) Data.--The Secretary shall post the following data
in accordance with subclause (I):
``(aa) The number and titles of draft and final guidance on
topics related to the process for the review of devices, and
whether such guidances were issued as required by statute or
pursuant to the letters described in section 201(b) of the
Medical Device User Fee Amendments of 2017; and
``(bb) The number and titles of public meetings held on
topics related to the process for the review of devices, and
if such meetings were required by statute or pursuant to a
commitment under the letters described in section 201(b) of
the Medical Device User Fee Amendments of 2017.
``(iv) Rationale for mdufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)--
``(I) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 201(b) of the Medical Device
User Fee Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food and Drug
Administration by each division within the Center for Devices
and Radiological Health, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs, and the
Office of the Commissioner;
``(II) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for the process for the review
of devices, including identifying drivers of such changes;
and
``(III) for each of the Center for Devices and Radiological
Health, the Center for Biologics Evaluation and Research, the
Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time
reporting is not required.''.
(c) GDUFA.--Section 744C(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-43(a)), as amended by section
304, is further amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(2) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the
data described in subparagraph (B) on the internet website of
the Food and Drug Administration, and may remove duplicative
data from the annual report under this subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance on
topics related to human generic drug activities and whether
such guidances were issued as required by statute or pursuant
to a commitment under the letters described in section 301(b)
of the Generic Drug User Fee Amendments of 2017.
``(ii) The number and titles of public meetings held on
topics related to human generic drug activities and whether
such meetings were required by statute or pursuant to a
commitment under the letters described in section 301(b) of
the Generic Drug User Fee Amendments of 2017.
``(3) Rationale for gdufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 301(b) of the Generic Drug User
Fee Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food and Drug
Administration by each division within the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs, and the
Office of the Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for human generic drug
activities, including identifying drivers of such changes;
and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research,
the Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time
reporting is not required.''.
(d) BsUFA.--Section 744I(a) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-53(a)), as amended by section
404, is further amended--
(1) by striking ``Beginning with'' and inserting the
following:
``(1) General requirements.--Beginning with''; and
(2) by adding at the end the following:
``(2) Additional information.--Beginning with fiscal year
2018, the report under this subsection shall include the
progress of the Food and Drug Administration in achieving
[[Page H5475]]
the goals, and future plans for meeting the goals,
including--
``(A) 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) the number of original biosimilar biological product
applications filed per fiscal year, and the number of
approvals issued by the agency for such applications; and
``(C) the number of resubmitted original biosimilar
biological product applications filed per fiscal year and the
number of approvals letters issued by the agency for such
applications.
``(3) Real time reporting.--
``(A) In general.--Not later than 30 calendar days after
the end of the second quarter of fiscal year 2018, and not
later than 30 calendar days after the end of each quarter of
each fiscal year thereafter, the Secretary shall post the
data described in subparagraph (B) for such quarter and on a
cumulative basis for the fiscal year on the internet website
of the Food and Drug Administration, and may remove
duplicative data from the annual report under this
subsection.
``(B) Data.--The Secretary shall post the following data in
accordance with subparagraph (A):
``(i) The number and titles of draft and final guidance on
topics related to the process for the review of biosimilars,
and whether such guidances were required by statute or
pursuant to a commitment under the letters described in
section 401(b) of the Biosimilar User Fee Amendments of 2017.
``(ii) The number and titles of public meetings held on
topics related to the process for the review of biosimilars,
and whether such meetings were required by statute or
pursuant to a commitment under the letters described in
section 401(b) of the Biosimilar User Fee Amendments of 2017.
``(4) Rationale for bsufa program changes.--Beginning with
fiscal year 2020, the Secretary shall include in the annual
report under paragraph (1)--
``(A) data, analysis, and discussion of the changes in the
number of full-time equivalents hired as agreed upon in the
letters described in section 401(b) of the Biosimilar User
Fee Amendments of 2017 and the number of full time
equivalents funded by budget authority at the Food and Drug
Administration by each division within the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, the Office of Regulatory Affairs, and the
Office of the Commissioner;
``(B) data, analysis, and discussion of the changes in the
fee revenue amounts and costs for the process for the review
of biosimilar biological product applications, including
identifying drivers of such changes; and
``(C) for each of the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research,
the Office of Regulatory Affairs, and the Office of the
Commissioner, the number of employees for whom time reporting
is required and the number of employees for whom time
reporting is not required.''.
SEC. 904. ANALYSIS OF USE OF FUNDS.
(a) PDUFA Reports.--
(1) Analysis in pdufa performance reports.--Section 736B(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-
2(a)), as amended by section 903(a), is further amended by
adding at the end the following:
``(5) Analysis.--For each fiscal year, the Secretary shall
include in the report under paragraph (1) an analysis of the
following:
``(A) The difference between the aggregate number of human
drug applications filed and the aggregate number of
approvals, accounting for--
``(i) such applications filed during one fiscal year for
which a decision is not scheduled to be made until the
following fiscal year;
``(ii) the aggregate number of applications for each fiscal
year that did not meet the goals identified in the letters
described in section 101(b) of the Prescription Drug User Fee
Amendments of 2017 for the applicable fiscal year.
``(B) Relevant data to determine whether the Center for
Drug Evaluation and Research and the Center for Biologics
Evaluation and Research have met performance enhancement
goals identified in the letters described in section 101(b)
of the Prescription Drug User Fee Amendments of 2017 for the
applicable fiscal year.
``(C) The most common causes and trends of external or
other circumstances affecting the ability of the Center for
Drug Evaluation and Research, the Center for Biologics
Evaluation and Research, Office of Regulatory Affairs, and
the Food and Drug Administration to meet the review time and
performance enhancement goals identified in the letters
described in section 101(b) of the Prescription Drug User Fee
Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 736B of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379h-2)
is amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year
2018, for each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of
the Senate. The report shall include the following
information, as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5),
that each of the goals identified in the letters described in
section 101(b) of the Prescription Drug User Fee Amendments
of 2017 for the applicable fiscal year have been met, the
corrective action report shall include recommendations on
ways in which the Secretary can improve and streamline the
human drug application review process.
``(2) Goals missed.--For any of the goals identified in the
letters described in section 101(b) of the Prescription Drug
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the
corrective action report shall include--
``(A) a detailed justification for such determination and a
description, as applicable, of the types of circumstances and
trends under which human drug applications that missed the
review goal time were approved during the first cycle review,
or application review goals were missed; and
``(B) with respect to performance enhancement goals that
were not achieved, a description of efforts the Food and Drug
Administration has put in place for the fiscal year in which
the report is submitted to improve the ability of such agency
to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers
with expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives to report on the
contents described in the reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the
Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to report on the
contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end of
each fiscal year for which fees are collected under this
part.''.
(b) MDUFA Reports.--
(1) Analysis in mdufa performance reports.--Section
738A(a)(1)(A) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 379j-1(a)(1)(A)), as amended by section 903(b), is
further amended by adding at the end the following:
``(iv) Analysis.--For each fiscal year, the Secretary shall
include in the report under clause (i) an analysis of the
following:
``(I) The difference between the aggregate number of
premarket applications filed under section 515 and aggregate
reports submitted under section 510(k) and the aggregate
number of major deficiency letters, not approvable letters,
and denials for such applications issued by the agency,
accounting for--
``(aa) the number of applications filed and reports
submitted during one fiscal year for which a decision is not
scheduled to be made until the following fiscal year; and
``(bb) the aggregate number of applications for each fiscal
year that did not meet the goals as identified by the letters
described in section 201(b) of the Medical Device User Fee
Amendments of 2017 for the applicable fiscal year.
``(II) Relevant data to determine whether the Center for
Devices and Radiological Health has met performance
enhancement goals identified by the letters described in
section 201(b) of the Medical Device User Fee Amendments of
2017 for the applicable fiscal year.
``(III) The most common causes and trends for external or
other circumstances affecting the ability of the Center for
Devices and Radiological Health, the Office of Regulatory
Affairs, or the Food and Drug Administration to meet review
time and performance enhancement goals identified by the
letters described in section 201(b) of the Medical Device
User Fee Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 738A(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
1(a)) is amended--
(A) by redesignating paragraphs (2) and (3) as paragraphs
(4) and (5), respectively; and
(B) by inserting after paragraph (1) the following:
``(2) Corrective action report.--Beginning with fiscal year
2018, for each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of
the Senate. The report shall include the following
information, as applicable:
``(A) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under paragraph (1)(A)(iv),
that each of the goals identified by the letters described in
section 201(b) of the Medical Device User Fee Amendments of
2017 for the applicable
[[Page H5476]]
fiscal year have been met, the corrective action report shall
include recommendations on ways in which the Secretary can
improve and streamline the medical device application review
process.
``(B) Goals missed.--For each of the goals identified by
the letters described in section 201(b) of the Medical Device
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the
corrective action report shall include--
``(i) a justification for such determination;
``(ii) a description of the types of circumstances, in the
aggregate, under which applications or reports submitted
under section 515 or notifications submitted under section
510(k) missed the review goal times but were approved during
the first cycle review, as applicable;
``(iii) a summary and any trends with regard to the
circumstances for which a review goal was missed; and
``(iv) the performance enhancement goals that were not
achieved during the previous fiscal year and a description of
efforts the Food and Drug Administration has put in place for
the fiscal year in which the report is submitted to improve
the ability of such agency to meet each such goal for the
such fiscal year.
``(3) Enhanced communication.--
``(A) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers
with expertise in the review of devices shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives to report on the
contents described in the reports under this section.
``(B) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the
Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to report on the
contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end of
each fiscal year for which fees are collected under this
part.''.
(c) GDUFA Reports.--
(1) Analysis in gdufa performance reports.--Section 744C(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
43(a)), as amended by section 903(c) is further amended by
adding at the end the following:
``(4) Analysis.--For each fiscal year, the Secretary shall
include in the report an analysis of the following:
``(A) The difference between the aggregate number of
abbreviated new drug applications filed and the aggregate
number of approvals or aggregate number of complete response
letters issued by the agency, accounting for--
``(i) such applications filed during one fiscal year for
which a decision is not scheduled to be made until the
following fiscal year; and
``(ii) the aggregate number of applications for each fiscal
year that did not meet the goals identified by the letters
described in section 301(b) of the Generic Drug User Fee
Amendments of 2017 for the applicable fiscal year.
``(B) Relevant data to determine whether the Food and Drug
Administration has met the performance enhancement goals
identified by the letters described in section 301(b) of the
Generic Drug User Fee Amendments of 2017 for the applicable
fiscal year.
``(C) The most common causes and trends for external or
other circumstances that affected the ability of the
Secretary to meet review time and performance enhancement
goals identified by the letters described in section 301(b)
of the Generic Drug User Fee Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 744C of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-43)
is amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year
2018, for each fiscal year for which fees are collected under
this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and the Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and the Committee on Appropriations of
the Senate. The report shall include the following
information, as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(4),
that each of the goals identified by the letters described in
section 301(b) of the Generic Drug User Fee Amendments of
2017 for the applicable fiscal year have been met, the
corrective action report shall include recommendations on
ways in which the Secretary can improve and streamline the
abbreviated new drug application review process.
``(2) Goals missed.--For each of the goals identified by
the letters described in section 301(b) of the Generic Drug
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the
corrective action report shall include--
``(A) a detailed justification for such determination and a
description, as applicable, of the types of circumstances and
trends under which abbreviated new drug applications missed
the review goal times but were approved during the first
cycle review, or review goals were missed; and
``(B) with respect to performance enhancement goals that
were not achieved, a detailed description of efforts the Food
and Drug Administration has put in place for the fiscal year
in which the report is submitted to improve the ability of
such agency to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested, representatives from the Centers
with expertise in the review of human drugs shall meet with
representatives from the Committee on Health, Education,
Labor, and Pensions of the Senate and the Committee on Energy
and Commerce of the House of Representatives to report on the
contents described in the reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the
Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to report on the
contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end of
each fiscal year for which fees are collected under this
part.''.
(d) BsUFA Reports.--
(1) Analysis in bsufa performance reports.--Section 744I(a)
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-
53(a)) as amended by section 903(d) is further amended by
adding at the end the following:
``(5) Analysis.--For each fiscal year, the Secretary shall
include in the report an analysis of the following:
``(A) The difference between the aggregate number of
biosimilar biological product applications and supplements
filed and the aggregate number of approvals issued by the
agency, accounting for--
``(i) such applications filed during one fiscal year for
which a decision is not scheduled to be made until the
following fiscal year; and
``(ii) the aggregate number of applications for each fiscal
year that did not meet the goals identified by the letters
described in section 401(b) of the Biosimilar User Fee
Amendments of 2017 for the applicable fiscal year.
``(B) Relevant data to determine whether the Center for
Drug Evaluation and Research and the Center for Biologics
Evaluation and Research have met the performance enhancement
goals identified by the letters described in section 401(b)
of the Biosimilar User Fee Amendments of 2017 for the
applicable fiscal year.
``(C) The most common causes and trends for external or
other circumstances affecting the ability of the Secretary to
meet review time and performance enhancement goals identified
by the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017.''.
(2) Issuance of corrective action reports.--Section 744I of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j-53),
as amended by section 404, is further amended--
(A) by redesignating subsections (c) and (d) as subsections
(e) and (f), respectively; and
(B) by inserting after subsection (b) the following:
``(c) Corrective Action Report.--Beginning with fiscal year
2018, and for each fiscal year for which fees are collected
under this part, the Secretary shall prepare and submit a
corrective action report to the Committee on Energy and
Commerce and Committee on Appropriations of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions and Committee on Appropriations of the
Senate. The report shall include the following information,
as applicable:
``(1) Goals met.--For each fiscal year, if the Secretary
determines, based on the analysis under subsection (a)(5),
that each of the goals identified by the letters described in
section 401(b) of the Biosimilar User Fee Amendments of 2017
for the applicable fiscal year have been met, the corrective
action report shall include recommendations on ways in which
the Secretary can improve and streamline the biosimilar
biological product application review process.
``(2) Goals missed.--For each of the goals identified by
the letters described in section 401(b) of the Biosimilar
User Fee Amendments of 2017 for the applicable fiscal year
that the Secretary determines to not have been met, the
corrective action report shall include--
``(A) a justification for such determination and a
description of the types of circumstances and trends, as
applicable, under which biosimilar biological product
applications missed the review goal times but were approved
during the first cycle review, or review goals were missed;
and
``(B) with respect to performance enhancement goals that
were not achieved, a description of efforts the Food and Drug
Administration has put in place for the fiscal year in which
the report is submitted to improve the ability of such agency
to meet each such goal for the such fiscal year.
``(d) Enhanced Communication.--
``(1) Communications with congress.--Each fiscal year, as
applicable and requested,
[[Page H5477]]
representatives from the Centers with expertise in the review
of human drugs shall meet with representatives from the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives to report on the contents described in the
reports under this section.
``(2) Participation in congressional hearing.--Each fiscal
year, as applicable and requested, representatives from the
Food and Drug Administration shall participate in a public
hearing before the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives, to report on the
contents described in the reports under this section. Such
hearing shall occur not later than 120 days after the end of
each fiscal year for which fees are collected under this
part.''.
SEC. 905. FACILITIES MANAGEMENT.
(a) Evaluation.--
(1) Study.--The Comptroller General of the United States
shall conduct a study on the expenses incurred by the Food
and Drug Administration related to facility maintenance and
renovation in fiscal years 2012 through 2019. The study under
this paragraph shall include the following:
(A) A review of purchases and expenses differentiated by
appropriated funds, and resources authorized by the Food and
Drug Administration Safety and Innovation Act (Public Law
112-144) and this Act, as applicable, that contributed to--
(i) the maintenance of scientific equipment and any
existing facility plan or plans to maintain previously
purchased scientific equipment;
(ii) the renovation of facilities in the Center for Drug
Evaluation and Research, the Center for Biologics Evaluation
and Research, and the Center for Devices and Radiological
Health, and the purpose of such renovation including the need
for the renovation;
(iii) the assets purchased or repaired under the ``repair
of facilities and acquisition'' authority under parts 2, 3,
7, and 8 of subchapter C of chapter VII of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379f et seq.);
(iv) the maintenance and repair of facilities and fixtures,
including a description of any unanticipated repairs and
maintenance as well as scheduled repairs maintenance, and the
budget plan for the scheduled or anticipated maintenance;
(v) the acquisition of furniture, a description of the
furniture purchased, and the purpose of the furniture
including purchases for the Center for Drug Evaluation and
Research, the Center for Biologics Evaluation and Research,
and the Center for Devices and Radiological Health; and
(vi) the acquisition of other necessary materials and
supplies by product category under the authority under parts
2, 3, 7, and 8 of subchapter C of chapter VII of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C. 379f et seq.).
(B) An analysis of the Food and Drug Administration's
ability to further its public health mission and review
medical products by incurring the expenses listed in clauses
(i) through (vi) of subparagraph (A). In conducting the
analysis, the Comptroller General shall request information
from and consult with appropriate employees, including staff
and those responsible for the fiscal decisions regarding
facility maintenance and renovation for the agency.
(2) Report.--
(A) In general.--The Comptroller General shall issue a
report to the Committee on Health, Education, Labor, and
Pensions of the Senate and the Committee on Energy and
Commerce of the House of Representatives not later than July
30, 2020, containing the results of the study under paragraph
(1).
(B) Recommendations.--As part of the report under this
paragraph, the Comptroller General may provide
recommendations, as applicable, on methods through which the
Food and Drug Administration may improve planning for--
(i) the maintenance, renovation, and repair of facilities;
(ii) the purchase of furniture or other acquisitions; and
(iii) ways the Food and Drug Administration may allocate
the expenses described in clauses (i) and (ii) of paragraph
(1)(A), as informed by the analysis under paragraph (1)(B).
(b) Administration.--
(1) PDUFA.--Section 736(f) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379h(f)) is amended by adding at the
end the following:
``(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 735(7)(C) shall include only
expenditures for leasing and necessary scientific
equipment.''.
(2) MDUFA.--Section 738(h) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j(h)) is amended by adding at the
end the following:
``(3) Limitation.--Beginning on October 1, 2023, the
authorities under section 737(9)(C) shall include only
leasing and necessary scientific equipment.''.
(3) GDUFA.--Section 744B(e) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 379j-42(e)) is amended--
(A) in the subsection heading, by striking ``Limit'' and
inserting ``Limitations'';
(B) by striking ``The total amount'' and inserting the
following:
``(1) In general.--The total amount''; and
(C) by adding at the end the following:
``(2) Leasing and necessary equipment.--Beginning on
October 1, 2023, the authorities under section 744A(11)(C)
shall include only leasing and necessary scientific
equipment.''.
(4) BsUFA.--Section 744H(e)(2)(B) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 379j-52(e)(2)(B)) is
amended--
(A) in the subparagraph heading, by striking ``limitation''
and inserting ``limitations'';
(B) by striking ``The fees authorized'' and inserting the
following:
``(i) In general.--The fees authorized''; and
(C) by adding at the end the following:
``(ii) Leasing and necessary equipment.--Beginning on
October 1, 2023, the authorities under section 744G(9)(C)
shall include only leasing and necessary scientific
equipment.''.
The SPEAKER pro tempore. Pursuant to the rule, the gentleman from
Oregon (Mr. Walden) and the gentleman from New Jersey (Mr. Pallone)
each will control 20 minutes.
The Chair recognizes the gentleman from Oregon.
General Leave
Mr. WALDEN. 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 on the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
There was no objection.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise today in support of H.R. 2430, the FDA
Reauthorization Act--FDARA--of 2017.
While it may not be headline news, for almost a year now, the Energy
and Commerce Committee has been working in a bipartisan fashion on this
critical legislation which will build on the landmark 21st Century
Cures Act. The FDARA will ensure that innovative and lower cost
treatments, as well as lifesaving medical technologies, reach patients
sooner.
Last month we reported this bill out of committee on a 54-0 vote.
Unanimously, Mr. Speaker.
For starters, the FDARA updates and reauthorizes four user fee
programs at the Food and Drug Administration. Though they sound like
just another set of wonky Washington acronyms, the UFAs, as they are
called--user fee agreements--are absolutely critical to the Food and
Drug Administration's timely and consistent review of brand and generic
drugs, biosimilars, and medical devices. They also maintain the
agency's gold standard of patient safety.
Before the generic drug user fee program was established 5 years ago,
there were literally thousands of applications pending at that agency--
thousands. Significant strides have been made to clear that backlog,
and the FDARA will build on that progress so that generics come to
market as soon as safely possible. Make no doubt about it, this bill
will increase competition and it will provide lower cost alternative
medications to patients.
Through a series of hearings and markups at the Energy and Commerce
Committee, Members on both sides of the aisle proposed a number of
additional provisions to improve the processes at the FDA and to
strengthen this legislation in ways that will benefit patients, medical
product manufacturers, and the agency itself.
For example, my colleague from Oregon (Mr. Schrader), who I know is
on the floor, partnered with the gentleman from Florida (Mr. Bilirakis)
on meaningful ways to incentivize generic entry into markets where
competition was lacking and patients were being exploited by bad
actors. I thank them for their work on this effort. Their work will
save patients money, and their work will get new products into the
market sooner.
In addition, there are a number of improvements to the regulation of
various medical technologies that will expand access, that will
streamline bureaucratic processes, and that will lower costs.
Further, this legislation includes provisions that have been
championed by Republicans and Democrats alike in both Chambers
throughout their discussions on the user fee agreements, including a
range of improvements to the pediatric drug and device development
process, and guidance on ways to expand patient access to clinical
trials.
[[Page H5478]]
Finally, this legislation includes a revised version of the RACE for
Children Act that Representatives McCaul, Mullin, and Butterfield have
worked tirelessly on for quite some time.
H.R. 2430 is the product of significant bipartisan and bicameral
discussions with a wide range of stakeholders that went throughout
regular order at the committee after a series of substantive hearings
and then received a unanimous vote. Which, Mr. Speaker, is probably why
nobody will ever read about this or see it on television, because we
actually worked together and did it in a bipartisan way and achieved
the unanimous vote that will bring drugs and devices to patients
quicker, sooner, and safer in the long run.
This legislation is yet another example of Congress getting good
things done. We are working together. And it is important to thank my
colleagues on both sides of the aisle for their work on this
legislation, particularly full committee Ranking Member Pallone, Health
Subcommittee Ranking Member Green, Health Subcommittee Chairman
Burgess. This bipartisan work has produced a big win for patients.
The FDARA will help bring lower-cost generic drug alternatives and
biosimilars to market faster, increasing competition, lowering drug
costs. It will streamline the process for reviewing or approving new
treatments and cures for patients, ultimately delivering new and
innovative therapies, drugs, and devices to patients more quickly.
Finally, this bill is a big win for the millions of Americans working
in the healthcare sector and the drug and device manufacturers that
help us live better and healthier lives.
Mr. Speaker, I urge my colleagues to vote ``yes.'' I want my
colleagues and all Americans to know this is just step one in a long-
term effort in our committee to help patients get access to better
medicines and lower costs.
Mr. Speaker, I reserve the balance of my time.
Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I rise in support of H.R. 2430, the FDA Reauthorization
Act, a bill that would allow the FDA to continue its critical mission
of reviewing and approving drugs and medical devices that save lives
and improve the quality of life for many Americans.
The legislation before us today is the product of compromise and
almost 2 years of work between FDA, Congress, industry, and other
stakeholders. The FDA Reauthorization Act reauthorizes FDA's medical
product user fee agreements, providing FDA with the resources the
agency needs to continue its critical public health work and hire the
necessary scientists and review staff, and improve the certainty and
efficiency of the drug review process.
The sixth reauthorization of the Prescription Drug User Fee Act will
maintain current review timelines, modernize the user fee structure,
and build on the work of 21st Century Cures Act by investing resources
in the development of biomarkers and innovative clinical trial designs.
The fourth reauthorization of the Medical Device User Fee Amendments
includes some important new policies that will help to increase the
consistency, efficiency, and effectiveness of drug and medical device
reviews.
The bill advances the use of the patient perspective and the risk-
benefit assessment of medical devices. It establishes a system
utilizing real world data for pre-market approval of new uses and post-
market safety monitoring, and it improves presubmission communication
with manufacturers in an effort to expedite the review process.
This legislation also reauthorizes two of our newer user fee programs
for generics and biosimilars. Both of these programs strive to expedite
access to high-quality, lower-cost drugs for American families.
The FDARA will also allow the agency to undertake new initiatives to
create a category of over-the-counter hearing aids, advance the
development of pediatric cancer treatments, and provide greater
assistance and incentives to encourage additional competition for
generic drugs.
Since this is a bipartisan compromise--and I want to stress that--as
my colleague Mr. Walden said, it really is important and people should
take note that this is a major piece of legislation that is being done
on a bipartisan basis by our committee. But it does not address every
issue that I would have liked. It also includes troublesome language
prohibiting the FDA from making the investments the agency needs as
part of future user fee agreements. It is important that the FDA
maintain a work environment that allows the agency to recruit and
retain the world's best and brightest. I am concerned that this final
agreement preserves language advanced in the Senate bill that will make
it difficult in the future for the FDA to make the investments needed
to recruit personnel and meet performance goals set out in the user fee
reauthorizations.
This is a concern, again, that was put in by the Senate that I hope
we can address in the future. But I do want to stress, at the end of
the day, that this final product represents all of the significant
discussions and compromises that were made, and, of course, the
legislation that is going to be effective is the result of compromise.
I am pleased that we are considering this in a very timely fashion,
because, as I mentioned, we don't want the personnel who work at the
FDA to be affected; and if we do this in a timely fashion, they won't
have to worry about pink slips or their jobs.
Mr. Speaker, I strongly urge my colleagues to support H.R. 2430 so
that we can continue to give the FDA the tools and resources it needs
to continue doing the critical work of reviewing and improving
lifesaving drugs and medical devices.
Mr. Speaker, I reserve the balance of my time.
Mr. WALDEN. Mr. Speaker, I thank my colleague from New Jersey for his
good work and kind comments on our legislation that we put together.
Mr. Speaker, I yield 1 minute to the gentleman from Texas (Mr.
Barton), the former chairman of the full committee.
(Mr. BARTON asked and was given permission to revise and extend his
remarks.)
Mr. BARTON. Mr. Speaker, I commend Chairman Walden and Ranking Member
Pallone, along with subcommittee Chairman Burgess and subcommittee
Ranking Member Green for their excellent leadership on this piece of
legislation.
If you look at the front page of The Washington Post this morning,
you will see on the left-hand column the story about a miracle living
drug to help cure cancer in children that have leukemia.
In the legislation before us, as the chairman just pointed out, there
is the RACE for Children Act, which was introduced by Congressmen
McCaul, Butterfield, and Mullin, and which I am a original cosponsor,
that will make it possible to help children sooner.
This particular drug that is discussed on the front page of The
Washington Post took decades to develop and has just now been approved.
How many thousands of children have died while that drug was being
developed?
The legislation before us includes, as I said, the RACE for Children
Act, which will make it possible to bring these innovative drugs to
market much more quickly.
Mr. Speaker, I commend all the leaders and the members of the
committee for this bipartisan piece of legislation, as Mr. Pallone has
just pointed out. I am proud to vote for it, and I encourage all
Members of the House to do the same.
{time} 1345
Mr. PALLONE. Mr. Speaker, I yield 3 minutes to the gentleman from
Texas (Mr. Gene Green), the ranking member of the Health Subcommittee.
Mr. GENE GREEN of Texas. Mr. Speaker, I rise in support of H.R. 2430,
the FDA Reauthorization Act of 2017.
For many months, we have worked on a bipartisan basis to negotiate
and prepare for the four FDA user fee agreements for reauthorization,
across party lines, and you are seeing that. That is why I am proud to
be a member of the Energy and Commerce Committee. We will fight when we
have to, but we also can work together on things that are really
important to our country.
[[Page H5479]]
These programs must be reauthorized in a timely manner to avoid a
meltdown of the medical product development pipeline. We have had great
collaboration and strong bipartisan working relationships throughout
the process, from the publication of the goals letters, to the
hearings, and the markups in the Health Subcommittee, all the way
through the unanimous vote out of the Energy and Commerce Committee
last month.
Since the first PDUFA was established in 1992, Congress has created
additional user fee programs for medical devices, generic drugs, and
biosimilars. In this cycle, we see shortened review timelines and have
given the FDA new tools to harness the latest science and streamline
the review process.
FDARA would build on previous success by reauthorizing the user fees
and make improvements in the review process like advancing the use of
biomarkers and patient experience data. The bill includes additional
provisions beyond the underlying agreements that are worthy of support.
To give some examples, it will promote generic drug development and
competition, establish a category of over-the-counter hearing aids,
crack down on counterfeit drugs, and foster innovation in medical
imaging.
FDA approval is the global gold standard and reauthorizing the user
fee programs will ensure the agency has the resources--particularly
capable, qualified staffers--to fulfill this mission.
I look forward to working with my colleagues to establish a user fee
program for over-the-counter products and reform the monograph systems
once we have reauthorized the existing user fee programs that will soon
expire.
I want to thank Ranking Member Pallone, Chairman Walden, and the
chair of the Health Subcommittee, Congressman Burgess, for their work
and commitment into timely user fee reauthorization.
I also want to thank the staff, Kim Trzeciak and John Stone, and my
own staff, Kristen O'Neill, for the countless hours of work they did to
get us to this place.
Mr. Speaker, I urge my colleagues to support H.R. 2430.
Mr. WALDEN. Mr. Speaker, I yield 3 minutes to the gentleman from
Texas (Mr. Burgess), chairman of the Subcommittee on Health.
Mr. BURGESS. Mr. Speaker, I thank the chairman for yielding me the
time.
It is significant today to be here and be supporting H.R. 2430, the
Food and Drug Administration Reauthorization Act of 2017.
The passage of this bill provides certainly the security to the
scientists who are working even now in pursuit of better cures and, of
course, hope for patients across the country who are awaiting better
treatments of the diseases that are afflicting them.
By reauthorizing the Food and Drug Administration user fee program,
we are ensuring that the Food and Drug Administration can continue to
officially operate and approve new drugs for the market.
Upon becoming chairman of the Subcommittee on Health this year, I had
the privilege of convening four separate legislative hearings on the
policies that are included in H.R. 2430. In each of those hearings, we
heard about the tremendous success of the user fee programs in
expanding access to affordable medications, supporting biomedical
innovation, and maintaining high standards at the FDA for safety,
efficacy, and quality.
H.R. 2430 will build upon these successes and will also build upon
the achievements that we achieved in the last Congress, in the 21st
Century Cures Act. And now we can ensure that the FDA has resources
necessary to get medical treatments and cures to patients and
healthcare providers as quickly as possible.
This bill is an important step forward for our committee and for this
Congress, and we continue to pursue meaningful improvements to the
healthcare system.
Mr. Speaker, I thank Chairman Walden, Ranking Member Gene Green,
Ranking Member Pallone of the full committee, all members of the Energy
and Commerce Committee, both subcommittee and full committee, who
worked hard to improve the substance of this bill as it came through.
Clearly, I wish to thank the majority and minority staffs who worked
so hard to bring this to fruition.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from Illinois (Ms. Schakowsky).
Ms. SCHAKOWSKY. Mr. Speaker, I rise in support of this legislation,
and I, too, want to thank all of the Members and staff who were engaged
in preparing this bill for a vote on the floor of the House.
I wanted to focus on two of the amendments that are included in the
bill--I am grateful for that--that I sponsored.
First, it includes my amendment to create a pilot project to evaluate
postmarket safety of medical devices. It also includes my amendment
which states that Congress and Federal agencies need to work together
to lower drug prices. Everyone has been impacted by rising costs of
prescription drugs, which is why 60 percent of Americans believe
addressing the cost of prescription drugs needs to be a top priority.
The drug pricing crisis cannot be attributed to a single bad actor or
a few blockbuster drugs. A recent study found that 97 percent of widely
used brand name drugs had a price increase that exceeded inflation.
This crisis requires a comprehensive solution that increases
transparency; lowers prices for patients, Medicare, and Medicaid; and
ensures that every American can get access to the drugs that they need.
It is time for Congress to get serious about lowering the cost of
drugs for Americans, and I urge my colleagues to support this
legislation.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Michigan (Mr. Upton), the former chairman of the committee, and the
leader of the 21st Century Cures Act legislation.
Mr. UPTON. Mr. Speaker, so this is a jobs bill. And those who know me
know that I have a long record of supporting innovation when it comes
to research and development of new drugs and devices.
That is why I was proud to help author the 21st Century Cures Act
with my Democratic colleague Diana DeGette. This bill broke down the
barriers for research and development, put a greater focus on patient-
centered care, and gave billions in resources to the National
Institutes of Health.
President Obama signed our bill into law at the end of 2016. It
marked a truly great victory for both patients and researchers across
the country. And now that Cures is law, we have got to make sure that
the FDA is able to handle the new breakthrough treatments in a timely
and predictable fashion, all while still maintaining the highest levels
of patient safety. That is why this agreement is so important.
My district in southwest Michigan has literally thousands of jobs on
the line that are affected by this legislation, and whether it is on
the drug side at Pfizer, or the device side at Stryker, or the generic
side at Perrigo--all in my district--passing this legislation is vital
to those good-paying local jobs, as well as to the patients who will
benefit from the new therapies that get those products to market.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman
from North Carolina (Mr. Butterfield).
=========================== NOTE ===========================
July 12, 2017, on page H5479, the following appeared: 1\1/2\
minutes to the gentleman from New York (Mr. Butterfield).
The online version has been corrected to read: 1\1/2\ minutes to
the gentleman from North Carolina (Mr. Butterfield).
========================= END NOTE =========================
Mr. BUTTERFIELD. Mr. Speaker, I thank the gentleman for yielding time
and for his leadership on the committee.
Mr. Speaker, I rise in strong support of H.R. 2430, the FDA
Reauthorization Act of 2017, which reauthorizes the FDA's user fee
programs that are critical to drug development, the medical device
approval process, and, most importantly, to the patients who will
benefit from these advances.
While I support this critical bill overall, I want to highlight, in
particular, sections 503 through 505, which is the RACE for Children
Act that my friend Mike McCaul, Congressman Mike McCaul, and I
introduced earlier this year. Scientific advances have shown that some
childhood and adult cancers share the same molecular targets.
RACE, Mr. Speaker, will help facilitate the expeditious development
of innovative and promising treatments for children living with cancer
by providing the FDA new authority to require a pediatric investigation
into an adult cancer drug if that drug uses molecular targeting and is
relevant to the cancer.
[[Page H5480]]
I am grateful to Mr. Walden and Ranking Member Pallone and their
respective staffs for understanding the urgent need to enact the RACE
for Children Act and for working with me, working with my staff, to see
that it was included.
I would also like to highlight section 701 and 702, which is the text
of a bill I introduced with Dr. Bucshon to modernize and streamline
FDA's medical device inspection process by moving to a risk-based
inspection approach. The provision will allow FDA to better use its
limited resources and improve patient safety by focusing on facilities
that have the most potential to impact public health.
Finally, passage of the FDA Reauthorization Act of 2017 will send a
strong signal to the administration that Congress values the critical
importance of medical research and patient safety.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from New
Jersey (Mr. Lance), a very important member of our committee.
Mr. LANCE. Mr. Speaker, I congratulate the chairman, the ranking
member of the full committee, and the chairman and the ranking member
of the subcommittee for this important work.
I rise in strong support of the Food and Drug Administration
Reauthorization Act. We need a strong FDA to make sure lifesaving
medicines reach the market and that patients have the peace of mind of
a safe regulatory process. This bill ensures the wheels of creation
keep turning, and in no part of our Nation is this more important than
New Jersey, one of the medicine chests of the world.
It means that patients here in the United States and hundreds of
millions around the world have benefited from the genius of our
biopharmaceutical and life science industries. Patient safety is always
the critical priority, and I am pleased this legislation includes
language I authored to crack down on counterfeit drugs that are
flooding into the United States. Too many Americans are falling victim
to knockoffs that have infiltrated the U.S. supply chain, and this
legislation significantly changes that.
Disease knows no bounds and, one way or another, each of us is
affected by disease. This work makes a difference in patients' lives
and makes sure the system from idea to pharmacy is working.
Mr. Speaker, I am honored to support this product.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from Colorado (Ms. DeGette).
Ms. DeGETTE. Mr. Speaker, at a time of hyperpartisanship when
traditions of consensus are seldom upheld, I am pleased to see Congress
continue its tradition of passing FDA user fee reauthorization with
broad bipartisan support.
It is absolutely critical that the FDA continue to promote medical
innovation and support public health. To do so, it must have consistent
funding, which this bill helps assure. I am also so proud that this
bill builds directly on the 21st Century Cures Act, which I coauthored
with Representative Fred Upton.
Consistent with Cures, the bill before us today ensures that both the
patient's voice and evidence from clinical practice can be considered
during drug development when it is appropriate. It also helps establish
a process for the FDA to qualify so-called biomarkers, which will
facilitate the development of future cutting-edge therapies.
By reinforcing these key provisions of the 21st Century Cures Act, I
am fully confident that the bill will help deliver on our bipartisan
promise to jump-start treatments for families and for patients with
unmet needs.
Mr. Speaker, I also want to thank Chairman Walden and Ranking Member
Pallone for incorporating provisions into the bill that will deepen our
understanding of the psychosocial impact of disease. These provisions
are based on the bipartisan Patient Experience in Research Act which
Representative Lance and I coauthored.
As more is learned about the social and emotional effects of disease,
we can deliver better outcomes for patients by improving medication
adherence, tailoring treatment regimens, and enhancing participation in
clinical trials.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Florida (Mr. Bilirakis), a very important member of our committee.
Mr. BILIRAKIS. Mr. Speaker, I rise today to urge the passage of the
FDA Reauthorization Act. With this legislation, we can modernize the
FDA and reduce the barriers to innovation and competition.
If America is going to lead the world in biomedical innovation, we
need an FDA that can efficiently review and approve new drugs. The FDA
must act with the same urgency that patients feel waiting for cures.
Importantly, this bill includes a bipartisan provision that I
authored with my colleague Kurt Schrader.
{time} 1400
The provision uses free market policies to help spur the development
of new generic drugs, increase competition, and combat high drug
prices.
I am also pleased we are including in the RACE for Children Act an
important provision to advance pediatric cancer research and
development.
With today's bill, we have an opportunity to truly make a difference
for our families, our friends, our neighbors, and the millions of
Americans living with a deadly disease. Let's get this done.
Mr. PALLONE. Mr. Speaker, I yield 2 minutes to the gentleman from
Vermont (Mr. Welch).
Mr. WELCH. Mr. Speaker, I thank the chairman of our committee, our
ranking member, Dr. Burgess, and Mr. Green.
Facilitating the approval of these drugs, having the FDA work in a
safe and constructive way, and having a quicker turnaround time is all
really good. It is really important. I thank them for their leadership.
This is something that had to be done. It is going to benefit everyone.
I want to talk about another issue that we didn't address but we did
debate, and that is the high cost of prescription drugs.
In this legislation, on the one hand, we are accommodating a
reasonable request by the pharmaceutical industry for a fast and
efficient approval process; but on the other hand, we are denying any
relief to consumers who are getting absolutely hammered day in and day
out with unjustified price increases because of the pricing power of
the pharmaceutical industry.
Yes, they do do good things, life-extending and pain-relieving drugs,
but that doesn't justify grinding consumers into the dust who can't
afford the cost of these prescriptions, where it is just within reach
that they can provide relief to their family.
We know how much pharmaceutical prices have been going up. It is
hurting our employers, who are working hard to provide good healthcare
to their employees. It is hurting taxpayers.
But every single one of us has met a constituent like a mom who is
struggling with this choice of trying to afford something she can't
afford or risk a loss she would never endure. I am talking about the
EpiPen; $600 to get an EpiPen here in the United States.
Mylan makes that. They are a Netherlands-based company now. They
moved over there for tax reasons. In the Netherlands, you can get it
for $100. This isn't justified. The chairman, the ranking member, and I
know this.
When Elijah Cummings and I met with President Trump, he knows it. He
talked about the rip-off pricing. He talked about the possibility of
importation of safe drugs from Canada as a way of getting some price
pressure on these companies.
We have got the committee that can address this. I would like us to
do that.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Indiana (Mr. Bucshon).
Mr. BUCSHON. Mr. Speaker, the FDA Reauthorization Act we are
considering today provides the FDA the resources it needs to ensure
innovative and lifesaving drugs and medical devices are brought to the
market in a safe and expedient manner, while providing transparency and
certainty to manufacturers.
Further, the device inspection and regulatory improvements title
reflects language I introduced with Representatives Brooks, Peters, and
Butterfield, which sets forth a risk-based approach to medical device
establishment inspections and improves predictability for scheduled
inspections, among other provisions.
[[Page H5481]]
Mr. Speaker, I urge my colleagues to support this legislation. I look
forward to moving it through Congress and sending it to the President's
desk.
Mr. PALLONE. Mr. Speaker, I yield 1 minute to the gentleman from
Oregon (Mr. Schrader).
Mr. SCHRADER. Mr. Speaker, I rise in strong support of the FDA
Reauthorization Act, FDARA as it is called.
It could not be more evident that the time has come for Congress to
reckon with the growing problem of exorbitant drug prices. Every few
months sees the headlines about another extreme price hike, as was just
mentioned. Some unscrupulous pharmaceutical CEO buys the rights to
produce drugs that have been on the market for decades, usually where
there are no competitors, then, seemingly overnight, they raise the
price astronomically.
In the case of Daraprim, a drug that is used by some transplant
patients and people living with AIDS, the price went from $13.50 per
pill to $750. That is outrageous, a price increase of 5,000 percent.
For this drug and many others, the drugs have been off patent for ages
and there is no generic competitor on the market.
Competition from generic drugs saves patients and the government
billions of dollars on a weekly basis. Unfortunately, generic drug
manufacturers who want to bring these markets to competition face a
long approval process, steep costs, and uncertainty. This FDA act
reckons with that.
It is time for Congress to act, also, on those unscrupulous
providers. Gus Bilirakis and I introduced a bill providing competition
to drive down those costs. We provide new incentives for generic drugs
to come to market and reform the process.
I am in support of the bill.
Mr. WALDEN. Mr. Speaker, I want to commend my colleague from Oregon
for his good work on this part of the bill.
Mr. Speaker, I yield 1 minute to the gentleman from Oklahoma (Mr.
Mullin).
Mr. MULLIN. Mr. Speaker, this spring in my district in Oklahoma, the
McAlpin family of Tahlequah lost their 2-year-old son, Kai, to
pediatric cancer. Kai's parents refer to Kai as Warrior Kai because he
fought cancer every day with courage and dedication like a true
warrior. Included in H.R. 2430 today is the RACE for Children Act,
which aims to create new and better pediatric treatment options for
warriors like Kai.
Currently, there are over 900 drugs in development to treat cancer in
adults, while only a handful of drugs are being developed to fight
cancer in children. Clearly, those statistics show that the law has not
kept up with scientific innovation.
RACE can help deliver lifesaving treatments for pediatric cancer
patients by updating the Pediatric Research Act. This bill requires all
drug manufacturers to test a new drug in a pediatric population before
applying it to children during cancer treatment. RACE for Children puts
safety first and ensures that researchers use scientific evidence when
declaring effectiveness of a drug before providing it to patients.
I am glad to see the RACE for Children Act included today, and I
thank Chairman McCaul and Congressman Butterfield for their work on the
bill. The fight of Warrior Kai continues with us.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman
from Massachusetts (Mr. Kennedy).
Mr. KENNEDY. Mr. Speaker, I thank Chairman Walden, Ranking Member
Pallone, Ranking Member Green, and Subcommittee Chairman Burgess for
their leadership in uniting our colleagues across the aisle on a bill
that supports patients and the life sciences industry. This user fee
bill is a testament to what can be achieved when we debate policies in
the open and confront challenges together.
I would also like to specifically focus on one piece of the
legislation, the Over-the-Counter Hearing Aid Act of 2017. A few weeks
ago, a friend of mine wrote to me and shared her story of hearing loss.
A 34-year-old lawyer, it nearly derailed her career by leaving her
unable to argue cases in the courtroom. She continued by outlining the
often overlooked side effects brought about by hearing loss--isolation,
anxiety, depression, and memory loss--all compounded by prohibitive
costs for hearing aids that aren't covered by Medicare or most private
insurers. Faced with prices upwards of $5,000, many Americans are
denied the relief and the treatment that they deserve.
With this bipartisan bill, we will not only spark innovation and
competition, we will help our constituents in their communities,
offices, factory floors, and even their own homes. I hope my colleagues
will support this bill.
I want to thank Representative Blackburn for her tireless work in
getting it across the finish line as well.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Michigan (Mr. Walberg).
Mr. WALBERG. Mr. Speaker, I rise today in strong support of the FDA
Reauthorization Act, and I want to thank Chairman Walden and the other
bipartisan leadership on the committee for bringing this bipartisan
bill to the floor today.
As science and technology advances at a rapid rate, the potential for
breakthroughs to treat and cure some of the worst diseases are truly
within our reach; yet all too often, our laws and regulations are stuck
in the past. That is why reauthorizing the Food and Drug
Administration's user fee programs is so important.
This bipartisan bill builds off the important work we accomplished
through the 21st Century Cures Act. It will help speed up the approval
process for lifesaving drugs, foster greater competition, and bring
down costs for patients. It will also help ensure America remains on
the forefront of medical innovation and that good-paying jobs in the
medical device industry remain here at home.
I urge my colleagues to support this bipartisan bill, and together we
can offer a healthier future for our patients.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentleman
from California (Mr. Cardenas).
Mr. CARDENAS. Mr. Speaker, I rise today to speak in support of H.R.
2430, the FDA Reauthorization Act.
I also would like to thank the chairman and ranking member of the
Energy and Commerce Committee for working so hard to get this important
bill on the floor here today.
This reauthorization bill provides the FDA with the resources to
complete an important and difficult job: ensuring timely and efficient
drug review processes while maintaining rigorous scientific and safety
standards to maintain the safety, efficacy, and security of drugs,
biological products, medical devices, and therapies that Americans have
access to today and tomorrow.
I am lucky to have been born and raised in this great country where
we have access to the latest innovation in the life sciences sector. I
wish my parents had been raised right here in this great, wonderful
country so they may still be here today, so that they could enjoy time
with their grandchildren if I have been so blessed to do so myself.
The FDA is seen as the gold standard around the world, and this bill
keeps us right there, right at the top.
I am encouraged to see my colleagues working together to ensure that
the FDA is able to continue to fulfill this responsibility, and I look
forward to continue working to have this reauthorization passed out of
Congress.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Pennsylvania (Mr. Costello), who is from the Philadelphia suburbs and
is an important member of our committee.
Mr. COSTELLO of Pennsylvania. Mr. Speaker, I rise today in support of
the FDA Reauthorization Act, which is very important to our country and
to Pennsylvania's Sixth Congressional District.
Many communities in my district are at the forefront of innovation in
the life sciences industry, and this legislation will make sure our
businesses remain competitive and on pace with public health needs.
This bill is critical to allowing us to continue our bipartisan work
to reduce drug costs, to advance therapies that can save lives, and to
develop safe and innovative treatments for patients and their families.
Finally, Mr. Speaker, it is important the public is aware that this
is a bipartisan bill. There are some things that perhaps some
Republicans would have liked to have seen in this bill that
[[Page H5482]]
didn't make their way in, and there are some things that perhaps some
Democrats would have liked to have seen make their way into this bill
that didn't. We found consensus and we worked together. It was a
unanimous vote out of the Energy and Commerce Committee. I am proud to
stand behind that, and this is a good day for America.
Mr. PALLONE. Mr. Speaker, I yield 1\1/2\ minutes to the gentlewoman
from Michigan (Mrs. Dingell).
Mrs. DINGELL. Mr. Speaker, I rise in strong support of H.R. 2430, the
FDA Reauthorization Act of 2017.
We all have loved ones, friends, and neighbors who are suffering from
life-threatening diseases and illnesses and who want hope that that
next generation treatment or therapy will still be available to them.
It is our shared responsibility to support the FDA as well as
countless researchers and patient advocates across the country who are
working to bring new cures to market. This critical, bipartisan
legislation helps us achieve that important goal by reauthorizing user
fee programs at FDA for 5 years.
I want to thank Chairman Walden, Ranking Member Pallone, Chairman
Burgess, and Ranking Member Green for continuing the longstanding
tradition on the Energy and Commerce Committee of advancing this
legislation in a bipartisan manner. Our work together on this bill
should be a model for how we can cooperate on other issues in the
future, and it is good that we are passing this bill on the House floor
well in advance of the September 30 deadline.
I also want to thank the committee for including provisions that I
worked on with Mr. Lance, Dr. Burgess, and Mr. Green to enhance
penalties for counterfeit and diverted drugs, and for including Mr.
Kennedy's over-the-counter hearing aid bill, which will go a long way
to providing real relief to the 30 million Americans who suffer from
hearing loss.
Hearing loss is a quality-of-life issue, plain and simple, and
passage of today's legislation will help many receive the treatment
that they need in a quick manner, while also ensuring safety.
It is a good bill that deserves our support.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Georgia (Mr. Carter), who is the resident pharmacist on the committee.
Mr. CARTER of Georgia. Mr. Speaker, I rise today to speak in support
of H.R. 2430, the FDA Reauthorization Act, because of its importance to
our healthcare system and the millions of people who depend on it. The
FDA Reauthorization Act is essential as we seek reforms to the way we
develop new drugs and therapies and the ways in which we are able to
get those to market.
Under this legislation, we are streamlining the approval process to
maintain the provisions that make our market, while making changes to
ensure new therapies aren't unnecessarily held up.
{time} 1415
We have set benchmarks for reviews to ensure that the drug approval
process is moving along and doesn't get bogged down by bureaucratic red
tape. And most importantly, we are providing patients with a chance to
pursue new and innovative drugs that can really make a difference in
their life.
We have seen progress in the approval of rare disease drugs, helping
millions who suffer from diseases that often have no treatment. With
this bill, we can provide them with new opportunities.
Additionally, we will be able to see more generics entering the
market, increasing competition and driving down costs for consumers.
I applaud Chairman Walden, Chairman Burgess, and all of my colleagues
on the committee for helping to get this essential legislation to the
finish line.
Mr. WALDEN. Mr. Speaker, I yield 2 minutes to the gentleman from
Texas (Mr. McCaul), chairman of the Homeland Security Committee and one
of the authors of a portion of this bill that is really important for
kids.
Mr. McCAUL. Mr. Speaker, I thank Chairman Walden for including my
bill, the Research to Accelerate Cures and Equity, or RACE, for
Children Act, in this FDA reauthorization. I introduced the bill with
my colleague, Mr. Butterfield, to strengthen the FDA's ability to
require pediatric studies of cancer drugs during development.
Despite current programs in place to require similar studies, they
have never been undertaken for cancer drugs. This bill will require a
study into any cancer drug that uses ``molecular targeting,'' which
attacks specific cancer cells rather than the part of the body where
the cancer resides. By requiring these studies, doctors can determine
whether a drug is safe and effective in children and, ultimately,
provide accurate labeling for pediatric use.
I founded the Childhood Cancer Caucus when I first entered Congress
to give a voice to the 15,000 children diagnosed with cancer every year
and the hundreds of thousands of survivors who face a lifetime of
medical challenges. Passing this bill will provide these children
access to the treatments they deserve.
I thank all those involved for their tireless work in bringing this
bill to the House floor. As my good friend, little Sadie Keller, who is
battling leukemia as I speak, once said: ``Together, we can make a
difference.''
To Sadie and all the children who are in the fight of their lives, I
want you to know that today we are making a difference.
Mr. WALDEN. Mr. Speaker, I yield 1 minute to the gentleman from
Arizona (Mr. Biggs), a passionate advocate for those who really need
access to medications at the end stage of their lives.
Mr. BIGGS. Mr. Speaker, I thank the chairman for bringing this bill
forward and also for granting me time to speak on an issue that I am
passionate about, which is Right to Try.
I support the underlying bill and hope that we have a chance, soon,
to consider the Right to Try bill, which has been worked on by myself,
Senator Johnson, and Representative Fitzpatrick.
As many know, Right to Try would allow terminally ill patients who
have no other options left to receive drugs that have passed the Food
and Drug Administration's basic safety testing but which have not been
fully approved.
In 2014, my home State of Arizona passed a similar Right to Try law
with nearly 80 percent of the vote, due in large part to the heroic
efforts of my late friend, Laura Knaperek, who was battling incurable
cancer at the time.
Today, nearly 40 States have enacted Right to Try legislation. This
is a bipartisan cause and one that has received strong support from the
White House. I look forward to continuing to work with the chairman to
find a path forward for Right to Try.
Mr. PALLONE. Mr. Speaker, I yield myself the balance of my time.
Mr. Speaker, as I said before, I am very proud of the fact that this
bill is bipartisan, continuing a tradition of dealing with these FDA
user fee and authorization bills on a bipartisan basis.
We worked long and hard to get this accomplished in a timely fashion,
in particular, so that the personnel at the FDA are not threatened in
any way. I am very hopeful that this will pass today, go over to the
Senate and also pass there quickly, and be signed by the President
soon.
Mr. Speaker, I urge all Members to support the bill, and I yield back
the balance of my time.
Mr. WALDEN. Mr. Speaker, I yield myself such time as I may consume.
Mr. Speaker, I encourage my colleagues to support this legislation.
As I have said, it is a bipartisan bill. I think even more importantly
than that, Mr. Speaker, this legislation will save lives. It will bring
about quicker cures for those who need new medicines and medical
devices.
This is the finest work that we can do in this body, working with
those scientists and innovators in helping develop a system where they
can get approvals and get new medicines to market that are safe and
that will save lives. We are doing that today.
I want to thank the staff, who have been incredibly important in this
effort and my colleagues on both sides of the aisle who worked
together. We didn't get everything everybody wanted in this bill, but
we got a bill that passed unanimously out of our committee and that I
believe the Senate will take up
[[Page H5483]]
and adopt, as well, and we can move forward in such a positive
direction for people that you heard about today from my colleagues.
Lives that are on the line can be saved by innovation. The quicker we
get that innovation to the market, the more we can reduce costs and
save lives.
Mr. Speaker, I call on my colleagues to support passage of this very
important lifesaving legislation, and I yield back the balance of my
time.
Ms. ESHOO. Mr. Speaker, I rise today in support of H.R. 2430, the FDA
Reauthorization Act of 2017 to reauthorize four important user fee
programs: the Prescription Drug User Fee Act, the Medical Device User
Fee Act, the Generic Drug User Fee Act, and the Biosimilar User Fee
Act. These critically important laws have improved patient access to
important therapies and expedited the FDA's approval times while
upholding the most rigorous standards for patient safety.
The Prescription Drug User Fee Act (PDUFA) was enacted in 1992 when
drug review times were lagging and FDA simply couldn't keep up with the
flood of new drug applications. Through user fees paid by applicants,
PDUFA gave FDA the resources it needed to hire and support more staff.
The program has been successful in reducing review-time backlogs and
expediting safe and effective therapies to patients.
My legislation created the Medical Device User Fee Act (MDUFA), which
was enacted in 2002 and has resulted in significant changes to the
medical device industry and within the medical device center at the
FDA. Through this user fee program, the device center has improved its
efficiency and reduced the time it takes to bring effective medical
devices to market. This legislation builds on the progress made in
previous user fee agreements and will produce important developments
for the medical device industry.
The Generic Drug User Fee Agreement (GDUFA) was enacted in 2012 and
takes important steps to bring lower-priced drugs to the market more
quickly for the American people. Finally, the Biosimilar User Fee
Agreement (BsUFA), which was first enacted in 2012 through legislation
I authored, is critical to supporting the nascent biosimilar industry
and will lead to meaningful progress, breakthroughs and cures for the
American people.
Previous user fee reauthorizations have included significant gains
for pediatric populations. Before the Better Pharmaceuticals for
Children Act (BPCA) and the Pediatric Research Equity Act (PREA), which
I authored, the vast majority of drugs (more than 80 percent) used in
children were used off-label, without data for their safety and
efficacy. Today, that number has been reduced to 50 percent because of
my legislation. Both programs were permanently reauthorized in 2012,
and while this agreement includes important changes to BPCA and PREA,
there remains a need for more meaningful improvements. This legislation
lays important groundwork and provides the foundation for future
progress.
Finally, I urge my colleagues in the Senate to take up this
legislation swiftly. It's imperative that both houses of Congress pass
this legislation and send it to the President in a timely manner for
him to sign into law in order to provide essential resources to the FDA
so they can continue to do their critical work.
Ms. MATSUI. Mr. Speaker, I rise today in support of H.R. 2430, the
FDA user fee reauthorization bill that I worked on with my colleagues
on the Energy & Commerce Committee.
Without Congress' swift action to reauthorize this bill, the FDA
would not be able to conduct its critical work ensuring that our
nation's drugs and devices are safe and effective.
Patients and families across the country battling diseases like
Alzheimer's, cancer, multiple sclerosis (MS), and diabetes, rely on
innovation to provide new life-saving and life-enhancing treatments and
hopefully one day, cures. Without the FDA, we would not be able to
ensure that those treatments and cures work and that they're safe.
To quote Dr. Jeff Allen of the Friends of Cancer Research, ``for the
people who currently depend on safe and effective medicines . . . for
those who are holding strong for breakthroughs to come . . . and for
every future patient . . . there isn't time to waste.''
I urge my colleagues to support the passage of this bill.
Mrs. MIMI WALTERS of California. Mr. Speaker, I am pleased that the
House is considering H.R. 2430, the FDA Reauthorization Act of 2017. I
note that H.R. 2430 would provide the U.S. Food and Drug Administration
(FDA) with new statutory authority to require the sponsor of an orphan-
designated drug, which has certain similarities to an already approved
drug, to demonstrate ``clinical superiority'' compared to the already
approved drug as a condition of receiving seven years of market
exclusivity.
This authority will limit the number of drugs that are automatically
entitled to seven years of exclusivity, while maintaining incentives
for the development of innovative treatments for rare diseases.
I also note that the bill would improve transparency of the FDA's
execution of the Orphan Drug Act. Specifically, the bill directs the
FDA to notify a sponsor in writing of any clinical superiority
rationale on which the FDA relied in designating the sponsor's drug as
an orphan drug. Further, it would require the FDA to publish its
clinical superiority findings summaries for all drugs granted
exclusivity based on a demonstration of clinical superiority.
I urge my colleagues to support the FDA Reauthorization Act of 2017.
The SPEAKER pro tempore (Mr. Murphy of Pennsylvania). The question is
on the motion offered by the gentleman from Oregon (Mr. Walden) that
the House suspend the rules and pass the bill, H.R. 2430, 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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