[Congressional Record (Bound Edition), Volume 163 (2017), Part 8]
[House]
[Pages 10425-10456]
[From the U.S. 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.

[[Page 10426]]

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 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;

[[Page 10427]]

       ``(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
       (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:

[[Page 10428]]

       ``(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
       (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

[[Page 10429]]

     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 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

[[Page 10430]]

     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--
       ``(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

[[Page 10431]]

       (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
       (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

[[Page 10432]]

     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 
     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

[[Page 10433]]

       ``(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.
       ``(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''.

[[Page 10434]]



     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 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.

[[Page 10435]]



     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 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;

[[Page 10436]]

       (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;
       (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.

[[Page 10437]]

       (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''.

     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--

[[Page 10438]]

       (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 ``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

[[Page 10439]]

     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--
       (i) that occurs over consecutive days; and
       (ii) to which each investigator conducting such an 
     inspection shall adhere unless the

[[Page 10440]]

     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

[[Page 10441]]

       ``(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.''.
       (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.

[[Page 10442]]

       ``(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 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

[[Page 10443]]

     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 
     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

[[Page 10444]]

     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.
       ``(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.

[[Page 10445]]



     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--
       (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

[[Page 10446]]

       (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:
       (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

[[Page 10447]]

     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 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

[[Page 10448]]

     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 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:

[[Page 10449]]

       ``(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, 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.

[[Page 10450]]

  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.
  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

[[Page 10451]]

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. 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.
  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

[[Page 10452]]

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).
  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.
  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.

[[Page 10453]]



                              {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.
  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.

[[Page 10454]]

  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 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.

[[Page 10455]]

  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 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

[[Page 10456]]

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.

                          ____________________