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[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4784 Introduced in House (IH)]

<DOC>

114th CONGRESS
  2d Session
                                H. R. 4784

        To increase competition in the pharmaceutical industry.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                             March 17, 2016

 Mr. Schrader (for himself and Mr. Bilirakis) introduced the following 
    bill; which was referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
        To increase competition in the pharmaceutical industry.

    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 ``Lower Drug Costs through Competition 
Act''.

SEC. 2. FINDINGS.

    Congress finds the following:
            (1) As part of the Food and Drug Administration's mission 
        to protect the public health, the Food and Drug Administration 
        approves generic drugs that help establish competitive markets 
        for treatments that improve the lives of millions of patients 
        in the United States.
            (2) Rising health care costs, including prescription drug 
        costs, continue to be a major concern for patients in the 
        United States.
            (3) Eighty-eight percent of prescription drugs dispensed in 
        the United States, or nearly 9 out of every 10 prescriptions 
        dispensed, are generic drugs.
            (4) Studies suggest that generic drugs account for only 28 
        percent of total prescription drug spending and were 
        responsible for $1,680,000,000,000 in estimated savings over 
        the period of 2005 to 2014.
            (5) Increasing generic competition can be an effective way 
        to help keep prescription drug costs low for patients, the 
        health care system, and Federal and State government.
            (6) While the Food and Drug Administration has made 
        progress toward a more consistent timeline for generic drug 
        approvals since the enactment of the Generic Drug User Fee 
        Amendments of 2012 (21 U.S.C. 379j-41 et seq.), a significant 
        backlog of abbreviated new drug applications for generic drugs 
        remains.
            (7) The sudden, aggressive price hikes for a variety of 
        recently acquired off-patent drugs that have been used widely 
        for decades, for which there is no generic drug competitor, 
        also affects access to affordable prescriptions for patients 
        and the overall cost of health care in the United States.
            (8) Improving the review of abbreviated new drug 
        applications and the approval of generic drugs would help to 
        improve competition and lower prices for patients.
            (9) Establishing a clear timeframe for the Food and Drug 
        Administration to expedite the review of certain applications 
        for generic drugs would also help keep drug prices down and 
        improve timely access for patients.

          TITLE I--REMOVING REGULATORY BARRIERS TO COMPETITION

SEC. 101. IMPROVING GENERIC ACCESS.

    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) The Secretary shall prioritize the review, and act not 
later than 180 calendar days after the date of the submission of an 
application, on an application that has been submitted and accepted for 
review under this subsection, or on a supplement to such an 
application, that is for a drug that--
            ``(i) has been introduced into interstate commerce by not 
        more than one manufacturer or sponsor, as applicable, in the 
        last 3 months and with respect to which tentative approval 
        under paragraph (5) has been granted for not more than 2 
        applications; or
            ``(ii) has been included on the list under section 506E.
    ``(B) The Secretary may expedite an inspection or reinspection 
under section 704 of an establishment that proposes to manufacture a 
drug described in subparagraph (A).''.

SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLICATIONS.

    Not later than 180 calendar days after the date of enactment of 
this Act, and every 180 calendar days thereafter until October 1, 2021, 
the Secretary of Health and Human Services shall submit to the 
Committee on Health, Education, Labor, and Pensions of the Senate, the 
Special Committee on Aging of the Senate, and the Committee on Energy 
and Commerce of the House of Representatives a report that provides--
            (1) the number of applications that were filed under 
        section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355(j)) prior to October 1, 2016, that are pending at 
        the time the report is submitted;
            (2) the average and median total time such applications 
        have been pending;
            (3) the number of such applications that contain 
        certifications under section 505(j)(2)(A)(vii)(IV) of such Act; 
        and
            (4) the number of such applications that are subject to 
        priority review.

                  TITLE II--INCENTIVIZING COMPETITION

SEC. 201. GENERIC PRIORITY REVIEW VOUCHER.

    Chapter V of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
351 et seq.) is amended by inserting after section 506F the following:

``SEC. 506G. GENERIC PRIORITY REVIEW VOUCHER.

    ``(a) Definitions.--In this section:
            ``(1) The term `priority review' with respect to an 
        application under section 505(j) means review and action by the 
        Secretary on such application by the Secretary not later than 
        180 calendar days after such application has been submitted and 
        accepted for review.
            ``(2) The term `priority review voucher' means a voucher 
        for priority review for an application under section 505(j). 
        Such voucher shall be awarded upon the approval of the 
        application described in 505(j)(11)(A), unless such application 
        contains a certification under section 505(j)(2)(A)(vii)(IV).
    ``(b) Generic Priority Review Vouchers, in General.--Beginning on 
October 1, 2017, the Secretary shall award a priority review voucher to 
the sponsor of an application described in section 505(j)(11)(A) upon--
            ``(1) approval by the Secretary of such application;
            ``(2) marketing of the drug subject to such application; 
        and
            ``(3) determination by the Secretary that the drug has a 
        sustained market presence.
    ``(c) Transferability.--
            ``(1) In general.--The recipient of a priority review 
        voucher under subsection (a) may transfer (including by sale) 
        the entitlement to such voucher. There is no limit on the 
        number of times a priority review voucher may be transferred 
        before such voucher is used.
            ``(2) Notification to the secretary.--Each person to whom a 
        voucher is transferred shall notify the Secretary of such 
        change in ownership of such voucher not later than 30 calendar 
        days after such transfer.
    ``(d) Notification.--The sponsor shall notify the Secretary not 
later than 30 calendar days prior to the submission of a human drug 
application that is intended to be the subject of a priority review 
voucher, except in the case of such an application that was pending as 
of October 1, 2017, in which case the sponsor of such pending 
application shall notify the Secretary not later than 30 days after the 
date on which such voucher is awarded.
    ``(e) Fees.--
            ``(1) In general.--The sponsor of an application that is 
        the subject of a priority review voucher shall be subject to 
        the fees required under subchapter C of chapter VII.
            ``(2) Priority review user fee.--
                    ``(A) In general.--The Secretary shall establish a 
                user fee program under which a sponsor of a human drug 
                application that is the subject of a priority review 
                voucher shall pay to the Secretary a fee determined 
                under subparagraph (B). Such fee shall be in addition 
                to any fee required to be submitted by the sponsor 
                under subchapter C of chapter VII.
                    ``(B) Fee amount.--The amount of the priority 
                review user fee shall be determined each fiscal year by 
                the Secretary, based on twice the difference between--
                            ``(i) the average cost incurred by the Food 
                        and Drug Administration in the review of a 
                        human drug application subject to priority 
                        review under this section in the previous 
                        fiscal year; and
                            ``(ii) the average cost incurred by the 
                        Food and Drug Administration in the review of a 
                        human drug application under section 505(j) 
                        that is not subject to priority review under 
                        this section in the previous fiscal year.
                    ``(C) Annual fee setting.--The Secretary shall 
                establish, before the beginning of each fiscal year 
                beginning after September 30, 2017, and in accordance 
                with subparagraph (B), the amount of the priority 
                review user fee for that fiscal year.
                    ``(D) Payment.--
                            ``(i) In general.--The priority review user 
                        fee required by this paragraph shall be due 
                        upon the notification by a sponsor of the 
                        intent of such sponsor to use the voucher, as 
                        specified in subsection (d). All other user 
                        fees associated with the human drug application 
                        shall be due as required by the Secretary or 
                        under applicable law.
                            ``(ii) Complete application.--An 
                        application described in clause (i) for which 
                        the sponsor requests the use of a priority 
                        review voucher shall be considered incomplete 
                        if the fee required by this paragraph and all 
                        other applicable user fees are not paid in 
                        accordance with the Secretary's procedures for 
                        paying such fees.
                            ``(iii) No waivers, exemptions, reductions, 
                        or refunds.--The Secretary may not grant a 
                        waiver, exemption, reduction, or refund of any 
                        fees due and payable under this paragraph.
                    ``(E) Offsetting collections.--Fees collected 
                pursuant to this paragraph for any fiscal year--
                            ``(i) shall be deposited and credited as 
                        offsetting collections to the account providing 
                        appropriations to the Food and Drug 
                        Administration; and
                            ``(ii) shall not be collected for any 
                        fiscal year except to the extent provided in 
                        advance in appropriations Acts.
    ``(f) Clarification.--Nothing in this section affects any period of 
exclusivity under this Act or the protection of any patent.
    ``(g) Sunset.--The authority of the Secretary to carry out the 
generic priority review voucher program under this section shall 
terminate on October 1, 2021.''.

SEC. 202. TROPICAL DISEASE PRODUCT APPLICATION.

    Section 524(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360n(a)(4)(A)) is amended--
            (1) in clause (i), by striking ``and'';
            (2) in clause (ii), by adding ``and'' after the semicolon; 
        and
            (3) by adding at the end the following:
                            ``(iii) that contains reports of new 
                        clinical investigations (other than 
                        bioavailability studies) essential to the 
                        approval of the application and conducted or 
                        sponsored by the applicant;''.

                        TITLE III--STUDY ON REMS

SEC. 301. STUDY ON REMS.

    (a) In General.--The Comptroller General shall conduct a review of 
the implementation and effectiveness of section 505-1 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355-1) (referred to in this 
section as the ``REMS program''), which section--
            (1) authorizes the Secretary of Health and Human Services 
        to require a risk evaluation and mitigation strategy (referred 
        to in this section as ``REMS''); and
            (2) codifies and expands regulations issued by the Food and 
        Drug Administration under which the Food and Drug 
        Administration may impose restrictions on distribution 
        necessary to ensure a drug is safely used.
    (b) Contents of Study.--In conducting the review under subsection 
(a), the Comptroller General shall examine each relevant element 
described in subsection (c) with respect to each of the following 
categories:
            (1) New drug applications under subsection (b) of section 
        505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
        355(b)).
            (2) Abbreviated new drug applications under subsection (j) 
        of such section.
            (3) Applications for the license of a biological product 
        under section 351 of the Public Health Service Act (42 U.S.C. 
        262).
            (4) Single, shared system REMS, as described in section 
        505-1(i) of the Food, Drug, and Cosmetic Act (21 U.S.C. 355-
        1(i)).
            (5) Controlled substances as defined in section 102 of the 
        Controlled Substances Act (21 U.S.C. 802).
            (6) RISKMAPs or other risk management processes employed by 
        the Food and Drug Administration.
    (c) Elements Under Review.--In conducting the review under 
subsection (a), the Comptroller General shall examine each of the 
following elements with respect to each relevant category described in 
subsection (b).
            (1) For each type of application, and by year, the number 
        of REMS required, submitted, voluntarily submitted, modified, 
        added, approved, or removed, and whether those REMS included 
        elements to assure safe use, such as restricted distribution.
            (2) For each type of application, the number of REMS in 
        effect at the time of the review and the number of years that 
        each such REMS has been in effect at such time.
            (3) If and how the REMS program has improved drug safety, 
        as compared to the time before the REMS program became 
        effective, and how the Food and Drug Administration tracks such 
        improvements.
            (4) The burdens associated with REMS, including burdens on 
        patients, health care providers, generic drug manufacturers, 
        brand drug manufacturers, pharmacies, and wholesale 
        distributors.
            (5) In the case of a REMS program for a drug containing a 
        controlled substance, the coordination between the Food and 
        Drug Administration and the Drug Enforcement Administration.
            (6) The effect of additional risk mitigation strategies, 
        including non-REMS restricted distribution systems, imposed by 
        companies outside of what is required under the REMS program.
            (7) The standards and policies applied by the Food and Drug 
        Administration to require, modify, add, or remove a REMS, and 
        how those standards and policies have changed since the REMS 
        program became effective.
            (8) The effect of REMS programs and additional risk 
        mitigation strategies, including non-REMS restricted 
        distribution systems, on generic entry into the marketplace.
            (9) The effect of REMS programs and additional risk 
        mitigation strategies, including non-REMS restricted 
        distribution systems, on pharmaceutical prices.
    (d) Report.--Not later than May 1, 2017, the Comptroller General 
shall submit a report to the Committee on Health, Education, Labor, and 
Pensions of the Senate, the Special Committee on Aging of the Senate, 
and the Committee on Energy and Commerce of the House of 
Representatives, containing the results of the review described in this 
section.
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