Title: Increasing Competition in Pharmaceuticals Act
Policy area: Health

Summary:
Increasing Competition in Pharmaceuticals Act
This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.
The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 150 days. User fees are waived for such an application unless the drug is under patent. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.
The FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application upon approval. A voucher may be used to have the FDA review and take action upon a generic drug application within 150 days of submission. The FDA may revoke a voucher awarded for a drug that is not marketed within one year of approval. This voucher program is terminated at the end of FY2022.
The FDA must periodically report on generic drug applications filed before FY2016 that are still pending.
For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[S. 297 Introduced in Senate (IS)]

<DOC>






115th CONGRESS
  1st Session
                                 S. 297

        To increase competition in the pharmaceutical industry.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                            February 2, 2017

 Ms. Collins (for herself and Mrs. McCaskill) introduced the following 
  bill; which was read twice and referred to the Committee on Health, 
                     Education, Labor, and Pensions

_______________________________________________________________________

                                 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 ``Increasing Competition in 
Pharmaceuticals 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) Despite enactment of the Generic Drug User Fee 
        Amendments of 2012 (21 U.S.C. 379j-41 et seq.), which was 
        established to provide the Food and Drug Administration with 
        industry funding to ensure a more consistent timeline for 
        generic drug approvals, 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 150 calendar days after the date of the submission of an 
application, on an application that has been submitted 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 fees pursuant to section 744B(a)(3) shall be waived with 
respect to an application described in subparagraph (A), unless such 
application contains a certification under paragraph (2)(A)(vii)(IV).
    ``(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).''.

SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLICATIONS.

    Not later than 90 calendar days after the date of enactment of this 
Act, and every 90 calendar days thereafter until October 1, 2022, 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, 2015, 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 506G the following:

``SEC. 506H. 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 
        150 calendar days after such application has been submitted 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 subclauses (III) and (IV) of 
        section 505(j)(2)(A)(vii).
    ``(b) Generic Priority Review Vouchers, in General.--The Secretary 
shall award a priority review voucher to the sponsor of an application 
described in 505(j)(11)(A) upon approval by the Secretary of such 
application.
    ``(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, 2015, 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.--The sponsor of an application that is the subject of a 
priority review voucher shall be subject to the fees required under 
section 744A.
    ``(f) Clarification.--Nothing in this section affects any period of 
exclusivity under this Act or the protection of any patent.
    ``(g) Revocation.--The Secretary may revoke any priority review 
voucher awarded under subsection (b) if the drug for which such voucher 
was awarded is not marketed in the United States within the 365-day 
period beginning on the date of the approval of such drug.
    ``(h) Sunset.--The authority of the Secretary to carry out the 
generic priority review voucher program under this section shall 
terminate on October 1, 2022.''.

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 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, 
        and brand drug manufacturers.
            (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 impact 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.
    (d) Report.--Not later than May 1, 2018, 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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