[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2562 Introduced in House (IH)]

<DOC>






115th CONGRESS
  1st Session
                                H. R. 2562

                To improve access to prescription drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 19, 2017

  Mr. Kelly of Pennsylvania introduced the following bill; which was 
            referred to the Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
                To improve access to prescription drugs.

    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 ``Making Pharmaceutical Markets More 
Competitive Act''.

          TITLE I--REMOVING REGULATORY BARRIERS TO COMPETITION

SEC. 101. IMPROVING ACCESS TO 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) The Secretary shall prioritize the review of, and act 
within 240 calendar days of the date of the submission of, an original 
abbreviated new drug application submitted for review under this 
subsection, or on a supplement to such an application, that is for a 
drug--
            ``(i) for which there are not more than 3 approved drugs 
        listed under paragraph (7), except that the review of an 
        application submitted more than 30 months in advance of the 
        last applicable expiration date for a patent for which a 
        certification under paragraph (2)(A)(vii)(III) has been 
        submitted, or of the expiration date for an applicable period 
        of exclusivity under this Act, will not be expedited; or
            ``(ii) that has been included on the list under section 
        506E.
    ``(B) The Secretary shall require the applicant, not later than 60 
days prior to the submission of an application described in 
subparagraph (A), to provide complete, accurate information regarding 
facilities involved in manufacturing processes and testing, including 
facilities in corresponding Type II active pharmaceutical ingredients 
drug master files submitted with an application and sites or 
organizations involved in bioequivalence and clinical studies used to 
support the application, in order to make a determination regarding 
whether an inspection of an establishment is necessary.
    ``(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 provide review status updates to 
applicants regarding applications under this subsection, as 
appropriate, including when the application is awaiting final 
regulatory action by the office charged with review.
    ``(13) The Secretary shall publish on the Internet website of the 
Food and Drug Administration a list of all drugs approved under 
subsection (b) for which all patents and periods of exclusivity under 
this Act have expired. Such list shall be updated at least once every 
180 days.''.

SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLICATIONS, PRIORITY 
              REVIEW APPLICATIONS, AND INSPECTIONS.

    (a) In General.--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 (referred to in this section 
as the ``Secretary'') shall post on the Internet website of the Food 
and Drug Administration a report that provides--
            (1) the number of applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        awaiting action by the applicant, including such applications 
        that were filed prior to October 1, 2014;
            (2) the number of applications filed under section 505(j) 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) 
        awaiting action by the Secretary, including such applications 
        that were filed prior to October 1, 2014;
            (3) 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 covered 
        by the report;
            (4) the mean and median approval and tentative approval 
        times for applications covered by the report;
            (5) the number of applications described in paragraphs (1), 
        (2), and (3) that are subject to priority review; and
            (6) the number of such applications on which the Secretary 
        has taken action pursuant to section 506H(b) of the Federal 
        Food, Drug, and Cosmetic Act, as added by section 101.
    (b) Annual Report on Priority Review Applications.--
            (1) In general.--The Secretary shall submit to the 
        Committee on Health, Education, Labor, and Pensions and the 
        Special Committee on Aging of the Senate and the Committee on 
        Energy and Commerce of the House of Representatives an annual 
        report, not later than March 31 of each year, on the following:
                    (A) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and are awaiting 
                action by the applicant.
                    (B) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and are awaiting 
                action by the Secretary.
                    (C) The number of applications filed under section 
                505(j) of the Federal Food, Drug, and Cosmetic Act (21 
                U.S.C. 355(j)) that are subject to priority review 
                during the most recent calendar year and have been 
                approved by the Secretary.
                    (D) For each of subparagraphs (A) through (C), the 
                number of such applications--
                            (i) for which there are not more than 3 
                        approved drugs listed under section 505(j)(7) 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355(j)(7)); and
                            (ii) the number of such applications that 
                        are for a drug on the drug shortage list under 
                        section 506E of the Federal Food, Drug, and 
                        Cosmetic Act (21 U.S.C. 356e).
    (c) Annual Report on Inspections.--Not later than March 1 of each 
year, the Secretary shall post on the Internet website of the Food and 
Drug Administration--
            (1) the average and median amount of time, following a 
        request by staff of the Food and Drug Administration reviewing 
        an application or report submitted under an applicable section 
        described in subparagraph (A), (B), or (C), to schedule and 
        complete inspections of facilities necessary for--
                    (A) approval of a drug under section 505 of the 
                Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355);
                    (B) approval of a device under section 515 of such 
                Act (21 U.S.C. 360e); and
                    (C) clearance of a device under section 510(k) of 
                such Act (21 U.S.C. 360(k)); and
            (2) the average and median amount of time to schedule and 
        complete for-cause inspections of facilities of drugs and 
        devices.

                  TITLE II--INCENTIVIZING COMPETITION

SEC. 201. EXPEDITING GENERIC COMPETITION.

    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. EXPEDITING GENERIC DRUG DEVELOPMENT.

    ``(a) In General.--The Secretary shall, at the request of an 
applicant, expedite the development and review of an application under 
subsection (j) of section 505 for a drug--
            ``(1) for which there are not more than 3 approved drug 
        products listed under section 505(j)(7); or
            ``(2) that is included on the list under section 506E.
    ``(b) Request From Sponsors.--A request to expedite the development 
and review of an application under subsection (a) shall be submitted by 
the applicant prior to the submission of such application.
    ``(c) Other Applications.--Nothing in this section shall prevent 
the Secretary from expediting the development and review of other 
applications as the Secretary determines appropriate.
    ``(d) Additional Communication.--The Secretary shall take such 
actions as are appropriate to expedite the development and review of 
the application for approval of a drug described in subsection (a), 
including, as appropriate--
            ``(1) holding meetings with the sponsor and the review team 
        throughout the development of the drug prior to submission of 
        the application;
            ``(2) providing timely advice to, and interactive 
        communication with, the sponsor regarding the development of 
        the application to ensure that the collection of nonclinical 
        and clinical data necessary for approval is as efficient as 
        practicable;
            ``(3) in the case of a complex product, assigning a cross-
        disciplinary project lead for the review team to facilitate an 
        efficient review of the development program and application, 
        including manufacturing inspections; and
            ``(4) in the case of a complex product, including drug-
        device combinations, involving senior managers and experienced 
        review staff, as appropriate, in a collaborative, cross-
        disciplinary review.
    ``(e) Reporting Requirement.--A sponsor of a drug expedited under 
this section shall report to the Secretary, one year following approval 
of an application under section 505(j), on whether the approved drug 
has been marketed in interstate commerce since approval.''.

SEC. 202. LIST OF GENERIC 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 201, the following:

``SEC. 506I. DRUG LISTING.

    ``(a) Removal, Withdrawal, or Transfer.--The holder of an 
application approved under subsection (b) or (j) of section 505 shall 
notify the Secretary within 180 days of removing the drug that is the 
subject of such application from interstate commerce, withdrawing such 
approved application, or transferring such approved application, and a 
reason for such removal, withdrawal, or transfer. If compliance with 
this subsection within such 180-day period is not practicable, then the 
holder shall comply as soon as practicable. The Secretary shall cross-
reference information listed pursuant to section 506C where applicable 
to avoid duplicative reporting. Notification to the Secretary by a 
manufacturer in accordance with section 506C(a) shall be deemed to be 
in compliance with this section.
    ``(b) Drugs With Limited Competition.--
            ``(1) Information.--The Secretary shall--
                    ``(A) maintain information with respect to 
                applications approved under section 505(j); and
                    ``(B) publish on the Internet website of the Food 
                and Drug Administration such information under 
                subparagraph (A) with respect to drugs for which there 
                are 3 or fewer application holders; and
                    ``(C) update the information published pursuant to 
                subparagraph (B) every 180 days.
            ``(2) Contents.--The public information maintained and 
        published under paragraph (1)(B) shall include--
                    ``(A) the name of the drug, name of the holder of 
                the approved application, and the marketing status for 
                each drug; and
                    ``(B) an indication of whether the Secretary 
                considers the drug to be for the treatment or 
                prevention of a serious disease or medical condition, 
                for which there is no alternative drug that is judged 
                by medical professionals to be an adequate substitute 
                available in adequate supply.
    ``(c) Public Health Exception.--The Secretary may choose not to 
make information collected under this section publicly available if the 
Secretary determines that disclosure of such information would 
adversely affect the public health.
    ``(d) Notification.--When the Secretary first publishes the 
information under subsection (b), the Secretary shall notify relevant 
Federal agencies, including the Centers for Medicare & Medicaid 
Services and the Federal Trade Commission, that the information has 
been published and will be updated regularly.''.

SEC. 203. SUITABILITY PETITIONS.

    (a) In General.--It is the sense of the Senate 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)(5)(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 102(b)--
            (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)(5)(C)); and
            (2) the number of such petitions pending a substantive 
        response for more than 180 days from the date of receipt.

SEC. 204. INSPECTIONS.

    Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355(j)), as amended by section 101, is further amended by adding 
at the end the following:
    ``(14) If the Secretary issues feedback pursuant to section 
704(b)(2) with respect to information submitted in response to a report 
under section 704(b)(1), and a report that was issued under section 
704(b)(1) is the only obstacle to approval of an application under this 
subsection or the Secretary determines that the public health benefit 
of approving an application under this subsection outweighs any risk to 
public health, the Secretary shall, within 45 days of notification by 
the applicant that necessary changes have been made to the 
establishment to address any findings or deficiencies identified 
previously by the Secretary--
            ``(A) re-inspect the establishment with respect to which 
        the report was issued; or
            ``(B) make a determination regarding the response to such 
        report and review of such application.''.
                                 <all>