Teacher:In this task, you are given text for US Congressional and California state bills, your task is to generate a summary for this bill.
Teacher: Now, understand the problem? Solve this instance: 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.
Student:
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. The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.