[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1878 Enrolled Bill (ENR)]
S.1878
One Hundred Fourteenth Congress
of the
United States of America
AT THE SECOND SESSION
Begun and held at the City of Washington on Monday,
the fourth day of January, two thousand and sixteen
An Act
To extend the pediatric priority review voucher program.
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 ``Advancing Hope Act of 2016''.
SEC. 2. REAUTHORIZATION OF PROGRAM FOR PRIORITY REVIEW TO ENCOURAGE
TREATMENTS FOR RARE PEDIATRIC DISEASES.
(a) In General.--Section 529 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 360ff) is amended--
(1) in subsection (a)--
(A) in paragraph (3), by amending subparagraph (A) to read
as follows:
``(A) The disease is a serious or life-threatening disease
in which the serious or life-threatening manifestations
primarily affect individuals aged from birth to 18 years,
including age groups often called neonates, infants, children,
and adolescents.''; and
(B) in paragraph (4)(F), by striking ``Prescription Drug
User Fee Amendments of 2012'' and inserting ``Advancing Hope
Act of 2016'';
(2) in subsection (b)--
(A) by striking paragraph (4) and inserting the following:
``(4) Notification.--
``(A) Sponsor of a rare pediatric disease product.--
``(i) In general.--Beginning on the date that is 90
days after the date of enactment of the Advancing Hope Act
of 2016, the sponsor of a rare pediatric disease product
application that intends to request a priority review
voucher under this section shall notify the Secretary of
such intent upon submission of the rare pediatric disease
product application that is the basis of the request for a
priority review voucher.
``(ii) Applications submitted but not yet approved.--
The sponsor of a rare pediatric disease product application
that was submitted and that has not been approved as of the
date of enactment of the Advancing Hope Act of 2016 shall
be considered eligible for a priority review voucher, if--
``(I) such sponsor has submitted such rare
pediatric disease product application--
``(aa) on or after the date that is 90 days
after the date of enactment of the Prescription
Drug User Fee Amendments of 2012; and
``(bb) on or before the date of enactment of
the Advancing Hope Act of 2016; and
``(II) such application otherwise meets the
criteria for a priority review voucher under this
section.
``(B) Sponsor of a drug application using a priority review
voucher.--
``(i) In general.--The sponsor of a human drug
application shall notify the Secretary not later than 90
days prior to submission of the human drug application that
is the subject of a priority review voucher of an intent to
submit the human drug application, including the date on
which the sponsor intends to submit the application. Such
notification shall be a legally binding commitment to pay
the user fee to be assessed in accordance with this
section.
``(ii) Transfer after notice.--The sponsor of a human
drug application that provides notification of the intent
of such sponsor to use the voucher for the human drug
application under clause (i) may transfer the voucher after
such notification is provided, if such sponsor has not yet
submitted the human drug application described in the
notification.''; and
(B) by striking paragraph (5) and inserting the following:
``(5) Termination of authority.--The Secretary may not award
any priority review vouchers under paragraph (1) after December 31,
2016.''; and
(3) in subsection (g), by inserting before the period ``,
except that no sponsor of a rare pediatric disease product
application may receive more than one priority review voucher
issued under any section of this Act with respect to the drug for
which the application is made.''
(b) Rule of Construction.--Nothing in this Act, or the amendments
made by this Act, shall be construed to affect the validity of a
priority review voucher that was issued under section 529 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360ff) before the date
of enactment of this Act.
SEC. 3. GAO REPORT.
(a) Study.--The Comptroller General of the United States shall
conduct a study on the effectiveness of awarding priority review
vouchers under section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff) in providing incentives for the development of drugs
that treat or prevent rare pediatric diseases (as defined in subsection
(a)(3) of such section) that would not otherwise have been developed.
In conducting such study, the Comptroller General shall examine the
following:
(1) The indications for which each drug for which a priority
review voucher was awarded under such section 529 was approved
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)).
(2) Whether the priority review voucher impacted sponsors'
decisions to invest in developing a drug to treat or prevent a rare
pediatric disease.
(3) An analysis of the drugs for which such priority review
vouchers were used, which shall include--
(A) the indications for which such drugs were approved
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));
(B) whether unmet medical needs were addressed through the
approval of such drugs, including, for each such drug--
(i) if an alternative therapy was previously available
to treat the indication; and
(ii) if the drug provided a benefit or advantage over
another available therapy;
(C) the number of patients potentially treated by such
drugs;
(D) the value of the priority review voucher if
transferred; and
(E) the length of time between the date on which a priority
review voucher was awarded and the date on which it was used.
(4) With respect to the priority review voucher program under
section 529 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff)--
(A) the resources used by the Food and Drug Administration
in implementing such program, including the effect of such
program on the Food and Drug Administration's review of drugs
for which a priority review voucher was not awarded or used;
(B) the impact of the program on the public health as a
result of the review and approval of drugs that received a
priority review voucher and products that were the subject of a
redeemed priority review voucher; and
(C) alternative approaches to improving such program so
that the program is appropriately targeted toward providing
incentives for the development of clinically important drugs
that--
(i) prevent or treat rare pediatric diseases; and
(ii) would likely not otherwise have been developed to
prevent or treat such diseases.
(b) Report.--Not later than January 31, 2022, the Comptroller
General of the United States 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 a report containing
the results of the study of conducted under subsection (a).
Speaker of the House of Representatives.
Vice President of the United States and
President of the Senate.