[Congressional Record Volume 162, Number 146 (Tuesday, September 27, 2016)]
[House]
[Pages H5945-H5946]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
ADVANCING HOPE ACT OF 2016
Mr. WALDEN. Mr. Speaker, I ask unanimous consent that the Committee
on Energy and Commerce be discharged from further consideration of the
bill (S. 1878) to extend the pediatric priority review voucher program,
and ask for its immediate consideration in the House.
The Clerk read the title of the bill.
The SPEAKER pro tempore. Is there objection to the request of the
gentleman from Oregon?
There was no objection.
The text of the bill is as follows:
S. 1878
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
[[Page H5946]]
(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).
The bill was ordered to be read a third time, was read the third
time, and passed, and a motion to reconsider was laid on the table.
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