[Congressional Bills 114th Congress]
[From the U.S. Government Publishing Office]
[S. 1878 Reported in Senate (RS)]
<DOC>
Calendar No. 415
114th CONGRESS
2d Session
S. 1878
To extend the pediatric priority review voucher program.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 28, 2015
Mr. Casey (for himself, Mr. Isakson, Mr. Brown, and Mr. Kirk)
introduced the following bill; which was read twice and referred to the
Committee on Health, Education, Labor, and Pensions
April 5, 2016
Reported by Mr. Alexander, with an amendment
[Strike out all after the enacting clause and insert the part printed
in italic]
_______________________________________________________________________
A BILL
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,
<DELETED>SECTION 1. SHORT TITLE.</DELETED>
<DELETED> This Act may be cited as the ``Advancing Hope Act of
2015''.</DELETED>
<DELETED>SEC. 2. REAUTHORIZATION OF PROGRAM FOR PRIORITY REVIEW TO
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC
DISEASES.</DELETED>
<DELETED> Section 529 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360ff) is amended--</DELETED>
<DELETED> (1) in subsection (a)--</DELETED>
<DELETED> (A) by amending paragraph (3) to read as
follows:</DELETED>
<DELETED> ``(3) Rare pediatric disease.--The term `rare
pediatric disease' means any of the following:</DELETED>
<DELETED> ``(A) A disease that meets each of the
following criteria:</DELETED>
<DELETED> ``(i) The disease primarily
affects individuals aged from birth to 18
years, including age groups often called
neonates, infants, children, and
adolescents.</DELETED>
<DELETED> ``(ii) The disease is a rare
disease or condition, within the meaning of
section 526.</DELETED>
<DELETED> ``(B) Any form of sickle cell
disease.</DELETED>
<DELETED> ``(C) Any pediatric cancers.'';
and</DELETED>
<DELETED> (B) in paragraph (4)--</DELETED>
<DELETED> (i) in subparagraph (E), by
striking ``and'' at the end;</DELETED>
<DELETED> (ii) in subparagraph (F), by
striking the period at the end and inserting
``; and''; and</DELETED>
<DELETED> (iii) by adding at the end the
following:</DELETED>
<DELETED> ``(G) is for a drug or biological product
for which a priority review voucher has not been issued
under section 524 (relating to tropical disease
products).'';</DELETED>
<DELETED> (2) in subsection (b), by striking paragraph (5);
and</DELETED>
<DELETED> (3) in subsection (d)(2), in the second sentence,
by striking the period and inserting ``, but the sponsor of a
drug that intends to request a priority review voucher under
this section shall notify the Secretary of such intent upon
submission of an application under section 505 or section 351
of the Public Health Service Act that is the basis of such
request.''.</DELETED>
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
September 30, 2022, unless the rare pediatric disease product
application--
``(A) is for a drug that, not later than September
30, 2022, is designated under subsection (d) as a drug
for a rare pediatric disease; and
``(B) is, not later than September 30, 2027,
approved under section 505(b)(1) of this Act or section
351(a) of the Public Health Service Act.''; 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).
Calendar No. 415
114th CONGRESS
2d Session
S. 1878
_______________________________________________________________________
A BILL
To extend the pediatric priority review voucher program.
_______________________________________________________________________
April 5, 2016
Reported with an amendment