H. Rept. 116-551 - CREATING HOPE REAUTHORIZATION ACT116th Congress (2019-2020)
Committee Report
Hide Overview| Report Type: | House Report |
|---|---|
| Accompanies: | H.R.4439 |
| Committees: | House Energy and Commerce Committee |
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116th Congress } { Report
HOUSE OF REPRESENTATIVES
2d Session } { 116-551
======================================================================
CREATING HOPE REAUTHORIZATION ACT
_______
September 29, 2020.--Committed to the Committee of the Whole House on
the State of the Union and ordered to be printed
_______
Mr. Pallone, from the Committee on Energy and Commerce, submitted the
following
R E P O R T
[To accompany H.R. 4439]
The Committee on Energy and Commerce, to whom was referred
the bill (H.R. 4439) to amend the Federal Food, Drug, and
Cosmetic Act to make permanent the authority of the Secretary
of Health and Human Services to issue priority review vouchers
to encourage treatments for rare pediatric diseases, having
considered the same, reports favorably thereon with amendments
and recommends that the bill as amended do pass.
CONTENTS
Page
I. Purpose and Summary..............................................2
II. Background and Need for the Legislation..........................2
III. Committee Hearings...............................................3
IV. Committee Consideration..........................................4
V. Committee Votes..................................................4
VI. Oversight Findings...............................................4
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures4
VIII.Federal Mandates Statement.......................................5
IX. Statement of General Performance Goals and Objectives............5
X. Duplication of Federal Programs..................................5
XI. Committee Cost Estimate..........................................5
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits......5
XIII.Advisory Committee Statement.....................................5
XIV. Applicability to Legislative Branch..............................5
XV. Section-by-Section Analysis of the Legislation...................5
XVI. Changes in Existing Law Made by the Bill, as Reported............6
The amendments are as follows:
Strike all after the enacting clause and insert the
following:
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Creating Hope Reauthorization Act''.
SEC. 2. EXTENSION OF AUTHORITY TO ISSUE PRIORITY REVIEW VOUCHERS TO
ENCOURAGE TREATMENTS FOR RARE PEDIATRIC DISEASES.
Section 529(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360ff(b)) is amended--
(1) by striking ``September 30, 2020'' each place it appears
and inserting ``September 30, 2024''; and
(2) by striking ``September 30, 2022'' and inserting
``September 30, 2026''.
Amend the title so as to read:
A bill to amend the Federal Food, Drug, and Cosmetic Act to
extend the authority of the Secretary of Health and Human
Services to issue priority review vouchers to encourage
treatments for rare pediatric diseases.
I. Purpose and Summary
H.R. 4439, the ``Creating Hope Reauthorization Act'', was
introduced on September 20, 2019, by Representative G.K.
Butterfield (D-NC) and referred to the Committee on Energy and
Commerce. H.R. 4439, as reported, will extend the Food and Drug
Administration (FDA) Pediatric Rare Disease Priority Review
Voucher (PRV) program for four years. Under this program,
certain manufacturers of rare pediatric disease drugs can be
eligible for a voucher that can be used or transferred to
obtain a priority review for a subsequent drug after the date
of approval of the rare pediatric disease drug.
II. Background and Need for the Legislation
The Pediatric Rare Disease PRV program was originally
enacted in 2012 with the intent to create an incentive for drug
manufacturers to develop therapies for rare pediatric diseases
that affect neonates, infants, children, and adolescents. The
program requires the FDA to award a PRV to the sponsor of a
rare pediatric disease product application that receives
approval as a drug or biological product to treat a rare
pediatric disease, defined as a serious or life-threatening
disease in which the serious or life-threatening manifestations
primarily affect individuals aged from birth to 18 years. The
incentive value is premised on the ability for the holder of a
PRV to shorten the FDA review time on another drug application
from the standard ten months to six months, or for the holder
of a PRV to sell the voucher to another manufacturer to be used
on a drug application of the manufacturer's choosing.
To date, FDA has awarded 22 PRVs for rare pediatric
diseases.\1\ PRVs have been redeemed to accelerate review of
applications for treatments of a variety of conditions,
including human immunodeficiency virus (HIV) and type 2
diabetes, and have been sold for prices that range between $65
million and $350 million.\2\ While these facts indicate that
PRVs carry some level of value, at least one study has shown
that the Pediatric Rare Disease PRV program has not improved
the rate of new pediatric drugs starting or completing clinical
testing, suggesting that the value of PRVs is an insufficient
incentive for drug development.\3\ Furthermore, observers have
noted that as more PRVs have been awarded, the price of PRVs
has reduced, suggesting that additional awards reduce the PRV
value to developers.\4\ Additionally, FDA has said that the
program strains agency resources and impairs the agency's
ability to set public health priorities.\5\
---------------------------------------------------------------------------
\1\Michael Mezher, Zachary Brennan, and Alexander Gaffney,
Everything You Need to Know about FDA's Priority Review Vouchers,
Regulatory Affairs Professionals Society (Feb. 25, 2020) (www.raps.org/
regulatory-focus/news-articles/2017/12/regulatory-explainer-everything-
you-need-to-know-about-fdas-priority-review-vouchers).
\2\Id.
\3\Thomas J. Hwang et al., Impact of the Priority Review Voucher
Program on Drug Development for Rare Pediatric Diseases, Health Affairs
(Feb. 2019).
\4\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of Aaron S. Kesselheim, M.D., J.D., M.P.H., Professor of
Medicine, Harvard Medical School, Legislative Hearing on Improving
Access to Care: Legislation to Reauthorize Key Public Health Programs,
116th Cong. (July 29, 2020).
\5\Government Accountability Office, Rare Diseases: Too Early to
Gauge Effectiveness of FDA's Pediatric Voucher Program (Mar. 2016)
(GAO-16-319).
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Proponents of H.R. 4439 argue that the program is an
important consideration for drug manufacturers when deciding
where to invest research and development dollars. According to
a review of PRV programs conducted by the U.S. Government
Accountability Office (GAO), six of seven drug manufacturers
interviewed by the GAO indicated that the PRV was one of a
number of factors in making drug development decisions, with
the seventh indicating that the PRV was ``pivotal'' in its
development of a drug.\6\ Proponents have also suggested that
the increase in the number of drug applications receiving
pediatric rare disease designation--from 24 in 2016 to 64 in
2019--indicates an increased level of drug development for
pediatric rare diseases under the program.\7\
---------------------------------------------------------------------------
\6\Government Accountability Office, Drug Development: FDA's
Priority Review Voucher Programs (Jan. 2020) (GAO-20-251).
\7\House Committee on Energy and Commerce, Subcommittee on Health,
Testimony of Nancy Goodman, M.P.P., J.D., Founder and Executive
Director, Kids v. Cancer, Legislative Hearing on Improving Access to
Care: Legislation to Reauthorize Key Public Health Programs, 116th
Cong. (July 29, 2020).
---------------------------------------------------------------------------
H.R. 4439, as introduced, would remove the sunset on the
authority of the Secretary of the U.S. Department of Health and
Human Services (the Secretary) to issue new pediatric rare
disease designations and PRVs, which is set to expire on
September 30, 2020. So as not to foreclose on the potential for
development of additional treatments for pediatric rare
diseases, but in recognition of concerns about effectiveness of
the program, the Committee adopted an amendment in the nature
of a substitute (AINS) that would extend the Pediatric Rare
Disease PRV program for four years.
III. Committee Hearings
For the purposes of section 103(i) of H. Res. 6 of the
116th Congress, the following hearing was used to develop or
consider H.R. 4439:
The Subcommittee on Health held a legislative hearing on
July 29, 2020, entitled ``Improving Access to Care: Legislation
to Reauthorize Key Public Health Programs''' to consider H.R.
4439, the ``Creating Hope Reauthorization Act'' and four other
bills. The Subcommittee received testimony from the following
witnesses:
Robert Boyd, M.C.R.P., M. Div., President,
School-Based Health Alliance;
Linda Goler Blount, M.P.H., President and
CEO, Black Women's Health Imperative;
Nancy Goodman, M.P.P., J.D., Founder and
Executive Director, Kids v. Cancer;
Aaron Seth Kesselheim, M.D., J.D., M.P.H.,
Professor of Medicine, Harvard Medical School;
Brian Lindbergh, Chief Legal Officer and
General Counsel, National Bone Marrow Donor Program;
and
Travis T. Tygart, CEO, U.S. Anti-doping
Agency.
IV. Committee Consideration
Representative Butterfield (D-NC) introduced H.R. 4439, the
``Creating Hope Reauthorization Act'', on September 20, 2019,
and the bill was referred to the Committee on Energy and
Commerce. The bill was then referred to the Subcommittee on
Health on September 23, 2019. A legislative hearing was held on
the bill on July 29, 2020.
On September 9, 2020, H.R. 4439 was discharged from further
consideration by the Subcommittee on Health as the bill was
called up for markup by the full Committee. The Committee on
Energy and Commerce met in virtual open markup session,
pursuant to notice, to consider the bill H.R. 4439. During
consideration of the bill, an amendment in the nature of a
substitute offered by Mr. Pallone of New Jersey was agreed to
by a voice vote. Upon conclusion of consideration of the bill,
the full Committee agreed to a motion on final passage by Mr.
Pallone, Chairman of the committee, to order H.R. 4439 reported
favorably to the House, amended, by a voice vote, a quorum
being present.
V. Committee Votes
Clause 3(b) of rule XIII of the Rules of the House of
Representatives requires the Committee to list each record vote
on the motion to report legislation and amendments thereto. The
Committee advises that there were no record votes taken on H.R.
4439, including the motion for final passage of the bill.
VI. Oversight Findings
Pursuant to clause 3(c)(1) of rule XIII and clause 2(b)(1)
of rule X of the Rules of the House of Representatives, the
oversight findings and recommendations of the Committee are
reflected in the descriptive portion of the report.
VII. New Budget Authority, Entitlement Authority, and Tax Expenditures
Pursuant to 3(c)(2) of rule XIII of the Rules of the House
of Representatives, the Committee adopts as its own the
estimate of new budget authority, entitlement authority, or tax
expenditures or revenues contained in the cost estimate
prepared by the Director of the Congressional Budget Office
pursuant to section 402 of the Congressional Budget Act of
1974.
The Committee has requested but not received from the
Director of the Congressional Budget Office a statement as to
whether this bill contains any new budget authority, spending
authority, credit authority, or an increase or decrease in
revenues or tax expenditures.
VIII. Federal Mandates Statement
The Committee adopts as its own the estimate of Federal
mandates prepared by the Director of the Congressional Budget
Office pursuant to section 423 of the Unfunded Mandates Reform
Act.
IX. Statement of General Performance Goals and Objectives
Pursuant to clause 3(c)(4) of rule XIII, the general
performance goal or objective of this legislation is to extend
the authority of the Secretary of Health and Human Services to
issue PRVs to encourage the development of treatments for rare
pediatric diseases.
X. Duplication of Federal Programs
Pursuant to clause 3(c)(5) of rule XIII, no provision of
H.R. 4439 is known to be duplicative of another Federal
program, including any program that was included in a report to
Congress pursuant to section 21 of Public Law 111-139 or the
most recent Catalog of Federal Domestic Assistance.
XI. Committee Cost Estimate
Pursuant to clause 3(d)(1) of rule XIII, the Committee
adopts as its own the cost estimate prepared by the Director of
the Congressional Budget Office pursuant to section 402 of the
Congressional Budget Act of 1974.
XII. Earmarks, Limited Tax Benefits, and Limited Tariff Benefits
Pursuant to clause 9(e), 9(f), and 9(g) of rule XXI, the
Committee finds that H.R. 4439 contains no earmarks, limited
tax benefits, or limited tariff benefits.
XIII. Advisory Committee Statement
No advisory committee within the meaning of section 5(b) of
the Federal Advisory Committee Act was created by this
legislation.
XIV. Applicability to Legislative Branch
The Committee finds that the legislation does not relate to
the terms and conditions of employment or access to public
services or accommodations within the meaning of section
102(b)(3) of the Congressional Accountability Act.
XV. Section-by-Section Analysis of the Legislation
Section 1. Short title
Section 1 designates that the bill may be cited as the
``Creating Hope Reauthorization Act''.
Sec. 2. Extension of authority to issue priority review vouchers to
encourage treatments for rare pediatric diseases
Section 2 amends the Federal Food, Drug, and Cosmetic Act
to extend the sunset on the Secretary's authority to issue new
Pediatric Rare Disease PRVs to September 30, 2024, provided
that the PRV is issued for a drug that, not later than
September 30, 2024, is designated as a drug for a rare
pediatric disease; and is, not later than September 30, 2026,
approved under section 351(b)(1) of the Federal Food, Drug, and
Cosmetic Act, or section 351(a) of the Public Health Service
Act.
XVI. Changes in Existing Law Made by the Bill, as Reported
In compliance with clause 3(e) of rule XIII of the Rules of
the House of Representatives, changes in existing law made by
the bill, as reported, are shown as follows (existing law
proposed to be omitted is enclosed in black brackets, new
matter is printed in italics, and existing law in which no
change is proposed is shown in roman):
FEDERAL FOOD, DRUG, AND COSMETIC ACT
* * * * * * *
CHAPTER V--DRUGS AND DEVICES
* * * * * * *
Subchapter B--Drugs for Rare Diseases or Conditions
* * * * * * *
SEC. 529. PRIORITY REVIEW TO ENCOURAGE TREATMENTS FOR RARE PEDIATRIC
DISEASES.
(a) Definitions.--In this section:
(1) Priority review.--The term ``priority review'',
with respect to a human drug application as defined in
section 735(1), means review and action by the
Secretary on such application not later than 6 months
after receipt by the Secretary of such application, as
described in the Manual of Policies and Procedures of
the Food and Drug Administration and goals identified
in the letters described in section 101(b) of the
Prescription Drug User Fee Amendments of 2012.
(2) Priority review voucher.--The term ``priority
review voucher'' means a voucher issued by the
Secretary to the sponsor of a rare pediatric disease
product application that entitles the holder of such
voucher to priority review of a single human drug
application submitted under section 505(b)(1) or
section 351(a) of the Public Health Service Act after
the date of approval of the rare pediatric disease
product application.
(3) Rare pediatric disease.--The term ``rare
pediatric disease'' means a disease that meets each of
the following criteria:
(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.
(B) The disease is a rare disease or
condition, within the meaning of section 526.
(4) Rare pediatric disease product application.--The
term ``rare pediatric disease product application''
means a human drug application, as defined in section
735(1), that--
(A) is for a drug or biological product--
(i) that is for the prevention or
treatment of a rare pediatric disease;
and
(ii) that contains no active
ingredient (including any ester or salt
of the active ingredient) that has been
previously approved in any other
application under section 505(b)(1),
505(b)(2), or 505(j) of this Act or
section 351(a) or 351(k) of the Public
Health Service Act;
(B) is submitted under section 505(b)(1) of
this Act or section 351(a) of the Public Health
Service Act;
(C) the Secretary deems eligible for priority
review;
(D) that relies on clinical data derived from
studies examining a pediatric population and
dosages of the drug intended for that
population;
(E) that does not seek approval for an adult
indication in the original rare pediatric
disease product application; and
(F) is approved after the date of the
enactment of the Advancing Hope Act of 2016.
(b) Priority Review Voucher.--
(1) In general.--The Secretary shall award a priority
review voucher to the sponsor of a rare pediatric
disease product application upon approval by the
Secretary of such rare pediatric disease product
application.
(2) Transferability.--
(A) In general.--The sponsor of a rare
pediatric disease product application that
receives a priority review voucher under this
section 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.
(B) Notification of transfer.--Each person to
whom a voucher is transferred shall notify the
Secretary of such change in ownership of the
voucher not later than 30 days after such
transfer.
(3) Limitation.--A sponsor of a rare pediatric
disease product application may not receive a priority
review voucher under this section if the rare pediatric
disease product application was submitted to the
Secretary prior to the date that is 90 days after the
date of enactment of the Prescription Drug User Fee
Amendments of 2012.
(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.
(5) Termination of authority.--The Secretary may not
award any priority review vouchers under paragraph (1)
after [September 30, 2020] September 30, 2024, unless
the rare pediatric disease product application--
(A) is for a drug that, not later than
[September 30, 2020] September 30, 2024, is
designated under subsection (d) as a drug for a
rare pediatric disease; and
(B) is, not later than [September 30, 2022]
September 30, 2026, approved under section
505(b)(1) of this Act or section 351(a) of the
Public Health Service Act.
(c) Priority Review User Fee.--
(1) In general.--The Secretary shall establish a user
fee program under which a sponsor of a human drug
application that is the subject of a priority review
voucher shall pay to the Secretary a fee determined
under paragraph (2). Such fee shall be in addition to
any fee required to be submitted by the sponsor under
chapter VII.
(2) Fee amount.--The amount of the priority review
user fee shall be determined each fiscal year by the
Secretary, based on the difference between--
(A) the average cost incurred by the Food and
Drug Administration in the review of a human
drug application subject to priority review in
the previous fiscal year; and
(B) the average cost incurred by the Food and
Drug Administration in the review of a human
drug application that is not subject to
priority review in the previous fiscal year.
(3) Annual fee setting.--The Secretary shall
establish, before the beginning of each fiscal year
beginning after September 30, 2012, the amount of the
priority review user fee for that fiscal year.
(4) Payment.--
(A) In general.--The priority review user fee
required by this subsection shall be due upon
the notification by a sponsor of the intent of
such sponsor to use the voucher, as specified
in subsection (b)(4)(A). All other user fees
associated with the human drug application
shall be due as required by the Secretary or
under applicable law.
(B) Complete application.--An application
described under subparagraph (A) for which the
sponsor requests the use of a priority review
voucher shall be considered incomplete if the
fee required by this subsection and all other
applicable user fees are not paid in accordance
with the Secretary's procedures for paying such
fees.
(C) No waivers, exemptions, reductions, or
refunds.--The Secretary may not grant a waiver,
exemption, reduction, or refund of any fees due
and payable under this section.
(5) Offsetting collections.--Fees collected pursuant
to this subsection for any fiscal year--
(A) shall be deposited and credited as
offsetting collections to the account providing
appropriations to the Food and Drug
Administration; and
(B) shall not be collected for any fiscal
year except to the extent provided in advance
in appropriations Acts.
(d) Designation Process.--
(1) In general.--Upon the request of the manufacturer
or the sponsor of a new drug, the Secretary may
designate--
(A) the new drug as a drug for a rare
pediatric disease; and
(B) the application for the new drug as a
rare pediatric disease product application.
(2) Request for designation.--The request for a
designation under paragraph (1) shall be made at the
same time a request for designation of orphan disease
status under section 526 or fast-track designation
under section 506 is made. Requesting designation under
this subsection is not a prerequisite to receiving a
priority review voucher under this section.
(3) Determination by secretary.--Not later than 60
days after a request is submitted under paragraph (1),
the Secretary shall determine whether--
(A) the disease or condition that is the
subject of such request is a rare pediatric
disease; and
(B) the application for the new drug is a
rare pediatric disease product application.
(e) Marketing of Rare Pediatric Disease Products.--
(1) Revocation.--The Secretary may revoke any
priority review voucher awarded under subsection (b) if
the rare pediatric disease product 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 under section 505 of this
Act or section 351 of the Public Health Service Act.
(2) Postapproval production report.--The sponsor of
an approved rare pediatric disease product shall submit
a report to the Secretary not later than 5 years after
the approval of the applicable rare pediatric disease
product application. Such report shall provide the
following information, with respect to each of the
first 4 years after approval of such product:
(A) The estimated population in the United
States suffering from the rare pediatric
disease.
(B) The estimated demand in the United States
for such rare pediatric disease product.
(C) The actual amount of such rare pediatric
disease product distributed in the United
States.
(f) Notice and Report.--
(1) Notice of issuance of voucher and approval of
products under voucher.--The Secretary shall publish a
notice in the Federal Register and on the Internet Web
site of the Food and Drug Administration not later than
30 days after the occurrence of each of the following:
(A) The Secretary issues a priority review
voucher under this section.
(B) The Secretary approves a drug pursuant to
an application submitted under section 505(b)
of this Act or section 351(a) of the Public
Health Service Act for which the sponsor of the
application used a priority review voucher
under this section.
(2) Notification.--If, after the last day of the 1-
year period that begins on the date that the Secretary
awards the third rare pediatric disease priority
voucher under this section, a sponsor of an application
submitted under section 505(b) of this Act or section
351(a) of the Public Health Service Act for a drug uses
a priority review voucher under this section for such
application, the Secretary shall submit to the
Committee on Energy and Commerce of the House of
Representatives and the Committee on Health, Education,
Labor, and Pensions of the Senate a document--
(A) notifying such Committees of the use of
such voucher; and
(B) identifying the drug for which such
priority review voucher is used.
(g) Eligibility for Other Programs.--Nothing in this section
precludes a sponsor who seeks a priority review voucher under
this section from participating in any other incentive program,
including under this Act, 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..
(h) Relation to Other Provisions.--The provisions of this
section shall supplement, not supplant, any other provisions of
this Act or the Public Health Service Act that encourage the
development of drugs for tropical diseases and rare pediatric
diseases.
(i) GAO Study and Report.--
(1) Study.--
(A) In general.--Beginning on the date that
the Secretary awards the third rare pediatric
disease priority voucher under this section,
the Comptroller General of the United States
shall conduct a study of the effectiveness of
awarding rare pediatric disease priority
vouchers under this section in the development
of human drug products that treat or prevent
such diseases.
(B) Contents of study.--In conducting the
study under subparagraph (A), the Comptroller
General shall examine the following:
(i) The indications for which each
rare disease product for which a
priority review voucher was awarded was
approved under section 505 or section
351 of the Public Health Service Act.
(ii) Whether, and to what extent, an
unmet need related to the treatment or
prevention of a rare pediatric disease
was met through the approval of such a
rare disease product.
(iii) The value of the priority
review voucher if transferred.
(iv) Identification of each drug for
which a priority review voucher was
used.
(v) The length of the period of time
between the date on which a priority
review voucher was awarded and the date
on which it was used.
(2) Report.--Not later than 1 year after the date
under paragraph (1)(A), the Comptroller General shall
submit to the Committee on Energy and Commerce of the
House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate, a report
containing the results of the study under paragraph
(1).
* * * * * * *
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