I 
115TH CONGRESS 
1ST SESSION 
H. R. 749 
To increase competition in the pharmaceutical industry. 
IN THE HOUSE OF REPRESENTATIVES 
JANUARY 30, 2017 
Mr. SCHRADER (for himself, Mr. BILIRAKIS, Mr. LIPINSKI, Mr. MOULTON, 
Mr. BERA, Ms. SINEMA, Mr. COOPER, Mr. POSEY, Mr. COSTA, and Mr. 
PETERS) introduced the following bill; which was referred to the Com-
mittee on Energy and Commerce 
A BILL 
To increase competition in the pharmaceutical industry. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Lower Drug Costs 
through Competition Act’’. 
SEC. 2. FINDINGS. 
Congress finds the following: 
(1) As part of the Food and Drug Administra-
tion’s mission to protect the public health, the Food 
and Drug Administration approves generic drugs 
that help establish competitive markets for treat-
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ments that improve the lives of millions of patients 
in the United States. 
(2) Rising health care costs, including prescrip-
tion 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 spend-
ing 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 ef-
fective way to help keep prescription drug costs low 
for patients, the health care system, and Federal 
and State government. 
(6) While the Food and Drug Administration 
has made progress toward a more consistent 
timeline for generic drug approvals since the enact-
ment of the Generic Drug User Fee Amendments of 
2012 (21 U.S.C. 379j–41 et seq.), a significant 
backlog of abbreviated new drug applications for ge-
neric drugs remains. 
(7) The sudden, aggressive price hikes for a va-
riety of recently acquired off-patent drugs that have 
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been used widely for decades, for which there is no 
generic drug competitor, also affects access to af-
fordable 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 ac-
cess for patients. 
TITLE 
I—REMOVING 
REGU-
LATORY BARRIERS TO COM-
PETITION 
SEC. 101. IMPROVING GENERIC ACCESS. 
Section 505(j) of the Federal Food, Drug, and Cos-
metic 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 180 calendar days after the date 
of the submission of an application, on an application that 
has been submitted and accepted for review under this 
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subsection, or on a supplement to such an application, 
that is for a drug that— 
‘‘(i) has been introduced into interstate com-
merce by not more than one manufacturer or spon-
sor, as applicable, in the last 3 months and with re-
spect to which tentative approval under paragraph 
(5) has been granted for not more than 2 applica-
tions; or 
‘‘(ii) has been included on the list under section 
506E. 
‘‘(B) The Secretary may expedite an inspection or re-
inspection under section 704 of an establishment that pro-
poses to manufacture a drug described in subparagraph 
(A).’’. 
SEC. 102. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS. 
Not later than 180 calendar days after the date of 
enactment of this Act, and every 180 calendar days there-
after until October 1, 2023, 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— 
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(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, 
2017, that are pending at the time the report is sub-
mitted; 
(2) the average and median total time such ap-
plications have been pending; 
(3) the number of such applications that con-
tain 
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 506F the following: 
‘‘SEC. 506G. 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 180 calendar days after 
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such application has been submitted and accepted 
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 section 505(j)(2)(A)(vii)(IV). 
‘‘(b) GENERIC PRIORITY REVIEW VOUCHERS, IN 
GENERAL.—Beginning on October 1, 2018, the Secretary 
shall award a priority review voucher to the sponsor of 
an application described in section 505(j)(11)(A) upon— 
‘‘(1) approval by the Secretary of such applica-
tion; 
‘‘(2) marketing of the drug subject to such ap-
plication; and 
‘‘(3) determination by the Secretary that the 
drug has a sustained market presence. 
‘‘(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. 
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‘‘(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 sub-
mission 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, 2018, in which case the sponsor of such pending appli-
cation shall notify the Secretary not later than 30 days 
after the date on which such voucher is awarded. 
‘‘(e) FEES.— 
‘‘(1) IN GENERAL.—The sponsor of an applica-
tion that is the subject of a priority review voucher 
shall be subject to the fees required under sub-
chapter C of chapter VII. 
‘‘(2) PRIORITY REVIEW USER FEE.— 
‘‘(A) 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 subpara-
graph (B). Such fee shall be in addition to any 
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fee required to be submitted by the sponsor 
under subchapter C of chapter VII. 
‘‘(B) FEE AMOUNT.—The amount of the 
priority review user fee shall be determined 
each fiscal year by the Secretary, based on 
twice the difference between— 
‘‘(i) the average cost incurred by the 
Food and Drug Administration in the re-
view of a human drug application subject 
to priority review under this section in the 
previous fiscal year; and 
‘‘(ii) the average cost incurred by the 
Food and Drug Administration in the re-
view of a human drug application under 
section 505(j) that is not subject to pri-
ority review under this section in the pre-
vious fiscal year. 
‘‘(C) ANNUAL
FEE
SETTING.—The Sec-
retary shall establish, before the beginning of 
each fiscal year beginning after September 30, 
2018, and in accordance with subparagraph 
(B), the amount of the priority review user fee 
for that fiscal year. 
‘‘(D) PAYMENT.— 
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‘‘(i) IN
GENERAL.—The priority re-
view user fee required by this paragraph 
shall be due upon the notification by a 
sponsor of the intent of such sponsor to 
use the voucher, as specified in subsection 
(d). All other user fees associated with the 
human drug application shall be due as re-
quired by the Secretary or under applicable 
law. 
‘‘(ii) COMPLETE
APPLICATION.—An 
application described in clause (i) for 
which the sponsor requests the use of a 
priority review voucher shall be considered 
incomplete if the fee required by this para-
graph and all other applicable user fees are 
not paid in accordance with the Secretary’s 
procedures for paying such fees. 
‘‘(iii) NO WAIVERS, EXEMPTIONS, RE-
DUCTIONS, OR REFUNDS.—The Secretary 
may not grant a waiver, exemption, reduc-
tion, or refund of any fees due and payable 
under this paragraph. 
‘‘(E) OFFSETTING
COLLECTIONS.—Fees 
collected pursuant to this paragraph for any fis-
cal year— 
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‘‘(i) shall be deposited and credited as 
offsetting collections to the account pro-
viding appropriations to the Food and 
Drug Administration; and 
‘‘(ii) shall not be collected for any fis-
cal year except to the extent provided in 
advance in appropriations Acts. 
‘‘(f) CLARIFICATION.—Nothing in this section affects 
any period of exclusivity under this Act or the protection 
of any patent. 
‘‘(g) SUNSET.—The authority of the Secretary to 
carry out the generic priority review voucher program 
under this section shall terminate on October 1, 2023.’’. 
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 bio-
availability studies) essential to the ap-
proval of the application and conducted or 
sponsored by the applicant;’’. 
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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 Federal 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 restric-
tions 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 exam-
ine 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 Cos-
metic Act (21 U.S.C. 355(b)). 
(2) Abbreviated new drug applications under 
subsection (j) of such section. 
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(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 proc-
esses employed by the Food and Drug Administra-
tion. 
(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, volun-
tarily submitted, modified, added, approved, or re-
moved, 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. 
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(3) If and how the REMS program has im-
proved drug safety, as compared to the time before 
the REMS program became effective, and how the 
Food and Drug Administration tracks such improve-
ments. 
(4) The burdens associated with REMS, includ-
ing burdens on patients, health care providers, ge-
neric drug manufacturers, brand drug manufactur-
ers, pharmacies, and wholesale distributors. 
(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 effect of additional risk mitigation 
strategies, including non-REMS restricted distribu-
tion 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. 
(8) The effect of REMS programs and addi-
tional risk mitigation strategies, including non- 
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REMS restricted distribution systems, on generic 
entry into the marketplace. 
(9) The effect of REMS programs and addi-
tional risk mitigation strategies, including non- 
REMS restricted distribution systems, on pharma-
ceutical prices. 
(d) REPORT.—Not later than May 1, 2018, the 
Comptroller General shall submit a report to the Com-
mittee 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 re-
view described in this section. 
Æ 
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