I 
114TH CONGRESS 
2D SESSION 
H. R. 4784 
To increase competition in the pharmaceutical industry. 
IN THE HOUSE OF REPRESENTATIVES 
MARCH 17, 2016 
Mr. SCHRADER (for himself and Mr. BILIRAKIS) introduced the following bill; 
which was referred to the Committee 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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‘‘(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, 2021.’’. 
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, 2017, 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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