I 
117TH CONGRESS 
2D SESSION 
H. R. 7472 
To amend the Federal Food, Drug, and Cosmetic Act to grant eligible 
researchers access to eligible products at a discounted price for qualified 
research, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
APRIL 7, 2022 
Mrs. CAROLYN B. MALONEY of New York (for herself, Mr. WELCH, Ms. 
SCHAKOWSKY, Ms. PORTER, Mr. DESAULNIER, and Mr. RASKIN) intro-
duced the following bill; which was referred to the Committee on Energy 
and Commerce 
A BILL 
To amend the Federal Food, Drug, and Cosmetic Act to 
grant eligible researchers access to eligible products at 
a discounted price for qualified research, and for other 
purposes. 
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 ‘‘Discounted Drugs for 
Clinical Trials Act’’. 
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SEC. 2. DISCOUNTED SALES OF ELIGIBLE PRODUCTS FOR 
QUALIFIED RESEARCH PURPOSES. 
(a) IN GENERAL.—Chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by inserting after section 505–2 of such Act (21 U.S.C. 
355–1) the following new section: 
‘‘SEC. 505–3. DISCOUNTED SALES OF ELIGIBLE PRODUCTS 
FOR QUALIFIED RESEARCH PURPOSES. 
‘‘(a) APPLICATION BY RESEARCHER.—To obtain an 
eligible product for qualified research at the discounted 
price, an individual or entity shall submit to the Secretary 
an application certifying and demonstrating that— 
‘‘(1) the individual or entity is an eligible re-
searcher; 
‘‘(2) the product being sought is an eligible 
product; 
‘‘(3) the researcher seeks to use the eligible 
product for qualified research; and 
‘‘(4) the amount of the eligible product sought 
is reasonable for completing the qualified research. 
‘‘(b) DUTIES OF SECRETARY.—The Secretary shall— 
‘‘(1) review each application submitted under 
paragraph (1) in a timely manner; 
‘‘(2) provide to the applicant, within a reason-
able time of such submission— 
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‘‘(A) a written order specifying the suffi-
cient quantity of the eligible product approved 
to be purchased by the eligible researcher at the 
discounted price; or 
‘‘(B) a written denial of the application; 
‘‘(3) require manufacturers and license holders 
to report to the Secretary any additional information 
determined by the Secretary to be necessary to carry 
out this section; and 
‘‘(4) annually publish information on the num-
ber and types of applications granted and denied 
under this section. 
‘‘(c) ACQUISITION OF DISCOUNTED DRUG.—Upon 
receipt from an eligible researcher of an order obtained 
under subsection (b)(2)(A) for the acquisition of an eligi-
ble product for qualified research, the manufacturer or li-
cense holder of the eligible product shall sell to the eligible 
researcher the quantity specified in the order at the dis-
counted price. 
‘‘(d) CIVIL ACTION FOR FAILURE TO PROVIDE SUF-
FICIENT QUANTITY OF AN ELIGIBLE PRODUCT.— 
‘‘(1) IN GENERAL.—An eligible researcher may 
bring a civil action against the manufacturer or li-
cense holder of an eligible product seeking relief 
under this subsection in an appropriate district 
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be greater than the revenue that the manufacturer 
or license holder earned on the eligible product be-
ginning on the date that is 31 days after the date 
on which the manufacturer or license holder received 
the request and ending on the date on which the eli-
gible researcher received the specified quantity of 
the eligible product. 
‘‘(7) AVOIDANCE OF DELAY.—The court may 
issue an order under paragraph (5)(A) before con-
ducting further proceedings that may be necessary 
to determine— 
‘‘(A) whether the eligible researcher is en-
titled to an award under subparagraph (B) or 
(C) of paragraph (5); or 
‘‘(B) the amount of any such award. 
‘‘(e) LIMITATION OF LIABILITY.—A manufacturer or 
license holder of an eligible product obtained by an eligible 
researcher pursuant to this section shall not be liable for 
any claim under Federal, State, or local law arising out 
of the failure of the eligible researcher to follow adequate 
safeguards to assure safe use of the eligible product, in-
cluding with respect to transportation, handling, use, or 
disposal. 
‘‘(f) RULE OF CONSTRUCTION.—This section shall 
not be construed to— 
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‘‘(1) undermine or abrogate any requirement 
imposed pursuant to a risk evaluation and mitiga-
tion strategy under section 505–1; or 
‘‘(2) interfere with the private right of action 
afforded under section 610 of division N of the Fur-
ther Consolidated Appropriations Act, 2020 (Public 
Law 116–94) (21 U.S.C. 355–2 note; commonly re-
ferred to as the ‘CREATES Act’). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) 
COMMISSIONER.—The 
term 
‘Commis-
sioner’ means the Commissioner of Food and Drugs. 
‘‘(2) COMBINATION PRODUCT.—The term ‘com-
bination product’ means a combination product de-
scribed in section 503(g). 
‘‘(3) DISCOUNTED
PRICE.—The term ‘dis-
counted price’ means the direct costs to the manu-
facturer or license holder of producing the eligible 
product. 
‘‘(4) ELIGIBLE PRODUCT.—The term ‘eligible 
product’ means— 
‘‘(A) any— 
‘‘(i) drug approved under section 
505(c) of this Act or biological product li-
censed under section 351(a) of the Public 
Health Service Act; 
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‘‘(ii) combination product including 
such a drug or biological product; or 
‘‘(iii) product, including any device, 
that is marketed or intended for use with 
such a drug or biological product; and 
‘‘(B) any product that is— 
‘‘(i) a covered part D drug (as defined 
in section 1860D–2(e) of the Social Secu-
rity Act) eligible for placement on, with re-
spect to a plan year, a specialty tier (as de-
fined in section 423.560 of title 42, Code 
of Federal Regulations) of a formulary for 
such plan year of a prescription drug plan 
under part D of title XVIII of such Act or 
an MA–PD plan under part C of such 
title; or 
‘‘(ii) a drug (including any biological 
product), or combination product, whose 
cost is determined by the Commissioner to 
be prohibitive to the advancement of quali-
fied research. 
‘‘(5) ELIGIBLE RESEARCHER.—The term ‘eligi-
ble researcher’ means any individual or entity seek-
ing to obtain an eligible product for qualified re-
search. 
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‘‘(6) LICENSE
HOLDER.—The term ‘license 
holder’ means the holder of an application approved 
under section subsection (c) or (j) of section 505 of 
this Act, or a license under subsection (a) or (k) of 
section 351 of the Public Health Service Act, for an 
eligible product. 
‘‘(7) QUALIFIED RESEARCH.—The term ‘quali-
fied research’ means— 
‘‘(A) research in furtherance of an applica-
tion under section 505(b) or (j) of this Act; 
‘‘(B) research in furtherance of an applica-
tion for a license under section 351(a) or (k) of 
the Public Health Service Act; 
‘‘(C) research for which an exemption for 
investigational use is granted pursuant to sec-
tion 505(i) of this Act or section 351(a) of the 
Public Health Service Act; or 
‘‘(D) research using an approved drug for 
an approved indication with the purpose of eval-
uating and comparing the clinical effectiveness, 
risks, or benefits of 2 or more of any of the fol-
lowing: 
‘‘(i) Health care interventions, proto-
cols for treatment, care management, de-
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livery procedures, diagnostic tools, or inte-
grative practices. 
‘‘(ii) Drugs (including biological prod-
ucts), devices, or combination products. 
‘‘(iii) Any other treatments, services, 
practices, or items being used in the treat-
ment, management, or diagnosis of, or pre-
vention of, illness or injury in individuals. 
‘‘(8) SUFFICIENT QUANTITY.—The term ‘suffi-
cient quantity’ means an amount of an eligible prod-
uct no greater than the eligible researcher deter-
mines to be necessary to accomplish the qualified re-
search and fulfill any related regulatory require-
ments.’’. 
(b) REGULATIONS.—Not later than 180 days of the 
date of enactment of this Act, the Secretary of Health and 
Human Services shall promulgate final regulations to 
carry out section 505–3 of the Federal Food, Drug, and 
Cosmetic Act, as added by subsection (a), including regu-
lations to appropriately calculate the discounted price ap-
plicable with respect to an eligible product (as such terms 
are defined in such section 505–3). 
Æ 
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