I 
117TH CONGRESS 
1ST SESSION H. R. 4991 
To require persons who undertake federally funded research and development 
of a biomedical product or service to enter into reasonable pricing agree-
ments with the Secretary of Health and Human Services, and for other 
purposes. 
IN THE HOUSE OF REPRESENTATIVES 
AUGUST 10, 2021 
Mr. DEFAZIO (for himself, Mr. DOGGETT, Ms. KAPTUR, Mr. COHEN, Ms. 
SCHAKOWSKY, Mr. POCAN, Mr. KHANNA, and Mr. GRIJALVA) introduced 
the following bill; which was referred to the Committee on Energy and 
Commerce 
A BILL 
To require persons who undertake federally funded research 
and development of a biomedical product or service to 
enter into reasonable pricing agreements with the Sec-
retary of Health and Human Services, 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 ‘‘Affordable Pricing for 
Taxpayer-Funded Prescription Drugs Act of 2021’’. 
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SEC. 2. REASONABLE PRICE AGREEMENT. 
(a) IN GENERAL.—All Federal agencies providing or 
receiving research funding, through a grant, contract, co-
operative agreement, or other agreement, shall require in 
such agreement, and in any license of the rights to a pat-
ent or regulatory test data for a biomedical product or 
service, that the price of any biomedical product or service 
developed with the benefit of such research be reasonable 
(as determined by the Secretary) unless the Secretary 
waives such reasonable price obligation under subsection 
(d). 
(b) PROHIBITION AGAINST CHARGING PRICES HIGH-
ER THAN IN OTHER LARGE ECONOMIES WITH HIGH IN-
COMES.— 
(1) IN GENERAL.—For purposes of subsection 
(a), any reasonable pricing formula shall ensure, 
without prejudice to any other standards or nego-
tiated provisions for reasonable pricing, that resi-
dents of the United States are not charged more for 
the biomedical product or service involved than the 
reference price for countries with large economies 
and high incomes. 
(2) REFERENCE PRICE.—For purposes of para-
graph (1), the phrase ‘‘reference price for countries 
with large economies and high incomes’’ means— 
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(A) the median price charged for the bio-
medical product or service involved in Canada 
and the additional six reference countries; or 
(B) a modification to such price that is 
adopted by regulation after providing notice 
and the opportunity for the public to comment, 
if the Secretary determines such modification to 
be an appropriate and reasonable measure to 
protect United States residents from paying 
prices that are higher than prices in other coun-
tries with large economies and high incomes. 
(c) ADDITIONAL REQUIREMENTS.— 
(1) IN GENERAL.—In carrying out subsection 
(a), the Secretary may promulgate by regulation ad-
ditional requirements to ensure that the price for the 
biomedical product or service described in subsection 
(a) be reasonable. 
(2) REQUIREMENTS.—The additional require-
ments under paragraph (1) shall— 
(A) address the public interest in ensuring 
that publicly supported innovations for bio-
medical products and services have reasonable 
prices; and 
(B) take into account— 
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(i) the importance of providing robust 
incentives to invest in biomedical research 
and development; and 
(ii) the challenges of administering 
agreements described in subsection (a), in-
cluding in cases where third parties control 
relevant intellectual property, know-how, or 
other assets. 
(3) POSSIBLE
MECHANISMS.—The additional 
requirements for reasonable pricing authorized by 
paragraph (1) may include— 
(A) mechanisms to— 
(i) lower prices or shorten exclusivity 
periods when revenues exceed targets; 
(ii) lower prices that exceed a stand-
ard of cost per health benefit achieved; or 
(iii) lower prices that constitute sig-
nificant barriers to access or fiscal burdens 
on patients; or 
(B) a combination of mechanisms listed in 
subparagraph (A) or other mechanisms. 
(d) WAIVER.— 
(1) IN
GENERAL.—The Secretary may waive 
part or all of a reasonable pricing obligation under 
this section upon a demonstration that such a waiver 
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