I 
115TH CONGRESS 
1ST SESSION H. R. 3536 
To require persons who undertake Federally funded research and development 
of drugs to enter into reasonable pricing agreements with the Secretary 
of Health and Human Services. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 28, 2017 
Mr. DEFAZIO 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 drugs to enter into reasonable pric-
ing agreements with the Secretary of Health and Human 
Services. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. REASONABLE PRICE AGREEMENT. 
(a) IN GENERAL.—If any Federal agency or any non-
profit entity undertakes Federally funded health care re-
search and development and is to convey or provide a pat-
ent for a drug, biologic, or other health care technology 
developed through such research, such agency or entity 
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shall not make such conveyance or provide such patent 
until the entity (including a nonprofit entity) that will re-
ceive such patent first agrees to a reasonable pricing 
agreement with the Secretary of Health and Human Serv-
ices (referred to in this section as the ‘‘Secretary’’) or the 
Secretary makes a determination that the public interest 
is served by a waiver of the reasonable pricing agreement 
provided in accordance with subsection (c). 
(b) PROHIBITION OF DISCRIMINATION.— 
(1) IN GENERAL.—For purposes of subsection 
(a), any reasonable pricing formula that is utilized 
shall not result in discriminatory pricing for the 
drug, biologic, or other health care technology in-
volved regardless of the number of bidders involved. 
In carrying out this subparagraph, the Secretary 
shall ensure that the Federal Government, with re-
spect to the drug, biologic, or other health care tech-
nology involved, is charged an amount that is not 
more than the lowest amount charged to countries in 
the Organization for Economic Co-Operation and 
Development for the same drug, biologic, or tech-
nology, that have the largest gross domestic product 
with a per capita income that is not less than half 
the per capita income of the United States. 
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(2) DISCRIMINATORY PRICING.—For the pur-
poses of paragraph (1), a cost based reasonable pric-
ing formula that is utilized shall be considered to re-
sult in discriminatory pricing if the contract for sale 
of the drug, biologic, or other health care technology 
places a limit on supply, or employs any other meas-
ure, that has the effect of— 
(A) providing access to such drug, biologic, 
or technology on terms or conditions that are 
less favorable than the terms or conditions pro-
vided to a foreign purchaser (other than a char-
itable or humanitarian organization) of the 
drug, biologic, or technology; or 
(B) restricting access to the drug, biologic, 
or technology under this section. 
(c) WAIVER.—No waiver shall take effect under sub-
section (a) before the public is given notice of the proposed 
waiver and provided a reasonable opportunity to comment 
on the proposed waiver. A decision to grant a waiver shall 
set out the Secretary’s finding that such a waiver is in 
the public interest. 
Æ 
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