I 
119TH CONGRESS 
1ST SESSION H. R. 3546 
To significantly lower prescription drug prices for patients in the United 
States by ending government-granted monopolies for manufacturers who 
charge drug prices that are higher than the median prices at which 
the drugs are available in other countries. 
IN THE HOUSE OF REPRESENTATIVES 
MAY 21, 2025 
Mr. KHANNA (for himself and Ms. SCHAKOWSKY) introduced the following bill; 
which was referred to the Committee on Energy and Commerce, and in 
addition to the Committee on the Judiciary, for a period to be subse-
quently determined by the Speaker, in each case for consideration of such 
provisions as fall within the jurisdiction of the committee concerned 
A BILL 
To significantly lower prescription drug prices for patients 
in the United States by ending government-granted mo-
nopolies for manufacturers who charge drug prices that 
are higher than the median prices at which the drugs 
are available in other countries. 
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 ‘‘Prescription Drug 
Price Relief Act of 2025’’. 
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SEC. 2. IDENTIFICATION OF EXCESSIVELY PRICED DRUGS. 
(a) IN GENERAL.—Not later than 30 days after the 
date of enactment of this Act, the Secretary shall establish 
a process to conduct a review of all brand name drugs, 
not less frequently than once per calendar year, under 
which the Secretary determines under subsection (b) 
whether the price of each such drug is excessive. 
(b) EXCESSIVE PRICE DETERMINATIONS.— 
(1) INTERNATIONAL REFERENCE PRICE.— 
(A) IN GENERAL.—The Secretary shall de-
termine that any brand name drug for which 
the domestic average manufacturing price ex-
ceeds the median price charged for such drug in 
the 5 reference countries to have an excessive 
price. In assessing the extent to which the price 
is excessive, the Secretary shall consider the 
factors described in paragraph (2). 
(B) REFERENCE COUNTRIES.—In this Act, 
the term ‘‘reference countries’’ means Canada, 
the United Kingdom, Germany, France, and 
Japan. 
(C) REQUIREMENT
WITH
RESPECT
TO 
DRUGS FOR WHICH CERTAIN REFERENCE COUN-
TRY
INFORMATION
IS
NOT
AVAILABLE.—The 
Secretary shall make a determination under 
paragraph (1) for every brand name drug for 
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which pricing information is available for at 
least 3 of the 5 reference countries. 
(2) DETERMINATIONS BASED ON OTHER FAC-
TORS.—With respect to any brand name drug that 
is not determined to have an excessive price by oper-
ation of paragraph (1) (including any drug for which 
there is insufficient data to make such a determina-
tion under such paragraph), the Secretary shall de-
termine that such drug has an excessive price if the 
price of the drug is higher than reasonable taking 
into account the following factors: 
(A) The size of the affected patient popu-
lation. 
(B) The value of the drug to patients, in-
cluding the impact of the price on access to the 
drug and the relationship of the price of the 
drug to its therapeutic health benefits. 
(C) The risk adjusted value of Federal 
Government subsidies and investments related 
to the drug. 
(D) The costs associated with development 
of the drug. 
(E) Whether the drug provided a signifi-
cant improvement in health outcomes, com-
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pared to other therapies available at the time of 
its approval. 
(F) The cumulative global revenues gen-
erated by the drug. 
(G) Whether the domestic average manu-
facturer price of the drug increased during any 
annual quarter by a percentage that is more 
than the percentage increase in the consumer 
price index for all urban consumers for the re-
spective annual quarter. 
(H) Other factors the Secretary determines 
appropriate. 
(c) PETITION FOR DETERMINATION.— 
(1) IN GENERAL.—Any person may petition the 
Secretary, in accordance with section 553(e) of title 
5, United States Code, to make an excessive drug 
price determination for an applicable drug under 
subsection (b)(2). Not later than 90 days after the 
date of receipt of such a petition, subject to para-
graph (2), the Secretary shall— 
(A) make a determination under subsection 
(b)(2) regarding such drug; or 
(B)(i) decline to make such a determina-
tion; and 
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