This bill lengthens the amount of time for which drug products must have market approval in order for the products to qualify for negotiation under the Medicare Drug Price Negotiation Program.
The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation.
The bill modifies these provisions so as to require drug products to also have had at least 11 years of market approval in order to qualify for negotiation.
The bill's changes apply retroactively.
[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1492 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 1492
To amend title XI of the Social Security Act to equalize the
negotiation period between small-molecule and biologic candidates under
the Drug Price Negotiation Program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
February 21, 2025
Mr. Murphy (for himself, Mr. Davis of North Carolina, and Mr. Hudson)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committee on Ways and
Means, for a period to be subsequently determined by the Speaker, in
each case for consideration of such provisions as fall within the
jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend title XI of the Social Security Act to equalize the
negotiation period between small-molecule and biologic candidates under
the Drug Price Negotiation Program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. EQUALIZING THE NEGOTIATION PERIOD BETWEEN SMALL-MOLECULE AND
BIOLOGIC CANDIDATES UNDER THE DRUG PRICE NEGOTIATION
PROGRAM.
(a) In General.--Section 1192(e)(1)(A)(ii) of the Social Security
Act (42 U.S.C. 1320f-1(e)(1)(A)(ii)) is amended by striking ``7 years''
and inserting ``11 years''.
(b) Effective Date.--The amendment made by subsection (a) shall
take effect as if included in the enactment of Public Law 117-169.
<all>
Introduced in House
Introduced in House
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
Referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned.
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