Bill Details

HR.1492 - 119th Congress

Track 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.? Stop tracking 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.?

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This bill would change the timing rules for the federal drug price negotiation program so that small-molecule drugs and biologic drugs are treated the same. Right now, small-molecule drugs can enter the negotiation process sooner than biologic drugs. The bill would make small-molecule drugs wait longer by changing the rule from 7 years to 11 years, matching the timeline already used for biologic drugs. In simple terms, it would delay when certain prescription drugs can be picked for price negotiation by the government.

  • It amends the Social Security Act section that sets the timeline for drug price negotiations.
  • The waiting period for small-molecule drugs would be changed from 7 years to 11 years.
  • The goal is to make the negotiation timeline the same for small-molecule drugs and biologic drugs.
  • The change would take effect as if it had been included in the law that created the current negotiation program.

Official Summaries

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.

Current Full Text

[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.
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