Plain English
GovGreed Synthesis ·
Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 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 beginning in 2028.
Market Impact Map
Action Timeline
2025-03-04
Read twice and referred to the Committee on Finance.
2025-03-04
Introduced in Senate
Full Bill Text
119 S832 IS: Ensuring Pathways to Innovative Cures Act of 2025 U.S. Senate 2025-03-04 text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. II 119th CONGRESS 1st Session S. 832 IN THE SENATE OF THE UNITED STATES March 4, 2025 Mr. Tillis (for himself, Mr. Budd , Mrs. Blackburn , Mr. Daines , and Mr. Lankford ) introduced the following bill; which was read twice and referred to the Committee on Finance 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. 1. Short title This Act may be cited as the Ensuring Pathways to Innovative Cures Act of 2025 or the EPIC Act of 2025 . 2. Equalizing the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program Section 1192(e)(1)(A)(ii) of the Social Security Act ( 42 U.S.C. 1320f–1(e)(1)(A)(ii) ) is amended— (1) by striking year, at least 7 and inserting “year— (I) for initial price applicability years 2026 and 2027, at least 7 ; and (2) by adding at the end the following: (II) for initial price applicability year 2028 and each subsequent initial price applicability year, at least 11 years will have elapsed since the date of such approval; and .
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