Medication Competition Act
Sponsored By: Senator Hassan, Margaret Wood [D-NH]
Introduced
Summary
Publishing exclusivity periods for certain biological drugs is the bill's main goal. It would require the Secretary of Health and Human Services to determine and post exclusivity expiration dates for first interchangeable products and reference biologics, and it sets specific deadlines for when those dates must appear on FDA lists.
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- Manufacturers: Developers of reference biologics and makers of first interchangeable products would get public expiration dates for exclusivity, helping them plan market entry and competition. Listings for new products must appear as soon as 30 days after the expiration date can be known.
- Regulators: HHS/FDA would have a new duty to identify and add these exclusivity periods to agency lists, with 30-day posting rules for many post-licensure cases and up to a 2-year deadline for some products licensed before the bill's enactment.
- Payers and health systems: More predictable, publicly posted exclusivity end-dates could improve timing for purchasing, budgeting, and introduction of lower-cost biosimilars.
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Bill Overview
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Publish biologic exclusivity expiration dates
This bill would require the Secretary of Health and Human Services to determine and publish exclusivity expiration dates for certain biological products on FDA's public list. For first interchangeable products licensed on or after the Act's enactment date, the Secretary would post any applicable exclusivity expiration within 30 days after the earliest date that expiration can be known. For first interchangeable products licensed before enactment, the Secretary would post the expiration within 30 days after the later of enactment or the earliest date the expiration can be known. For reference (original) products licensed on or after enactment, the Secretary would post the exclusivity expiration within 30 days after licensure. For reference products licensed before enactment, the Secretary would post the expiration no later than two years after enactment.
Sponsors & CoSponsors
Sponsor
Hassan, Margaret Wood [D-NH]
NH • D
Cosponsors
Sen. Budd, Ted [R-NC]
NC • R
Sponsored 4/16/2026
Roll Call Votes
No roll call votes available for this bill.
View on Congress.gov