Medication Competition Act
- Bill Number
- S. 4332
- Origin Chamber
- Senate
- Congress
- 119th Congress, Session 2
- Policy Area
- Health
- Status
- Introduced
- Latest Action
- 2026-04-16: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- Last Updated
- 2026-05-12T21:15:08Z
AI-Generated Summary
Purpose
The Medication Competition Act (S. 4332) aims to promote competition in the biologics market—medicines derived from living cells, such as vaccines or antibodies—by requiring the Secretary of Health and Human Services (HHS), through the Food and Drug Administration (FDA), to determine and publicly list exclusivity periods. These periods protect original biologics or first copycat versions (biosimilars) from competition for a set time, after which cheaper alternatives can enter the market.
Key Provisions
- Amends Section 351(k)(9)(A)(iv) of the Public Health Service Act, which governs FDA's list (known as the Purple Book) of licensed biological products.
- Requires FDA to list exclusivity for first interchangeable biosimilars (under paragraph (6), typically 180 days from first commercial marketing):
- For products licensed on or after enactment: Within 30 days of when the expiration date is known.
- For products licensed before enactment: Within 30 days of enactment or when the expiration date is known, whichever is later.
- Requires FDA to list exclusivity for reference products (original biologics under paragraph (7), typically 12 years from licensure):
- For products licensed on or after enactment: Expiration date within 30 days of licensure.
- For products licensed before enactment: Expiration date within 2 years of enactment.
Significant Changes to Existing Law
- Previously, FDA published lists of licensed biologics but was not explicitly required to determine or include specific exclusivity expiration dates and timelines.
- Adds mandatory deadlines (30 days or 2 years) for listing these periods, split by products licensed before vs. after enactment, ensuring timely transparency.
Potential Impacts
- Government agencies: Increases FDA workload to review and update the Purple Book promptly, potentially streamlining approvals for biosimilars.
- Citizens: Could lower drug costs faster by clarifying when biosimilars (cheaper alternatives) can launch, improving access to affordable biologics.
- International relations: Minimal direct impact, though it may influence global biotech firms competing in the U.S. market.
Main Stakeholders Affected
- Biotech and pharmaceutical companies: Original makers gain clearer protection timelines; biosimilar developers benefit from faster market entry clarity.
- FDA/HHS: Must comply with new listing requirements.
- Healthcare providers and patients: Indirectly benefit from potential price competition.
- Insurers and payers: Could see reduced biologic costs.
Notable Legal, Constitutional, or Political Implications
- Legal: Strengthens implementation of the 2010 Biologics Price Competition and Innovation Act (BPCIA) by mandating FDA action, reducing litigation over exclusivity disputes.
- Constitutional: No apparent issues; falls under Congress's commerce clause authority over interstate drug markets.
- Political: Bipartisan (introduced by Sens. Hassan (D) and Budd (R)); promotes competition without altering exclusivity lengths, balancing innovation incentives with affordability goals. Referred to Senate HELP Committee for further review.
This summary was generated by AI and may contain inaccuracies. Refer to the official source document for the authoritative text.
Sponsor
Sen. Hassan, Margaret Wood [D-NH]
Cosponsors (1)
Recent Actions
- 2026-04-16: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
- 2026-04-16: Introduced in Senate
Bill Versions
- Medication Competition Act — issued 2026-04-16 — PDF (4 pages)