Improved Access to Affordable Medications Act
This bill amends rules to improve access to generic drugs and biosimilars by requiring brand-name drug manufacturers (license holders) to provide samples for development. It establishes a "designated delivery service" standard for overnight/2-day shipping and sets strict timelines: the FDA must respond to sample requests within 60 days for non-clinical testing or 120 days for clinical trials. Manufacturers must publicly post clear policies within 45 days of product approval, including contact details, request procedures, and responsible officers. These changes directly affect generic drug developers seeking samples and brand companies managing product access. The bill focuses on streamlining the sample request process to accelerate generic drug development without altering drug safety requirements.
Bill status
in committee
1 of 4 stages cleared
Introduction
Mar 2023
Committee Review
Floor Vote
President
Introduced Mar 30, 2023
Last action Mar 30, 2023
Floor votes
How they voted
No floor votes recorded yet.
Full legislative history
Actions timeline
Total actions
2
Key actions
0
Committee
1
Mar 30, 2023
Senate · Referred to committee
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Mar 30, 2023
Senate · Introduced
Introduced in Senate
1 primary · 1 co-sponsor
Sponsors
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