S. 1120 · 118th Congress
Improved Access to Affordable Medications Act
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Never voted on. It didn't reach a floor vote before the 118th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
D
HassanSponsor1 cosponsor · 1 R
1 signed on when it was introduced; the rest joined later. Cosponsors who withdrew aren't shown.
This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development.
What it does: CRS summary · Introduced in Senate · Mar 30, 2023
Improved Access to Affordable Medications Act
This bill modifies provisions relating to the ability of generic drug manufacturers to obtain samples of brand-name drugs for purposes of generic drug development.
Under current law, brand-name drug manufacturers must provide sufficient quantities of their products on commercially reasonable, market-based terms to generic drug manufacturers upon request for purposes of generic drug development. Brand-name drug manufacturers are subject to civil actions if they fail to do so. The bill modifies provisions relating to this requirement and the criteria needed for related civil actions, such as specifying that generic drug manufacturers may use certain delivery services to make their requests.
Additionally, under current law, generic drug manufacturers must obtain authorization from the Food and Drug Administration (FDA) in order to request sufficient quantities of brand-name drugs that are subject to a Risk Evaluation and Mitigation Strategy (REMS) with elements to ensure safe use (ETASU). The bill requires the FDA to approve an authorization request within 60 days (rather than 120 days), if testing and development does not involve human clinical trials. (The FDA sometimes requires a REMS program for certain drugs with safety risks, which may include restrictions on a drug's distribution through ETASU, such as special requirements for pharmacies that dispense the drug.)
The bill also requires brand-name drug manufacturers to post their policies on evaluating and responding to requests from generic drug manufacturers for their products, including relevant contact information and procedures.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: Improved Access to Affordable Medications Act
Latest action (Mar 30, 2023): Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Policy area: Health · Origin: Senate · Introduced: Mar 30, 2023
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.