Nonpartisan civic infrastructure
AllCiv·Legis1
·

S. 1120

BillFederalSenateIn Committee
To improve the actions available to eligible product developers in the event of delays in receiving covered product for purposes of generic drug or biosimilar biological product development.
About This Bill
Committee
Latest Action · March 30, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Congress
118th (2023–2025)
Introduced
March 30, 2023
Cosponsors (1)
0D 1R
View PDF ↗

Summary

Highlight any text to annotate
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.

Take Action

Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.