H.R. 2883

Reported by Committee

Stop Stalling Access to Affordable Medications

Introduced 4/28/2021•117th Congress•House

Congress.gov

Latest Action

Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 31 - 9.

9/29/2021 • House

Summary

Stop Stalling Access to Affordable Medications

This bill makes it an unfair method of competition to submit an objectively baseless petition to the Food and Drug Administration (FDA) in an attempt to interfere with a competitor's application for market approval of a drug.

The bill authorizes the Federal Trade Commission to sue an individual or entity that submits such a petition to the FDA. A party found liable in such a lawsuit shall be subject to civil penalties, such as a fine of up to $50,000 for each day that the FDA spent reviewing the baseless petition.

Introduced in House • 4/28/2021

Enter your district to see how this bill affects your community

Topics & Subjects

Policy Area: Health

Administrative remediesBusiness ethicsCivil actions and liabilityCompetition and antitrustDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Licensing and registrationsPrescription drugsPublic participation and lobbying