S. 1425

Introduced

Stop STALLING Act

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

Latest Action

Placed on Senate Legislative Calendar under General Orders. Calendar No. 179.

12/8/2021 • Senate

Summary

Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act or the Stop STALLING Act

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.

Reported to Senate • 12/8/2021

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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

CBO Cost Estimates (1)

Estimated Budgetary Effects of S. 1425, the Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics (Stop STALLING) Act

As reported by the Senate Committee on the Judiciary on December 8, 2021

Published: June 6, 2022