Stop STALLING Act

To enable the Federal Trade Commission to deter filing of sham citizen petitions to cover an attempt to interfere with approval of a competing generic drug or biosimilar, to foster competition and facilitate the efficient review of petitions filed in good faith to raise legitimate public heath concerns, and for other purposes.

Subjects

Health

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.

Full Text

Related Legislation

S. 1224Stop STALLING Act
2019-06-28Placed on Senate Legislative Calendar under General Orders. Calendar No. 130.
Related
S. 3384Lowering Prescription Drug Prices for America’s Seniors and Families Act of 2020
2020-03-03Read twice and referred to the Committee on Finance.
Related

Legislative Actions

2019-04-29
Introduced in House
2019-04-29
Introduced in House
2019-04-29
Referred to the House Committee on the Judiciary.
2019-04-30
Committee Consideration and Mark-up Session Held.
2019-04-30
Ordered to be Reported by Voice Vote.
2020-12-24
Reported by the Committee on Judiciary. H. Rept. 116-694.
2020-12-24
Reported by the Committee on Judiciary. H. Rept. 116-694.
2020-12-24
Placed on the Union Calendar, Calendar No. 577.

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