A bill 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 health concerns, and for other purposes.
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.
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 31 - 9.
Introduced in Senate
Read twice and referred to the Committee on the Judiciary.
Committee on the Judiciary. Ordered to be reported without amendment favorably.
Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report.
Committee on the Judiciary. Reported by Senator Durbin without amendment. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 179.
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