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.
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.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 179.
Introduced in House
Introduced in House
Referred to the House Committee on the Judiciary.
Committee Consideration and Mark-up Session Held.
Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 31 - 9.
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