Stop Stalling Access to Affordable Medications
- Last Action
- 9/29/2021
Actions
- 2021-09-29Ordered to be Reported in the Nature of a Substitute by the Yeas and Nays: 31 - 9.
- 2021-09-29Committee Consideration and Mark-up Session Held.
- 2021-04-28Referred to the House Committee on the Judiciary.
- 2021-04-28Introduced in House
- 2021-04-28Introduced in House
CRS Summary
As of 2021-04-28 (00)
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.
Cosponsors (8)
- Ken Buck (R-CO)
- JERROLD NADLER (D-NY)
- David Cicilline (D-RI)
- CAROLYN MALONEY (D-NY)
- Burgess Owens (R-UT)
- SHEILA JACKSON LEE (D-TX)
- Val Demings (D-FL)
- Ted Budd (R-NC)
Subjects
- Administrative remedies
- Business ethics
- Civil actions and liability
- Competition and antitrust
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Licensing and registrations
- Prescription drugs
- Public participation and lobbying
Sourced from Congress.gov (public domain).
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.