Stop Stalling Access to Affordable Medications
USA117th CongressHR-2883| House
| Updated: 9/29/2021
Hakeem S. Jeffries
Democratic Representative
New York
Cosponsors (8)
Judiciary Committee
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
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.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
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.
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
Stop Stalling Access to Affordable Medications
USA117th CongressHR-2883| House
| Updated: 9/29/2021
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.
View Full TextSuggested Questions
Get AI-generated questions to help you understand this bill better
Timeline
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.
Hakeem S. Jeffries
Democratic Representative
New York
Cosponsors (8)
Judiciary Committee
Health
Related Bills
- Introduced
- In Committee
- On Floor
- Passed Chamber
- Enacted
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