Ensuring Timely Access to Generics Act of 2019
- Last Action
- 4/11/2019
CRS Summary
As of 2019-04-11 (00)
Ensuring Timely Access to Generics Act of 2019
This bill requires the Food and Drug Administration (FDA) to consider certain factors in determining whether a petition is submitted for the primary purpose of delaying the approval of a drug application.
The FDA must (1) publish a list of petitions that were submitted with an intent to delay, and (2) establish procedures to refer such petitions to the Federal Trade Commission.
The FDA may establish a timeline for submitting petitions.
Cosponsors (4)
- Jeanne Shaheen (D-NH)
- Bill Cassidy (R-LA)
- Michael Bennet (D-CO)
- Kevin Cramer (R-ND)
Subjects
- Administrative remedies
- Department of Health and Human Services
- Drug safety, medical device, and laboratory regulation
- Food and Drug Administration (FDA)
- Government information and archives
- Prescription drugs
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.