Ensuring Timely Access to Generics Act of 2019
Summary
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.
- 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).
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