Ensuring Timely Access to Generics Act of 2019
- Last Action
- 5/2/2019
Actions
- 2019-05-02Referred to the Subcommittee on Health.
- 2019-05-01Referred to the House Committee on Energy and Commerce.
- 2019-05-01Introduced in House
- 2019-05-01Introduced in House
CRS Summary
As of 2019-05-01 (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 (6)
- Anthony Brindisi (D-NY)
- Ron Wright (R-TX)
- Jason Crow (D-CO)
- Michael Waltz (R-FL)
- Brian Fitzpatrick (R-PA)
- Lloyd Smucker (R-PA)
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.