S 1169
116th Congress
Senate
Health
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
Ensuring Timely Access to Generics Act of 2019
Introduced: April 11, 2019
See on congress.gov
Everywhere this bill has been
2 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Apr 11, 2019
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Apr 11, 2019
Introduced in Senate
Plain-English 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.
What's happening now
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committees of jurisdiction
1