S. 1169

Referred to Committee

Ensuring Timely Access to Generics Act of 2019

Introduced 4/11/2019•116th Congress•Senate

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Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

4/11/2019 • Senate

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.

Introduced in Senate • 4/11/2019

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Topics & Subjects

Policy Area: Health

Administrative remediesDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulationFood and Drug Administration (FDA)Government information and archivesPrescription drugs