To amend the Federal Food, Drug, and Cosmetic Act with respect to citizen petitions.
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.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Read twice and referred to the Committee on Finance.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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