Ensuring Timely Access to Generics Act of 2019

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.