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.