After years of concern, the Food and Drug Administration issued draft guidelines that are designed to limit the use of citizen petitions to delay approval of generic drugs or biosimilars. The move comes after long-standing complaints by agency officials that many petitions generally do not raise valid scientific concerns and appear to have been filed solely to delay rival medicines.
The new guidance indicates that the agency would highlight any improper use of these petitions in its annual reports filed with to Congress and may refer purportedly inappropriate petitions to the Federal Trade Commission, which could then pursue violations of antitrust laws.
“We will not shy away from calling out instances where we believe brand firms may be leveraging tools intended to serve a useful purpose to instead thwart competition that can drive down prices for patients, FDA Commissioner Scott Gottlieb said in a statement. “We’re taking the abuse of this system seriously. And we hope that this increased transparency will reduce gratuitous hurdles to generic drug development and approval.”
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
About the Author Reprints
To submit a correction request, please visit our Contact Us page.
