FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FTC Supports Plan to Crack Down on Petitions to Delay Generics

Dec. 13, 2018
A A

The Federal Trade Commission endorsed FDA draft guidance that aims to deter drugmakers from gaming the citizen petition process to delay generics.

The FDA issued guidance in early October outlining a new process for assessing whether a branded drugmaker has submitted a petition specifically to delay generic competitors — and said it may deny petitions on that basis.

The FDA said it will consider several factors in assessing whether a petition was primarily designed as a delaying tactic, including: how long after the petitioner knew the relevant information they went on to submit it; the submission’s proximity to the expiration of a patent; and its similarity to any earlier petitions to which the agency already responded.

View today's stories