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Pharmaceuticals / Regulatory Affairs

FTC Supports Plan to Crack Down on Petitions to Delay Generics

Dec. 13, 2018

The Federal Trade Commission endorsed FDA draft guidance that aims to deter drugmakers from gaming the citizen petition process to delay generics.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

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