FDA takes action to further deter 'gaming' of the generic drug approval process via citizen petitions

FDA released on Tuesday a revised draft guidance intended to allow for a more efficient approach to 505(q) petitions, or citizen petitions, of the Federal Food, Drug, and Cosmetic Act. According to FDA Commissioner Scott Gottlieb, MD, "This revised draft guidance ...

FDA released on Tuesday a revised draft guidance intended to allow for a more efficient approach to 505(q) petitions, or citizen petitions, of the Federal Food, Drug, and Cosmetic Act. According to FDA Commissioner Scott Gottlieb, MD, "This revised draft guidance ... describes some of the factors the FDA will consider in determining whether a petition is submitted with the primary purpose of delaying the approval of a generic drug application." He explained that if the agency determines that a delay was the objective, it will review whether the petition can be denied for that reason and may also note this finding in the response to the petition. The petition response will be a public document. FDA will also note in its annual report to Congress its determinations of petitions that were found to have been submitted with the primary objective of delaying an approval. Gottlieb adds, "The guidance also outlines our intention to refer these matters to the Federal Trade Commission. ... 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." He said the revised draft guidance aims to reduce the effects that the agency's review of petitions could have on any pending approval actions. Gottlieb noted that while some citizen petitions may have valid concerns, the "new approach will help reduce approval decision delays in certain scenarios simply because a citizen petition has been submitted." Furthermore, he said, "by addressing challenges associated with the 505(q) citizen petition process we aim to provide greater regulatory certainty, improve the efficiency and predictability of the generic drug review process, and help to drive down costs of generic drug development and create incentives for new market entrants."