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FDA commissioner addresses actions to deter ‘gaming’ of generic drug approval process

Noting that citizen petitions that are subject to section 505(q) of the Federal Food, Drug, and Cosmetic Act have rarely delayed specific generic drug approvals, FDA commissioner Scott Gottlieb issued a statement today saying, “There’s no doubt that the process requirements associated with 505(q) petitions can add to resource burdens on the generic drug review process and the FDA’s regulatory decision making. This increased burden on the FDA can take resources away from the daily work of application review. A key to improving the speed and predictability of the generic drug review process — and reducing the multiple cycles of review many applications undergo — is to improve our own review process efficiency.”

Gottlieb said, “This revised draft guidance, which will be finalized after an opportunity for public comment, describes some of the factors the FDA will consider in determining whether a petition is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. If the agency determines that this is the case, the FDA will consider whether the petition can be denied on that basis and may in any case note this determination in the petition response. The agency’s determination will be part of the petition response, a public document available through the citizen petition docket. We believe this will provide an additional deterrent to pursuing these tactics.”

“To further dissuade companies from improperly using these petitions, the FDA also intends to highlight in our annual report to Congress our determinations of petitions that are judged by the agency to have been submitted with the primary purpose of delaying an approval. Importantly, the guidance also outlines our intention to refer these matters to the Federal Trade Commission. This is the agency that oversees anticompetitive business practices. 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. 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,” Gottlieb said.

Gottlieb continued, "The revised draft guidance also seeks to lessen the impact that our review of petitions may have on any pending approval actions. Our new approach would help the FDA focus our resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs. Once an application is submitted, the FDA has a goal date of making an approval decision on that application within 10 months, or, for some priority applications, within eight months. If a citizen petition is received while a product application is already under review, and if the goal date for that review falls within the next 150 days, the draft guidance states that the FDA would expect to respond to that petition within 150 days.

This policy aligns the FDA’s 150-day timeline to review and respond to these petitions described in federal law with the timeline for review of the applications themselves. We will continue to ensure that any scientific and regulatory issues raised in a petition are considered prior to the product approval. Sometimes citizens' petitions can raise relevant concerns. This new approach will help reduce approval decision delays in certain scenarios simply because a citizen petition has been submitted."

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, Gottlieb said.
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