FDA Revises 505(q) Petition Guidance
FDA commissioner Scott Gottlieb says a new revised draft guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act, will allow for a more efficient approach to 505(q) petitions and allow the agency to focus more reviewer resources on scientific reviews. In a statement, Gottlieb says the revised guidance is part of the FDA effort to increase competition in the market for prescription drugs and help facilitate entry of lower-cost alternatives to improve patient access to affordable medicines.
The draft describes some of the factors the agency will consider in determining whether a petition is submitted with the primary purpose of delaying approval of a generic drug application, Gottlieb writes. “If the agency determines that this is the case,” he says, “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.”
As part of the effort, he says, FDA will highlight in its annual report to Congress its determinations of petitions that are judged to have been submitted with the primary purpose of delaying an approval. FDA also will refer such 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 the prices for patients,” Gottlieb says. “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.”
While many have argued that some petitions block generic entry, Gottlieb writes, the record shows that they have rarely delayed specific generic drug approvals, but 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 FDA’s regulatory decision making.
He says the revised draft seeks to lessen the impact that the review of petitions may have on pending approval actions by helping the agency to focus resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs.
“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 concludes.