FDA issues latest guidance to stop ‘gaming’ of system
Scott Gottlieb, commissioner of the Food and Drug Administration (FDA), yesterday announced another set of guidelines aimed at facilitating the entry of generic drugs to the market and preventing “gaming” of the approval system.
In a bid to tackle the potential anti-competitive use of citizen petitions, the FDA has issued revised draft guidance designed to allow for a more efficient approach to petitions based on section 505(q) of the Federal Food, Drug, and Cosmetic Act.
Section 505(q) governs the manner in which the FDA handles certain citizen petitions. The agency is required to take a final action within 150 days on a petition that requests any form of action that may delay the approval of a currently pending Abbreviated New Drug Application.
“While the record shows that citizen petitions have rarely delayed specific generic drug approvals, 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,” said Gottlieb.
The revised guidance describes some of the factors the FDA will consider when determining whether a petition has been submitted with the primary purpose of delaying the approval of a generic drug application.
If the agency finds this to be the case, the FDA will consider whether the petition can be denied on this basis, and the determination will be part of the petition response. Gottlieb believes this will act as a deterrent to pursuing these tactics.
The FDA will also highlight its determinations of these petitions in its annual report to Congress.
Gottlieb explained that the new approach will help to focus the FDA’s resources on addressing petitions that are most likely to present an obstacle to the availability of generic drugs.
He added: “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.”
The FDA has focused on shutting down practices used by branded firms to “game” the system and delay generic approval—in May, the FDA made public a list of companies that have potentially been blocking access to the samples of their branded products.
And in June last year, the FDA announced its plan to target the barriers to generic drug competition.
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