- Food and Drug Administration Commissioner Scott Gottlieb spelled out steps the agency will take to crack down on companies that "game" the generic drug approval process to delay competition, the latest in a series of moves aimed at juicing up the market for cheaper drugs.
- In a revised draft guidance open for public comment, the FDA said it wants to effectively name and shame companies that inappropriately use citizens petitions and refer cases of potential uncompetitive behavior 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," Gottlieb said in announcing the moves.
Gottlieb has made speeding generics to market one feature of his tenure, with some harsh warnings to pharmas not playing by the rules.
One tactic used by drugmakers is using the FDA citizen petition process, created to allow individuals and community groups to make requests for changes to health policy. Pharma companies have been using this route to counter the impact of the Drug Price Competition and Patent Term Restoration Act, which aims to make generic drugs more widely available.
"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," Gottlieb said. "This increased burden on the FDA can take resources away from the daily work of application review."
The FDA will now publish the factors it will consider to determine whether to allow the petition through. If the agency determines a petition has been set up with the primary purpose of delaying the approval of a generic drug application, it will look to deny it and explicitly note the reason.
This would be a public document, effectively naming and shaming the company in question. The FDA will also consider referring the company to the Federal Trade Commission, which oversees anticompetitive business practices.
"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," said Gottlieb.
The review process will also be tailored to combat efforts to block generic entry. This includes focusing on those petitions that are most likely to present an obstacle, and aim to respond to them more quickly.
Another anticompetitive practice in FDA's crosshairs is when drugmakers limit access to the samples of branded drug that generic companies need to prove equivalence.
"Such practices upset the careful balance that Congress sought between product innovation and access. They can make the development and approval process unpredictable, and potentially more costly, for generic manufacturers," said Gottlieb in an FDA statement.