One tool drugmakers have used to delay generic versions of their blockbuster drugs is a seemingly humble, yet often effective one: the FDA citizen petition. But thanks to new agency guidance, that tool may not be so effective anymore.
FDA Commissioner Scott Gottlieb said Tuesday that the agency would be taking a harder look at each citizen petition to determine whether it was filed primarily to delay a generic. If so? The agency would simply reject it.
That approach might have stopped some high-profile citizen petitions in their tracks—and, in some cases, thwart some last-minute legal drama. And though the FDA has already raised the bar for citizen petitions once, the new guidance, now open for public comment, could raise it higher.
Under draft guidance proposed this week, if the FDA finds a petition was filed “with the primary purpose of delaying the approval of a generic drug application," the agency can forego investigating the petition's claims, which in some cases are complicated and technical. Those rejections would be publicized in an annual report to Congress and the agency would refer the cases to the Federal Trade Commission, which enforces antitrust law.
The move is the latest in a series of FDA changes designed to step up generics competition and speed copycat drugs to market. “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 a statement announcing the guidance.
Market watchers might remember, for instance, AstraZeneca's attempt to delay Crestor generics with an FDA petition; that review then triggered a last-ditch lawsuit that, in the end, delayed all but one authorized generic by several months. Mylan tried to hold off Teva's EpiPen generic with a petition claiming the copycat wasn’t equivalent because its cap was different. Novo Nordisk has asked the agency to force companies seeking to market Victoza copies to conduct their own clinical trials. Takeda cited multiple reasons in asking the agency to hold off on approving Velcade generics.
Such attempts to block copycat launches rarely work, Gottlieb said, but the petitions add another hurdle for generics companies seeking to reach the market with cheap copies.
PhRMA, the branded drug industry's trade group, said it's reviewing the draft guidance. Petitions "provide an important avenue for raising critical scientific, policy and legal issues to the U.S Food and Drug Administration," a spokesman told FiercePharma in a statement.
"These petitions promote the transparent exchange of information and ideas about scientific, legal and regulatory matters, which is critical to achieving the FDA’s public health mission," he added. "Through petitions, the FDA receives valuable input reflecting various perspectives, and, through comments on pending petitions, the public may engage in the agency’s deliberative process." PhRMA is reviewing the draft guidance and looks "forward to engaging in the public comment process as appropriate," he added.
Aside from the agency's efforts with citizen petitions, the FDA has started to highlight cases where generics companies are claiming that branded drugmakers are thwarting their attempts to obtain samples for bioequivalence testing. The agency has also put out a "hit list" of drugs with little competition and put new versions of generics now available from single sources on a faster track to approval.
The changes at the FDA come as the Trump administration works to get a handle on drug prices, notably in May with the release of its pricing blueprint. The administration aims to bring more negotiation and transparency to the industry, plus create incentives to lower list prices and lower out-of-pocket costs for patients. In addition, the administration has been reviewing potential changes to drug rebates that could bring widespread changes to drug pricing.
Despite the efforts, a recent Associated Press investigation concluded that drug prices have climbed during the Trump presidency.