US FDA to crackdown on citizen petition ‘loophole’ hindering generic entry

By Ben Hargreaves

- Last updated on GMT

(Image: Getty/Grafner)
(Image: Getty/Grafner)

Related tags Fda Generics

The FDA has issued draft guidance designed to prevent branded firms from ‘gaming’ the generic drug approval system.

Citizen petitions are designed to allow the public to have a say on any regulatory or scientific issues, such as generics approvals; however, researchers found that the process had “primarily been used by for-profit industries, often to deter competition. Historically one fifth of these petitions have been successful”​, in a published paper​.

According to​ Scott Gottlieb, US Food and Drug Administration (FDA) commissioner, the guidance will see any citizen petition reviewed within the same approval timeframe as a generic drug’s assessment to prevent branded firms delaying generic drug approvals.

The draft guidance could also see the agency respond, in a public document, by denying a citizen petition request if it determines that the primary purpose is to create a delay.

Gottlieb played down the overall impact these petitions had made on generic drug approvals, stating: “Many have argued that these petitions block generic entry. 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.”

The revised draft guidance will also allow the agency to divert more resources to addressing scientific reviews. Though this may seem counterproductive, it will allow the FDA to determine the purpose of citizen petition, potentially denying or even referring it to the Federal Trade Commission on the grounds of anticompetitve business practices.

The public nature of such FDA action, Gottlieb considers will “provide an additional deterrent to pursuing these tactics.”

The FDA’s revised draft guidance will be finalised once there has been an opportunity for public comment.

This latest announcement from the FDA marks a concerted effort to reduce the prices of drugs by increasing generic competition​, such as the creation of the competitive generic therapy designation​.

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