New Drug and Device Reviews Still on Hold at FDA

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Despite progress to resolve the current fiscal crisis, drug and medical device companies poised to seek regulatory approval from the FDA are still waiting for action as the agency puts new reviews on hold.

This article published with permission from The Burrill Report.

Despite progress on Capitol Hill to resolve the current fiscal crisis, drug and medical device companies poised to seek regulatory approval from the U.S. Food and Drug Administration are still waiting for action as the agency puts new reviews on hold until it can accept new user fees from industry.

A variety of possible plans to re-fund the government, at least for a few weeks, are under discussion in Washington. But, nearly two weeks into the shutdown, the FDA is still running at limited capacity. It is pushing ahead with “carryover user-fees” to fund reviews of product applications filed prior to fiscal 2013’s end, Oct. 1, but it is not accepting most new regulatory submissions or the fee payments that would come with them.

As of Oct. 11, the agency had about $119.7 million in user fees collected under the Prescription Drug User Fee Act, $152.5 million from generic user fees, and $18.4 million from medical device user fees, according to The Alliance for a Stronger FDA, a non-profit that advocates for the agency to receive sufficient resources to carry out its mission. However, it was unclear how long each of the pools of money would last.

“The best case for FDA is that the government shutdown ends as part of a deal on the debt ceiling,” wrote Steven Grossman, the alliance’s deputy executive director, in a recent analysis of the situation. “However, the lack of progress and the Republican offer covering only the debt ceiling is discouraging.”

About three-quarters of the FDA employees still working during the shutdown, or about 6,000, are supported by the availability of carryover user fees, according to the alliance.

While the FDA does not anticipate that the lapse in fiscal year 2014 appropriations will affect its routine review process for submissions with user fees paid prior to Oct. 1, in a detailed rundown of the shutdown’s impact on its work, it says that it cannot predict delays in the event of a protracted lapse in appropriations.

Companies developing biosimilars are out of luck too, for now. The agency has suspended review of all pending regulatory submissions and initial advisory meeting and biosimilar product development meeting requests, as it has no access to Biosimilar User Fee Act funding during the shutdown.

Medical devicemakers seeking premarket approvals, 510(k) clearances, and other regulatory go-aheads from the agency after Oct. 1 are on hold too, since the user fees that would support the work won’t be accepted until after the shutdown is resolved.

Scheduled advisory committee meetings regarding the approval of products, or postmarketing safety issues within the scope of user fee acts covering prescription drugs, generics, and medical devices may go forward, but are still subject to constraints on resources and travel, the agency says.

In the short-term, piecemeal funding for the FDA could appear, if House members were able to find support in the Senate and White House for the approach. So far, however, piecemeal funding seems unlikely to materialize, especially as hopes for a broader resolution to the crisis rise.

“The shutdown will end, we just don’t know when,” writes Grossman. “At that point, FDA will have a huge backlog of work to do, but everyone will sigh with relief.”