Government shutdown would likely roil FDA's drug-approval process

Provided by FierceBiotech

September 24, 2013 | By John Carroll

So what happens at the FDA in the event of a government shutdown next Tuesday? For now, the agency isn't saying, referring reporters to an OMB statement guiding government agencies to prepare to execute "an orderly shutdown."

But the FDA has been here before and agency watchers are referring to some of the old guidelines to prepare for what may--or may not--be about to happen. For drug developers in particular, it seems clear that a government shutdown would delay PDUFA dates for any companies looking to get a near-term approval. FDA panel reviews for drugs under regulatory review are also likely to get pushed back.

A short interruption in government services would not likely have a big impact on the regulatory timelines. But all bets are off if there's a lengthy interruption, which has the potential to roil the arrival of some closely watched therapies. Gilead ($GILD), for example, is looking for an approval by early December for sofosbuvir--with the chance of an early OK for a key breakthrough therapy.

Says the OMB: "Agencies are still in the process of reviewing relevant legal requirements and updating their plans.  Determinations about specific programs are being actively reviewed as agencies undertake this process."

- here's the OMB statement

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