Tuesday, September 24, 2013

Gilead's (Sofosbuvir) FDA review could be delayed because of government shutdown?

Adam Feuerstein writes the FDA's October 25th meeting to review Gilead's (GILD) Sofosbuvir may be in jeopardy because of a government shutdown.

U.S. Government Shutdown Could Postpone FDA Advisory Panels

BY Adam Feuerstein | 09/24/13 - 08:04 AM EDT
WASHINGTON D.C. (TheStreet) -- Advisory committee meetings scheduled for October by the U.S. Food and Drug Administration to review drugs from Amarin (AMRN), Johnson & Johnson (JNJ) and Gilead Sciences (GILD) might be postponed or cancelled if the political stalemate over the U.S. budget and debt-ceiling limit leads to a government shutdown. 

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Government shutdown would likely roil FDA's drug-approval process
September 24, 2013 | By
 @ FierceBiotech

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.

Continue reading @ FierceBiotech


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