Christmas might be quiet at the FDA

With the possibility of a government shutdown looming, the FDA is in tough spot: Congress never got around to passing the measure that would fund its operations.

As STAT’s Ike Swetlitz reports, a shutdown would mean automatic furloughs for about 40 percent of FDA staff if it were to take effect at the end of this week. That wouldn’t put a halt to ongoing reviews of new drugs, as that work is funded through fees paid by the industry. But it could spark a rush to get in under the wire with new applications.

“If I was about to file an [new drug application] or other paperwork requiring a product registration fee, I’d get the paperwork and fee to FDA this week in time for them to process it,” said Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, a nonpartisan advocacy group.

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