Federal shutdown would mean FDA delays

Federal shutdown would mean FDA delays

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A federal shutdown could push back FDA reviews and facility inspections amid a furlough of nearly half of the agency’s employees.

MASSDEVICE ON CALL — A federal government shutdown could mean some serous setbacks for the FDA, which would have to resort to furloughs that could mean delays in reviews and inspections.

Without a continuing resolution to keep the government funded, all “non-essential” FDA personnel would face near immediate furlough. That could spell trouble for companies awaiting review for new devices and drugs, such as CardioMEMs, which was slated to get its 2nd shot at FDA approval at an advisory panel meeting this month.

A furlough would affect some 40,500 Health & Human Services workers, more than half its total workforce, according to an HHS memo.

“FDA would continue limited activities related to its user fee funded programs including the activities in the Center for Tobacco Products,” according to the notice. “FDA would also continue select vital activities including maintaining critical consumer protection to handle emergencies, high-risk recalls, civil and criminal investigations, import entry review, and other critical public health issues.”

Activities on the chopping block could include “routine establishment inspections, some compliance and enforcement activities, monitoring of imports, notification programs (e.g., food contact substances, infant formula), and the majority of the laboratory research necessary to inform public health decision-making.”

The agency has some funds that it can carry over from user fees, and much of its staff would be excepted from furloughs in order to “protect human life.” The agency will get to keep about 55% of its total workforce, which numbers about 14,800, according to the HHS report.

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