What a government shutdown would mean for the FDA

About 41 percent of the FDA's employees will be furloughed if President Donald Trump and lawmakers cannot agree on a spending bill by Dec. 21 at midnight, reports Regulatory Focus.

President Trump on Dec. 20 said he would not sign a continuing resolution approved by the Senate to keep the government open through Feb. 8. The House presented its proposal the night of Dec. 20, which includes $5 billion in funding for a border wall. The Senate will take up this proposal Dec. 21.

If lawmakers cannot come to an agreement, 7,000 FDA employees will have to take leave without pay, which could result in pauses in inspections, research and labeling updates, according to STAT's Morning Rounds e-newsletter published Dec. 21. Drug and device companies with upcoming review meetings and clinical trial start dates, among other activities, may also face delays in their development timelines.

In the event of a government shutdown, the agency would still continue some regulatory activities within its user fee programs, such as work on prescription drugs, biosimilars and medical devices, according to a contingency plan from HHS. 

A government shutdown would not affect HHS, CDC and the National Institutes of Health, as these agencies were funded by a separate bill President Trump signed in September, according to STAT.

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