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Regulatory Focus™ > News Articles > 12 > FDA Shutdown Likely as Trump Refuses to Sign Senate CR

FDA Shutdown Likely as Trump Refuses to Sign Senate CR

Posted 20 December 2018 | By Zachary Brennan 

FDA Shutdown Likely as Trump Refuses to Sign Senate CR

The US Food and Drug Administration (FDA) and other parts of the federal government may be headed for a shutdown after President Donald Trump said Thursday he would not sign a Senate-passed continuing resolution (CR) to keep the government open through 8 February.

The news from the White House comes as both the Senate and the House had hoped to kick the government funding can down the road to allow for more debate on border security and the president’s wall.

But now a shutdown seems likely, particularly as as Democrats have said they will not vote for additional border funding, according to press reports from Capitol Hill.

FDA Specifics

If a shutdown takes place, FDA would, in addition to keeping essential public health-related employees working, continue specific activities within its user fee programs, including work on prescription drugs, generic drugs, biosimilars, medical devices, animal drugs and tobacco products, according to the Department of Health and Human Services’ contingency plans.

“Medical product companies with near-term expectations — review meetings, initiating clinical trials, etc. — are faced with the possibility of slippage in their development timelines but the impact will be subject to decisions that may be driven by individual situations as well as interpretation of whatever general directions are provided by HHS,” the nonprofit StrengethenFDA said.

Steven Grossman of StrengthenFDA told Focus: "Congress has until the wee hours of Wednesday morning to resolve the impasse with little consequence. Whether Congress would actually work Christmas weekend and other impediments can be overcome to strike a deal….is impossible to discern at the moment...Once the new Congress starts on January 3, all bills from the prior Congress are wiped out and procedurally will need to be reintroduced and acted upon."

About 7,000 FDA staff, or 41%, would be furloughed if the shutdown occurs, while the remaining 10,344 would be retained, according to the plans.

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