As Border Fight Looms, is an FDA Shutdown Coming?

Regulatory NewsRegulatory News | 17 December 2018 |  By 

Friday is the deadline by which the US House and Senate must come to an agreement on funding the parts of the government that have yet to see their spending bills pass, which includes the US Food and Drug Administration (FDA).

But with the House coming back on Wednesday and the fight over border funding continuing, the House and Senate may find difficulties in averting this partial government shutdown.

So what happens if the funding does not get figured out by Friday at midnight? According to the Department of Health and Human Services’ contingency plans, FDA would continue specific activities within its user fee programs, including work on prescription drugs, generic drugs, biosimilars, medical devices, animal drugs and tobacco products.

More specifically, the nonprofit StrengthenFDA explained that user fee exemptions from the shutdown are task driven not individual driven, meaning that an FDA employee working on user fee tasks cannot work on other tasks just because they are in the office.

“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,” StrengethenFDA said.

FDA is also expected to continue its work on other activities deemed vital by HHS, including responding to emergencies, managing high-risk recalls, and pursuing criminal enforcement work and civil investigations related to imminent threats to human health or life.

StrengthenFDA added: “Based on past shutdown planning, products on which user fees have already been paid (e.g. NDAs) are more likely to be staffed than earlier stage activities. However, we do not know where the precise lines are being drawn and cannot provide assurance than any given activity will be fully continued (or partly continued or not continued) during a shutdown.”


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