With US legislators in the midst of terse and ongoing negotiations over funding for the next fiscal year, regulatory professionals are facing the prospect of something that hasn't happened since the last time a government shutdown occurred in 1995: a respite from new regulations or guidance documents from the US Food and Drug Administration (FDA).
Background and Effect on FDA
The current budget authority for the US government-including FDA-ends at midnight on 30 September 2013. Should legislators fail to either authorize a new budget or pass a continuing resolution (CR), all government personnel deemed to be "non-essential" would be furloughed. Some employees would be asked to stay at their posts, but would not be paid until a new budget is passed.
According to a statement posted on 27 September 2013 by the US Department of Health and Human Services (DHHS), FDA "would continue limited activities related to its user fee funded programs including the activities in the Center for Tobacco Products."
DHHS said out of a total of 14,779 FDA employees, 6,620 would be furloughed, leaving 8,180 (55%) retained.
FDA would have the staff in place to "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," DHHS wrote. "Carryover funding from user fees paid by industry" might also support FDA in a shutdown, DHHS explained.
However, DHHS said "routine establishment inspections," some "compliance and enforcement activities," the "majority" of its laboratory research testing, and the "majority" of its food safety and nutrition testing would not be carried out.
In addition, it remains to be seen if FDA's advisory committees-essential for the review of new molecular entities and high-risk medical devices-would be convened according to schedule, or if they would be postponed. Advisory committee members are technically "special government employees," and might not be seen as "essential" under the law.
What about Regulations and Guidance?
But the DHHS document doesn't address one question of particular relevance for regulatory affairs professionals: What happens to regulations and guidance documents ordinarily released by FDA on a regular basis?
That question is answered in an advanced Federal Register notice due to be published on 30 September 2013 by the Federal Register Office (FRO).
In the notice, FRO explains that in the event of a government shutdown, it would only publish "documents directly related to the performance of governmental functions necessary to address imminent threats to the safety of human life or protection of property." FDA would be charged with making this determination for its own documents.
However, with most of its non-essential staff out of the office, it seems unlikely that FDA would be publishing many-if any-regulations of guidance documents, particularly since it would lack many of the staff who ordinarily support the release of those document (i.e. press officers).
OFR also wrote that documents set to be published on shutdown days could be postponed "to permit a limited number of exempt [OFR] personnel to process emergency documents."