US FDA Enters Shutdown Mode: Reviews Will Continue, But Will Morale?
Executive Summary
User fee funding will allow many functions to continue, but only 58% of staff will be retained until funding deal is reached.
The US FDA will continue some user fee-related activities for during the government shutdown, but will forgo many other routine activities and furlough thousands of workers.
After the Senate was unable to pass a continuing resolution to extend government funding beyond Jan. 19, FDA and other federal agencies were forced to shutter until an agreement is reached.
Operations within FDA will continue, including what contingency plans describe as "limited activities related to its user fee funded programs." The agency also will 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."
That likely means drug reviews, which are supported by user fee revenue already in hand, will not be entirely interrupted, at least for the time being. The agency has carry-over balances of user fee money that can be accessed in a shutdown situation. (Also see "FDA In Twilight: Gov’t Shutdown Has Not Slowed Rx Operations Too Visibly Yet" - Pink Sheet, 7 Oct, 2013.)
During the 2013 shutdown, the agency could not accept regulatory submissions or associated user fee payments. (Also see "FDA Will Not Review New Applications During Government Shutdown" - Pink Sheet, 1 Oct, 2013.)
But that money will not sustain the review function for an extended period. After several days of the 2013 government shutdown, the agency had to begin sending some employees home who had been supported with user fee dollars as funding grew scarce.
FDA also will not be able to "support the majority of its food safety, nutrition, and cosmetics activities" during the shutdown, according to the plan.
"FDA will also have to cease safety activities such as 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," HHS said in the contingency plan.
The Alliance for a Stronger FDA said in a Jan. 19 statement that it did not expect the shutdown to last more than a week, but the damage to the agency could take longer to repair.
"The degree of damage to FDA depends a lot on how long a shutdown lasts and how effective the agency is in allocating resources to urgent and emergency tasks, both during a shutdown and immediately after," the Alliance said. "If the government is shut for a week, it may take several weeks (in some cases, longer) for the backlog to be worked down."
While not an ideal situation, FDA appeared to handle the 2013 shutdown as well as could have been expected. (Also see "Shutdown Week Two: Could Sponsors Find A More Focused FDA?" - Pink Sheet, 14 Oct, 2013.)
42% Of Staff Furloughed
FDA will furlough 7,244 workers, which is about 42% of its staff. About 58%, 10,050 workers, will be retained, according to shutdown staffing plans.
Nearly 7,000 of the retained workers are staff paid from carryover funding, and another more than 1,100 are members of the US Public Health Service Commissioned Corps.
FDA also will retain nearly 1,000 others that will perform duties "related to the safety of human life," according to the plan. Those employees would inspect regulated products and manufacturers and analyze samples on products and review imports entering the US.
"This number includes active investigators who will be needed to perform inspections, recall operations, emergency response, review import entries and make admissibility decisions," HHS said in the contingency plan. "These FDA staff members would be conducting and overseeing adverse event reporting and lot release protocol reviews as well as providing support with surveillance, product incidents, compliance, recalls, and emergencies."
The latest shutdown plan retains a larger percentage of employees than prior plans. During the 2013 shutdown, the agency retained 55% of its workers, and in 2011, contingency plans would have retained only 14% of the staff (see chart).
CMS expects to retain at least 36% of its workforce, 2,280 people, but the shutdown plan said more could be funded depending on the availability of some Medicaid dollars.
Overall, HHS will lay off about half its workforce, 40,959 workers, and retain 40,956.
White House Says This Shutdown Will Be Different
The White House suggested Jan. 19 that the shutdown will appear differently than the 2013 "lapse period," as FDA termed it.
Office of Management and Budget Director Mick Mulvaney said during a Jan. 19 briefing that national parks will be open, , unlike during the last shutdown, although trash may not be collected. Those and employees at other agencies who will be working, such as military members and firefighters, will not be paid, however.
Despite the effort to keep operations as normal as possible, there still could be effects on FDA. Margaret Hamburg, who was commissioner during the 2013 shutdown, said her attempt to recruit a candidate for a high-level leadership position was hindered by the shutdown and budget sequester. Hamburg also said the shutdown hurt agency morale. (Also see "Sequester, Shutdown Hurt FDA Recruitment, Morale – Hamburg" - Pink Sheet, 21 Apr, 2014.)
With shutdowns now becoming almost as common as user fee renewals, the question for FDA employees (and potential employees) is whether the work is otherwise rewarding enough to stomach the annoyances of the occasional shutdown. If the answer is no, the talent pool and performance culture at the agency will begin to decline, and industry and FDA alike will both have lost more that a few furlough days.
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