The partial government shutdown that started Saturday will affect quite a few activities of the Food and Drug Administration.
Although most of the agency’s employees weren’t working over the weekend and on Monday and Tuesday because of federal holidays, FDA will furlough some 40 percent of its staff starting Wednesday.
However, much of the agency’s workforce will continue through the shutdown, with more than 10,000 FDA employees — nearly 60 percent — reporting to work, according to numbers released by the agency Friday.
The majority of those people are doing work funded by user fees paid by pharmaceutical and medical device companies, according to an analysis by the Alliance for a Stronger FDA, an advocacy group representing patient and consumer advocates as well as trade associations.
Here is a quick breakdown of how the shutdown will affect the agency’s work.
Activities that will continue during the shutdown
The FDA will continue work that’s critical to public health and safety. It will be able to respond to emergencies, like the flu and foodborne illnesses. It will continue recalls of any foods, drugs and medical devices that pose a high risk to human health.
As FDA Commissioner Scott Gottlieb tweeted over the weekend, the agency will also continue to screen “food and drug imports” and inspect any facilities that might pose “an imminent threat to health and life.”
Some criminal and civil investigations where there is an immediate risk to public health will also continue through the shutdown, as will all of the agency’s work that is funded by user fees.
For example, the agency will continue to oversee the manufacturing and distribution of all tobacco products. “The tobacco program is 100 percent user-fee funded,” says Steven Grossman, deputy executive director at the Alliance for a Stronger FDA.
Similarly, much of the agency’s work with new products is funded by fees paid by industry, so the FDA will continue reviewing and approving drugs and medical devices where the fees have already been paid. It will also continue to review requests for clinical research and issue any necessary guidance.
Activities that will stop during the shutdown
Broadly speaking, all activities that are less likely to have an immediate impact on health and safety of consumers will come to a halt. For example, routine regulatory and compliance work for medical products, animal drugs and most foods will be paused, according to a contingency staffing plan put forward by the Department of Health and Human Services.
Routine inspections of facilities and all work related to cosmetics and nutrition will also be paused during this period.
And the shutdown may affect some aspects of the drug review process as an estimated 30 percent of that work is funded by appropriations, according to the analysis by the Alliance for a Stronger FDA.
Should consumers be concerned about food and drug safety during the shutdown?
Probably not, at least not for now, says Grossman. “In the short term, consumers should not see much of an impact,” he says. That’s because “anything that could affect human health and safety [in the near term] will be staffed.”