Government shutdown puts the brakes on key FDA functions

While most of the FDA is already funded through 2019, 41 percent of its workforce is being furloughed.

An HHS contingency plan provides for the continuation of specific FDA activities, including those focused on prescription drugs, generic drugs and medical devices, while other services will be stalled. (Photo: Shutterstock)

While it’s not the whole government shut down over the border wall fight, and a number of essential activities will continue nevertheless, there are plenty of ways in which the shutdown will affect health care.

The FDA is among the agencies affected by the shutdown. According to a report from AJMC, while most of the Department of Health and Human Services, including the National Institutes of Health and the CDC, is already funded through 2019, as of today, 41 percent of the FDA is being furloughed.

An HHS contingency plan provides for the continuation of specific FDA activities, including those focused on prescription drugs, generic drugs, biosimilars, medical devices, and tobacco products—which are funded by user fees. However, some routine regulatory and compliance activities, including some medical product-related and most food-related activities, will be unsupported.

Related: FDA chief Scott Gottlieb isn’t pharma’s BFF after all

Responses to existing critical public health challenges, such as drug shortages and outbreaks related to foodborne illness and infectious diseases, will be functional, as will responses to emergencies, high-risk recalls, criminal enforcement work and civil investigations tied to imminent threats to human health or life and other critical public health issues.

But according to STAT News, the shutdown will also cripple bipartisan efforts to reauthorize the 2006 Pandemic and All Hazards Preparedness Act, which allows the government to respond to health-related emergencies as well as to work with private companies on the development of medical technology for emergency responses.

In advance of the shutdown, Scott Gottlieb, M.D., commissioner of the FDA, tweeted: “I recognize the consequences of a federal shutdown to the public we serve, our employees and their families—especially during this holiday season. I know the burdens will intensify the longer there is a lapse in funding and I am doing everything possible to ease the impact.”

“The administration and Congress’s inability to approve funds to keep the federal government open is unacceptable and poses a threat to public health,” said Georges C. Benjamin, M.D., executive director of the American Public Health Association, in a statement.

Benjamin added, “This shutdown is a political failure, and AHPA urges the government to put ideology aside and reach a funding solution as soon as possible.”