FDA expands excepted activities as government shutdown drags on

• The partial shutdown of the U.S. government, now into its 24th day, has impacted the Food and Drug Administration, with Commissioner Scott Gottlieb tweeting Sunday that it is “not business as usual” for the agency, which is facing one of the most significant operational challenges in the FDA’s recent history.
• Throughout the shutdown, the FDA has continued activities that address immediate threats to public health. There are, however, additional activities that need to be “considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life,” Gottlieb tweeted.
• After consulting with senior career leaders and public health experts, the FDA determined some of those activities include inspections of high-risk food, drug, medical, device and pharmacy compounding products and facilities — both at home and overseas — as well as food safety and foodborne illness outbreak surveillance, detection and response.

The latest government shutdown, which surpassed the record duration previously held by the 21-day shutdown in 1995-1996 under President Bill Clinton, is showing no sign of ending.

And the FDA is feeling the pressure. The latest Twitter thread from Gottlieb detailed a list of activities that FDA staff will have to carry out unpaid in order to keep food and drugs safe for the American public.

Scott Gottlieb, M.D.

@SGottliebFDA

 · Jan 13, 2019

THREAD – SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.

Scott Gottlieb, M.D.

@SGottliebFDA

We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats

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1:39 PM – Jan 13, 2019

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Gottlieb identified surveillance sampling of imported high-risk foods, drugs, and devices as another excepted, unpaid task the FDA needs to do. Expanding activities related to surveillance and response for recalls was also on the commissioner’s list.

“Many key functions aren’t getting done,” Gottlieb tweeted. “But we’re focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions.”

Last week, the FDA warned that Prescription Drug User Fee Act funding is going to run dry in about a month, as the agency cannot accept 2019 user fees during the shutdown.

Drug approval programs for medical devices and generic drugs have between one and three months of funding left. The funding constraints could lead to delayed drug approvals — a potentially risky situation for smaller pharma and biotech companies who will be relying on projected income of new therapies.

https://www.biopharmadive.com/news/fda-shutdown-update-gottlieb-twitter-excepted-work/545954/