The Food and Drug Administration, U.S. Customs and Border Protection and a Government Shutdown: What Importers Can Possibly Expect

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Sep. 25, 2023
By: Frederic D. Van Arnam, Jr.

The news cycle is filled with talk about a pending showdown between the Congress and the White House over the country’s annual budget, and how this showdown could result in a partial government shutdown on October 1, 2023. If that were to happen, it would impact the ability of administrative agencies, including the Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP), to provide all the services normally associated with the agency.

According to the FDA’s most current published contingency staffing plans, approximately 70% of its staff will continue working in the event of a government shutdown. Nevertheless, certain services will be curtailed when funding expires:

1. Existing FDA activities already funded through user fees as of the date of the shutdown will continue, including the regulation and testing of medical devices and human drugs. However, during periods of government shutdown, the FDA cannot:

• Process new user fees, including medical device user fees or prescription drug user fees. 
• In turn, this means that the FDA cannot accept new medical device or new drug applications or other regulatory submissions requiring a user fee payment.
• For medical device companies, this means that as of October 1, 2023, new applications for premarket approvals (PMA), 510(k) premarket submissions, annual reports, and annual registration/device listing cannot be accepted and processed until the shutdown is resolved.

2.    Thus, companies should be mindful that applications meeting the criteria for PMAs or 510(k) submissions that the FDA receives and are paid for with user fees before the shutdown begins will be reviewed during a shutdown. Anything after that date cannot be processed.

3.     All vital FDA activities related to imminent threats to human health or life will continue, including responding to public health emergencies, managing recalls, surveillance of adverse event reports, outbreaks related to foodborne illness and infectious diseases. Criminal and certain civil investigations will continue too. Other routine regulatory and compliance activities will be paused, including the release of guidance documents and routine inspections (those not “for cause” inspections). 

Similarly, CBP will retain a large portion of its workforce during a shutdown, as it has designated over 90% of its workforce as exempt or excepted workers according to its most recently published contingency plan. This means that border operations and activities related to the introduction of merchandise into the U.S. through the various U.S. ports of entry should proceed as usual. This includes CBP working with the FDA to review import entries of FDA regulated products, including medical devices and drugs, to interdict against products that pose potential risks to human health.   

If you have any questions regarding the impact of a government shutdown do not hesitate to contact any attorney at Barnes, Richardson & Colburn, LLP.