FDA: What’s Open? What’s Shut?

Oct 4

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Advocacy at a Glance offers you the bullet point summary of current advocacy issues associated with the goals of the Alliance for a Stronger FDA.

FDA: What’s Open? What’s Shut? The broad outlines have been set: 55% of FDA’s workforce are retained and 45% furloughed. With the exception of agencies that provide patient care, this is a very high percentage and is a result of the FDA having carryover user fee funding. Without those fees, less than 20% of FDA employees would be working during the shutdown.
- As a result, FDA’s allowable activities are unevenly distributed: most retained employees are carrying out reviews of medical product applications, programming specified in FDASIA technical agreements and regulation of tobacco products, all activities supported by user fees.
- Beyond that, retained staff are working only on the most urgent safety issues and those are narrowly defined. Patient, consumer, and industry considerations are not factors. A very large swath of mission-critical activities are not being done, including most of the agency’s food and safety work.
- Staff retained to handle safety issues will continue working regardless of the appropriation situation. User fee funded positions will last only as long as carryover funds are available, since new user fee payments (and the underlying product applications) will not be accepted.

Debt Limit and CR: One Issue or Two? The relationship between the two issues has evolved during the week. In today’s Analysis and Commentary, we examine the timing and potential impact on FDA.

Could Shutdown Go Beyond October 17?