It’s Not Business as Usual as FDA Works Only on 'Imminent Threats'

It’s Not Business as Usual as FDA Works Only on 'Imminent Threats'

During shutdown, agency can only address imminent threats to the safety of human life and those funded by carryover user fee funds.

January 14, 2019
— Lisa Lupo

The government shutdown officially became the longest in U.S. history on January 12. So, if you’re looking for information on what FDA is able to do during the shutdown to continue protecting the safety of U.S. foods, the FDA website pretty much says it all:

“In the absence of either an FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the date of enactment of an FY 2019 appropriation or Continuing Resolution ("lapse period"), agency operations continue to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.”

And that is further restricted by the fact that the agency is operating with only about 50% of its workers, as nearly half have been furloughed since December 22, 2018.

FDA Commissioner Scott Gottlieb has been maintaining a fairly steady stream of tweets, with one thread, in particular, providing a view of what the agency is doing:

“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.

"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.

 “FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:

“The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:

  • Expanded inspection activities beyond ‘for-cause’ inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;
  • Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;
  • Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
  • Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;
  • Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;
  • These actions are being taken in close consultation with, and based on direct feedback from, senior career leadership of FDA, our program officers, and our range of experts. Our mission is focused squarely on securing consumer safety and protecting Americans during these times.”

From this, it’s evident that, as Gottlieb also states, “It is not business as usual at FDA.” While many key functions are not able to be done, the agency is focusing on “maintaining core activities that directly impact consumer safety and save lives.”

However, the longer the shutdown continue, the worse it is likely to get, as any non-immment-threat activities are operated only under carryover user fees, which Gottlieb said will last only one to two months. After that more employees could be furloughed.

Follow Gottlieb on Twitter at @SGottliebFDA.