‘Not business as usual at FDA’: Only addressing immediate threats due to shutdown

With the US government shutdown continuing, the US Food and Drug Administration (FDA)’s abilities are limited due staff shortages and limited funding, and reviews of drugs like Aimmune Therapeutics’ biologic have been postponed.

FDA commissioner Scott Gottlieb tweeted out a statement​ recently detailing that the pause in funding, due to the shutdown, has created a shift in the agency’s abilities:

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) January 13, 2019

The agency stated that its plans are to address immediate threats to human life and safety. However, as the shutdown does not have a clear end date, the agency is evaluating additional activities needed that it can pursue.

“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,”​ Gottlieb tweeted.

Additional monitoring, food safety surveillance, and laboratory support for inspections and evaluation are also being operationalized.

Gottlieb summarized the effects of the shutdown to the agency, when he tweeted, “It is not business as usual at FDA.”​

Placed on hold: Biologics reviews​

The shutdown has already caused tangible issues for companies looking to have applications assessed by the agency. Aimmune Therapeutics was notified by the FDA that due to the shutdown and a lapse in funding, the FDA could not commence the review of Aimmune’s biologics license application (BLA).

Aimmune’s investigational biologic oral immunotherapy, AR101​, for the treatment of peanut allergies in children and adolescents was not able to be reviewed at this time. AR101 has shown success in clinical trials as an oral immunotherapy for the de-sensitization of peanut allergies.

The FDA stated that it will initiate the review of the BLA after the shutdown ends and funding is restored.