FDA missing more approval target dates as COVID slows inspections

FDA
The FDA continues to fall behind on plant inspections amid COVID-19 as a pair of companies report the agency will miss PDUFA target dates. (Andrew Harnik, Associated Press)

Hamstrung by the demands caused by the COVID-19 pandemic, the FDA is missing more PDUFA targets. A pair of companies says the agency won’t be able to meet drug reviews as previously scheduled.

The first, Avadel Pharmaceuticals, had a target action date of Oct. 15 for its candidate to treat narcolepsy—submitted in February—but was notified by the agency that won’t happen. Without elaborating on the cause for the delay, the company said the agency would set a new target action date “as quickly as possible.”

The FDA told the company it has no outstanding information requests, Avadel added.

A day later, UCB reported the FDA has pushed back its target date for review of the company’s application for bimekizumab to treat moderate to severe plaque psoriasis.  

“The FDA indicated that they were unable to conduct the inspections during the current review cycle due to COVID-19 related restrictions on travel,” UCB said in a statement, adding that the agency is deferring action on the application until inspections can be completed.

Iris Loew-Friedrich, executive vice president for UCB, said the company is working to schedule inspections of the manufacturing facilities as soon as possible and has provided the agency with its production schedule through the first quarter of 2022.

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Avadel and UCB aren't alone, of course, as drug companies big and small have experienced FDA delays and setbacks stemming from the pandemic. Last year, the agency had to postpone its visit to a third-party manufacturer for Bristol Myers Squibb's high-profile CAR-T medicine liso-cel, which eventually won approval in 2021 as Breyanzi.

In another example, Intercept Pharmaceuticals had to weather a delay related to advisory committee scheduling at the start of the pandemic.

The FDA said in an August report that a combination of a surge in volume, travel limitations and social distancing measures have slowed its PDUFA process. In its report, the agency said PDUFA applications reviewed on time dropped to 91% in the third quarter of 2021 compared to 98% for the same period in 2020.