As the government shutdown enters its 25th day with no end in sight, because President Donald Trump won’t agree to a budget deal that would fund his border wall, the Federal Drug Administration has stopped accepting applications for life-saving drugs.
According to a report at Axios, the FDA is woefully understaffed, with workers sent home as non-essential — leading to delays in no only reviewing drug applications, but also accepting new requests.
The reports notes that drug-maker Aimmune Therapeutics, which is seeking approval for a new drug to help children with deadly peanut allergies, noted in a financial filing that the FDA won’t give them the go-ahead on the drug until after the government reopens.
According to Axios, the process for reviewing drugs only begins when the FDA accepts a fee to start the process — but during the shutdown, no new fees or applications are being accepted and the whole process has ground to a standstill.
Some existing reviews are moving forward, with FDA commissioner Scott Gottlieb admitting on Monday that the agency has shifted some funding that would allow them to continue working for five more weeks.
STAT is reporting that other drugs, working their way through the approval process are at risk of being held up, including “highly anticipated new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies.”
The hold-up has also put the financial health of some of the drug-makers at risk.
“Every bit of predictability in process —the heart of [the FDA user fee program] — melts away in the face of this,” explained Steven Grossman, deputy executive director of the Alliance for A Stronger FDA . “If you don’t have a lot of cash, this could put you out of business.”
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