- Programs responsible for approving medicines and medical devices are strapped for money as the government shutdown drags on. FDA Commissioner Scott Gottlieb said Tuesday at the current burn rates, user fees will run out of funding within months.
- Gottlieb, speaking at the J.P. Morgan Healthcare Conference via webcast because of shutdown-related travel restrictions, said the MDUFA program covering medical devices has two to three months of funding left. GDUFA, which covers generics, has between one and two months of funding left. The predicament threatens other user fee programs too, such as those covering biosimilars or animal drugs.
- PDUFA, short for prescription drug user fee act, is the program charged with reviewing new drugs. Typically, pharmas pay fees when submitting a candidate for approval — in 2018, these fees ranged from about $1.5 million to $2.7 million for PDUFA. But with the government shutdown, the FDA can't accept any new 2019 user fees because an appropriations bill for fiscal year 2019 hasn't been cleared.
Closing in on its third week, the government shutdown is already weighing heavily on the FDA's money reserves.
The agency is using carryover funding for now, but it doesn't look like that will last for very long. On Tuesday, Gottlieb tweeted the FDA is prioritizing safety surveillance rather than pre-market drug reviews with its available funds.
THREAD - UPDATE ON SHUTDOWN: We’re making decisions across our portfolio to focus #FDA resources to key consumer protection functions. One action we’ll be taking is to re-allocate user fee money from certain pre-market drug review work to post market drug safety surveillance.— Scott Gottlieb, M.D. (@SGottliebFDA) January 8, 2019
An active Twitter user, Gottlieb has provided updates on these challenges via the social media platform.
He has noted that while the FDA is still performing tasks deemed essential, like overseeing food recalls or monitoring adverse drug reactions, its hands are largely tied when it comes to regulatory submissions to any program which requires a user fee payment
"Look, it's not business as usual," Gottlieb said in his webcast presentation at JPM.
In addition to being a burden on industry, the shutdown is of course problematic for many FDA employees.
Gottlieb said those working within the approval programs are getting paid through the user fee funding, but elsewhere — particularly on the food side — essential employees are going without pay. The agency announced Monday it's having employees bill all travel to a central credit to alleviate their financial burden.
"We're trying to look at whatever accommodations we can make to help offset the personal burdens," he said.