It’s now the longest partial FDA and government shutdown in history.
As we write these words, the agency has about three weeks of funding left to review new drug applications.
For the devices, the cash flow burn rate of user fees already collected gives the agency about three months of funding to review and process device applications.
Calling the shutdown “the most significant operational challenges in the agency’s history,” FDA head Dr. Scott Gottlieb has had to send more than 7,000 or 40% of his workforce home.
In mid-January Gottlieb recalled 400 workers to support inspections. But not pay them.
Approximately 100 of those 400 will focus on inspections of high-risk medical device manufacturing facilities, with an additional 90 employees focused on high risk biological manufacturing facilities, Gottlieb said. An additional 70 employees will focus on high risk drug manufacturing facilities.
He noted the FDA staffers are expected to work unpaid to perform work that is “necessary to identify and responds to threats to safety of human life.”
A week earlier Gottlieb said he had been forced to cut back on non-urgent activities to meet FDA’s consumer protection mandate. So far, the agency has been living on user fee cash from fiscal 2018. But the agency is not allowed to accept new user fees until the shutdown is over.
“We’re shifting operating dollars to payroll dollars in order to maximize our runway and preserve program functions,” stated Gottlieb.
Some of the activities that will have to be performed by unpaid staffers include an expansion of 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.”
Also, on that list is “expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices.”
Gottlieb tweeted: “Many key functions aren’t getting done…but we’re focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions.”
Some Democratic senators sent a letter to Gottlieb expressing their concern that the shutdown will halt “vital regulatory and compliance activities” and could result in slower approvals for drugs and devices—and a backlog when the shutdown ends.
According to a STAT analysis of upcoming regulatory decisions, the shutdown could soon jeopardize anticipated new drugs from Janssen, Sanofi and Novartis for depression, diabetes and multiple sclerosis, as well as a host of other potential new therapies.
We’ve reached out to device company lawyers and representatives to alert us when device companies experience significant problems. We’ll keep you posted.
