Senate Democrats question Gottlieb on FDA shutdown impact
UPDATE: Jan. 16, 2018: FDA announced Tuesday it has returned 100 inspection staff to work to oversee high-risk medical device facilities.
This includes about 100 staff focused on inspections of high risk medical device manufacturing facilities; about 70 staff focused on inspections of high risk drug manufacturing facilities; and about 90 staff focused on inspections of high risk biological manufacturing facilities.— Scott Gottlieb, M.D. (@SGottliebFDA) January 15, 2019
- Three weeks into the partial government shutdown, 34 Senate Democrats are asking FDA Commissioner Scott Gottlieb what impact the agency's hampered funding may have on public health.
- In a letter late Friday, the lawmakers raised concern the shutdown will slow approvals for devices and drugs, hinder important regulatory and compliance activities, and limit oversight of the food supply.
- As the shutdown continues, Prescription Drug User Fee Act carryover funds are slated to run out in about a month and the Medical Device User Fee Amendments program has two to three months remaining, according to Gottlieb.
More than 40% of FDA's workforce is currently furloughed due to the shutdown, but Democrats worry that number is set to grow as user fee programs run out of funding.
"Should the remaining FY 2018 balance for these programs expire, the vast majority of FDA's ongoing product review functions will cease to continue, and user fee-funded employees (just under half of the agency) would no longer be paid," the Democrats wrote.
Even if the shutdown comes to a close before the medical product user fee programs run out of funding, the letter notes FDA has been legally prohibited from accepting new applications that necessitate user fee payments.
"As a result, the agency will likely receive a large influx of applications from drug and device makers following the conclusion of the shutdown, requiring the agency to triage review activities and probably causing a backlog in the approval process," the lawmakers said.
The letter, led by Senate HELP Committee Ranking Member Patty Murray, D-Wash., requested Gottlieb provide information on how each additional week of the government shutdown will contribute to the anticipated backlog of medical product applications.
The lawmakers also asked what the burn rate for each of the user fee programs is, what additional steps FDA plans to take to mitigate the financial impact of the shutdown on field inspectors, whether any employees have left FDA due to the shutdown and what the impact will be on the ability of the agency to attract new employees.
"We recognize FDA's efforts to mitigate the impact of this government shutdown on the public health and its employees," the Democrats wrote. "However, we remain alarmed that the continued shutdown will result in increasingly harmful effects on the agency's employees and the safety and security of the nation's food and medical products."
Gottlieb wrote on Twitter Sunday that the agency is expanding 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," as well as "expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices."
It is not business as usual at FDA. 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— Scott Gottlieb, M.D. (@SGottliebFDA) January 13, 2019
- Senate HELP Committee Senate Democrat Letter to FDA
- MedTech Dive FDA warns it won't be long before user fee funding runs dry
- MedTech Dive Government shutdown partially shutters FDA
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