As the House preps to take action on individual appropriations bills this week, including one that will fund the FDA, Commissioner Scott Gottlieb has further clarified what the agency has left in user fee funds, what review activities will take place and how the agency is helping its employees conduct inspections.
Due to the partial shutdown, the FDA cannot accept new 2019 user fees, which means the agency cannot accept new medical product applications unless they are user-fee-program related but don’t require the payment of a user fee, which is “a very small subset of applications,” Gottlieb noted.
And though the FDA will continue to work on existing applications where user fees were paid prior to 22 December 2018, FDA can only use user fee carryover balances from FY 2018, and Gottlieb noted that among the medical product user fee programs, the one that will run out of carryover balance first is likely the Prescription Drug User Fee Act (PDUFA) funds, which are used for new drug reviews. “We have about one month of funding left,” Gottlieb said.
Gottlieb has promised to release further information on the account balances, burn rate and approximately how long activities can continue under carryover balances, according to the nonprofit Alliance for a Stronger FDA’s shutdown toolkit.
On the generic drug end, during the partial shutdown, the FDA will not accept generic drug submissions that require payment of a fee.
Gottlieb clarified that FDA will be able to process certain submissions for generic drugs using carryover user fees, such as changes being effected (CBE) and prior approval supplements, amendments, annual reports and applications for positron emission tomography (PET) drugs. He also said that the agency can accept drug master files (DMFs) to be referenced in generic drug applications, but that the agency won’t be able to conduct initial completeness assessments on Type II active pharmaceutical ingredient (API) DMFs if the user fee has not been paid.
“Sponsors who haven’t paid GDUFA facility fees for FY19 shouldn’t remit payment during the lapse period because FDA cannot accept the fees,” he added.
And if a generic drug application references, for the first time after 22 December 2018, a Type II API DMF for which the fee has not been paid, then FDA will notify the applicant that the fee must be paid within 20 calendar days. If the fee is not paid within 20 calendar days of that notice, the FDA will not receive the application. “At this time, FDA has not determined what approach it will take if the 20-calendar-day period expires during the lapse period,” Gottlieb said.
While praising the work of FDA staff conducting critical inspections of food and drug facilities who are in an “unpaid, excepted status,” meaning they’re working on critical public health functions without pay or reimbursement, Gottlieb said the employees’ work has not gone unnoticed.
“We’ll support them in any way we can in their execution of these vital public health functions. Toward these goals we’re adopting new procedures that’ll reduce the likelihood that they accrue balances on their government travel credit cards for cost of airfare and hotel/lodging,” he added.
First published here. Regulatory Focus is the flagship online publication of the Regulatory Affairs Professionals Society (RAPS), the largest global organization of and for those involved with the regulation of healthcare and related products, including medical devices, pharmaceuticals, biologics and nutritional products. Email email@example.com for more information.
Image: Scott Gottlieb. SHUTTERSTOCK
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