US FDA May Start To Miss User Fee Deadlines
Executive Summary
As the COVID-19 response begins to strain agency’s resources, Commissioner Hahn acknowledges that ‘it is possible that we will not be able to sustain our current level of performance indefinitely’ in other review areas.
US FDA Commissioner Stephen Hahn acknowledged in a 16 April statement that the strain the agency is feeling from its coronavirus response could cause it to miss some of its user fee deadlines.
“At this time, the New Drug Program, the Generic Drug Program, and the Biologics and Biosimilars Programs are continuing to meet key review program user fee performance goals, approve applications and communicate with applicants,” Hahn said.
“With many staff working on COVID-19 activities, it is possible that we will not be able to sustain our current level of performance indefinitely. Our staffs are working at full capacity and we are striving to ensure that the drug programs continue to see minimal interruptions during this time. However, if there is an increase in drugs shortages and supply disruptions, we will be ready to reprioritize more of this work, as necessary.”
Hahn’s communique is a shift from the agency’s earlier emphasis that the pandemic would not impinge on regular agency operations, even though they might have to be carried out remotely. At the end of March, CDER’s review leadership was saying that deadlines would not be missed. (Also see "US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework" - Pink Sheet, 29 Mar, 2020.)
Pre-approval inspections remained a potential major stumbling block, but the agency was even preparing for remote advisory committees. (Also see "Virtual Advisory Committees Are Coming: US FDA Panels Will Be Smaller, More Focused" - Pink Sheet, 15 Apr, 2020.)
Just as coronavirus infections seem to spread slowly and then explode, though, the agency’s workload in response to the pandemic appears to have experienced an exponential increase. (Also see "US FDA Coronavirus Response Features Three-Step Triage Process For Inquiries" - Pink Sheet, 15 Apr, 2020.)
So by 8 April, CBER’s Tejashir Purohit-Sheth, clinical deputy division director for the Office of Tissues and Advance Therapies, told an Alliance for Regenerative Medicine webinar that for cell and gene therapies, “we are trying our best to juggle the numerous competing priorities. But I think that this is something that is somewhat challenging.”
And now the commissioner has put it in writing. It’s hard to say what deadlines – if any – might be missed, but scheduling meetings, often difficult for the agency even in the pre-COVID era, could now be even harder to achieve within the commitment letter timeframes.
Product approvals might slip as well. For a chart of pending applications and their goal dates, visit the Pink Sheet’s user fee performance tracker.
FDA’s device center had already extended due dates for marketing applications on hold by 90 days. Hahn cautioned that it’s “likely this extension of time will have an impact on the FDA and industry’s ability to meet the shared outcome goals for total time to decision as listed in the MDUFA IV commitment letter.”
Setting New Standards In The Midst Of Crisis
MDUFA had been the user fee program that was furthest along in its renewal cycle, having had its kick-off meeting announced before the pandemic upended life in the US. The public meeting was initially scheduled for 7 April at FDA headquarters in Silver Spring, MD, but was pushed back to a 5 May webcast. Now, the agency has postponed it indefinitely, though the docket is still closing on 5 June.
That doesn’t bode well for the kick-off events for the new drug, generic, and biosimilar user fee programs, despite agency optimism about them a few weeks ago. (Also see "US FDA User Fee Renewals Remain On Schedule Despite Coronavirus" - Pink Sheet, 2 Apr, 2020.)
Even if the renewal negotiations become a secondary undertaking this cycle, that doesn’t mean that FDA isn’t going to dramatically change over the next several years. Many aspects of society will likely undergo significant shifts in the wake the pandemic, and the agency could both experience and create them. Remote meetings may become the norm, and many in industry expect a similar decentralization for clinical trials. (Also see "COVID-19 Trial Changes Are "Propulsive Force" For Digital Adoption" - Pink Sheet, 9 Apr, 2020.)
Just as the AIDS crisis paved the way for accelerated approval and other changes, the regulatory flexibility the agency is exhibiting now may become confided pathways in the 2027 user fee renewal. From trial designs, to review processes, to basic oversight functions, the changes that agency staff is making for coronavirus could end up being the new standards even after the last COVID-19 patient is treated.
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