Hahn: User fee-related reviews on schedule amid COVID-19
The US Food and Drug Administration’s (FDA) user fee funded reviews of drugs, biologics and medical devices are progressing according to schedule despite the disruption caused by the coronavirus disease (COVID-19) pandemic, FDA Commissioner Stephen Hahn said on Thursday.In addition to shifting resources in its response to COVID-19, much of FDA’s staff has been directed to work remotely during the crisis.
The pandemic has also prompted the agency to cancel or postpone several advisory committee meetings, including meetings to discuss Intercept’s investigational nonalcoholic steatohepatitis (NASH) drug, a new indication for GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder) and DBV Technologies’ peanut allergy patch.
“We continue to perform our user fee review activities and our application review teams across the agency remain focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation,” Hahn said, noting the agency is currently meeting its performance goals for the various user fee programs.
However, Hahn cautioned that staff at the agency’s drug, biologics and medical device centers may not be able to continue apace.
“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,” Hahn said.
Hahn noted that the agency has extended response due dates by 90 days for 510(k)s, premarket approval applications (PMAs), humanitarian device exemptions (HDEs) and De Novo classification requests, which could impact the agency’s ability to meet its goals for total time to decision under its Medical Device User Fee Amendments commitments.
“It is difficult to speculate on what the exact impact will be on incoming submissions moving forward. We are seeing and hearing from industry that companies are taking a role as partners in the defense of the public health by prioritizing their work and submissions,” Hahn said.
Despite guidance from FDA on conducting ongoing and new clinical trials amid the pandemic, many drugmakers have reported disruptions to ongoing studies or said they will not initiate new trials as a result of the outbreak. (RELATED: FDA Unveils Guidance for Trials Impacted by COVID-19, Regulatory Focus 18 March 2020; Clinical trials during COVID-19: Updates from FDA, MHRA and TGA, Regulatory Focus 1 April 2020).
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