While many facets of our lives have been put on hold due to COVID-19, the United States Food and Drug Administration (FDA) has announced that user fee review activities and application reviews are still happening. According to a recent statement released by Stephen M. Hahn, MD, Commissioner of the FDA, “the agency remain[s] focused on their work as we do everything possible to maintain continuity of operations in a very dynamic situation.” To that end, the agency has been “looking at ways to use technology and established agreements with our foreign counterparts to minimize impact to applications under review.”
Despite reviews continuing, Hahn does note that staff at the agency’s drug, biologics and medical device centers may not be moving at the typical pace. “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.
Prescription Drugs and Biologics
On the prescription drugs and biologics side, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research (CBER) are working diligently. Staff from both Centers are focused on addressing challenges with the COVID-19 pandemic while continuing to safeguard public health and helping to ensure that safe and effective high-quality drugs and biologics are available to the public.
Hahn noted that 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.
However, with many staff focused on COVID-19, it is possible that the agency will not be able to sustain the current level of performance. Currently, FDA staff is working at full capacity and are working 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, the FDA may have to shift focus to those shortages and disruptions.
Medical Devices
Hahn noted that with respect to medical devices, the Center for Devices and Radiological Health (CDRH) and CBER continue to meet all Medical Device User Fee Amendments (MDUFA) review goals. Further, he indicates that the agency has taken steps to contact industry stakeholders to convert previously scheduled meetings to a teleconference, through May.
Additionally, with many staff in CDRH working on COVID-19 activities related to pre-Emergency Use Authorizations (pre-EUAs), EUAs, and Immediately In Effect (IIE) guidance documents, it is again possible that the FDA will be unable to sustain the current level of performance. Hahn expects to assess that sustainability on an ongoing basis.
Extensions
In his announcement, Hahn also reiterated 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. This time extension may impact the agency’s ability to meet its goals for total time to decision under its Medical Device User Fee Amendments commitments.
Hahn did not want to expound upon any potential impact of the time extension or the shift in employee focus, noting, “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.”