The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
It seems completely logical that as the U.S. Food and Drug Administration (FDA) shifts much of its focus to the COVID-19 pandemic, some of its other duties will slow. The agency issued a statement saying that it will continue its activities, such as reviewing new drug applications and clinical trial, both COVID-19 and non-COVID-19, applications, “as we do everything possible to maintain continuity of operations in a very dynamic situation.”
The agency is also trying to leverage technology and work with regulatory agencies outside the U.S. to “minimize impact to applications under review.”
The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are continuing their work on approvals and oversight of prescription drugs and biologics side. “At this time, the New Drug Program, the Generic Drug Program, and the Biologics and Biosimilars Programs are continuing to meet key review program users fee performance goals, approve applications and communicate with applicants. 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.”
The FDA is keeping a close eye on any supply chain disruptions or drug shortages and will reprioritize its work to address them, if necessary.
Its medical devices divisions, the Center for Devices and Radiological health (CDRH) and CBER are meeting all of their Medical Device User Fee Amendments (MDUFA) review goals. The agency has contacted industry stakeholders to shift previously scheduled meetings to teleconferences, and extended response due dates by 90 days for several different marketing applications, including the Premarket Notifications (510(k)s), Premarket Approval (PMA) applications, Humanitarian Device Exemption (HDE) and De Novo classification requests.
“It is 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,” the agency stated. “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 possible that we will not be able to sustain our current level of performance indefinitely. However, this will be assessed on an ongoing basis.”
This is clearly an area of concern. Not a day has gone by in the past few weeks when the agency has not issued an EUA for a clinical diagnostic test either for SARS-CoV-2, the novel coronavirus that causes COVID-19, or increasingly, for diagnostic tests that identify antibodies against the virus, which would suggest immunity. As these tests are viewed as critical to reopening the country with widespread testing and contact tracing, it’s an understandable area of priority and resources.
The agency also provided an update on its animal drug and generic animal drug user fee programs in its Center for Veterinary Medicine, noting it continues to stay on track and doesn’t expect any change in its ability to meet those goals.
“As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and as transparent as possible as we work to address the COVID-19 pandemic, as well as keep other key mission-critical initiatives unrelated to the pandemic moving forward,” the agency stated.
