FDA Issues Guidance on Formal Meetings and User Fees Applications During the COVID-19 Crisis
Recently, the US Food and Drug Administration (“FDA”) issued a guidance regarding the effects of the COVID-19 crisis on formal meetings and user fee applications. The guidance was issued without prior public comment, as the FDA determined that public participation was neither feasible nor appropriate, under the circumstances.
The guidance, which is presented in a Q&A format, addresses the following issues:
Formal Meetings with Industry under PDUFA and BsUFA: The guidance notes that the FDA is leveraging technology to replace all in-person meetings with virtual meetings for Prescription Drug User Fee Act (“PDFUA”) and Biosimilar User Fee Act (“BsUFA”) sponsors and applicants. The FDA is continuing to accept new meeting requests and will grant them according to its usual practices. The guidance also notes that the FDA is in the process of evaluating the feasibility of conducting advisory committee meetings virtually.
PDUFA and BsUFA Goals and Timelines: The FDA notes that the Centers for Drug Evaluation Research (“CDER”) and the Center for Biologics Evaluation and Research (“CBER”) are experiencing considerable increases in work due to pandemic-related activities. As a result, the agency may not be able to sustain its current performance level in meeting goal dates. If the FDA anticipates missing a PDUFA or BsUFA goal date, it will communicate that with the sponsor or applicant directly.
GDUFA Goals and Timelines: The FDA is continuing its Generic Drug Program application assessment activities, however, as more potential drug shortages are identified, the agency may have to shift resource to address urgent public health needs. As with other in-person meetings, pre-ANDA meetings are being converted to teleconferences. The agency is currently prioritizing ANDA submissions that could help address the pandemic, which is permitted by CDER policies and procedures. To determine if an ANDA qualifies for priority review, the FDA considers the ANDA is for a drug being investigated to treat or prevent COVID-19, but is not labeled for this use, or for a drug being used for its labeled use to treat or prevent conditions associated with COVID-19.
The guidance is being implemented immediately, however, comments may still be submitted to the agency for consideration.