Report Touts FDA’s Actions in Responding to the Pandemic

The COVID-19 pandemic has brought out many of the FDA’s strengths, including its commitment to science-based decisionmaking, according to a new report on the agency’s Pandemic Recovery and Preparedness Plan (PREPP) initiative that includes a dozen recommendations for improving the agency’s response going forward.

Since the start of the public health emergency, the FDA has published and revised more than 65 guidance documents related to COVID-19, assessed more than 2,300 Emergency Use Authorization (EUA) submissions and granted more than 600 EUAs linked to COVID-19 products, the report notes. The agency has also reviewed and conducted inspections or related activities on nearly 400 therapeutic candidates.

In addition to releasing shorter, more focused guidance documents, the agency produced EUA templates for sponsors and increased transparency and public trust by publicly releasing its risk-benefit analyses for several COVID-19-related EUA decisions. The agency also introduced remote, document-based inspections because of travel restrictions.

The report does not set out to offer policy advice but instead makes suggestions for possible future actions by the agency, such as explaining to product sponsors how the FDA will approach marketing applications for COVID-19 therapeutics and vaccines that are now in development.

“To be clear, the report’s recommendations are not a ‘to do’ list for the FDA and are deliberative, not binding and not exhaustive,” said FDA Commissioner Stephen Hahn in announcing the release of the independent, third-party analysis. The agency’s "experience so far has taught us that transparency and continuous improvement are the essential drivers of a successful response," he said.

The suggestions for improvement include strengthening supply-chain surveillance for COVID-19 products. For example, the agency “has launched several efforts to enable effective post-authorization and post-market surveillance of safety and efficacy of COVID-19 medical products,” the report states, adding that the agency now has “an opportunity to define a framework for [real-world data] driven surveillance and monitoring activities for COVID-19 vaccines and therapeutics. This framework could help to address questions related to real-world use of these products and/or scientific hypotheses that cannot be practically answered in clinical trials.”

The report also calls on the agency to “create an environment conducive to sustained innovation in clinical trial conduct.” For example, the agency could “further develop regulatory frameworks to encourage broader use of adaptive trial designs and master protocols,” the report suggests.

Among other actions, the report says, the agency could “undertake a review of potential regulatory barriers to broader adoption of master protocols and progress new guidance and industry engagement to address the identified barriers.

The agency’s March 2020 Guidance on the Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency “provided important clarity to the scientific community on how to adapt clinical trials to support patient safety and operational continuity,” the report states, adding that the agency could “further clarify its plan for this guidance and the timing and scope of forthcoming guidances” that would extend beyond the pandemic.

Looking to the future, the agency could “use the COVID-19 experience as a catalyst to define a broader agency-wide approach to encouraging sustained innovation in clinical trial conduct to drive efficiency and effectiveness in trial execution while improving patient experience and access,” the report says.

The full list of suggested action areas include:

• Continue to plan and prepare for the review of COVID-19 medical products;
• Strengthen EUA processes and supporting tools;
• Strengthen the agency’s COVID-19 communications;
• Deepen U.S. government partnerships;
• Consider how to carry forward interactive engagement with innovators and industry;
• Create an environment conducive to sustained innovation in clinical trial conduct;
• Collectively strengthen policy guidance and transition processes;
• Enhance real-world monitoring of COVID-19 products;
• Continue to evolve and optimize inspectional operations, building on the COVID-19 experience as a catalyst;
• Strengthen the supply-chain surveillance for regulated products;
• Further develop the agency’s emergency management capabilities and approaches; and 
• Further develop regulatory frameworks to encourage broader use of adaptive trial designs and use of master protocols.

Read the full report here: www.fdanews.com/01-18-21-FinalReport.pdf. ― Jason Scott