This week, FDA Commissioner Stephen M. Hahn, M.D., along with Dr. Anthony S. Fauci, M.D., of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, and officials from the Centers for Disease Control and Prevention and U.S. Department of Health and Human Services testified on Capitol Hill on the federal response to COVID-19, including the latest on vaccine development and facility inspections.  FDA also issued an updated guidance on conducting clinical trials during COVID-19, showing its willingness to continue to adapt its policies to facilitate remote patient access during COVID-19.

Latest on Vaccine Development.  At this time, there is no FDA-approved vaccine to prevent SARS-CoV-2 infection or COVID-19.  The NIAID is leveraging NIAID-funded clinical trial networks to enroll volunteers in large-scale clinical trials to test investigational vaccines and monoclonal antibodies.  Four candidate COVID-19 vaccines have entered Phase 3 clinical trials in the US, and a fifth is expected to begin Phase 3 testing in October 2020.  Dr. Fauci reported that “the rigorous clinical testing required to establish vaccine safety and efficacy means that it might take some time for an FDA-licensed COVID-19 vaccine to be available to the general public, but there is growing optimism that one or more of these vaccine candidates will prove safe and effective by late 2020 or early 2021.”

Addressing skepticism on the political nature of vaccine development efforts, Commissioner Hahn stated emphatically that the FDA “will not cut corners” and that it has “not lost sight” of its responsibility to maintain regulatory independence and ensure decisions related to medical products, including COVID-19 vaccines, are based on science and the available data.  Commissioner Hahn also stated that it is clear that manufacturing will need to be “scaled up on U.S. soil” in order to have a vaccine widely available in the US in a timely manner.  FDA has been working with companies to provide advice and technical assistance to help support scale-up activities, including sponsors who may be proceeding at risk to scale-up manufacturing while clinical trials are being completed.

Update on Domestic Inspections.  As indicated in this prior post, FDA resumed on-site domestic and foreign inspections in July 2020.  The agency developed a “COVID-19 Advisory Level” risk-based rating system to assess where prioritized inspections could safely resume.  Commissioner Hahn testified that for the foreseeable future, prioritized domestic inspections will be pre-announced to FDA-regulated businesses.  The agency continues to use non-inspection enforcement tools, such as conducting physical examinations and product sampling at the US borders and using remote regulatory assessment tools to verify compliance with safety regulations.

Conducting Clinical Trials During COVID-19.  This week the FDA also updated its guidance on conducting clinical trials during COVID-19.  The updated guidance adds a question to its long list of FAQs appended to the guidance on investigator responsibilities for reviewing safety reports.  In brief, the pandemic does not relieve investigators of their responsibility to review safety reports received from sponsors during the trials, or from reporting unexpected adverse events to the investigator’s institutional review board (IRB).

The guidance continues to permit the use of video conferencing when on-site monitoring visits are not possible.  FDA regulations require sponsors to monitor the conduct and progress of their clinical investigations, and the guidance continues to allow flexibility to accommodate remote patient access to investigators.  The guidance also continues to permit flexibility in obtaining patient consent, when traditional means of communicaiton are not feasible.

To read more about FDA actions to address COVID-19, click here.

This article is not an unequivocal statement of the law, but instead represents our best interpretation of where things currently stand. This article does not address the potential impacts of the numerous other local, state and federal orders that have been issued in response to the COVID-19 pandemic, but which are not referenced in this article.