Updates to U.S. FDA Legislation and Guidance – Fall 2020

During the fall, the FDA’s main focus remained on responding to the COVID-19 pandemic. The main event was the Emergency Use Authorization (EUA) of two COVID vaccines (by Moderna and Pfizer-BioNtech), both based on the mRNA platform following favorable review by the Vaccines and Related Biological Products Advisory Committee. This EUA allows for the distribution and use of these vaccines pending the full review and approval of the license application. In addition, FDA continued the posting of major COVID-related activities in a daily roundup and on the dashboard for the Coronavirus Treatment Acceleration Program (CTAP), a special emergency program for potential coronavirus therapies. At present, more than 590 drug development programs are being reviewed, which includes over 390 trials (excluding vaccines), and authorization of eight COVID-19 treatments under Emergency Use Authorizations (EUAs). The variety of treatment modalities being evaluated are shown below. In October, Remdesivir was the first FDA approval of a treatment for selected COVID-19 patients following initial authorization under a EUA. In addition, as part of oversight of COVID-19 tests, the FDA has authorized a large number of COVID tests under EUAs inclusive of 235 molecular tests, 63 antibody tests and 11 antigen tests to date. This includes 32 molecular authorizations that can be used with home-collected samples and one molecular and one antigen prescription at-home test and one over-the-counter (OTC) at-home antigen test. The FDA continues to monitor authorized tests and, based on available data, may revise and revoke tests based on their benefit/risk profiles.

Source: FDA CTAP dashboard Data as of November, 2020.

The FDA has published more than 67 COVID-19 related guidances, with the following significant publications issued during fall, 2020:

• Emergency Use Authorization for Vaccines to Prevent COVID-19
• Review Timelines for Applicant Responses to Complete Response Letters When a Facility Assessment Is Needed During the COVID-19 Public Health Emergency Guidance for Industry
• Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
• Investigational COVID-19 Convalescent Plasma: Guides the clinical investigation of plasma derived from individuals recovered from COVID-19 as treatment for those with severe COVID-19 infection.
• Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment (FINAL): Provides guidance on patient recorded outcomes and scale used to rate the severity of assessments.
• Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

To protect consumers from fraudulent or unsafe products, the FDA identified over 1,100 fraudulent products and sent warning letters to companies marketing unapproved products for the treatment of COVID-19 and to producers of hand sanitizers found to contain less than the required amount of alcohol or to contain methanol or 1-propanol which can be toxic and life threatening when ingested. The FDA also warned consumers about hand sanitizers packaged in food and drink packages, which could lead to inadvertent use. To aid consumers, the FDA has published a list of hand sanitizers that should not be used.