FDA COVID-19 response roundup
In the past week, the US Food and Drug Administration (FDA) has issued a number of announcements and resources in response to nationwide COVID-19 developments. Many of these could have significant impact on professionals in the pharmaceutical and clinical trial fields.
The agency is offering the FDA-ARGOS SARS-CoV-2 Reference Grade Sequence Data to support the efforts of test, vaccine and treatment developers. The data was put together in collaboration with the Centers for Disease Control and Prevention (CDC), the Biodefense and Emerging Infections Research Resources Repository (BEI Resources) and the Institute for Genome Sciences at the University of Maryland and the National Center for Biotechnology Information (NCBI).
The collaboration was assembled to provide stakeholders with quality-controlled reference sequence data for the SARS-CoV-2 reference strain. According to the agency, this traceable, quality-controlled data will help test developers and vaccine developers expedite treatment, identify new or more stable targets for future tests, enable in silico confirmation of targets, support development of synthetic reference material, and enable viral population/quasi species analysis.
The FDA has announced significant shortages in hydroxychloroquine sulfate tablets. Approved for use in treatment of malaria, lupus and rheumatoid arthritis, the drug has come in short supply recently, likely due to members of the current presidential administration touting the use of the drug as a potential COVID-19 treatment.
The agency also has provided a number of announcements on the COVID-19 diagnostics front. For example, the FDA reported it has heard from more than 270 test developers that plan to submit emergency use authorizations (EUA) requests to FDA for tests that detect the virus. As of April 7, 30 EUAs have been issued for diagnostic tests.
Additionally, the FDA announced more than 150 laboratories have notified the agency that they have started testing, under the policies set forth in the COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
The agency has issued warning letters to a number of companies for selling allegedly fraudulent and untested COVID-19 products, in order to protect consumers. These include a company hawking colloidal silver products, homeopathic treatments, and essential oils.
Last week, the administration enacted the Coronavirus Aid, Relief and Economic Security (CARES) Act. The $2tn (€1.8tn) emergency relief bill includes funding to help support COVID-19 response, including development of tests, vaccines and treatments.