Resource: FDA Action and Ongoing COVID-19 Updates
Source: U.S. Food and Drug Administration
Synopsis: The FDA has issued the following updates:
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FDA revised its Emergency Use Authorization (EUA) to reflect changes in the distribution and allocation of the antiviral drug Veklury (Remdesivir). More information about the revised EUA can be found here.
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FDA has issued a warning letter to Kerri Rivera and her company KetoKerri, LLC, for the sale of unapproved and misbranded drugs related to the Coronavirus. Products “KK Black Seed Oil,” “KK Breakthrough Vitamin D with Chondroitin & Oleic”, “Stonebreaker,” “KK EDTA with Selenium and Minerals,” “Zeolite,” “Ultra Liquid Zeolite,” and “DR. FITT FIRE FIGHTERS” make fraudulent claims to mitigate, prevent, treat, or cure COVID-19 in people.
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FDA awarded a new research contract to the Stanford University School of Medicine to perform an in-depth analysis of tissue samples to learn more about how SARS-CoV-2—the virus that causes COVID-19—affects different systems in the body, and identify immune correlates. This regulatory science project could potentially help inform development and evaluation of medical countermeasures for COVID-19.
Comment: Beginning October 1, 2020 American hospitals can now purchase Veklury (Remdesivir) directly from the drugs distributor. The distributor is AmerisourceBergen. This is an antiviral drug which has emergency use authorization to treat hospitalized adult and pediatric patients with suspected or laboratory confirmed COVID-19. This drug was recently used to treat the President of the United States. Over the past five months the United States government has overseen the allocation and distribution of this drug due to its limited supply. The drug will now be more widely available by allowing the drug to be purchased directly from the distributor. The drug will now be more widely available by allowing the drug to be purchased directly from the distributor. Hospitals will pay no more than Gilead’s wholesale acquisition price which is $3,200, per treatment course. Patients do not pay directly for the drug because Medicare and private insurers are incorporating the overall treatment cost based on the patient’s diagnosis.
The FDA awarded Stanford University a $1.55 million contract to study the pathogenesis of an immune response to SARS-CoV-2 and other coronaviruses. Knowledge databases will be generated to inform medical countermeasures against these viruses. This information will be critical to any future COVID-19 response including any preparation needed for future outbreaks.
