FDA COVID-19 response roundup
The US Food and Drug Administration (FDA) continues to provide updates, issue guidance documents, issue warning to fraudulent product manufactures and offer other assistance to life-sciences professionals during the COVID-19 pandemic. Below are some of the latest updates coming from the agency.
Last week, the FDA revised its emergency use authorization (EUA) to reflect changes to distribution and allocation of Veklury (remdesivir), an antivirual from Gilead that has been used on COVID-19 patients.
As of October 1, hospitals are authorized to purchase the drug directly from the drug’s distributor. Over the past five months, the US government has overseen allocation and distribution of the drug, due to the limited supply.
US Department of Health and Human Services (HHS) secretary Alex Azar said the government had overseen the supply to ensure the resources were fairly distributed.
“Over the past five months, HHS rapidly, fairly, and equitably worked to distribute approximately 150,000 treatment courses of donated Veklury and make more than 500,000 treatment courses of the commercial drug available to help treat patients in US hospitals,” Azar said. “Now, federal government oversight of the allocation of Veklury is not required because the drug is no longer a scarce resource—a tribute to progress we have made against COVID-19 and to the strength of our partnerships with the private sector.”
The revised EUA identifies Gilead and its authorized distributors as the responsible parties for the distribution of Veklury.
The FDA updated its SARS CoV-2 reference panel comparative data on the agency’s website to in order to reflect the latest available information. The reference panel is a standardized performance validation step for authorized SARS-CoV-2 molecular diagnostic tests.
According to the agency, the reference panel allows for a more precise comparison of the analytical performance of different molecular in vitro diagnostic (IVD) assays intended to detect SARS-CoV-2. Agency representatives intend to continue to update the tables on the website.
Additionally, the FDA re-issued an EUA for the Assure COVID-19 IgG/IgM Rapid Test Device, making it the first authorized antibody test that can be used at the point of care. This means the diagnostic tool is authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
To date, the FDA has not yet approved any products to prevent, treat or cure COVID-19. The agency has issued numerous warning letters to companies promoting and selling products that make such claims.
The agency has issued a warning letter to Nephron Pharmaceuticals after the firm sent promotional emails about its Budesonide Inhalation Suspension product. The emails reportedly make claims that the product is intendent for treatment of COVID-19 symptoms, a use for which the product does not have agency approval.
The firm KetoKerri LLC has been cited for the sale of unapproved and misbranded drugs related to COVID-19. These items include 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.
The FDA issued a joint warning (along with the Federal Trade Commission) to Tonic Therapeutic Herb Shop and Elixir Bar for selling unapproved products with fraudulent COVID-19 claims. The company hawks a number of herbal products purported to treat COVID-19.