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Food and Drug Administration and Compliance Issues
Friday, October 2, 2020
Coronavirus (COVID-19) Update: Daily Roundup October 2, 2020
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
The FDA has issued a warning letter to Nephron Pharmaceuticals Corporation (Nephron) due to emails Nephron’s CEO and a sales representative sent concerning its product Budesonide Inhalation Suspension, which were the subject of complaints submitted to the FDA Bad Ad Program. The emails provide evidence that Budesonide is intended for a new use for which it lacks approval, specifically the treatment of symptoms associated with COVID-19, and for which its labeling does not provide adequate directions for use. This renders Budesonide misbranded within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and makes its distribution violative. The emails are also false or misleading in that they represent that Budesonide has certain benefits, but fail to include any risk information about the drug. This also renders Budesonide misbranded and makes its distribution violative. These violations are concerning because they create a misleading impression about the safety and effectiveness of Budesonide for the treatment of COVID-19 and suggest a use for which the labeling does not provide adequate directions for safe and effective use of the product.
The FDA posted a transcript of Dr. Stephen M. Hahn, M.D.’s remarks to the National Consumers League earlier this week about the vaccine review process.
As of today, 267 tests are authorized by FDA under EUAs; these include 212 molecular tests, 51 antibody tests, and 4 antigen tests.