As American patients receive the first round of COVID-19 vaccines, the US Food and Drug Administration (FDA), continues to keep professionals and civilians apprised of the latest findings and developments related to the global pandemic.
CARES Act update
The agency updated its webpage educating about the on the Coronavirus Aid, Relief, and Economic Security (CARES) Act, which outlines authorities intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages, via boosting the visibility into drug supply chains.
The recent CARES Act amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act include:
- Expanding the the requirement for manufacturers of certain drugs to provide information to the FDA on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply.
- Including a provision requiring manufacturers of drugs described in section 506C(a) of the FD&C Act or of any active pharmaceutical ingredient (API) or any associated medical device used for preparation or administration included in the drug to develop, maintain, and implement, as appropriate, a redundancy risk management plan.
- Requiring pharma manufacturers registered under section 510 of the FD&C Act to annually report on the amount of each drug that they "manufactured, prepared, propagated, compounded, or processed” for commercial distribution (the FDA reportedly is still exploring the best way to receive data).
Warnings on virus variants
As reports of mutations to the SARS-CoV-2 virus continue to circulate, the FDA reportedly is closely monitoring the potential impacts of these mutations. For example, the B.1.1.7. variant discovered in the UK reportedly can yield false negative results with molecular tests.
“The FDA will continue to monitor SARS-CoV-2 genetic viral variants to ensure authorized tests continue to provide accurate results for patients,” said FDA commissioner Stephen Hahn. “While these efforts continue, we are working with authorized test developers and reviewing incoming data to ensure that health care providers and clinical staff can quickly and accurately diagnose patients infected with SARS-CoV-2, including those with emerging genetic variants.”
Hahn added FDA officials believe currently approved COVID-19 vaccines likely are effective against this strain.
Frauds and fakes
No consumer products intended to prevent, detect, treat or cure COVID-19 have been given the FDA’s blessing to date. The agency and other departments have worked to block such attempting to sell such unauthorized products.
FDA chief counsel Stacy Amin said US consumers have the right to have access to treatments that have been approved by the agency, demonstrating their safety and effectiveness.
“Making claims that unproven drugs can cure or prevent diseases, including COVID-19, places consumers’ health at risk,” she said. “We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and distributing unapproved products.”
The latest COVID-19 product scofflaws include:
- Coco’s Holistic Specialties and Apothecary received a warning letter from the FDA and Federal Trade Commission (FTC)for selling various unapproved drug products, including 4-Thieves Florida Tea Concentrate and 4-Thieves Florida Tea Powder.
- A US District Court in Georgia granted a consent decree of permanent injunction against Fusion Health and Vitality LLC, Fusion Ionz LLC and Matthew Ryncarz for violating federal law by distributing products containing vitamin D and hordenine HCl, claiming they prevent or treat COVID-19.
