FDA Roundup: January 6, 2023

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Jan 06, 2023, 16:06 ET

SILVER SPRING, Md., Jan. 6, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA posted an update that the agency is closely monitoring the emergence of the XBB.1.5 subvariant, a SARS-CoV-2 Omicron variant that is currently estimated to account for 28% of circulating variants in the U.S. Because of its similarity to variants that are not neutralized by Evusheld (e.g., XBB), the FDA does not anticipate that Evusheld will neutralize XBB.1.5. This means that Evusheld may not provide protection against developing COVID-19 for individuals who have received Evusheld and are later exposed to XBB.1.5. However, we are awaiting additional data to verify that Evusheld is not active against XBB.1.5. We will provide further updates as new information becomes available.

Health care providers should inform individuals of the increased risk, compared to other variants, for COVID-19 due to SARS-CoV-2 variants not neutralized by Evusheld.

If signs and symptoms of COVID-19 occur, advise individuals to test for COVID-19 and seek medical attention, including starting treatment for COVID-19 as appropriate.
On Dec. 27, the FDA issued a warning letter to globalpharmacyplus.com for selling unapproved and misbranded drugs for use in treating or preventing COVID-19. The letter also warns the company for offering Risk Evaluation and Mitigation Strategy (REMS) drugs and narrow therapeutic index (NTI) drugs. Consumers concerned about COVID-19 should consult with their health care provider.
Each month, the FDA Grand Rounds lecture series highlights a key public health challenge and how the FDA is applying science and innovation to its regulatory activities. The agency invites you to attend the next presentation on Jan. 12, 2023, from 12 to 1 p.m. ET, on the topic, "The Scientific Basis of Proposed Tobacco Product Standards to Prohibit Menthol as a Characterizing Flavor in Cigarettes and Flavors in Cigars."

On Apr. 28, 2022, the FDA announced proposed product standards to prohibit menthol as a characterizing flavor in cigarettes and prohibit all characterizing flavors (other than tobacco) in cigars. These actions have the potential to significantly reduce disease and death from combusted tobacco product use, the leading cause of preventable death in the U.S., by reducing youth experimentation and addiction, and increasing the numbers of smokers that quit. This presentation will provide an overview of the scientific evidence that informed the development of these proposed rules, with an explanation of the external peer review process FDA utilized for review of the highly influential scientific assessments for these proposed rules.
COVID-19 testing updates:

As of today, 442 tests and sample collection devices are authorized by the FDA under emergency use authorizations (EUAs). These include 297 molecular tests and sample collection devices, 85 antibody and other immune response tests, 59 antigen tests, and one diagnostic breath test. There are 79 molecular authorizations and one antibody authorization that can be used with home-collected samples. There is one EUA for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four for molecular OTC at-home tests.
The FDA has authorized 43 antigen tests and eight molecular tests for serial screening programs. The FDA has also authorized 1197 revisions to EUA authorizations

Additional Resources:

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Media Contact: FDA Office of Media Affairs, 301-796-4540
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration