June 7, 2024 - FDA Roundup: June 7, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS-CoV-2 viruses. This action is based on the totality of the evidence and input from Wednesday’s Vaccines and Related Biological Products Advisory Committee, which unanimously voted to recommend a monovalent JN.1-lineage vaccine composition. Following the vote, the committee discussed considerations for the selection of a specific JN.1 lineage SARS-CoV-2 strain (e.g., JN.1 or KP.2) and expressed a strong preference for JN.1. It is expected that the updated vaccines will be available this fall. 
• On Thursday, the FDA updated the Manufacturer and User Facility Device Experience (MAUDE) database, which contains medical device reports (MDRs) of adverse events, to provide additional information to the public. To help further promote transparency, the FDA is updating the MAUDE database so search results display supplement report dates. Corresponding updates have been made to the field descriptions of MDRs on the About MAUDE Database web page. The FDA continues to seek ways to improve the MAUDE database and the availability of MDR information for the public.
• On Thursday, the FDA approved imetelstat (Rytelo, Geron Corporation), an oligonucleotide telomerase inhibitor, for adults with low- to intermediate-1 risk Myelodysplastic Syndromes (MDS) with transfusion-dependent anemia requiring four or more red blood cell units over 8 weeks who have not responded to, have lost response to, or are ineligible for erythropoiesis-stimulating agents (ESAs). The most common adverse reactions (≥ 10% with a difference between arms of > 5% compared to placebo), including laboratory abnormalities, were decreased platelets, decreased white blood cells, decreased neutrophils, increased aspartate aminotransferase, increased alkaline phosphatase, increased alanine aminotransferase, fatigue, prolonged partial thromboplastin time, arthralgia/myalgia, COVID-19 infections, and headache. Full prescribing information for Rytelo will be posted on Drugs@FDA. 
• On Thursday, the FDA provided an update on the status of the agency’s review of the premarket tobacco product applications (PMTAs) submitted by JUUL Labs, Inc.; The FDA rescinded marketing denial orders (MDOs) issued in June 2022 to JUUL Labs, Inc. This action was taken, in part, as a result of new case law, as well as the FDA’s review of information provided by the applicant. Rescission of the MDOs is not an authorization or a denial and does not indicate whether the applications are likely to be authorized or denied. Rescission of the MDOs returns the applications to pending status, under substantive review by the FDA. The agency’s continued review does not alter the fact that all e-cigarette products, including those made by JUUL, are required by law to have FDA authorization to be legally marketed.
• On Wednesday, the FDA issued a safety alert, advising restaurants and retailers not to serve or sell and consumers not to eat certain shellfish from Oregon and Washington potentially contaminated with paralytic shellfish toxins.
• On Wednesday, the FDA published a draft guidance for industry describing the processes and practices applicable to inspections of sites and facilities under FDA’s Bioresearch Monitoring (BIMO) program, as conducted in accordance with section 704(a)(5) of the Federal Food, Drug, and Cosmetic Act. Specifically, this guidance addresses matters including the types of records and information required to be provided and best practices for communication between FDA and industry. FDA is issuing this draft guidance to comply with section 3612(b)(2) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, 2023. The deadline for submitting comments to the docket is August 5, 2024. 
• On Wednesday, the FDA announced the closing date of the public comment period on Swedish Match U.S.A., Inc’s modified risk tobacco product (MRTP) renewal application for General Snus products. Public comments on these applications must be submitted to the docket by 11:59 p.m. EDT on July 5, 2024 to ensure they receive consideration by FDA. The final materials on this application have now been posted.
• On Wednesday, the FDA issued an advisory for a multistate outbreak of Salmonella Africana infections potentially linked to cucumbers. CDC and FDA are also investigating an outbreak of Salmonella Braenderup infections, with 158 illnesses in 23 states. The two outbreaks share several similarities, including where and when illnesses occurred and the demographics of ill people. Investigators are working to determine whether the two outbreaks could be linked to the same food vehicle. Fresh Start Produce Sales, Inc. has recalled cucumbers grown in Florida and distributed to retail distribution centers, wholesalers, and food service distributors in AL, FL, GA, IL, MD, NC, NJ, NY, OH, PA, SC, TN, VA, and WV from May 17 through May 21, 2024. Although these cucumbers have resulted in a positive Salmonella sample result, the FDA has not linked these products to any ongoing outbreaks. Retailers and distributors that purchased recalled Fresh Start cucumbers should notify their customers of the recall. Retailers that have or had recalled product should clean and sanitize any areas that could have come into contact with recalled products.
• On Tuesday, the FDA published an article in the FDA Voices series: “Join Us in Recognizing National Black Family Cancer Awareness Week,” by Richard Pazdur, M.D., Director, Oncology Center of Excellence (OCE), and Rea Blakey, Associate Director for External Outreach and Engagement, OCE. OCE invites the public to join the “4th Annual National Black Family Cancer Awareness Week, Engaging the Generations” initiative and the #BlackFamCan social media campaign this year, June 13-19, 2024. The event is virtual and open to the public. Register now for the June 13 Conversations on Cancer public panel discussion which will be live streamed from 2:30 – 4:00 p.m. ET.
• This week the FDA presented Congress with its Report on Drug Shortages for Calendar Year 2023, the 11th annual report, to summarize major actions the agency took to prevent or mitigate drug shortages in the United States. 2023 was a challenging year for shortages as manufacturers in the U.S. and abroad continue to experience quality issues and capacity constraints. FDA also saw an additional strain on the pharmaceutical supply chain from increased demand for numerous drugs, as well as unexpected events like facility closures and natural disasters.
  
  Considering these challenges, the agency made a significant impact in helping to prevent or mitigate drug shortages. During CY 2023 there were 55 new shortages (33 drug shortages handled by the Center for Drug Evaluation and Research, and 22 biological product shortages handled by the Center for Biologics Evaluation and Research), and the FDA helped prevent 236 shortages.

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