FDA Roundup: June 11, 2024

FDA News Release

• For Immediate Release: June 11, 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 issued an advisory warning consumers and retailers to not eat, sell, or serve any flavor of Diamond Shruumz- Brand Chocolate Bars, Cones, and Gummies. The FDA and CDC, in collaboration with America’s Poison Centers and state and local partners, are investigating a series of illnesses associated with eating Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies. As of June 10, 2024, additional Diamond Shruumz-brand products have been reported by people who became ill, including the Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies. A total of 12 illnesses have been reported from eight states including AL (1), AZ (4), IN (2), KY (1), MO (1), NV (1), PA (1), and SC (1). All 12 people have reported seeking medical care; 10 have been hospitalized. No deaths have been reported. The FDA is working to determine the cause of these illnesses and is considering the appropriate next steps.
• On Monday, the FDA updated the Artificial Intelligence Program: Research on AI/ML-Based Medical Devices web page to include six new web pages about the Office of Science and Engineering Laboratories regulatory science research activities related to AI/ML.
• On Monday, the FDA launched the Emerging Drug Safety Technology Program (EDSTP), which will administer the Emerging Drug Safety Technology Meeting (EDSTM) Program. The EDSTP intends to focus on the use of artificial intelligence (AI) and other emerging technologies in pharmacovigilance as part of CDER’s multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used throughout the drug product lifecycle.
• On Monday, the FDA and the U.S. Department of Justice (DOJ) announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Along with the FDA and the DOJ, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF); the U.S. Marshals Service (USMS); the U.S. Postal Inspection Service (USPIS); and the Federal Trade Commission (FTC), to coordinate and streamline efforts to bring all available criminal and civil tools to bear against the illegal distribution and sale of e-cigarettes responsible for nicotine addiction among American youth. Additional agencies may join the task force in the coming weeks and months. 
• On Monday, the FDA approved Iqirvo (elafibranor) oral tablets for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. PBC is a rare autoimmune disease in which the small bile ducts in the liver become injured and inflamed and without treatment are eventually destroyed. Use of Iqirvo is not recommended in patients who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). Providers should also verify that patients are not pregnant prior to starting Iqirvo, inform them of the potential risk to a fetus, and advise the use of effective contraception. See full prescribing information for additional information on risks associated with Iqirvo.
• On Friday, the FDA approved Arexvy, a Respiratory Syncytial Virus Vaccine, Adjuvanted, for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. Arexvy has been approved for the prevention of LRTD caused by RSV in individuals 60 years of age and older since May 2023. Arexvy is manufactured by GlaxoSmithKline Biologicals.
• On Friday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Principal Deputy Commissioner, Dr. Namandjé Bumpus discusses the FDA’s Prescribe with Confidence campaign, three biosimilar approvals, a public meeting on Engaging the Generations as part of National Black Family Cancer Awareness Week, and the virtual listening session on advisory committee meetings. 
• On Friday, the FDA issued an update on the conclusion of the FDA co-sponsored National Academies of Sciences, Engineering, and Medicine report, The Role of Seafood in Child Growth and Development. The update noted key conclusions of the report and how it impacts future FDA-EPA Advice About Eating Fish and the Closer to Zero Initiative.