November 1, 2024 - FDA Roundup: November 1, 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 published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER) and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research (CBER). The FDA Rare Disease Innovation Hub (the Hub) is an FDA cross-center program that will act as the single point of engagement and connection with outside parties for drug and biological product development and as a forum for CBER and CDER to collaborate on cross-cutting rare disease-related issues. Through the Hub, we plan to foster a community at the FDA for open dialogue and knowledge sharing to identify new approaches to drug and biologic development and overcome hurdles that have traditionally impeded progress for rare disease treatments.
• Today, the FDA published a final Compliance Policy Guide (CPG) intended to provide the FDA’s current thinking on the adulteration of fish and fishery products with Scombrotoxin (histamine). The CPG will assist the FDA in addressing adulteration associated with decomposition and histamine identified during surveillance sampling and testing. It also will increase consumer protections related to scombrotoxin (histamine) fish poisoning (SFP) by lowering the levels of histamine in fish at which the FDA indicates that it may take action.
• On Thursday, the FDA announced it will host a public meeting on Nov. 20, 2024, on recommendations for reauthorization of the OTC Monograph Drug User Fee Program (OMUFA). Registration information for this event can be found at the meetings page. The FDA welcomes comments from the public until Dec. 20, 2024. Details on how to submit to the docket can be found at the Federal Register notice. 
• On Thursday, the FDA announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS). With this approval, companies participating in the OA REMS Program have been notified that they will be required to begin providing pre-paid drug mail-back envelopes upon request to outpatient pharmacies and other dispensers of opioid analgesics by March 31, 2025. This approval follows an April 2023 letter FDA sent to manufacturers of opioid analgesics used in outpatient settings, informing them that they were required to submit a proposed modification to the OA REMS within 180 days of the date of the notice.
• On Wednesday, the FDA’s Human Foods Program (HFP) released its 2025 Priority Deliverables, which highlights activities the HFP plans to focus on during its first year following a reorganization of the program’s design and responsibilities that went into effect on October 1, 2024. These priority deliverables are being shared while the HFP works on a more comprehensive multi-year strategic plan to advance its vision and mission.  
• On Wednesday, the FDA updated the outbreak advisory for E. coli O157:H7 infections linked to slivered onions served on McDonald’s Quarter Pounders. The FDA continues to work with CDC, USDA FSIS, state partners and involved firms to investigate the outbreak. 
  
  As of Oct. 30, 90 people from 13 states have been infected with the outbreak strain of E. coli O157:H7. Of 83 people with information available, 27 have been hospitalized, and 2 people developed hemolytic uremic syndrome (HUS), a serious condition that can cause kidney failure. One death has been reported from an older adult in Colorado. This person is not one of those who developed HUS. 
  
  More illnesses have been reported but they are from before McDonald’s and Taylor Farms took action to remove slivered onions from food service locations. Epidemiologic and traceback data show that slivered onions served at affected McDonald’s locations are the likely source of this outbreak. USDA FSIS conducted a thorough investigation in response to this outbreak, including traceback and testing of beef patties served on Quarter Pounders at McDonald’s, and evidence does not point to ground beef as the likely source of contamination. Testing on beef patties by the Colorado Department of Agriculture is complete and all samples were found to be negative for E. coli.
  
  Additionally, the FDA is working with Taylor Farms and their direct customers to determine if additional downstream customer recalls are necessary after Taylor Farms recalled yellow onions that were supplied to McDonald’s and other food service customers on Oct. 22, 2024. According to available information, it is unlikely that recalled yellow onions were sold to grocery stores or directly to consumers. Food service customers who received recalled onions were contacted and should no longer be using or serving recalled onions. In addition to recall activities, the FDA has initiated inspections at a Taylor Farms processing center in Colorado and an onion grower of interest in Washington state. The FDA’s investigation is ongoing.
• On Wednesday, FDA announced that the agency issued warning letters to nine online retailers and one manufacturer for selling and/or distributing unauthorized disposable e-cigarettes with designs and functionalities that resemble smart technology, including phones and gaming devices. The products cited in the warning letters are advertised as having a variety of designs and functions that may appeal to youth, such as the ability to play games, connect to a smartphone, receive text or call notifications, play music, or personalize products with custom wallpaper. This latest round of warning letters marks another step in FDA’s continued efforts to remove unauthorized e-cigarette products from the market, particularly those that appeal to youth. 
• On Wednesday, the FDA posted a new video in the “FDA In Your Day” series. In this video, Chief Medical Officer, Dr. Hilary Marston discusses food safety.
• On Wednesday, the FDA’s Center for Devices and Radiological Health published the fall edition of the Digital Health Center of Excellence Newsletter. This edition features the Digital Health Advisory Committee that will hold a meeting on Nov. 20-21, 2024, a Digital Health and Artificial Intelligence Glossary, another update to the list of medical devices that incorporate AR/VR or AI/ML, and more.
• On Tuesday, the FDA granted accelerated approval to Scemblix (asciminib, Novartis AG) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). In the pooled safety population in patients with newly diagnosed and previously treated Ph+ CML in CP, the most common adverse reactions (≥20%) were musculoskeletal pain, rash, fatigue, upper respiratory tract infection, headache, abdominal pain and diarrhea. The most common laboratory abnormalities (≥40%) in patients with newly diagnosed Ph+ CML in CP were decreased lymphocyte count, decreased leukocyte count, decreased platelet count, decreased neutrophil count and decreased calcium corrected. Full prescribing information for Scemblix will be posted on Drugs@FDA. 

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