FDA Roundup: December 17, 2024

SILVER SPRING, Md., Dec. 17, 2024 /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 four warning letters to companies for introducing
        unapproved GLP-1s, including semaglutide, tirzepatide and/or retatrutide
        products into interstate commerce. The letters were sent to:
        --  Xcel Peptides
        --  Swisschems
        --  Summit Research
        --  Prime Peptides

The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1 products, including one that claims to be approved by FDA.

    --  Today, the FDA announced new EU requirements for importing honey and
        other apiculture products, effective November 29, 2024. The EU
        regulation requires that all establishments importing apiculture
        products into the EU (including honey, beeswax, royal jelly, propolis,
        and pollen) must register in the EU's Trade Control and Expert System
        (TRACES). Before applying for registration, exporters need an on-site
        assessment by the USDA AMS. Upon successful completion of this on-site
        assessment, exporters should apply for inclusion on the export list
        through the FDA's Export Listing Module. The FDA will maintain and
        update a list of establishments in good standing and intends to transmit
        an initial list to the EU by December 31, 2024. Establishments wishing
        to be included on the initial list should apply by December 23, 2024.
        For more details and application instructions, contact the FDA's Export
        Certification Team (hfpexportcertification@fda.hhs.gov) or the Specialty
        Crops Inspection Division (sciinspectionoperations@usda.gov).


    --  On Monday, the FDA's Center for Veterinary Medicine issued a letter to
        veterinarians regarding its evaluation of adverse events reported in
        dogs of various ages treated with Librela (bedinvetmab injection). The
        adverse events identified and analyzed include ataxia, seizures, other
        neurologic signs, including but not limited to, paresis, recumbency,
        urinary incontinence; polyuria, and polydipsia. In some cases, death
        (including euthanasia) was reported as an outcome of these adverse
        events.


    --  On Monday, the FDA issued a safety communication to alert patients,
        caregivers, and health care providers about the potential need for early
        device replacement of Boston Scientific Accolade pacemaker devices,
        which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard
        Life and Extended Life pacemakers, and the Visionist and Valitude
        cardiac resynchronization therapy pacemakers. Boston Scientific
        announced a recall for a subset of Accolade pacemaker devices with an
        increased risk to permanently enter Safety Mode, which has limited
        functionality and has been associated with the pacemaker being unable to
        properly regulate the heart's rhythm and rate in some patients. A device
        that enters Safety Mode should be replaced. The increased risk of
        permanently entering Safety Mode in this subset of Accolade pacemaker
        devices is due to the battery underpowering the system because of a
        manufacturing issue.


    --  On Monday, the FDA announced a continuation of their webinar series
        exploring food safety culture. The FDA is again partnering with Stop
        Foodborne Illness, a non-profit public health organization, on this
        seven-part webinar series. Registration is now available for all seven
        webinars. The first webinar in the new series is scheduled for January
        29, 2025.


    --  On Monday, the FDA Office of Inspections and Investigations (OII)
        published a feature story titled, "FDA Office of Criminal Investigations
        Agents Catch Doctor Who Poisoned Patients with tainted IV Bags." The
        feature story highlights the work conducted by the Office of Criminal
        Investigations that identified the suspect responsible for tampering
        with IV bags at Baylor Surgicare in North Dallas, TX.


    --  On Monday, the FDA updated a prior Drug Safety Communication with the
        addition of a Boxed Warning due to a known risk of serious liver injury
        with use of Veozah (fezolinetant), a drug indicated to treat hot flashes
        caused by menopause.


    --  On Friday, the FDA approved Unloxcyt (cosibelimab-ipdl), a programmed
        death ligand-1 (PD-L1) blocking antibody, for adults with metastatic
        cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC
        (laCSCC) who are not candidates for curative surgery or curative
        radiation. The most common adverse reactions (>=10%) were fatigue,
        musculoskeletal pain, rash, diarrhea, hypothyroidism, constipation,
        nausea, headache, pruritis, edema, localized infection, and urinary
        tract infection.


    --  On Friday, the Interagency Food Safety Analytics Collaboration's (IFSAC)
        issued its annual report, "Foodborne illness source attribution
        estimates for Salmonella, Escherichia coli O157, and Listeria
        monocytogenes - United States, 2022." IFSAC is a collaboration between
        the FDA, the U.S. Centers for Disease Control and Prevention, and the
        U.S. Department of Agriculture Food Safety and Inspection Service. The
        group was established in 2011 to improve coordination of federal food
        safety analytic efforts and address cross-cutting priorities for food
        safety data collection, analysis, and use.


    --  On Friday, the FDA approved Crenessity (crinecerfont) to be used
        together with glucocorticoids (steroids) to control androgen (a
        testosterone-like hormone) levels in adults and pediatric patients 4
        years of age and older with classic congenital adrenal hyperplasia
        (CAH). Classic congenital adrenal hyperplasia is a rare genetic
        condition affecting the adrenal glands, which produce hormones such as
        cortisol and androgens.
    --  On Friday, the FDA Office of Criminal Investigations was involved in a
        Justice Department announcement regarding the resolution of a criminal
        and civil investigation into work the consulting firm McKinsey & Company
        did with opioids manufacturer Purdue Pharma L.P. (Purdue). The
        resolution pertains to McKinsey's advice to Purdue concerning the sales
        and marketing of Purdue's extended-release opioid drug, OxyContin,
        including a 2013 engagement in which McKinsey advised on steps to
        "turbocharge" sales of OxyContin. A former McKinsey senior partner was
        charged with obstruction of justice in connection to the crime.
        Additionally, McKinsey knowingly misled the FDA by assigning consultants
        to concurrently work on both FDA projects and competitively sensitive
        Purdue projects, contrary to McKinsey US' conflict of interest policy.
        McKinsey will pay $650 Million, cease work relating to controlled
        substances for five years, and implement significant new compliance
        measures. The resolution marks the first time a management consulting
        firm has been held criminally responsible for advice resulting in the
        commission of a crime by a client and reflects the government's ongoing
        efforts to hold actors accountable for their roles in the opioid crisis.
        The resolution is also the largest civil recovery for such conduct.

Additional Resources:

    --  FDA Newsroom

Media Contact: FDA Office of Media Affairs, 301-796-4540
Consumer Inquiries: 888-INFO-FDA

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, radiation-emitting electronic products, and for regulating tobacco products.

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SOURCE U.S. Food and Drug Administration