FDA Roundup: December 17, 2024

For Immediate Release:: December 17, 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 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:

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.

Related Information

###

Boilerplate

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.