FDA Roundup: October 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 has issued an immediately-in-effect guidance, Temporary Policies for Compounding Certain Parenteral Drug Products, for compounders to help fill the gaps from the impact of Hurricane Helene on Baxter International’s North Cove facility.  The FDA also added three new drug products to the Drug Shortages Database as a result of Hurricane Helene. The agency now considers Dextrose 70% IV solution, Lactated Ringers IV Solution, and Peritoneal Dialysis Solution to not be commercially available in adequate supply to meet national demand.

  The FDA is working continuously to address the shortages and supply disruptions to ensure patients have access to certain parenteral drugs, including IV solutions. For the most recent information on drug and biologic products that were impacted by Hurricane Helene, please see FDA’s Baxter Recovery webpage.

• On Thursday, the FDA posted a new video in the “FDA In Your Day” series. In this video Chief Medical Officer, Dr. Hilary Marston, discusses the at-home test options available for respiratory illness. 
• On Thursday, the FDA announced the publication of the 2023 Summary Report on Antimicrobials Sold or Distributed for Use in Food-Producing Animals. The 2023 data indicated that U.S. sales and distribution of medically important antimicrobial drugs approved for use in food-producing animals decreased by 2% between 2022 and 2023; this represents a 37% decrease in sales since they peaked in 2015. In addition, the FDA updated its Biomass-Adjusted Antimicrobial Sales and Distribution Data in Food-Producing Animals: Interactive Summary to include the 2023 data.
• On Thursday, the FDA’s Center for Devices and Radiological Health (CDRH) published a list of proposed guidances for fiscal year (FY) 2025. CDRH identified guidance document priorities in the A-list and B-list and identified final guidance that will be retrospectively reviewed during FY 2025. Additionally, CDRH provided a new list, Under Construction, which is intended to further promote transparency on CDRH guidance development plans. Feedback is critical in shaping CDRH’s guidance development plans. Submit comments on CDRH’s FY 2025 proposed guidance document development at www.Regulations.gov under docket number FDA-2012-N-1021.
  • On Thursday, the FDA approved Itovebi (inavolisibwith) palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy. The FDA also approved the FoundationOne Liquid CDx assay as a companion diagnostic device to identify patients with breast cancer for treatment with inavolisib with palbociclib and fulvestrant. The most common adverse reactions (≥20%), including laboratory abnormalities, were decreased neutrophils, decreased hemoglobin, increased fasting glucose, decreased platelets, decreased lymphocytes, stomatitis, diarrhea, decreased calcium, fatigue, decreased potassium, increased creatinine, increased ALT, nausea, decreased sodium, decreased magnesium, rash, decreased appetite, COVID-19 infection, and headache.
• On Thursday, October 2, the FDA, CDC, and NIH released a consensus statement on a recent advisory council report on premature infants and Necrotizing Enterocolitis (NEC). The consensus statement notes that there are two key points about feeding practices and NEC: (1) there is no conclusive evidence that preterm infant formula causes NEC; and (2) there is strong evidence that human milk is protective against NEC. In addition, the consensus statement notes that evidence to date suggests that preterm birth is the primary risk factor for developing NEC, but important scientific gaps exist for understanding the epidemiology of NEC, biologic mechanisms of NEC and the exposures and feeding practices that may be positively or negatively associated with the risk of NEC development, severity and mortality. As collective work continues on this important topic, one point remains clear: while there is a preference for human milk, all infants should be fed as soon as is medically feasible through whatever appropriate nutritious food source is available.
   

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