In May 2024, the U.S. Food and Drug Administration (FDA) made several significant announcements and approvals, highlighting its dedication to advancing medical treatments, ensuring public health, and modernizing regulatory practices. These updates underscore the FDA’s commitment to enhancing its operational efficiency, expanding access to critical medical treatments, and addressing public health challenges through innovation and collaboration.
By implementing strategic changes and approving new treatments, the FDA continues to demonstrate its proactive approach to safeguarding public health and fostering an environment where medical advancements can thrive. This month’s developments reflect the agency’s ongoing efforts to adapt to the evolving landscape of healthcare, improve the regulatory framework, and support the introduction of innovative solutions that address the diverse needs of the population.
FDA Advances Regulatory Reorganization and Approvals
The FDA announced the approval of its reorganization plan to create a unified Human Foods Program (HFP) and a new model for field operations, targeted for implementation by October 1, 2024. This reorganization aims to enhance the agency’s ability to oversee and protect the human food supply and other regulated products. The restructuring will consolidate various functions under the HFP, including the Center for Food Safety and Applied Nutrition and the Office of Food Policy and Response. The Office of Regulatory Affairs will be renamed the Office of Inspections and Investigations to better reflect its core mission of inspections and investigations. This modernization effort will allow the FDA to respond more effectively to industry changes, globalization, and public health emergencies. (https://www.fda.gov/news-events/press-announcements/fdas-reorganization-approved-establishing-unified-human-foods-program-new-model-field-operations-and)
The FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Bkemv is a monoclonal antibody that inhibits the complement system to prevent the breakdown of red blood cells. This approval marks the 53rd biosimilar approved in the U.S. and underscores the FDA’s commitment to increasing access to affordable treatments for rare diseases. (https://www.fda.gov/news-events/press-announcements/fda-approves-first-interchangeable-biosimilar-two-rare-diseases)
The FDA issued final guidance to clarify the definition of “remanufacturing” for reusable medical devices needing maintenance or repair. The guidance aims to ensure consistency and promote a better understanding of federal laws and regulations related to remanufacturing activities. This clarification will help maintain the safety and performance of medical devices while facilitating proper servicing and repair. (https://www.fda.gov/news-events/press-announcements/fda-issues-final-guidance-clarify-remanufacturing-devices-need-maintenance-or-repair)
In response to President Biden’s Executive Order 14081, the FDA, along with the EPA and USDA, developed a plan to update and streamline regulations for biotechnology products. This plan aims to improve transparency, predictability, coordination, and efficiency in the regulatory system for biotechnology. The agencies will focus on clarifying regulatory oversight for genetically engineered plants, animals, and microorganisms, among other areas. (https://www.fda.gov/news-events/press-announcements/epa-fda-and-usda-issue-joint-regulatory-plan-biotechnology)
FDA has greenlit several treatments addressing various medical needs. The FDA approved Moderna’s mRESVIA, an mRNA-based vaccine, for preventing lower respiratory tract disease caused by respiratory syncytial virus (RSV) in individuals aged 60 and older. Additionally, lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) received approval for adult patients with relapsed or refractory mantle cell lymphoma (MCL), following at least two prior lines of systemic therapy, including a BTKi, with a Risk Evaluation and Mitigation Strategy in place due to potential severe side effects. The FDA also advanced its START Pilot Program, designed to accelerate the development of treatments for rare diseases by facilitating rapid, ad-hoc communication with selected participants. Moreover, selpercatinib (Retevmo, Eli Lilly and Company) was granted accelerated approval for pediatric patients with RET alterations, marking the first FDA approval of a targeted therapy for patients under 12 years of age with these genetic changes. Finally, the FDA approved the first generics of Entresto (sacubitril and valsartan) tablets, aimed at reducing cardiovascular death and hospitalization risks in adult patients with chronic heart failure, as well as treating symptomatic heart failure in pediatric patients aged one year and older. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-31-2024)
FDA made several key announcements and approvals aimed at advancing medical treatments and clinical trial inclusivity. The FDA approved the first two interchangeable biosimilars to Eylea (aflibercept), Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy), which work by inhibiting vascular endothelial growth factors (VEGF) to prevent abnormal blood vessel growth in the eye and preserve vision. The FDA also published an article, “FDA Promotes Clinical Trial Innovation,” highlighting the progress made in clinical trials due to the contributions of participants, healthcare professionals, and the research community. Additionally, the FDA Oncology Center of Excellence (OCE) announced the formation of The OCE Equity Program, expanding efforts to improve access to oncology clinical trials for historically underrepresented populations, including racial and ethnic minorities, rural residents, and those with economic or cultural barriers. Furthermore, the FDA launched the precisionFDA Phase 1 of the Digitally-Derived Endpoints for Freezing-of-Gait Detection Challenge, seeking AI models to predict freezing of gait events in Parkinson’s disease, demonstrating a continued commitment to leveraging technology for medical advancements. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-21-2024)
Advancing Healthcare, Public Safety, and Innovation
FDA made several significant announcements, underscoring its commitment to public health and safety. On Thursday, Medline Industries, LP, and Jiangsu Shenli Medical Production Co. Ltd, both involved in distributing unauthorized plastic syringes made in China, initiated recalls of these products. The FDA continues to monitor and address issues with these syringes. Additionally, the FDA Commissioner, Dr. Robert M. Califf, discussed the “Prescribe with Confidence” campaign aimed at raising awareness and providing resources for opioid use disorder (OUD) treatment. In another development, the FDA cleared the CamAPS FX app by CamDiab Ltd, designed for automated insulin dosing to manage type 1 diabetes, marking the first such device approved for use in pregnant patients. Furthermore, the FDA issued a supplemental approval for Safe-Guard (fenbendazole) for treating gastrointestinal worms in wild quail, providing a crucial tool for wildlife management. These updates reflect the FDA’s ongoing efforts to enhance medical treatment options, ensure product safety, and support public health initiatives. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-24-2024)
FDA made several important announcements, reflecting its dedication to advancing medical treatments and ensuring public health. On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for treating extensive stage small cell lung cancer (ES-SCLC) with a Boxed Warning for serious side effects like cytokine release syndrome (CRS) and neurologic toxicity. The same day, the FDA qualified a patient-reported outcome instrument to assess ocular symptoms post intraocular lens implants. Additionally, the FDA issued an import alert for Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. due to quality issues with their plastic syringes and advised transitioning away from these products. On Wednesday, the FDA granted accelerated approval to lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for adults with relapsed or refractory follicular lymphoma (FL), with a Risk Evaluation and Mitigation Strategy for CRS and neurologic toxicities. Furthermore, on Tuesday, the FDA expanded the indications for use (IFU) of the Beckon, Dickinson (BD) and Co. Onclarity HPV Assay and the Roche Molecular Systems, Inc. cobas HPV Test, allowing for patient self-collected vaginal swabs in clinical settings, thereby enhancing cervical cancer screening options. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-17-2024)
FDA issued guidelines on safely charging medical devices like hearing aids and insulin pumps to prevent overheating and potential fires or burns. Additionally, Sol-Millennium Medical, Inc. initiated a recall of unauthorized plastic syringes made in China, with the FDA continuing to monitor and evaluate these products’ safety. The FDA also alerted healthcare providers about ongoing safety concerns with Getinge/Maquet/Datascope Intra-Aortic Balloon Pump devices, recommending a transition to alternative solutions. On Tuesday, the FDA announced the opening of registration for a June 27 public workshop focused on the therapeutic use of ketamine, aimed at exploring its scope, safety, and online promotion. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-10-2024)
FDA’s Office of Science and Engineering Laboratories launched an enhanced online Regulatory Science Tool (RST) Catalog, which now offers improved search and browse capabilities and supports long-term growth in published tools. The catalog, organized by research program and device type, provides peer-reviewed resources for medical device companies. Additionally, the FDA issued a safety communication warning against the use of Cue Health’s COVID-19 Tests due to an increased risk of false results and a Warning Letter to Cue Health following an inspection that revealed reliability issues. On Friday, the FDA conditionally approved UpCard-CA1 (torsemide oral solution), the first torsemide animal drug for dogs, for managing pulmonary edema in dogs with congestive heart failure caused by myxomatous mitral valve disease (MMVD). (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-14-2024)
FDA announced the qualification of the Apple Atrial Fibrillation History Feature through the Medical Device Development Tools (MDDT) program. This tool is the first digital health technology to be qualified under the MDDT program and provides a non-invasive method to estimate atrial fibrillation (AFib) burden within clinical studies. The device is designed as a biomarker test to evaluate AFib burden estimates as a secondary effectiveness endpoint in studies assessing the safety and effectiveness of cardiac ablation devices. It is intended to be used throughout the clinical study, both before and after cardiac ablation treatment, to monitor participants’ weekly AFib burden estimates. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-3-2024)
FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to discuss a new drug application for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the treatment of post-traumatic stress disorder. Additionally, the FDA’s Center for Biologics Evaluation and Research rescheduled the May 16 meeting of the Vaccines and Related Biological Products Advisory Committee to June 5, to discuss the selection of strains for the 2024-2025 COVID-19 vaccine formula. This change allows for more up-to-date surveillance data to ensure the vaccines are suitable for the upcoming Fall vaccination campaign. On Monday, the FDA and the National Institutes of Health (NIH) published a request for public comments on a proposed glossary of clinical research terminology to establish a common vocabulary and improve communication within the clinical research community. (https://www.fda.gov/news-events/press-announcements/fda-roundup-may-7-2024)
In conclusion, the FDA’s updates in May 2024 reflect a comprehensive approach to advancing healthcare, ensuring public health and safety, and fostering innovation in medical treatments and technologies. The agency’s efforts span a wide range of areas, from regulatory modernization and biosimilar approvals to enhancing clinical trial inclusivity and addressing public health challenges through collaboration and technological advancements.
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