FDA Roundup: September 27, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: 

• On Thursday, the FDA updated the Mycotoxins in Domestic and Imported Human Foods Compliance Program to include monitoring of additional mycotoxins of regulatory interest in human foods, specifically T-2/HT-2 toxins and zearalenone. The new data gained by the compliance program update will support enforcement actions, risk assessments, and international activities, as well as provide information on mycotoxin incidence, extent of contamination, and co-occurrence.  
• On Thursday, the FDA approved for marketing Motiva USA, LLC’s SmoothSilk Round and Round Ergonomix Silicone Gel-Filled Breast Implants, indicated for breast augmentation for patients of at least 22 years of age. The device approval is supported by an open-label, prospective study of 560 patients followed up to three years at more than 20 U.S. and European study sites. As a condition of the Premarket Approval Application (PMA) approval, the FDA is requiring the manufacturer to conduct post approval studies to continue follow-up of the premarket cohorts for 10 years to assess the long-term clinical performance of the device and provide these data to the FDA on an annual basis, and to conduct a new enrollment multicenter non-randomized prospective study following 2,400 patients for 10 years to assess selected safety and effectiveness issues not addressed during premarket studies, while requiring these data to be provided to FDA every six months. As with all breast implants marketed in the U.S., as a condition of approval of the PMA, Motiva is restricted to selling and distributing its breast implants only to users and user facilities that provide information to patients about the risks and benefits of this device before its use as specified in the approved labeling.
• On Thursday, the FDA announced the virtual Medical Device Sterilization Town Hall: Sterilization Short Topics and Open Q&A that will be held from 2-3 p.m. ET on Wednesday, October 9, 2024. Registration is not necessary. During this town hall, the FDA will discuss Predetermined Change Control Plans. We will also host an open question and answer session. We encourage attendees to submit questions to MedicalDeviceSterilization@fda.hhs.gov by 4 p.m. on Wednesday, October 2, 2024.  
• On Thursday, the FDA published a digital health and artificial intelligence glossary as an educational resource to help support consistent use of digital health and artificial intelligence terminology by the FDA and interested parties (such as industry, digital health developers, academia, health care professionals, and patients). The FDA encourages input and questions about the glossary by sending an email to digitalhealth@fda.hhs.gov with “Attn: DH/AI Glossary” in the subject line. The FDA plans to update the glossary as appropriate. 
• On Thursday, the FDA announced that on October 20, 2024, the Center for Veterinary Medicine (CVM) will reorganize its Office of New Animal Drug Evaluation (ONADE) into two separate offices – Office of New Animal Product Evaluation (ONAPE) and the Office of Generic Animal Drugs (OGAD).

  These changes come at a critical time in the animal drug review program. ONAPE can continue to build capacity to support review of new and innovative technologies, which CVM sees as the future of animal agriculture and animal health products. Standing up OGAD as an independent office will provide for concentrated focus for the generic animal drug program and maximize the program’s effectiveness. The reorganization also includes certain changes to CVM’s Office of Management. A full list of the upcoming changes can be found in the Federal Register notice. 

• On Wednesday, the FDA released a video titled “Importing FDA-Regulated Products: Seafood” that provides basic information for importers, foreign suppliers/exporters, and customs brokers on the steps they need to take to successfully import safe and compliant seafood into the United States.  Importers need to know many things to successfully import seafood products into the United States, including answers to such basic questions as what’s in the product, how is it handled and processed, and how it is packaged, as well as the biological, physical, and chemical hazards associated with it. Familiarity with the FDA’s seafood rules and regulations and verifying that the supplier is in compliance is also important. These topics, and more, are addressed in the video. The seafood video is the third in a series; the first video, outlining the general FDA admissibility process for imports, has been viewed over 47,000 times on YouTube since debuting in March 2022. The second video, “Importing FDA-Regulated Products: Human Foods," has been viewed over 24,000 times since its September 2023 release. Spanish and Simplified Chinese language versions of the food video will be available soon.
• On Wednesday, the FDA’s Center for Veterinary Medicine announced that it is supporting a collaborative agreement to the Reagan-Udall Foundation for the FDA (the Foundation) to conduct a strengths, weaknesses, opportunities, and threats (SWOT) analysis. This SWOT analysis aims to research the challenges within, and unmet needs of, the animal health, animal food and veterinary industries, and explain the economic impact of these gaps.
• On Wednesday, the FDA’s CVM announced the establishment of four Animal and Veterinary Innovation Centers (AVICs), which are the recipients of funding for work to advance regulatory science and further development of innovative products and approaches to better support animal health and veterinary interventions. These AVICs further the goals outlined in the FDA’s Animal and Veterinary Innovation Agenda (AVIA), which describes the agency’s plans to spur innovation to better protect human and animal health. The three areas of concentration for the AVICs focus on:
  • Highly Pathogenic Avian Influenza (HPAI) and emerging zoonotic disease threats or One Health issues; 
  • Intentional genomic alternations (IGAs) in animals and the advancement of regulatory science in this field, with a focus on IGAs that support agricultural resilience, food security, animal health, or public health; and 
  • Unmet veterinary medical needs in both minor and major species that create a significant animal or public health burden.
• On Wednesday, the FDA approved Tagrisso (osimertinib) for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. The most common adverse reactions, including laboratory abnormalities (≥20%), were lymphopenia, leukopenia, interstitial lung disease/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough, and COVID-19 infection. Full prescribing information for Tagrisso is posted on Drugs@FDA.
• On Wednesday, the FDA released its updated Information Technology (IT) Strategy for Fiscal Years 2024 – 2027, which continues to advance the agency’s efforts to modernize and enhance its technological capabilities. Developed with extensive collaboration with FDA centers, offices and internal and external stakeholders, the strategy is designed to address today's rapidly evolving technological landscape and includes new performance metrics, examples of stakeholder benefits, updated objectives and a strengthened commitment to global collaboration and strategic alignment. The strategy is paired with the FDA IT Operating Plan, which guides the agency’s efforts in transforming its technology ecosystem, enhancing governance and leveraging emerging technologies. The FDA IT Strategy and Operating Plan are updated annually to ensure the agency’s position at the forefront of technological innovation in public health. 
• On Wednesday, the FDA’s Office of Criminal Investigations, as co-lead on an investigation with the Department of Health and Human Services Office of Inspector General, was involved in an indictment in the District of Puerto Rico charging 27 individuals with conspiracy to introduce misbranded drugs and to defraud the United States, as well as unlicensed wholesale distribution and various violations of the Drug Supply Chain Security Act (DSCSA). The defendants included unlicensed wholesale distributors and pharmacy owners and employees who, in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) and the DSCSA, conspired to sell  misbranded and diverted prescription drugs from unauthorized trading partners to pharmacy customers, without the customers’ knowledge that the products were misbranded and diverted. The scheme was identified, investigated and dismantled through the efforts of FDA-OCI, HHS OIG and the U.S. Attorney’s Office, District of Puerto Rico. The co-conspirators and others engaged in this scheme unlawfully generated revenue in an amount exceeding $13,000,000 by selling and distributing misbranded and diverted prescription drugs and billing insurance, costing Medicare and Medicaid over $7.6 million.

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