March 1, 2024 - FDA Roundup: March 1, 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 issued a letter of enforcement discretion for certain qualified health claims regarding the consumption of yogurt and the reduced risk of type 2 diabetes. The letter states that the FDA does not intend to object to the use of these claims, provided that they are worded so they do not mislead consumers and that other factors for the use of the claim are met. The FDA responded to a qualified health claim petition submitted on behalf of Danone North America.
   
• Today, the FDA published the FDA Voices: “FDA Works to Make Informed Consent Easier to Understand,” by Patrizia Cavazzoni, M.D., director, Center for Drug Research and Evaluation and Hilary Marston, M.D., M.P.H., chief medical officer. The FDA and the Office for Human Research Protections have published a draft guidance titled “Key Information and Facilitating Understanding in Informed Consent.” This draft guidance provides research sponsors, investigators, and institutional review boards with recommendations on how to implement two proposed requirements in the FDA proposed rule, “Protection of Human Subjects and Institutional Review Boards” and the corresponding current requirements under the revised Common Rule, including that: informed consent begins with key information about the research presented in a clear and concise manner; and, informed consent as a whole be presented in a way that facilitates understanding of the reasons why someone might or might not want to participate in the research.
   
• Today, the FDA reminded consumers that measles is not a harmless childhood disease in the Vaccination Is the Best Protection Against Measles Consumer Update. Measles is dangerous and can be life-threatening. Our most effective public health measure against measles is prevention with a measles vaccine. Vaccines approved by the FDA for the prevention of measles are proven both safe and effective. Most people who get the recommended two doses of a vaccine to prevent measles will have lifelong protection and will never get sick with measles, even if they’re exposed to the virus. 
   
• On Thursday, the FDA published the FDA Voices: “FDA Helps to Deliver Meaningful Advances for Rare Disease Patients,” by FDA Commissioner Robert M. Califf, M.D., and Sandy Retzky, D.O., J.D., M.P.H., director, Office of Orphan Products Development. Advancing the understanding of rare diseases and innovative tools to support product development is part of the FDA’s commitment to promoting safe, effective treatment options for patients. We strive to help include patient experience into development programs for all medical products, and we consider the patient experience, as appropriate, when we review the safety and efficacy of these products. 
   
• On Thursday, the FDA issued an EUA for SEKISUI Diagnostics, LLC’s OSOM Flu SARS-CoV-2 Combo Home Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first four days of symptom onset when tested at least twice over three days with at least 48 hours between tests. The test is authorized for people aged 14 years or older with self-collected anterior (nares) nasal swab specimens and those aged two years or older when an adult collects the nasal swab specimens. The OSOM Flu SARS-CoV-2 Combo Home Test is the first over the counter at-home antigen test that detects both flu and COVID-19 viruses to receive an EUA following collaboration with the National Institutes of Health Independent Test Assessment Program.
   
• On Thursday, the FDA approved the Boston Scientific Corporation’s premarket approval application for the AGENT Paclitaxel-Coated Balloon Catheter (AGENT DCB). This first of a kind, breakthrough-designated drug coated balloon is intended to be used in adult patients undergoing percutaneous coronary intervention (PCI) in certain coronary arteries and lesions for the purpose of improving myocardial perfusion when treating in-stent restenosis, a condition where a diseased artery previously treated with a stent becomes diseased again and restricts normal blood flow. The balloon catheter, which is typically inserted through the femoral artery (artery in the thigh), is guided by the physician to the coronary where it opens the diseased artery and restores blood flow while simultaneously delivering the drug Paclitaxel, which helps prevent future restenosis.
   
• On Thursday, the FDA alerted patients, caregivers, and health care providers about a higher-than-expected risk of device failure with the Hintermann Series H3 Total Ankle Replacement (TAR) system manufactured by DT MedTech LLC. The FDA is evaluating interim post-approval study (PAS) results for the Hintermann Series H3 TAR system and other real-world data. For patients with the Hintermann Series H3 TAR system, the results suggest a higher rate of failure, specifically, additional surgery (removals or revisions of metal components, at least 16.1%) associated with the implanted device compared with the rate in the premarket clinical studies (9.9%).
   
• On Thursday, the FDA updated the advisory for the Investigation of Elevated Lead & Chromium Levels in Cinnamon Applesauce Pouches to share that after additional analysis of the cinnamon collected from the manufacturer in Ecuador (Austrofoods), the FDA has confirmed that the lead and chromium previously detected in the cinnamon are from lead chromate. Historically, lead chromate has been illegally added to certain spices to increase their weight and enhance their color, which increases the monetary value of the adulterated spices. The FDA’s leading hypothesis remains that this was likely an act of economically motivated adulteration.
   
• On Wednesday, the FDA announced that grease-proofing substances containing Per and Polyfluoroalkyl Substances (PFAS) are no longer being sold by manufacturers for food contact use in the U.S. market. The completion of the voluntary market phase-out of these substances used on food packaging paper and paperboard, eliminates the primary source of dietary exposure to PFAS from authorized food contact uses. Deputy Commissioner for Human Foods, Jim Jones, issued a statement on this announcement highlighting the actions of the FDA and industry to achieve this important milestone in protecting public health. 
   
• On Wednesday, the FDA granted marketing authorization of the Technozym ADAMTS13 Activity to Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH. This is an enzyme-linked immunosorbent assay (ELISA) intended to measure ADAMTS13 activity in platelet poor human citrated plasma and to be used with other clinical and laboratory findings to help healthcare providers diagnose thrombotic thrombocytopenic purpura (TTP) in certain patients. TTP is a very rare, life-threatening blood clotting disorder caused from either a congenital or acquired absence/decrease of the von Willebrand factor-cleaving protease ADAMTS13. This action is the latest example of the FDA’s ongoing commitment to advance access to safe and effective diagnostic testing intended to aid health care professionals in making more informed decisions for patients.
   
• On Wednesday, the FDA issued a safety communication to inform patients and health care providers about the potential risk of serious complications with the use of Hologic BioZorb Marker and BioZorb LP Marker devices in breast tissue. The BioZorb Marker and BioZorb LP Marker are devices implanted in soft tissue, including breast tissue, where the site needs to be marked for future medical procedures, such as radiation for breast cancer treatment. The FDA has received reports and is aware of published literature describing serious adverse events in patients who were implanted with the BioZorb Marker or BioZorb LP Marker devices in the breast tissue.
   
• On Wednesday, the FDA announced a virtual public workshop titled Accreditation Scheme for Conformity Assessment (ASCA) Expansion that will be held on Weds., April 17from 11 a.m. to 1 p.m. ET. The purpose of this workshop is for the FDA to engage with stakeholders about potentially expanding the ASCA program, which is designed to streamline conformity assessment aspects of medical device regulatory review.
   
• On Wednesday, the FDA published an interview with Dr. Brian King, Director of the FDA Center for Tobacco Products, as part of the blog series “From a Global Perspective.” The interview focused on Dr. King’s recent participation in the Tenth Conference of the Parties, which was held in Panama City, Panama, and attended by representatives from the parties, state non-parties, and international intergovernmental and nongovernmental organizations. 
   
• On Wednesday, the FDA published the National Center for Toxicological Research (NCTR) 2023 Annual Report. The report highlights the outstanding accomplishments of NCTR research scientists and how they continue to support the FDA in generating data, advancing innovative tools and approaches that are vital to the agency's research capability, predicting risk and efficacy, and addressing emerging issues of concern to public health.
   
• On Monday, the FDA published a Center for Drug Evaluation and Research (CDER) Conversation highlighting how the center helps ensure the dosage range of narrow therapeutic index (NTI) drugs falls within a safe and effective therapeutic window for patients. The experts also discuss the specific challenges and opportunities in developing NTI generic drugs.

Related Information

###

---