FDA Roundup: February 23, 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 announced its final decision to withdraw approval of Pepaxto (melphalan flufenamide), which was approved for use in combination with dexamethasone to treat certain patients with multiple myeloma. The agency determined the following grounds for withdrawal were met: (1) the confirmatory study conducted as a condition of accelerated approval did not confirm Pepaxto’s clinical benefit, and (2) the available evidence demonstrates that Pepaxto is not shown to be safe or effective under its conditions of use. The final decision was issued by the FDA’s Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., as the Commissioner’s designee. The decision is effective immediately. The FDA plans to publish a Federal Register notice announcing the availability of today’s decision and remove Pepaxto from the Orange Book. It is the FDA’s understanding that Oncopeptides does not currently market Pepaxto in the U.S.
• On Thursday, the FDA published the FDA Voices: “FDA Science, Research, and Collaboration Advance Generic Medicines,” by Iilun Murphy, M.D., Director, Office of Generic Drugs, Center for Drug Evaluation and Research. In 2023, the FDA continued to apply its rigorous review process for generic drug approvals and approved or tentatively approved 956 ANDAs including 90 first generics. The Office of Generic Drugs 2023 Annual Report provides a comprehensive look at what the agency accomplished in 2023 and how it is well-positioned to continue this critical work in 2024.
• On Thursday, the FDA provided an update about the Diagnostic Data Program advancing the FDA's mission and goals. The program has made substantial progress toward harmonizing diagnostic data, enhancing data quality, and creating analytics tools to optimize data use. The FDA invites interested individuals to visit the website and learn more about opportunities to engage in these efforts, including applying for future funding. The FDA is also working with numerous stakeholders through the SHIELD Collaborative Community and encourages interested parties to engage in this effort.
• On Thursday, the FDA issued a guidance for industry that describes how firms can voluntarily engage with the FDA before marketing food from genome-edited plants. The guidance reaffirms that the risk-based approach the FDA has taken for foods derived from new plant varieties also applies to foods from genome-edited plants. In addition, this guidance describes two processes through which developers may voluntarily inform the FDA of the steps they have taken to ensure the safety of foods from their genome-edited plant varieties: voluntary premarket consultations and voluntary premarket meetings. These processes can help ease the pathway to market for foods from genome-edited plants, while keeping FDA safeguards in place.      
• On Thursday, Brian King, director of the FDA’s Center for Tobacco Products (CTP), published a statement acknowledging the center’s progress on tobacco product regulation in 2023, including significant advances across key programmatic areas, and sharing updates as CTP moves ahead into 2024.
• On Wednesday, the FDA issued a safety communication warning consumers, patients, caregivers, and health care providers of risks related to using smartwatches or smart rings that claim to measure blood glucose levels (blood sugar) without piercing the skin. These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce the skin, like continuous glucose monitoring devices (CGMs). The FDA has not authorized, cleared, or approved any smartwatch or smart ring that is intended to measure or estimate blood glucose values on its own.
• On Wednesday, the FDA updated the agency’s Ingredient Directory, including renaming the web page to be Information on Select Dietary Supplement Ingredients and Other Substances. These changes are the result of some constructive stakeholder feedback received since we initially published the directory. In addition to the new title, the directory updates include adding categories to classify the type of FDA action or communication for each listed ingredient; recording the date each listed ingredient was added to the directory; and streamlining the introductory text on the page.
• On Wednesday, the FDA issued the final guidance Assessing COVID-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID-19 Prevention or Treatment. This supersedes the guidance of the same name initially published in September 2020. This guidance provides sponsors and investigators with considerations for approaches on how common COVID-19-related symptoms can be measured and analyzed in clinical trials evaluating drugs or biological products for the prevention or treatment of COVID-19 in outpatient adults and adolescents.  
• On Tuesday and Thursday, the FDA updated the advisory for the outbreak of Listeria monocytogenes linked to Cotija and Queso Fresco Cheese. Rizo Lopez, Inc. has provided a list of Retail Establishments that received Rizo-López Foods Dairy Products. This list may not include all retail establishments that have received the recalled product or may include retail establishments that did not actually receive the recalled product. Additionally, Rico Brand recalled Ready-to-eat Enchiladas distributed in northern Utah Supermarkets (Smith’s, Harmons, Macey’s The Store, Fresh Markets). They are packaged in a Deep Meal tray – Plant Fiber - Film 800 with the following lot numbers and expiration dates: Lot. 0234 02/13/24, Lot. 0264 02/16/24, Lot. 0304 02/20/24, Lot. 0334 02/23/24.
• On Tuesday, February 27, the FDA Oncology Center of Excellence presents its 6th annual Conversations on Cancer program commemorating Black History Month, “Real Talk: Our Stories as Black Oncologists at the FDA.” This virtual public panel discussion will be held from 1:00 pm to 2:30 pm ET, virtually.

  Recently, the American Society of Clinical Oncology (ASCO) released data showing that African Americans will likely continue to be under-represented in medical oncology and African Americans compose only 4% of hematology/oncology fellows in the U.S. Trends of graduating physicians from medical schools by race in the U.S. reveal the proportion of racial minorities in the field has increased substantially, except for African Americans. The relatively low number of African American medical oncologists has implications for the oncology workforce and delivery of quality cancer care. Furthermore, the National Academy of Medicine has reported a relationship between a shortage of minority health care providers and poor health outcomes for minority patients. The discussion will feature several African American medical oncologists who work at FDA to discuss their experiences, perspectives, and advice. Register here to receive the YouTube link.

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