FDA Roundup: June 28, 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 updated the advisory for illnesses associated with eating Diamond Shruumz-brand Chocolate Bars, Cones, and Gummies to announce that all flavors of Diamond Shruumz-brand products have been recalled. Consumers should not eat, sell, or serve any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies, and should discard them. Retailers should not sell or distribute any flavor of Diamond Shruumz-brand Chocolate Bars, Cones, or Gummies. Additional instructions on how to return or dispose of the product are available on the firm’s press release.  As part of this investigation, the FDA and state partners have collected multiple samples of Diamond Shruumz-brand products for testing and analysis. Additional sample analysis is ongoing, but as of June 25, 2024 test results for two individual chocolate bars collected from a retail store have been reported on the advisory. The FDA and CDC medical officers are interpreting these test results to understand the health risks of ingesting these chemical substances and to determine the appropriate next steps. 
• Today, the FDA issued a Constituent Update highlighting the updated list of draft and final guidance topics that are a priority for the agency’s Foods Program to complete during 2024. 
• Today, the FDA announced the draft guidance, Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. The guidance is intended to facilitate and streamline development of stand-alone devices, and combination products with device constituent parts, intended to deliver drugs and biological products, by improving the consistency of drug delivery performance information included in applications and submissions. Drug delivery performance information is intended to demonstrate that the device drug-delivery function consistently performs as intended. The guidance includes examples of potential essential drug delivery outputs for several product types including prefilled syringes, injectors, nasal sprays, and inhalation devices.
• On Thursday, the FDA published the “Catching Up with Califf: The Concerning Trend in Men’s Health,” by Robert M. Califf, M.D., Commissioner of Food and Drugs. In this article Dr. Califf brings attention to a startling paradox: despite unprecedented technological advances that have saved lives globally, and despite spending more on healthcare than any other nation on earth, life expectancy in the U.S. is trending downward. Taking a closer look at the data, it’s clear that one group in particular is falling behind—men.
• On Thursday, the FDA announced the seizure of 53,700 unauthorized e-cigarette products valued at more than $1.08 million. The FDA worked with U.S. Customs and Border Protection to seize the shipment at the Chicago port of entry, though the unauthorized products were intended for a wholesaler based in Mississippi.
• On Thursday, the FDA released a From Our Perspective blog titled, “FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program.” Bylined by Dr. Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research and Dr. Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research, the blog shares the names of the selected pilot program participants and how the pilot will help accelerate the development of novel drugs and biologics. CBER and CDER look forward to actively working together to fulfill our shared vision of accelerating the development of better treatment options for patients and their families. For questions about the START Pilot Program, please contact CDER’s START Pilot Program mailbox (CDER.STARTProgram@fda.hhs.gov) or CBER’s Office of Communication, Outreach and Development (ocod@fda.hhs.gov). For additional information about individual sponsors and products, please contact the sponsors directly.
• On Thursday, the FDA determined the national supply of cisplatin now exceeds demand, ending the national shortage for the important cancer drug. Since the shortage was announced on February 10, 2023, the FDA has taken every step within our statutory authority to tackle cancer drug supply issues, including: 
  • Working closely with five cancer drug manufacturers to provide assistance and support their efforts to increase manufacturing capacity. 
  • Helping another manufacturer who had previously stopped producing an approved cisplatin product reenter the market. 
  • Temporarily exercising discretion not to enforce importation requirements with regard to cisplatin to help meet patient needs during the shortage. As with all temporary importation, the product and manufacturing sites were thoroughly evaluated to help protect U.S. patients. That manufacturer has since received FDA approval for cisplatin, bringing the total number of approved manufacturers to seven.   
  The FDA will continue to work with drug manufacturers and health care providers to help restore access to essential cancer treatments and other medicines that are currently in short supply.
• On Thursday, the FDA published the Medical Countermeasures Initiative (MCMi) Program Update report, which showcases the agency's work each year to prepare for all types of public health emergencies. Covering fiscal year 2023, the report includes updates on the FDA's work agency-wide to support development of and access to medical countermeasures for a variety of public health threats.
• On Thursday, the FDA announced the 26th Session of the International Medical Device Regulators Forum that will be held in Seattle, Washington, on September 16-20, 2024. Medical device stakeholders — including regulators, industry, academia, and the media — are invited to attend a free event that is open to the public, virtually or in-person, on September 16-17. The last three days (September 18-20) are for IMDRF invitees only. Please note that space is limited for in-person attendance and early registration is encouraged. You can also attend the meeting by livestream. The deadline to register is August 26, 2024.
• On Wednesday, the FDA’s Center for Veterinary Medicine and the European Medicines Agency announced updates to the Parallel Scientific Advice (PSA) program for new animal drug products to increase harmonization and facilitate development of new products to support animal health. The animal drug industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of drug product development. The PSA program allows for animal drug sponsors to engage in concurrent scientific conversation with both agencies, the FDA and the EMA, on key issues during the development phase of new animal drug products.
• On Wednesday, the FDA warned consumers in Safely Soothing Teething Pain in Infants and Children about the dangers of treating children's teething pain with medicines containing benzocaine or lidocaine. Teething is a normal experience for infants and children. Soothing children’s gums with prescription or nonprescription medicines containing benzocaine or lidocaine – or homeopathic tablets and other products – might seem like good options. But those products can be dangerous to children and can lead to serious injury, and even death. 
• On Wednesday, the FDA announced the virtual Medical Device Sterilization Town Hall: Mock Pre-Submission on Implementing a Change in Sterilization Method that will be held on July 10, 1-2:30 p.m. ET. We will present a mock pre-submission for a fictional medical device and explore regulatory, design and testing considerations when there is a change in sterilization method. Registration is not required to attend.
• On Wednesday, the FDA announced a partnership with the Bill and Melinda Gates Foundation to create new analytical methods to help the development of breath-based diagnostic devices for infectious disease detection in underserved populations, thereby promoting and fostering health equity. “Guided by our shared interest in advancing health equity and equality, this partnership can ultimately open the possibility of widespread disease detection in medically underserved populations both domestically and globally,” said CDRH Director Jeff Shuren, M.D., J.D., and CDRH’s Office of Science and Engineering Laboratories (OSEL) Director Ed Margerrison, Ph.D. The methods will include a database of chemical information, criteria for classifying confidence of a chemical identification and a web application for analysis of mass spectrometry data. These methods are intended to help drive confidence in measurement techniques and ultimately reduce risk for developers, medical device innovators and regulators.
• On Wednesday, the FDA granted accelerated approval to Epkinly (epcoritamab-bysp), a bispecific CD20-directed CD3 T-cell engager, for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The most common adverse reactions (≥20%) were injection site reactions, cytokine release syndrome, COVID-19 infection, fatigue, upper respiratory tract infection, musculoskeletal pain, rash, diarrhea, pyrexia, cough, and headache. The most common Grade 3 to 4 laboratory abnormalities (≥10%) were decreased lymphocyte count, decreased neutrophil count, decreased white blood cell count, and decreased hemoglobin. 
• •    On Tuesday, the FDA announced the availability of final guidance for industry (GFI) #276 entitled “Effectiveness of Anthelmintics: Specific Recommendations for Products Proposed for the Prevention of Heartworm Disease in Dogs.” The guidance is intended for animal drug sponsors interested in pursuing approval of new heartworm prevention products for dogs. The FDA received eight comment submissions on the draft guidance, and all comments were considered as the guidance was finalized. The guidance announced in the June 25 notice finalizes the draft guidance dated November 30, 2022.
• On Tuesday, the FDA announced the availability of final guidance for industry #283 entitled “Priority Zoonotic Animal Drug Designation and Review Process.” The guidance is intended to help animal drug sponsors pursuing Priority Zoonotic Animal Drug (PZAD) designation for a new animal drug. PZADs are new animal drugs that have the potential to prevent or treat a zoonotic disease in animals, including a vector-borne disease, that has the potential to cause serious adverse health consequences for, or serious or life-threatening diseases in humans. This guidance is intended to help expedite the development and review of these drugs. The FDA received several comments on the draft guidance, and those comments were considered as the guidance was finalized. The guidance announced in the June 25 notice finalizes the draft guidance dated December 2023.
   

Related Information

###