FDA Roundup: June 13, 2023

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Jun 13, 2023, 16:09 ET

SILVER SPRING, Md., June 13, 2023 /PRNewswire/ -- Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

Today, the FDA published the FDA Voices: "Accelerating Rare disease Cures (ARC) Program Emerges as a Conduit for Empowering Rare Disease Stakeholders," by Kerry Jo Lee, M.D., Associate Director for Rare Diseases, Rare Diseases Team, Division of Rare Diseases and Medical Devices, Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine, Office of New Drugs, Center for Drug Evaluation and Research. The ARC Program strives to increase the number of treatments by promoting innovative scientific design, providing a deeper understanding of regulatory policies, and engaging with patients and their advocates, and other rare disease stakeholders.
On Monday, the FDA announced that Guidance for Industry (GFI) #263 has been fully implemented and all affected animal drug sponsors opted to either voluntarily change the approved marketing status of certain medically important antimicrobial drugs for animals from over-the-counter (OTC) to prescription (Rx) or to voluntarily withdraw approval of their affected OTC animal drug applications. As a result, all products affected by GFI #263 that enter the marketplace will now have prescription labels. Animal owners and caretakers will still have access to appropriate antimicrobials to address animal health issues by consulting with a licensed veterinarian. The successful implementation of GFI #263 is an encouraging demonstration of the commitment of animal drug sponsors and veterinarians to support the judicious use of antimicrobials in animals.
On Friday, the FDA authorized for marketing Futura Medical Developments Limited's Eroxon (MED3000), a non-medicated hydro-alcoholic gel indicated for treatment of erectile dysfunction in adult males aged 22 years and over. Upon application, the volatile components of the formulation (alcohol and water) evaporate to create a rapid, localized cooling effect on the glans penis followed by a recovering slower warming effect. This stimulates the nerve endings leading to tumescence and erection. This authorization marks the first over-the-counter gel intended to treat erectile dysfunction.
On Thursday, the FDA hosted its fourth Online Controlled Substances Summit, "Reducing the Availability of Controlled Substances Online." Addressing the illegal availability of opioids and other controlled substances online is an integral part of FDA's overall efforts to protect the public, including youth, from harm associated with drugs that have abuse potential. The proliferation of prescription drugs being sold through unsafe websites and social media platforms presents unique challenges for regulators, law enforcement, parents, policy makers, and others working to preventing these dangerous products from reaching and harming the American public. Summit attendees from the public and private sector - including those from the internet ecosystem, academia, and regulatory organizations - discussed these challenges and ways to develop strategic and effective solutions.
On Thursday, June 15, at 2:30 pm ET, the FDA Oncology Center of Excellence will host Conversations on Cancer - National Black Family Cancer Awareness Week, Engaging the Generations, an online public panel discussion kicking off National Black Family Cancer Awareness Week, June 15-21, 2023, which begins annually on the Thursday before the Federal Juneteenth Holiday. The mission is to increase cancer awareness, increase cancer equity, reduce morbidity and mortality, and prevent unnecessary cancer burden on families in the most vulnerable populations.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration