Drugs

Act Against Compounded Semaglutide: Petition

Writing on behalf of an unnamed client, Wiley Rein is petitioning FDA to take “specific and necessary actions to address the significant and escalating public health risks associated with the large-scale production and distribution of compounded drug preparations purporting to contain semaglutide.” The petition asks for these specific FDA actions:

issue an order and guidance clarifying that any active pharmaceutical ingredient (API) intended for use in compounding semaglutide must be manufactured in a facility that is registered with FDA and has been inspected and found to fully comply with current good manufacturing practice regulations;
issue an order and/or guidance mandating that for any compounded semaglutide product where the API is produced via a fermentation process, the compounder or API manufacturer must conduct and submit to FDA for review a comprehensive immunogenicity risk assessment that rigorously evaluates the potential risks arising from process-related impurities;
issue an order or guidance classifying compounded semaglutide preparations dispensed to patients in multi-dose vials for self-injection with a manual syringe as “demonstrably difficult to compound” based on the high risk of clinically significant dosing errors;
issue new guidance or reinforce existing guidance to clarify that injectable drug products intended for subcutaneous administration, but which are dispensed without an integrated delivery system designed to ensure proper injection depth and prevent inadvertent intradermal or intramuscular administration, pose unacceptable risks to safety and efficacy;
establish and implement an enhanced, dedicated pharmacovigilance program for high-risk compounded drugs with widespread use, beginning with semaglutide;
issue an order requiring all facilities that compound semaglutide to develop and disseminate a letter to healthcare professionals to clearly and conspicuously articulate the multifaceted risks identified in the petition; and
ensure comprehensive analytical methods are validated to detect impurities, especially those derived from fermentation processes.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome