Comment from National Association of Manufacturers
AnonymousSupportTrade association
Summary: The National Association of Manufacturers (NAM) supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B Bulks List. They argue that mass-compounding these drugs poses significant patient safety risks, lacks clinical necessity, and undermines the substantial investments made by manufacturers in developing FDA-approved therapies.
The National Association of Manufacturers (NAM) appreciates the opportunity to submit the attached comments in response to FDA's evaluation of "List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act".