Comment from Towe Harold
AnonymousSupportIndividual
Summary: Mr. Harold Towe supports the FDA's proposal to exclude semaglutide, tirzepatide, and liraglutide from the 503B bulk drug substances list. He argues that the current compounded GLP-1 market poses significant patient safety risks due to inadequate medical evaluations and lack of FDA oversight.
List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act,
I am writing in support of the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide
on the 503B bulks list. One of the most troubling aspects of the compounded GLP-1 market is how it reaches patients — through online platforms where a brief questionnaire substitutes for a real medical evaluation, and where patients may not even realize they are receiving a product that has never been through FDA review. This is not a safe or appropriate model for prescribing medications that carry real risks when improperly dosed or manufactured.
The FDA's proposed finding addresses this patient safety crisis directly. I urge the agency to finalize this rule and reaffirm that the approval process exists to protect patients — not to be bypassed.
Sincerely,
Mr. Harold Towe