Comment from King Jacqueline
AnonymousSupportIndividual
Summary: Jacqueline King supports the FDA's proposed finding that there is no clinical need to include semaglutide, tirzepatide, or liraglutide on the 503B bulks list. She argues that compounded GLP-1 drugs lack the necessary safety safeguards and clinical trials required by the standard FDA approval process.
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.
The FDA's approval process is one of the most important patient protections in American healthcare. When it works as intended, patients can trust that the medicines they take have been scrutinized by independent scientists, tested in clinical trials, and manufactured under rigorous quality controls. Compounded GLP-1 drugs sidestep every one of those safeguards. The result has been a wave of recalls, adverse events, and preventable patient harm.
I urge the FDA to finalize this proposed finding and reaffirm that bulk compounding is not a lawful or safe substitute for the approval process that protects patients.
Sincerely,
Ms. Jacqueline King