Comment from American Association of Clinical Endocrinology (AACE)
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Summary: The American Association of Clinical Endocrinology (AACE) supports the FDA's proposal to remove semaglutide, tirzepatide, and liraglutide from the section 503B bulk drug substance list. They argue that the initial shortages have ended and that compounded versions of these medications pose significant safety, quality, and efficacy risks to patients.
The American Association of Clinical Endocrinology (AACE) respectfully submits the attached comments regarding FDA's proposal concerning semaglutide, tirzepatide, and liraglutide under the 503B Bulks List (Docket No.FDA-2018-N-3240).
AACE supports policies that promote patient safety, evidence-based medical care, product quality, and access to FDA-approved therapies. As outlined in the attached letter, AACE has concerns regarding the safety, quality, efficacy, and oversight of compounded GLP-1 receptor agonist products and encourages FDA to continue prioritizing measures that protect patients while supporting appropriate access to treatment for chronic diseases such as obesity and diabetes.
Thank you for the opportunity to provide comments on this important matter.