Comment from Florida Osteopathic Medical Association

The Florida Osteopathic Medical Association strongly supports this proposed FDA decision. As the third largest osteopathic medical association in the country, we represent thousands of doctors who believe in a holistic approach to treating our patients. GLP-1s have been an important part of our approach to managing diabetes and obesity with our patients. That is why we believe in the strongest safety standards for these medications. At the same time, we recognize that 503A compounding pharmacies can play an important role for patients who need clinically necessary, patient-specific alternatives, including alternative dosage forms or other appropriate adjustments when determined by a licensed provider. This proposed decision does not stop that important, legitimate role. However, large-scale compounding of GLP-1 products outside of patient-specific medical need has expanded in a way that puts patients at risk. These compounded products do not undergo the same safety review, manufacturing standards, or oversight as FDA-approved medications, and this can have serious consequences for patients. The FDA has received almost 1,500 reports of adverse events associated with compounded GLP-1s, including hundreds of hospitalizations and even deaths. Now some compounders are adding ingredients such as Vitamin B12, even though these combinations have not gone through clinical trials or safety testing. The medical need for the previous level of compounding during shortages is over, and with it must come a return to the level of safety patients and providers alike expect from medication produced in the United States. The FDA has taken recent enforcement actions to protect consumers, and this proposed decision is another important example of that work. By maintaining appropriate limits on bulk compounding of these drugs, FDA can help ensure that patients maintain access to safe, FDA-approved versions of their medications, while preserving access to legitimate, medically necessary compounded alternatives when clinically appropriate.