Drug Marketer BioTE Didn’t Report 4,202 Adverse Events: FDA (1)

Drug marketer BioTE Medical got some negative attention from the FDA Sept. 9 for allegedly failing to report over 4,000 adverse events related to its personalized hormone drugs.

The company had an online portal to collect the information from customers but didn’t report it to the Food and Drug Administration or any of the companies it partnered with, including Carie Boyd’s Prescription Shop and AnazaoHealth Corp., the FDA said. Carie Boyd’s and AnazaoHealth produced custom-made hormone pellets that were marketed to physicians and hospitals by BioTE Medical, which the agency said was not registered as an outsourcing facility.

The personalized ...