Woodcock Raps Outsourcer for Failing to Report AERs

An unregistered outsourcing facility’s failure to report details of more than 4,200 potentially serious adverse events related to compounded hormones drew the ire of CDER Director Janet Woodcock, who reminded outsourcing compounders that they must report serious adverse events to the agency.

Woodcock scolded BioTe Medical, an Irving, Texas medical center for failing to report the adverse events to the agency between 2013 and 2018. The adverse events uncovered during an inspection of the company last year, “suggested compounded hormone pellets were possibly associated with endometrial cancer, prostate cancer, strokes, heart attacks, deep vein thrombosis, cellulitis and pellet extrusion,” she said.

Because the facility’s reports lacked key information, the agency was only able to link a small percentage of the adverse events — 61 reports — to the use of compounded hormone pellets containing testosterone.