FDA cracks down on missing postmarket trial

FDA determined the Perrigo Israel Pharmaceuticals Ltd. unit of Perrigo Co. plc (NYSE:PRGO; Tel Aviv:PRGO) has failed to comply with a postmarketing trial requirement to assess the risk of major cardiovascular events (MACE) associated with its testosterone gel. As a result, the agency has determined that the testosterone replacement therapy product is misbranded, according to a June 15 letter released Friday.

FDA Commissioner Scott Gottlieb tweeted about the letter, making clear that it was intended as a warning to other companies that they must comply with postmarket trial commitments. “Postmarketing studies are important, providing additional evaluation after a drug is approved,” Gottlieb tweeted. “A company is responsible for adhering to the timetable for completing postmarketing studies.” ...