File this under “What were they thinking?”
At a time when selling opioid painkillers is fraught with challenges, two companies committed an unnecessary blunder. The US Food and Drug Administration decided that Pain Therapeutics and Durect were jointly touting an experimental drug on their web sites in a way that appeared so misleading that the agency issued a rare letter to criticize their marketing practices.
According to the Sept. 8 letter, which the FDA posted on its website this week, the companies made statements that consumers might construe to mean the drug, Remoxy ER, is already approved for use. The agency pointed to certain language on the company websites — such as “long-acting” and “tamper-resistant” — that gave the impression these were “established facts” pertaining to an approved drug.
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