The FDA and drug manufacturers failed to act when Risk Evaluation and Mitigation Strategy (REMS)–mandated data showed that doctors were prescribing potentially deadly fentanyl products to patients for whom the drugs were contraindicated or not appropriate, according to a new study.
The research was published in JAMA (2019;321 [7]:676-685).
“Both the FDA and the fentanyl makers failed to design and implement an effective monitoring program,” said study senior author G. Caleb