F.D.A. Failed to Ensure Safe Prescribing of Opioids

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Watched People Die Every Day –

Dec. 30, 2019 – “What’s surprising here is the design of the program was deficient from the start,” said Caleb Alexander, the senior author of the study, who serves as a paid expert witness in litigation against opioid manufacturers and distributors. “It’s unclear why the F.D.A. didn’t insist upon a more scientifically rigorous evaluation of this safety program.”

Dr. Andrew Kolodny, the co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis, said the safety program was a missed opportunity. He is a leader of a group of physicians who had encouraged the F.D.A. to adopt stronger controls, and a frequent critic of the government’s response to the epidemic.

He called the program “a really good example of the way F.D.A. has failed to regulate opioid manufacturers. If F.D.A. had really been doing its job properly, I don’t believe we’d have an opioid crisis today.”