F.D.A. Failed to Ensure Safe Prescribing of Opioids, Documents Show

The researchers also found that the F.D.A. did nothing to sharpen the safety program for the drugs, known as transmucosal immediate release fentanyls, even though it was aware of the broader prescribing. Top executives of one manufacturer, Insys Therapeutics, were criminally convicted in May of bribing doctors to prescribe and give sham educational talks about its drug Subsys, and of misleading insurers about patients’ need for the drug.

Extended-release, long-acting opioids are a much larger drug class, used by many more people. In addition to OxyContin, they include methadone and the extended-release versions of hydrocodone, hydromorphone and morphine, as well as fentanyl patches and buprenorphine, which, like methadone, is not only for pain but to treat withdrawal in people addicted to opioids.

These drugs are prescribed for pain severe enough to require daily, around the clock, long term opioid treatment. But they have often been diverted for illicit use, with many people crushing and snorting or injecting them for a particularly potent, dangerous high.

Dr. Joshua Sharfstein, a vice dean at the Johns Hopkins Bloomberg School of Public Health, and one of the paper’s authors, said it was “extraordinarily important” for the F.D.A. to not only ensure safe prescribing programs are effective, but to keep the public informed if they are not. Dr. Sharfstein was the principal deputy commissioner of the F.D.A. from March 2009 to January 2011, and said that while he was not deeply involved in developing the safety. program for long-acting opioids, “I wish I had focused on it more.”

In 2017, the F.D.A. began requiring safety programs for all opioid painkillers — not just the long-acting formulations — and updated its blueprint for the programs’ prescriber training. But Dr. Kolodny said the revised blueprint still implies that long-acting opioids are safe and effective for chronic pain, contradicting a growing body of research.

Prescription painkillers were the main cause of overdose deaths in the United States until heroin, and then fentanyl, surpassed them over the last decade. The national opioid prescribing rate started rising steadily in 2006 and peaked in 2012, at 81.3 prescriptions per 100 people, according to the Centers for Disease Control and Prevention. By 2017, the prescribing rate had fallen to the lowest it had been in more than a decade, at 58.7 prescriptions per 100 people.

But prescribing rates remain high in certain regions, and even as deaths from prescription opioids have dropped, deaths from illicitly manufactured fentanyl have continued to rise.

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