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October 3, 2017

FDA to require immediate-release opioid makers to fund voluntary provider training

Daily Briefing

FDA on Thursday notified 74 manufacturers of immediate-release opioids that they will be required to make training available to health care professionals involved in pain management.

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Immediate-release opioids account for about 90 percent of opioids prescribed in the United States. FDA currently requires manufacturers of extended-release opioids, which comprise the remaining 10 percent of opioids prescribed in the country, to offer prescriber training, though health care professionals are not required to participate in the training.

Program details

In a blog post, FDA Commissioner Scott Gottlieb said immediate-release opioids will be added to the agency's Risk Evaluation and Mitigation Strategy (REMS) program, which requires drugmakers to make training available on safe prescribing practices and non-opioid treatment options. The agency also said it was expanding the REMS program to feature additional material on pain management, including details on non-opioid alternatives, the safe use of opioids, and "basic information" on addressing substance misuse disorders.

The training will not be mandatory for clinicians, but FDA said it is mulling "whether there are circumstances when FDA should require some form of mandatory education for health care professionals, and how the agency would pursue such a goal." Additionally, FDA for the first time will make the training available to health care professionals other than doctors who are involved in pain management, such as nurses and pharmacists. According to Gottlieb, the revamped and expanded training is expected to take roughly a year to finalize and implement.

In addition, Gottlieb said FDA will soon release final guidance for drugmakers on how they can win approval for generic versions of misuse-deterrent opioid products. Currently, according to Gottlieb, all misuse-deterrent opioid products are brand-name only.

Gottlieb wrote, "By putting in place safety measures for immediate-release opioid analgesics, and creating a more robust path to converting the high dose opioids to formulations that are more resistant to manipulation, we are addressing both ends of this crisis." He added, "Our hope is that we can help prevent new patients from becoming addicted, and keep some individuals from experiencing the serious adverse effects associated with these medications."

Separately, Andrew Kolodny, the founder of Physicians for Responsible Opioid Prescribing, praised the announcement, but he said the specifics of the training will be vital in determining whether it makes a difference. "To have the head of the FDA talk about addiction caused by medical treatment really suggests a change in what we hear about opioids," he said (Johnson, AP/ABC News, 9/28; Gever, MedPage Today, 9/28; FDA blog post, 9/28).

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