FDA Commissioner Scott Gottlieb on Monday announced the agency plans to require manufacturers of immediate-release opioids to offer extensive training to health care professionals on how to properly prescribe the drugs.
According to the Washington Post's "To Your Health," 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.
Gottlieb made the announcement during an FDA meeting on strategies to evaluate the effects of opioid misuse. He said the agency will implement the requirements by adding immediate-release opioids to FDA's Risk Evaluation and Mitigation Strategy (REMS) program.
Gottlieb said the United States is "awash in immediate-release opioid products" and that the new requirements "will be aimed at making sure providers who write prescriptions for the opioids are doing so for properly indicated patients and under appropriate clinical circumstances."
While FDA will not require health care providers to take part in the training, Gottlieb said the agency is contemplating whether to pursue such requirements. "Based on the feedback we’ve received from two public meetings over the past year,” Gottlieb said, "we're actively exploring the question of whether, in the future, there should be mandatory provider education, and how we’d operationalize such a condition."
Gottlieb added that requiring opioid manufacturers to offer training on how to prescribe the drugs is "not just important from a public health standpoint in its own right, but [is] an important foundational step in [the agency's] ability to consider and contemplate broader programs" related to prescriber training.
Further, Gottlieb during the meeting said FDA plans to:
- Conduct a study to gauge physicians' understanding of misuse-deterrent opioids;
- Consider legal actions it can take regarding opioids with higher risks than benefits; and
- Mandate drugmakers offer prescriber training on non-medical treatments for pain management and opioid misuse disorders (McGinley, "To Your Health," Washington Post, 7/10; Burton, Wall Street Journal, 7/10; Fiore, MedPage Today, 7/10; Diamond, "Pulse," Politico, 7/11).
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