The Food and Drug Administration Commissioner said on Thursday that makers of fast-acting opioids will have to fund voluntary training for healthcare professionals who prescribe the drugs, including education on safe prescribing practices and non-opioid alternatives.
FDA Commissioner Scott Gottlieb announced that “This week, we issued letters notifying 74 manufacturers of IR opioid analgesics intended for use in the outpatient setting that their drugs will now be subject to a more stringent set of requirements under a Risk Evaluation and Mitigation Strategy (REMS). The REMS requires that training be made available to health care providers who prescribe IR opioids, including training on safe prescribing practices and consideration of non-opioid alternatives.”
The medications, which include Vicodin and Percocet, often combine oxycodone or hydrocodone with less powerful painkillers like acetaminophen. They account for 90 percent of all opioid painkillers prescribed.
Manufacturers of long-acting opioids such as OxyContin, which release their doses over 12 hours or more, have been subject to the requirements since 2012.
Gottlieb called the immediate-release versions a “potential gateway to addiction” in a blog post Thursday.
Dr. Andrew Kolodny, founder of Physicians for Responsible Opioid Prescribing and an advocate for opioid reform, said the details of the trainings will be important in determining whether they have the potential to make a difference, but said Gottlieb’s choice of words is significant.
“To have the head of the FDA talk about addiction caused by medical treatment really suggests a change in what we hear about opioids,” Kolodny said.
The prescriber training, which could take a year to organize and implement, must include consideration of non-opioid alternatives.
Gottlieb wrote in the blog post that the agency’s new opioid policy steering committee is considering “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.”