FDA requires opioid makers to develop doctor training
The agency notified 74 manufacturers of so-called immediate-release opioids that their drugs will now be subject to the tougher requirements
By Carla K. Johnson
WASHINGTON — The Food and Drug Administration is requiring manufacturers of the most widely prescribed painkillers to provide extensive training to doctors in an attempt to reduce the number of patients who become addicted, and stem the ongoing opioid crisis.
The agency notified 74 manufacturers of so-called immediate-release opioids this week that their drugs will now be subject to the tougher requirements, although doctors would not be compelled to take part in the training.
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.
FDA Commissioner Scott Gottlieb called the immediate-release versions a "potential gateway to addiction" in a blog post Thursday.
About 2 million Americans are addicted to prescription opioids, and more than 15,000 died from overdoses involving prescription opioids in 2015.
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."