July 11, 2017
The FDA will begin requiring drug makers to provide and pay for training for clinicians prescribing immediate-release (IR) opioids – mirroring existing mandates for extended-release (ER) opioids.
Noting that “America is simply awash in immediate release opioid products,” FDA Commissioner Scott Gottlieb, MD, announced new FDA initiatives targeting the opioid epidemic. At a recent FDA meeting on abuse-deterrent drug formulations, Dr. Gottlieb said that 90% of all U.S. opioid prescriptions are for IR formulations, translating to 200 million prescriptions a year.
The FDA will notify manufacturers of the new requirements over the next few weeks. All IR formulations will be subject to the same Risk Evaluation and Mitigation Strategy (REMS) program as ER opioids, with drug makers being required to cover the cost of prescriber training.
While drug makers must provide and pay for the training, the training is voluntary for clinicians.