FDA chief to impose tougher doctor-training rules on opioid manufacturers

(BY: LAURA MCGINLEY, THE WASHINGTON POST) – Food and Drug Administration Commissioner Scott Gottlieb, stepping up the agency’s efforts against the nation’s opioid epidemic, announced plans Monday to require manufacturers of painkillers to provide more extensive education for physicians and other health-care professionals who prescribe the drugs.

In remarks that opened a two-day FDA meeting on painkiller abuse, Gottlieb said the agency will now require makers of immediate-release opioids to provide prescriber training. These formulations, which account for 90 percent of the opioids prescribed in the United States, include hydrocodone as well as oxycodone/acetaminophen combinations.

Currently, only makers of extended-release products, which make up the other 10 percent of prescriptions, are required to provide such training.

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