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

FDA Commissioner Scott Gottlieb has made curbing the opioid epidemic a top priority for the agency. (Courtesy of American Enterprise Institute)

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.

“America is simply awash in immediate-release opioid products,” Gottlieb said. The new education 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.”

The FDA does not require doctors to undergo the training, but Gottlieb has said repeatedly that he wants to pursue that possibility — a point he again made on Monday.

“Based on the feedback we’ve received from two public meetings over the past year,” he 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 also said the agency is making drugmakers broaden the information provided to prescribers to include more about pain management and to detail non-medication therapies as well as drug treatments.

The updated requirements represent the latest step by Gottlieb and other FDA officials to put a dent in new opioid addictions.

Last week, drug manufacturer Endo Pharmaceuticals agreed to withdraw its opioid painkiller Opana ER from the market, acceding to a request the FDA made in June. It was the first time the agency had asked for an opioid to be pulled because of the public health consequences of abuse. The FDA said Opana ER's benefits no longer outweighed the risks and that its abuse-deterrent technology didn't prevent abuse.

Also last week, a new court filing against Endo and another drug company, Purdue Pharma, were added to lawsuits initially brought in 2014 by two counties in California. The lawsuits were some of the first in a growing wave of legal actions against drug manufacturers, distributors and retailers. Filed by states, counties and cities across the country, the suits seek to make the drug industry pay for the costs of addressing the opioid epidemic.

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