FDA Would Require Risk Management Plans From Painkiller Makers : Shots - Health News Last summer, a panel of experts advising the FDA voted against an agency plan for managing the risks from prescription painkillers, saying it was too timid. But an Obama administration proposal unveiled Tuesday reprises the approach.

White House Plan To Curb Prescription Drug Abuse Is Heavy On Education

The Obama administration this morning unveiled a plan to stem the rising abuse and misuse of prescription painkillers.

There were, as you might expect, some terribly sobering statistics on the scope of the problem. Drug overdoses are the leading cause of accidental death in 17 states and the District of Columbia, said Gil Kerlikowske, director of the White House's Office of National Drug Control Policy. They're a bigger hazard than car accidents.

Dr. Howard Koh, assistant secretary for health at the Department of Health and Human Services, said abuse of legal drugs now accounts for about 1 million emergency room visits a year — on par with the number for illegal drugs.

So what to do to tame the problem? There was support for a change in the law that would require doctors to undergo training on the risks of opioid painkillers in order to get certified by the Drug Enforcement Administration to prescribe them. The federal government will track use of the medicines better and do more to educate consumers and doctors. The officials also spoke out on plans to make it easier for people to dispose of unused medicines.

But one of the most concrete parts of the plan was rejected last year as too timid by a panel of experts advising the Food and Administration.

Agency commissioner Dr. Margaret Hamburg said FDA would now require all makers of extended-release and long-acting opioid medications — such as OxyContin, Duragesic and a whole slew of generic medicines — to implement so-called Risk Evaluation and Mitigation Strategies.

That mouthful means drugmakers will have to submit specific plans to FDA for educating patients and doctors about the risks and proper uses of the medicines.

There's just one catch. Last summer a panel of experts advising the agency voted 25-10 against the REMS approach when it was proposed then by FDA, saying, essentially, that it didn't go far enough. One big beef: the training needs to be mandatory. (See a summary of the meeting here.)

A reporter asked Hamburg today if the latest REMS proposal would make a difference. Without providing specifics, she replied, "We think very strongly what we're moving forward on today will really make a difference."