The FDA is recruiting drugmakers to help fight painkiller abuse. The agency says it will require some manufacturers of high-powered pain drugs to develop new educational materials for doctors and patients, hoping that better-informed prescribers and users will help curtail now-widespread abuse. As the Boston Business Journal reports, the new rules apply to 16 companies that produce 25 pain pills and patches.
Under the new requirements, each painkiller manufacturer will have to develop new medication guides and physician training tools, which will be vetted by FDA--and accredited by professional physician-education providers--before use, the Wall Street Journal reports. The companies have 120 days to submit their materials. The physician training won't be mandatory unless Congress makes it so, FDA officials said, but suggested that lawmakers might be interested in doing so.
The FDA's move comes as state officials nationwide are battling a plague of painkiller addiction. As the New York Times reports, fatal overdoses in Ohio more than quadrupled over 10 years, surpassing car crashes as the leading cause of accidental death. "The toll our nation's prescription drug abuse epidemic has taken in communities nationwide is devastating," Gil Kerlikowske, director of the White House Office of National Drug Control Policy, said in a statement. "We share a responsibility to protect our communities from the damage done by prescription drug abuse."
The drugs affected by FDA's move include long-acting and extended-release opioids such as oxycodone, morphine and methadone. The drugs are made by several companies, including Pfizer's King Pharmaceuticals unit, which makes Avinza and Embeda; Johnson & Johnson, which produces Duragesic; Actavis, which makes Kadian; Endo Pharmaceuticals, which markets Opana ER; and Covidien, whose Mallinckrodt brand makes six affected products, including generic morphine and oxycodone.
"We really support [FDA's] efforts," Covidien CMO Herbert Neuman told the WSJ. "We think education is the right way to tackle this issue." Covidien would also support legislation requiring painkiller education for physicians, he said.
- see the BBJ piece
- get more from the NYT
- read the WSJ article
- check out the news from Reuters