The strategy recommends that lawmakers change federal law to require practitioners — such as physicians, dentists and other professionals authorized to prescribe drugs — to be trained on opioid safety as a condition of being allowed to prescribe controlled substances.
It also requires drug manufacturers to develop educational materials and initiatives to train practitioners about opioid safety. Food and Drug Administration Commissioner Margaret Hamburg addressed concerns that this would put drug makers in the driver's seat by explaining that the materials would be reviewed by federal regulators prior to implementation.
As a first step, the FDA sent letters to opioid manufacturers on Tuesday requiring that they provide a plan for training prescribers and educating patients about the safe use, storage and disposal of opioids. They have 120 days to respond, setting in place a regulatory process that officials hope to have in place within 12 months.
"We have determined that a Medication Guide and a Communication Plan are not sufficient to mitigate the serious risks," the letters state. "Your (strategy) must include tools to manage these risks."
The letter was sent to the makers of Dolophine (methadone); MS Contin, Kadian, Avinza, Embeda, Oramorph (morphines); OxyContin (oxycodone); Exalgo (hydromorphone); Duragesic (transdermal fentanyl); Butrans (buprenorphine); and Opana ER (oxymorphone).
Some members of Congress have asked the FDA to further restrict the uses for which certain painkillers are approved, but Janet Woodcock of the Center for Drug Evaluation and Research made it clear Tuesday that that isn't the agency's favored approach. Rather, she said, the government wants to make sure doctors and patients are better informed about the drugs' uses and benefits so no one who needs pain relief will risk going without.