The Food and Drug Administration began notifying opioid pharmaceutical manufacturers today that they will be required to develop educational materials for patients and training programs for physicians aimed at reducing patients' misuse and abuse of those medications. The initiative calls on drugmakers to submit the educational materials they develop to the FDA for approval before the program formally launches early next year.
FDA seeks opioid-prescription training for docs
"We want to reach prescribers as early as possible as they develop their prescribing practices," Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, told reporters Wednesday.
President Barack Obama's administration also will push for enactment of as-yet-unintroduced legislation to require physician participation in opioid prescribing training. And Gil Kerlikowske, director of National Drug Control Policy, said he is confident that Congress would enact such a measure promptly based on the previous passage of other recent measures focused in part on opioid-abuse control.
However, if Congress does not enact a law requiring mandatory physician participation in such training, the FDA could aim to tighten control on opioid prescribing through restricted formularies.
"The more restrictive the tools are that we impose, the more likely people would go without needed pain medications," Woodcock said about the agency's reluctance to use the latter approach.
The initiative followed the rejection by a joint FDA advisory committee of the FDA's proposed opioid risk-evaluation and mitigation strategy in July 2010. The committee members rejected the plan at that time in part because it did not include mandatory physician training and patient registration.
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