FDA Panels Vote Against Plan to Reduce Opioid Abuse

Key issue cited by an FDA official was lack of mandatory training for prescribing doctors
By Beth Gilbert
HealthDay Reporter

MONDAY, July 26 (HealthDay News) -- On July 23, two U.S. Food and Drug Administration advisory panels voted against the FDA's plan for reducing abuse of long-acting and extended-release opioid drugs.

In February, the FDA issued a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid drugs in an attempt to rein in the growing misuse and abuse of the drugs by educating physicians and patients about associated risks. Extended-release and long-acting opioids pose an increased risk of serious adverse events compared with shorter-acting formulations due to their formulations and chemical properties.

However, during the joint meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, committee members voted 25 to 10 against the FDA's proposal. John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said at a news conference that the members who voted no believe a REMS is needed but that the FDA's proposal did not go far enough. Specifically, he said those who voted no wanted the training for prescribing physicians to be mandatory, not voluntary. He noted that the magnitude of such a training program would be extremely large.

"There are concerns about the burden that would place on the health care system. Because of the size of the program, there were concerns that some prescribers might choose to opt out of the program, and that might impact on patients' access to care for relief of their pain," Jenkins added.

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