FDA Advisors Reject Agency Plan to Control Opioid Use as Too Soft

July 24, 2010— -- ADELPHI, Md. -- A U.S. Food and Drug Administration advisory committee voted 25 to 10 to reject the agency's proposed plan to prevent inappropriate prescribing, misuse, and abuse of extended-release opioid painkillers, saying the plan lacks the teeth to stem the "public health crisis" of opioid addiction, overdose, and death.

The agency's plan to put a risk evaluation and mitigation strategy (REMS) in place would have required drug companies that make extended-release opioids to develop educational programs to guide physicians in patient selection, dosing, and patient monitoring. Prescribers were also to have been trained to counsel their patients on how to safely store and dispose of opioids.

The REMS would also have required manufacturers to provide FDA-approved patient education sheets for physicians to use in their interactions with patients and create "medication guides" highlighting safe use of opioids to be dispensed with the drugs.

"FDA has to have a more robust plan," said Dr. Mori Krantz, director of the prevention department at the University of Colorado in Denver. "This is a huge public health issue," Krantz said.

The advisory committee meeting comes about a month after new data showed that painkiller abuse now matches abuse of illegal drugs.

The panel was in universal agreement that the FDA's REMS plan fell short. Even the 10 panelists who voted for the proposed REMS said the plan might not do much to stem the growing abuse and misuse problem, but they said at least it was a start.

Panelists also said they understood that the FDA could only do so much to curb a widespread drug abuse problem that stretches far beyond the FDA's role of assuring that medications are safe and effective.

Many of the panelists endorsed a statement calling for Congress to pass a law to urge other government agencies -- including the Drug Enforcement Agency (DEA) -- to work together to quash the growing problem.

Still, the panel had a litany of criticisms of the FDA's proposed REMS.