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

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.

For one, several panelists said it would be inappropriate for drugmakers to tell physicians how to prescribe the drugs.

"I think the committee would feel more comfortable if FDA created the program," said Dr. Jeffrey Kirsch, chairman of a joint panel of the Anesthetic and Life Support Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee. Kirsh is the chairman of the department of anesthesiology and perioperative medicine at Oregon Health and Sciences University in Portland, Ore.

Furthermore, merely requiring drug makers to provide education -- but not requiring doctors and other healthcare workers who write prescriptions to undergo the education -- would not ensure responsible prescribing, the panelists said.

Most committee members supported requiring healthcare providers to undergo thorough training about which patients need opioids and how to spot patients faking pain in order to score drugs.

One panelist, Dr. Jane Ballantyne, professor of anesthesiology at the University of Pennsylvania's Penn Pain Medicine Center, said physicians are in dire need of pain managment training.

"It's where we all struggle," she said. "I wouldn't even pretend that we know how to select patients. That's something we need to learn."

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