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.

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."

One reason opioid use is so prevalent is because of unscrupulous doctors who are quick to dole out prescription narcotics said Dr. Roland Gray, director of the Physicians Health Program at the Tennessee Medical Foundation in Brentwood, Tenn.

"They don't need a course in writing prescriptions, they need a course in ethics," said Gray. "If they don't have a conscience, we can't give them that."

That's beyond the scope of the FDA, said John Jenkins, MD, director of the agency's Office of New Drugs.

"The REMS cannot address the entire scope of the problem of prescription abuse and misuse," Jenkins said.

Physicians and nurse practitioners who prescribe certain opioids already have to register with the DEA, and some panelists favored linking that registration to completion of a training program. That approach, too, is out of the purview of the FDA and would require an act of Congress.

In a press briefing following the meeting, Jenkins told reporters that the FDA could work with its parent agency, the Department of Health and Human Services, to craft legislative language. Or a member of Congress could introduce a bill that would require any prescriber registering with the DEA to undergo opioid training.

About 700,000 physicians prescribe opioids for about 4 million patients, so creating such registries would be an epic undertaking, Dr. Bob Rappaport, director of the FDA's division of anesthesia and analgesia products, wrote in briefing documents released in advance of Friday's hearing.

Another problem the panel had with the FDA's proposal is that it governs only extended-release opioids, which are responsible for more overdoses than immediate release opioids. The panel felt that a REMS should govern immediate-release opioids as well.

"If we don't include immediate release products, we'll be back in two years discussing another REMS," said panelist Patrick Beardsley, professor of pharmacology and toxicology at Virginia Commonwealth University.

The FDA announced it would implement a REMS for opioids in February 2009, and held a public meeting a few months later during which physicians, patients, pharmacists, hospice workers, addiction groups, and others voiced their views on what moves the agency should make.

A number of members of the public who spoke at that meeting urged the FDA to also require patients who take opioids to sign a registry. The panel didn't discuss that idea.