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FDA Panels Reject Plan to Curb Opioid Painkiller Abuse
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FRIDAY, July 23 (HealthDay News) -- Two advisory panels to the U.S. Food and Drug Administration voted Friday against the agency's plan to curb abuse of opioid painkillers.
In February, the FDA issued a proposal called a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid drugs. The proposal was an attempt to curtail the growing misuse and abuse of the powerful and potentially addictive drugs, according to the agency.
But during a joint meeting of the FDA's Anesthetic Life Support Drugs and Drug Safety and Risk Management advisory committees, members voted 25 to 10 to recommend against the proposal.
"There was only one voting question, where they were asked to vote on whether they thought that the proposed REMS that [the] FDA had put forward was an appropriate approach to the problem we are trying to address," Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, said during a news conference after the vote.
"Ten voted yes to that question, and 25 voted no," he said. "Those who voted no agreed that a REMS was needed, but they voted no because they didn't think the proposal from [the] FDA was all that was needed."
The main stumbling block appeared to be that the panel members who voted against the plan wanted the training for prescribing doctors to be mandatory instead of voluntary, Jenkins said.
Jenkins noted the agency did not choose to make the training mandatory because it would have been too much for the agency to manage.
The FDA could make manufacturers run such training programs, Jenkins said. "There are approximately 750,000 prescribers who have a registration number with the DEA [Drug Enforcement Administration], and are therefore authorized to prescribe the products, and there are approximately 4 million patients who receive these drugs every year," he explained.
"We were concerned about the magnitude of that program being significantly larger than any we have ever instituted before," he said. "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."
The REMS proposal consists of educating doctors and patients about the risks posed by extended-release and long-acting opioid painkillers. For doctors, the FDA wants them to know about proper prescribing and dosing of the drugs, and the monitoring of patients. Doctors need to counsel patients about the safe use, storage and disposal of these drugs, according to the agency.
The FDA also wants drug makers to provide patient education sheets approved by the agency.
OxyContin is at the center of the problem, the agency said. Since 1995, when the drug was approved by the FDA, prescriptions have skyrocketed -- from some 821,000 in 1997 to about 6.2 million in 2002, according to the most recent statistics supplied by the FDA.
Much of OxyContin abuse is among relatives and friends of people who have prescriptions. More than 40% of those who misuse this drug are relatives or friends of people with prescriptions, the agency said.
The long-acting and extended-release forms of opioids pose unique risks because of their formulations and chemical properties. For example, there appears to be a bigger problem of serious adverse outcomes with the misuse of the extended-release form of OxyContin, compared with immediate-release oxycodone. Over a three-year period, the rate of emergency room visits was five times higher for OxyContin than for oxycodone, according to the FDA.
"Many people directly affected by this crisis have been previously healthy and have had no history of substance abuse," the agency said on its Web site. "Data on unintentional drug poisoning in the United States from the Centers for Disease Control and Prevention have shown that drug overdose death rates in the United States have never been higher and that they have increased approximately fivefold since 1990."
"By 2006, data showed that prescription opioids were involved in more overdose deaths than heroin and cocaine combined," according to the agency.
The FDA said it recognizes that abuse of prescription drugs is a complex problem that involves many factors. But the agency hopes that educating people about the potential dangers posed by the drugs will affect at least part of the problem.
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SOURCE: July 23, 2010, teleconference with: John Jenkins, director, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Rockville, Md.