WASHINGTON (AP) – Federal health advisers said a government proposal to curb misuse of powerful painkillers does not go far enough to fix a problem linked to hundreds of fatal overdoses annually.
The Food and Drug Administration summoned a panel of 35 outside experts to review its plan to reduce the misuse and abuse of long-acting pain relievers. The agency’s plan consists mainly of educating doctors and patients about appropriate use of the drugs.
But the FDA panel voted 25-10 to reject the agency’s proposal, saying more requirements and training are needed for health professionals who prescribe the drugs.
The government’s proposal would apply to extended release versions of opioid narcotics like morphine, oxycodone and methadone.
In one key disagreement with the FDA, panelists said doctors who prescribe opioids should be required to undergo training. The FDA suggested in its briefing that making such training mandatory could be overly burdensome, since the drugs are prescribed by thousands of physicians across the U.S.
Panelists also questioned whether the FDA’s so-called “risk evaluation and mitigation strategy,” or REMS, would have any significant impact on the epidemic of opioid abuse, which is responsible for more fatal overdoses each year than heroin and cocaine combined.
Dr. John Jenkins, the director of the FDA’s office of new drugs, said the agency’s plan was designed to address legitimate use of the drugs, not deliberate abuse.
“We freely acknowledged that the REMS cannot address the entire scope of the problems for society on prescription drug misuse and abuse,” Jenkins told reporters in a post-meeting news conference.
Jenkins said the FDA would review the panel’s recommendations and adjust its plan in coming months.
The government’s risk management plan is specific to extended release versions of opioid drugs, which come in both pill and patch forms and are designed to give long-lasting effects. That potency carries serious risks when patients abuse them as stimulants.
Some panelists suggested FDA restrictions should also expand to more conventional, immediate-release painkillers.
The FDA has issued a number of warnings on prescription pain relievers in recent years but with little success. A federal survey conducted in 2007 found 5.2 million people in the U.S. reported using prescription pain drugs inappropriately.
The companies most likely to be impacted by new regulations include Purdue Pharmaceuticals, maker of the blockbuster pill OxyContin, and King Pharmaceuticals, which markets Embeda morphine capsules.
Date: July 23, 2010
Source: Associated Press
Filed Under: Drug Discovery