FDA advisers have overwhelmingly rejected the agency's plan for reducing the inappropriate prescribing, misuse and abuse of extended-release opioids.
During a July 22-23 joint meeting(www.fda.gov) of the FDA's Anesthetic and Life Support Drugs and Drug Safety and Risk Management advisory committees, committee members voted 25-10 against a proposed Risk Evaluation and Mitigation Strategy, or REMS, for extended-release and long-acting opioid analgesics after deeming the plan insufficient to stop abuse of the painkillers.
John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research, explained during a July 23 press briefing that the agency's two-year effort to develop the REMS focused on the legitimate medical use of the drugs. The FDA, he said, was chiefly concerned about ensuring that physicians were selecting the right patients and the right drug dosages and making sure that patients were using the medications as directed.
However, Jenkins said, the committee members focused much of their discussion on nonmedical use of these opioids.
"We tried to help the committee understand that some of the other activities are beyond our REMS authority," he said. "But I don't think we helped them understand that enough. It didn't creep back into a lot of their concerns and recommendations."
The REMS called for physicians who prescribe opioids to complete a voluntary training program, but Jenkins said many members of the committees wanted training to be mandatory.
According to Jenkins, FDA officials considered such an option but determined that mandatory training might place an undue burden on the health care system because more than 700,000 physicians are authorized by the DEA to prescribe extended-release opioids.
The FDA was concerned that some physicians would stop prescribing the drugs rather than complete the training, thereby decreasing access to care for the estimated 4 million patients who have a legitimate need for the medications each year, said Jenkins.
Although physicians must register with the DEA, Jenkins said it would require a legislative change by Congress to give the FDA the authority to require training as part of that registration.
The agency currently does have the authority to require drug manufacturers to provide mandatory training of this type, but Jenkins said that option was less than ideal.
The FDA also was concerned, he noted, about the sheer magnitude of a mandatory training program for opioids because it would be significantly larger than any similar program the agency has undertaken for other medications.
In addition, the panel took issue with the fact that the REMS dealt only with extended-release opioids and did not cover immediate-release products, Jenkins said.
He added that there was no timeline for the agency to make a decision about the REMS.
"We do want to move on this as rapidly as possible," Jenkins said, "but there's a lot of information we heard, a lot of feedback. We have to go back internally and discuss it, and decide whether we want to make some modifications to what we had proposed based on the committee's feedback or whether we want to go forward with what we had proposed."
According to the Substance Abuse and Mental Health Services Administration, or SAMHSA, 52 million people(www.fda.gov) in the United States ages 12 years or older have used prescription drugs for nonmedical reasons at least once in their lifetime, including 35 million who have used prescription painkillers for nonmedical reasons.
SAMHSA also reported(oas.samhsa.gov) that from 1998 to 2008, a 400 percent increase was seen in substance abuse treatment program admissions for misuse of prescription pain relievers.
Moreover, according to a CDC report on unintentional drug poisoning(www.cdc.gov) released June 3, some 26,400 unintentional drug overdose deaths occurred in 2006 in the United States. During that year, opioids were involved in more fatal overdoses than heroin and cocaine combined.