A top DEA official is calling on federal regulators to impose tougher rules on the way pharmaceutical companies market narcotic painkillers to physicians, noting that such drugs are involved in more than twice as many deaths as heroin and cocaine combined.
Joseph T. Rannazzisi, who heads the Drug Enforcement Administration's Office of Diversion Control, urged the Food and Drug Administration in a letter to adopt stricter limits on OxyContin, Vicodin and similar medications to "safeguard the American public."
"The DEA is concerned about the potential public health risks resulting from abuse of opioid drug products," Rannazzisi wrote in the letter. "Additional regulatory measures are necessary."
Rannazzisi sent his letter in support of a petition asking the FDA to rein in the use and misuse of the addictive drugs. His endorsement came as a welcome surprise to advocates of the effort.
"The DEA is turning up the heat on the FDA," said Andrew Kolodny, a New York addiction doctor leading the petition.
Fueled by prescription overdoses, drug fatalities now exceed deaths from car crashes, long the leading cause of accidental death in this country. Officials have responded to the mounting deaths by focusing largely on illicit prescription drug sources, such as teenagers stealing from their parents' medicine cabinets and pharmacy robberies.
A Los Angeles Times analysis last year of 3,733 prescription drug-related fatalities in Southern California found that nearly half involved at least one drug that had been prescribed to the decedent by a physician. Seventy-one doctors prescribed drugs to three or more patients who later fatally overdosed. Several of the doctors lost a dozen or more patients to overdoses.
The petition being considered by the FDA focuses on how drug makers sell painkillers and the way doctors prescribe them. It asks the FDA to revise labels to limit daily doses of painkillers and restrict their use to 90 days or less for people with non-cancer pain. It would also prohibit pharmaceutical companies from marketing such medications for moderate pain, limiting their use to severe pain in non-cancer patients.
The FDA regulates the manufacturing and marketing of pharmaceuticals and approves the wording of prescription medication labels. Such labels govern how drug makers can market medications. Physicians, however, don't have to abide by the label and may prescribe "off label." Nonetheless, the labels are a strong influence on prescribing practices and often form the basis for what health insurers will cover.
The DEA is responsible for enforcing laws against drug dealing. In recent years, its efforts have tilted toward the burgeoning market for narcotic painkillers, which mimic the effect of heroin and can be as dangerous.
For decades, fear of addiction and overdose led physicians to limit the use of narcotic painkillers to patients with severe cancer pain and the terminally ill. But in the late 1990s, a movement to address the chronic and moderate pain of more common ailments — such as arthritis, sports and workplace injuries — encouraged a more liberalized approach. Since then, prescriptions for narcotic painkillers soared, as did overdose deaths.
"This is a national epidemic of avoidable deaths directly attributable to drug company and physician irresponsibility," said Dr. Allen Frances, a professor emeritus of psychiatry at the Duke University School of Medicine and an authority on misuse of prescription drugs.