FDA panel: Tighten limits on hydrocodone painkillers
Under the proposed rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone. Only written prescriptions from a doctor would be allowed, and pharmacists and distributors would be required to store the drugs in special vaults.
The New York Times
Trying to stem the scourge of prescription-drug abuse in the United States, a Food and Drug Administration (FDA) advisory panel voted Friday to toughen restrictions on Vicodin and other hydrocodone products, the most widely used narcotic painkillers in the country.
The panel voted 19-10 in favor of the recommendation, which the FDA will likely follow. The recommendation would limit access to the drugs by making them harder to prescribe.
The recommendation would subject Vicodin and dozens of other medicines to the same restrictions as other narcotic drugs, such as oxycodone and morphine. Indeed, hydrocodone belongs to a family of drugs known as opioids, which include morphine, heroin, oxycodone, codeine and methadone.
The change would have sweeping consequences for doctors, pharmacists and patients. Under the proposed rules, refills without a new prescription would be forbidden, as would faxed prescriptions and those called in by phone.
Only written prescriptions from a doctor would be allowed, and pharmacists and distributors would be required to store the drugs in special vaults. The vote comes after similar legislation in Congress failed last yearamid intense lobbying by pharmacists and drugstores.
Prescription drugs account for about three-quarters of all U.S. drug overdoses, with the number of deaths more than tripling since 1999, according to federal data. Since 2008, deaths from overdoses have outpaced deaths from car accidents.
The FDA convened the panel, made up of scientists and other experts, after a request by the Drug Enforcement Administration (DEA), which contends that the drugs are among the most frequently abused painkillers in the country.
“This is the federal government saying, ‘We need to tighten the reins on this drug,’” said Scott Drab, associate professor of pharmacy and therapeutics at the University of Pittsburgh’s School of Pharmacy. “Pulling in the rope is a way to rein in abuse, and consequently, addiction.”
At a two-day hearing at FDA headquarters in Silver Spring, Md., many speakers opposed the change, including advocates for nursing-home patients, who said older, frail residents needing pain medication would now be required to make the arduous trip to a doctor’s office to continue using hydrocodone products. Other experts questioned how effective the change would be. Oxycodone, another much-abused painkiller and the active ingredient in OxyContin, has been in the more restrictive category since it came on the market, but the limited access does not seem to have stemmed abuse, they said.
Others, including parents who had lost their children to prescription-drug abuse, doctors and pharmacists, testified in favor of the proposed restrictions, sometimes emotionally. Sen. Joe Manchin, D-W.Va., made an impassioned plea.
“When I go back to West Virginia, I hear how easy it is for anybody to get their hands on hydrocodone drugs,” Manchin said Friday. “For underage children, these drugs are easier to get than beer or cigarettes.”
Dr. James Rathmell, chief of the division of pain medicine at Massachusetts General Hospital, said hydrocodone products have biological effects similar to those of oxycodone products and should unquestionably be in the same category of restrictiveness.
“Knowing what we know today, it was a mistake,” Rathmell said, referring to hydrocodone products being placed in the looser category when they came on the market. “It should be corrected.”
Material from The Associated Press is included in this report.