NY TIMESTrying to stem the scourge of prescription drug abuse, an advisory panel of experts to the Food and Drug Administration voted on Friday to toughen the restrictions on painkillers like Vicodin that contain hydrocodone, the most widely prescribed drugs in the country.
...At 19 to 10, the vote was far from unanimous, with some opponents expressing skepticism that the change would do much to combat abuse. Oxycodone, another highly abused painkiller and the main ingredient in OxyContin, has been in the more restrictive category since it first came on the market, they pointed out in testimony at a public hearing. They also said the change could create unfair obstacles for patients in chronic pain.
Painkillers now take the lives of more Americans than heroin and cocaine combined, and since 2008, drug-induced deaths have outstripped those from traffic accidents. Prescription drugs account for about three-quarters of all drug overdose deaths in the United States, with the number of deaths from painkillers quadrupling since 1999, according to federal data.
The change would have sweeping consequences for doctors, pharmacists and patients. 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. Distributors would be required to store the drugs in special vaults.
The vote comes after similar legislation in Congress failed last year, after aggressive lobbying by pharmacists and drugstores.
But at the panel’s two-day hearing at F.D.A. headquarters in Silver Spring, Md., many spoke against the change, including advocates for nursing home patients, who said frail residents with chronic pain would have to make the trip to a doctor’s office. The change would also ban nurse practitioners and physician assistants from prescribing the drugs, making it harder for people in underserved rural areas.
Panelists also cautioned that the change would produce a whack-a-mole effect, pushing up abuse of other drugs, like heroin, which has declined in recent years.
While hydrocodone products are the most widely prescribed painkillers, they make up a minority of deaths, because there is less medication in each tablet than some of the other more restricted drugs, like extended-release oxycodone products, said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine in Boston. Oxycodone and methadone products account for about two-thirds of drug overdose deaths, he said, despite accounting for only a fraction of hydrocodone prescriptions.
The importance of Friday’s vote was more symbolic, he said, a message to doctors that they will need to think twice before prescribing hydrocodone, and to patients that the days of “unbridled access” are coming to an end. The tide has been turning against easy opioid prescriptions, as the medical system and federal regulators slowly make adjustments to reduce the potential for abuse.