After dithering for 14 years, the FDA takes a modest step to limit the use of a hazardous drug.
Hydrocodone may not be a household word, but it’s a common household product. The opioid narcotic—sold in prescription painkillers such as Vicoden and Lortab—is the nation’s most widely prescribed drug. Americans fill more than 130 million hydrocodone prescriptions each year, and many of them die as a result. Prescription pain relievers kill more Americans than cocaine and heroin combined (16,600 in 2010 alone)—and hydrocodone is the biggest seller in the bunch.
This week, after 14 years of inaction, the Food and Drug Administration took a modest step to reduce the harm the drug causes. At the urging of expert advisors, the agency recommended that the Justice Department regulate hydrocodone in the same way it does other prescription narcotics such as methadone, fentanyl and oxycodone. The new standard could take effect next year.
Unlike other narcotics, hydrocodone has long been classified as a low-risk drug that doctors can prescribe by phone and patients can take for six months at a time on a single prescription.Those conveniences have driven the drug’s blockbuster sales—hydrocodone controls 70% of the market for narcotic painkillers—and fueled growing epidemics of dependence and death.
The FDA’s proposal would end those special privileges. By designating hydrocodone a Schedule II drug, it would bar phone-in prescriptions and place a 90-day limit on refills. Drug makers and some medical groups complain that the restrictions will burden patients by forcing them to schedule more frequent doctor visits. Health officials counter that folks taking narcotics for more than three months need and deserve that extra medical attention.
Holding all narcotic drugs to the same standards may seem like common sense, but the FDA has resisted the idea since 1999, when health advocates started pushing it. The Justice Department's Drug Enforcement Administration, which classifies drugs with the FDA’s guidance, proposed reclassifying hydrocodone in 2004 and again in 2009, but FDA officials sided with the drug lobby, saying the restrictions would harm people in chronic pain.
Finally last January,the FDA held a public hearing on the issue. After reviewing the testimony and the evidence, the agency’s expert advisors voted two-to-one in favor of tightening the restrictions. Now that the FDA has accepted that recommendation, its parent agency (Health and Human Services) will forward it to the Justice Department, which will implement it through the DEA.
While praising the FDA’s belated action, health groups are still pushing other reforms to reduce the harm from narcotic painkillers. In a petition, submitted last year, several of them asked the agency to drop “moderate pain" as an indication for narcotic drugs and limit the maximum daily dose to the equivalent of 100 mg of morphine. If past experience is any guide, those reforms could be a long way off, but this week’s action is a critical first step.
For more on the prescription painkiller controversy, read this recent MSNBC report: The FDA dithers as prescription painkillers claim more lives.