A bipartisan group of congressmen is demanding the Food and Drug Administration “act without delay” by restricting access to Vicodin and other hydrocodone products, the most widely used and abused narcotic painkiller in the U.S.
Last month an advisory panel to the FDA voted 19 to 10 to reclassify hydrocodone products from a Schedule III controlled substance to a Schedule II drug, which will make it harder for pain patients to obtain or get refills for. The FDA, which usually follows the recommendations of its advisory panels, has not yet made a final decision on the matter.
“The American people have waited too long for action from this agency,” wrote Sen. Joe Manchin (D-West Virgina) in a letter to FDA Commissioner Margaret Hamburg. “Hydrocodone combination drugs are some of the most commonly abused prescription drugs nationwide, and your own experts agreed it is time we take the necessary steps to address this deadly epidemic.”
The letter was also signed by Sen. Jay Rockefeller (D-West Virginia), Sen. Mark Kirk (R-Illinois), Sen. Chuck Schumer (D-New York), Sen. Dianne Feinstein (D-California), Sen. Kirsten Gillibrand (D-New York), Rep. Ed Markey (D-Massachusetts) and Rep. Vern Buchanan (R-Florida).
“The message could not be more clear,” the February 14 letter says. “Consequently, we respectfully request that the FDA hasten the rescheduling process and that you provide us with a written response detailing the FDA’s next steps and your timeline for rescheduling hydrocodone combination drugs.”
Reclassification of hydrocodone was rejected by the FDA in 2008, but the Drug Enforcement Agency asked the agency to reconsider because of rising rates of hydrocodone abuse.
Hydrocodone is often combined with other pain relievers such as acetaminophen and aspirin to make combination products like Vicodin. In 2011, U.S. doctors wrote over 131 million prescriptions for hydrocodone products, making it the most prescribed drug in the country.
Under current rules, a 30-day prescription for hydrocodone can be refilled five times before a patient has to see a physician again – meaning the prescription would be good for 6 months. If hydrocodone is reclassified as a Schedule II drug, a prescription would only be good for 90 days. No refills will be allowed unless a patient sees a doctor again and a new prescription is written.
Many pain patients with legitimate prescriptions for hydrocodone fear rescheduling will make the painkiller harder to get. Doctors may be reluctant to write prescriptions for hydrocodone and pharmacies worried about being labeled as “pill mills” could refuse to fill the prescriptions.