The Food and Drug Administration has forwarded a recommendation to the Department of Health and Human Services to reclassify hydrocodone combo drugs such as Vicodin as a Schedule II controlled substance.
After HHS forwards its expected approval to the Drug Enforcement Administration, that would put the common prescription pain reliever in the same category as cocaine, amphetamines, opium and morphine.
Janet Woodcock, M.D., director for the FDA Center for Drug Evaluation and Research said the decision came about because of the government’s concern “about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States.”
“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” Woodstock said.
“Going forward, the agency will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.”
No Schedule II prescription can be refilled without another written prescription from the doctor.
Currently, hydrocodone compounds such as Vicodin and Tylenol 3 can be filled with a written or phone prescription and refilled up to five times.
Sen. Joe Manchin (D-W.Va.) had been pressing for the reclassification because of hydrocodone abuse “that has ravaged West Virginia and our country.”
“Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands and devastating families and communities,” said Manchin, noting he’d been informed by Health and Human Services Secretary Kathleen Sebelius about the change. “…I am also extremely grateful that the Food and Drug Administration has finally implemented its own advisory committee’s recommendations to reclassify these addictive drugs. The agency has just saved hundreds of thousands of lives.”
Back in 2012, Manchin first introduced an amendment to the Food and Drug Administration Safety and Innovation Act to reschedule hydrocodone. It passed by unanimous consent but was pulled out in the version passed by the House.
Last year, five pharmacy groups sent a letter to Manchin and his supporters opposing the reclassification: the American Pharmacists Association, the Food Marketing Institute, the International Academy of Compounding Pharmacists, the National Association of Chain Drug Stores, and the National Community Pharmacists Association.
“Moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products, and it will result in adding to the nation’s healthcare costs with no assurance of a reduction in diversion and abuse,” they wrote.
The American Society of Consultant Pharmacists has said such a proposal would “make it difficult for long-term care (LTC) residents to receive adequate pain treatment in a timely manner by exacerbating existing barriers to pain medication access.”