FDA calls for reclassification of hydrocodone products to Schedule II

FDA is recommending to the US Department of Health and Human Services (HHS) that hydrocodone combination products, such as Vicodin, be reclassified as a Schedule II product, placing tighter controls on the pain medications. Hydrocodone is currently a Schedule III drug, according to an FDA announcement.

“This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings,” stated Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research.

In December, FDA will submit its recommendation formally to HHS for the reclassification of these products. The agency expects that the National Institute on Drug Abuse will agree with its recommendation. The final decision will be made by the Drug Enforcement Agency, according to the FDA statement.

At the beginning of 2013, FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of the reclassification. FDA had rejected a similar request for reclassification in 2008.

In March, a bipartisan bill was introduced to reclassify hydrocodone drugs, moving them from Schedule III to Schedule II of the Controlled Substances Act.