CDER Director Proposes Reclassification of Opioid Products

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CDER recommends reclassifying opioid products as Schedule II.

Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research (CDER) has issued a statement that FDA plans on submitting formal recommendations for the reclassification of hydrocodone combination products into Schedule II. FDA has been evaluating the appropriate use of opioid analgesic drug products after years of concern about the misuse of such products.

The US Department of Health and Human Services (HHS) was asked by the US Drug Enforcement Administration in 2009 to provide recommendations for the possible change for hydrocodone combination products from Schedule III to Schedule II to increase the control of the products. In response, CDER plans to submit recommendations by early December to reclassify opioid analgesic drugs into Schedule II.

“Due to the unique history of this issue and the tremendous amount of public interest, we are announcing the agency’s intent to recommend to HHS that hydrocodone combination products should be reclassified to a different and more restrictive schedule,” states Woodcock. “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, during which we received input from a wide range of stakeholders, including patients, health care providers, outside experts, and other government entities.”