Member Alert: FDA to submit formal recommendation to reclassify hydrocodone combination products into Schedule II

October 25, 2013

October 25th, 2013

Janet Woodcock, MD, Director, FDA Center for Drug Evaluation and Research, has released a statement that, “by early December, FDA plans to submit our formal recommendation package to HHS to reclassify hydrocodone combination products [including Vicodin] into Schedule II.  We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.”

Director Woodcock’s statement further notes that “the FDA has become increasingly concerned 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.”

The FDA’s decision comes in response to a 2009 request from the Drug Enforcement Administration to reschedule hydrocodone from Schedule III to Schedule II. As of today, there is no opportunity for AAOMS to provide official comment; however, we have commented on this specific issue several times in the past and will continue to seek opportunities to comment on this latest action.

The AAOMS has worked closely with the ADA and others to alert the agencies about the benefits of hydrocodone for oral and maxillofacial surgery patients and the difficulties involved in making legitimate pain prescriptions available for these individuals should hydrocodone combination products be rescheduled. On October 16, 2012 the AAOMS and the ADA provided joint comments to the FDA and in January of 2013, the FDA accepted our joint testimony during a hearing on this important matter. 

We recognize that the FDA’s announcement will create a potential burden to the practicing oral and maxillofacial surgeon. AAOMS will continue to monitor the situation closely and advocate for the specialty.