FDA yesterday recommended rescheduling of hydrocodone combination products from Schedule III to Schedule II following its advisory committee’s vote last January in favor of rescheduling.
The recommendation will not result in the immediate rescheduling of hydrocodone. FDA cannot reschedule hydrocodone independently. FDA plans to submit its formal recommendation package to U.S. Department of Health & Human Services (HHS) Secretary Kathleen Sebelius by early December. FDA anticipates that the National Institute on Drug Abuse will agree with the recommendation. HHS will then submit its recommendation to DEA, which will make the final decision on appropriate scheduling of these products.
“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,” FDA said yesterday in a statement by Janet Woodcock, MD, Director of FDA’s Center for Drug Evaluation and Research. “This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundred 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.”
FDA’s Drug Safety and Risk Management Advisory Committee voted 19–10 on January 25, 2013, in favor of reclassifying hydrocodone to Schedule II.
The Association strongly opposes the proposed reclassification.
“APhA opposes FDA’s recommendation to reschedule hydrocodone to Schedule II because there is clear evidence that this change will reduce patient access to medications and cause harm—largely to patients living with chronic pain. Furthermore, rescheduling these medications will introduce inefficiencies and increase health care costs at a time when policy makers are seeking to do precisely the opposite,” said the Association.
Public opposition to FDA’s recommendation also came from the National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS).
“The FDA’s reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings,” NCPA said in a statement. “There are more practical means available to reduce prescription drug abuse. For starters, more effective education of prescribers, electronic prescription drug monitoring programs and tracing systems, and shutting down rogue pain clinics are all steps that can combat abuse without harming patients and the pharmacists caring for them.”
“This proposal is not the best avenue to address abuse, and would negatively impact access to needed medications for those who suffer from chronic pain,” NACDS said in a statement. “In the interest of patient care, we have worked with patient advocacy groups in opposition to this recommendation as we support and advance workable solutions.”