FDA calls for reclassification of hydrocodone products to Schedule II

October 24, 2013

The FDA is recommending to the U.S. Department of Health and Human Services (HHS) that hydrodone 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.

The FDA is recommending to the U.S. 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. 

Pharmacy associations respond

The National Association of Chain Drug Stores (NACDS) continues to oppose the rescheduling of hydrocodone products to Schedule II, citing "the loss of  pain control for millions of Americans."

In February 2013, NACDS, the National Community Pharmacists Association (NCPA), the Long Term Care Pharmacy Alliance, and other health professional grours as well as patient advocacy groups sent a letter to FDA Commissioner Margaret A. Hamburg, MD, stating that "No evidence currently exists to show that reclassifying hydrocodone will curb misuse and abuse of pain medications. In contrast, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm."

NACDS President and CEO Steven C. Anderson, IOM, said in September that pharmacies have two main objectives when tackling the problems of prescription drug abuse. "They have to be part of the solution by working with law enforcement officials to stop prescription drug abuse, but they also have to maintain their responsibilities to patients by making sure they receive the medications they legitimately need."  

NACDS suggests that Congress pass the Senate Bill 1277, the "Combatting Prescription Drug Abuse Act," that was introduced by Senator Barbara Boxer (D-Calif). It would establish a commission for the coordination of efforts to reduce prescription drug abuse.

NCPA CEO B. Douglas Hoey, RPh, MBA, issued a statement on Friday, calling for greater education efforts for prescribers, electronic prescription drug-monitoring programs and tracking systems, and the closing of rogue pain clinics as first steps toward combating prescription drug abuse, while still providing access to needed pain medications. 

NCPA Vice President of Policy and Regulatory Affairs Ronna Hauser, PharmD, provided testimony to FDA's advisory committee in January against rescheduling of hydrocodone products to Schedule II. "Rescheduling the products to Schedule II would create significant hardships for all, leading to delayed access for vulnerable patients with legitimate chronic pain, especially those in nursing home and long-term care settings," Hauser said.