FDA to Put Plan Forward to Restrict Hydrocodone By December

FDA officials have decided to place new limits on the painkiller Vicodin, known generically as hydrocodone, following recommendations from consumer watchdog groups, members of congress and the health regulatory agency’s own advisors.  

On October 24, Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research issued a statement announcing a plan to reclassify hydrocodone-based painkillers as Schedule II drugs. The move will limit how many hydrocodone-based pills doctors can prescribe to patients and would require stricter storage and handling requirements.

The reclassification’s goal is to prevent theft and abuse of the pills, which is one of a number of ways federal regulators are trying to combat what some have called a painkiller abuse epidemic in the U.S.

“In recent years, 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,” Woodcock said in her statement. “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.”

Woodcock says the U.S. Drug Enforcement Agency (DEA) first began seeking guidance on what to do about hydrocodone abuse in 2009. The determination comes following an analysis of scientific literature, public hearings and review of public comments and talking with doctors, patients, experts, the drug industry and other government agencies.

Over the last year the call for action has increased. In January, an FDA drug safety advisory panel voted 19-10 for the reclassification. That recommendation came at about the same time as a similar call to action by the consumer watchdog group Public Citizen.

Just a couple weeks later, the FDA received a letter from a bipartisan group of senators calling for tougher hydrocodone restrictions as well.

Woodcock says that by early December, the FDA will submit a formal recommendation package to the U.S. Department of Health and Human Services (HHS), which oversees the FDA.

“We anticipate that the National Institute on Drug Abuse (NIDA) will concur with our recommendation,” Woodcock wrote. “This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products.”

A schedule III drug is classified as having “moderate to low potential for physical or psychological dependence,” according to the DEA. A schedule II drug is known to have high potential for abuse.

Rescheduling hydrocodone drugs would require fewer prescriptions be written at one time and prohibit patients from receiving more than a three month prescription at a time.

Last year, the U.S. Centers for Disease Control and Prevention (CDC) declared that unintentional prescription drug overdose deaths had hit “epidemic” levels in the U.S.

Misuse and accidental overdoses of painkillers like OxyContin and morphine have driven the skyrocketing numbers, with opioid painkillers responsible for more deaths than cocaine and heroin combined since 2003.

In 2007, there were about 27,000 unintentional prescription drug overdose deaths in the United States, the CDC reported. Since 2008, prescription drug overdoses have accounted for more deaths than traffic accidents.