FDA to recommend rescheduling of opioid painkiller hydrocodone from CIII to CII

Recommendation, planned for December, draws pharmacy retailers' opposition

SILVER SPRING, Md. — The Food and Drug Administration plans to recommend stronger regulations for a commonly used opioid painkiller.

In a statement Thursday, FDA Center for Drug Evaluation and Research director Janet Woodcock said the agency would formally recommend to the Department of Health and Human Services that products containing 15 mg or less of the drug hydrocodone's be reclassified as Schedule II controlled substances, from the current Schedule III. The higher scheduling would impose tougher regulations on hydrocodone, which is an active ingredient in products like AbbVie's Vicodin, among other products. The Drug Enforcement Administration, which regulates controlled substances, proposed the change in 2009, and the FDA will submit its recommendation in December.

The change is being recommended in light of Vicodin being a common target for abuse and misuse, which itself feeds the problem of pharmacy robberies and can have potentially fatal consequences for people taking the drug improperly or recreationally.

Abuse and misuse of opioids has become a growing problem across the country in recent years. According to the Centers for Disease Control and Prevention, more than 36,000 people died from drug overdoses, most of them from prescription drugs, and three-fourths of prescription drug overdoses are caused by opioid painkillers. The rise in overdose deaths in the United States has run parallel to the 300% increase since 1999 in the sale of opioid painkillers, which were involved in 14,800 overdose deaths in 2008, more than cocaine and heroin combined. They were further responsible for more than 475,000 emergency department visits in 2009.

To combat abuse, some drug makers have sought to make opioid painkillers tamper-resistant to prevent them from being ground or dissolved for snorting or injection. Examples of drugs that have been changed in this way include Purdue Pharma's OxyContin (oxycodone) extended-release tablets and Endo's Opana ER (oxymorphone).

Nevertheless, pharmacy groups say rescheduling hydrocodone could have the unintended side effect of making it harder to get for patients using it for legitimate purposes. In a statement Friday, the National Community Pharmacists Association, while supporting the FDA's intent, said the move to restrict the drug could be harmful to patients. In the past, the NCPA has suggested that the federal government instead use such strategies as electronic prescription drug monitoring programs and tracking systems.

"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 B. Douglas Hoey said. "Community pharmacists support aggressive efforts to combat the abuse and diversion of prescription drugs. Such abuse has ruined lives, devastated families and fostered dangerous crimes against pharmacies. At the same time, there are more practical means available to reduce prescription drug abuse."

The National Association of Chain Drug Stores echoed the NCPA's views.

"Pharmacies have a zero tolerance for prescription drug abuse and a 100% commitment to patient care," the NACDS' statement read. "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. 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."


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