FDA votes in favor of Vicodin restrictions

HealthDay News -- An FDA advisory panel voted 19 to 10 in favor of moving hydrocodone combination products, including Vicodin, Lortab and Norco, into the more restrictive Schedule II category of controlled substances, on Friday.

Currently, hydrocodone combination drugs are classified as Schedule III drugs, but the agency wants them recategorized into the more tightly controlled Schedule II designation. Other opioid medications, including Oxycontin and Percocet, are already classified in the higher Schedule II category.

Moving the drugs from schedule III to schedule II would eliminate a clinician's ability to prescribe up to a 6-month supply of the drugs as well as the ability to simply call in a prescription.


For schedule II drugs, doctors can write for no more than a 3-month supply, and a written prescription is mandatory.

Hydrocodone is currently the most widely prescribed medication in the U.S., accounting for 131 million prescriptions for 47 million patients in 2011, according to the FDA.

The FDA's two-day hearing was the result of a 1999 citizen's petition initiated by Ronald Dougherty, MD, the former director of an addiction treatment center in Syracuse, N.Y., who felt he had treated too many patients addicted to easy-to-obtain hydrocodone pills.

In response to the petition, the Drug Enforcement Administration (DEA) conducted an eight-factor analysis in 2004 -- covering factors including the drug's actual or relative potential for abuse; it's history or current pattern of abuse; scope, duration and significance of abuse; and risk to public health. 

The FDA originally decided that there no need to up-schedule hydrocodone combination products, but in 2009, after collecting updated data on hydrocodone abuse, the DEA asked HHS to reconsider this decision.

The need to reclassify hydrocodone products was also included as a provision in a 2009 amendment to the Food and Drug Administration Safety and Innovation Act (FDASIA). The Senate passed the bill, but it met heavy resistance from pharmaceutical groups and was stripped from the final version of FDASIA. As a compromise, HHS agreed to hold a hearing to help the FDA with its scheduling recommendation to DEA for hydrocodone products.

At the hearing, representatives from the American Cancer Society, the American Academy of Pain Management, the National Association of Chain Drug Stores (NACDS) and the Healthcare Distribution Management Association (HDMA) expressed concern that up-scheduling hydrocodone products would limit treatment options for patients with chronic pain, who truly need the drugs.

Others in attendance, including addiction specialists and bereaved families who had lost children to prescription painkillers, countered these concerns.

Despite the majority decision that it's appropriate to reclassify hydrocodone products as Schedule II category of controlled substances, it remains to be seen how the FDA will interpret the advisory panel's recommendations.

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