FDA Panel Recommends Tighter Restrictions for Vicodin, Hydrocodone Combo Meds

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January 25, 2013 – This week, an advisory panel from the U.S. Food & Drug Administration (FDA) voted in favor of moving Vicodin and other hydrocodone combination drugs into the more restrictive schedule II category of controlled substances. The panelists who favored tighter restrictions on the popular class of drugs believe they are pharmacologically similar and carry the same propensity for addiction as other opioid medications that fall into more regulated categories. And while the committee admitted that the reclassification of hydrocodone-based drugs would not solve the problem of addiction, they believe it would act as an important step in getting physicians to rethink prescribing practices and looking at alternative approaches to pain management.

What’s the problem?

The panel’s recommendation to move Vicodin and other hydrocodone-containing drugs from schedule III to schedule II would eliminate a clinician’s ability to prescribe up to a six-month supply of the medications, as well as the ability to simply phone in a prescription. Schedule II drugs can only be prescribed for up to three months at a time, and handwritten prescriptions are mandatory.

“We’ve seen the terribly serious consequences of poor prescribing practices stemming from obvious misclassification of hydrocodone combinations,” said panelist Mary Ellen Olbrisch, PhD, professor of psychiatry at Virginia Commonwealth University. “I don’t think the reclassification is a panacea for the opiate abuse problem in the U.S., but I think it’s an important step in getting physicians to rethink prescribing practices and look at other approaches to pain management.”

There has been a considerable amount of controversy over hydrocodone since at least 1999, when a citizen’s petition sparked an inter-agency war between the DEA and FDA. This week’s hearing was a compromise that resulted from hydrocodone being removed from a reclassification provision in 2012’s Prescription Drug User Free Act (PDUFA). The hearing was originally scheduled for October, but was cancelled due to the damage caused by Hurricane Sandy.

The meeting was attended by industry and advocacy organizations, including pharmacists and pain specialists who were concerned that reducing access to hydrocodone medications would limit treatment for patients in severe pain. That message was quickly countered by addiction specialists and families who had lost loved ones to drug overdoses.

Hydrocodone-containing drugs are currently the most prescribed agents in the United States, with some 41 million prescriptions written for 47 million patients in 2011 alone. To get a better understanding of the medications’ scope of abuse, FDA and DEA epidemiologists calculated ‘abuse ratios’ to assess whether the massive volume of hydrocodone prescriptions was tied to more severe outcomes. Numerators in the agencies’ calculations included hospital visits and overdoses, which were divided by such factors as the U.S. population and number of tablets dispensed. Depending on which figures were divided against which, hydrocodone medications appeared both more and less abusable than oxycodone products.

Joseph Rannazzisi, deputy assistant administrator of the office of diversion control at the DEA, spoke out against the reliability of statistics: “I’m not going to talk about denominators. I’m not a statistician or a PhD. I’m just a cop,” he said. “Every day I deal in reality, and I know these abusers are taking 10, 20, 30, or 40 tablets of hydrocodone drugs. This drug has got a hold of this society and it’s just killing us,” he said.

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