FDA seeks more controls on combination painkillers

Oct. 31, 2013

In a significant shift in policy that has major implications for American healthcare, The Food and Drug Administration (FDA) has recommended that much tighter controls be placed on how doctors prescribe the most common narcotic painkillers. The decision to reduce the number of refills of drugs such as Vicodin and Lortab—combination drugs that include both the narcotic hydrocodone and over-the-counter painkillers—comes in the context of a debate that has raged for years over whether control of such drugs should be increased. They would now be regulated much the same as more powerful painkillers such as OxyContin.

The FDA proposal would re-classify the combination painkillers as “Schedule II” medications; they are currently classified as “Schedule III.” In addition to limiting the number of refills a patient could get without a follow-up visit to the doctor, the change would require patients to take a prescription to a pharmacy (it could no longer simply be called in by the physician). The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription.

Dr. Janet Woodcock, director of the agency’s center for drug evaluation and research, believes that the new regulations could take effect as early as next year. The recommendation requires the approval of the Department of Health and Human Services and adoption by the Drug Enforcement Administration, which has been a vocal proponent of the measure. Read a comprehensive account of this national news story in the New York Times.