The Food and Drug Administration on Thursday recommended tighter controls on how doctors prescribe the most commonly used narcotic painkillers.
The move, which represents a major policy shift, follows a decade-long debate over whether the widely abused drugs, which contain the narcotic hydrocodone, should be controlled as tightly as more powerful painkillers such as OxyContin.
The drugs at issue contain a combination of hydrocodone and an over-the-counter painkiller like acetaminophen or aspirin and are sold either as generics or under brand names like Vicodin or Lortab. Doctors use the medications to treat pain from injuries, arthritis, dental extractions and other problems.
The change would reduce the number of refills patients could get before going back to see their doctor. Patients would also be required to take a prescription to a pharmacy, rather than have a doctor call it in.
Dr. Janet Woodcock, director of the agency's center for drug evaluation and research, said she expected 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 pushing for the measure.
For years, FDA officials had rejected recommendations from the DEA and others for stronger prescribing controls as a way to curb abuse of the drugs, saying it would create undue hardships for patients. A number of doctors' groups, including the American Medical Association and pharmacy organizations, have continued to fight the measure, citing the impact on patients.
In a telephone interview, Woodcock said FDA officials were aware that changing the prescribing rules would affect patients. She said, however, that the impact on public health caused by the abuse of the drugs as well as their medical use had reached a tipping point.
The new regulations would reduce by half, to 90 days, the supply of the drug a patient could obtain without a new prescription.