FDA: Expect Delays Before Hydrocodone Combination Drugs Reclassified

The Food and Drug Administration (FDA) told lawmakers this month that the process of reclassifying hydrocodone combination products, in order to make them more difficult to prescribe, will be long, The Hill reports.

In January, an FDA advisory panel voted to strengthen restrictions on hydrocodone combination drugs, such as Vicodin. The panel recommended that the FDA make the drugs more difficult to prescribe.

The Drug Enforcement Administration (DEA) classifies drugs on a five-stage scale, which takes into account the potential for addiction. Currently, hydrocodone is considered by the DEA to be a Schedule II controlled substance, the second-highest level.

Hydrocodone combinations, such as Vicodin, are Schedule III, and therefore have fewer restrictions on sales. Under the advisory panel recommendation, Vicodin and other hydrocodone combination products would move from Schedule III to Schedule II.

The proposal forbids refills without a new prescription, as well as faxed prescriptions and those called in by phone. Distributors of the drugs would have to store the drugs in special vaults. Nurse practitioners and physician assistants would be banned from prescribing the drugs.

Following the vote, U.S. Representatives Vern Buchanan of Florida and Edward Markey of Massachusetts sent a letter to the FDA, urging the agency to follow the recommendations of the advisory panel.

In response, the FDA wrote a letter to the Congressmen explaining that many regulatory obstacles must be overcome before the drug can be reclassified. The DEA must first publish information in the Federal Register and receive public comment. The FDA also must research the addictiveness of the medication, the article notes.