The FDA wants to tighten the reins on hydrocodone combination drugs such as Vicodin, recommending that they be classified as Schedule II narcotics like OxyContin and fentanyl.

The move -- more than a decade in the making -- will 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.

"This determination comes after a thorough and careful analysis of extensive scientific literature, review of hundreds of public comments on the issue, and several public meetings, during which we received input from a wide range of stakeholders, including patients, healthcare providers, outside experts and other government entities," the FDA said in a Drug Safety Communication.

FDA said it will send its formal recommendation package to the Department of Health and Human Services (HHS) by early December, and the Drug Enforcement Administration will make the final change.

Experts say it could be more than a year before the process is finalized.

Still, many who have been pushing for the change were more than satisfied with the results.

"I'm thrilled by this news," said Andrew Kolodny, MD, chief medical officer of Phoenix House, who has long fought for tighter control of prescription opioids. But he said it's "bittersweet" because of the "thousands of lives lost since the point at which the DEA first asked FDA about [upscheduling] and all of the patients who became addicted during that time."

Long Road

The decision follows a 2-day meeting held last January that produced an advisory panel recommendation to move hydrocodone combination products -- which in addition to Vicodin also includes brand names like Lortab and Norco -- to the more restrictive schedule II category of controlled substances.

Prior to that meeting, the FDA had not signaled its support for a change in the current scheduling, as evidenced in a review posted in advance of meeting.

Advocates didn't expect the FDA to take a different stance at that point. The agency and the DEA, by that point, had had a back-and-forth over the issue for nearly a decade, since a 1999 Citizen Petition that called on FDA to make the schedule change.

Some experts have attributed the long stretch to clashing ideology between the FDA and the DEA, the latter of which seemed keen to have tighter restrictions on hydrocodone products, particularly in light of what the federal government has dubbed an "epidemic" of addiction to prescription opioid painkillers.

In the meantime, some states took matters into their own hands. New York, for instance, passed the Internet System for Tracking Over-Prescribing Act (I-STOP), which made any drugs containing hydrocodone a Schedule II drug -- along with other reforms.

Potential Impact

Vicodin was the most prescribed medication in the U.S. in 2010, with 131 million filled prescriptions -- far surpassing the second-place drug, the statin simvastatin (Zocor), which had 94 million filled prescriptions.

Some researchers maintain that hydrocodone combos are just as likely to be abused as other opioids and subject to similar high rates of diversion. It is generally accepted among clinicians and patients alike that a Vicodin prescription is easy to obtain.