Painkiller Reclassification in FDA’s Hands

Posted November 2, 2012 at 12:00am

The Food and Drug Administration is considering whether to put more stringent limits on drugs such as the painkiller Vicodin that contain hydrocodone, although the process is moving more slowly than some lawmakers would like.

Sen. Joe Manchin III, D-W.Va., and other lawmakers have pushed to reclassify combination hydrocodone products to schedule II from schedule III, which they say will make them more difficult to abuse. But doctors and hospital groups have said such a move could limit access to the drugs for patients, and the FDA has recommended against the reclassification in the past.

Now, in part thanks to compromise language in the FDA user fee reauthorization law (PL 112-144), the agency is taking another look at moving the products to the stricter category.

An FDA advisory committee meeting on reclassifying the drugs was scheduled to take place this week, but the agency postponed it because of the storm that hit the East Coast.

When it does meet, the advisory committee will discuss the products’ potential for abuse compared with schedule II drugs and the effect a reclassification would have on prescribing patterns, patient access and abuse or misuse of the products. The committee will vote on whether to recommend the reclassification, and although the FDA does not have to accept the recommendations, it usually does.

Manchin plans to speak at the FDA advisory committee meeting, an aide said. He also continues to look at other options, including his bill (S 2297) to reclassify the hydrocodone products.

Potential for Abuse

Combination hydrocodone products are a popular treatment for pain, and provider groups say they do not want to limit access to patients who have legitimate needs. Combination hydrocodone products made up 66 percent of all opioid painkiller prescriptions in 2011, according to the FDA. Approximately 47 million patients received 131 million prescriptions for combination hydrocodone painkillers that year. In comparison, about 15 million patients received prescriptions for combination oxycodone drugs.

But abuse of the drugs is increasing, helping make prescription drug abuse the fastest-growing drug problem in the country, according to the Centers for Disease Control and Prevention (CDC). There were 14,800 deaths from overdosing on prescription painkillers in 2008, more than from cocaine and heroin combined, CDC says. That’s more than three times the number of people who died from prescription painkiller overdoses in 1999.

Reclassification would place many more regulations on the drug throughout the supply chain, from manufacturers to doctors and hospitals. For example, prescriptions for schedule II drugs are acceptable only when written and signed by a provider, whereas those for schedule III drugs can come in oral, faxed or written form. In addition, prescriptions for schedule II drugs cannot be refilled.

On its own, without being combined with other products, hydrocodone is a schedule II drug.

Manchin won a victory in May during Senate debate on the FDA user fee reauthorization when his colleagues adopted his amendment to reclassify all combination hydrocodone products to schedule II. But the language was removed during negotiations with the House for the final version of the bill.

Instead, as part of the compromise, the law calls for a public meeting to assist the FDA in recommending whether the Drug Enforcement Agency (DEA) should reclassify the products. Manchin blamed interest groups who had lobbied against his provision.

“The influence of special interest groups suppressed the voice of the people,” he said on the Senate floor in June. “I can assure you, I will not give up this fight.”

Several groups, including the American Medical Association, the Generic Pharmaceutical Association and the National Association of Chain Drug Stores, had expressed concerns about the scheduling change. In letters to lawmakers, they said the change could limit access to treatment for patients and put more burdens on providers.

It’s unclear how the FDA would advise on the reclassification this time around. In 2004, the DEA requested that the FDA evaluate and make a recommendation on reclassifying the products, and in 2008 the FDA recommended against it. The next year, the DEA resent its request, along with new information on the drugs and their abuse statistics.

The last time, the FDA found that hydrocodone combination products have less potential for abuse than other drugs and substances in schedule II. In part, that’s because combining hydrocodone with another product reduces the amount of hydrocodone needed for the therapeutic effect – so doses can stay low, according to an FDA briefing memo.

The memo, released last week, also notes that the abuse potential of the drugs can be difficult to determine.

“Overall a scientific and comprehensive evaluation of the relative abuse potential of hydrocodone combination product needs to be weighed in the final recommendation of whether to up-schedule or not these products,” it says.