Oct. 1, 2014 SIGN IN | REGISTER

Painkiller Reclassification in FDA’s Hands

“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.

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