Dr. Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, said by early December, the agency planned to submit a formal recommendation package to the U.S. Department of Health and Human Services to reclassify hydrocodone -- a opioid derived from codeine used orally as a painkiller and cough suppressant -- from Schedule III to Schedule II, which would impose new restrictions on how they are prescribed and used. For example, the new designation would limit the number of refills patients could receive before having a doctor write a new prescription.
"Over the past several years, the FDA has been carefully evaluating and weighing the appropriate use of opioid analgesic drug products," Woodcock said. "However, in recent years, the FDA has become increasingly concerned about the abuse and misuse of opioid products, which have sadly reached epidemic proportions in certain parts of the United States."
The agency conducted a thorough and careful analysis involving "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," Woodcock said.
"We anticipate that the National Institute on Drug Abuse will concur with our recommendation. This will begin a process that will lead to a final decision by the DEA on the appropriate scheduling of these products," Woodcock said.
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