Janet Woodcock, MD, director of the Center for Drug Evaluation and Research at the Food and Drug Administration, issued a statement about the agencys plan to more closely regulate opioid analgesic drug products.
Woodcock noted the abuse and misuse of opioid products have sadly reached epidemic proportions in certain parts of the United States.
In response to a request from the Drug Enforcement Administration to the Department of Health and Human Services, the FDA will recommend reclassifying hydrocodone-containing products from Schedule III to Schedule II, indicating they have a higher potential for abuse. The DEA will make the final decision on the classification.
Schedule II controlled substances require a written prescription signed by a practitioner, with oral orders permitted only in emergency situations and refills prohibited. Schedule III substances can be prescribed orally, and refills are permitted.
The proposal for reclassification 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, Woodcock stated.
“Going forward, the agency will continue working with professional organizations, consumer and patient groups, and industry to ensure that prescriber and patient education tools are readily available so that these products are properly prescribed and appropriately used by the patients who need them most.”