FDA Discusses Possible Rescheduling of Hydrocodone Combination Products as Schedule II Drugs

October 31, 2012 3:39 pm

On October 29 and 30, 2012, the Food and Drug Administration (FDA) Drug Safety and Risk Management Advisory Committee met to discuss the potential for abuse of hydrocodone combination products in order to reach a recommendation regarding whether the drugs should be reclassified as Schedule II. The committee focused on four questions during the meeting:

1. Is the pharmacology and epidemiological data sufficient to demonstrate that abuse potential is equal to Schedule II products?
2. Do they have recommendations for implementing approaches to reduce abuse and misuse?
3. What is the impact of rescheduling on appropriate patient access?
4. Should the product be rescheduled?

The advisory committee’s decisions will inform FDA's ultimate recommendation to the Assistant Secretary of Health. A scientific and medical evaluation and scheduling recommendation for drugs containing hydrocodone either combined with other analgesics or as an antitussive, was requested of FDA by the Drug Enforcement Administration, as the agency is considering whether to reschedule the products to Schedule II under the Controlled Substances Act. Currently hydrocodone combination products are Schedule III drugs. An FDA Briefing Document (PDF) presents reviews and data that were considered by the committee. A meeting overview (PDF) is also available on the FDA Web site.