FDA Recommends Tighter Restrictions On Certain Painkillers

REPEATING FROM YESTERDAY EVENING: In a major change of policy, the FDA has recommended reclassifying commonly used prescription painkillers that contain hydrocodone, such as Vicodin, to a more restrictive ranking on the national law enforcement schedule. The drugs are currently classified as Schedule III controlled substances. The moves comes amid a growing effort to find a midpoint that balances patient need for pain relief with ongoing concerns over abuse and addiction associated with these medications. Last March, a bill was introduced in Congress to reschedule the drugs (see this and this). And the agency decision follows an advisory committee meeting was held earlier this year at the request of the US Drug Enforcement Agency, which has argued for nearly a decade that these drugs need to be more tightly controlled, and voted to reclassify the medicines. In announcing the move, the FDA cited “the unique history of this issue and the tremendous amount of public interest” in access to these painkillers. And the agency says it took this step after a “thorough and careful analysis of extensive scientific literature” and reviews of hundreds of public comments (here is the FDA statement). "These are very difficult tradeoffs that our society has to make," Janet Woodcock, who heads the FDA Center for Drug Evaluation and Research tells The New York Times. “The reason we approve these drugs is for people in pain. But we can’t ignore the epidemic on the other side.” A 2...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs