US FDA’s Most Unusual Advisory Committee

26 Dec 2018

• By Laura Helbling and Michael McCaughan

Agency's opioid response efforts have pushed advisory committee into unusual territory in recent years. But a two-day meeting to discuss potential labeling changes to recommend co-prescribing of the overdose reversal agent naloxone moved way beyond any of the conventional boundaries of committee meetings.

The Dec. 17-18 joint meeting of the US FDA’s Anesthetic & Analgesic Drugs Products and Drug Safety & Risk Management Advisory Committees was probably the single most unusual and creative use of the advisory committee format by the agency’s new drug review center.

The formal discussion topic was itself unusual, but well within the boundaries of advisory committee fare: whether FDA should consider...