The US Food and Drug Administration is gearing up for the first major overhaul of its current Good Manufacturing Practice guidelines in 25 years, according to the agency's Commissioner Mark McClellan.
The move is just one strand among a series of new measures that McClellan has implemented, since taking over the post of Commissioner in last October, which are designed to boost the agency's productivity and cost-efficiency.
The new GMPs are expected to encourage innovation in the production of drugs, including biologics, he told the Food and Drug Law Institute's annual education conference. The overhaul comes at a time when manufacturers have been having problems meeting requirements for cGMPs, a situation which has led to significant delays in product approvals at companies such as Schering-Plough and Eli Lilly.
On the issue of labelling, McClellan told the meeting that drug package inserts are now so heavy with legal jargon to avoid manufacturer liability that "consumers can't understand and doctors ignore" them. Another high-tech approach being considered is universal bar coding of all prescription drugs, including biologics and vaccines and even over-the-counter drugs. McClellan said the eventual goal is to reduce adverse events by 50 per cent.