FDA slows down approvals, firms claim

The US Food and Drug Administration is to blame for the slow down in new drug approvals, according to research-based drug firms. The agency is viewed by many analysts as taking a stricter line on safety as a reaction to the political and public outcry over the withdrawal of US drug major Merck & Co's COX-2 inhibitor arthritis painkiller Vioxx (rofecoxib; Marketletters passim).

However, Janet Woodcock, Director of the FDA's Center for Drug Evaluation, rejects the drug industry's analysis, stating that a reduction in applications is to blame for the lowest number of marketing approvals, 19 in 2007, since 1984. Noting a 33% drop in New Drug Applications in 2006, Dr Woodcock said: "you can't approve drugs you don't get applications for." She added that the criticism has been damaging to staff morale and not helped attempts to recruit 500 extra staff to process drug reviews, a shortage which the FDA has acknowledged as contributing to delays in handling product reviews.