FDA review time for new drugs at all time low, FDLI meeting hears

In the fiscal year 2006, the US Food and Drug Administration approved 101 new products, including 97 New Drug Applications and four Biological License Applications, noted Steven Galson, director of the FDA's Center for Drug Evaluation and Safety, who added there were 22 New Molecular Entities and 21 priority drugs. Speaking at the Food and Drug Law Institute's annual conference in Washington DC, he said that the median review time remained at six months, unchanged from 2005, though he expressed concern about innovation in noting that the number of products approved is still down from the figure of the late 1990s.

Review time is at a historic low for prescription drugs, he said, but that cannot be said for the review time for generic drugs, which are increasingly important for the bottom line in US health care costs. The workload in this area is outpacing resources, with applications continuing to increase; the median application now takes 16.6 months to review, noted Dr Galson.

There has been support from Congress to increasing resources in this area and the agency is trying to redesign the approval process to make it more efficient. In responding to the recent Institute of Medicine report on drug safety (Marketletter October 26, 2006), the agency is committed to improving the science that supports the medical product safety system by making it smarter and more efficient, to improving the flow of communication and information to the public, and by improving operations and management to strengthen the drug safety system. The agency also has said it agrees with the IOM on improving the culture of safety throughout the lifecycle of the product.