US FDA sets out to improve advisory c'tee process as rate of approvals tumbles

The US Food and Drug Administration's rate of new drug approvals has fallen sharply so far this year, according to a new report from Friedman, Billings, Ramsey industry analysts James Kumpel. He said that the agency had cleared just 59 new medicines in the period to end October, a reduction of 29% on the like year-earlier figure, pointing out that, significantly, the problem is not in the pharmaceutical industry's R&D pipeline.

His views are confirmed by other sector observers, who say that the FDA has cracked down on New Drug Applications since the withdrawal of Merck & Co's COX-2 painkiller Vioxx (rofecoxib) three years ago after studies linked it with increased risk of heart attacks, notes a report by CNN Money. It quotes the FDA Office of New Drugs Director, John Jenkins, as saying that the agency is now requiring long-term studies for cardiovascular risks for the non-steroidal anti-inflammatory drug class. However, he interprets this as a change in the available scientific knowledge regarding side effects, not a change in the regulatory process, and that it would be "irresponsible" to ignore it.

For his part, Mr Kumpel argues that claims that the pharmaceutical industry's submission of applications has fallen, are wrong. Clearance of biotechnology drugs in particular, he said, "have fallen off the cliff." He said that the FDA is heading for a ratio of 60% of total 2007 NDAs versus 76% in 2006, which would be a 13-year low.