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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2025 | Headless Content Management with Blaze