U.S. drug regulators aren't playing fair, says outgoing Wyeth CEO Bob Essner. New meds that should be allowed on the market--because they're safe and effective--are blocked if they're not demonstrably better than existing products. That effectively hands monopoly status to the first company to market with a given type of drug, Essner says.
Essner is echoing concerns raised by Novartis CEO Daniel Vasella (photo), who questioned the FDA's right to ask whether new drugs are better than those already being sold. Both companies suffered painful denials recently, Wyeth for bifeprunox, a schizophrenia treatment, and Novartis for Prexige, a painkiller.
- check out the report from the Financial Times
- read this interview for more
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