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 [1] 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 [2]), 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 [3], a schizophrenia treatment, and Novartis for Prexige [4], a painkiller.

- check out the report [5] from the Financial Times
- read this interview [6] for more

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Industry exec says FDA approval process too strict. Report [9]