Out-going Wyeth CEO slams FDA for creating monopolies and going beyond its mandate

The US Food and Drug Administration is going beyond its legal mandate by denying approval for new drugs, alleged Bob Essner, the outgoing chief executive of American pharmaceutical major Wyeth, in a hard-hitting interview with the UK's Financial Times. He said that the FDA was blocking new drugs after their efficacy was compared to those already on the market, which is not its job, and could therefore prompt legal action. "If you're the first company to get approved in a certain area and competitors can't get on the market, the FDA is establishing monopolies," Mr Essner told the FT.

The newspaper quotes the FDA as saying it "does not have what is called a 'comparable effectiveness' standard for drugs," but does consider already-marketed ones in its risk/benefit decisions for new compounds.