As Bob prepares to leave the ceo job on Jan. 1 and become chairman for an unspecified period of time, he’s using his final weeks to sound off quite sharply about the FDA, which has caused Wyeth unending aggravation this year by refusing to approve some of its drugs.

In an interview with The Financial Times, Bob say the FDA “is establishing monopolies” by denying drug approvals. He’s concerned that FDA assessments now include whether a drug can work better than an existing product, instead of allowing the market to determine what it wants. Specifically, he says the FDA was blocking new drugs after their efficacy was compared to those already on the market. This is, he claims, beyond the FDA’s mandate and could prompt legal action. Whether he is about to sue isn’t clear.

“If you’re the first company to get approved in a certain area and competitors can’t get on the market, the FDA is now establishing monopolies. And that’s certainly not their mandate,” Bob fumes, noting that the FDA delayed or rejected approval for three drugs this year - Viviant, for osteoporosis; the Pristiq antidepressant and menopause treatment; and bifeprunox for schizophrenia. “It could well be legally challenged. Although that may not be a formal standard, it does appear to be a growing practice.”

In general, pharma complains the FDA is becoming too strict in reaction to safety controversies. The FT recalls that Novartis ceo Dan Vasella, last month said: “The discussion on what this drug brings over and above what’s on the market is a question that’s being asked. The FDA doesn’t seem to trust the physicians any more.” Novartis decided not to seek approval for its Prexige painkiller after safety questions arose overseas, its Galvus diabeted med was delayed after the FDA sought more data and its Tasigna cancer drug was approved only last week after a three-month delay.

The FDA told the paper that it “does not have what is called a ‘comparable effectiveness’ standard for drugs. We do consider other products already available as we make benefit/risk decisions for new products.”