The drugmaker’s No. 2, who will soon succeed the retiring Bob Essner as ceo, characteristically downplays the recent setbacks Wyeth suffered attempting to get FDA approval for two drugs believed to have huge sales potential - one for treating post-menopausal symptoms and the other for schizophrenia.

“It’s an overreaction to say, ‘Two delays, problem, problem,’” Bernie tells The Star-Ledger of New Jersey (which owns Pharmalot). “My belief is that we should get these drugs approved in the end.” And he goes on to note that the FDA approved two other Wyeth drugs this year - an oral contraceptive and a renal cancer treatment. Five more drug candidates, he continues, have been filed with regulators, which suggests only more surprises await him.

Like other pharma execs, Essner blames a shift in thinking at the FDA for Wyeth’s problems. “No one at the FDA would dispute the fact that their decision-making has changed a great deal,” he says during the same interview. “In the case of Pristiq (the med for post-menopausal symptoms), we looked at the data package over and over again. In a normal FDA environment, that would have been approved, easily.” Adds Poussot: “We are looking at every single project with a team of executives who can help us anticipate the right answers to (the FDA’s) questions.”

“This is an interesting time for the industry. The regulatory environment is far more restrictive,” says Wyeth board member John “Jake” Mascotte, retired ceo of Blue Cross and Blue Shield of Kansas City. “The real challenge Bernard is going to have is making sure the company does not miss opportunities that the last 10 years of research capability has (produced). If there are greater challenges in obtaining regulatory approval, Bernard is going to have to get the staff to put the shoulder to the wheel. I don’t think that’s going to be easy.”