Bob Temple has a sharp mind and a thick skin. But after 25 years at the FDA, well, some things change. Lately, the director of the Office of Medical Policy admits that some of the withering criticism of the agency is getting under his skin.

“It’s a particular subset of people who do that,” Temple tells The RPM Report. “A lot of them over the years, I’ve considered friends. But I’m probably re-evaluating that.”

Who’s on the list? Curt Furberg, a health policy professor at Wake Forest University, University of Washington epidemiologist Bruce Psaty, and Ray Woolsey, who heads the Critical Path Institute. They’ve all testified before Congress, offering ideas about fixing the FDA.

But nobody gets more of a rise out of Temple than Steve Nissen, the Cleveland Clinic cardiologist whose study in The New England Journal of Medicine called into question the safety of Avandia, and the actions of the FDA and Glaxo toward the drug, as well.

“I’ve had perfectly civil conversations about various things with him, but you know, I’m sort of stunned when he testifies at a hearing that the leaders of a division always overruled their virtuous reviewers. He served four years on the cardiorenal committee, and I can tell you he didn’t see that. So that’s funny thing to say.”

Separating the public remarks from the discourse during the usual review process is tricky, he acknowledges, but he says he tries to be philosophical about it.

“Some of the people that have different views have continued to serve on an FDA advisory committee and been perfectly useful, so you kind of have to divide up what they’re doing in one phase from what they’re doing in the other and make the best of it.”

“You don’t like criticism, but people have a right to do it. I wish we responded more often, but our problem is they can say whatever they want and we have to respond with perfect truth. If we ever made a mistake in a response, we’d get creamed.”

You can read more of this except from RPM Report here;
And you can read the complete Temple profile here.
[tags]Bob Temple[/tags]