The FDA's Gary Buehler will soon find out what life is like on "the other side." The ex-chief of the agency's generics division is joining Teva Pharmaceutical Industries as VP for regulatory strategic operations, the Wall Street Journal reports. He's worked for the government for 40 years--24 of those years at the FDA.
"I am curious about how the other side operates," Buehler tells the Journal. "Teva is a very successful generic firm. I look forward to learning the ins and outs of the generic industry and seeing where my experience with FDA can help the process."
There's plenty for Buehler to work on. The FDA is in the middle of developing new rules for copycat versions of biologic drugs, so Buehler will no doubt be lobbying the agency for Teva-friendly policies. And as the WSJ points out, Teva is part of a coalition working on ways to assess proposed FDA user fees for generics makers. The fees are seen as a way to fund faster review of generic meds; the agency's generics division has built up such a backlog of approval apps that new copycat drugs take an average of two years to make it through the process.
- read the WSJ piece