Biotech Values

[flatlander_60048]

I work in a regulatory compliance field and one of the ways industry often tries to cope with changes in regulations (or changes in the playing field) is to hire a regulator who is perceived to be able to grease the skids to expedite approvals. While Teva has a wealth of experience in conventional pharma products, I think they sense that the game is changing and they believe that Mr, Buehler might help overcome some of the difficulties they are experiencing or that he might help with some deficiencies they might have with regulator relationships. I see this as a possible move by Teva to counter some of the FDA ties/credibility that MNTA established by helping to identify the contaminated heparin source and through the educational process of wining approval for m-enox.

I agree with Dew that the science must be there to support the application, however they may be gray areas where Teva believes lobbying may be useful. As noted in the attached link, Teva appears to be signaling a strategy to try to finesse technical impasses and regulatory issues through lobbying.

http://www.fiercepharma.com/story/teva-recruits-fdas-former-generics-chief/2010-10-18