Bio industry hopes for help from Obama, closely watching FDA & stem cell research

[Amerigo Vespucci]

Friday, November 14, 2008
Bio industry hopes for help from Obama
Silicon Valley / San Jose Business Journal - by Lisa Sibley

http://sanjose.bizjournals.com/sanjose/stories/2008/11/17/story1.html?ana=e_ph

President-elect Barack Obama hasn’t outlined details of his administration’s biotechnology agenda yet, but industry leaders in Silicon Valley are closely watching what he will do with the U.S. Food and Drug Administration and stem cell research.

The industry has fallen into a “comfort zone” with the FDA and could be in for a shock, suggested John Manthei, a partner and global co-chair of Latham & Watkins LLP life sciences practice group in Washington, D.C.

The FDA is likely to be more aggressive next year, he said, because Democrats believe the agency hasn’t enforced laws as well as it could.

He said there will probably be more investigations with an increased emphasis on product safety issues, which could ultimately slow approvals of new drugs and therapies.