April 10, 2008, 7:32 am
Stem Cells to Take FDA’s Center Stage
Posted by Joe Mantone
The
FDA will hold two days of hearings starting today on how to regulate
controversial therapies made from embryonic stem cells, but the
proceedings, which could be contentious, will also give companies a
chance to showcase their technologies, the WSJ reports. The hearings will discuss the safety of human trials and one concern is that unchecked stem cells could lead to cancer, Bloomberg reports. For their part, the biotech industry and investors seek assurance the FDA won’t nix embryonic stem cell therapies because of political reasons.
Backers of stem cells fret the agency has been pushed into establishing tough standards too soon. “The FDA is nervous. It’s under tremendous pressure. They can’t appear adversarial but they can’t seem to be rolling over for industry, either,” Richard Garr, CEO of Neuralstem, which works on adult stem cells, tells WSJ.
A few pioneers are selling products derived from less controversial adult stem cells, but thesales are pretty low. Big Pharma has largely stayed clear of stem cells because the research is at an early stage. But favorable industry regulations could further boost biotech, a corner of the health-care sector that has been relatively unscathed by the ailing stock market.
Geron, which calls itself “the world leader in the development of human embryonic stem cell-based therapeutics,” is likely to submit this summer a proposal for a clinical test of a therapy to repair acute spinal injury. Geron is expected to present at the FDA hearing.
http://blogs.wsj.com/health/2008/04/10/stem-cells-to-take-fdas-center-stage/?mod=WSJBlog