Permanent leadership needed at FDA

WASHINGTON, D.C.-The future leadership of the Food and Drug Administration remains highly uncertain following the surprise resignation of Commissioner Lester Crawford in September.

The White House named Andrew von Eschenbach, director of the National Cancer Institute (NCI) at the National Institutes of Health (NIH), as acting FDA commissioner, but he got into trouble for trying to keep his NCI hat while taking the helm of FDA. Although he handed over day-to-day leadership of NCI to a deputy, that move failed to fully appease critics concerned about inherent conflicts of interest in advocating for speedy access to new cancer treatments while overseeing the safety and effectiveness of those therapies. HHS Secretary Michael Leavitt has indicated that von Eschenbach is not likely to get the top job at FDA on a permanent basis.

DAY-TO-DAY DEALINGS

But the uncertain atmosphere at FDA is making it difficult to move forward with important initiatives. A much-anticipated white paper on generic versions of costly biotech therapies, for example, has been delayed while the lawyers further examine policy and legal issues. FDA also plays a central role in ensuring public access to vaccines and therapies to guard against a possible flu epidemic, responsibilities that require strong leadership and ample resources.

All sides are looking to see if von Eschenbach bites the bullet and approves non-prescription use of Plan B, but as a close friend of President Bush, FDA's current leader may not be willing to do so.