The FDA Awaits a Cure for Its Malaise
WASHINGTON — The Food and Drug Administration has been without a permanent leader for more than two-thirds of President Bush's tenure, and major unresolved problems are piling up at the federal agency in a time of huge medical and scientific change.
With the FDA stuck in the bureaucratic equivalent of slow gear, critics as well as supporters -- in a rare point of agreement -- say the agency is in danger of losing its standing in setting regulatory policy in the rapidly evolving medical and scientific fields.
At the heart of the continuing stalemate over Senate confirmation of a permanent FDA commissioner is the unresolved question of what role religion and ideology should play in making science policy.
Many experts think the impasse could continue for the rest of Bush's term.
The last permanent FDA commissioner, Lester M. Crawford, was confirmed in 2005 then quit unexpectedly after two months. The current nominee, acting chief Andrew C. von Eschenbach, a cancer specialist with ties to the Bush family, may never get a vote in the Senate.
The circumstances under which Crawford left remain murky. He did not explain his abrupt departure to his closest staff. He is under investigation by the Health and Human Services inspector general into a possible undisclosed financial conflict of interest, a federal official said Friday.
Meanwhile, the problems awaiting decisive action at the agency include fixing the drug safety system and reversing the decline in new medications submitted for approval.
The immediate issue is a standoff between the Bush administration and Senate Democrats over how to regulate sales of the "morning-after" birth control pill known as Plan B.
"At this point, the political process has overwhelmed any middle ground," said Dr. Eve Slater, former assistant secretary for health in Bush's first term. "Let's do away with the cumbersome political process that paralyzes the ability of the FDA to do its job."
Slater said she was "disgusted with both sides" in the standoff. "Science is just being put into the meat grinder and is being politicized," she said.
The lack of a permanent FDA commissioner has aggravated the strains between the administration and much of the scientific community, coming on top of disagreements over such issues as global warming, stem cell research and teaching evolution.
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