FDA is mired in bureaucracy, observers say

WASHINGTON -- The Food and Drug Administration has been without a permanent leader for more than two-thirds of President Bush's tenure in office, 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 specialists think the slide at the FDA could continue for the rest of Bush's term.

The last permanent commissioner, Lester M. Crawford, was confirmed in 2005, then quit unexpectedly after two months. The current nominee, acting Commissioner Andrew C. von Eschenbach, a recognized 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 at the agency. He is under investigation by the Health and Human Services inspector general over possible undisclosed financial conflict of interest, a federal official said Friday.

Meanwhile, among problems awaiting decisive action at the agency: Fixing the drug safety system, which too often fails to catch deadly side effects of medications already on the market and reversing the worrisome decline in new drugs being 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, a 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 the teaching of evolution.

''There is a problem with this administration in its lack of attention to science, and its lack of willingness to follow science," said Dr. Brian Strom, chairman of biostatistics and epidemiology at the University of Pennsylvania medical school. ''It's an administration that doesn't seem to want to hear scientific results it doesn't like."

The FDA's stalling of a decision on whether to allow over-the-counter sales of the ''morning-after" contraceptive has galvanized critics on the left and alienated some Republicans, who had hoped the agency would find a middle ground and make the drug more easily available for adult women.

Ignoring its own medical reviewers' recommendations for approval, the agency has adopted delaying tactics recently characterized by a federal judge as having ''all the earmarks of an administrative agency filibuster."

The judge is hearing a lawsuit filed by the Center for Reproductive Rights that seeks to compel approval. Some religious conservatives in the administration's political base are concerned that Plan B is tantamount to an abortion drug. Making it widely available without a prescription will encourage promiscuity, they argue.

Without a decision on Plan B, influential senators will not permit a vote on the FDA commissioner.

''We agree that the FDA needs a permanent commissioner," said Senator Hillary Clinton, Democrat of New York, one of the senators blocking a floor vote on von Eschenbach. ''However, I think there is a larger issue here, which is the standard by which the FDA is making decisions. If they are beholden to an ideological position, I don't think it matters whether they have an acting or a permanent commissioner."

Senate confirmation of the commissioner was originally seen as a reform that would insulate the FDA from political pressure.