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Just What the Doctor Ordered for the FDA?


From the first days of the Bush Administration, the White House had one overarching goal for the Food & Drug Administration. No, it wasn't picking an agency head who would ban the abortion drug RU-486, a red-flag issue to the Religious Right. Instead, the Bushies wanted a low-key, compliant commissioner who would be the antithesis of Dr. David A. Kessler, the crusading FDA chief who railed against Big Tobacco and bedeviled Bush Sr. "The White House is absolutely committed to not having another Kessler," says a source close to the recruiting process.

Still, finding a candidate who fits this prescription has proved difficult, which explains why an agency that is routinely lashed by industry and conservative critics for slow drug approvals remains leaderless after 18 months.

The void at the top may soon be filled. The White House is expected to nominate Dr. Mark B. McClellan, 39, a highly regarded health-care economist at Stanford University and a current member of the President's Council of Economic Advisers. Low-key, smart, and largely apolitical, he could be on the job by the end of the year. His academic studies examine the cost-effectiveness of new health-care innovations--and the agenda he'll carry out at the FDA is expected to be favorable to industry. Already, the agency is considering easing restrictions on everything from drug ads to food labels, stirring up controversy and internal tensions.

McClellan isn't Bush's first choice. Last summer, the White House settled on Michael J. Astrue, a top Health & Human Services Dept. (HHS) official in the Bush Sr. Administration and vice-president at Transkaryotic Therapies Inc.--only to have him nixed by Senator Edward M. Kennedy (D-Mass.), who insisted that the new chief not have industry ties. McClellan's name is also raising eyebrows on Wall Street, where analysts fret that a cost-effectiveness expert may not be a good fit in an agency charged only with ensuring that drugs are safe and effective.

But otherwise, McClellan fits the bill. He's an M.D. who passes Kennedy's litmus test. More important, he's a Bush team player, with strong ties to the President. Brother Scott is a White House press spokesman, and his mother, Carole Keeton Rylander, is Texas' comptroller and former mayor of Austin. "Unless someone digs up dirt on him, it's a pretty clean confirmation," says one observer.

If he gets the Hill O.K., McClellan would head an FDA that's already being reshaped. HHS Secretary Tommy G. Thompson "has his hands all over the agency"--vetting most regulations--says one industry source. More important, chief counsel Daniel E. Troy, who was appointed nearly a year ago, is already pushing the FDA down a deregulatory path. His philosophy: Agencies should limit their actions to what the law explicitly authorizes them to do.

For the FDA, which often creatively adapted its creaky old laws to fit new circumstances--especially under Kessler--that means limiting its reach. "The fact that Kessler stretched the law is the reason why Daniel Troy is there now," says one longtime FDA watcher.

Agency staffers are already complaining of micromanagement, delays, and being unable to carry out their mission of protecting the public. Some are thinking about leaving. "There is a fundamental philosophical clash," says one agency official.

McClellan's task, if he gets the job, will be to lead the FDA smoothly down this less activist path. Some loosening of regulations is probably healthy, many agency watchers say. But if the FDA finds itself in hot water over unsafe products or egregious advertising claims, McClellan may find himself in a brighter spotlight than the White House expected. House Ways & Means Committee Chairman Bill Thomas (R-Calif.) held up a conference committee on the fast-track trade bill for a week by insisting it was his turn to chair the panel. Senate Democrats insisted it was their turn to chair a conference, and Majority Leader Tom Daschle (D-S.D.) complained that Thomas was "jumping up and down and throwing things again." But on July 23, the conference finally got under way after both sides agreed that Thomas could fill the rotation. California's 12th congressional district voters can't say they lack choices. If they don't want to vote for incumbent Democrat Tom Lantos, a Holocaust survivor, they can choose Maad Abu-Ghazalah, a Palestinian-American software engineer running as a Libertarian. Lantos, a liberal and supporter of Israel, backs the Administration's anti-terror campaign. Abu-Ghazalah is a fiscal conservative, critic of Israel, and opponent of U.S. military action in Afghanistan. Lantos is favored. Latino activists had been expecting at least six new Hispanic-majority House districts to be created by redistricting this year and as many as 10 Latinos to win election to the House in November. But early calculations by UCLA's Leo F. Estrada show that only three Latino districts will be fashioned from the new electoral map. Hispanics are particularly incensed that in Texas, where they accounted for 60% of the state's 1990s growth, no Latino district was created.


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