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By Brian Reid

August 13, 2002 | WASHINGTON – The FDA bills itself as one of the nation’s most respected consumer protection agencies, overseeing vast swaths of commerce that account for 20 cents of every dollar spent in the United States. But the leading public health agency has been leaderless for a year- and-a-half, dating back to President George W. Bush’s inauguration in January 2001.

Though there have been voids at other federal health and science agencies during the George W. Bush administration—the directorship of the National Institutes of Health was filled in May after a vacancy of more than two years—the failure to install an FDA commissioner has raised concern among drug industry members, advocates, and financial analysts.

In May, the Biotechnology Industry Organization (BIO) wrote to Bush to ask for quick action on the FDA commissioner—one of the powerful lobbying group’s most important goals. The letter, signed by dozens of executives, was the second letter from BIO to Bush this year pushing for a new commissioner. That, BIO argues, would give the agency a point person for the ongoing Washington budget battles.

“The FDA needs a compelling spokesperson to act as an advocate for the agency,” Carl Feldbaum, BIO’s president, told a New York City audience earlier this year. “Our nation is funding fundamental biomedical research at unprecedented levels, but starving the agency that handles the other end of the pipeline, where products are developed and, ideally, are approved to benefit patients.”

Feldbaum and pharmaceutical executives are worried about a slowdown in drug approval times. The issue has also caught the attention of investors who are worried that a cautious FDA is already stunting drug industry growth.

Another complaint of BIO and others was the agency’s invisibility in the wake of the anthrax attacks last fall. Though FDA researchers had carefully studied anthrax treatments and vaccines, the agency gave no hint of its expertise.

“The place where a commissioner was sorely missed was in the aftermath of 9/11, with anthrax,” says Ira Loss, an analyst at Washington Analysis, an equities research firm. “There really was no authoritative public health figure who was able to step up to the plate.”

The politics of the position have been problematic. The agency is caught between a socially conservative, pro-business White House, which will nominate the next commissioner, and Democrat Sen. Edward Kennedy, who leads the Senate Health, Education, Labor, and Pensions committee, which oversees the confirmation of that candidate.

After media reports last summer that Bush was considering Transkaryotic Therapies Inc.’s Michael Astrue and Merck & Co.’s Eve Slater for the top job, Kennedy said he would not back any candidate from within the drug industry, jettisoning those efforts.

The views of industry have also made it perilous for those who advocate stronger drug-safety stances. The Bush administration reportedly weighed Raymond Woosley, now the dean of the University of Arizona School of Medicine, who has called for an overhaul of the way the agency monitors side effects. Woosley removed himself from consideration citing the slow-moving and uncertain process. Alistair Wood, a Vanderbilt University professor, was also interviewed last year, but analysts said drug industry concerns about his firm position on drug safety helped derail his candidacy.

 

Wishin’ and Hopin’

In the interim, Bush has named two political appointees to fill lower leadership positions. Lester Crawford, a food-safety expert, was named deputy commissioner in February. And last year, the administration installed Daniel Troy as the agency’s chief counsel, a position that had been held by a civil servant—not an appointee—for more than a decade. Those moves have helped quell some concerns.

“Dan Troy has been one of the go-to guys for the administration,” says Paul Heldman, an analyst at the Charles Schwab Corp.’s Washington Research Group. “When it comes to oversight of [drug] manufacturing issues, he’s Bush’s point man. You might as well call him the commissioner on those issues.”

Still, Heldman says Troy does not appear play a major role in the drug approval process, giving the industry no one to turn to with complaints. Troy has not been considered a candidate for commissioner.

The commissioner’s role in individual drug approvals, however, is usually small. The FDA’s teams of medical officers and statisticians generally make the decisions on whether a particular product should be on the market. The letter informing drug companies that they’ve won approval does not come from the commissioner’s office.

Heldman cautions that it would take a powerful—and opinionated—leader to make big changes in the way drugs are approved. “I think that potentially, if you have a strong commissioner that feels there are flaws in the drug approval process that are keeping drugs from that market, that could make a difference,” Heldman says. Still, biotech and drug firms should not hold their breath: A commissioner fitting that profile is unlikely to appear, analysts agree.

“If people are expecting instant changes in the drug approval process or the way that the FDA approaches its business, they’re going to be disappointed,” says Loss.

Despite the delays, those inside and outside of government remain optimistic that a new commissioner will be in place this year. The only question is the kind of boss the agency will be given. In a note to investors, SG Cowen Securities Corp. analyst Eric Schmidt listed his key predictions surrounding a new commissioner. His final point, however, was a question: “Will Bush pick the best Republican,” Schmidt asked, “or the best leader?”

 

Sidebar: Many Are Called, But Not One Has Been Chosen

A half dozen candidates to lead the FDA have reportedly been floated, but the critical position remains vacant. Here are some candidates who either declined or were passed over:

Ray Woosley

Dean, University of Arizona Medical School

Woosley researched the risks of Seldane, a popular allergy drug pulled from the market after being linked to heart rhythm abnormalities. A Georgetown University pharmacologist when the search began, he withdrew his name from consideration to take the Arizona job.

Michael Astrue

General counsel, Transkaryotic Therapies Inc.

Biotechnology lawyer Astrue served as general counsel to the Department of Health and Human Services, which oversees the FDA. Industry links and lack of a medical degree made him unacceptable to Sen. Kennedy (D-Mass.) who controls the Senate’s confirmation of the FDA commissioner.

Eve Slater

Assistant secretary of health, Department of Health and Human Services

Considered last year, Slater was a senior vice president at Merck & Co., and oversaw Merck’s effort to win FDA approval of the blockbuster painkiller Vioxx. But her nearly two decades of work for Merck made her an unacceptable candidate for Senator Kennedy.

Alastair Wood

Pharmacologist, Vanderbilt University

He proposed, with Woosley, an independent drug safety board. The drug industry was reportedly concerned about Wood’s cautious stance on drug safety. That stance prompted a Wall Street Journal editorial opposing his nomination.





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