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Duke doctor is a possible candidate to run FDA

Dr. Robert Califf may have a second shot at running the Food and Drug Administration.

The respected Duke University cardiologist and head of the Duke Clinical Research Institute is among people mentioned as possible candidates for FDA commissioner in the administration of President-elect Barack Obama.

Nobody from the Obama transition team has contacted him to confirm he's a candidate, Califf said this week. But he's had plenty of calls from friends and colleagues.

One of them told him, "You'd be crazy to do it, but it would be good for the country," he said.

Califf said he is aware the job of FDA commissioner would come with "a million headaches and constant pressure. But I would consider it if people thought I was the right person for it."

Califf, 57, who has spent more than 30 years at Duke, was considered for the job by the Bush administration eight years ago. He was invited to the White House for interviews in March 2001 but didn't make the final cut.

This time around, Califf might have more luck, said Curt Furberg, a professor of public health sciences at Wake Forest University. Califf is smart, has a vision of what regulation should accomplish and understands science and public health, said Furberg, a drug safety adviser to the FDA and a frequent critic of the agency.

Califf is also a Democrat, Furberg said. Indeed, Durham voter records show him as a registered Democrat.

The FDA is one of the most influential federal agencies, regulating about one-fourth of the U.S. economy. It has nearly 11,000 employees and an annual budget of more than $2 billion.

Its responsibilities include making sure that new medicines and medical devices are safe and that foods and cosmetics are free of contaminants. The health of the pharmaceutical and biotechnology industry, which employs more than 50,000 in North Carolina with a concentration in the Triangle, is closely tied to FDA decisions.

But in recent years, the agency has increasingly come under attack for lax enforcement of safety measures. Medicines that had been approved by the FDA caused deadly side effects. Inspectors had a difficult time tracking down produce that caused people to get sick, and they missed imported goods contaminated with industrial chemicals. Drug manufacturers have complained that the FDA's drug approval process has slowed to a trickle, increasing costs and delaying important new treatments.

Critics such as Furberg are calling for a total restructuring of the agency.

Names of other qualified possible candidates are also making the rounds, said Marc Scheineson, an Alston & Bird lawyer in Washington who represents food and drug companies.

"Everyone is looking for a strong manager," he said. "Somebody with experience in managing high-powered medical professionals. Somebody with a strong medical and research background. Somebody who's a good communicator and who can recruit talent for the FDA."

Other potential candidates include Dr. Steven Nissen, the Cleveland Clinic's cardiology chief. Nissen gained attention recently as a whistle-blower when he raised questions about the safety of GlaxoSmithKline's diabetes pill Avandia.

The FDA commissioner position is a full-time job, and it is unclear what would happen to Califf's appointments at Duke should he be tapped. Duke's long-term research project at the N.C. Research Campus in Kannapolis would continue. Califf oversees the the research project, which is looking at finding genetic causes for disease.

Obama transition officials couldn't be reached for comment.

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