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Woodcock Gains Support From Drugmakers for U.S. FDA's Top Job

By Justin Blum

Nov. 7 (Bloomberg) -- Janet Woodcock, a 22-year insider at the Food and Drug Administration, is the top choice of drugmakers who are lobbying for her to be named the agency's chief by President-elect Barack Obama, according to people associated with the industry.

Cardiologist Steven Nissen and Baltimore City's health commissioner, Joshua Sharfstein, are among candidates being backed by consumer advocacy groups critical of the agency. Both doctors have pressed the FDA for changes on drug safety.

The FDA's current commissioner, Andrew von Eschenbach, plans to submit his resignation before Obama takes office, according to agency spokeswoman Judy Leon. The FDA and von Eschenbach, who was appointed by President George W. Bush, have faced criticism from lawmakers who say the agency has approved unsafe medications and hasn't done enough to block tainted imports of food and drugs.

``You need to have someone who changes the culture at the agency,'' said Representative Rosa DeLauro, a Connecticut Democrat, in a telephone interview. DeLauro, who declined to comment on possible candidates, heads a House subcommittee that oversees agency funding. ``Rather than allowing political and corporate interests to permeate the decision-making process, you need to have more influence of science.''

Representatives of drugmakers are advocating to lawmakers that Woodcock, 60, be chosen to serve as commissioner on either an acting or permanent basis, according to two people associated with the industry who spoke on condition of anonymity.

The Pharmaceutical Research and Manufacturers of America, a drugmakers' trade association in Washington, declined to discuss individual candidates.

$2 billion Budget

Obama and his advisers haven't indicated who they are considering to head the agency that polices food, drugs and cosmetics. The commissioner, who must be confirmed by the Senate, oversees an agency that employs about 11,000 people and has a budget of more than $2 billion.

Obama campaigned for president promising to overhaul the U.S. health-care system, and he spoke at times about the need to improve food and drug safety.

Presidents typically have first hired a secretary of Health and Human Services, who in turn helped pick an FDA commissioner. Former Senator Tom Daschle and Kansas Governor Kathleen Sebelius are contenders for health secretary, according to people in contact with Obama's health-care advisers.

Woodcock, named head of the FDA's drug division in March, is an internist and rheumatologist. She joined the FDA in 1986, according to the agency's Web site, and previously served as deputy commissioner and chief medical officer. Advocacy groups questioned whether she would get the job, saying she wouldn't be seen as someone who would significantly change the agency.

Woodcock declined to comment, according to the FDA's Leon.

Cancer Research Group

Woodcock is also among a number of candidates supported by Ellen Sigal, chairwoman of Friends of Cancer Research, based in Arlington, Virginia. The group, which receives some of its funding from drugmakers, seeks to raise awareness and speed up finding ways of preventing and treating cancer.

``You have an agency that has been grotesquely under- funded,'' Sigal said in a telephone interview. ``Their infrastructure needs to be rebuilt.''

Another FDA insider, its chief scientist, Frank Torti, has spoken with Obama representatives about the agency, according to a source familiar with the conversation. Torti declined to comment, according to Leon.

Torti, 61, joined the agency in May after serving as chairman of the cancer biology department and director of the Comprehensive Cancer Center at Wake Forest's School of Medicine in Winston-Salem, North Carolina.

A critic of the FDA, Diana Zuckerman, said in a telephone interview that she is discussing the possibility of recommending FDA candidates with a coalition of groups. Zuckerman is president of the National Research Center for Women & Families, an advocacy group in Washington.

Nissen, Sharfstein

Among candidates Zuckerman said she would support are Nissen, 60, head of cardiology at the Cleveland Clinic in Ohio, and Sharfstein, 39, a pediatrician who is commissioner of the Baltimore City Health Department.

Nissen disclosed heart risks associated with GlaxoSmithKline Plc's diabetes drug Avandia in a May 2007 study, and he has criticized the agency's handling of drug safety. Even some of his supporters said he may be an unlikely choice for the job because he would face strong opposition from drugmakers.

Sharfstein also was named as a likely candidate by Ipsita Smolinski, an analyst for J.P. Morgan Securities Inc., in a note to investors on Oct. 5.

Sharfstein gained prominence last year after petitioning the FDA to ban marketing of over-the-counter cough and cold medicines marketed to young children. Sharfstein previously worked for Representative Henry Waxman, a California Democrat. Sharfstein declined to comment on the FDA position.

No Discussion

Nissen said in a telephone interview that he hadn't discussed the job with Obama or his advisers. ``When the time comes, if somebody approaches me, I'll certainly talk to them,'' Nissen said.

Zuckerman also backs Susan Wood, a professor at George Washington University in Washington who previously was the FDA's assistant commissioner for women's health. Wood served on an Obama campaign advisory panel on women's health policy.

``Whoever the FDA commissioner is needs to re-establish the trust of the American people,'' said Zuckerman. ``There are a lot of years' worth of decisions that have really eroded the public confidence.''

She said the agency should have taken stronger action on drug safety and faulted its handling of Avandia and Merck & Co.'s painkiller Vioxx.

Wood, 50, said in a telephone interview that she hadn't spoken with Obama representatives about the job.

To contact the reporter on this story: Justin Blum in Washington at jblum4@bloomberg.net.

Last Updated: November 7, 2008 00:01 EST

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