ANALYSIS-Industry, critics seek strong US FDA leader

By Susan Heavey and Lisa Richwine

WASHINGTON, Nov 5 (Reuters) - Drugmakers and consumer advocates alike are looking for U.S. President-elect Barack Obama to appoint a strong leader who can restore confidence in the battered Food and Drug Administration.

The FDA lacked a permanent commissioner for more than half of U.S. Republican President George W. Bush's nearly eight years in office and struggled through a string of drug safety and tainted food controversies.

Pharmaceutical companies, advocacy groups and others are anxious for the new administration to decide who should run the agency, which oversees more than $1 trillion worth of medicines, foods, devices and other products that account for nearly 25 cents of every dollar Americans spend each year.

The withdrawal of Merck & Co Inc's painkiller Vioxx, dangerous side effects from other medicines, plus recalls of peanut butter, spinach and other foods, hurt the FDA's reputation.

"What's important is that the agency has credibility ... that's important not just for consumers but also for industry," said Dr. Joshua Sharfstein, who oversees the Baltimore Health Department and has been mentioned as a possible contender for the FDA's top job.

Current FDA commissioner, cancer physician Andrew von Eschenbach, is expected to leave his post once Obama is sworn in next January. An acting commissioner likely will hold the reins until a permanent leader is confirmed.

Von Eschenbach was criticized for keeping his title as National Cancer Institute chief for more than six months after he was tapped to lead the FDA. Consumer advocates have said he has maintained a hands-off approach, while industry representatives have largely remained neutral.

"The evolution of the agency and its role in society demands a more public, visible and transparent commissioner than we've had in a long time -- not just in the Bush administration," regulatory consultant Steven Grossman said.

The agency needs a steady hand who understands complex science and can defend the FDA's actions to Congress and others, experts said. A medical doctor or someone with a science background who can play a more active role in decision-making would be key, some said.

"The FDA's going to have to re-earn the trust of the public," said Dr. Sidney Wolfe, director for the consumer group Public Citizen's Health Research Group.

INDUSTRY VIEW

Drugmakers also favor a leader who will help the FDA regain its footing. The industry sees growing caution at the agency and has complained about delays in approving new drugs.

"Due to the vital nature of the FDA's public health oversight, identifying a strong, independent FDA commissioner should be among the first accomplishments of the new administration," Billy Tauzin, head of the Pharmaceutical Research and Manufacturers of America, said in a statement.

Ian Spatz, vice president of global health policy for Merck, said the FDA needs a leader "with not only the trust of the president but also the trust of key members of Congress."

"It's absolutely important that patients have confidence in the medicines they take," he said.

Still, it could be months before Democrat Obama makes his choice and secures the Senate's approval.

Finding a chief for the Department of Health and Human Services, the parent agency of the FDA, is expected to take priority, as is work on the nation's financial crisis.

Janet Woodcock, head of the FDA's drug division, is often mentioned as a candidate for the acting FDA commissioner's job. But analysts, lobbyists and others said it is too early for a serious permanent candidate to emerge.

Obama "could easily take 6-18 months to nominate a new commissioner. This could lead to a months-long confirmation process," Stanford Group analyst Gregory Frykman said in a research note.

Some others see an opportunity for a renewed sense of political independence and focus on science.

"The most important job of the FDA commissioner is to insulate the agency from political interference ... the agency gets hit from the left and the right every day, and nobody ever responds to it. It's like they're a punching bag," said Ira Loss, an FDA analyst for Washington Analysis.

Under the Bush administration, the FDA was accused of allowing politics to interfere with science, particularly when it initially rejected over-the-counter sales of the Plan B emergency contraceptive.

An Obama administration should re-establish the FDA as an independent agency, said Susan Wood, former head of the FDA's Office of Women's Health.

"It's been extraordinarily difficult for the agency over the past eight years," said Wood, who resigned over the Plan B decision and has been mentioned by consumer advocates as a candidate for FDA commissioner.

"The scientific decisions ... of the approvals and any regulations that are issued need to be valued and used appropriately, and I think the commissioner plays an important role in ensuring that happens," said Wood, now a professor at George Washington University. (Reporting by Lisa Richwine and Susan Heavey, editing by Tim Dobbyn)