Industry, critics seek strong FDA leader

By Susan Heavey and Lisa Richwine - Analysis

WASHINGTON (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.