A big dose of change prescribed for FDA

President-elect Barack Obama is prowling for a new head for the U.S. Food and Drug Administration, which, in the eyes of some outraged Americans, is like hunting for someone to put tainted toothpaste back in its tube.

In the last several years, the agency has lurched from crisis to crisis. Whether the problem was poisonous pet food, sullied toothpaste and blood-thinner from China; food-borne salmonella; or dangerous drugs such as Vioxx, the FDA has appeared to be unprepared at best and compromised by industry at worst.

Critics of the agency, including some of its own scientists, have said it caters more to the pharmaceutical industry than to the public's safety needs. Some scientists wonder whether it's even possible to protect everyone in the modern economy, where drugs and food ingredients come from all over the world.

And another thing: The FDA has a budget of only $2 billion to oversee $1 trillion in drugs, medical devices and food. It's a pittance by Washington standards. The Centers for Disease Control and Prevention, by contrast, has $8.8 billion.

Who would want the job?

"There is so much wrong with the FDA that what is needed is a new approach. That includes more funding and more regulation and leadership that comes from outside, not inside," said Tom Kline, a Philadelphia plaintiff's lawyer who was involved in suing Merck & Co. Inc. over its Vioxx pain reliever.

Garret FitzGerald, who heads the pharmacology department at the University of Pennsylvania School of Medicine and was coauthor of a recent report on the agency, agreed.

"The first challenge is to restore the American public's confidence in the FDA, and also the world's, because they tend to rely on us," FitzGerald said.

The need for change could collide with the wishes of the pharmaceutical industry, which donates millions to politicians every year.

The current FDA commissioner, Andrew von Eschenbach, has told his staff that he plans to resign effective Jan. 20. Von Eschenbach, a Philadelphia native who graduated from St. Joseph's University, said he would work with Obama's transition team to ensure a smooth transfer of leadership.

Even the FDA has admitted that change is necessary.

The list of candidates has focused on:

Joshua Sharfstein, a member of Obama's transition team and Baltimore's health commissioner.

Steven Nissen, the head of the cardiology department at the Cleveland Clinic and a leading drug researcher who has called for an industry overhaul.

Also on the list, but generating less buzz, are:

Frank Sasinowski, a former FDA staffer who now is an industry lawyer.

Susan Wood, who left the FDA after a battle over whether politics influenced the agency's decision about the emergency contraceptive known as Plan B, or the "morning-after pill."

Cardiologist Robert Califf, who oversees clinical trials at Duke University.

Janet Woodcock, the current director of the FDA's Center for Drug Evaluation and Research.

Only Sasinowski agreed to an interview. He would not say whether he had been contacted about the job but said he wanted to restore the public's confidence in the FDA and to capitalize on its expertise as the country considers overhauling its health-care system.

Most media attention has focused on Sharfstein and Nissen, who may prove bitter pills for the pharmaceutical industry to swallow. Both men have brought attention to problem drugs and pressed for major changes.

At 39, Sharfstein would be young for the job. As a staffer for California Democrat Henry A. Waxman, the new chairman of the influential House Energy and Commerce Committee, Sharfstein worked on legislation that would give the FDA power over the tobacco industry. As Baltimore's health commissioner, he pressed the FDA to take unsafe children's cold medicines off the market.

He graduated from Harvard University Medical School and has published several articles criticizing the medical and pharmaceutical industries. One analyzed the political contributions of the American Medical Association and said it often backed pro-tobacco candidates, possibly because those politicians tended to support limits on medical malpractice awards.

Nissen, 60, was one of the first doctors to bring attention to heart problems caused by Vioxx, a drug that has become a synonym for industry problems. He also has raised questions about Avandia, a diabetes drug made by GlaxoSmithKline P.L.C., a London-based company with large operations in the Philadelphia region. He concluded that Avandia caused heart problems in many diabetes patients.

Nissen also tests drugs for pharmaceutical companies, but the money goes to the Cleveland Clinic, not to him. He directs any industry consulting fees to charity and gets no tax deduction for them. But critics have questioned his motives. He published the Avandia research, for example, at a time when the clinic was getting paid for research on a competing drug, Actos.

Members of Congress and others have blamed the FDA for letting problem drugs reach the market and for failing to prevent the outbreak of food-borne salmonella.

But Virginia Cardin, a doctor and senior health-care consultant at the consulting firm Frost & Sullivan, said some of that blame was unfair.

"I think one of the biggest problems is our expectations for what the FDA is supposed to do," Cardin said.

Many factors contribute to such problems, she said. Patients often don't take drugs the way they are supposed to. Food and drug companies toss ingredients from so many countries into their products that keeping all diseases and toxins out might not be possible, she said.

Even so, she and others said the agency could do better. A recent report by the Institute of Medicine, a nonprofit organization created by Congress to advise the federal government on health issues, recommended that:

The FDA approve drugs for five-year periods so that it can review safety questions once a product is on the market.

Newly approved drugs display a black triangle on their labels to warn consumers that their safety is more uncertain than that of older drugs.

The FDA be given the authority to issue fines and injunctions and withdraw drugs when their makers fail to complete required safety studies.

Many of the desired changes will be extraordinarily difficult, said Steve Mahinka, chair of the life-sciences practice at the law firm Morgan, Lewis & Bockius, of Philadelphia. One example: The FDA must inspect the rapidly growing number of overseas drug trials.

That won't be easy, he said. U.S. inspectors wouldn't necessarily be able to do the job as well in another country.

"You have different customs and languages, among other things," Mahinka said.

The FDA also must find new ways to test drugs in the era of so-called personalized medicine, which calls for different kinds of tests to more accurately match a patient with a medication.

Jane L. Delgado, chief executive of the National Alliance for Hispanic Health, said increasing the FDA's budget and improving its technology were musts.

"They are always asked to look at cutting-edge food, drugs, everything," she said, "and yet they don't have the tools to look at them."

She also advocates improving methods of communicating drug information to consumers. Symbols like those used on road signs could help patients understand the risks of a drug better than the pages of small print that consumers get now.

Penn's FitzGerald said change was crucial.

"The FDA is the safeguard for integrity of our drug supply and our food supply," he told Congress last year. "Failure of the FDA to fulfill its mission would expose each and every one of us to danger, either from the willful intent of terrorists or the incompetence of manufacturers."