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New FDA Chief Has Lots on Her Plate

Margaret Hamburg figured she'd follow her parents' example and pursue a career in academic medicine, perhaps as an endocrinologist.

"I'd never planned a career as a public health official," Hamburg, who was recently confirmed as the second woman to helm the Food and Drug Administration, said Tuesday in an interview with USA TODAY in the agency's Capitol Hill office.

But she changed her mind when, as an internal medicine resident in New York in the early 1980s, she began caring for patients with the condition that would come to be called AIDS. She wanted to understand how to translate medical discoveries into patient care.

A quarter-century later, Hamburg, 53, leads the federal agency that arguably has the biggest impact on the public's health.

As she and Joshua Sharfstein, principal deputy commissioner at the FDA, noted last week in "The New England Journal of Medicine", the agency oversees more than $2 trillion in medical products, food and other consumer goods. And just last week, Congress overwhelmingly voted to add tobacco products to the list. As Hamburg says, "the FDA has a lot on its plate already."

Adding to the agency's workload is the fact that many of the products it regulates are manufactured in other countries. "It represents a tremendous challenge," Hamburg says, adding that the FDA must step up as a leader on the global scene.

Earlier this year, there were rumors that the agency would be split in two. Hamburg, who has expertise in bioterrorism, would oversee food safety and tobacco, while Sharfstein, 39, the former Baltimore health commissioner who prompted the FDA to warn against the use of pediatric over-the-counter cold and cough remedies, would oversee medical products.

Hamburg says there's no truth to that. She says much of her career, including stints as New York City health commissioner and assistant director of the National Institute of Allergy and Infectious Diseases, has focused on vaccines and diagnostics.

In recent years, the FDA has drawn criticism for approving drugs too quickly or not quickly enough and for not preventing food-related salmonella outbreaks.

"For many, many years, FDA has been under-resourced, and it has taken a toll," Hamburg says.

She discussed some of the items on her agenda:

-- Tobacco. The agency will be setting up a new center on its main campus to oversee tobacco products, Hamburg says, just as it has centers that oversee drugs and other products. Many people have expressed interest in working for the new FDA tobacco center, she says, because they view its creation "as a historic moment in public health."

-- Drugs. While "FDA does play a critical role in fostering innovation," Hamburg says, the agency also has "almost a sacred responsibility to assure safety in the use of these products." The FDA plans to require additional safety studies of drugs once they are on the market, she says, and it will encourage health care professionals and consumers to be more conscientious about reporting adverse effects.

-- Direct-to-consumer advertising. "There certainly have been concerns about the quality and authenticity of some of the messages," Hamburg says. "We have a dedicated staff working on the issue."

Advisers from outside the agency periodically suggest placing a moratorium on ads for drugs, but, Hamburg says, the FDA doesn't have the authority to do so. "I hope that we can continue to work with companies to improve the content of the ads," she says.

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