FDA pick answers lawmakers on tobacco regulation, flu

Washington -- President Obama's pick to serve as the next commissioner of the Food and Drug Administration defended a plan to have the FDA regulate tobacco products and pledged a vigorous response to the ongoing outbreak of influenza A(H1N1) before a largely supportive Senate committee in early May.

Senators from both parties said they would back FDA Commissioner-designate Margaret A. Hamburg, MD, currently a senior scientist with the Nuclear Threat Initiative in Washington, D.C. At this article's deadline, her nomination was expected to be approved by the committee -- and subsequently the full Senate -- within weeks. "I just wanted to let you know that I support you and I intend to help you," Sen. Orrin Hatch (R, Utah) said to Dr. Hamburg during her May 7 nomination hearing before the Senate Health, Education, Labor and Pensions Committee.

Dr. Hamburg addressed what is expected to be one of the more controversial issues that would be on her plate as FDA chief, responding that she supports a proposed change in law to give the agency regulatory authority over tobacco products. She said the health burden that smoking places on the nation as well as the unique characteristics of tobacco products make the move imperative.

"This is a critical moment, I think, to take a more aggressive look at how we regulate tobacco products ... and to reduce the risks of tobacco products to the American people," Dr. Hamburg said.

"I think the FDA is the appropriate agency to regulate tobacco. They have the scientific expertise," she added.

But not all committee members agreed.

"FDA resources are already stretched too thin," said Sen. Mike Enzi (R, Wyo.). "I have serious concerns about adding tobacco to the list of products the agency must regulate." Other lawmakers have questioned the logic of having an agency devoted to protecting the public health overseeing a product that they say can never be safe.

Still, Congress is moving forward. The House on April 2 passed the Family Smoking Prevention and Tobacco Control Act by a 298-112 vote. The Senate was expected to follow suit soon after the Memorial Day congressional recess.

The measure would grant the FDA the ability to regulate the manufacture, marketing and sale of tobacco products, a move cheered by numerous health care groups. The measure, however, would not allow the FDA to ban tobacco products outright or to eliminate nicotine.

The bill would codify a 1996 rule under which the FDA stated its authority to regulate cigarettes and smokeless tobacco products. The rule was struck down in 2000 when the U.S. Supreme Court in FDA v. Brown & Williamson Tobacco Corp. ruled that the agency did not have the authority to enforce the regulation.

American Medical Association President Nancy H. Nielsen, MD, PhD, said the legislation is "critical to combat smoking-related diseases and help get cigarettes out of the hands of children."

Handling the influenza scare

One of the first matters Dr. Hamburg addressed before the HELP committee was how she would handle the recent flu outbreak. Her confirmation hearing was moved up by nearly a week primarily because of concerns about the nation's response.

"If confirmed, I will review FDA's work on the H1N1 influenza situation to determine if there are additional steps FDA can take to make safe and effective medical products and laboratory tests available," she said. Senators noted Dr. Hamburg's past experience with handling infectious diseases, particularly in her role as New York City's health commissioner, where she worked on the development of a rapid-response model to battle an epidemic of drug-resistant tuberculosis.

"Dr. Hamburg is widely respected for her expertise in community health, biodefense, and nuclear, biological and chemical preparedness," said Sen. Edward Kennedy, (D, Mass.), chair of the HELP committee. "Her expertise is valuable for problems we now face, such as combating food-borne illness, cooperating with other agencies to address the new flu outbreak and drug-resistant diseases, and protecting our food and drug supplies."