WASHINGTON, D.C.—The Senate confirmed Margaret Hamburg, MD, to lead the Food and Drug Administration last month. The unanimous confirmation came as no surprise considering the ease of her confirmation hearing and her backing by both Democrat and Republican Senate leaders. A widely respected expert in community health and bio-defense, Dr. Hamburg has served as New York City’s acting health commissioner, and as the Department of Health and Human Services’ assistant secretary for planning and evaluation. Most recently she has served as senior scientist at the Nuclear Threat Initiative. Her confirmation vote came on May 21, with the swearing in scheduled for after the Memorial Day break.

Restoring an Agency’s Integrity

The strong showing on the Senate floor in favor of Dr. Hamburg came not only on the strength of her resume, but on her assurance to legislators that she would follow President Obama’s push for subtracting politics from the drug regulatory process.

“[Doing that] means operating an agency that is accessible and transparent, strengthening FDA’s science base, hiring and retaining the best and brightest scientists that FDA can recruit, and ensuring that FDA has the resources and capacity to understand the latest advances in science and apply them to regulatory and public health issues. The FDA must carefully protect scientific integrity as the cornerstone of the regulatory process,” Dr. Hamburg said at her May 7 confirmation hearing before the Senate Health, Labor and Pensions Committee.

Asked to comment on what committee chair Sen. Patty Murray, D.-Wash., referred to as the tendency for FDA in recent years to “blow with the political winds,” Dr. Hamburg said, “I am aware of that. I’m very concerned with some of what I heard. If confi rmed, I hope that as commissioner I can, through my leadership, create an environment where scientists feel very free to raise issues of concern without any fear of retaliation, an environment that fosters open debate,” Dr. Hamburg said. “I think science is served by robust discussion and I think we need to have a clearly defined process to ensure the integrity of the science-based decision making at the FDA.”

On the subject of whistleblowers, Dr. Hamburg added, “I think whistleblowers serve a very important role in government in surfacing critical issues and concerns and making sure they’re addressed. As leader of FDA, I would very much want to create a culture that enables all voices to be heard.”

New Duties, Insufficient Budget

Currently legislation is pending that would put tobacco under the regulatory auspices of FDA. While similar legislation has faced roadblocks in previous years, support for it has grown and President Obama has spoken in support of it.

Asked whether she believes if it is FDA’s job to regulate something that is so obviously detrimental to the public health, Dr. Hamburg said that such regulation would fall squarely in FDA’s mission.

“Smoking represents a terrible burden to health in this country. Tobacco products are unlike any other product on the market in that they are unusually lethal, but yet not highly regulated. This is a critical moment, I think, for us to take a more aggressive look at how we can regulate tobacco products to reduce smoking and to reduce the risk of tobacco products to the American people,” Dr. Hamburg said. “I think the FDA is the appropriate agency to regulate tobacco. It has the scientific expertise, the regulatory experience, and the public health mission to do so.”

As for whether FDA has the resources to take on new regulatory action, Dr. Hamburg said that would depend on the legislation that Congress passes.

“I have heard the concerns as to whether this is a time when FDA can take on more tasks when it has so many challenges already before it,” Dr. Hamburg said. “But as I understand it, the legislation being considered does include in it a mechanism [for funding] to support [new hiring and infrastructure].”

Asked how the agency stands in terms of resources in general, Dr. Hamburg spoke frankly about what amounts to years of underresourcing.

“I think that, unfortunately and for quite a long time now, the demand and mission of FDA have far outstretched the available resources to enable FDA to do its job appropriately, effi ciently, and with the kind of strength of scientists and personnel that we need,” Dr. Hamburg said. “I know there is no magic wand, but I’m eager to provide leadership to make sure that we have the best and the brightest staff.”