FDA chief: Regaining your trust

    The FDA's newest commissioner, Margaret Hamburg, wants to restore Americans' faith in the much-maligned agency.

    By David Ewing Duncan

    In May, Margaret Hamburg became the 21st commissioner of the Food and Drug Administration, a beleaguered agency that has long been criticized for its mishandling of food crises and for drug recalls such as the Vioxx debacle.

    Hamburg's grounding is in science and public health. A physician, she was the commissioner of New York City's Department of Public Health from 1990 to 1997 and later became vice president for Biological Programs and senior scientist at the Nuclear Threat Initiative foundation.

    She recently took time out during a health care summit at the Cleveland Clinic to speak with David Ewing Duncan about finding more money for the agency, making it tougher and stronger, and restoring the public's faith in the FDA. Below are excerpts from the full interview.

    Q. Could you share your vision and priorities for the FDA?

    A. First, I want to restore faith and trust in the FDA as a science-driven agency. I want to be a vocal advocate for the resources we require. It's stunning how underfunded we are given the importance of what we do. 25% of every dollar spent by Americans is regulated by the FDA.

    Q. How do you make regulatory science a critical part of innovation?

    A. I think, as a nation, it is critically important that we strengthen our commitment to regulatory science to make it a robust and respected discipline in the broader scientific enterprise. This is the key to ensuring that recent scientific discoveries which hold such promise are actually translated into new therapies and treatments.

    Q. A Harris poll a couple of years ago said only 36% of Americans trust the FDA, down from 80% in the 1970s. How do you restore trust?

    A. I think it's important to break down the perception of the FDA as a bureaucratic "black box." That's why the transparency initiative we've undertaken is so important. The FDA makes important decisions every day relating to the approval of drugs and medical products and safeguarding the food supply. To the extent that we can make the decision-making process more open and public, I think it goes a long way to restore public trust and confidence.

    I also think we have to recognize that we live in a world where there will always be risk and crises, but I think there is a great deal more we can do to prevent these problems. During a crisis we have to not be afraid to communicate rather than circle the wagons, which has happened before. We have been taking a very clear-eyed look at past problems to learn from those mistakes.

    Q. You have had no real crises since you took office.

    A. We've been very lucky since I became commissioner, we haven't had a crisis or felt under siege -- knock on wood. And that's given us a chance to build our team and to look at important questions about organization.

    Q. The budget is being increased by 19% this year, to $3 billion. That's still just $10 per American to regulate $2 trillion of the U.S. economy. Is this enough?

    A. The FDA has been underfunded for a very long time, and it will probably take many budget cycles to restore the funding levels to where they need to be. But we are now moving in the right direction.

    There have been increases in resources for the FDA in the last couple of years. It looks like it will be sustained. We're undermining our own best interests if we have a very robust investment in biomedical research and a scrawny investment in regulatory science and support for the FDA.

    Q. Is there any talk of separating the food from the drugs?

    A. Even before I took on this role I felt we had a near crisis in respect to food safety. That means strengthening it within its current organization, and deferring any decisions about reorganization until we have more of a system in place that will protect the American people.

    I have created a new position, deputy commissioner for food, which will help us align the different components of food safety within the FDA, to be sure that we have someone with real authority and responsibility.

    Q. Will some of these new resources go to improve the inspection process overseas?

    A. We clearly need to expand our inspectional capabilities overseas. We need to work more closely with our sister regulatory agencies to share information and strategies, and to share responsibility. We have a responsibility in countries that have less developed systems to help provide technical assistance and capacity building.

    Q. The FDA has a new power to regulate tobacco. You already have banned flavored cigarettes. What are your further plans?

    A. We are starting up a new center for tobacco products, and we've hired on a terrific new director. We will be moving forward on areas of labeling and issues around the marketing of tobacco products, especially marketing to youth. We will be examining the composition of tobacco products. Tobacco is the leading cause of preventable death in this country, so this is a historic chance for us to fulfill our public health mission.

    Q. How are you planning to speed up the drug development process?

    A. We need to look at how we can streamline and make more effective the regulatory process. There are real opportunities to apply emerging science to the regulatory process. We need to look at how to develop and implement biomarkers and test-animal models. This is something that FDA badly needs.

    Q. You delivered a speech recently about enforcement -- what are your goals?

    A. Our goal is to work with industry to try to prevent problems from happening and to quickly identify them when they do happen. But if they don't act, then we have to prepare to quickly take action. The public wants to know that there is a strong FDA -- it strengthens their trust in FDA approved products, so ultimately this strengthens the industry.

    Q. How much will the FDA work to improve the nutritional composition of foods?

    A. Obviously sodium and fats and sugar are hugely important in contributing to disease -- obesity, diabetes, and cardiovascular disease. By our activities in the area of nutritional labeling we can not only inform consumers about how to make healthy choices, but we can also help move the industries to develop production strategies that reduce some of those contributors to disease.

    David Ewing Duncan's latest book is "Experimental Man: What one man's body reveals about his future, your health, and our toxic world."