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Margaret A. Hamburg, M.D., -- Annual Conference of the Endocrine Society

Keynote Address by Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Annual Conference of the Endocrine Society
Washington, D.C.
June 12, 2009


Good afternoon, and thank you, Bob, for your generous introduction.

I am greatly honored to address this conference. I am impressed by your organization with its world-wide membership and significant role in the practice and advancement of science to which millions of people with endocrine disorders look for ways to restore their health.

I also feel that this honor is not entirely deserved because I was sworn in as FDA commissioner less than three weeks ago, and I have yet to accomplish anything that would merit appearing before this large and distinguished audience.  In fact, I have been turning down formal speaking engagements because I still feel that I have so much to learn about the FDA and its myriad activities and issues.

Nevertheless, when I received this invitation, I said yes. This is, in part, because former Senator Lowell Weicker, who is the president of the Trust for America’s Health where I served on the Board, had a hand in inviting me take part in your conference.   

But also because endocrinology is a field that I've always found fascinating.  In fact, as I began my career in medicine I intended to pursue a path related to endocrinology.  I planned to be an academic physician, with a professional life mixing clinical care, research and teaching.  For a year before medical school and during my first summer after medical school began, I worked at the National Institutes of Health in a neuroendocrine/neuropharmacology lab…and did additional research later at Rockefeller University.

Back then my plan was to do subspecialty training in endocrinology.  However, my interests and direction changed during the course of my training as I watched the AIDS epidemic emerge and spread, and witnessed the profound implications it had for medical care, public health and society.  At that time, medicine had little to offer beyond supportive care . . . and in those earliest days, science could not even offer an understanding of the nature of the disease and its causative agent. 

Yet the ramifications of this new disease were far-reaching and raised complex legal, social, ethical and economic issues.

This is when I began to think about public health and health policy, and a career that would enable me to work at the interface of medicine with an array of other important, pressing concerns.

My Chair of Medicine was very disturbed when, at the end of residency, I decided to go to work in Washington at the Department of Health, Education, and Welfare.  (as it was called way back then).   He said to me, “If you are not back in two years to do your subspecialty training – in endocrinology – you will be throwing away all your training.” 

I did not return . . . and I cannot say that I have really looked back. 

But I appreciate being able to be here today, despite the fact that I am not a legitimate, card-carrying endocrinologist.

I am struck by the fact that since the formation of your organization in 1916 as the Association for the Study of Internal Secretions, the Endocrine Society has devoted itself to advancing the field of endocrinology to benefit patients.  Over almost a century, you have contributed to incredible advances in the treatment of previously devastating disorders.  And with each advance, the quality of life for countless patients has improved. 

I must also comment that you have definitely traded up in terms of your name.

So too for the FDA, which was created by President Teddy Roosevelt in 1906 as the Bureau of Chemistry in the U.S. Department of Agriculture.  The agency’s mission from the start was to stop adulteration of medications and foods in order to protect the public health. Over time, our agency has grown into the Food and Drug Administration, with regulatory authority over more than $2 trillion dollars in food and medical products.

Through countless medical advances and challenges, the agency’s public health mission has remained.  And it is what has drawn me to the FDA … and it is what makes me eager to talk with you today.

Endocrinology faces numerous critical public health challenges … from the rising prevalence of diabetes to the importance of finding novel treatments for endocrine cancers.  The Endocrine Society is on the front lines confronting these challenges, by supporting cutting edge research, excellent clinical care, and advocacy.

My vision is for FDA to be a public health partner, embracing a unique and vital regulatory role, but also committed to a core mission to promote and protect the health of the public.  Using the best available science, the agency should take every opportunity to save lives and reduce suffering from disease…and we should work closely with organizations such as yours.

I see the FDA as an agency that's dedicated to science for action -- science that helps translate the discoveries made in laboratories into medical products and devices that can save lives and limit disease, that safeguards consumers from health hazards they cannot control on their own, and that helps to prevent unnecessary threats to health.  In my view, these are among the most meaningful services a government can provide for its citizens.

As the FDA commissioner, I have a simple goal.  I hope to help assure in the United States “conditions in which people can be healthy”, which is how the Institute of Medicine defines the mission of public health.

To that end, I will do my best to make full use of the FDA’s wealth of experience, the remarkable dedication of its staff, and all of the agency’s intellectual and scientific resources to help advance science in the domains that are in the FDA’s purview -- a vast area that includes all drugs, biological products and medical devices; all blood products and vaccines; the entire food supply except for meat and poultry, which are regulated by the U.S. Department of Agriculture; all equipment that emits radiation; and all cosmetics, animal medications and animal feed.

This is an enormous task that I will seek to accomplish the only way it can be done, which is in cooperation with the numerous stakeholders, both in the U.S. and abroad, who share the FDA's interest of protecting and promoting health, well-being and vitality.

So what does this mean from the perspective of a medical discipline such as endocrinology? Let me offer a few thoughts.

The work starts with a key principle of public health – prevention.  I am interested in exploring how FDA can better work with the food industry, consumers and others to take steps to reduce the rising tide of obesity and diabetes.  The agency has authority, for example, over the food label, as well as other potential venues and mechanisms to address such important threats to health. This is an arena where I am sure we could work together, and I would welcome your ideas and input.

The agency should also be open to the concept of effective preventive therapy and interventions for people at very high risk of developing diabetes, working with researchers to define how to study and demonstrate the safety and efficacy of such approaches.

A second key principle of public health is the importance of balancing risk and benefit, using the best available data and judgment to make decisions.  Endocrinology has been struggling with some of these issues recently, with controversies over the safety of medications used for diabetes. 

The challenge facing clinicians is similar to what faces the agency – how to respond in the face of uncertainty.  There is no simple answer.  Like good clinicians, we need to be deliberate, careful, and clear in our reasoning and judgment.  We need to reach out to expert advisers, and where appropriate, seek additional data.  Regardless of our conclusions, we must transparently explain how and why the agency makes its decisions.

A third key principle of public health is collaboration.  We must work with many different partners, often in unusual ways, to accomplish real victories for health.

I have been pleased to learn about recent efforts at the agency to work with medical specialty societies to improve outcomes for patients.

For example, our Division of Metabolism and Endocrinology Products is participating in the pilot of a "Safe Use" initiative to think about how we can reduce common medication errors and improve health.

I am also aware that Dr. Mary Parks, an endocrinologist and the director of the Division of Metabolism and Endocrinology Products, keeps in close contact with organizations representing her field of science.

For example in April, she conducted a joint public workshop with the American Thyroid Association, and two days ago she discussed regulatory perspectives in your session on “Biomarkers in Cardiovascular Endocrinology in Clinical Trials and Drug Development.”

To some outside, this may seem like an obscure topic, and certainly not at the heart of public health.  But, in fact, work such as this, goes to the core of our public health mission. If those biomarkers in cardiovascular endocrinology lead to the development of a breakthrough treatment, thousands or even millions of patients may benefit.

Good public health and clinical practice depend on good science…and so does the work of the FDA.  If we can develop the right scientific tools to address public health problems, clinical practice and patient outcomes will improve dramatically.

That’s why one of my early and top priorities is strengthening FDA’s scientific capacity and improving regulatory science for public health. Everything we do at the FDA must rest on a strong foundation of science.  The quality of our work – and our credibility – will be forever jeopardized without this.  We have extraordinary talent at the FDA, but over the years important aspects of our scientific endeavor have been under-resourced and under-appreciated. 

This must change. 

We must be able to recruit and retain the best possible scientists.  And we must give them the facilities and opportunities they need to do their jobs…and to do them as well as possible.  I think that there are many valuable—and doable-- strategies to enhance our science base, some of which are already underway, and others still need to be developed and implemented.

But success will also depend on stronger collaboration with the broader scientific community.  Regulatory science is an essential, yet still under-developed field.  It would be my hope to see expanded efforts in this arena, including the engagement of academic scientists and research universities, and more research aimed at addressing the unmet scientific needs involving the safety and effectiveness of regulated products, as well as at how best to leverage emerging science and technology to strengthen and streamline the drug and product review process.

On the subject of regulatory science, let me thank the Endocrine Society for recently releasing a statement on Endocrine Disrupting Chemicals.  I appreciate the willingness of the Society to think about broad policy issues and provide your perspective on how the best available evidence should influence decisions that affect our whole society.

The agency is now taking a fresh look at the evidence on bisphenol-A, and I will refer your report to the scientists leading this effort.

Thank you for your time this afternoon.  I see today as the start of a valuable working relationship, and I look forward to exchanges and discussion between the agency and the Society.

I may not have become an endocrinologist … but standing here, I feel that we have a lot in common. I look forward to working with you toward our common goal to improve the health of millions of people in the United States and around the world.

Thank you very much.