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Remarks at the National Medical Association 2011 Annual Meeting

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
National Medical Association 2011 Annual Meeting
July 23, 2011

Good evening - and thank you for that generous introduction and for inviting me to be here today. I am very pleased to be part of this important meeting. I was surprised and impressed to learn that, for the past 109 years, the NMA has been conducting an Annual Convention and Scientific Assembly. That is a long tradition, and one that has always been associated with a set of very important goals and ideals.

You are the largest and oldest national organization representing African American physicians and their patients - and you are ardent advocates for the right of all minorities to quality and accessible healthcare.

Needless to say, this is a historic and continuing struggle. I'm proud that, in many ways, my family and I have been on the frontlines. More than 60 years ago, my mother, Beatrix, was the first African-American woman to attend the Yale School of Medicine...and this followed on her being the first African-American ever accepted at Vassar College.

Now almost 88 years old, she has spent her life as a practicing physician, an academic and scientific researcher, and a ceaseless advocate for the needs of the underserved, especially children and youth. I am proud of her legacy and what she has done to pave the way for others, myself included.

Organizations like NMA are an essential component of what it takes to address the critical needs of our time, and to pave the way for others to take up the banner going forward.

The mission of the National Medical Association, as you well know, is to advance the art and science of medicine for people of African descent through education, advocacy, and health policy to promote health and wellness, eliminate health disparities, and sustain physician viability.

This is a noble and critical mission - and a mission that we at the FDA share in spirit and in many of the functions we perform. But I must also add that it is an area where we can and must do more.

As an administration, we are in the midst of turning a corner in our efforts to find better, more sustainable ways of protecting the interests of minority populations. And the FDA is eager to help lead the way. As we work to build and grow our new Office of Minority Health, we are also working to implement the recently released Department of Health and Human Services Health Disparities Action Plan.

In other words, we are looking with new focus and vigor toward, as the Action Plan states, a nation free of disparities in health and health care...a message we must refocus, reinforce and repeat until we get there.

But before I go into more detail about that, let me take a step back and speak to you about my agency and our scientific priorities - and why it is so important for our nation to have a strong, modern FDA that takes action on behalf of the public health.

The FDA was created when President Teddy Roosevelt signed the Pure Food and Drugs Act more than 100 years ago and vowed to promote and protect the health of the American people. We are, in other words, America's public health agency...and both Senator Orrin Hatch and the much missed Senator Kennedy both have described it as such, so this is one of the few things in Washington these days with bipartisan agreement!

The FDA is entrusted with using the best available science to ensure the safety, efficacy, and security of drugs, medical devices, vaccines and biological products - as well as the safety of our nation's food supply, cosmetics, dietary supplements, animal drugs and feed, certain products that emit radiation, and, most recently, tobacco products, as well. In other words, our agency is tasked with protecting the health and well-being of anyone who eats, takes medicine, uses a medical device like a pacemaker, has an x-ray, and so much more.

In fact, FDA regulates products that make up somewhere between 20 and 25 percent of consumer spending in the United States - and, for the most part, these are products that the American people care about and rely on in fundamental, sometimes lifesaving, ways.

But our mission also includes another role. We are the agency charged with promoting the science and innovation it takes to produce tomorrow's new breakthrough products and to ensure that our nation is fully equipped to address the public health challenges of the 21st century.

Of course, this is not just about new ideas, but also about making sure that those new ideas - and new science - truly translates into the products and opportunities that people need and count on. To me, innovation is about changing systems - about replacing outmoded or insufficient patterns with new, better, more effective ones that truly promote safety and help bring effective products to market.

Today, we need this more than ever before. Most of you here today are either directly responsible for delivering care to patients, or are working in some aspect of medical science to support improvements in health and health care. I suspect that you share my deep concern that we are a scientific and medical community are not seeing the kinds of advances in available care and new treatments for patients that we hope for based on the breakthroughs in science and technology today.

We are in a veritable golden age for biomedical discovery - the sequencing of the human genome has revealed new candidates targets; combinatorial chemistry, high throughput screening, and biosynthesis has led to thousands of candidate drugs; cutting-edge electronics, nanotechnology, and materials science has driven device innovation; and that barely scratches the surface. We need to see this make more of a difference in the lives of patients.

And then there is the fundamental tension about how best to balance safety and innovation. People joke that there are two speeds of FDA action when it comes to our review of medical products: too fast and too slow...too fast to ensure safety or too slow to promote innovation. I don't think it has to be either or, but appropriately balancing risks and benefits is a very real and continuing challenge - for us as an agency, for you as health care providers, and for all of us as a society.

So our job at FDA is pretty complex. But this is a critical time, and we must do more for the patients we serve. One of my chief priorities as Commissioner is to accelerate the transformation of the FDA into a regulatory agency fully capable of regulating medical products - and promoting and protecting the health of the American people - in the modern era.

So I want to use some of my time today to focus on regulatory science - perhaps not the sexiest or most dramatic topic I could focus on - but an area of activity that has become close to my heart, and that I think is, and should be, increasingly recognized as critical to progress for patients.

Regulatory science is the science and tools needed to examine and assess a product's safety, efficacy, quality, and performance. It involves the development of new methods, standards, and models that we can use to speed the development, review, approval, and ongoing oversight of medical products.

Why is it important? The reality is that billions of billions of dollars are being invested in biomedical research - last year close to $100 billion by the private sector and the NIH - an effort that is clearly imperative for medical progress. We know that there is phenomenally exciting new science emerging from these efforts.

In fact, if you look back over recent years, the number of new therapies has actually been on the decline while the R&D timelines have increased and the costs of bringing them to market have soared.

I do want to insert one glimmer of hope. Last week, FDA announced for this year the approval of 21st new molecular entity, which is our way of saying a significant new drug and not just a "me-too" 21 groundbreaking new drugs thus far this year, including two new therapies for treating hepatitis C, and a new drug for metastatic melanoma. This is notable because this is the same number that we approved in all of 2010. I should also mention that our time for the review of drug applications has halved over the last decade.

All this speaks to the fact that when high quality drug applications come before us, based on good science to address critical health care needs, FDA acts swiftly and surely. But we recognize the troubling gap between advances in science and patient care. We need to build a bridge across this gap...and that bridge, in my view, is regulatory science.

Regulatory science is an essential component of the scientific enterprise. But it has, for years, been under-appreciated, under-developed, and under-funded. As a result, we are left relying on 20th century approaches for the development, review, approval, and oversight of the treatments and cures of the 21st century.

We cannot take full advantage of the extraordinary advances in biomedical research unless we also emphasize innovation in regulatory science. just as biomedical research has evolved over the past few decades, regulatory science must also evolve in important and powerful ways.

If you are talking about drugs, for example, a scientist may develop a new approach to a disease and a clinician may be able to show it can work. But we need regulatory science to help develop the knowledge and tools to translate these discoveries - discoveries like stem cell therapies and nanotechnology - into the diagnostics, treatments, and cures that hold so much promise.

Without advances in regulatory science, promising therapies may be discarded during development because we lack the tools to recognize their potential and because outdated, inefficient review methods unnecessarily delay the approval of critical treatments. On the other hand, both significant dollars and many years may be wasted assessing a novel therapy that with better tools might be shown to be unsafe or ineffective at an earlier stage.

Now is the time to move forward. A robust field of regulatory science will help us do so.

I should emphasize that regulatory science includes an array of disciplines and approaches. It takes place in laboratories, but it also involves clinical, epidemiologic, and statistical tools and information-gathering systems. Unlike work performed by specific sponsors, regulatory science is important for multiple products and stakeholders. The knowledge generated from such studies informs a whole body of innovation - and entire classes of drugs - rather than single products.

Let me give you some examples.

With more advanced regulatory science, we could usher in an era of personalized medicine. And by this I don't mean expensive, boutique medical care, but the ability - using genetic data and biomarkers - to optimize targeted delivery and dosing of drugs and therapies so that patients receive the most benefit and the lowest risk.

We are beginning to see the pay-off of these approaches: in cancer treatment, in the dosing of drugs like Coumadin, and in our deepening understanding of subpopulation differences in response to certain therapies, either in effectiveness or with respect to safety concerns. But there is so much more to be done to make these opportunities real.

Regulatory science can also help to better identify and characterize new targets for disease intervention that will then pave the way for more focused - and hopefully more successful - product development.

And regulatory science can support efforts to use more innovative and adaptive clinical trial designs to speed the process and get products to patients faster...designs that enable us to get robust, scientific answers, but in a more timely and cost-effective way.

And we could find better ways of mining and applying the vast quantities of data at the FDA and within other agencies and organizations to better inform us about safety, efficacy, differential subpopulation effects, and much more.

The bottom line is that we need new and better tools to do this - and we need them now.

For all of these reasons, I have made regulatory science a top priority since I became Commissioner. In addition to strengthening the science base at the FDA, we are building the partnerships - across government and with academia, industry, and the non-profit community - that will drive the development of innovative medical products and the delivery of better, safer products to the American people and to people around the world.

Regulatory science is particularly important in the development of new and innovative approaches to address inequities in health. While medical advances and new technologies have provided Americans with the potential for longer and healthier lives, we know that it is well-documented that health disparities affecting racial and ethnic minority populations exist. Investments in regulatory science can both help provide better, safer, more cost-effective medical products to meet their needs and also help us better understand the needs and appropriate use of these products for various populations.

If we can truly achieve this, it will allow us to take major leaps forward for the future of medicine and public health - for all kinds of diseases and all kinds of patients.

I want to leave some time for questions, but before I conclude, let me tell you more about our Office of Minority Health - and a bit more about our efforts to address health disparities.

As many of you know, the Office was established by the 2010 Patient Protection and Affordable Care Act, and its mission is to advance FDA's regulatory mission with respect to the reduction of racial and ethnic health disparities and in achieving the highest standard of health for all. Note some similarities between that sentence and your own mission statement.

The goals of the Office are threefold:

  • First, to strengthen FDA capacity to address minority health and health disparities across the agency through coordinated leadership on regulatory actions and decision making.
  • Second, to promote effective communication and the dissemination of information to the public, particularly underserved, vulnerable populations.
  • And third, to improve and strengthen the research and the evaluation of sub-population data associations with race and ethnicity.

These goals, as you can see, lend themselves to a wide range of activities, both internally and externally.

For example, a main priority for our Office of Minority Health is Enhancing Diversity Among FDA Advisory Committees. FDA Advisory committees provide FDA with independent advice from outside experts on issues related to human and veterinary drugs, vaccines and other biological products, medical devices, and food.

We are strengthening our current recruitment efforts to ensure ethnic, gender, and geographic diversity on FDA Advisory Committees, and seeking to bring in health professionals who have expertise working in underserved communities and understand the context of health disparities. The expertise provided by advisory committee members is essential for understanding the safety and efficacy of regulated products on the target populations, especially racial and ethnic populations who are disproportionately impacted by higher rates of disease, disability, and premature death.

We are currently in the midst of a broad the search for qualified advisory committee candidates with experience with underserved communities - and more than 100 vacancies have already been identified. Please feel free to send us names!

Another key priority is Data Standardization of Submitted Clinical Trials Data as it relates to Race and Ethnicity. Through FDA's ongoing comparative effectiveness research and current development of Data Standardization Initiatives. FDA will begin to examine clinical trial data submitted by industry for focal disease areas, like diabetes, that disproportionately affect minorities.

We are also focusing on Promising Practices in Clinical Trials Among Women and Minority Communities. This September, here in D.C., the Office of Minority Health is co-sponsoring - with 11 pharmaceutical industry groups, the Society for Women's Health Research, and FDA's Office of Women's Health - a Promising Practices Clinical Trials Conference focused on women and racial and ethnic subpopulations. The conference will bring together government, industry, advocacy groups, academic institutions, health care providers, and patients for a dialogue about practices related to all aspects of clinical trial research.

The goals of the conference are 1) to increase the participation of underserved populations in clinical trials and 2) to share successful practices in recruitment, retention and analysis of women and minorities in clinical trials.

This will be a unique opportunity to focus on successful strategies rather than the common challenges and pitfalls of clinical trials inclusion that are often highlighted.

We anticipate that products of the conference will include a white paper capturing best practices and new strategies identified during the conference, and, in partnership with the Society for Women's Health Research, an electronic repository of strategies for successful trials recruitment and retention of racial and ethnic subpopulations.

I must emphasize that this is only a snapshot of all the work we're doing. We are also, for example, working to increase fellowship and internship opportunities for racial and ethnic minorities, a very high priority of mine and something we hope to link with other training programs offered by FDA, as well. And, as some of you may know, many of FDA's other Offices and Centers have longstanding relationships with NMA and are promoting initiatives to enhance minority health, as well.

But it is also just a start. Our new Office of Minority Health is still being developed under the excellent leadership of Acting Director Dr. Michelle Yeboah. We have a big vision for what we can achieve...and what we can do together with your organization.

After all, we are both here, ultimately, for the same reason. Because we are fighting for the health and well-being of the American people - and because we want to ensure that this fight extends to everyone.

In 1908 - just two years after President Roosevelt signed the FDA into law - Dr. C.V. Roman, a founding member of the NMA and the first editor of the Journal of the National Medical Association, described the spirit in which your organization was created.

"Conceived in no spirit of racial exclusiveness, fostering no ethnic antagonism, but born of the exigencies of the American environment," he said, "the National Medical Association has for its object the banding together for mutual cooperation and helpfulness..."

That is why I am here speaking to you today: because I believe that, especially in today's complex world full of new challenges, we must commit to mutual cooperation and helpfulness...and we must find ways to work and succeed together. I hope that we can continue to do so for many years to come.

Thank you.

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