NEHI Conference on Bridging the Innovation Gap FDA Innovates, from FDA.gov

FDA Innovates

Remarks given at the NEHI Conference on Bridging the Innovation Gap
By Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
Boston, Massachusetts
April 26, 2012

Thank you, Beverly for the generous introduction.

I am honored to be invited here today.

It is a privilege to address one of the largest, most diverse health care organizations in the United States. But I am especially pleased to be asked to address a topic that is very close to my heart—and occupies much of the thought, creativity and work of everyone at FDA.

I’ll get to innovation at FDA in a moment. But I want to start by commenting on the NEIH Innovation Barometer survey that Glen and Chrystine presented an hour ago. I thought it was very interesting. Working on the inside of a large complex agency, it is always valuable to gain the insights of health care leaders, and I don’t ever want to lose sight of how what we do affects health care and the public. Yes, we innovate. And, yes, we regulate. But we also need to make sure we’re listening and working together. That is why I was very pleased to learn from your survey that the great majority of the healthcare opinion leaders appreciate FDA’s work.

My colleagues and I take that appreciation to heart, and we will continue to work hard to earn the trust and support that Glen and Chrystine talked about.

I am particularly encouraged by the support indicated for increased funding for FDA.

This is a vital concern. Money alone does not guarantee a success, but FDA’s responsibilities have grown dramatically in recent years. It is hard to imagine, but FDA is actually responsible for the regulation of products that account for somewhere between 20 and 25 cents of every dollar of consumer product spending in this country. We regulate drugs, medical devices, biologics and vaccines, the safety of our nation’s blood supply and the vast majority of our food supply; cosmetics, dietary supplements, products that emit radiation…and most recently, tobacco products. The scope of our responsibilities is vast, and they concern things that really matter, to all of us, each and every day.

Increased funding would certainly help us address the many mandates given to us by Congress—and to fulfill our unique and essential mission to promote and protect the health of the public. I believe strongly that both consumers and industry groups have a tremendous stake in a strong FDA that takes science-based actions on behalf of public health.

And—without doubt—that includes promoting innovative products and advancing regulatory science.

So let me turn now to the topic of innovation. It is an issue that is important to us all, whether you come from industry, from academia, from clinical practice, or from government. Of course we each bring our own set of questions and concerns to the table. But we all recognize that we are at a critical juncture.

For the people here from the medical products side—those who develop new devices, diagnostics, and drugs—these have not been easy times. The trend lines for innovative products relative to investments in research and development are not what any of us would like. The costs of bringing new drugs to market have skyrocketed and the pipeline of promising new drug candidates is distressingly low.

Many companies are facing the so-called "patent cliff." Worsening the situation is the unstable economy, changing rules for reimbursement, and, I know, concerns with the FDA…fears that a lack of predictability, consistency, and transparency in our decision-making processes and actions will lead to less investment in innovative technologies and companies, as well as increased competition from foreign companies.

These are challenges that I understand, appreciate, and we are working hard to address.

And for the people here from the healthcare side—those responsible for delivering care to patients—many of you are frustrated that we, as a scientific and medical community, have not been able to adequately realize all of the seeming opportunities in science today. And that is true. Patients are urgently waiting for new therapies—and often not getting them. And we are not adequately addressing burgeoning public health needs. Disease conditions such as obesity and Alzheimer’s, are taking a growing toll, profoundly affecting American families, and measurably adding to our health care costs and our national debt.

How is it that we are in a veritable golden age for biomedical discovery…the sequencing of the human genome has revealed new potential drug targets; combinatorial chemistry, high throughput screening, and biosynthesis has led to thousands of candidate drugs; cutting-edge electronics, nanotechnology, and materials science has the power to transform medical devices...yet despite this, we are not effectively translating these scientific discoveries into therapies, prevention or cures.

There is nothing I would like better than to find a single solution to all of these challenges. But there isn’t one. Instead, we need a comprehensive, integrated strategy that engages the full "eco-system" to advance biomedical product innovation. This includes new and strategic investments in research, driven by American ingenuity and science with input from our global partners, and more thoughtful design and implementation of policies on everything from patents and intellectual property to economic incentives for innovative medicines, reimbursement issues, and, of course, sound regulation. Meaningful and enduring solutions will require true collaboration by stakeholders – and strong leadership from business, academia and government.

And that is why a meeting like this is so important.

History tells us that full engagement and leadership can work.

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