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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at Announcement of FDA/NIH Collaboration

Remarks of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the
Announcement of FDA/NIH Collaboration
February 24, 2010


Thank you, Secretary Sebelius and Dr. Collins.

It is a great pleasure to be here this morning with you … and I am so pleased to be participating in this announcement … which marks a new stage in a wonderful relationship.

FDA and NIH are two remarkable agencies … staffed by thousands of world-class scientists dedicated to serving the public interest…and the public’s health.

We share the goal of bringing basic biomedical discoveries to their practical application in the form of safe and effective drugs, vaccines, diagnostics, and other therapeutics.

Here at NIH, you conduct and support the research that identifies the mechanisms of disease. You use this knowledge to identify new strategies to diagnose, treat or even cure or prevent them. You develop novel therapies with the potential to reduce suffering and save lives.

But with new candidate therapies come critical questions: Does this really work? Is it safe? Do the benefits outweigh the risks?

Many people think of FDA as the judge – the agency that reviews the data and either gives a thumbs up or a thumbs down to each application.

If it were only so easy.

Before FDA can make any decision, we have to figure out what it means for a product to be safe and effective … we have to determine the right standards to apply.

The methods we use to do this make up what we call regulatory science -- the development and use of the scientific knowledge, tools, standards, and approaches necessary for the assessment of medical product safety, efficacy, safety, quality, potency, and performance.

For example, FDA provides scientific guidance to industry on how to design clinical trials that will answer key questions of concern.

We validate surrogate endpoints that can dramatically reduce the time and expense of clinical trials.

We set standards for novel cell-based therapies so researchers can reliably produce the same therapy time and again.

We develop and provide the reagents that vaccine makers use to test the potency of their yearly flu vaccines.

And much more….

Regulatory science is the critical bridge between biomedical research and new medical products.

But just as biomedical research has evolved in important and powerful ways in the past decades, regulatory science must also evolve. We must harness advances in science and technology to ensure that we have the most effective and efficient regulatory pathways to address the opportunities before us.

A bench scientist may develop a new approach to a disease. A clinician may be able to show it can work. But regulatory scientists must have the knowledge and tools to help translate discovery, innovation, and promise into real world products for those who need them.

With the right scientific foundation, FDA can set standards for such efforts as evaluating novel stem cell therapies … for example, the artificial pancreas, and personalized treatment for a variety of diseases.

We can help develop and implement strategies to screen compounds for serious adverse effects so that critical time and funding is not wasted in scientific dead-ends.

And FDA can facilitate the development of new kinds of countermeasures for biological threats, both natural and man-made.

Building this foundation of regulatory science is a critical priority … and it will require all of our best efforts.

Today’s announcement will lead to unprecedented cooperative efforts between NIH and FDA to identify key questions in regulatory science – and then answer them.

We will bring together top scientific leaders from both institutions to develop and work through an agenda … defining key areas for research, critical needs, and opportunities to apply new science to address those needs … and measuring our progress by real steps forward.

We will support outside institutions and academic experts to address critical research questions and gaps in knowledge, and to develop specialties within regulatory science.

And we will accomplish these goals in a transparent fashion … starting with our decision to seek public input about all the ways FDA and NIH can work together for the public health.

In recent months I have come to compare the biomedical enterprise to a rower on a river. The rower has one powerful arm, representing the progress of basic biomedical research and discovery. The rower’s other arm is regulatory science.

We have allowed the arm of regulatory science to become weak and under-developed. We cannot allow this imbalance to persist….for if we do, we will not realize all the potential of the revolution in biomedical science. Instead of pulling us to an exulted future, we will row in circles.

But we’re getting stronger. We’re starting to pull together.

I am confident that our strengthened coordination and collaboration with NIH will enhance our efforts and add important momentum toward achieving our common goals of improving health, reducing disease and saving lives.

We have extraordinary opportunities and an important mission. I look forward to working with all of you to accomplish our goals.