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FDA-NIH Partnership Press Conference

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February 24, 2010

Bethesda, MD

Good morning, and thank you all for being here.

Today, we’re announcing a new partnership with the goal of developing more life-saving cures and getting them to Americans faster.

For decades, the National Institutes of Health and the Food and Drug Administration have played leading roles in the development of important new treatments and medicines.

The National Institutes of Health are the world’s leaders in biomedical research. NIH scientists are constantly advancing our understanding of how diseases work and developing new approaches for how to diagnose, treat, and even prevent them. Today, that work continues under the terrific leadership of Dr. Francis Collins.

The FDA is the world’s gold standard for regulating drugs and devices. FDA scientists are the reason why Americans have access to so many safe and effective drugs and medical devices. And under the excellent leadership of Dr. Peggy Hamburg, the FDA is taking new steps to strengthen their regulatory process.

These agencies have always worked side by side. The first step for many medicines on their way to our pharmacy shelves is a discovery in an NIH-funded laboratory. The last step for all of them is a careful analysis at the FDA.

Both roles are vital. And today, these diagnostics and medicines offer hope to every American and millions of people around the world, preventing deaths, extending lives, easing pain, increasing function, and reducing the spread of disease.

We’re here today because we know we can deliver these treatments faster and safer if these agencies strengthen their partnership, working not just side by side, but also hand in hand.

Let me give you an example. Today, some of our most promising new treatments are based on emerging technologies like cell-based and targeted small molecule therapies. From early in development, basic researchers at NIH should be sharing information about these technologies with scientists at FDA to help them develop standards for safety and effectiveness.

At the same time, the FDA can help inform the NIH’s research by identifying important issues in safety or quality that can be addressed early in the development of new treatments.

By communicating throughout this process, we’ll help researchers navigate the regulatory process and give regulators the scientific tools they need to quickly assess a treatment’s risks and benefits.

For Americans, this is going to mean that new treatments are available, safer and sooner, whether it’s an artificial pancreas for patients with Type 1 diabetes or a safer pain medicine that’s just as effective.

In a few minutes, you’ll hear more about this partnership from Dr. Collins and Dr. Hamburg, but I want to briefly give you the highlights. The announcement we’re making today has three parts.

First, we’re going to create a Joint NIH-FDA Leadership Council that will be co-chaired by Dr. Collins and Dr. Hamburg, to bring together top scientists from both agencies. This Leadership Council will oversee work between the agencies on a wide range of issues and make it easier than ever for them to find new areas for cooperation.

Second, we’re making $6.75 million in grants available over the next three years for research on regulatory science, which is the science of how to best assess the risks and benefits associated with certain treatments. This investment will build on President Obama’s 2011 budget, which for the first time in history, makes a direct investment in regulatory science.

Third, the FDA and NIH will be reaching out to the American people, including the private and non-profit organizations that also play key roles in bringing new medicines to market. We want to hear all your ideas about how we can work together better to benefit patients and public health.

The announcement we’re making today reflects two of this administration’s biggest priorities. More than ever before, we’re working to bring the benefits of science to the American people. That means listening to our scientists. But it also means doing our best to take their insights and recommendations and turn them into more effective policies and more treatments and cures.

That’s what we’re doing today, and Dr. Hamburg in particular deserves credit for putting a new emphasis on making sure the FDA is taking advantage of the best science possible.

This partnership is also a good example of our new focus on leveraging all of our assets to reach our highest potential. Solving complicated problems often takes different skill sets. And the work we do is far better if we collaborate and bring all our resources and talent together to tackle challenges. That’s why President Obama has asked all the members of his Cabinet to look for new opportunities to work together. And it’s why I’ve said the same thing to our new leaders at HHS.

When we can apply all the department’s resources towards a common goal like getting new medicines to America faster, that’s when we can have the biggest impact.

So I want to thank you for joining us here today. And now, I’d like to turn things over to Dr. Collins and Dr. Hamburg to give you a few more details about this ground-breaking partnership…