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Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for oral testimony before the House Committee on Energy and Commerce Hearing, “Implementing the 21st Century Cures Act: An Update from FDA and NIH”

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SILVER SPRING, Md., Nov. 30, 2017 /PRNewswire-USNewswire/ — Chairman Burgess, Ranking Member Greene, members of the subcommittee: Thank you for the opportunity to testify today on the anniversary of the 21st Century Cures Act, and to update you on FDA’s progress in implementing the provisions of this landmark legislation.

The Cures Act gave FDA a broad new set of authorities and resources to adapt our policies and organizational structure, to make sure that our efforts are as modern as the transformative medical products that we’re seeing.

Congress wanted us to have a strong workforce and policies that will enable the American people to capitalize on the breakthrough science that’s transforming medicine.

I’m proud that my colleagues at FDA have worked hard to meet our commitments under this statute.

I want to commit to you that timely implementation of this legislation is one of our highest priorities. The Cures Act is a defining element of my own policy planning at FDA.

When I arrived at FDA seven months ago, I remarked that I couldn’t imagine a better time to be leading the agency owing to two important new opportunities.

The first is the opportunities offered by new science and technology. Gene and cellular therapies, more targeted drugs, regenerative medicine, digital health tools, and new biomaterials offer the potential for dramatically better, and even curative, therapies for many disorders.

The second is the opportunities provided by Congress.

The reauthorization of the user fees, and more notably, the Cures Act, offers FDA a new platform to fashion these scientific advances into practical treatments for patients.

If I came before Congress five years ago, and said that within the next five years we might have a cure for sickle cell disease, hemophilia, or many common, early stage cancers, such predictions would have been unrealistic.

Such discussions are no longer imprudent.

In fact, we should expect these opportunities.

While these scientific advances won’t be risk-free, these and equally profound clinical opportunities are before us.

The Cures Act inspired a new approach to our work.

It was a direction from Congress that you wanted us to think differently when it came to the potential for breakthroughs that could transform human health.

We pledged to remain steadfast to our gold standard for safety and efficacy. But at the same time, you asked us to look for ways that we can make our

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