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Identifying Opportunities for Meaningful Reform to Our
Nation’s Medical Product Discovery and Development

revolution in health care. Advances in molecular medicine will allow us to develop powerful new treatments that can cure or even prevent diseases like Alzheimer's and cancer. Tomorrow's high-tech cures can also slash healthcare costs and eliminate ineffective
treatments. What will it take to realize the potential of the new medicine?”
Andrew von Eschenbach, former FDA Commissioner, 2012

The federal government has been an enthusiastic investor in biomedical research for five decades.
That investment has helped drive rapid innovation and bring us to a crossroads: Will we use what we have learned to transform the discovery and development of new drugs and medical devices, or will we maintain the status quo, depriving patients of cutting-edge products?

With the release of this report, the Senate Health, Education, Labor and Pensions (HELP)
Committee is beginning an inclusive and transparent process to:

? Candidly assess the status quo: What works? What’s not working? What can we do better?
? Identify how Congress can improve public policies to promote the efficiency and
effectiveness of medical product development to cut down on the total time it takes for
these products to get to American patients.
? Pass transformational legislation that the President can sign this year.

Every American is personally affected by the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH). Anytime we take medicine, have a routine check-up, or undergo a serious procedure for a health problem, like surgery or cancer treatment, we are using medical products regulated by the FDA. In many cases, the research leading to the discovery and development of these products has been advanced, funded, or enabled in some way by the NIH.

These two agencies have an enormous influence on our economy. FDA-regulated products account for about 25 cents of every dollar spent by American consumers each year.

For generations, America has led the world in medical innovation. The dedicated professionals at the NIH and FDA have helped to instill confidence in FDA-approved products. Scientists from across the globe take seriously the findings and caliber of research that NIH funds, as well as the safety and efficacy of products FDA approves.

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