Wednesday, July 8, 2015

“Alexander: NIH and FDA Must Keep Pace with Today’s Cutting-edge Scientific Advances”

Senator Burr and I released a white paper in January that looked at the process of getting drugs and devices from discovery to medicine cabinet, and much of what the report covered is relevant here today.
We found that medical products take more time and money to discover, develop, and reach American patients than ever before. 
We also found that FDA has struggled to regulate the most cutting-edge medical products. The disparity between the pace of scientific discovery and FDA’s scientific knowledge is threatening America’s position as a global leader in medical innovation. 
We reported that the venture capital community is shifting investments away from early-stage drugs and devices as a result of increasing regulatory burden and uncertainty. 
Without this venture capital investment, researchers are not able to scale up their research or bring their ideas from the laboratory to the development of medicines or medical devices. 
We also found that countries across the globe have sought to capitalize on America’s shrinking competitive advantage in the biomedical space. 
For example, in China, between 2007 and 2012, funding for biomedical research increased 33 percent, which has translated into rapid growth for its businesses.
These are big challenges that are slowing down the process for getting the cutting edge innovations we are discovering into the medicine cabinet and the doctor’s office.
The NIH and FDA must keep pace with today’s cutting-edge scientific advances.”

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