Rep. Kevin McCarthy, Biomedical Industry Leaders Focus on FDA, NIH, at CHI Roundtable

The House Majority Whip, California Congressman Kevin McCarthy met with California biomedical innovators at a CHI-California Healthcare Institute roundtable at Gilead Sciences in Foster City, Calif. on June 7. In addition to Gilead, among the prestigious research institutions and companies represented were The J. David Gladstone Institutes, Amgen, Thallo Bioscience, Proteus Biomedical, and Abbott Vascular. CHI President & CEO David Gollaher introduced Congressman McCarthy, who was honored with CHI’s Leadership Award earlier in the year, and thanked him for his support for California biomedical research, investment and innovation. Rep. McCarthy was eager to hear about the latest research, treatments and new medical technologies from participants. They shared news of breakthrough research demonstrating that the use of HIV medication reduced the risk of HIV infection in uninfected people, a discovery that topped Time Magazine’s list of medical breakthroughs of 2010, the development of embedded computers and sensors inside proven drugs and devices to monitor real-time patient compliance and response, and less invasive heart valve replacement surgeries.

Rep. McCarthy was interested in the group’s perspective on what policies are stifling innovation and U.S. competitiveness. The U.S. Food and Drug Administration (FDA) is not keeping pace with U.S. biomedical innovation. The Agency-industry partnership is strained by unexplained regulatory delays, by a lack of clear standards for what clinical data are necessary for product approval, and by a bureaucracy whose communications are neither consistent nor predictable. In this regulatory environment, companies are launching products first abroad forcing jobs and investment offshore. NIH funding must also be preserved to ensure a healthy pipeline of new research for product development. Rep. McCarthy is optimistic on American ingenuity and innovation and wants to make better government to advance it: “We have the framework to turn it around, but do we have the willpower?”

CHI-Advancing California biomedical research and innovation