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Contents : October 28 2011 The Honorable Fred Upton Chairman House Energy and Commerce Committee 2125 Rayburn House Office Building Washington DC 20515 Dear Chairman Upton: On behalf of the California Healthcare Institute (CHI) the public policy association representing California s statewide life sciences sector research universities and institutes biopharmaceutical and medical device companies and venture capital firms I am writing to thank you and your House colleagues for introducing the package of FDA reform measures that will improve the predictability consistency efficiency and rationality of medical device approval processes which too often impede safe new technologies from reaching patients in a timely fashion. California is the global leader in medical technology investment and innovation. Our state is home to more than 1 300 medical technology firms employing over 107 000 workers representing nearly a quarter of the entire U.S. medical device workforce. In 2010 medical technology venture capital investment in our state was $1.15 billion or half of the total $2.3 billion invested in medical technology nationwide. Unfortunately in recent years the number one issue and concern of our membership both device and biopharm -- has been the environment at the FDA. More specifically with concerns over growing uncertainty unpredictability and inefficiency in the FDA s management of its review and approval processes. CHI supports a strong science-based FDA and strong science-based safety and efficacy standards. CHI also supports improvements to remove needless delays in FDA product reviews leading to a more efficient and predictable process. We can have both. Indeed this legislative package will help innovative medical products reach patients in a more timely manner without compromising appropriate and rigorous safety standards. It will also serve to improve processes that have become unnecessarily burdensome on developers and the FDA itself. Finally given our still uncertain economy it is especially important that we do everything we can to encourage not hamper U.S. investment entrepreneurship and innovation. As noted in our recent Competitiveness and Regulation report with the Boston Consulting Group a s the global economy grows ever more connected American leadership in the biopharmaceutical and medical device industries faces intense competition: for capital for markets for talent and jobs. As these competitive forces gather momentum investors managers and policymakers ignore them at their peril. If FDA regulation is just one factor among several it nonetheless can be pivotal. CHI commends you and your colleagues on both sides of the aisle for ongoing efforts to thoughtfully and responsibly address the FDA regulatory environment and we look forward to working with you as these measures proceed. Thank you again for your leadership and please let me know if CHI may be of any assistance. Sincerely Todd Gillenwater Senior Vice President Public Policy cc: California congressional delegation HEADQUARTERS 888 Prospect Street Suite 220 La Jolla CA 92037 858.551.6677 SACRAMENTO 1215 K Street Suite 940 Sacramento CA 95814 916.233.3497 WASHINGTON D.C. 1608 Rhode Island Avenue NW Room 238 Washington D.C. 20036 Fax 858.551.6688 Fax 916.233.3498 202.974.6313 Fax 202.974.6330 WWW.CHI.ORG

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