|(CHI roundtable participants pictured from left): Heather Turner (Orexigen), Terry McCune (K-Tube), Christen Chavez (ReMed), Mick Farrell (ResMed), Rep. Mary Bono Mack, David Gollaher (CHI) and Pedro Lichtinger (Optimer).|
Michael “Mick”Farrell, President of the Americas for CHI member ResMed, recently hosted a CHI roundtable with Rep.Mary Bono Mack (R-Palm Springs) led by CHI President & CEO David Gollaher at the company’s headquarters in San Diego. CHI members Heather Turner (Orexigen), Pedro Lichtinger (Optimer Pharmaceuticals), Terry McCune (K-Tube) and Christen Chavez (ResMed) participated. Bono Mack serves on the House Energy & Commerce Committee which has jurisdiction over FDA, so the regulatory environment for medical innovation was a key topic of discussion. Participants gave examples of companies moving abroad, pushing jobs and revenues offshore because of inconsistency and unpredictability at the Agency. Investors cite the FDA regulatory environment as the greatest threat to the industry’s growth. According to the July 20 MoneyTree Report by PwC and the National Venture Capital Association, life sciences investing declined for the fourth consecutive quarter, most notably in the biotechnology sector representing the lowest quarterly total for the industry since the first quarter of 2003. Bono Mack stated her commitment to working with CHI and its members to improve the regulatory environment for new technologies and therapies to get to market. CHI members also expressed concerns about government coverage and payment policies that do not reward innovation and limit patient access to new therapies. CHI has worked with legislators to prevent changes to coverage and reimbursement policies, such as Medicare Parts B and D, that would discourage future investment and innovation. CHI has addressed concerns with IPAB and continually monitors implementation of government-sponsored comparative effectiveness research. In closing, Bono Mack invited those who participated and any CHI member to come to her with concerns and to offer proposed solutions that she could consider.
CHI-Advancing California biomedical research and innovation