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
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