Congressional Hearing on Challenges Confronting FDA
The House Energy and Commerce Subcommittee on Oversight and Investigations will hold a legislative hearing on Tuesday, Jan. 28, at 10:00 a.m. (EST) entitled “Science and Mission Risk: FDA’s Self-Assessment.”  The hearing will focus on a report, completed at the request of FDA Commissioner Andrew Von Eschenbach, by a blue ribbon scientific panel assessing the agency’s ability to protect the safety of the nation’s food and medicines.  The report portrays an agency unable to fulfill its core mission, owing largely to what it calls a “growing disparity between responsibilities and resources.”  Also testifying before the committee will be CHI board member Peter Barton Hutt, partner, Covington & Burling LLP, whose findings on funding and personnel shortfalls at the FDA were included as appendix B to the report.  CHI believes that the FDA needs increased federal funding, rather than depending increasingly on industry user fees, in order to fulfill its mission of bringing safe and effective products to market without unnecessary regulatory delays.

New Democrat Coalition Creates Health Task Force
Members of the New Democrat Coalition (NDC) in the House recently announced the formation of a health policy task force co-chaired by California Congresswoman Lois Capps (D-Santa Barbara).  The NDC is a group of moderate Congressional Democrats who support policies that balance economic growth and fiscal responsibility.  The goal of the task force is to produce an agenda of health related proposals that could be accomplished during the shortened 2008 election year.  Given the leadership of Rep. Capps as well as New Democrat Chairwoman Ellen Tauscher (D-Walnut Creek), CHI is in a strong position to enter a dialogue with the task force.  Objectives and proposals of interest to CHI include: comparative effectiveness research, legislation that would create a pathway for the approval of follow-on biologics, technology transfer, and health IT.  For more information, contact Todd Gillenwater, CHI vice president-public policy (202-974-6313 or gillenwater@chi.org).

Congressional Briefing Highlights Industry-University Workforce Partnership
While the future of biomedical innovation in California appears bright, the industry’s growth and vitality depends on the availability of well-educated, talented scientists and engineers, along with professionals with skills in areas like quality assurance, regulatory affairs and compliance.  To meet these workforce demands, an increasing number of colleges and universities nationwide are adopting Professional Science Master’s (PSM) programs designed to allow students to learn workplace skills highly valued by employers.  On Tuesday, Jan. 15, in collaboration with the California Institute for Federal Policy Research, CHI President and CEO David Gollaher, Ph.D., moderated a Washington, D.C. briefing, attended by nearly 50 congressional staff and others, describing the PSM program and how the California State University system is implementing it.  Also participating were CHI board members Gail Naughton, Ph.D., dean, College of Business Administration, San Diego State University, and Robert Hance, senior vice president, Abbott Diabetes Care, along with Michael Teitelbaum, D. Phil., vice president, Alfred P. Sloan Foundation, and Carol Lynch, Ph.D., senior scholar in residence and director of the PSM Initiative, Council of Graduate Schools.
 
CHI Board Approves 2008 Federal Policy Agenda
At its first quarterly board meeting held Jan. 24 in Sacramento, the CHI board of directors approved the organization's 2008 federal policy agenda.  With our state’s congressional delegation holding leadership positions of great importance to the industry, CHI is well positioned to advocate policies to advance biomedical research and development.  Priorities for CHI in 2008 include:
•  Patent Reform / Intellectual Property (IP) – advocate for strong patent and IP principles that will ensure continued biomedical investment and  innovation;
•  Evidence-Based Medicine – develop principles, including comparative effectiveness research, focusing on how evidence can inform and improve clinical decision making for individuals;
•  Government Coverage and Payment – support reimbursement policies that value novel technologies, sustaining incentives for future innovation;
•  Food and Drug Administration – support increased funding for the agency.  Monitor and respond to FDA initiatives and guidance documents addressing in-vitro diagnostics;
•  Science Research and Education – bring together academia and industry to enact strong policy that promotes biomedical growth through research and education.
•  Tax and Fiscal Policy – advocate for tax policy and fiscal incentives that will promote private life sciences investment.

CHI Focus on Diagnostics Regulatory and Reimbursement Issues
To address the increasing number and complexity of policy issues facing California’s diagnostics firms, CHI recently announced the formation of a new diagnostics working group.  The working group will serve as a forum for CHI members to discuss and develop positions and activities surrounding regulatory approval, reimbursement, and personalized medicine.  As an initial activity, the working group will develop a CHI statement of principles addressing the importance of a modernized regulatory framework that protects patient safety, ensures that physicians and patients receive accurate information, and promotes innovation.  For more information, or to join the working group, contact Todd Gillenwater CHI vice president-public policy (202-974-6313 or gillenwater@chi.org).