CHI Supports Introduction of Biosimilars Legislation
On Friday, March 14, the California Healthcare Institute (CHI), sent a letter of support to Congresswoman Anna Eshoo (D-Menlo Park), commending her for the introduction of H.R. 5629, the “Pathway for Biosimilars Act,” legislation that would create a science-based approach for U.S. Food and Drug Administration (FDA) approval of follow-on biologics.  The legislation gives the FDA the tools and authority to formulate scientific standards for approval and determination of interchangeability through a clear, public guidance process.  The measure also provides strong patent and data exclusivity protections that appropriately reward companies for the long and risky research and development process, preserving incentives that will foster the next generation of biotechnology innovations.  CHI continues to advocate for congressional action on follow-on biologics this year, and is reaching out to other members of the California delegation to garner support for this important legislation.  For more information, contact Todd Gillenwater, CHI vice president- public policy (gillenwater@chi.org or 202-974-6313).

Preemption Case Draws Attention from Lawmakers
Following the Supreme Court ruling, Reigel v. Medtronic, some Congressional Democrats are preparing to introduce legislation explicitly stating that FDA regulation of medical devices does not preempt state tort suits.  The Court’s 8-1 decision in February prohibits patients and their families from suing makers of medical devices that have been granted premarket approval (PMA) by the FDA.  Reps. Frank Pallone (D-NJ) and Henry Waxman (D-Los Angeles) will put forth legislation shortly that would amend medical device provisions of the Food, Drug and Cosmetic Act to add the following statement: “Nothing in this section shall be construed to modify or otherwise affect any action for damages or liability of any person under the law of any State.”  The measure would be retroactive, taking effect as if it had always been a part of the Medical Device Amendments Act.  CHI strongly opposes this legislation, as it will take away important protections necessary for innovative companies to introduce new medical device products.  The legislation would also seriously undermine the approval authority of the FDA and its process of balancing the risks versus benefits when it reviews promising new medical technologies.  Preemption of drug makers is expected to see action before the Supreme Court sometime this fall.

Appropriations Committee to Discuss Funding Allocation Affecting Biomedical Industry
As Congress returns from spring recess, attention will turn to the Appropriations Committees, as lawmakers continue the process of allocating funds to government agencies and programs for the coming fiscal year.  Over the past few weeks, CHI has met with California members on the House Appropriations Committee to address funding requests that are of importance to our biomedical community.  On Wednesday, April 2, the Commerce, Justice, Science and Related Agencies Subcommittee will hold a hearing to discuss funding priorities under its jurisdiction.  CHI is advocating for full funding of the National Science Foundation, as allocated in the “COMPETES” Act of 2007, as well as for important math and science education programs that will improve the ability of future students to meet the workforce demands of the California biomedical industry.  Jesse Goodman, director of the FDA's Center for Biologics, Evaluation and Research will testify before the Agriculture, Rural Development, FDA, and Related Agencies Subcommittee the same day.  The hearing comes on the heels of a speech last week by FDA Commissioner Andrew Von Eschenbach, who said the agency is falling short of compliance with the FDA Amendments Act of 2007 because of a lack of resources.  CHI continues to advocate for increased funding for the agency to reduce the reliance on industry user fees and provide the critical resources necessary for the review of innovative new drugs and devices currently in the pipeline.

CHI Forms Diagnostics Working Group; Meeting Set for May 8
To address the increasing number and complexity of policy issues facing California’s diagnostics firms, CHI is launching a new diagnostics working group. The inaugural meeting of the group will be held Thursday, May 8, 10:30 a.m. to 1:30 p.m. at BD Biosciences in San Jose. The group will provide a forum for CHI members’ regulatory affairs and policy staff to discuss and develop positions and activities surrounding diagnostics product regulatory approval and reimbursement, personalized medicine, and other issues of importance, including proposals to modernize the regulatory process for in vitro diagnostics, issues regarding the 510(k) process, ASR regulation, comments and related activities surrounding the Secretary’s Advisory Committee of Genetics, Health, and Society (SACGHS) Draft Report on Oversight of Genetic Testing, the FDA Draft Guidance on In Vitro Diagnostic Multivariate Index Assays (IVDMIA), and other public policy initiatives impacting the diagnostics sector. To participate or for more information, contact Todd Gillenwater, CHI vice president- public policy (gillenwater@chi.org or 202-974-6313).

ROI: Return on Innovation, April 23; Registration Now Open
Registration is now open for CHI’s 15-year anniversary celebration April 23, 5:30 p.m. to 7:30 p.m. – ROI: Return on Innovation, Celebrating California’s Biomedical Breakthroughs.  The Gold Room at the Rayburn House Office Building will be the venue for cocktails and conversation between public policy makers and California’s biomedical industry leaders. To reserve a hotel room at the St. Regis Hotel, as part of CHI's special rate of $425 per night, please call Starwood's St. Regis Desk at (888) 627-8087 and identify yourself as a CHI member.  The last date to reserve a room at this rate is April 3, 2008.  This function is a widely attended event and only drinks and passed hors d'oeuvres will be served, in compliance with Congressional ethics laws.