Patent Legislation Moving in House and Senate
The Senate and House Judiciary Committees continue to work on the largest overhaul to patent law in recent history, approving separate drafts of the Patent Reform Act of 2007.  CHI is working with Senator Feinstein and key California members on the House Judiciary Committee to address important issues of concern to California’s biomedical community.  Specifically, current language pertaining to apportionment of damages, post-grant review, and PTO rule-making authority will encourage infringement, weaken the value of patents and diminish the protections needed to ensure continued life sciences innovation.  CHI issued a press statement following passage by the House Judiciary Committee.  For more information, contact Todd Gillenwater, CHI vice president-public policy (858-551-6677 or gillenwater@chi.org).
 
FDA Reauthorization Passes House; Follow-on Biologics Language Omitted
On Wednesday, July 11, the U.S. House of Representatives approved H.R. 2900, legislation reauthorizing the Food and Drug Administration (FDA) user fee programs and pediatric research laws.  The measure also includes language on drug safety, clinical trial registries for drugs and devices, incentives for making children’s medical devices and financial conflicts limits for FDA advisors.  CHI is working closely with AdvaMed, BIO, MDMA and PhRMA to advocate provisions of importance to the California biomedical community.  Language relating to follow-on biologics, which was added to the Senate-passed legislation earlier this month, was not included in the House measure.  CHI is working with Congresswoman Anna Eshoo (D-Menlo Park) and other members of the California delegation in support of a sound science-based solution for the approval of follow-on biologics that maintains appropriate incentives and patent protections, driving continued biomedical innovation in the state. 
 
House Panel Holds Informational Hearing on Bayh-Dole
On Tuesday, July 17, the House Science Committee’s Subcommittee on Technology and Innovation held an informational hearing with witnesses from academia and industry to discuss the Bayh-Dole Act.  Bayh-Dole was implemented in 1980 to improve the commercialization of basic federally funded research by creating incentives and intellectual property protections so that new technologies could be brought to market.  The rise of the biomedical industry in California can be directly attributed to the foresight of legislators who enacted this legislation.  The biomedical industry was not represented by a witness at the hearing, but CHI worked with Subcommittee member Rep. Mike Honda (D-San Jose) to highlight the importance of Bayh-Dole to the industry in the state.  Subcommittee Chairman David Wu (D-OR) announced his intention to hold additional hearings on Bayh-Dole and CHI will work with his office in order to address the perspective of California’s biomedical R&D community.
 
FDA Appropriations Package Passes Committee
The House and Senate Appropriations Committees on Thursday, July 19, approved its FY 08 agriculture spending packages allocating funding to the Food and Drug Administration (FDA).  Highlights of interest to California's biomedical industry include:

• Funding levels: The House package includes $1.69 billion dollars for the FDA, an increase of $125 million over last year and $62 million more that the President's request.  CHI has advocated higher funding levels for the agency to remove its dependence on industry paid user fees and to improve drug safety capabilities.
• Drug importation: The measure included language that would prohibit the FDA from spending funds to prevent the importation of prescriptions drugs and biologics.  CHI communicated strong opposition to this provision to the California members on committee, outlining the harm that imported price controls would have on innovation as well as the significant safety concerns.  The Senate approved package allocates $1.76 billion for the FDA and contains no importation language.

NIH Funding Falls Short in House and Senate Spending Packages
On Thursday, July 19, the House approved its spending package for the Labor, Health and Human Services, Education and Related Agencies totaling $154.2 billion by a vote of 276-140.  The measure faces an uncertain future because it did not receive the two-thirds majority needed to override a threatened Presidential veto due to its cost -- $12.5 billion over the Administration budget request.  CHI has joined other stakeholders in calling for a 6.7 percent increase in funding for the National Institutes of Health (NIH).  Because of the tight fiscal environment, the legislation included agency funding significantly less than what CHI urged.  NIH funding levels in the Senate version are slightly higher than in the House package, but still far short of the allocation needed to reverse the current trend.  The Senate package also contains embryonic stem cell research language, sure to draw the ire of the administration, which would allow researchers to use federal funds on stem cell lines derived prior to June 15, 2007.  For more information contact David Burt, CHI legislative director (858-551-6677 or burt@chi.org). 

CHI California Healthcare Policy Forum
Join the membership of the California Healthcare Institute (CHI) for a lively and informative forum on the implications of healthcare reform for life sciences innovation. CHI’s annual California Healthcare Policy Forum will take place Thursday, August 2 at The Salk Institute in La Jolla, California.  CHI has convened an extraordinary group of biomedical industry leaders and influential policymakers for focused discussion on how healthcare reform will reshape the market for medical innovation and patient access to new therapies and medical technologies.  Special thanks to forum sponsors BIO, Deloitte, DLA Piper, Ernst & Young, Manatt, Phelps & Phillips and PhRMA.  Contact Callie Robbins (robbins@chi.org or 858-551-6677) for additional information.  View the forum agenda and topics.