Year in Review

Patent Reform
During 2007, patent reform escalated from a struggle between the high tech and biotech industries to a larger discussion between high tech companies (e.g. Cisco, Microsoft) and the larger biomedical community (biotech, medical device and diagnostics, venture capitalists, universities and research institutions), each with different priorities.  CHI has focused on specific provisions: apportionment of damages, a post-grant review “second window,” lower post-grant evidentiary standards, authority to allow the Patent & Trademark Office (PTO) to issue restrictive rules, such as those limiting continuation applications, and new expansive and expensive mandatory search requirements. CHI’s activities and accomplishments on patent reform include:

• Leading a unique coalition with California academic institutions (UC, Stanford, Scripps, Salk et al) committed to common biomedical goals.
• Educating the California congressional delegation: meetings with key leaders, including Speaker Nancy Pelosi, House Judiciary Committee members Zoe Lofgren, Adam Schiff, and Darrell Issa, Senate Judiciary Committee member Dianne Feinstein, New Democrat Coalition Chair Ellen Tauscher, Senator Barbara Boxer, and members representing biomedical clusters: Susan Davis, Brian Bilbray, Loretta Sanchez, and Mike Honda.
• Published and distributed to Congress, the press, and health policy, life sciences and academic leaders, a white paper summarizing patent law developments that could have serious implications for the biomedical industry. 
• Organized Senate staff and press briefings addressing the perspectives of emerging biotechnology, medical device, and nanotechnology firms and the venture capital community.
• Led and activated the California biomedical community in cross-industry coalition letter-writing campaigns to House and Senate leaders that included more than 100 California companies and organizations.

On Sept. 7, the House passed its version of patent reform legislation, H.R. 1908, by a narrower-than-expected vote of 220-175.  The Senate is likely to take up its version of patent reform in early 2008.  Senators Feinstein and Boxer, along with moderate House Democrats, will strongly influence the outcome.

Follow-On Biologics
Congressional leadership has identified follow-on biologics (FOBs) legislation as a way to cut drug costs.  Hence House and Senate leadership have sought to give the U.S. Food and Drug Administration (FDA) authority to approve “biosimilar” products once innovators’ patents expire.  CHI has worked to ensure that any approach to follow-on biologics is based on sound science, requires appropriate pre- and post-market testing to ensure patient safety, and maintains intellectual property protections and incentives for funding future research and development. CHI’s activities and accomplishments on FOBs include:

• Educating the California delegation about the issues.  Meetings with Reps. Anna Eshoo, Lois Capps, Hilda Solis, Mary Bono, and George Radanovich, Judiciary Committee members Howard Berman, Zoe Lofgren, Adam Schiff, Brad Sherman, Darrell Issa, Dan Lungren, Elton Gallegly, and other key offices including Speaker Nancy Pelosi, Ellen Tauscher, Loretta Sanchez, David Dreier, and Brian Bilbray.
• Organized a letter to the state’s congressional delegation signed by 22 CHI member company biotechnology executives expressing concern over Waxman/Clinton/Schumer legislation.  The letter stressed the need for a comprehensive debate and a thorough examination of the patient safety, scientific, and intellectual property considerations surrounding FDA approval of follow-on products.

In September, pivotal FDA legislation, the Food and Drug Administration Act of 2007, was enacted into law without any FOBs language.  Heading into 2008, CHI will continue to work with key members of Congress, including Rep. Eshoo, to craft responsible FOBs legislation.

Comparative Effectiveness
As lawmakers, agencies such as the Center for Medicare and Medicaid Services (CMS) and the Congressional Budget Office (CBO), and presidential candidates look for ways to restrain healthcare costs, drugs and medical technologies have become primary targets. CHI is concerned that some approaches to cost containment could restrict patient access to innovative treatments and therapies, undermining future biomedical advances by reducing incentives for research and development.

CHI supports the principles of evidence-based medicine, including comparative effectiveness research, as a means to inform and improve treatment decisions made by physicians for individual patients.  However, CHI is opposed to payers using comparative effectiveness research as a blunt cost-containment tool to deny or limit coverage of innovative diagnostics, therapies and medical technologies. CHI has organized a project on comparative effectiveness and evidence-based medicine for 2008, which will entail meetings with CMS and CBO officials, and members of the California Congressional delegation and staff.

Science and Education
CHI expanded our activities in Washington in 2007 to advocate for programs and policies to improve science research and enhance science, technology, engineering and mathematics (STEM) education programs.  In February, CHI worked with members and staff at the House Science Committee to approve H.R. 363, the “Sowing the Seeds Through Sciences and Engineering Research Act,” that would establish a National Coordination Office for Research Infrastructure responsible for setting priorities and promoting incentives and opportunities for aspiring researchers.  The bill was included in the larger National Science Foundation (NSF) reauthorization package that provided more than $16 billion for research and almost $3 billion to improve STEM education.

CHI also entered into discussions with policymakers addressing reauthorization of the "No Child Left Behind Act."  Given the leadership roles of key members of the California delegation on the House Education and Labor Committee, and the desire among members of Congress in general to have the support and input of academic, business, and R&D leaders on education reform, CHI is well-positioned to take a leadership role in this debate.  In 2007, CHI began this work through a number of activities including:

• Met with members of the House Science Committee, including Chairman Bart Gordon (D-TN), Ranking Member Ralph Hall (R-TX) and Rep. Brian Bilbray, focusing the evolving interdisciplinary nature of life sciences research occurring at the intersection of biology, chemistry, engineering, mathematics and computer science.  These activities led to the inclusion of legislative language in H.R. 363 as well as report language accompanying the bill.  CHI followed up with a letter to all delegation offices in the House supporting final passage of the bill.
• Held preliminary meetings on the reauthorization of "No Child Left Behind" with members of the California delegation, including House Education and Labor Committee Chairman George Miller, as well as with Governor Schwarzenegger’s D.C. office.

CHI will build on these efforts in 2008 to ensure that federal education programs are in place to attract and retain promising students and provide career opportunities in the biomedical industry.

Stem Cell Research
CHI and other supporters of stem cell research were successful in moving legislation that would reform current federal human embryonic stem cell policy by permitting new research, subject to strict ethical guidelines and appropriate oversight.  Both the House and Senate passed S. 5, the Stem Cell Research Enhancement Act, however the president vetoed the measure and neither chamber had the support to garner the two-thirds vote necessary to override a presidential veto. Despite this setback, CHI continues to work with members of the California delegation in the House and Senate to advocate for a reasonable stem cell policy that will provide appropriate federal resources for U.S. researchers to explore this promising field, allowing the nation to retain its position as the global leader in biomedical research.

NIH Funding and FDA Appropriations
As the legislative year draws to a close, negotiations continue between the president and Congress over an appropriations package that will fund the government in 2008.  Movement on stand-alone spending bills ran into significant roadblocks over differences between the administration and democratic leadership on spending levels and priorities.  National Institutes of Health (NIH) funding and FDA appropriations are caught up in this political wrangling.
NIH Funding: This year’s biggest hurdle was the Labor/Health and Human Services package, which includes funding for the NIH.  Legislation providing a $900 million increase (3.7 percent above FY 07) in NIH funding was vetoed by President Bush in November.  In the current omnibus package that is being discussed by Congress the NIH is funded at $29.2 billion, a 1.1 percent increase over last year. CHI activities to increase NIH funding included:

• Outreach with members of the state’s delegation to increase funding for the NIH.  Participation in numerous coalition efforts and letters to garner support for and increase in NIH funding.
• Hosted roundtables in Washington, D.C. and at Stanford with NIH Director Elias Zerhouni, the CHI board of directors and members of the California delegation.
• Held a focused policy discussion at the Burnham Institute in La Jolla, Calif., with Dr. Story Landis, director, National Institute of Neurological Disorders and Stroke (NINDS) and members of the California biomedical community.

FDA Funding: While the House passed its version of the agriculture spending package including $1.7 billion for the FDA ($324.5 million for Center for Drug Evaluation and Research (CDER); $155.1 million for Center for Biologic Evaluation and Research (CBER); and $240.1 million for the Center for Devices and Radiological Health (CDRH)), the Senate never completed work on this package.  In the current omnibus package being discussed by Congress, the FDA is funded at $1.726 billion ($353 million for CDER; $155 million for CBER; and $238 million for the CDRH). In 2007, CHI conducted outreach with members of the California delegation highlighting the need for additional appropriated funds for the FDA to cut back the reliance on industry user fees and ensure that the agency has the appropriate resources available to move new drug applications safely and efficiently through the approval process.

Policy Roundtables
As part of CHI’s Policy Perspectives series, CHI hosted several policy roundtables in California with legislators and policymakers including Reps. Brian Bilbray, Zoe Lofgren, Susan Davis, Loretta Sanchez, Vito Fossella (R-NY), NIH Director Dr. Elias Zerhouni, and National Institute of Neurological Disorders and Stroke Director Dr. Story Landis.  Established in 1995, the event series is designed to bring government officials face-to-face with influential leaders in the California biomedical community for substantive public policy dialogue.  CHI will continue to expand upon its Policy Perspectives series and is already planning roundtables in early 2008 with Reps. John Campbell, Lois Capps and Xavier Becerra. For more information on these events, contact David Burt, CHI legislative director (burt@chi.org or 858-551-6677).