Follow-On Biologics Set To Receive Boost
After a flurry of activity last year, congressional proposals to provide a pathway for U.S. Food and Drug Administration (FDA) approval of follow-on biologics (FOBs) were seemingly put on hold. However, recent reports indicate that the issue is set to receive a major boost with the forthcoming introduction of legislation by Reps. Anna Eshoo (D-Menlo Park) and Joe Barton (R-Texas). The measure is expected to incorporate important provisions that recognize the complexity of biologics product development and manufacturing, emphasize patient safety, and contain adequate incentives for continued innovation – including 12 years of data exclusivity. With these elements, CHI is hopeful that the legislation is enacted into law this year. For more information, contact Todd Gillenwater, vice president-public policy (202-974-6313 or gillenwater@chi.org).

President’s FY09 Budget Flat-Lines NIH
President Bush released his proposed FY2009 federal budget last week, including $29.5 billion for the National Institutes of Health (NIH). The amount, which mirrors the amount received by the agency in FY08, marks the sixth straight year that the NIH budget has failed to keep up with inflation. The impact on California, the nation’s largest recipient of NIH funding, will be significant. As the NIH budget diminishes, grant durations will shorten, leading researchers to spend more time either reapplying to the NIH for funding, reaching out to additional sources for funding or abandoning valuable projects altogether. In all of these cases, research and, ultimately, public health suffer as more and more time is spent locating and securing funding sources.

Patent Reform Heats Up
As congressional supporters of patent reform legislation (S. 1145) continue their push in the Senate, recent events have buoyed the efforts of those who have voiced opposition to certain provisions. Last week, the U.S. Department of Commerce submitted a letter to Senate Judiciary Committee Chairman Patrick Leahy (D-Vt) highlighting the administration’s opposition to the legislation’s damages provision. The letter stated that the provision would "create more problems than it solves" and further, that "such a dramatic change from current jurisprudence may have the unintended consequence of reducing the rewards of innovation and encouraging patent infringement." Similarly, 14 labor unions, including the United Steelworkers and the Patent Office Professional Association, blanketed the Senate with a letter urging opposition to the bill in its current form. Finally, in response to documents being distributed by supporters of the legislation claiming that universities now fully support S. 1145, the Association of American Universities (AAU) and four other university associations submitted a letter to Chairman Leahy clarifying that "significant problems remain for universities, particularly with respect to the determination of damages, mandatory prior art searches, and the post-grant "second window."

CHI To Participate In Diversity and Innovation Caucus Planning Meeting
In response to figures illustrating the under-representation of women and minorities in science, technology, engineering and math (STEM) professions, members of Congress including Reps. Mike Honda (D-San Jose) and Zoe Lofgren (D-San Jose) launched the Diversity and Innovation Caucus to discuss and promote policies designed to strengthen STEM workforce opportunities in these communities. It is critical for the growth of California’s life sciences industry that appropriate incentives, coursework and job training are available to foster a highly skilled and diverse STEM talent pool in the state. On Feb. 28, CHI Vice President-Public Policy Todd Gillenwater is scheduled to participate in a meeting to help shape the caucus’ policy objectives for the remainder of the current Congress and beyond. For more information, contact Todd Gillenwater (202-974-6313 or gillenwater@chi.org).