Sweeping Patent Reform Legislation Introduced in Congress
On Wednesday, April 18, lawmakers in the House and Senate introduced S. 1145 / H.R. 1908, the “Patent Reform Act of 2007,” legislation that would make the most sweeping changes to U.S. patent law in over 50 years. The bill, introduced by Senators Patrick Leahy (D-VT) and Orrin Hatch (R-UT) in the Senate and Representatives Howard Berman (D-CA) and Lamar Smith (R-TX) in the House, includes a number of provisions of concern to California’s life sciences industry, venture capital community, and research universities. Specifically, provisions addressing apportionment of damages as well as a post-grant “second window” threaten to reduce patent certainty and the intellectual property foundations of biomedical investment and innovation. On Thursday, April 26, CHI submitted a statement for the record on the legislation at a hearing of the House Judiciary Subcommittee on Courts, the Internet and Intellectual Property. View statement and press release. For more information, contact Todd Gillenwater, CHI vice president-public policy (858-551-6677 or gillenwater@chi.org).
FDA Reauthorization Deliberations Begin in Senate
On Monday, April 30, the Senate began deliberations on a comprehensive legislative package for the Food and Drug Administration (FDA) that will allocate industry user fees for the drug and device industries as well as grant the agency greater authority to monitor safety. Provisions to create a pathway for the approval of follow-on biologics were not included in the mark-up language that passed out of the Health, Education, Labor and Pensions (HELP) Committee on Wednesday, April 18. However, following committee approval, HELP Committee Chairman Edward Kennedy (D-MA) expressed his intention to attach follow-on biologics to the bill when the measure goes to the floor. CHI opposes attaching follow-on biologics to user fee reauthorization owing to the complexity of the intellectual property and safety issues surrounding these products. The House will hold its first hearing on follow-on biologics Wednesday, May 2, and it is expected that other hearings on user fee reauthorization and drug safety will follow. In the House, meanwhile, there is disagreement between those who would use FDA legislation as a vehicle for issues like follow-on biologics and enhanced drug safety and others who would separate such issues in discrete bills.
Drug Negotiation Language Stalls in the Senate
On Tuesday, April 17, legislation that would permit the federal government to negotiate prescription drug prices failed to garner the 60 votes necessary to proceed through the Senate. The measure, which was passed out of the Health, Education, Labor and Pensions (HELP) Committee earlier in the week, would have eliminated language in the 2003 Medicare Modernization Act (MMA) that prohibits the Secretary of Health and Human Services from participating in price negotiations for prescription drugs offered to seniors in Medicare Part D. In January, the House swiftly passed similar legislation requiring the Secretary to negotiate lower prices. Proponents in the Senate have stated their intention to reconsider the legislation at a later date. In light of the recent vote, along with the President’s announcement that he would veto such a measure, it remains unclear whether the issue will be brought up again this year. CHI maintains that the current Medicare drug benefit has exceeded expectations; it has come in below budget forecasts and is extremely popular among Medicare beneficiaries. The risk of expanding government’s role in purchasing drugs is the imposition of a national formulary that could limit seniors’ access to needed medicines and slow the introduction of new therapies.
NSF Funding Increase Would Stimulate Collaboration with Industry
The House Science and Technology Subcommittee on Research and Science Education passed legislation on Thursday, April 19, to reauthorize funds for the National Science Foundation (NSF) for fiscal years 2008-2010. This legislation would increase funding for the agency to provide new grants for young researchers to stimulate high-risk projects, encourage greater collaboration with industry to increase national competitiveness, and build upon existing efforts to improve education, programs and teachers in science, technology, engineering, and mathematics fields. CHI has engaged members of the committee to discuss the life sciences and the interdisciplinary nature of biomedical research. CHI submitted language that recommended allocating resources for projects that cut across traditional lines, which was included in the bill. The Senate Science Committee held its first hearing on U.S. competitiveness on Thursday, April 19, and CHI will support efforts to include similar language in Senate legislation.
Senate Passes Legislation to Loosen Restrictions on Stem Cell Research
The Senate approved legislation on Wednesday, April 11, that would ease limits on federally funded embryonic stem cell research. S. 5, the “Stem Cell Research Enhancement Act,” passed by a vote of 63-34 (supported by Senators Boxer and Feinstein), though falling short of the two-thirds majority needed to override a promised presidential veto. The measure will now move to the House, which in January passed similar legislation. Unlike the Senate bill, the House legislation did not include language that would promote alternative forms of stem cell research. CHI continues to advocate a more expansive federal policy promoting ethical research on embryonic stem cells.
Upcoming Hearings and Events:
April 30 – 4:15 pm (EST)
Senate Floor
Consideration of S.1082, the FDA Authorization bill
Link
May 1
House Floor
Consideration of H.R.1867, the "National Science Foundation Authorization Act of 2007"
Link
May 1 – 1:00 pm (EST)
House Oversight and Government Reform Committee
Full committee hearing on "FDA's (Food and Drug Administration) Critical Mission and Challenge for the Future."
2154 Rayburn House Office Building
Link
May 1 – 2:30 pm (EST)
Senate Judiciary Committee
Full committee hearing on "Process Patents."
226 Dirksen Senate Office Building
Link
May 2 – 10:00 am (EST)
House Finance Committee
Full committee hearing on "The Medicare Prescription Drug Benefit: Monitoring Early Experiences."
215 Dirksen Senate Office Building
Link
May 2 – 10:00 am (EST)
House Energy and Commerce Committee
Health Subcommittee hearing on "Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States."
2123 Rayburn House Office Building
Link