May 2008 Advocacy Update

Senate Seeks to Provide Additional FY 2008 Funding for NIH; FY 2009 Funding Process Continues
The Senate Appropriations Committee is expected to consider legislation this week that would provide funding for the wars in Iraq and Afghanistan and include additional fiscal year (FY) 2008 funding for the National Institutes of Health (NIH). Senator Tom Harkin (D-IA), Chairman of the Labor-Health and Human Services Appropriations Subcommittee, successfully sought the inclusion of an additional $400 million in FY 2008 funding for NIH. According to Senator Harkin, this funding would allow for approximately 700 additional research grants this year. However, as with other funding bills, President Bush has indicated his intent to veto the bill if it goes above his requested funding level.

Congressional leaders have reached a tentative agreement on a final version of the FY 2009 budget resolution, which establishes a budgetary blueprint for each appropriations subcommittee to use as a guideline in drafting their respective funding bills. Meanwhile, the House and Senate Appropriations Committees are continuing to hold hearings on FY 2009 funding issues but have not yet drafted any of the major spending bills. Because of the President’s continued indication that he will veto any appropriations bill that exceeds his request for discretionary spending, congressional leaders have continued to indicate that they will likely wait to enact a final FY 2009 budget after a new president takes office in January 2009. For more information about FY 2009 NIH funding and to participate in ASH's online advocacy campaign, please visit the ASH Advocacy Center.

Genetic Information Nondiscrimination Act (GINA) Passes Congress
On May 1, 2008, GINA passed the House of Representatives overwhelmingly by a 414 to 1 vote, six days after it passed the Senate unanimously by a 95 to 0 vote. The House approved the version of the bill (H.R. 493) amended by the Senate. The bill now awaits the signature of President Bush, who has expressed support for GINA and is likely to sign the bill. ASH actively supported GINA for the last several years and ASH grassroots advocacy contributed to the bill’s passage.

Additionally, the Department of Health and Human Services (HHS) Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) recently released a final report on the "U.S. System of Oversight of Genetic Testing: A Response to the Charge of the Secretary of Health and Human Services". The report provides a comprehensive map of the U.S. oversight system for genetic testing, identifies components of the system that need to be strengthened, urges enhanced interagency coordination of activities associated with the oversight of genetic testing, and recommends steps that could be taken by the public and private sectors to help assure public health and safety.

House Stops Proposal to Increase Mandatory NIH Transfers to Small Business Programs
During consideration of a bill (H.R. 5819) to reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer Research (STTR) Acts last month, the House adopted an amendment offered by Representative Vernon Ehlers (R-MI) to prevent an increase in the required levels of setasides federal science agency budgets are required to contribute to help fund these programs. Federal agencies that fund more than $100 million in extramural research – including NIH – are currently required to devote 2.5 percent and 0.3 percent of their total extramural research funding to SBIR and STTR respectively. As originally drafted, the bill would have increased the SBIR set-aside to 3 percent and the STTR set-aside to 0.6 percent per year.

The amendment offered by Representative Ehlers (and ultimately adopted by the entire House) removed these increases and kept the current set-asides in place. House Appropriations Chair David Obey (D-WI) supported the Ehlers amendment and presented a strong statement on the House floor about the impact that increasing the SBIR/STTR set-asides would have on NIH in the current budget climate, emphasizing that increasing the set-asides would result in $187 million less being available for traditional medical research grants.

CMS Official Indicates Plans to Reopen National Coverage Decision on Clinical Trial Policy
Last week, at a meeting of the American Health Lawyers Association, Centers for Medicare and Medicaid Services (CMS) Chief Medical Officer Barry Straube, who is also director of the agency’s Office of Clinical Standards and Quality, indicated that CMS will likely once again attempt to make changes to the National Coverage Decision on Medicare’s Clinical Trial Policy. Dr. Straube did not give a timeframe for a possible reopening of the issues.

CMS attempted to make revisions to the policy on two occasions in 2007, ultimately leaving the policy largely unchanged because of concerns expressed by ASH and others about proposed new requirements for public release of research study information and self-certification requirements.

Dr. Straube also indicated that CMS and Food and Drug Administration (FDA) officials have been holding discussions on establishing "parallel review," which would allow clinical trial sponsors to receive a determination as to whether the trial meets the approval standards of each agency. These discussions have been hampered by the differing approval determinations used by each agency – FDA approvals are based on a "safe and effective" determination, while CMS approval decisions are based on a "reasonable and necessary" determination. Dr. Straube noted that the discussions with the FDA are ongoing and that CMS hopes to develop a document to provide clarifications as to what is meant by "reasonable and necessary" in the near future.

ASH is continuing to closely follow this issue and will alert members if CMS makes any formal attempt to reopen the Clinical Trial Policy.

Senate HELP Committee Has Hearing on Cancer Issues; Former ASH President Among Those Testifying
The Senate Health, Education, Labor, and Pensions (HELP) Committee held a hearing on "Cancer: Challenges and Opportunities in the 21st Century" on May 8. The hearing was convened by HELP Committee Chairman Senator Edward Kennedy (D-MA) in anticipation of comprehensive cancer legislation that he and Senator Kay Bailey Hutchison (R-TX) are drafting to address all aspects of cancer, including research, treatment, and preventions. Among the witnesses at the hearing was former ASH president Edward Benz, MD, who testified on behalf of the Dana-Farber Cancer Institute about the need for additional cancer research and the advancements that have been realized as a result of past research. Dr. Benz’s full testimony may be found on the HELP Committee Web site.

ASH is working with Senators Kennedy and Hutchison to ensure that the research and treatment needs of hematologic cancers are addressed in the legislation they are beginning to develop. The Society will continue to update members as additional hearings take place and the legislation is introduced.

House Holds Hearing on Stem Cell Research; Experts Urge Congress to Lift Ban on Research Efforts
On May 8, the House Energy and Commerce Health Subcommittee convened a hearing entitled "Stem Cell Science: The Foundation for Future Cures". Leading stem cell research experts – including NIH Director, Dr. Elias Zerhouni, and ASH member George Q. Daley, MD, PhD, from Harvard University – testified and urged Congress to ensure that all avenues of stem cell experimentation are available for researchers. A full version of Dr. Daley’s testimony can be found on the Subcommittee Web site. ASH’s policy statement on stem cell research is available on the ASH Web site.

The hearing was held in anticipation of new legislation being drafted by Representatives Diana DeGette (D-CO) and Michael Castle (R-DE) that would lift the federal ban on funding for new lines of embryonic stem cells, and create an ethical oversight mechanism for all research in the area. Both Representative DeGette and Castle have indicated that it is unlikely their new legislation will move forward in this Congress. Rather, they hope that the legislation and the hearing will serve as a "placeholder" for early 2009 and the next Congress and new administration. ASH will continue to monitor this issue and will keep members apprised of any new legislative or regulatory efforts in this area.

ASH’s 50th Anniversary Recognized in U.S. House of Representatives
Representative Michael Castle (R-DE) congratulated ASH on its 50th anniversary during a speech on the floor of the U.S. House of Representatives. Representative Castle recognized the many accomplishments of hematologists in the area of stem cell research, an area he has led efforts to expand federal funding for through his sponsorship of the Stem Cell Research Enhancement Act (H.R. 3).

National Institute on Aging (NIA) Publishes RFA for Consortium to Facilitate Clinical Trials in Anemia in the Elderly
The National Institute on Aging (NIA) published a Request for Applications (RFA) for a clinical trials consortium to facilitate clinical trials on anemia in the elderly. Letters of intent are due October 7, 2008, and applications must be completed and received by November 7, 2008, with an anticipated start date of July 2009. NIA intends to commit $800,000 in total costs (direct plus indirect) in fiscal year 2009 and $3 million per year in total costs (direct plus indirect) in fiscal years 2010 through 2014 to fund one six-year award. ASH’s many advocacy efforts, including the ASH sponsored Workshop on the Clinical Implications of Anemia in the Elderly helped lead to the development of this funding opportunity.

ASH Submits Comments in Response to National Center for Research Resources (NCRR) Draft Strategic Plan
ASH submitted comments on April 23 in response to the draft strategic plan for 2009-2013 that was released by NCRR in early April. ASH’s comments offered support for NCRR’s draft strategic plan and thanked the Center for incorporating many of the suggestions from the Society’s 2007 comments into the draft strategic plan. ASH’s comments also encouraged NCRR to continue to support the research and development of animal models, novel and high-end biomedical technologies, informatics tools, and to facilitate dissemination of these models and technologies to the broad scientific community. The Society also noted the critical need to build the research workforce and encourage training programs that support multi-disciplinary, team-based approaches.

NCRR Director Barbara Alving, MD, has indicated that NCRR will be reviewing all of the comments submitted and finalizing the strategic plan over the next several weeks.