August 2008 Advocacy Update

Senate Seeks Second Increase in FY 2008 Funding for NIH
Seeking to build upon efforts earlier this year that led to an extra $150 million in fiscal year (FY) 2008 funding for the National Institutes of Health (NIH), Senator Tom Harkin (D-IA) and Senate NIH champions have added an additional $500 million in FY 2008 funding for NIH to a second "stimulus supplemental appropriations bill" the Senate is expected to consider upon returning from the annual August district work recess.

Advocacy by the research community is making a difference in securing funding for NIH, but it remains important for you to visit the ASH Advocacy Center to contact your Senators now and urge their support for this bill containing additional funding for NIH.

FDA Orders Change in ESA Labeling
The Food and Drug Administration (FDA) ordered changes in the label for erythropoietisis-stimulating agents (ESAs). These changes respond to recommendations made by the FDA's Oncologic Drugs Advisory Committee (ODAC) on March 13 of this year. For hematology, the changes will mostly affect the treatment of Hodgkin lymphoma, intermediate grade lymphoma, and mantel cell lymphoma where physicians have curative intent. The revised label does not address the use of ESAs in patients with myelodysplasia.

Additional information on the ESA label changes may be found on the ASH Web site.

ASH's 50th Anniversary Celebrated by Representative Jesse Jackson Jr. in U.S. House of Representatives
Representative Jesse Jackson Jr. (D-IL) congratulated ASH on its 50th anniversary and recognized the many accomplishments of hematologists in the area of sickle cell disease research during a speech on the floor of the U.S. House of Representatives.

FDA Announces New Policies Regarding Transparency, Public Disclosure for Advisory Committees
The FDA announced several new policies and procedures strengthening the management of its advisory committees. The new policies include stricter limits on financial conflicts of interest for committee members, changes in voting procedures, and changes to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings. To learn more about these changes and view the guidance documents, please visit the FDA Web site.

Stem Cell Research Coalition Submits Testimony to Presidential Campaigns
The Coalition for the Advancement of Medical Research (CAMR), of which ASH is a member, has asked both the Democratic and Republican parties to include a pro-stem cell position in their party platforms and to receive supporting oral testimony from CAMR on the issue. On August 1, CAMR testified at the Democratic National Committee National Platform Hearing and submitted a written statement in support of expanding federally funded embryonic stem cell research. CAMR has sought a similar opportunity to present the Coalition’s policy on embryonic stem cell research to the Republican National Committee but has not yet done so.

Despite overwhelming support in Congress and the American public, President Bush has twice vetoed the Stem Cell Research Enhancement Act, which would have expanded the current federal policy on embryonic stem cell research by allowing federal research funding on stem cell lines derived after August 9, 2001. Stem cell research supporters are looking forward to the start of a new presidential administration as an opportunity to expand federally funded stem cell research. Both Republican presidential candidate Senator John McCain (R-AZ) and Democratic presidential candidate Barack Obama (D-IL) have voted in favor of the Stem Cell Research Enhancement Act in both the 109th and 110th Congresses and have made statements during their presidential campaigns in support of expanding federally funded embryonic stem cell research.

ASH was one of the first and few physician organizations at the forefront of the debate over federal funding for embryonic stem cell research. ASH's policy in support of all avenues of stem cell research is available online.

NHLBI Issues Notice of Intent to Publish RFA on Characterizing the Blood Stem Cell Niche
The National Heart, Lung, and Blood Institute (NHLBI) has published a notice of intent to issue a Request for Applications (RFA) in the fall of 2008 in support of the blood stem cell niche, a specific area of stem cell research critical to advancing stem cell biology and its applications to cellular therapeutics including hematopoietic stem cell transplantation. NHLBI intends to fund up to eight awards in fiscal year 2009 through a focused program being initiated to foster collaborative research projects including studies that incorporate in vivo cell imaging. Though no applications are being accepted at this time, the notice encourages investigators with expertise and insights into this area of stem cell biology to begin to consider applying for this new RFA.

CMS Posts List of Research Priorities
The Centers for Medicare and Medicaid Services (CMS) has posted a list of topics that Medicare considers to be priority research areas for researchers to consider when designing studies for items or services that have a direct impact on the health of the elderly. Of particular relevance to hematology, CMS is seeking information on the "the optimal strategy of transfusion in seriously ill patients, including ESAs vs. amount to transfuse." Additional information on the Medicare Evidentiary Priorities Initiative may be found on the CMS Web site.

Senate Committee Approves Small Business Programs Reauthorization
The Senate Committee on Small Business and Entrepreneurship unanimously approved the SBIR/STTR Reauthorization Act of 2008 (S. 3362) on July 30 to reauthorize the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.

Currently, federal agencies that fund more than $100 million in extramural research – including NIH – are required to devote 2.5 percent and 0.3 percent of their total extramural research funding to SBIR and STTR respectively. The Senate bill increases the SBIR allocation from 2.5 percent of federal agencies’ extramural research budgets to 3.5 percent over the course of 10 years (0.1 percent per year) for all agencies except for the Department of Health and Human Services (HHS), home to NIH. Similarly, the Senate bill doubles the STTR allocation from 0.3 percent of STTR agencies’ extramural research and development budgets to 0.6 percent, over the course of 6 years, for all STTR agencies except HHS. In specifically exempting HHS and its various agencies and programs, including NIH, from the transfer increases, the bill includes language requiring HHS to expend "not less than 2.5 percent of the extramural budget for research or research and development of the department'' on small business concerns.

The House passed its version of the SBIR/STTR Reauthorization Act (H.R. 5819) earlier this year after removing language to increase the mandatory SBIR and STTR transfers required by all federal science agencies, including NIH. As originally drafted, the House bill would have increased the SBIR set-aside to 3 percent (up from 2.5 percent) and the STTR set-aside to 0.6 percent (up from 0.3 percent) per year. However, efforts by Representative Vernon Ehlers (R-MI) ultimately led to the increases being removed from the version of the bill that passed the House. At that time, House Appropriations Chair David Obey (D-WI), who supported Representative Ehlers’ efforts, 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.

NIH Loan Repayment Programs Available
NIH announced the continued availability of educational loan repayment under the NIH Extramural Loan Repayment Program (LRP). NIH intends to commit approximately $70 million annually to repay qualified educational loans in the five extramural LRP areas. Applications will be accepted from September 1, 2008 until December 1, 2008, via the NIH Loan Repayment Web site.

Reminder: Upcoming NIDDK Workshops to Focus on EpoR and Iron Overload
The Hematology Program of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) will be hosting two upcoming workshops that may be of interest to ASH members. A two-day Workshop on Erythropoietin (EpoR) Expression and Function in Non-Hematopoietic Tissues will be held in Bethesda, MD, at the Doubletree Bethesda Hotel Meeting Center on September 8 and 9, 2008. The second program, a two-day workshop on Iron Overload: Mechanisms, Measurement, and Management, will be held at The Historic Inns of Annapolis in Annapolis, MD, on October 27 and 28, 2008.

NIH News and Information
View the latest issues of the "NIH Public Bulletin" and the "NIH Extramural Nexus" for information on the latest news, public events, and activities at the Institutes.