March 2007 Advocacy Update

Focus on NIH Appropriations
The Senate has approved its FY 2008 Budget Resolution. While the original draft of Senate Budget Resolution contained an additional $1.6 billion over the president's FY 2008 budget request for Function 550 health-related programs, an effort on the Senate floor by Senators Tom Harkin (D-IA) and Arlen Specter (R-PA) during consideration of the resolution added an addition $2.2 billion for these public health programs, which include the National Institutes of Health (NIH). The House is expected to consider its similar Budget Resolution this week.

Each chamber's Budget Resolution sets forth a budgetary blueprint, that each Appropriations subcommittee uses as guidelines in drafting their respective funding bills. House and Senate Appropriations Committee leaders have stated their desire to have initial drafts of all the FY 2008 spending bills completed by later this spring. The Senate hopes to pass its FY 2008 Labor, Health, and Human Services spending bill by May, though as in past years that deadline is likely to shift.

Although President Bush's proposed budget for FY 2008 includes proposed cuts totaling $310 million for NIH, ASH and the biomedical research community are advocating an increase of 6.7 percent for FY 2008 over the final FY 2007 levels. This requested level represents the expected 3.7 percent rate of biomedical inflation for 2008 plus a 3 percent "catch-up" for lost purchasing power because of budgetary shortfalls since the completion of the doubling of the NIH budget in 2003.

Grassroots advocacy by researchers around the country will be necessary to ensure hematologic research is adequately funded at NIH. For more information about FY 2008 NIH funding and to participate in ASH's most recent online advocacy campaign, please visit the ASH Advocacy Center.

Update on Stem Cell Debate; NIH Director Testifies
Though many had expected the Senate to act on legislation to expand the current federal policy on embryonic stem cell research in February or March, Senate leaders now expect to consider the legislation in April following a week-long Easter break.

The Senate version of the Stem Cell Research Enhancement Act (S. 5) is identical to embryonic stem cell legislation passed by the House in January. The bill would allow federal funding on stem cell lines derived after August 9, 2001, and would establish strict ethical guidelines for this field of research by requiring that federal funds not be used to derive stem cells or destroy embryos.

Although President Bush has reiterated his intention to veto this legislation, congressional supporters of the bill remain hopeful that a compromise can be reached with the White House. Additionally, in response to a question posed by Senator Tom Harkin (D-IA) during a hearing before the Senator Labor-HHS Appropriations Subcommittee concerning the FY 2008 NIH budget, NIH Director Elias Zerhouni backed away from the Bush Administration's current policy on embryonic stem cell research by stating that "From my standpoint, it is clear today that American science would be better served and the nation would be better served if we let our scientists have access to more cell lines." Zerhouni's statement generated a lot of attention in the media and marked his first significant public comments in support of the expansion of embryonic stem cell research.

ASH's embryonic stem cell research advocacy campaign generated numerous e-mails from across the country during House consideration of H.R. 3 in January. The Society is continuing to work with Senators Harkin and Arlen Specter (R-PA), the primary Senate sponsors of the Stem Cell Research Enhancement Act, to ensure approval of this legislation in the Senate.

Please visit the ASH Advocacy Center to contact your Senators to urge their support of this important legislation.

Genetic Information Nondisclosure Act Moves Forward Slowly
Both the House and Senate are moving forward in their efforts to pass legislation to protect individuals from discrimination in health insurance policies and employment on the basis of their genetic information. The legislation seeks to encourage individuals to take advantage of genetic testing and participate in genetic research without fear of the potential for discrimination in hiring and in availability and costs of health insurance.

Thus far, all three House committees with jurisdiction over H.R. 493 have approved the bill. This paves the way for consideration of the measure by the full House as early as this week. The Senate Health, Education, Labor, and Pensions (HELP) Committee approved the Senate version of the legislation (S. 358) in January. Though the full Senate has not yet acted on the measure, identical legislation easily passed the Senate in the last several Congresses.

Both bills currently enjoy widespread bipartisan support in both the House and Senate and President Bush has indicated his support for legislation to protect genetic information privacy.

Please visit the ASH Advocacy Center to contact your Member of Congress and Senators to urge their support of this important legislation. View ASH's policy statement in support of genetic information non discrimination for more information.

Congress Begins Review of Prescription Drug Safety Legislation
House and Senate Committees have begun holding hearings on prescription drug safety and the reauthorization of the Prescription Drug User Fee Act (PDUFA). The Senate Health, Education, Labor, and Pensions (HELP) Committee spent much of the month of March focusing on issues related to the Food and Drug Administration (FDA) and the House Energy and Commerce Committee has also held initial hearing into drug safety and PDUFA reauthorization issues.

It is widely believed that any FDA reform or drug safety legislation will be combined with PDUFA reauthorization legislation. PDUFA is the law that was enacted in 1992 to provide resources for the Food and Drug Administration (FDA) to improve drug review; PDUFA's current authorization is set to expire on September 30, 2007. Although Senate HELP Committee Chairman Edward Kennedy has tentatively planned to markup PDUFA reauthorization legislation at a March 28 Committee meeting, the markup has been postponed until after the Senate spring recess period during the first week in April.

FDA Proposes Rules to Prevent Conflicts of Interest Among Agency Advisory Committee Members The Food and Drug Administration (FDA) has announced proposed rules under which medical experts with more than $50,000 financial interest in pharmaceutical companies could not serve on agency advisory committees that review their products or the products of their competitors. Under the current rules, medical experts with more than $100,000 or 15 percent or more of their net worth invested in pharmaceutical companies cannot serve on advisory committees. Initial congressional reaction has been favorable with several Members of Congress indicating that the proposed guidelines implicitly acknowledge critics' claims of an industry bias at the Agency. More details are available on the ASH Web site.

Medicare Announces Review of Coverage Policy for Erythropoietin-Stimulating Agents
The Centers for Medicare and Medicaid Services (CMS) has announced plans to review the Medicare coverage policy for darbepoetin alfa and epoetin alfa after recent studies have linked the treatments with increased risk for serious side effects. The review follows a March 9 announcement by the Food and Drug Administration (FDA) that manufacturers of the medications must include black box warnings on the labels to physicians and patients about the increased risk for serious side effects linked with the treatments. In addition, FDA advised physicians that they should use only the lowest dose of the medications necessary to avoid the need for blood transfusions caused by anemia.

Based on the FDA safety alert, CMS issued instructions to local Medicare Carriers to prohibit Medicare coverage of erythropoietin-stimulating agents (ESAs) – Aranesp, Epogen, Procrit – when used for the treatment of the anemia of cancer (ICD-9 code 285.22). ESAs used for treatment of anemia due to chemotherapy would not be affected by this change in policy. Some Medicare Part B Carriers have begun to announce new local carrier decisions that will require that ESAs should be used only in accordance with its approved product labeling.

ASH is currently reviewing the latest studies concerning patient safety and will be working with clinical and scientific experts to comment on the CMS policy as well as local carrier decisions. Of particular concern will be changes in the use of ESAs for treatment of anemia associated with myelodysplastic syndromes. ASH also is in the process of updating its guideline "Use of Epoetin in Patients with Cancer" jointly published by ASH and ASCO. For more details, please see the ASH Web site.

For more information on any of these issues, please contact Tracy Becker, ASH Research Advocacy Manager, at 202-776-0544 or tbecker@hematology.org.