March 2008 Advocacy Update
House and Senate Approve Budget Resolutions; Senate Includes Amendment to Increase NIH Funding
On March 14, by a vote of 51-44, the Senate approved its version of the fiscal year (FY) 2009 Budget Resolution (S.Con.Res. 70). The Senate-passed budget includes an amendment offered by Senators Arlen Specter (R-PA) and Tom Harkin (D-IA), which had been approved by a vote of 94-5, to increase FY 2009 funding for the National Institutes of Health (NIH) by $2.1 billion. The draft Budget Resolution approved by the Senate Budget Committee had included a $950 million increase for NIH; the Specter-Harkin amendment would bring the total increase for NIH to $3 billion (or approximately 10.3 percent) over President Bush's proposed funding of $29.3 billion for NIH.
The House also passed its version of the FY 2009 Budget Resolution (H.Con.Res. 312) on March 13 by a vote of 212-207. The House Budget Resolution includes funding overall discretionary funding for federal public health programs, including NIH, in the amount of $57.6 billion.
Each chamber's Budget Resolution sets forth a budgetary blueprint that each Appropriations subcommittee uses as guidelines in drafting their respective funding bills. Over the course of the next several months, the various House and Senate Appropriations Subcommittees will begin the task of determining precise spending levels for federal programs and agencies such as NIH. Congress is currently in the midst of a two-week spring recess, and the Appropriations Committees are expected to begin the process of drafting their individual spending bills.
The outlook for the entire appropriations process remains unclear. The President has said that he will veto any appropriations bill that exceeds his request for discretionary spending. Meanwhile, House Appropriations Committee Chairman David Obey (D-WI) has publicly stated that unless the President is willing to negotiate on funding levels for programs such as NIH, Congress will simply wait to enact a final FY 2009 budget after a new president takes office in January 2009, more than a quarter of the way through the fiscal year.
For more information about FY 2009 NIH funding and to participate in ASH's online advocacy campaign, please visit the ASH Advocacy Center.
ASH Government Affairs Committee Visits Congress
Coinciding with the congressional action on the FY 2009 budget was the ASH Government Affairs Committee's annual Capitol Hill Day. On March 12, ASH Committee members met with over 30 congressional offices to advocate for increasing funding for NIH and to seek support for ASH recommendations for language supporting hematology research at NIH. Committee members also shared ASH's concerns about the Medicare physician payment cut scheduled to be implemented on July 1, and urged Congress to prevent the cuts and replace the flawed Medicare formula for calculating payments.
ASH will continue its advocacy efforts on Capitol Hill during the FY 2009 budget debate and encourages all members to take action to support increased funding for NIH. Grassroots advocacy by researchers around the country will be necessary to ensure hematologic research is adequately funded at NIH.
ODAC Recommends ESAs Continue to be Indicated for Treatment of Chemotherapy-Induced Anemia but With New Restrictions
On March 13, the Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) convened to discuss the risks of erythropoeisis-stimulating agents (ESAs) when administered to patients with cancer. Dr. Samuel Silver testified on behalf of ASH regarding the safety and appropriate use of ESAs.
The advisory committee recommended continuing the ESA indication for treatment of chemotherapy-induced anemia; however, the panel also recommended several changes to the safety labels on the drugs Aranesp, Epogen, and Procrit, placing significant restrictions on their use for cancer patients.
ODAC's recommendations are non-binding and the FDA now will review ODAC's recommendations and make a decision on whether to further revise the drug labeling. ASH will continue to meet with FDA and Congress about its concerns on the impact these potential restrictions could have on patients with hematologic diseases.
For detailed information on this issue, please see the March 2008 Practice Update.
NHLBI Announces Realignment of Its Sickle Cell Disease Research Program
The National Heart, Lung, and Blood Institute (NHLBI) announced a comprehensive and innovative restructuring of its research program in sickle cell disease (SCD). ASH submitted recommendations in response NHLBI's request for public information regarding the top scientific and clinical priorities in SCD. The Society is pleased to see many of its recommendations incorporated into the realignment.
ASH will be providing additional details about the NHLBI plan in upcoming announcements.
ASH Comments on Final Draft of the NIH 2007-2008 Peer Review Self-Study
ASH submitted comments to NIH in response to the Final Draft of the NIH 2007-2008 Peer Review Self-Study. The Final Draft Report, which marked "the end of the diagnostic phase of the peer review enhancement effort," was submitted to NIH Director Zerhouni at the end of February, and the research community was given a very brief time period to submit comments to the report.
The comments submitted by ASH on March 17 reflected the Society's concerns with the "brief amount of time set aside for comments" and a number of the proposals put forth in the Final Draft Report and encouraged "the NIH director to solicit broad input from the multiple NIH stakeholders in developing the second phase (implementation) of the plan."
These comments followed comments submitted last year by the Society in response to a request for information from a Working Group of the Advisory Committee to the NIH Director seeking "comments regarding NIH's support of the biomedical and behavioral research, including peer review, with the goal of examining the current system to optimize its efficiency and effectiveness." The comments submitted by the Society at that time were fairly broad and offered the Society's support of the peer review process and support of ways to encourage senior investigators to serve on study sections and ways to make the entire process less burdensome.
Generic Biologic Bill Introduced in House
Prior to adjourning for a two-week Easter recess, Representative Anna Eshoo (D-CA) and House Energy and Commerce Committee Ranking Member Joe Barton (R-TX) introduced legislation to give the FDA the authority to approve follow-on (or generic) biologics.
In his FY 2009 budget proposal, the President indicated his support for a process that "establishes a pathway for FDA's approval of follow-on biologics" and "proposes new FDA authorities to approve follow-on protein products through a new regulatory pathway that protects patient safety, promotes innovation, and includes a financing structure to cover the costs of this activity through user fees."
The "Pathway for Biosimilars Act" (H.R. 5629) would grant brand-name biologic drugmakers 12 years of exclusivity when they are free from follow-on competition with the potential to add two and half more years. The measure also allows FDA to deem follow-on biologics interchangeable with a brand biologic drug at the pharmacy counter if the agency has developed guidance, typically a long process, on what is required to prove interchangeability for a product class. The Senate Health, Education, Labor, and Pensions Committee passed a bipartisan follow-on biologics bill in the summer that has 12 years of exclusivity for brand biologic companies.
In his FY 2009 budget proposal, the President indicated his support for a process that "establishes a pathway for FDA's approval of follow-on biologics" and "proposes new FDA authorities to approve follow-on protein products through a new regulatory pathway that protects patient safety, promotes innovation, and includes a financing structure to cover the costs of this activity through user fees."
The legislation introduced by Representatives Eshoo and Barton is similar to legislation passed last year by the Senate. Several other bills dealing with follow-on biologics have also been introduced in the House over the past year and a half. It is unclear if and when the House will move to consider any of these bills.
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