April 2008 Advocacy Update
Senate Seeking Agreement to Consider Genetic Information Nondiscrimination Legislation; Take Action to Support Passage
After many months of delay, the Senate is expected to consider the Genetic Information Nondiscrimination Act (GINA) (S. 358) within the next several weeks.
GINA would prohibit health insurers from using individuals' genetic information to deny coverage or determine rates or premiums. In addition, the bill would bar employers from using individuals' genetic information when making hiring, firing, job placement, or promotion decisions.
Though exact timing for consideration of the bill has not yet been announced, Senate leaders are working with Senator Tom Coburn (R-OK) to overcome the objections he has to the bill and reach an agreement to bring to the Senate floor for consideration.
The House easily passed its version of the bill (H.R. 493) in May 2007, and similar legislation has passed the Senate in the last several Congresses. With President Bush's indication of support for legislation to protect genetic information privacy, there is still a real opportunity to enact legislation this year.
Please join ASH's advocacy efforts by contacting your Senators in support of GINA.
Congressional Efforts Underway to Create Blood Cancer Research Program Within the Department of Defense
Efforts are underway in Congress to create a new Blood Cancer Research Program within the Department of Defense (DoD). In the Senate, Senator Jack Reed (D-RI) has led an effort asking his colleagues in the Senate to sign-on to a letter to the Senate Appropriations Committee in support of establishing a blood cancer research program at DoD. Representative Lois Capps (D-CA) and Mike Ferguson (R-NJ) led a similar effort in the House earlier this year.
The DoD cancer research program funded a leukemia project from 2001 to 2006, but the program was eliminated in 2007. The DoD research programs have been praised by researchers, advocates, and Congress for the outstanding research they have supported and their contribution to a stronger understanding of, and improved treatment for, a wide range of cancers, including blood cancers. The current effort in Congress seeks to establish a $10 million peer reviewed research program within DoD for all forms of blood cancers.
Several blood cancers, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, Hodgkin lymphoma, and multiple myeloma, have been determined by the Institute of Medicine (IOM) to be associated with exposure to chemical and biological agents from the Vietnam and two Gulf Wars. The IOM conclusion underscores the need to begin a special research program that is responsive to the health care needs of the military personnel and veterans.
The Society thanks all those who participated in ASH’s recent advocacy campaign and contacted their senators in support of establishing a program and funding for blood cancer research at DoD. ASH Grassroots Network members assisted in gaining the support of several senators on the letter to the Senate Defense Appropriations Subcommittee that contained the signatures of 22 members of the Senate.
FY 2009 NIH Funding Update; Continued Grassroots Advocacy Needed
The House and Senate Appropriations Subcommittees are continuing the process of drafting the bills that will fund federal departments, agencies, and programs for fiscal year (FY) 2009. The House and Senate Labor, Health, and Human Services Appropriations Subcommittees have held a series of hearings examining funding for various federal agencies, including the National Institutes of Health (NIH), though neither of the subcommittees has yet begun the formal process of drafting the FY 2009 funding bills.
ASH continues to advocate for an increase of 6.6 percent for FY 2009 over the final FY 2008 levels, despite a proposed budget form the White House for FY 2009 that includes no increase in funding for NIH.
The outlook for the appropriations process continues to remain unclear. The President continues to indicate that he will veto any appropriations bill that exceeds his request for discretionary spending and congressional leaders have indicated 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. An additional complication is that Senator Arlen Specter (R-PA), Ranking Member of the Senate Labor-HHS Appropriations Subcommittee and one of the chief proponents of increasing funding for NIH, has been diagnosed with a recurrence of Hodgkin lymphoma and will be receiving chemotherapy over the next three months.
For more information about FY 2009 NIH funding and to participate in ASH's online advocacy campaign, please visit the ASH Advocacy Center.
National Center for Research Resources (NCRR) Releases Draft Strategic Plan
NCRR released its draft Strategic Plan for 2009-2013 on April 8. NCRR Director Barbara Alving, MD, indicated that “based on recommendations emerging from our Strategic Planning Forum and comments we received through our Web site, the draft provides strategies and action items to guide NCRR in transforming clinical and translational research across the country.” ASH submitted comments to NCRR last year during the initial phase of the Center’s strategic planning process.
NCRR has invited public comments on the draft Strategic Plan through April 23. ASH will be submitting comments in support of NCRR’s draft Strategic Plan and thanking the Center for incorporating many of the Society’s suggestions into the draft Strategic Plan.
NIH Seeks Comments on Public Access Policy
On March 31, NIH released a “Request for Information” (RFI) on its Public Access Policy.
As of April 7, 2008, all final peer-reviewed manuscripts that result from research conducted with NIH funds must be submitted to PubMed Central upon acceptance for publication.
ASH’s scientific journal, Blood, already complies with this policy by submitting final NIH-funded research articles to NIH on behalf of its authors. ASH was the first nonprofit publisher to agree to the NIH policy over a year and a half ago when it was voluntary. Through this agreement, ASH removes the burden for authors to submit their manuscripts while also maintaining its publisher embargo period of up to 12 months. As a result of ASH’s participation in this agreement, all Blood authors who have NIH-funded research articles have no obligation to submit manuscripts to the NIH archive because Blood will do this on their behalf.
NIH will be accepting public comments on the RFI through May 31, 2008. NIH is seeking specific input from the public, including all stakeholders, in three main areas:
- Recommendations for alternative implementation approaches to those already reflected in the NIH Public Access Policy.
- Recommendations for monitoring and ensuring compliance with the NIH Public Access Policy now that it is mandatory.
- Whether there is a need for additional information, training, or communications related to the NIH Public Access Policy.
House Continues Efforts on Generic Biologic Bill
Several competing bills have been introduced in the House of Representatives to give the FDA the authority to approve follow-on (or generic) biologics. House leaders are continuing efforts to reach a consensus on legislation to bring to the House floor.
Several issues, including interchangeability and brand-name exclusivity remain major sticking points. Legislation (H.R. 5629) introduced in March by Representative Anna Eshoo (D-CA) and House Energy and Commerce Committee Ranking Member Joe Barton (R-TX) 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 Eshoo-Barton measure would also allow 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. Competing legislation (H.R. 1038) introduced last year by House Oversight and Government Reform Committee Chairman Henry Waxman (D-CA) would leave interchangeability decisions up to FDA on a case-by-case basis and would offer brand-name biologic drugmakers no exclusivity period.
The Senate Health, Education, Labor, and Pensions Committee passed a bipartisan follow-on biologics bill (S. 1695) in June 2007 that has 12 years of exclusivity for brand biologic companies and allows FDA to deem follow-ons interchangeable with brand biologics based on guidelines the agency must formulate. The bill, however, has not been considered by the full Senate.
It is unclear if and when the House will move to consider any of these bills and the Senate has indicated that it is waiting on the House to reach an agreement before moving forward.
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