September 2009 Washington Update | Friends of Cancer Research

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September 2009 Washington Update

Friends of Cancer Research Newsletter

 


Congress Returns from Recess: What's Next?

Members of both the House and Senate are  scheduled to return to Washington September 8th from the August recess. When congress adjourned August 7th they were debating healthcare reform in both chambers. There are three healthcare reform bills that will now resume debate, two in the Senate and one in the House.

 
What's Next for Healthcare Reform?

The Senate Finance Committee Bill: The Finance Committee met over the recess and will resume debate when congress reconvenes. Sen.Max Baucus (D-ND), Chairman of the Finance Committee, and Sen. Charles Grassley (R-IA), Ranking Member of the committee, have been working as part of a bipartisan group of six that includes Sen. Kent Conrad (D-ND), and Sen. Jeff Bingaman (D-NM), who rank No. 3 and 4 in seniority on the Democratic side, Sen. Olympia Snowe (R-ME), and Sen. Michael Enzi (R-WY). This bill is expected to be completed soon after recess, and be the only bipartisan proposal.

 
The House Tri-Committee Bill: Speaker Nancy Pelosi (D-CA) and Leader Steny Hoyer (D-MD) said they want to bring their bill (being referred to as the Tri-Committee Bill House because it was drafted among the three House Committees; Ways and Means, Energy and Commerce, and Education and Labor) to a vote after the recess as soon as they negotiate the amendments added by the three committees. Energy and Commerce completed their markup during the last week before the recess began.
 
The Senate Health, Education, Labor and Pensions Committee (HELP): The HELP committee approved its version of a reform bill, The Affordable Health Choices Act, on July 15th. The bill aims to make health coverage and care more affordable. It does so in a number of ways, most notably, by providing substantial subsidies for insurance premiums, as well as out-of-pocket protections. This bill will need to be negotiated, along with the final Finance Committee bill, into one.
Once each chamber has passed their version of Healthcare Reform, House and Senate Leadership will meet in conference to negotiate a compromise bill between each chambers proposed legislation. If then that compromise legislation passes both chambers, it would then be sent to the White House for the president's signature into law.

NIH/NCI Appropriations Update: FY 2010

 
President Obama Budget Request to Congress for FY10
$30.759 billion for NIH for fiscal year 2010, an increase of $443 million (1.5%) over 2009 appropriations levels. 
$5.15 billion for NCI for fiscal year 2010, an increase of $181 million (3.6%) over 2009. 

 
The U.S. House of Representatives Appropriations FY10$31.259 billion for NIH for fiscal year 2010, an increase of $942 million (3.1%) over 2009 appropriations levels. 

$5.15 billion for NCI for fiscal year 2010, an increase of $181 million (3.6%) over 2009. 

 
The U.S. Senate Appropriations FY10
$30.8 billion** for NIH for fiscal year 2010, an increase of $442 million (1.45%) over 2009 appropriations levels. 
An NCI number has not yet been set by the Senate. 

 
The Appropriations Process Next Steps:
When both chambers have passed their appropriations bills, leaders in the House and Senate will meet in conference to negotiate the differences between the bills. After both the House and Senate approve the conference report, it will be sent to President Obama for signature (Due by October 1st).
 **Note: This number has been approved by the Labor HHS Subcommittee. The full Senate Appropriations Committee is expected to vote on this number soon.  
 
For a continually updated breakdown of Appropriations please [CLICK HERE]
 

Comparative Effectiveness Research Update
 

Comparative Effectiveness Research (CER) Legislative Proposals CER continues to be an important component of the health reform debate. The House and Senate both have provisions on comparative effectiveness research that are, or likely will be, included in the health reform legislation from the House and Senate, and are designed to improve medical decision-making through expansion of the federal government programs for research comparing the effectiveness of medical options.
 
Currently language relating to CER has been included in the Senate HELP Committee Health Reform proposal, from the House Tri-Committee proposal, and it is expected that a form of the previously proposed Baucus-Conrad bill, "The Patient-Centered Outcomes Research Act of 2009" will be included in the yet-to-be-released Senate Finance Committees health reform proposal. All of the proposals create a trust fund to support such research through a combination of appropriations and a per-capita fee on Medicare and private insurers.   A major difference between the bills is their governance structure. The Baucus-Conrad CER proposal would establish an independent, multi-stakeholder Board to set research priorities and award grants. Sen. Max Baucus (D-MT), chairman of the Senate Finance Committee, said, "Doctors and patients need reliable, unbiased information about the effectiveness of treatments to determine the best care possible, but right now that data is scarce and unorganized." 
 
The House Tri-Committee version would create a center for outcomes research housed within the Agency for Health Research and Quality (AHRQ) in conjunction with a new advisory committee. The Comparative Effectiveness Research Center, included in the House bill, would coordinate information across a broad spectrum of medical research. 
 
The Senate HELP proposal would establish a Center for Health Outcomes Research and Evaluation to, according to the legislation, identify ways to most effectively prevent, diagnose, treat and clinically manage diseases, disorders and health conditions.To view the Senate HELP Committees Health Reform Bill [CLICK HERE] 
To view the House Tri-Committee Section-by-Section Analysis (CER on pg.19) [CLICK HERE]
To view The Patient-Centered Outcomes Research Act of 2009 [CLICK HERE]

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American Recovery and Reinvestment Act CER Funds and Progress 
 
On February 17, 2009, President Obama signed into law the American Recovery and Reinvestment Act (ARRA) of 2009. Among its many provisions, ARRA provided $1.1 billion for comparative effectiveness research (CER). This expansion of funding for CER, the largest ever federal investment in CER, carries significant potential opportunities for patients and doctors.
 

ARRA provides that the $1.1 billion for CER will be dispersed as follows:

  • $400 million to National Institutes of Health (NIH), which may be transferred to the Institutes and Centers of the NIH and to the Common Fund.
  • $300 million to the Agency for Healthcare Research and Quality (AHRQ).
  • $400 million to be allocated at the discretion of Secretary of Health & Human Services.

For a complete overview of the CER Provisions in ARRA [CLICK HERE]


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NIH Comparative Effectiveness Research Funds
 

NIH released an implementation plan focuses on the $400 million of funds in the Recovery Act for NIH as part of a trans-agency research effort in CER. The NIH's objective is to target dollars to support scientific research opportunities that "help support the goals of the Recovery Act." The projects will support CER that aims to enhance patient and clinician decision-making and to improve "real world" health outcomes for the nation. These projects are in addition to CER-related projects funded by the $10 billion provided to NIH through the ARRA for grants.

 
NIH has said that it will focus initially on peer reviewed projects that were approved, but not funded, in FY 2008 or approved but not likely to be funded in FY 2009 or FY 2010 within regular NIH appropriations related to CER.
 

To read more details about NIH's ARRA fund plan [CLICK HERE]
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AHRQ Comparative Effectiveness Research Grants
 

The AHRQ announced, on August 6th, their intention to support new CER projects, with the $300million appropriated from the American Recovery and Reinvestment Act (ARRA) for support of CER.

ARRA funding will focus, initially, on 14 priority conditions established by the Secretary of the Department of Health and Human Services under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003.

AHRQ is soliciting research grant applications for CER in the amount of $148 million for evidence generation. This includes $100 million for the Clinical and Health Outcomes Initiative in Comparative Effectiveness (CHOICE), a new, coordinated, national effort to establish a series of prospective pragmatic clinical comparative effectiveness studies that measure the benefits treatments produce in routine clinical practice and will include novel study designs focusing on real-world and under-represented populations, and $48 million for the establishment or enhancement of national patient registries. To read more details about AHRQ's ARRA funds [CLICK HERE]

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Federal Coordinating Council and Institute of Medicine Reports

On June 30, 2009 The Institute of Medicine (IOM) and the Federal Coordinating Council for Comparative Effectiveness Research both released reports, as mandated by the American Recovery and Reinvestment Act (ARRA).

 
To Continue Reading about the FCC and IOM Reports [CLICK HERE]

For more information on CER, recent news and updates, please visit: www.focr.org/comparative-effectiveness 

Focus On: The National Cancer Institute 

Expediting Clinical Trial Contract Negotiations May Speed Availability of New Cancer Treatments  Contract negotiations between pharmaceutical companies, biotech companies, and academic medical centers often add months to the process of starting a clinical trial, delaying the availability of new cancer drugs to patients in need. To help overcome this key barrier, representatives from the Life Sciences Consortium of the CEO Roundtable on Cancer and several NCI-designated Cancer Centers have streamlined the clinical trial contract negotiation process through the development of the "Standard Terms of Agreement for Research Trial" (START) clauses for use in clinical trial agreements.  The START clauses were developed following a confidential, third party review of approximately 50 redacted copies of final negotiated clinical trial agreements provided by 14 Cancer Centers and 11 Life Science Consortium companies.  According to the NCI, the review revealed that negotiations concerning certain key concepts reach a common endpoint at least 70% of the time.  The START clauses provide model language embodying those common endpoints for six key agreement concepts: intellectual property, study data, indemnification, subject injury, confidentiality, and publication rights. 

Use of the START clauses may simplify and reduce the length of the contract negotiation process by allowing the parties to start at the place where negotiations usually end, thereby significantly accelerating the delivery of new therapies to cancer patients. Although developed with cancer clinical trials in mind, the START clauses are applicable to all types of clinical research.

For more information about START visit NCI's website [HERE]

Upcoming Events
 

Friends and Brookings 2009 Conference on Clinical Cancer ResearchSeptember 14, 2009 8:30 a.m. - 5:00 p.m.Hyatt Regency Washington on Capital Hill400 New Jersey Ave., NW, Washington, DC
In September 2008, an initial conference was held to develop recommendations for specific barriers to clinical cancer research. This year's 2009 Conference on Clinical Cancer Research will be held Monday, September 14 from 8:30 a.m. to 5:00 p.m. EDT at the Hyatt Regency Washington on Capital Hill in Washington, DC. The event, which will provide an overview of the work done since 2008, as well as address new topics, is hosted by the Engelberg Center for Health Care Reform at Brookings, and convened in collaboration with Friends of Cancer Research.Throughout the day-long conference, panelists will facilitate dialogue among different stakeholders and produce a final report that will outline consensus-driven solutions to critical questions regarding the future of clinical cancer research. Discussions will be centered around data submission standards and evidence, evaluation of progression-free survival data, accelerating development and approval of targeted cancer therapies and the development of novel therapeutics targeting multiple pathways. Time will be allotted for audience members to ask questions following each panel discussion.Several distinguished panelists will join us at this conference, as well as keynote addresses from NCI Director Dr. John Neiderhuber and FDA Commissioner Dr. Margaret Hamburg.
 
For more information on this conference please [Click Here]
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Upcoming events from other organizations advancing research:
 
The 2009 AACI/CCAF Annual Meeting:
The Ritz-Carlton, Washington, DC, October 18-20, 2009
 

The meeting will bring leaders of AACI cancer centers-center directors and executive-level administrators-together with top personnel of national cancer research and advocacy organizations, industry, and government health agencies to share best practices and devise solutions to common challenges.
  
Information on the meeting, including the program and electronic registration is available at AACI's website [HERE]. ____________________________________________________________________________
 
FasterCures 2009 "Partnering for Cures"
Millennium Broadway Hotel, New York, NY, December 1-3, 2009

 
Partnering for Cures - convened by FasterCures, the Washington, DC-based center of the Milken Institute. The meeting will bring together three separate and distinct pieces of the cure puzzle: research organizations with innovative medical approaches, biopharmaceutical companies that develop cures, and philanthropists who fund the search. 
 
For more information on this meeting please visit the conference webste [HERE].

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ASCO 2009 Breast Cancer SymposiumSan Francisco Marriott, San Francisco, CA, October 8-10, 2009The Breast Cancer Symposium to Focus on Clinical Applications of Emerging Science- This two-and-a-half-day event is an opportunity to learn about the latest multidisciplinary research in breast cancer research and treatment. It will highlight clinically-relevant translational science with supporting educational sessions. The Symposium will foster "cross talk" among practitioners and scientists and allow participants to explore the information they need to provide high-quality care to patients with breast cancer.For more information, visit the symposium website [HERE]

 

www.focr.org