Advocacy Groups Rally Against Potential Cuts in NIH Funding

Congress is trying to wrap up its work on the 2006 budget and a Labor-HHS Conference Report that will set the level of NIH funding for next year.   On November 17th, the House narrowly voted against a Labor-HHS spending bill reported out of conference committee that called for less than a 1% percent increase for NIH, which falls below the medical inflation index and would have marked the lowest increase to the NIH in 36 years.   The vote was 209-222. (Click here to see the breakdown of that vote by member).

The Senate did not take up the measure, opting instead to send it back to the Labor-HHS Conference Committee. The Senate also passed a motion introduced by Senator Durbin (D-IL) (pictured at left, from pbs.org) that instructed conferees to restore the Senate’s original increase for the NIH of around $1 billion or 3.7% (click here to see a breakdown of that vote by member).  The leadership in the House recently agreed to return to conference on the Labor-HHS spending bill (HR 3010).  Negotiations are expected immediately. 

According to a Dec. 7^th CQ Today article by Bill Swindell,  “Appropriators said Wednesday that they think a few tweaks to the conference report for the fiscal 2006 spending bill for the departments of Labor, Health and Human Services, and the Education will win enough votes to assure its adoption by the House.”  The same article reports that appropriators believe such tweaks “could allow the Labor-HHS bill to be passed on its own rather than attached to the must-pass fiscal 2006 Defense appropriations bill (HR 2863), which could be the final spending measure to move this year.”

Numerous advocacy groups have been rallying over the past few days to urge members of Congress to push for a bill that incorporates the Senate’s provision for a 3.7% increase in NIH appropriations. Click here to read FOCR’s policy alert on this issue.

If the Congress fails to pass a new Labor-HHS spending bill, then the funding to keep those agencies operating would have to be provided through a Continuing Resolution (CR).  The CR approach being considered raises serious concerns for cancer advocates, because NIH funding would be set at whatever the lowest level was over the past two years.   

Another possible scenario which is of great concern to the cancer advocacy community is an across-the-board-cut of 1 to 2 percent in all discretionary spending.  Rumors abound that such cuts will be proposed in the near future.   Thus, stakeholders are being encouraged to urge members of Congress to oppose any measures that might result in budget cuts to the NIH.  Such cuts would severally damage important programs for cancer researchers and patients.  Please read the Op-ed from the Chicago Sun Times below for more information. 

Friends Activities

Chicago Sun-Times Publishes Op-Ed by FOCR Chair and President

Numerous health-related advocacy groups from across the country are rallying support for federal spending on biomedical research as the Congress continues to wrestle with various appropriations and budget issues that are likely to reduce funding levels at the National Institutes of Health.  FOCR Executive Committee Members Sherry Lansing, Ellen Sigal, and Marlene Malek recently sent out a policy alert to thousands of people electronically.  In addition, FOCR Chair, Ellen Sigal, and President, Marlene Malek, recently submitted the following Op-ed addressing the potential impact of cuts in NIH funding.  The op-ed was published on December 3rd, 2005 in the Chicago Sun-Times. 

"This year, America witnessed the passing of countless heroes, celebrities, mothers, fathers, brothers, sisters and friends because of deaths related to cancer. Millions of Americans mourned the passing of news icon Peter Jennings, as they coped with the realities of members of their own families dealing with and dying from this disease. Today, the National Institutes of Health -- and more specifically the National Cancer Institute -- is struggling to fund research that could change the outcome for individuals stricken with lethal forms of cancer -- and to improve the quality of life they have while fighting the disease. 

Ironically, just at the time when the NIH is poised to make major contributions in the fight to eradicate disease, Congress is contemplating across-the-board budget cuts that would significantly hobble research efforts... " read the rest online at the Chicago Sun-Times website: http://www.suntimes.com/output/otherviews/cst-edt-refb03.html

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FOCR Participates in Public Meeting on PDUFA

On November 14th, Friends’ Chair Dr. Ellen Sigal provided an advocacy perspective on the Prescription Drug User Fee Act (PDUFA) at a public meeting held at the National Institutes of Health.  This legislation is set to expire in September of 2007, and a concerted reauthorization effort is expected. 

According to the FDA, this event marked the launch of the their “public process toward reauthorization of PDUFA, the law that allows the agency to help fund programs that have helped product developers get early and frequent advice about how to develop some of the last decades' most innovative and important medicines.”  The meeting included a series of panels representing different stakeholder interest groups, such as patient advocates, consumer organizations, industry, health professionals and academic researchers. [Click here for more]

Dr. Pazdur, Dr. Staube Speak at GW/FOCR Distinguished Lecture Series

This past month, the GW Cancer Institute and Friends of Cancer Research, in conjunction with the GW Department of Medicine and Medical Grand Rounds hosted the final lectures of the Distinguished Lecture Series entitled “Cancer Health Policy, Delivery Systems and Regulatory Affairs.” The keynote speaker for the third lecture was Dr. Barry Staube of CMS and the fourth and final lecture was given by Dr. Richard Pazdur of the FDA. 

Dr. Barry Straube, Acting Chief Medical Officer and Director, Office of Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (CMS), discussed CMS’s goal of promoting high quality healthcare in the U.S.  CMS currently provides health benefits to 80 million Americans.  Straube believes that CMS is in a unique position, due to the large number of people it serves and its large budget, to act as an influential public health agency that educates its beneficiaries not only about the health services it provides, but teaches people how to prevent illness and maintain their health.  CMS is looking for new ways to pay for healthcare, including pay for performance (P4P) which aims to reward quality care versus encouraging more care.

The final installment of this series featured Dr. Richard Pazdur, Director of the FDA’s Office of Oncology Drug Products.  Dr. Pazdur addressed some of the unique aspects of the cancer drug approval process, stressing the “risk-benefit” ratio as he discussed issues of safety and efficacy.  Pazdur highlighted additional issues that are treated differently in oncology drug approval including toxicity, surrogate endpoints, and response rate. While leading the audience through challenges the FDA encounters in the oncology drug approval process, Dr. Pazdur took the opportunity to discuss international efforts and how they could be useful to overcoming some barriers at FDA.  Given the increasing number of oncologists coming from countries outside the international scope of most drug companies’ operations, Dr. Pazdur said a more collaborative international effort will be fruitful in the years to come – from producing better understanding of basic science to collecting more comprehensive data in clinical trails. Pictured above: Dr. Alan Wasserman, Chairman of Department of Medicine at GWU, Dr. Ellen Sigal of FOCR, Dr. Richard Pazdur of the FDA, Dr. Stephen Patierno of the GW Cancer Institute.

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FOCR Presentations

FOCR Presents at DIA Meeting

On November 29, FOCR Chair, Dr. Ellen Sigal, presented at a Drug Information Association (DIA) meeting entitled, “Clinical Drug Development from Strategy to Implementation.”  Dr. Sigal spoke at a breakout panel session that addressed “Challenges in the Development of a Cancer Therapeutic.”  This session reviewed the unmet medical need for cancer treatments and pathways for accelerated drug development and approval.  The discussion explored the topic from multiple perspectives including patients, investigators, industry, and regulators.  Joining Dr. Sigal on the panel were Dr. Richard Pazdur (Director, Division of Oncology Drug Products, FDA), Dr. Susan Weiner (Founder, Children’s Cause for Cancer Advocacy), Dr. Michael Gordon (Associate Dean for Research, University of Arizone-Phoenix Programs), and Dr. David Schenkein (Sr. VP Clinical Research, Millennium Pharmaceuticals).

FOCR Participates on panel at Oncology World Congress

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