Message From the Chair & President

Dear Friends,

Please join us as we take a brief look back at reaching a major milestone this past year with our tenth anniversary, and then look ahead to what we hope to accomplish in 2007, including the release of an expert white paper by our drug safety working group comprised of leaders from the cancer community and beyond.

This past year also produced the second annual "Cancer Research: Benefiting All Americans" event on Capitol Hill where Friends joined two of the cancer community’s largest and most important organizations: the American Association for Cancer Research (AACR) and the Association of American Cancer Institutes (AACI).  This event continues to be very well received by Members and their staff, as well as the cancer centers and researchers participating, as it provides a very productive outlet to articulate the importance and greater impact of cancer research across the country.

Additionally, 2006 brought an exciting opportunity for Friends to participate in the Saks Fifth Avenue “Key to the Cure” Weekend this past October.  Friends added another level to the weekend dedicated to raising awareness about women’s cancer issues by hosting an educational “Think Pink” kick-off luncheon with women’s cancer experts Dr. Jocelyn Rapelyea of George Washington University Medical Center and Dr. Anna Barker of the National Cancer Institute with Susan Dentzer of the Newshour with Jim Lehrer moderating. 

One of our most in-depth and long-term projects, that began in 2006 and will culminate early 2007, has been devoted to drug safety and efficacy.  Friends established a working group comprised of advocacy groups and members from our Scientific Advisory Board to explore scientific, medical, and policy issues relevant to assessing the benefits and risks of prescription drugs.  Chaired by Dr. Robert C. Young, President, Fox Chase Cancer Center, the working group is in the process of developing recommendations aimed to strengthen FDA by proposing changes in resources, personnel, training, enhanced product surveillance and data collection, as well as advancing the scientific foundation of the agency.  The drug safety group has formulated their recommendations into a comprehensive white paper that will be used for drug safety education and targeted Capitol Hill meetings and staff briefings.

This is only a small selection of our achievements over the last year. Our annual year in review will be mailed out by March.  Additional copies will be available at request: please email your mailing address to: agarber@focr.org

We have a full calendar planned for 2007, including another large educational event on Capitol Hill, several town halls around the country at pre-eminent cancer centers with leading members of Congress and renowned cancer experts, and the previously discussed white paper from our drug safety working group.  A full in-depth 'look ahead' of the cancer policy landscape follows.

Here is to a very special tenth anniversary coming to a close and a very exciting 2007 ahead.

Wishing you all a happy and healthy New Year,
Ellen V. Sigal, PhD, Chair and Founder
Marlene Malek, RN, President

Looking Ahead to 2007

With the Democrats assuming control of the House and Senate on January 4, 2007, the 110th Congress has declared its intent to bring several issues to the top of their agenda.  While most of the critical issues for the cancer community face competing priorities, many will be undertaken in the near-term and are outlined below.

FY 2007 Appropriations

When the 109th Congress adjourned in December, it postponed final action on the remaining fiscal year (FY) 2007 appropriations bills until next year, approving a long-term continuing resolution (CR) that funded the remaining nine annual appropriations bills through February 15, 2007.  The current CR uses the lower number of the House-passed FY 2007, Senate- passed FY 2007, or FY 2006 enacted level for its funding basis. The National Institutes of Health (NIH), National Cancer Institute (NCI), and the other agencies in the Department of Health and Human Services (HHS) are funded under this CR.

In mid-December, incoming House and Senate Appropriations Committee Chairs Senator Robert C. Byrd (D-WV), and Representative Dave Obey (D-WI) issued a joint statement outlining their plan to complete the unfinished federal funding bills for FY 2007.  They proposed to “clear the decks quickly so that we can get to work on the American people's priorities, the President's anticipated war funding request, and a new budget,” by approving a year-long continuing resolution through September 30, 3007. They held out the possibility that they would make limited adjustments for some agencies/programs to address the nation's most important policy concerns.  Chairmen Byrd and Obey also stated that there would be no earmarks in the FY 2007 CR and that a moratorium would be placed on all earmarks until a reformed process is put in place.

Efforts are underway in the health and education advocacy communities to ensure that NIH and NCI as well as other priority programs are included in the adjustments that Chairmen Byrd and Obey put forward for FY 2007 funding increases.  Nearly 250 organizations signed a letter to House and Senate Democratic Leaders that urged them to add $7 billion above President George W. Bush’s FY 2007 budget request for a broad range of programs and services administered by the Departments of Labor, HHS, and Education. 

In March 2006, a bipartisan group of 73 Senators, including every Democrat, voted for the Budget Resolution Amendment introduced by Senators Arlen Specter (R-PA) and Tom Harkin (D-IA) to provide an additional $7 billion above the President’s budget request for a broad range of labor, health, and education programs.  In addition, several Members of the House of Representatives, including the entire incoming House Democratic leadership team and the Democratic leadership of the House Appropriations Committee, have repeatedly spoken out in support of providing the additional $7 billion and against the President’s proposed budget levels for these programs. 

An FY 2007 CR approved without any adjustments to FY 2006 levels would leave labor, health, and education programs $2 billion short of the goal established by the full Senate when it adopted the Specter-Harkin Budget Amendment as well as the commitment made by the House leadership to significantly increase funding for these urgent priorities.  Moreover, failure to meet these commitments would result in total funding for these programs $2 billion below the FY 2005 level.  Most health and education advocacy organizations remain very concerned about the final FY 2007 funding levels and are actively pursuing the additional $7 billion in the Specter-Harkin amendment for labor, health, and education programs. 

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FY 2008 Appropriations

After the new Congress resolves the funding issues for the remainder of FY 2007, it has to quickly change gears and begin addressing FY 2008 discretionary funding.  The President will introduce his budget blueprint in early February and the House and Senate Budget Committees are busy formulating their budget proposals.  Controlling the federal budget deficit and funding for the wars in Iraq and Afghanistan remain top priorities for the White House and Congressional Democrats.  Most observers feel that the new Democratic leadership in the House and Senate will put forward FY 2008 Budgets that offer flat funding or only modest increases for health programs such as NIH and NCI. 

There are strong indications that the Democrats are reluctant to propose large discretionary funding increases for health programs in FY 2008 because of concerns about the rising federal budget deficit and to belie the perception that they are freewheeling spenders and not careful stewards of the public’s funds.  The medical research advocacy community expects to mount an aggressive campaign to support efforts to increase NIH and NCI funding for FY 2008. 

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Prescription Drug User Fee Act/Drug Safety

The authorization for the Prescription Drug User Fee Act (PDUFA) is set to expire on September 30, 2007.  Since PDUFA provides vital resources to off set the cost of new product review and has been a successful program from the perspective of the pharmaceutical and biotechnology industries, patient groups, the Food and Drug Administration (FDA), and members of Congress, it will be reauthorized this year.  Right now, the PDUFA debate is centered on the new level of user fees for 2007-2012 and what issues will be included in this iteration of the legislation, such as the extent of drug safety provisions, post-market surveillance, direct-to-consumer advertising, clinical trials registry/database, and generic drugs. 

For Friends of Cancer Research, drug safety is an especially important component of and a top priority to the entire PDUFA debate.  Last year, Health, Education, Labor, and Pensions (HELP) Committee Chair Michael B. Enzi (R-WY) and Ranking Democrat Edward M. Kennedy (D-MA) introduced a bill entitled “The Enhancing Drug Safety and Innovation Act of 2006.”  This legislation creates a framework for better pre-approval planning of how sponsors and FDA will identify, assess and manage risks post-approval.  Senators Kennedy and Enzi feel that the result would be both a more efficient and effective way to obtain safety information, without compromising access.  It calls for the creation of risk evaluation and mitigation strategies (REMS) for the approval of drugs and biologics, and new indications for these products.  REMS are designed to be integrated, flexible mechanisms to acquire and adapt to new safety information about a drug.    

The legislation also calls for the creation of a public-private partnership—the Reagan-Udall Institute for Applied Biomedical Research.  This institute would spur innovation, advance the Critical Path Initiative, and improve the sciences of developing, manufacturing, and evaluating the safety and effectiveness of drugs, devices, biologics and diagnostics. 

Moreover, the bill would establish a publicly-available database at the National Institutes of Health to enhance patient enrollment in clinical trials of drugs for any disease or condition and provide a mechanism to track subsequent progress of trials.  This clinical trials database would build on clinicaltrials.gov, but be augmented by an additional component that would include the results of all clinical trials, so that patients and providers have the most up-to-date information.  The bill would also make improvements to FDA’s process for screening advisory committee members for financial conflicts of interest, with new guidance on how FDA should evaluate advisory board candidates, disclose potential conflicts, and review past panel members. 

Friends has been very active in the entire drug safety debate; our organization spearheaded the development of a scientific advisory board to make recommendations for improving drug safety, ensuring new drug access, and strengthening FDA.  The committee Friends formed includes academic scientists and clinicians, research advocates, and representatives of the patient community, and is completing work on a white paper that includes the recommendations on how product evaluation should be strengthened. 

At this point, new HELP Committee Chair Kennedy and ranking Republican Enzi are planning to re-introduce “The Enhancing Drug Safety and Innovation Act of 2006” in January.  Whether that bill will be exactly the same as the 2006 version is unclear, but it appears that the general ideas and framework will be unchanged.  Sources indicate that FDA will publish its proposal for a new PDUFA agreement in mid-January and that will provide Congress and the patient and professional community with the opportunity to comment on the agreement that the agency reached with the pharmaceutical and biotechnology industries.  More than likely, debate on the Kennedy-Enzi Drug Safety bill will be rolled into the larger PDUFA deliberations with several public meetings and Congressional hearings planned for late February, March, and April.  Right now it appears that the Senate HELP Committee plans to move at least five FDA-related pieces of legislation together as one package: PDUFA, Kennedy-Enzi Drug Safety bill, Best Pharmaceutical for Children Act, Pediatric Research Equity Act, and Medical Device User Fee Act. 

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Federal Funding of Embryonic Stem Cell Research

A prominent item on the agenda of the new Democratic-led Congress is approval of the “The Stem Cell Research Enhancement Act.”  This legislation is expected to be brought to the House floor as part of the Democrats “100 hours” plan on January 11 and will come before the Senate for a vote in the near-term.  It appears that the House and Senate have enough votes to pass the bill this year, however, it is unclear whether Congress has the 2/3 majorities in the House and Senate to override a Presidential veto. 

During the 109th Congress, the House approved this legislation by a 238 to 194 vote on May 24, 2005.  The Senate passed the bill on July 18, 2006, by a 63 to 37 vote.  On July 19, President Bush followed through with his pledge to veto the bill. 

“The Stem Cell Research Enhancement Act” provides for federal funding of embryonic stem cell research on lines derived after August 9, 2001, and requires ethical guidelines on stem cell lines that are eligible for federally-funded research.  

The bill also states that no federal funds will be used to derive stem cells or destroy early-stage embryos.  In addition, it directs the Secretary of the Department of Health and Human Services to support appropriate research on stem cell lines derived from early-stage embryos that also meet the following criteria: originally created for fertility treatment purposes and are in excess of clinical need; would otherwise be discarded; and, the individuals for whom the embryos were created have provided written consent for embryo donation.

Medical research groups are mounting an aggressive advocacy campaign to ensure passage of “The Stem Cell Research Enhancement Act” in the 110th Congress.  As part of this effort, hundreds of organizations are working on a letter to the House and Senate in support of the bill.