APRIL  2007

FY 2008 UPDATES

FY 2008 Budget and Appropriations Move Forward in House and Senate

During March, the House and Senate each completed work on their respective fiscal year (FY) 2008 Budget Resolutions.  The FY 2008 appropriations process for the Department of Health and Human Services (HHS) also began in earnest with hearings on National Institutes of Health (NIH) and Food and Drug Administration (FDA) appropriations.  When Congress returns from its April recess, conferees will begin work to reconcile the House and Senate budget proposals into one Congressional Budget Resolution.  The FY 2008 appropriations process will also continue with several efforts to increase funding for NIH already underway.    

House and Senate Budget Resolutions

On March 23, the Senate approved its FY 2008 budget proposal by a vote of 52 to 47.  The House approved its plan on March 29, by a vote of 216 to 210.  While the House and Senate Budget Resolutions do not set spending for specific programs, they do provide the broad parameters under which the Appropriations Committees will work.

The House Budget Resolution includes $19 billion more in non-defense discretionary spending than requested in the Bush Administration’s Budget proposal.  In the Senate, two interesting amendments were approved as part of its FY 2008 Budget Resolution.  Labor, Health and Human Services, and Education Appropriations Subcommittee Chair Tom Harkin (D-IA) and Ranking Member Arlen Specter’s (R-PA) amendment increased the funding provided for Function 550 discretionary health programs by $2.2 billion. The amendment specifies restoring NIH funds to the FY 2005 inflation-adjusted level, an increase of $3.5 billion, along with several other provisions.  In addition, Health, Education, Labor, and Pensions Committee Chair Ted Kennedy’s (D-MA) amendment included $40 million for drug safety oversight at FDA in FY 2008.   

FY 2008 NIH and FDA Appropriations

NIH Director Elias Zerhouni, MD, testified before the House Labor, Health and Human Services, and Education Appropriations Subcommittee on March 6 and this Subcommittee’s Senate counterpart on March 19.  His testimony emphasized that the nation is at a critical point in biomedical research and must maintain the momentum we have built up over the past number of years to reach our vision.  He also discussed how the 21st century will be for the life sciences what the 20th century was for the physical sciences and how NIH-supported research of the past several decades has contributed to dramatically improved health outcomes across many diseases and conditions. Dr. Zerhouni also highlighted that his strategic vision for the future is to move medicine from curative to preemptive.  Dr. Zerhouni’s testimony is available online.  

Also of interest, Dr. Zerhouni discussed the Bush Administration’s embryonic stem cell research policy while before the Senate Appropriations Subcommittee on March 19.  In response to a question from Chairman Harkin about how limiting the Administration’s current policy is, Dr. Zerhouni responded, “it is clear today that American science would be better served and the nation would be better served if we let our scientists have access to more [human embryonic stem] cell lines.”   

To support NIH in the FY 2008 appropriations process, several Representatives are preparing to send a letter to House Appropriations Committee Chair David Obey (D-WI) and Ranking Member Jerry Lewis (R-CA) requesting a 6.7 percent increase for NIH over the next three years.  Led by Representatives Ed Markey (D-MA) and Dave Reichert (R-WA), the effort cites the fact that since the end of the doubling in 2003, NIH funding has failed to keep pace with biomedical inflation and the agency has lost 13 percent of its purchasing power as a result.  Although they would like to see NIH funded to its full authorized level in FY 2008, the 6.7 percent increase would at least restore the funding lost to the agency since 2003 and preserve our nation’s investment in biomedical research.  As of March 29, the letter had 131 Representatives signed on; they are seeking more signatures and plan to send it to Chairman Obey and Ranking Member Lewis on April 23.   

In late February, FDA Commissioner Andrew C. von Eschenbach, MD, testified before the Senate Agriculture, Rural Development, and Related Agencies Appropriations Subcommittee.  He emphasized that his goals for FY 2008 were strengthening food safety and ensuring access to safe and effective medical products.  He discussed how FDA’s proposed budget allows the agency to strengthen the tools we use to ensure the safety of foods, evaluate new products, and better predict – earlier and more accurately – the safety and efficacy of drugs, biologics and medical devices.  His testimony is available online. 

If you have questions, or need more information, please contact FOCR Director of Government Affairs Jeff Coughlin at (703) 302-1543 or jcoughlin@focr.org. 
 

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"Drug Safety and Drug Efficacy: Two Sides of the Same Coin"

White Paper Released, Over 24 Organizations Sign-on With Support

With Congress considering a number of measures to enhance drug safety, an independent committee of leading medical experts and patient advocates convened by Friends of Cancer Research released a report on drug safety this past month to ensure the voices of scientists, physicians, and patients are heard in this important debate.  The report, titled “Drug Safety and Drug Efficacy: Two Sides of the Same Coin,” is available online at www.focr.org/drugsafetyreport.htm and emphasizes the importance of a systemic approach to simultaneously evaluating drug safety and efficacy that supports science and innovation. 

Chair of the Committee and President of the Fox Chase Cancer Center, Dr. Robert Young, explained, “We need a system which improves drug safety monitoring and post-marketing surveillance, but does not increase the drug approval complexity, result in delays, or inhibit future innovation.”

The report has already received endorsement from over 20 leading groups in the cancer community and beyond including American Cancer Society, Lance Armstrong Foundation, Alliance for Aging Research, Men's Health Network,  and the National Alliance on Mental Illness (NAMI).  For a full listing of authors and supporting organizations, please visit: www.focr.org/drugsafetyreport/signons.htm.

The report outlines four major recommendations that would enhance drug safety and strengthen the FDA:

• Continually and simultaneously evaluate safety and efficacy when determining public access to, and marketing of, new products.
• A systematic approach to safety surveillance should be established to allow the use of a variety of existing healthcare databases in order to identify and describe post-market safety and efficacy signals associated with new drugs.
• IT advancements and increased personnel and training are needed within the FDA to enhance post-market safety surveillance and product review.
• Advance current scientific opportunities to create a stronger, safer, science-based FDA.

 For more information, please contact Jeff Allen at jallen@focr.org

 

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Friends hosts briefing “Drug Safety: Defining Safe” March 21

Representative Diana DeGette Delivers Opening Remarks, Expert Panel includes Dr. Mark McClellan

Above from left to right: Dan Perry, Executive Director, Alliance for Aging Research, Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer, FDA; Dr. Mark McClellan, former CMS Administrator and former FDA Commissioner;  and Dr. Robert Young, President, Fox Chase Cancer Center; moderator Susan Dentzer of the NewsHour with Jim Lehrer on PBS.

Friends presented an educational briefing “Drug Safety: Defining Safe” on Capitol Hill on March 21 to over fifty congressional staffers and patient group advocates.  The panel discussion provided various expert perspectives on drug safety. Panelists included Dr. Robert Young, President, Fox Chase Cancer Center; Dr. Mark McClellan, former CMS Administrator and former FDA Commissioner; Dr. Janet Woodcock, Deputy Commissioner and Chief Medical Officer, FDA; and Dan Perry, Executive Director, Alliance for Aging Research.  The panel discussion was moderated by Susan Dentzer, health correspondent for The NewsHour with Jim Lehrer. (Friends Chair and Founder Ellen Sigal is pictured above with Friends President Marlene Malek.)

Congresswoman Diana DeGette (D-CO) (pictured left) delivered welcoming remarks to the panel and attendees that provided a snapshot of what the Congress will be dealing with in terms of drug safety this year.  Congresswoman DeGette stated that the House Energy & Commerce committee will be working on reauthorizing the Prescription Drug User Fee Act (PDUFA) and a pressing issue surrounding the legislation will be drug safety.  She felt that a “thoughtful policy discussion on safety and efficacy” is needed to ensure that effective drugs are brought to the market quickly while simultaneously maintaining safety.

Ms. Dentzer began the panel discussion by directing a question to Dr. Young (pictured below) regarding the recently released white paper “Drug Safety & Drug Efficacy: Two Sides of the Same Coin.”  Dr. Young served as chair to the working group of authors who drafted the paper.  Dr. Young stated that the report discusses recommendations about enhancing FDA by encouraging more resources for training, personnel and recommendations for improving a post-market surveillance system to monitor drug safety.  Dr. Young also clarified that there “is no such thing as a completely safe drug.”  There are balances to each particular disease and the severity of each patient’s condition.

Mr. Perry (pictured left), speaking from the patients’ perspective, reiterated that point stating “People with chronic diseases have a higher tolerance for risk.”  He also stated that if we mismanage the current system for post-market surveillance and overreact then we will see a slow down in the pipeline for new drugs and patients will lose access.

Dr. McClellan (pictured below wit Dr. Woodcock) spoke about the special opportunity we have at this time to pass legislation regarding drug safety due to the reauthorization of PDUFA. A systematic approach to post-marketing surveillance is needed and FDA already has a system in place that can be utilized.  However, he also stressed that more resources need to be provided for training and personnel at FDA to be able to have the most effective systematic approach to drug safety and efficacy.

Dr. Woodcock discussed the science of drug safety, stating that there are generally not enough participants in clinical trials to assess all the risks of any particular drug, which is why we need to have a sound strategy for post-marketing surveillance.  She emphasized three points: 1) this is the first time we have the opportunity to monitor drugs through electronic health records; 2) new biomedical research will provide information to find personalized factors for reactions to certain drugs – we can get the “right drug to the right person at the right time;” and 3) we should use caution to avoid unintended consequences, i.e. a patient does not get a drug because it will only be available in a hospital setting, and not in a physician’s office.

Ms. Dentzer asked the panelists about anticipating adverse events in monitoring drug safety. Dr. Young explained that unanticipated events are the most difficult to discern because we do not know what we are looking for in this realm.  We can anticipate expected toxicities in some drugs but until the drug is taken by a larger population, we cannot anticipate all events. Dr. Woodcock stated that we need to build “safety into a systemic approach after a drug is on the market to confirm that safety happens.”

Ms. Dentzer summarized the panel discussion with a few take home points for the audience:

1) No drug is 100% safe and effective for 100% of patients;

2) Partnerships should be developed to allow for routine probes of existing healthcare databases to identify post-market safety and efficacy signals;

3) Additional resources are needed for IT  advancements, increased personnel and training at FDA; and

4) Support the current opportunities to develop new tools and scientific methods to identify signals for adverse events sooner. 

 

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FRIENDS PRESENTS AT IOM MEETING ON FUTURE OF DRUG SAFETY

On Monday March 12^th, the Institute of Medicine convened a meeting entitled “The Future of Drug Safety: Challenges for the FDA.”  The symposium included a broad panel of experts and stakeholders who examined the FDA's role in ensuring the safety and efficacy of drugs, the resource constraints that impact its capacity to do so, and the types and magnitudes of resources needed to fully achieve its mission now and in the future.  Dr. Ellen Sigal participated in the opening panel along side former Secretary of HHS Tommy Thompson, former Commissioner of FDA Jane Henney, and Director of the Center for Drug Evaluation and Research at FDA, Dr. Steve Galson.

Dr. Sigal addressed the current public perception of drug safety and the need for managed expectations because all drugs have risks associated with their use.  While highlighting the needs of patients, she discussed solutions for improving FDA surveillance of products once they have reached the market through routine data monitoring of existing electronic data sources.  To view Dr. Sigal’s full presentation please visit:

http://www.iom.edu/?id=41328

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UPCOMING FRIENDS EVENTS

Stopping Cancer Before it Starts: A Town Hall Event at University of Michigan on April 11 with Representative John Dingell

The exciting future of cancer prevention and early detection is happening right now in our nation's leading cancer centers.  However, without collaboration across disciplines - from policy to technology - the promising future cannot be fully realized.  (Click on invitation at left to enlarge/view details)

Please join Friends of Cancer Research (Friends) and the University of Michigan Comprehensive Cancer Center (UMCCC) on April 11 from 9:30-11:30am at the University of Michigan for a special town hall on the latest in prevention and early detection of cancer.  The event will also be webcasted live to www.mcancer.org/webcast

UMCCC's Director, Dr. Max Wicha, will be joined by Michigan's longest serving Member of Congress, Representative John Dingell, as well as the Director of the National Cancer Institute (NCI) Dr. John Niederhuber, the Commissioner of the Food and Drug Administration and former NCI Director Dr. Andrew von Eschenbach, and several other leading scientists and researchers in an in-depth and interactive event.  For the event flyer with more details and full listing of panel, please visit:
www.focr.org/stoppingcancernow.htm

Watch the event live online! www.mcancer.org/webcast

Beginning at 9:30AM EST

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Cancer Research Educational Day on Capitol Hill 

Next month, Friends will join the American Association for Cancer Research (AACR), the Association of American Cancer Institutes (AACI), and Friends of Cancer Research (FOCR) to host the third-annual educational hill day.  Cancer researchers, scientists, and patients will gather in Washington, D.C. to educate members of Congress and their staffs about the need to seize current scientific opportunities to maximize progress against cancer.  This year’s theme coincides with AACR’s Centennial Anniversary, celebrating 100 years of progress.  For more information, please contact Heather Chaney at hchaney@focr.org or (703) 302-1540.

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