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MARCH 2007
On
February 15, 2007, President George W. Bush signed the $463.5 billion joint
resolution into law that provides funding for the remaining nine months in
fiscal year (FY) 2007 appropriations bills that the 109th Congress postponed
final action on in December 2006. The Senate approved the bill on
Wednesday, February 14, and the House completed its work on the spending
package on Wednesday, January 31.
NCI
FDA
FY 2008 Budget Update The House and Senate are preparing their proposals and will hold a series of hearings this month. Friends of Cancer Research will continue to monitor the process. If you have questions, or need more information, please contact Friends Director of Government Affairs Jeff Coughlin at (703) 302-1543 or jcoughlin@focr.org.
A public meeting was held on Friday, February 16th to provide comments on the upcoming reauthorization of the Prescription Drug User Fee Act (PDUFA). Conducted by the Food and Drug Administration (FDA), the meeting allowed stakeholders to speak and/or submit comments to the record. Friends of Cancer Research participated in the public meeting by providing testimony. To view the full written submission please visit <link to FOCR Written Statement pdf>Several weeks ago, FDA and industry representatives presented their agreed upon recommendations for the reauthorization of PDUFA. PDUFA was first passed in 1992 to authorize the collection of “user fees” in exchange for drug application review time goals. The authorization must be renewed every five years. This act is “must-pass” legislation due to the vital funds that it supplies to the FDA for enhancement of the drug review process. The public meeting provided a detailed explanation of the PDUFA agreement by FDA officials as well as comments from the perspective of patients, consumers, health professionals, and industry. With completion of the public meeting and closing of the formal written comment period on February 23rd, the recommendations were sent to Congress for consideration and eventual vote to reauthorize the collection of user fees for the next 5-year period. It is expected that Congress will begin to consider legislation and hold further hearings throughout March. More information on the PDUFA agreement can be found at: Friends Policy Alert on PDUFA: http://www.focr.org/news/pressreleases/archive/PDUFA%202007.htm Or FDA Press Release: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01544.html For further questions about Friends’ testimony or PDUFA please contact Jeff Allen at jallen@focr.org or 703-302-1597.
On February 20-21st the American Association for Cancer Research (AACR) held the 2007 AACR-Industry Roundtable. The conference was entitled “Sustaining and Developing Partnership to Advance the Prevention and Cure of Cancer.” Friends Director of Science Policy Dr. Jeff Allen delivered a presentation at the conference. Dr. Allen’s presentation outlined the current legislative environment regarding drug safety. Recent legislative proposals could have impact on patient access to promising therapies, as well as to future development of innovate new medicine. Bringing together leaders from the world’s largest scientific organization with representatives from leading healthcare corporations, the conference recognized the need for continued partnership from all sectors through discussion of strategies for further advancement in cancer research and prevention.
On February 21, four former FDA Commissioners gathered in Washington, D.C. to discuss the status and future of the Food and Drug Administration. The panel discussion entitled, “A Conversation with FDA Commissioners: Strengthening the FDA” was sponsored by The Project on Scientific Knowledge and Public Policy at The George Washington University School of Public Health and Health Services. Former commissioners in attendance included Jane Henney, MD, David Kessler, JD, MD, and Frank Young, MD, PhD. Donald Kennedy, PhD, joined the discussion by telephone. While the former commissioners had various opinions on how to strengthen the FDA, all agreed that maintaining the integrity and credibility of the organization rests on its ability to base its decisions on scientific evidence. Integral to this endeavor is the adequate funding of the agency, including increased direct appropriations from Congress in addition to funds generated through user fees under PDUFA. Henney expressed that more resources, not more mandates, will make the FDA a stronger organization. Friends has been very active in the debate on how to strengthen the FDA, especially in the area of drug safety. Friends spearheaded the development of a scientific advisory board to make recommendations for improving drug safety while ensuring new drug access. Several views of the former commissioners coincide with those of our advisory board, including the importance of strong leadership at the FDA and the need to lengthen the appointment of each commissioner. Acting and interim leadership is not good enough, Henney said. Friends agrees that, in the future, we must ensure that leadership gaps at the FDA are minimized. Kessler expressed that, as much as possible, drugs should be tailored to the population that needs it and will benefit from it most, thereby reducing the drug’s benefit-risk ratio. We agree that no drug can be 100% effective for 100% of the population 100% of the time, and we must look at the benefit and risk in tandem for each patient’s particular situation. Some fundamental changes in FDA’s review process and the pharmaceutical industry’s focus may be needed to move from the era of blockbuster drugs to personalized medicine. Other areas that were discussed as needing strong support or improvement included: a modernized information technology system and strong database capabilities (Young and Kennedy); better trained employees with the opportunity to conduct their own research so that the organization remains on the cutting edge of science (Kessler and Young); and all former commissioners agreed FDA needs greater authority to enforce its recommendations, both in pre-market and post-market situations. Kessler stated that he believes that the Kennedy-Enzi bill, which was recently re-introduced in the 110th Congress, is a strong step in the right direction for addressing some of the needs at the FDA. The reauthorization of PDUFA will also be an important vehicle to strengthen the FDA. Friends of Cancer Research is dedicated to fostering continued discussion among the diverse stakeholders concerned with the success of the FDA as these issues move forward. If you would like to watch this event in its entirety, a webcast is posted on kaisernetwork.org’s website at http://www.kaisernetwork.org/health_cast/hcast_index.cfm?display=detail&hc=2043.
Ms. Lansing has been an active board member of Friends since its inception ten years ago, working tirelessly not only for our organization but for the entire cancer and greater medical community. One of her earliest involvements included advocating for Congress to double the NIH budget, which funds the majority of our nation's medical research. As shown through recent news like the American Cancer Society's report of cancer deaths decreasing for the second year in a row, the investment in research is paying off in lives saved. Ms. Lansing’s support of these efforts, from giving congressional testimony to recruiting top executives from all the major studios to meet with then Vice-President Al Gore, are only a few examples of her incredible commitment and passion to fighting this horrible disease. Friends would like to publicly congratulate Ms. Lansing on an extremely well-deserved award, one she has earned several times over and will no doubt continue to live up to. Additionally, Friends Chair and Founder Ellen Sigal was personally recognized by Ms. Lansing in her oscar.com "thank you cam" post-acceptance speech. After thanking friends and family, Ms. Lansing concluded by saying, "And mostly I want to thank the people who work in cancer research... Ellen and everyone who does such good work....Ellen Sigal, you are my saint!" To view the full post-acceptance "thank you cam" video, please visit http://oscar.com/video/index?channel=5173, scroll down to categories and click on the Jean Hersholt Award/Sherry Lansing (last name listed in first column on left side) For highlights of her involvement with Friends of Cancer Research, please visit our website: http://www.focr.org/news/sherrylansingoscartribute.htm
Release of Drug Safety White Paper Report
With nearly 3.2 billion prescriptions filled annually, decisions affecting drug regulation impact a majority of Americans. The 110th Congress faces a number of bills that have been introduced to enhance drug safety and strengthen FDA. The committee behind “Drug Safety and Efficacy: Two Sides of the Same Coin” created the report’s recommendations to ensure the voice of scientists, physicians, and patients concerns are heard in this important debate. The committee includes representation from many of the major cancer organizations and institutions including MD Anderson, Dana-Farber, Susan G Komen For the Cure, and American Cancer Society. Additionally, the report has already received endorsement from several other leading groups in the cancer community and beyond including Alliance for Aging Research, Men's Health Network, Lance Armstrong Foundation, and the National Alliance on Mental Illness (NAMI). For a full listing of authors and supporting organizations and the ultimate posting of the official report, please visit: www.focr.org/drugsafetyreport.htm
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.
Friends of Cancer Research Full staff directory: www.focr.org/move.html
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Last
year, Friends convened an expert working group chaired by President of Fox
Chase Cancer Dr. Robert Young to address pressing issues surrounding drug
safety. Next week, the independent working group will be releasing a
special report titled “Drug Safety and Efficacy: Two Sides of the Same
Coin.” 
On
March 21st,