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JUNE 2007
FY 2008 Budget and Appropriations Process Moves Forward, Increases in Funding Seen Across the Board On May 17, Congress passed the fiscal year (FY) 2008 budget resolution which contains $953.1 billion for discretionary spending, over $20 billion higher than the President’s request. The passage of the budget resolution is an important first step in the appropriations process, showing that the appropriations process is on track to be completed by the end of the fiscal year in September. Last year Congress failed to adopt a budget resolution, later resulting in the failure to pass almost all of the FY 2007 appropriations bills.
From: CQ Today, Tuesday, June 5, 2007 302(b) Allocations On June 5, the House Appropriations Committee divided its $953.1 billion spending cap among the 12 appropriations subcommittees into what are known as 302(b) allocations. The House Labor, Health and Human Services, and Education (Labor-HHS) Appropriations Subcommittee, which funds programs such as the National Institutes of Health and the National Cancer Institute, was allotted $151.1 billion, an increase of 4.6% over last year’s enacted level of funding. The Labor-HHS budget rises even higher when adding the $2 billion in advance funding allotted to that subcommittee in last year’s appropriations cycle. This is good news considering the President had proposed a 2% cut in Labor-HHS funding in his FY 2008 budget request. While Bush has threatened to veto any spending measures that exceed his budget request, the Democrat-led Congress says they are prepared to defend their funding priorities. Also of interest is the 302(b) allocation for the House Appropriations Agriculture Subcommittee which funds the Food and Drug Administration. The Agriculture Subcommittee received $18.8 billion to fund its programs in FY 2008. This figure reflects a 5.9% increase over last year’s enacted level of funding, and is $990 million higher than the President’s FY 2008 budget request. Adequate funding for FDA will be particularly important in order to fund new programs created in the Food and Drug Revitalization Act, which passed the Senate in May and will now be considered in the House. What this means to research With the extra funding allocated to the Labor-HHS Subcommittee, major research programs could see increases in their FY 2008 budgets rather than the cuts proposed by the President. The medical and research community has continued to be active in pushing for a 6.7 percent, or $1.9 billion, increase in funding in FY 2008 for the National Institutes of Health (NIH). A 6.7 percent increase is needed in each of the next three years just to get NIH back to FY 2003 levels, when adjusted for biomedical inflation. The Washington Post recently published an article highlighting the struggle that many biomedical researchers currently face due to an NIH budget which has remained virtually flat since the end of its doubling period from 1998 to 2003. Predictable funding increases in the future, the article states, would allow researchers to be better able to plan their studies to accommodate future inflationary costs. Click here to read this article in The Washington Post: http://www.washingtonpost.com/wp-dyn/content/article/2007/05/27/AR2007052700794.html Key Players Senator Tom Harkin, the chairman of the Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, has expressed his support in getting the Senate Labor-HHS bill passed early in the appropriations process to demonstrate the Democrats’ support of health and education issues. Strong funding for the NIH is also a priority for Congressman David Obey of Wisconsin, who chairs the House Appropriations Committee as well as the Labor-HHS Appropriations Subcommittee, and Senator Arlen Specter, who has been a long-time advocate for research funding. With support from these and other leaders in the House and Senate, it is likely that the NIH will see a boost in funding for FY 2008.
USA TODAY publishes letter to the editor on drug safety from Friends of Cancer Research Chairperson and Founder Dr. Ellen Sigal and Fox Chase Cancer Center President Dr. Robert Young
Earlier this month, USA TODAY published an editorial piece “Our view on pharmaceutical safety: Latest drug scare shows need for FDA overhaul,” (May 23, 2007) addressing the recent news about the diabetes drug Avandia, calling it another Vioxx. Friends Chairperson and Founder Dr. Ellen Sigal joined with Dr. Robert Young, Fox Chase Cancer President and co-author and chair of the drug safety white paper report “Drug Safety and Drug Efficacy: Two Sides of the Same Coin,” to respond with a letter to the editor. Published in the May 31, 2007 edition, the response stressed the reality that no drug is 100% safe or 100% effective. It also referenced the drug safety white paper report that both Dr. Sigal and Dr. Young served as co-authors of along with 20 other authors from leading cancer and healthcare groups (www.focr.org/drugsafetyreport.htm). While suggesting that “the public, the media and members of Congress need to put money where their mouths are,” in terms of sufficiently funding a resource-starved and responsibility-laden agency, Dr. Sigal and Dr. Young’s letter to the editor commended recent legislation as part of the solution in saying, “Existing legislation already passed by the Senate would create post-marketing surveillance systems and increase communication, which is precisely what we could use right now to clarify the Avandia controversy. This legislation would enhance drug safety and, most important, save patients' lives.”
Issue Update: Drug Safety
Draft legislation incorporating all of these elements is expected to be released by House Energy and Commerce Committee Chairman John Dingell this week. It is expected that the subcommittee on health will hold one final hearing to discuss elements of the draft before proceeding to markup of the bill. Reauthorization provisions in the bill are set to expire at the end of September, making this bill “must-pass” legislation because of the vital resources that it adds to FDA. Congress has made it a priority to pass a reauthorization bill before the August recess. In order to meet this timeframe, it is expected that the subcommittee on health will hold a markup of the legislation as early as the week of June 11 to allow the full Energy and Commerce committee to hold a mark-up before the end of June. At this pace, it is expected that the full House of Representatives will vote on the bill shortly after the July 4th recess. After a bill is passed through the House, leadership from the House and Senate will meet in conference to finalize a joint bill. The Senate passed the FDA Revitalization Act to address these issues by an overwhelming majority of 93-1 on May 9th. Friends of Cancer Research has been focused on drug safety legislation due to the impact that it will have on the biomedical community. Enhancements to the drug safety system are important, but should be handled very carefully to prevent unintentional consequences that could negatively impact patient access, physician practice, and future innovation.
Highlights
from Friends involvement in drug safety issues over the last six months: 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, and Friends of Cancer Research participated in the public meeting by providing testimony. To view the full written submission please visit.
• Drug Safety Report Released, Over 22 prominent cancer and healthcare groups sign-on with support
• Friends participation in IOM Forum On Monday March 12th, 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. • Friends Hosts Drug Safety Briefing on The Hill, Representative Diana DeGette Delivers Opening Remarks, Expert Panel includes Dr. Mark McClellan
• Friends Chairperson Gives Congressional Testimony
The House of Representatives held this hearing as they begin to consider similar legislation that recently passed through the Senate sponsored by Senator Kennedy. Titled, "Assessing the Safety of our Nation's Drug Supply," the hearing included two panels of witnesses. The first panel showcased testimony from Steven K. Galson, M.D., M.P.H., Director of the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER); and Marcia Crosse, Ph.D., Director of Health Care Issues for the U.S. Government Accountability Office. The second panel, on which Dr. Sigal served, included representatives from PhRMA, Elizabeth Glaser Pediatric AIDS Foundation, and the University of Pennsylvania School of Medicine. • AACR CCR Journal Publishes Editorial on Drug Safety White Paper The drug safety white paper, "Drug Safety & Drug Efficacy, Two Sides of the Same Coin," recently received attention as an editorial in the May 1st edition of the prestigious AACR Clinical Cancer Research (CCR) Journal. The report, which was released in its entirety earlier this year, was a result of an expert working group spearheaded by Friends and chaired by Dr. Robert Young, past-president of the Fox Chase Cancer Center. The editorial appearing in CCR is signed by four of the twenty original authors: Dr. Robert Young, Dr. Ellen Sigal, Dr. Richard Schilsky, and Dr. Michael Friedman.
Friends of Cancer Research Full staff directory: www.focr.org/move.html
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The
U.S. House of Representatives recently completed several hearings on topics
that will likely be components of a comprehensive Food and Drug
Administration (FDA) bill. These issues include drug safety and the
reauthorization of the Prescription Drug User Fee Act (PDUFA),
reauthorization of the Medical Devices User Fee and Modernization Act (MDUFMA),
and reauthorization of the Best Pharmaceuticals for Children Act (BPCA) and
Pediatric Research Equality Act (PREA). 
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
earlier this year 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 
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
On
May 9, Friends of Cancer Research Chair Dr. Ellen Sigal offered
congressional testimony at the House Energy & Commerce Health Subcommittee
Hearing on drug safety held in the Rayburn House Office Building.