June 2003 NEWSLETTER

July 1, 2003

Friends of Cancer Research is a non-profit organization dedicated to accelerating the nation’s progress toward prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues.

CONGRESSIONAL UPDATE

NIH Appropriations
On June 25th, the House Appropriations Committee approved the FY 2004 appropriations bill providing $27.66 billion to the National Institutes of Health (NIH), an increase of 2.5% (7% if considering FY 2003 one-time costs) or $682 million. The National Cancer Institute (NCI) would receive $4.77 billion. The Senate Appropriations Committee approved the respective Labor, HHS, Education Subcommittee FY 2004 bill on June 26th. The Senate bill includes $27.9 billion for NIH, an increase of 1 billion (3.7%) over the FY 2003 appropriation and $318.6 million over the President’s proposal. The NCI figure is identical to the House mark-$4.77 billion. The Senate subcommittee allotment, $137.6 billion, is $445 million less than the House subcommittee had to work with and $389 million less than it would take to fund all of its programs at the level requested by the President. Senate committee staffers anticipate floor action in mid-July.

FDA DEVELOPMENTS

10% Reduction In Length of Drug Reviews
In a speech to the annual Biotechnology Industry Organization (BIO) Conference, on June 23rd, the Food and Drug Administration (FDA) Commissioner Mark McClellan announced that the FDA is planning to decrease regulatory review time for new drugs by 10% in the next five years. Assuming the 10% target is met, the reduction would cut the cost of developing new medications by $12.8 million and shorten review time for drugs on the standard track from 18 to 16 months and priority drugs (those for diseases with no known treatment) from 6 months to less than 5 months. In order to streamline the review process, the commissioner plans to revise the FDA good manufacturing practices (GMPs) -- last updated 25 years ago -- as well as improve post market monitoring by implementing an electronically-based monitoring system, in addition to the current voluntary reporting systems.

NIH-FDA Interagency Agreement
On May 30th, the FDA and NCI established a multi-part Interagency Agreement in order to increase efficiency in clinical cancer research and scientific review. An NCI/FDA Oncology Task Force comprised of senior staff from both agencies will oversee implementation of the agreement. The taskforce will focus on various objectives including:

• developing useful biomarkers (which can be used as surrogate endpoints in clinical trials)
• creating a cancer bioinformatics infrastructure to improve data collection, integration, and analysis for preclinical, preapproval, and post-approval research
• collaborating on technology development including clinical proteomics
• developing clinically meaningful endpoints for cancer chemoprevention agents

This partnership is a seminal step in the FDA initiative to improve the availability and use of safe and effective treatments for cancer. The full press release on this interagency agreement can be found here.

FRIENDS ACCOMPLISHMENTS

Ellen V. Sigal, PhD, Appointed to Council of Public Representatives (COPR).
The NIH appointed 9 new members to the Director’s Council of Public Representatives (COPR), including Ellen V. Sigal, PhD, Founder and Chairperson of Friends of Cancer Research. They join 12 current members of the Council. The COPR is a federal advisory committee, made up of members of the public, that advises the NIH Director on issues related to: (1) public input and participation in NIH activities; (2) public input and participation in the NIH research priority setting process; and (3) NIH outreach programs and efforts. The full press release can be seen here.

Friends of Cancer Research Hosts Cancer Advocacy Study Group Dinner at ASCO with Aventis UK
On June 1st at the American Society of Clinical Oncologists (ASCO) Annual Meeting, Friends hosted a Cancer Advocacy Study Group Dinner together with Aventis UK. The event focused on strengthening patient group-government interaction in the United Kingdom (UK), and specifically on issues such as patient education, attention for ‘orphan’ cancers, successful lobbying strategies, and government-patient relations. The UK contingency included Members of Parliament, government health officials, and patient-group leaders, and the US delegation was comprised of patient advocacy leaders from a broad spectrum of cancer patient groups, president of a cancer center, as well as director of public policy at ASCO. This is the second year that Friends has engaged thought leaders from both continents in a policy and information sharing opportunity in hopes of continuing to developing successful and novel cancer advocacy strategies.

From left to right: Sam Held, Patient Involvement Co-ordinator, South East of Scotland Cancer Network; Candace J. Rosen, JD, Executive Director, Friends of Cancer Research; Liz Porterfield, Cancer Services Co-ordinator, Scottish Executive

In attendance from the US:

• Ellen V. Sigal, PhD - Chairperson, Friends of Cancer Research
• Candace J. Rosen, JD - Executive Director, Friends of Cancer Research
• James G. Asher - Executive Director, Alliance for Lung Cancer Advocacy
• Richard N. Atkins, MD - CEO, National Prostate Cancer Coalition
• Nancy M Macgregor - International Director, Susan G. Komen Breast Cancer Foundation
• William Price Bro - CEO, Kidney Cancer Association
• Greg Brozeit - Consultant, International Myeloma Foundation
• Paula Kim - President & Founder, Pancreatic Cancer Action Network, Inc. (PanCAN)
• William T. Schmidt - CEO, National Coalition of Cancer Survivorship
• Deborah Y. Kamin, PhD - Sr. Director, Public Policy & Practice, ASCO
• Robert C. Young, MD - President, Fox Chase Cancer Center; Immediate Past President, American Cancer Society

From left to right: Dr. Anna Gregor, Lead Cancer Clinician, Scotland; Robert C. Young, MD, President, Fox Chase Cancer Center; Prof. Mike Richards, National Cancer Director, Department of Health UK

In attendance from the UK:

• Prof. Mike Richards - National Cancer Director, Department of Health
• Dr. Anna Gregor - Lead Cancer Clinician, Scotland; Chairman, Scottish Cancer Group
• Earl Howe - Conservative Peer (UK’s second party), Lead Party Health Spokesperson in Lords
• Laura Moffatt MP - Labour (UK’s largest party), Parliamentary aide to Lord Chancellor, Lord Irvine
• Liz Porterfield - Cancer Services Co-ordinator, Scottish Executive
• Helen Shirley-Quirke - System Reform Program Manager, Department of Health
• Dr. Jesme Baird - Director of Patient Care, Roy Castle Lung Cancer Foundation
• Joanne Rule - Chief Executive, CancerBACUP
• Sam Held - Patient Involvement Co-ordinator, South East of Scotland Cancer Network

Cancer Advocacy Study Group Dinner hosted by Friends and Aventis UK

Secretary Tommy Thompson to Announce on July 9th, Grant Recipients of Friends of Cancer Research and the Foundation for NIH’s Public-Private Partnership, “Overcoming Barriers to Early Phase Clinical Trials”
Join Friends of Cancer Research on July 9th on Capitol Hill (Senate Dirksen Building 138) as Secretary Thommy Thompson announces grant awards for six cancer centers involved in a unique public-private partnership between the NCI and five pharmaceutical companies, “Overcoming Barriers to Early Phase Clinical Trials.” Friends of Cancer Research (Friends) and the Foundation for the National Institutes of Health (FNIH) developed this groundbreaking partnership, and the awards come less than a year after this collaboration between cancer advocacy leadership, private sector interests and government research enterprise was launched. Five pharmaceutical companies: Aventis, Bristol-Myers Squibb, Eli Lilly and Company, GlaxoSmithKline, and Novartis together with NCI put forth a total of $5.6 million for this partnership. The six cancer centers will use the grants to design and implement new approaches to enlarge minority and geriatric access to and participation in Phase I and II clinical trials.

If you would like to attend the July 9th announcement or would like more information, please contact Malinda Simon at msimon@focr.org or by phone at 202.944.6711.