JUNE 2005

On June 9^th, the House Labor-HHS Appropriations Subcommittee is scheduled to start marking up the $142.5 billion FY06 spending measure, a $163 million decrease from the previous year. The proposed bill reflects a 0.1 percent cut that, according to a recent article published in the National Journal entitled “Appropriations: House Plots Cuts, Senate Eyes Accounting on Labor-HHS,” is still beyond anything proposed even in the early years of the revolution led by former House Speaker Gingrich, and appropriators are bracing for the ramifications when the bill reaches the floor, probably in the third week in June." With House leadership aiming to deliver the bill to the floor before the July 4th recess, the mark-up in the full House Committee on Appropriations should occur around June 14th to stay on schedule.

The Senate is expected to pass a slightly different version of the Labor-HHS Appropriations bill, which will lead to a showdown in conference. According to the same National Journal article, “appropriators in that chamber already are considering the use of accounting maneuvers to add more than $3 billion to the bill's total while staying within its 302(b) allocation, expected to be essentially flat from last year's enacted discretionary total of nearly $142.7 billion.”

FDA Funding: House Appropriations Committee Slices $6 Million from FDA Budget

According to a recent report from the Associated Press, the House Appropriations Committee cut roughly $6 million from the FDA's 2006 budget. This cut was made after the FDA declined to testify before the panel about their '06 budget proposal at the request of the Bush administration. During a House Appropriations Committee hearing, Representative Rosa DeLauro (D-Conn) noted that "the FDA is facing serious scientific and management challenges which could have equally serious public health consequences. Yet they have refused to testify about their budget request."

House Passes New Stem Cell Legislation

On May 24^th, the U.S. House of Representatives passed two bills that could have a major impact on the future of cancer research. The Stem Cell Research Enhancement Act of 2005, H.R. 810, passed the House by a margin of 238 to 194. The bill was introduced by Representative Michael Castle (R-DE) and was cosponsored by 200 members including Representative Diana DeGette (D-CO). H.R. 810 would expand public funding to research on embryonic stem cell lines that were nonexistent in 2001, when President Bush limited funding to lines in existence at the time. This bill is now being considered in the Senate as S. 471. While this bill has considerable bipartisan support in Congress, President Bush has threatened to veto the bill if it reaches his desk. Strong continued support from organizations representing scientific research will be important in passing this bill through the Senate and getting it signed into law.

The House of Representatives also passed H.R. 2520, the Stem Cell Therapeutic and Research Act of 2005. This bill was sponsored by Representative Christopher Smith (R-NJ) and would establish a network of cord blood stem cell banks to assist in the collection of cord blood for stem cell transplantation and peer-reviewed research. H.R. 2520 received strong support from the President and passed the House by a vote of 431 to 1. This bill will now be taken up for consideration by the Senate.

HHS Secretary Leavitt announces personal “500 Day Plan”

As Secretary Leavitt approached the completion of his 100^th day heading the Department of Health and Human Services, he announced a 500 day plan to augment the department's strategic plan. His 500 day plan is a self-described management tool and personal expression of priorities. Among the Secretary’s main goals for advancing medical research are increasing technological capabilities for risk assessment, building more interdisciplinary research teams, and improving the research network to advance better prevention, early diagnosis, and treatment of disease.

SPOTLIGHT on The Early Detection Research Network (EDRN) and its head scientist, Dr. Sudhir Srivastava

The National Cancer Institute recently completed its second round of funding to the Early Detection Research Network (EDRN). In light of this milestone, Friends of Cancer Research spoke with head EDRN scientist, Dr. Sudhir Srivastava about the announcement and what it means to the future of the network’s research.

For the complete article, please see www.focr.org/news/spotlight.html

FOCR President and Chair Respond to Wall Street Journal Editorial

Friends’ Chair, Ellen Sigal, and President, Marlene Malek, submitted a letter to the Wall Street Journal in response to an editorial that ran on May 19^th entitled “The FDA vs. Cancer Patients.” The editorial accuses the FDA of not approving drugs quickly enough and of treating industry “as an adversary, not a partner, in the anti-cancer fight.” In addition to criticizing Dr. Lester Crawford, Acting FDA Commissioner, the article calls the recent selection of Dr. Richard Pazdur as the Director of the newly established Office of Oncology Drug Products (ODP) a “blow for cancer patients.” Such a claim stands in sharp contrast to the strong support numerous cancer organizations expressed for the selection of Dr. Pazdur. The following letter was submitted in response to the WSJ’s characterization of the FDA’s efforts on behalf of cancer patients:

To the Editor:

Your criticism of the FDA, its Acting Commissioner and the head of its new oncology drug office differs greatly from the view of many cancer advocacy organizations (The FDA vs. Cancer Patients, 5/19).

This Administration's FDA has made tremendous strides to accelerate the approval process for cancer treatments. Acting Commissioner Lester Crawford has fought hard to implement his predecessor's proposal for an oncology-specific drug office. He also has been instrumental in supporting the interagency task force between the FDA and the National Cancer Institute. Both of these efforts were designed to find ways to improve the efficiency and predictability of the review process for oncology products.

Dr. Richard Pazdur's selection as head of the recently created oncology office was greeted with enthusiasm from many in the cancer community (including patient advocates, cancer center directors, and leaders of professional societies). He has shown himself to be a thoughtful and rigorous scientist both during his 6-year tenure at FDA and his previous career as a practicing oncologist at distinguished academic institutions like the M.D. Anderson Cancer Center in Texas.

As your editorial demonstrates, the people at FDA face a no win proposition in terms of public relations. If they approve too many drugs too quickly, they are accused of being the pawn of industry. If they approve too few drugs too slowly, they are accused of not putting the patient first. The fact that Dr. Pazdur has received criticism and support from both ends of that spectrum suggests that he is doing something right.

Unfortunately, Dr. Pazdur's already difficult job of assessing the balance between the safety and efficacy of a cancer product is only going to increase if the media frenzy surrounding drug safety translates into new layers of regulations and bureaucracy at FDA. Such efforts could definitely "turn back the clock" on advances made in the speed of the FDA's approval process -- a concern we share with the Wall Street Journal.

Ellen V. Sigal, PhD.

Chairperson

Marlene Malek

President