MAY 2005

> NIH Update
> New FDA Office of Oncology Announced
> In the Spotlight: Dr. Pazdur, FDA
> FOCR President featured at Annual AACR Meeting

> Hot topics: Pharmacogenetics


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FOCR is a non-profit organization that raises awareness and provides public education on cancer research in order to accelerate the nation's progress toward prevention and treatment of cancer.

 

NIH OUTLOOK

NIH Funding Update

By very narrow margins, both the House and Senate recently passed a $2.56 trillion federal budget proposal for 2006.  The vote was 214-211 in the House and 52-47 in the Senate.  The federal budget sets the stage for the appropriations bills, which determine the spending levels for the various departments and agencies (e.g., NIH).  Similar to the White House’s budget proposal, the Congressional plan calls for cuts in all areas of discretionary spending except for defense and homeland security.  Defense spending would receive a 4.8 percent increase, reaching a total of nearly $420 billion, and national security spending would receive a 2.3 percent increase to $32.5 billion.   The total budget allocation for all other spending areas would shrink by about 1 percent to $391.1 billion.  The President is expected to sign the measure. 

These figures have tremendous implications for domestic spending on health care and research.  Because there will be significantly less money to be allocated during the appropriations process for non-defense spending,  the various domestic spending categories like environment, health care, and education will be competing for a smaller pot of money than in previous years.  Consequently, most departments and agencies will face budget cuts. 

Although Senator Arlen Specter (R-PA) was able to win approval by a vote of 63 to 37 for an amendment (S. AMDT 173) to the Senate’s version of the budget resolution (S.Con.Res. 18) that called for an additional $1.5 billion appropriation for NIH, that amendment was not included in the conference agreement negotiated by House and Senate leaders to reconcile differences in the budget resolutions passed by their respective chambers.   The revised budget proposal that emerged from that process was then passed by both houses on April 28th


Pazdur named Director of FDA’s new Oncology Office

After an intensive national search, the Food and Drug Administration named Dr. Richard Pazdur to head the new Office of Oncology Drug Products (ODP).  The search committee for the position included not only internal FDA personnel, but also several members of the academic oncology community. 

Dr. Pazdur (pictured left at a FOCR Town Hall last June), an experienced medical oncologist, brings over twenty years of leadership in exploring and developing solutions to the often complex issues of oncology drug development.  Following the announcement, Dr. Pazdur remarked “I am honored to have been selected from such a highly qualified group of applicants.  I look forward to working with Acting Commissioner Crawford, Dr. Galson and the talented and dedicated scientists who will comprise the office to realize FDA's vision for it.”   

The selection of Dr. Pazdur as Director of the Office of Oncology Drug Products was met with great enthusiasm from across the cancer community.  The numerous cancer advocacy groups and professional societies that have pushed for the consolidation of cancer activities at FDA over the years also felt that the leadership for any new administrative structures dedicated to oncology was critical for success.  To that end, the cancer community sought a highly trained oncologist with broadly recognized credentials and experience in cancer research, trial design, and patient care: qualifications Dr. Pazdur clearly meets.

As noted in the FDA’s official press release regarding the announcement, Dr. Steven Galson (Acting Director of CDER) feels that, "Dr. Pazdur's work will benefit cancer patients everywhere and reaffirm FDA's ongoing commitment to improving the efficiency and consistency of product development and review, so cancer patients will have access as quickly as possible to quality new treatments." 

The office that Dr. Pazdur will head was announced last June as part of an ongoing effort to improve the consistency and efficiency of the review of  oncology products. The FDA’s proposed changes will consolidate much of CDER’s review authority over cancer products into a single office dedicated entirely to oncology.  More specifically, the new office will have control over an array of biologics, drugs and imaging technologies with cancer indications in addition to the capacity to help coordinate and integrate cancer-related activities across FDA.  


SPOTLIGHT on Dr. Richard Pazdur, Head of the New FDA Office of Oncology Drug Products

Dr. Pazdur addresses priorities for the new office, including the challenges of accelerating advancements in cancer prevention and early detection and the critical issues of drug approval cancer patients should consider.

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


AACR holds 96th Annual Meeting, FOCR Chair a Key Note Speaker

Representatives from Friends of Cancer Research recently attended the AACR’s 96th Annual Meeting in Anaheim, California.  As part of that meeting, FOCR participated in a public forum focused on “Science Policy & Legislative Affairs.”  The session was introduced and moderated by Dr. William G. Nelson of Johns Hopkins, the Chairperson of the AACR Science Policy and Legislative Affairs Committee.  Dr. Sigal, Chair of Friends of Cancer Research, provided an in-depth look at recent issues involving FDA, such as the newly formed Office of Oncology Drug Products and drug safety concerns.

Dr. Sigal also served as a keynote speaker at the Second Annual President’s Circle Dinner at the 2005 AACR Annual Meeting in Anaheim, California. 

The Annual AACR (American Association of Cancer Research) Meeting is attended by more than 15,000 participants from 60 countries, who gather to discuss over 6,000 abstracts and to hear more than 250 invited presentations on new and significant discoveries in basic, clinical, and translational cancer research.

For more information on the AACR and the AACR Annual Meeting, please visit:  www.aacr.org (Pictures compliments of and credited to Todd Buchanan and AACR)


HOT TOPICS in Cancer Research   

Pharmacogenetics, a "buzz word" at the recent AACR annual meeting, is one of the new fields that will undoubtedly play a huge role in the treatment of numerous diseases, including cancer.   Researchers from the University of Texas M. D. Anderson Cancer Center announced at the AACR meeting that they have developed a "genetic blueprint" that will predict response to cancer treatments for esophageal cancer, improving outcome for patients. The study, led by Xifeng Wu, M.D., Ph.D., a professor in the Department of Epidemiology at MD Anderson, extends beyond esophageal cancer to that of all cancers;  Wu explained, "This points to a promising new direction for cancer pharmacogenetics.  Our hope is to have a gene chip one day that can analyze a patient's genetic makeup and help physicians predict response to a wide variety of therapeutic drugs before treatment even begins." 

This month the FOCR Newsletter features an article by Dr. Marc Teitelbaum explaining the innovative and promising science in the field of pharmacogenetics and how it also raises two of today's hottest medical issues: post-market drug safety, and patient accrual to new drug trials.  To learn more, click here. 


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