Leadership Changes at the FDA

In the wake of the sudden and unexpected resignation by Dr. Lester Crawford, Dr. Andew C. von Eschenbach was named as the Acting Commissioner of the Food and Drug Administration on Friday, September 23rd.  According to the most recent reports, Dr. von Eschenbach has taken a leave of absence from his NCI position to focus his attention solely on serving as Acting Commissioner of FDA.   Dr. John Niederhuber, who recently joined NCI as Deputy Director in the area of Translational and Clinical Sciences, will serve as chief operating officer to handle day-to-day management at NCI.

Dr. von Eschenbach (pictured left) is perhaps best known at NCI for announcing a national goal of "eliminating the suffering and death due to cancer by 2015."   He also has played a pivotal role in fostering a strong inter-agency relationship between the NCI and FDA.   In May of 2003, Dr. von Eschenbach and the FDA Commissioner at the time, Dr. Mark McClellan, announced an FDA-NCI Oncology Task Force designed to enhance the efficiency of clinical research and the scientific evaluation of new cancer medications. 

This interagency agreement allows the institutions to share knowledge and resources that will facilitate the development of new cancer drugs and speed their delivery to patients.  For example, the two agencies recently announced an NCI-FDA Research and Regulatory Review Fellowship program designed to train a cadre of researchers in the "skills and processes that must be incorporated into the current research and regulatory system" in order to effectively accommodate "the new generation of targeted therapies and diagnostic products."   Dr. von Eschenbach has been highly supportive of these and other activities, such as the Critical Path Initiative, that will help facilitate the FDA's efforts to integrate the most cutting-edge science possible into the agency. 

Dr. Von Eschenbach is assuming the acting leadership role at FDA in the wake of several positive changes with regard to oncology.  In July of last year, for example, Dr. Lester Crawford announced a plan to consolidate the review of drugs and therapeutic biologics used to diagnose, treat, and prevent cancer into a newly created Office of Oncology Drug Products.  An “Oncology Program” was also established to “facilitate cross agency expert consultation, provide a forum to discuss and develop regulatory policy and standards, and serve as a focal point for agency interaction and collaboration…”  However, Dr. von Eschenbach also is inheriting some complex problems as the agency is in the midst of a prolonged period of critical scrutiny surrounding safety concerns involving COX2 inhibitors and other approved products. 

As an accomplished academic physician as well as a cancer survivor, Dr. von Eschenbach brings a tremendous amount of knowledge and experience to the FDA with regard to clinical research, clinical practice, and patient care.  He is a nationally recognized urologic surgeon and has contributed more than 200 articles, books, and chapters to the scientific literature.  Much of his academic career was spent at the highly prestigious M.D. Anderson Cancer Center in Houston where he held numerous positions including executive vice president and chief academic officer.  He also directed the Genitourinary Cancer Center and was founding director of the Prostate Cancer Research Program.

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2015 Goal Receives Support from 92 Senators and 280 Representatives

On September 21st, the co-chairs of the House Cancer Caucus and the House 2015 Caucus held a press conference in support of the 2015 Goal.  These two groups, along with the Senate Cancer Coalition, sent letters this month to President Bush expressing support for the NCI’s goal of eliminating cancer death and suffering by the year 2015.   “The 2015 goal is about spurring hope into action, and making the impossible possible,” in the words of Congresswoman Pryce who helped to lead the sign-on effort in the House.  “By working together and implying all the tools at our fingertips, from research to treatment to patient advocacy, we are on our way to making cancer a manageable disease.”

Ninety-two Senators signed onto a bipartisan letter led by Senator Diane Feinstein of California and Senator Sam Brownback of Kansas – the co-chairs of the Senate Cancer Coalition.  According to Senator Feinstein, “The most immediate step Congress can take to help achieve the goal of eliminating cancer in 10 years is to maintain $29.4 billion in funding for the National Institutes of Health in the next fiscal year that is pending in the Senate.”  [Click for full article]

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NIH UPDATES

Update on NIH Reauthorization

While there has been little official activity with regard to NIH Reauthorization since a second discussion draft was circulated at the end of August, Chairman Barton has continued to signal his strong desire to move a reauthorization bill through the House Energy and Commerce Committee in the coming weeks if possible. 

Many groups, such as the Association of American Medical Colleges, have expressed their support for changes that would enhance the NIH’s capacity to plan and coordinate trans-NIH initiatives and strengthen the NIH Director’s authority to oversee and coordinate the nation’s medical research portfolio.  However, many of those same stakeholders also have expressed concern over some of the provisions proposed in the current discussion draft.  The primary points of discussion seem to be revolving around 3 key issues:

1) The current levels for appropriations in the discussion draft have yet to be determined. 

The recommended ceiling for annual NIH appropriations in FY 2007, 2008 and 2009 as established through the authorizing language is of great importance to stakeholders.

2) The plan to group the various ICs into either a mission-specific or science-enabling category for the purposes of appropriations.

The current draft calls for each of the existing ICs to be classified into one of two categories (presently defined as either mission-specific or science-enabling).  The draft then proposes a new appropriations system by which Congress would allocate three lump sums: one to the NIH director’s office, one for all the mission-specific ICs, and one for all the science-enabling ICs.  The process for the distribution of these funds to the individual ICs is yet “to be determined.”  Many stakeholder groups have expressed concern over the proposed classification system and have voiced a desire to maintain the current process by which Congress identifies a specific amount for each IC.

3) The specific level of funding for the proposed “common fund” for trans-NIH research and the specific level of “transfer-authority” provided to the NIH Director.

The current discussion draft would establish a “common fund” for trans-NIH research.  The draft also reaffirms the NIH Director’s authority to transfer funds in order to pursue such things as unanticipated research opportunities or to address public health emergencies, as long as the transfer of funds does not result in any agency of the National Institutes receiving an amount less than that agency received for FY 2006.  While “transfer authority” and the “common fund” are two distinct funding mechanisms, the maximum level allowed for each as a percentage of the NIH budget has yet to be determined.   A 2003 IOM Report entitled “Enhancing the Vitality of the National Institutes of Health” suggested that 5% of the overall NIH budget may be appropriate for trans-NIH initiatives, with the potential for growth in that amount to around 10% or more over 4 to 5 years.  However, in an era of flat funding and tight fiscal constraints, some NIH watchers are recommending a total of 3% with the possibility for modest growth over time.

NIH Appropriations Update

Although we are already a week into the new fiscal year, Congress has yet to complete the appropriations process for fiscal year 2006.  Before leaving town for a two week recess, Congress passed a continuing resolution (CR) to keep the government open until November 18th.  The CR that was enacted will fund government programs at the lowest level of current funding (FY 2005) or the level proposed in the House or Senate appropriations bills.  In the next six weeks, Congress will try to complete the appropriations process and ultimately will have to reconcile the House and Senate versions of the Labor, Health and Human Services and Education (Labor-HHS) appropriations bills.  As readers may recall, the Senate Labor-HHS appropriations bill would provide nearly $1 billion more for the National Institutes of Health (NIH) than the House proposal. 

Exactly how the NIH appropriations process will play out this year is the subject of much speculation.  The various possible scenarios include the following: The Congress could pass a stand-alone Labor-HHS bill, or it could be rolled into an omnibus package like last year, or Congress could pass a 1 year CR that provides funding for the remainder of FY 2006.

Dr. Steven Galson, Director of the Center for Drug Evaluation and Research, gave the keynote presentation.  He outlined the strengths and limitations of FDA’s current drug safety system and provided insight into some new safety efforts that FDA plans to implement in the near future.  One such program is the Drug Watch website, which would provide preliminary online safety warnings for medications that are undergoing safety investigations.  Another proposal is the creation of patient and healthcare-professional drug information sheets.  These “one-pagers” would detail a particular medication’s risks and benefits so patients and physicians can make informed decisions about their treatment options. 

Dr. Alan Goldhammer of PhRMA discussed what drug companies are doing to assure that the drugs patients receive through the web or mail order are not counterfeits.  Possible protections include adding a barcode or radio frequency identification (RFID) tag to the packaging of drugs at highest risk of counterfeit. 

Dr. Gretchen Dieck, Vice President of Safety and Risk Management for Pfizer, provided an overview of pharmaceutical companies’ roles and responsibilities in ensuring drug safety.  Drug companies employ a team of epidemiologists, physicians, and other scientists who oversee an extensive safety system that assesses risk vs. benefit in each stage of drug development.

Dr. Alan Balch, Executive Director of Friends of Cancer Research, explained that although safety is an important issue for patients and scientists, so are other issues such as efficacy, access, and the speed of the review process.  He noted that efforts to improve the FDA’s safety systems should not compromise the access and timely approval many patients facing life-altering diseases need and deserve.  According to Dr. Balch, the debate should focus on improving the FDA’s capacity in the areas of safety, efficacy, and efficiency simultaneously.

FOCR Organizes Meeting With Wall Street Journal Editorial Writers

In light of the Wall Street Journal printing more than half a dozen major editorials dealing with cancer-related issues over the past ten months, Friends of Cancer Research organized a meeting between a group of key stakeholders from the cancer community and senior editorial writers from the Wall Street Journal to foster a positive dialogue about the future of cancer research.  

The meeting featured a wide-ranging discussion between the editorial writers and prominent figures representing patients, scientists, and physicians on topics such as the significance of rigorous clinical trials, early access and compassionate use of unapproved drugs for cancer patients, and recent changes at the FDA with regard to oncology.  Participants included 3 members of FOCR’s Board of Directors:  Dr. Martin Abeloff, Director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Ellen Stovall, President and CEO of the National Coalition for Cancer Survivorship, and Dr. Ellen Sigal, Chair of Friends of Cancer Research. 

GW and FOCR present second guest in “Distinguished Lecture Series”

The George Washington Cancer Institute will host the second speaker in its “Distinguished Lecture Series” on October 20th, 2005.  Friends of Cancer Research is proud to be a non-financial sponsor and partner for this series.  Featuring key decision makers from the health policy community, the upcoming installment will showcase Dr. Mark Clanton, Deputy Director of Cancer Care and Delivery for the National Cancer Institute.  The event will take place in the GW Hospital Auditorium from 12-1pm.  To RSVP for the event, please email info@focr.org .