1. Advocacy Groups Rally Against Potential Cuts in NIH Funding - DECEMBER 2005
2. NCI Deputy Director Dr. Mark Clanton Speaks at GW/FOCR Distinguished Lecture Series - NOVEMBER 2005
3. FOCR and AACI Bring Cancer Center Leaders to Capitol Hill - NOVEMBER 2005
4. Advocacy Groups Rally Against Potential Cuts in NIH Funding - NOVEMBER 2005
5. NIH Update:  Appropriations and Reauthorization - OCTOBER 2005
6. 2015 Goal Receives Support from 92 Senators and 280 Representatives – OCTOBER 2005
7. Leadership Changes at the FDA - OCTOBER 2005
8. AAMC/FASEB Town Hall on NIH Reauthorization Highlights Major Issues and Concerns - SEPTEMBER 2005
9. A Second Draft of a Bill to Reauthorize the NIH is Circulated - SEPTEMBER 2005
10. NIH Reauthorization – AUGUST 2005
11. NIH Funding:  Highlights of FY06 Labor, HHS, Education Appropriations Bill - SEPTEMBER 2005
12. IOM Looking Post-Market Drug Safety System-JULY 2005
13. Highlights of FYO6 Labor, HHS, Education Appropriations Bill - JUNE 2005
14. House Passes New Stem Cell Legislation - MAY 2005
15. Pazdur named Director of FDA's new Oncology Office - MAY 2005
16. FOCR and NPAF Respond to Senate HELP Committee Questions on Safety Issues - APRIL 2005
17. FOCR and NPAF Partner To Testify Before Congress - MARCH 2005
18. FOCR signs on to OVAC Letter for Cancer Funding Priorities - FEB 2005
19. FY 2005 Omnibus Bill Passes with 2.9% Increase for NIH-NOVEMBER 2005
20. Vioxx aftermath may impact cancer community- NOVEMBER 2004
21. Stem Cell Hearing- SEPTEMBER 2004
22. FDA Announces Oncology Office-JULY 2004
23. Joint National Research Council & Institute Of Medicine Report Recommendation
24. Reduction in Length of Drug Reviews at FDA
25. NIH-FDA Interagency Agreement

2005

IOM Looking into Post-Market Drug Safety System
The Institute of Medicine recently formed an ad hoc committee at the request of the Food and Drug Administration that will assess the current post-marketing drug safety system and make recommendations for its improvement.  The committee, whose project is called “Assessment of the U.S. Drug Safety System,” includes an impressive list of physicians, lawyers, statisticians, and others who are familiar with the issues surrounding drug safety.

At the first meeting held on June 8, 2005, the committee heard from government, industry, and patient organizations who gave their perspectives on the current drug safety system.  The second meeting of the committee will be July 19^th to 21^st at the National Academy of Sciences in Washington, D.C.  The meeting will be open to the public from 3:00-6:00pm on July 19^th and will be devoted to public comments regarding post-marketing drug safety.  If you would like to speak at this meeting you must sign up in advance by sending an email to drugsafety@nas.edu, including your full name, organization/affiliation, address, and phone and fax numbers.  You will be allotted 5 to 8 minutes to speak.  This meeting will also be open to the public on July 20^th from 1:00-5:30pm.  If you would like to attend the meeting but not be a presenter, you may register at www.iom.edu/drugsafety/meetingtwo.   

NIH Funding: Highlights of FY06 Labor, HHS, Education Appropriations Bill
On June 24, the House of Representatives passed the appropriations bill for the Departments of Labor, Health and Human Services, and Education, and Related Agencies (HR 3010) by a vote of 250-151.  The bill has now been referred to the Senate Committee on Appropriations, and subcommittee markups are scheduled for July 12^th and full committee markups are scheduled for the 14^th. 

The funding levels in the bill were established by the House LHHS subcommittee on June 9^th.  According to the bill, the National Institutes of Health would receive $28.5 billion in FY 2006, a 0.5% increase over FY 2005. The NIH had requested $28.59 billion, a $196 million or 0.7% increase.  The funding levels approved by the House would be the lowest increase of funds for the NIH in more than two decades. 

As part of the NIH’s allocation, the NCI would receive $4.84 billion in FY 2006, a $16.5 million or 0.34% increase over the FY 2005 level.  The NCI had requested 6.17 billion for 2006.

The following links justify the NIH and NCI’s budget request and emphasize the importance of a budget increase.
NCI Budget Justification
NIH Budget Justification

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.

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 clearly was seeking a highly trained oncologists with broadly recognized credentials and experience in cancer research, trial design, and patient care.  Dr. Pazdur perfectly matches those qualifications. 

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.  

FOCR and NPAF Respond to Senate HELP Committee Questions on Safety Issues
On March 1 of this year, Friends of Cancer Research and the National Patient Advocate Foundation partnered to present testimony on drug safety concerns before the Senate HELP Committee. As a follow-up to that testimony, the Chairman Enzi (R-WY) submitted 2 questions in writing the responses to which were included in the public record. Below are the questions and a highlight from the response. To read the responses in their entirety, please click here. Also, please click here to view the complete testimony.

1) In light of recent controversies, some people have proposed requiring longer-term and larger studies of drugs before they are approved. Could you comment on whether and how this might impact patients?

Time is a highly precious commodity to someone diagnosed with a life altering and/or life threatening condition like cancer, AIDS, or diabetes. The diagnosis not only impact the patient, but also their families, friends and communities. When you are suffering from a potentially fatal or severely debilitating disease, you shouldn’t have to wait any longer than is necessary for the FDA to approve new medical products.  Any attempt to mandate longer or larger clinical trials would obviously increase the length of time before patients would have access to new products if they are deemed safe and effective. When you are suffering and dying, the risk/benefit ratio of significantly different than in patient populations in other circumstances.

2) Many have called for a greater separation between the Office of New Drugs, which is responsible for drug approvals, and the Office of Drug Safety, which is responsible for post-market surveillance of drugs that have already been approved. Are you concerned that an independent Office of Drug Safety would only look at risks and problems, potentially ignoring the benefits?

Patients and their families, physicians and caregivers must always weigh the benefits and risks associated with a particular treatment option. Similarly, we feel that the FDA must carefully weigh the benefits and risks associated with a new drug when making decisions about approval or post marketing activity. Safety and efficacy are the inseparable foundation of the FDA’s ability to best define the appropriate risk/benefit ratio of a product. Risk cannot be considered separately from benefit, nor safety from efficacy. To review one without an equal measure of the other could easily lead to misjudgments and false conclusions. For that reason, we would advise against any effort that creates new regulations or bureaucracy that isolates or further separates the drug safety function from the overall drug review and monitoring process.

FOCR and NPAF Partner To Testify Before Congress
On March 1st, 2005, Friends of Cancer Research and the National Patient Advocate Foundation (NPAF) partnered to present testimony on patient safety issues and the FDA before the Senate Health, Education, Labor, and Pensions (HELP) Committee.  Nancy Davenport-Ennis, CEO of the NPAF, participated in a 5-member witness panel and provided oral remarks that highlighted the key elements of the full statement submitted for the record available at http://help.senate.gov/testimony/t201_tes.html.

The purpose of the joint testimony was to provide insights into the complex nature of cancer, and explain why timely access to new technologies for the prevention, detection, and treatment of cancer is so essential.  Although it was generally supportive of efforts to strengthen the FDA's role in evaluating and monitoring safety concerns, our testimony urged caution because some strategies might unintentionally slow down the flow of better tools for fighting cancer, or worse, discourage their creation altogether.  "We want safer and more effective drugs moved through the system as efficiently as possible,” the testimony states, “so they can be used as soon as possible by those who need them most, such as cancer patients and/or those at high risk for cancer. We would prefer strategies and solutions designed to improve the FDA’s capacity in the areas of safety, efficacy, and efficiency simultaneously." 

As a foundation for developing an even more effective FDA, our testimony outlined five key "Pillars of Safety" critical to reforms:

 1. Safety and Efficacy must continue to be the foundational elements of the FDA regulatory process.  Safety cannot exist in a vacuum apart from efficacy.
 2. Mechanisms to enhance existing structures and processes for post market safety monitoring and adverse event reporting should be explored. 
 3. Efforts to bring even greater efficiency and scientific expertise to the FDA’s review and monitoring processes must continue; such efforts must be done in a manner that empowers the Agency to keep pace with the rapid advancements now occurring in areas such as genomics, proteomics, and nanotechnology.
 4. FDA must continue to work with industry, patient groups, physicians, hospitals, academia, and other government agencies to enhance the critical path.
 5. The FDA must be sufficiently resourced in order to insure more effective pursuit of its existing mandates.  Additional resources are even more essential if FDA is to successfully implement a comprehensive suite of reforms.

For the full testimony, please visit the U.S. Senate's Website at:
http://help.senate.gov/testimony/t201_tes.html

OVAC Letter
Friends of Cancer Research recently joined 35 other health policy organizations in a sign on letter from “One Voice Against Cancer” to the White House respectfully urging both the Administration and Congress to make funding for cancer research and programs a priority in fiscal year (FY) 2006. The letter made several funding recommendations including a 6% increase of $1.7 billion for the NIH (for a total of $30.1 billion).

The letter also voiced strong support for the NCI’s Professional Judgment budget, which “represents our national battle plan against cancer, outlining the critical core research that is currently underway as well as the most promising and extraordinary research opportunities.” This year’s Professional Judgment budget request is $6.17 billion for FY 2006. As explained in the letter, this request is arrived at “through an open and public process and reflects the best thinking of cancer researchers, patients, clinicians, and other constituency groups and is focused on the Institute’s goal of eliminating suffering and death from cancer by the year 2015.” Although the Professional Judgment budget represents the ideal funding level, the signatories also identified a $386 million increase (8%) for NCI as the minimum amount necessary to protect our cancer research enterprise and maintain the current pace of discovery.

The health policy community has a tough road ahead in pursuing these funding recommendations as the White House’s budget is likely to call for flat or reduced funding for many health related agencies like NIH.

According to a Washington Fax story released on December 8th, the budget outlook for 2006 remains grim.  The draft FY 06 budget sent from the White House's Office of Management and Budget to HHS for comment contains about a 1% cut for the NIH.  While these are only the initial "passback" figures, there is little hope that considerable improvements can be made to these amounts before the White House submits its final budget to the Congress.  The story also points out that Rep. Ralph Regula (R-Ohio), who chairs the key subcommittee on the House Appropriations Committee with jurisdiction over NIH, "has told advocacy groups he is not interested in appropriating more funds for NIH until he sees strong accountability in the agency."