Senate HELP Committee Holds Hearing on Cancer Challenges and Opportunities
On May 8, the Senate Health, Education, Labor and Pensions (HELP) Committee held a hearing on cancer research and prevention, and challenges and barriers to access to care in the 21st century.

Sen. Edward Kennedy (D-MA), Chairman of the Senate HELP Committee, convened the hearing to highlight issues he expects to address in a cancer omnibus bill later this year. ASCO and others in the cancer community have been working closely with Sen. Kennedy to support his efforts. Individuals testifying at the hearing included Elizabeth Edwards, wife of former Democratic presidential hopeful Sen. John Edwards (D-NC); cancer survivor and seven-time Tour de France winner Lance Armstrong; AOL Founder and CEO of Revolution Health Steve Case; Hala Moddelmog, CEO of Susan G. Komen for the Cure; Edward Benz, MD, president of the Dana Farber Cancer Institute; and Greg Simon, president of Faster Cures.

At the hearing, Sen. Kennedy emphasized that his goal is to examine the current model for cancer care, research, prevention and treatment in the United States, including intensified focus on personalized medicine and targeted therapies, better access to and expanded research on early detection of cancer, and removal of barriers that prevent patients from accessing quality care.

Sen. Kennedy plans to introduce legislation to address this range of issues related to improving cancer care for all Americans. He stated that he and Sen. Kay Bailey Hutchison (R-TX) have already secured significant support from other Senators.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.

Sen. Brown Introduces Access to Cancer Clinical Trials Act
On May 8, Sen. Sherrod Brown (D-OH) introduced the “Access to Cancer Clinical Trials Act” in the Senate (S. 2999). The legislation was also introduced in the House by Rep. Deborah Pryce (R-OH) in June 2007 as H.R. 2676.

The Access to Cancer Clinical Trials Act would require health insurers and plans to pay for routine care costs when a cancer patient enrolls in a clinical trial. The legislation would only cover routine care costs, following the Medicare definition. It would not require health insurers and plans to pay for clinical trial costs, including the actual drug or device being tested and the research-related costs.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.

Senate Appropriations Committee To Include Increases to NIH and FDA in Supplemental Funding Bill
Sen. Tom Harkin (D-IA), chairman of the Senate Labor-HHS-Education Appropriations Subcommittee, indicated that the Senate version of the FY 2008 supplemental spending bill will include $400 million for the National Institute of Health (NIH). This amount would roughly double the increase provided to the FY 2008 NIH budget by Congress this past December and would fund approximately 700 additional research grants in FY 2008.

In addition, Sen. Herb Kohl (D-WI), chairman of the Senate Agriculture Subcommittee on Appropriations, has included $275 million in additional funding for the Food and Drug Administration (FDA) in the supplemental spending bill. Notably, FDA Administrator Andrew von Eschenbach sent a letter to Sen. Arlen Specter (R-PA), requesting an additional $275 million for FDA funding to ensure the safety of imported food, drugs and medical devices. Von Eschenbach’s request is especially significant in that it is unusual for an Agency head to diverge from the president’s budget proposal.

The total funding package will reportedly include more than $8 billion for investments in various priorities, as well as provide Department of Defense funding for Iraq and Afghanistan. The House bill is unlikely to include the same increase for NIH, and it is unclear whether the additional NIH and FDA funding will remain in the bill when the House and Senate reconcile their two versions of the bill in conference committee. The President has promised to veto any supplemental that exceeds his request.

ASCO will monitor the legislation’s progress and continue to keep members informed as the bill moves forward. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or researchpolicy@asco.org.

House Passes Genetic Information Nondiscrimination Act
On May 1, the House of Representatives passed H.R. 493, the Genetic Information Nondiscrimination Act (GINA) by a vote of 414-1, a week after the Senate passed the bill by a vote of 95-0.

The GINA legislation provides important federal protections against the misuse of genetic information by employers and health insurers. Specifically, the law will:

• Prohibit the use of genetic information to deny employment or insurance coverage.
  
• Ensure that genetic test results are kept private.
  
• Prevent an insurer from basing eligibility or premiums on genetic information.

The bill now goes to President Bush, who has indicated that he will sign it in to law.

ASCO has supported the passage of the GINA bill as a member of the Coalition for Genetic Fairness, a group founded in 2000 to address growing concern surrounding the misuse of genetic information in insurance and employment decisions.

ASCO will monitor GINA’s progress and keep members informed as the bill moves forward. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department, at 703-299-1050 or publicpolicy@asco.org.

FDA Plans To Add 1,300 Employees in Next Six Months
On April 30, the FDA announced plans to hire 1,300 employees within the next six months. Nearly two-thirds of the positions are allocated to the Center for Drug Evaluation and Research, which is responsible for review and approval of drug applications.

The Agency, which currently has more than 10,000 employees, wants to fill more than 600 new positions and backfill more than 700 others by October, tripling the number hired between 2005 and 2007.

Nearly 500 of the new jobs will be funded through user fees that FDA collects from the industries it regulates. Congress has been pressuring FDA to improve its operations, strengthen its inspections and hire more experts. For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.

ASCO Provides Feedback on Biosimilars to House Subcommittee on Health
ASCO responded to the House Committee on Energy and Commerce Subcommittee on Health’s request for feedback on questions related to biosimilars.

The purpose of the Subcommittee on Health’s request was to help lawmakers understand issues surrounding biosimilars in order to craft legislation that would create a pathway allowing the FDA to approve generic biologic products.

ASCO’s answers to the Subcommittee on Health were based on the Society’s principles for legislation that would create a regulatory pathway to approve biogenerics.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.

FDA Changes Acceptance Criteria for Foreign Clinical Trails
FDA is amending its regulations on accepting data that supports an application for marketing approval for a drug or biological product from foreign clinical studies that are not conducted under an investigational new drug (IND) application.

The final rule, effective October 27, updates standards for acceptance of foreign clinical studies not conducted under an IND and helps ensure protection of human subjects and the quality and integrity of data obtained from these studies.

The final rule replaces the requirement that these studies be conducted in accordance with ethical principles stated in the World Medical Association’s Declaration of Helsinki, with a new requirement that the studies be conducted in accordance with good clinical practice, including review and approval by an independent ethics committee.

For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.

Scientists Form International Cancer Genome Consortium
On April 29, research organizations from around the world announced the launch of the International Cancer Genome Consortium (ICGC), designed to generate high-quality genomic data on up to 50 cancer types over the next decade.

Each ICGC member intends to conduct a comprehensive, high-resolution analysis of the full range of genomic changes in at least one specific type or subtype of cancer. Each project is expected to involve specimens from approximately 500 patients and cost approximately $20 million.

Current ICGC members include:

• Australia: National Health and Medical Research Council (Observer Status)
  
• Canada: Genome Canada; Ontario Institute for Cancer Research
  
• China: Chinese Cancer Genome Consortium
  
• Europe: European Commission (Observer Status)
  
• France: Institute National du Cancer
  
• India: Department of Biotechnology, Ministry of Science & Technology
  
• Japan: Riken; National Cancer Center
  
• Singapore: Genome Institute of Singapore
  
• United Kingdom: The Wellcome Trust; Wellcome Trust Sanger Institute
  
• United States: National Institutes of Health (NIH)

For more information, visit the ICGC Web site.

Participate in the Physician Practice Information Survey
The American Medical Association (AMA) and more than 70 other organizations are conducting a comprehensive multi-specialty survey of America’s physician practices. The results will be used to positively influence national decision makers to ensure accurate and fair representation for all physicians and patients, and to articulate the challenges of running a practice that provides expert patient care, while operating a business that is sustainable. Of particular importance is the section of the study pertaining to practice expenses and the amounts that are attributable to you.

CMS has indicated it will use the results of this study to help determine physician payment. The survey firm, Dmrkynetec, will contact randomly selected physicians and practice managers to collect responses. All responses will remain confidential.

Please alert your staff regarding your willingness to participate in this survey and the importance of accepting incoming calls, faxes or emails from Dmrkynetec, the firm administering the survey.

If you have been selected to participate in this important effort and have any questions about this survey, please call Dmrkynetec toll-free at 1-877-816-8940 and ask to speak with an executive interviewers about the 2008 Physician Information and Practice Expense Survey.

News and Notes
ASCO Encourages Members to Share their Experiences about Flat Funding of NIH
ASCO is encouraging members with past or current experience applying for NIH funding to fill out a survey developed by the Federal Advocates Policy Partnership Research Working Group to encourage Congress to increase funding for the NIH. Please complete the survey by May 30, and contact Monica Ruiz with any questions at monica.ruiz@amfar.org.

ASCO Conducting Learning Needs Assessment of Member Physicians
ASCO is conducting a Needs Assessment of community practice members, focusing on learning styles, barriers to learning, access to technology, and other educational topics. This information will allow ASCO to more closely tailor products and meetings to members’ individual needs. You may be invited to join a focus group or to simply answer a few questions about your specific educational needs and how ASCO can help.

Reimbursement Session at the ASCO Annual Meeting
A “Forum on Reimbursement” special session will take place at 2008 ASCO Annual Meeting, on Monday, June 2, from 9:45 to 11:00 a.m. in the Arie Crown theater. For more information, contact Julia Tomkins at Julia.Tomkins@asco.org.

New ESA Instruction Sheet Available on ASCO Web site
An instruction sheet on reporting hematocrit/hemoglobin in conjunction with claims for erythropoiesis-stimulating agents (ESAs) is available on ASCO’s Web site.

Join ASCO's Advocacy Network
Advocacy is most effective when Members of Congress and government agencies hear from you, their constituents. By participating in ASCO's Advocacy Network, you will have the opportunity to develop ongoing relationships with your legislators while helping ASCO raise awareness on important cancer issues. To join the Advocacy Network, visit ASCO's Grassroots Action Center.

ASCO Extends Resources to Practice Administrators
ASCO encourages members whose practice administrators are interested in receiving Cancer Policy Today to forward their administrator's contact information to practice@asco.org.