ASCO Urges Senators to Support Comprehensive Cancer Care Improvement Act
ASCO is urging all members of the Senate to support the Comprehensive Cancer Care Improvement Act (S. 2790) introduced March 31 by Sen. Mary Landrieu (D-LA). Key provisions of the Comprehensive Cancer Care Improvement Act include:
- Establishing a new Medicare service for a written care plan, treatment summary and survivor care plan that is communicated to survivors.
- Authorizing Medicare demonstration projects to evaluate the cost and effectiveness of comprehensive cancer care that incorporates curative and palliative care.
- Authorizing programs to enhance training in comprehensive cancer care and establishing model comprehensive cancer care systems.
The companion bill in the House, H.R. 1078, now has nearly 100 co-sponsors. For more information, contact ASCO's Cancer Policy & Clinical Affairs Department at 703-299-1050 or publicpolicy@asco.org.
FDA Releases Draft 5-year Drug Safety Plan as Part of PDUFA IV
The Food & Drug Administration (FDA) has released a draft 5-year drug safety plan as part of its obligations under the Prescription Drug User Fee Act (PDUFA).
Under the PDUFA IV program, $29.29 million in user fees (plus an annual inflation factor) will be allocated annually to enhance the Agency’s drug safety capabilities through 2012. With these funds, FDA will be able to increase the number of employees dedicated to safety evaluation of marketed medications. FDA also will be able to add resources for adopting new scientific approaches to drug safety, reducing the risk of medication errors, improving existing tools for detection and prevention of adverse events, and incorporating the new approaches into the Agency’s drug safety program.
The strategy for enhancing and modernizing the drug safety program includes the following elements:
- Strengthening management and operations.
- Improving collection and analysis of adverse event data.
- Implementing epidemiology best practices.
- Expanding database acquisition and use for targeted post-marketing surveillance and epidemiology.
- Strengthening risk management and communication tools.
- Improving post-market information technology systems.
- Increasing timely, consistent review of new drug trade names to prevent name confusion.
Congress enacted PDUFA in 1992 to provide authority for FDA to collect fees from industry to address significant delays in its new drug evaluation process. Congress reauthorized the law last year.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or researchpolicy@asco.org.
ASCO Submits Comments on Evidentiary Priorities for Research in the Medicare Population
Last fall, CMS initiated an effort to develop a list of the most important evidentiary gaps for the elderly. CMS put together a list of 100 research questions and has since narrowed the list down for further discussion at an April 30 meeting of the Medicare Evidence Development and Coverage Advisory Committee (MedCAC). CMS has signaled that it will rely on these evidentiary priorities and related research efforts to make coverage decisions.
Included among the cancer-specific issues that will be reviewed are: 1) the benefit of cancer prognostic markers, 2) the question of whether some cancer treatments are more toxic in older patients with comorbidities, and 3) more general health policy topics, such as how to reduce barriers to clinical trials participation in the Medicare population.
ASCO submitted comments April 2 addressing the list of evidentiary priorities. ASCO’s comments focus on the need for collaboration with professional organizations, oncology researchers, and clinicians in investigating these issues. ASCO also recommended that financial barriers to Medicare beneficiaries’ participation in trials continue to be addressed by a predictable and reliable clinical trials coverage policy.
For more information, contact ASCO’s Cancer Policy & Clinical Affairs Department at 703-299-1050 or practice@asco.org.
House Energy and Commerce Committee Advances Family Smoking Prevention Act
On April 2, The House Energy and Commerce Committee voted to advance The Family Smoking Prevention and Tobacco Control Act (H.R.1108) with bipartisan support to the full House for a vote. The final committee vote was 38-12.
H.R.1108 would grant FDA the ability to regulate tobacco products, restrict advertising and marketing of tobacco products, control nicotine levels, and prescribe warning labels. S.625, the Senate companion bill, passed out of committee August 1, 2007. The House bill has 220 co-sponsors, and the Senate bill has 56 co-sponsors.
More than 600 national and local public health organizations support H.R.1108. ASCO thanks all committee members that voted to advance the legislation, and urges all members of Congress to support this bill.
Contact Cancer Policy and Clinical Affairs with any questions at 703-219-1050 or publicpolicy@asco.org.
FDA Appoints Dr. Frank M. Torti to Senior Leadership Position
FDA appointed ASCO member Frank M. Torti, M.D., M.P.H. as the Agency’s Principal Deputy Commissioner and first-ever Chief Scientist. The newly created Chief Scientist position stems from the FDA Amendments Act of 2007.
Dr. Torti will work to ensure the quality and regulatory focus of the intramural research programs of the agency, placing special emphasis on the importance of clinical research trials as a part of the foundation of the FDA's regulatory structure. Dr. Torti also will support the launch of the FDA Fellowship Program.
Dr. Torti is currently serving as Charles L. Spurr Professor of Medicine, Chair of the Department of Cancer Biology, and Director of the Comprehensive Cancer Center at Wake Forest University School of Medicine in Winston-Salem, N.C. Dr. Torti will join FDA in May.
News and Notes
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.
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