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Capitol Report

Senior Director, Pharmacia Corporation Marguerite.D.Baxter{at}pharmacia.com

TERRORISM REMAINS FOCUS FOR THE 107TH CONGRESS

Two months after the terrorist attacks in New York and Washington, D.C., bioterrorism has emerged as the key focus of the 107th Congress. New dimensions in the federal response to September 11th occurred last month with the first case of anthrax being reported in Florida. Since then numerous initiatives in the Public Health Service have been launched, and legislators typically involved in health and human services legislative initiatives have turned their attention to terrorist threats using biological agents within U.S. borders.

Senators Kennedy (D-MA) and Frist (R-TN) are expected to introduce during the week of November 5th a comprehensive bill to put in place an infrastructure and national capacity to deal with bioterrorism. House efforts under the leadership of Congressman Tauzin (R-LA) are about a week or two behind Senate efforts.

The Kennedy/Frist proposal is believed to carry a price tag of about $3 billion. This will be in addition to the $1.5 billion that the Bush Administration is requesting to implement legislation enacted last year relative to bioterrorism. The Kennedy/Frist proposal will provide resources to states for augmenting public health capacity; incentives to develop vaccines; liability protection for vaccines; expansion of the Food and Drug Administration's authority to protect the food supply and other initiatives imperative to public health initiatives such as pharmaceutical stockpile and the role of the Environmental Protection Agency.

In addition, the Administration is working with congressional leaders on a $20 billion spending package for homeland defense. Further, the Administration and Congress are working to define an economic stimulus package prior to the congressional recess. Health issues are a component of the stimulus package as the House and the Senate versions are each grappling with how to deal with COBRA (Consolidated Omnibus Budget Reconciliation Act of 1985) eligibility, further federalization of private health insurance, expansion of the National Emergency Grant Program, and refundable and advanceable tax credit.

S. 1094 MARKED UP BY THE SENATE HELP COMMITTEE

S. 1094, the Hematological Cancer Research Investment and Education Act, passed a Senate HELP Committee markup by voice vote. The legislation would require the federal government to add to its hematologic cancer research and educational initiatives. S. 1094 was introduced by Senators Mikulski (D-MD) and Hutchinson (R-TX) after learning that a former colleague, Geraldine Ferraro, was suffering from multiple myeloma. The legislation requires that the Director of the National Institutes of Health (NIH) establish a blood cancer research, information, and education program emphasizing leukemia, lymphoma, and multiple myeloma. In addition, the legislation requires that the Centers for Disease Control and Prevention (CDC) create a public information program addressing these diseases. Passage of this bill will facilitate the ability of the Senate to appropriate additional resources to these programs.

PEDIATRIC DRUG TESTING AND LABELING INITIATIVES EXTENDED BY THE SENATE

On October 18, the U.S. Senate enacted the Best Pharmaceuticals for Children Act, extending authorities created in 1997 that are set to expire in December 2001. The House is expected to take up its version of the legislation the week of November 11th.

The legislation reauthorizes a 6-month period of exclusivity for products that proceed with and conduct pediatric studies at the request of the Food and Drug Administration (FDA). In addition, the legislation instructs the NIH to create a list of off-patent drugs for which pediatric testing is necessary. If the original sponsor does not pursue the testing of these products, the NIH has been given the authority to issue grants to third parties to undertake the required studies.

The legislation also establishes an Office of Pediatric Therapeutics within the FDA. This office is expected to coordinate the FDA's activities with regard to pediatrics.

CANCER CLINICAL TRIALS SUMMIT V

On October 4-5, 2001, the Cancer Research Foundation of America, the Coalition of National Cancer Cooperative Groups, Inc., the American Society of Clinical Oncology, the Oncology Nursing Society, and the Cancer Leadership Council convened the fifth annual Summit on Cancer Clinical Trials. Approximately 200 individuals attended the Summit. The meeting was entitled "Retooling the System: The Changes Ahead and How to Prepare for Them."

The purpose of the Summit Series is to provide an opportunity for the stakeholders in clinical cancer research to come together to address the existing clinical trials system. In addition, the Summit Series was designed to establish a platform for the stakeholders to work collaboratively throughout the year on outcomes of the summits. Previous summits have addressed how to bridge the gap that exists regarding reimbursement issues for clinical trials, develop strategies for improved patient participation in clinical trials, and increase public awareness of cancer clinical trials.

The objective of the fifth Summit was to examine the barriers to the clinical trial enterprise and outline strategies to overcome them in the next 3-5 years. The participants at this year's Summit addressed the following issues:

• the impact of molecular medicine on the design, development, and participation in clinical trials;
  
• endpoints and other regulatory review issues imperative to the design of clinical trials in molecular medicine;
  
• resource and infrastructure requirements in the public and private sectors that will be necessary to make the shift from traditional models of clinical trials to those on the cutting edge of molecular medicine;
  
• provider strategies to increase accrual to clinical trials, and
  
• issues affecting the oversight process of clinical trials, including informed consent, confidentiality, and randomization.
  

The meeting participants created six work groups, and long-term follow-up is planned. Each of the work groups has a set of leaders as well as a coordinator, and specific intervals for follow-up have been established to move the recommendations and findings forward from the Summit.

STEM CELL RESEARCH LEGISLATION ON HOLD

The Labor, Health and Human Services and Education Appropriations Bill will not include legislative provisions relative to stem cell research. The Senate Subcommittee on Labor, Health and Human Services (HHS), and Education has held nine hearings on stem cell research since late 1998. This past August the Administration issued an opinion that the National Institutes of Health could proceed with funding stem cell research using the 60 existing cell lines only. During consideration of the Senate Labor-HHS Appropriations bill on the Senate floor, it was determined that no amendments would be made to the bill, either expanding or decreasing the existing NIH authority. A commitment was made that the stem cell legislation introduced by Senators Harkin and Specter will be considered on the Senate floor independent of the appropriation early next spring. Opponents to the legislation concurred with the strategy to address stem cell issues at that time.

FISCAL YEAR 2002 APPROPRIATION FOR NATIONAL CANCER INSTITUTE

The fiscal year (FY) funding for the NIH remains on track for a doubling by 2003. In that regard, funding for cancer research at the National Cancer Institute is proposed by the Senate at $4.2 billion, $105 million above the Administration's proposal and $542 million more than the FY 2001 appropriation. The enactment of the bill is expected before the adjournment of Congress.

OUTPATIENT PAYMENTS FOR ONCOLOGY WILL UNDERGO ADJUSTMENT ONE YEAR EARLY

The Administration issued a "final" rule on outpatient passthrough payments on November 2, 2001. Heretofore, oncology products were exempt for a 3-year period from the Ambulatory Payment Classifications bundling, which went into effect 2 years ago. However, the Administration has made a decision to repeal the third year of exemption and roll in all exempt products, including chemotherapy. With that said, it is difficult to calculate the full impact of the final rule on reimbursement rates until December when Center for Medicare and Medicaid Services intends to issue a second final rule outlining payment rates. However, based upon the passthrough payment rule issued in November, there will be a reduction of payment of chemotherapeutic products from the current rates. More information on the actual payment rates will be provided in the next update.

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