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Executive Summary

NATIONAL VACCINE INJURY COMPENSATION PROGRAM: ADVERSARIAL PROCESS set up by the existing U.S. claims court procedures is inappropriate, Advisory Commission on Childhood Vaccines Chairman Stephan Lawton maintained in a June 9 letter to HHS Secretary Louis Sullivan. The commission, which held its first meeting May 24-25, is charged with advising HHS on implementation of the 1986-established compensation program. "We believe that the existing rules and procedures unnecessarily create an adversarial process through imposition of requirements that may be appropriate for the usual type of civil case, but inappropriate for what Congress intended to be 'a Federal no fault compensation program under which awards can be made to vaccine-injured persons quickly, easily, and with certainty and generosity,'" Lawton wrote. "As a general rule, HHS should work to insure that the procedure before the claims court becomes simpler and less time consuming." If the "claims court proceedings were made less adversarial, clearly costs to all parties would be minimized," Lawton contended. The issue of litigation costs recently came to the forefront when the Department of Justice asked for a 90-day suspension of the program to seek additional resources to support attorney and staff participation in the proceedings. That request was denied by the claims court. Commenting on funding for Justice, Lawton told Sullivan that "the commission is opposed to earmarking money from the vaccine injury compensation trust fund for the purpose of paying staff of the Justice Department for representation of HHS in compensation proceedings." The commission, Lawton continued, "concluded [at its meeting] that monies in the trust fund should be reserved for the compensation of injured children, which is the primary purpose of the trust fund." The commission has established a working group to provide HHS with advice on implementation of the compensation program. The group, Lawton said, will "review the rules and practices developed by the claims court . . . as well as regulatory and statutory changes that would facilitate adjudication of claims, with or without participation by the Department of Justice." A second working group also has been formed "charged with the development of vaccine information materials and possible recommendations for any statutory changes necessary to simplify the materials," Lawton reported. HHS published a proposed draft of the information materials in the March 3 Federal Register. The commission is recommending that the proposed rule be withdrawn and redrafted with the aid of the commission, FDA, the Centers for Disease Control, and the American Academy of Pediatrics and patient advocacy groups. The HHS proposed materials, Lawton explained, "are too lengthy and difficult to understand, perhaps because their initial development was by government and not in consultation with the Commission, health care providers and parent organizations, as required by" the law establishing the program.

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