Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

NATIONAL VACCINE INJURY COMPENSATION PROGRAM: ADVERSARIAL PROCESS

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.

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS015795

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel