NATIONAL VACCINE COMPENSATION PROGRAM HAS PROCESSED OVER 517 PETITIONS
Executive Summary
NATIONAL VACCINE COMPENSATION PROGRAM HAS PROCESSED OVER 517 PETITIONS as of Sept. 7 and petitions are being filed at a rapid rate as the Oct. 1 program deadline draws near. At a Sept. 17 meeting of the National Vaccine Advisory Committee, Compensation Program Director Anthony Albertini, MD, announced that "unofficially" the program has now processed "well over 600 petitions." Albertini told the committee that many more petitions are coming in, and "the rate of increase is dramatic, with over 40 new petitions filed per day." Albertini reported that the program has received more than 5,000 inquiries and has awarded more than $55 mil. in compensation funds. Established in 1986, the program was originally intended to extend over four years, but the recent dramatic increase in petitions has spurred debate over whether the filing deadline should be extended. Proponents of an extension argue that early program activities did not adequately inform parents about the program. However, in the last two years, Albertini said, the program has launched an extensive multi-media campaign, mailing out more than 60,000 leaflets to 47 states and establishing a 24-hour "800" number, he said. A bill that would extend the program another six months was introduced Aug. 4 by Sen. Levin (D-Mich.). In response to a request from Barbara Lois Fisher, exec VP of Dissatisfied Parents Together, the National Vaccine Advisory Committee agreed that an extension was "appropriate," without discussing the length of the extension. Fisher had specifically requested a one year extension. However, Committee Chairman, D. A. Henderson, MD, Johns Hopkins University, pointed out that the committee was not in a position to determine the exact length of time required to process whatever number of applications are filed after the deadline. The new HHS Vaccine Adverse Events Reporting System (VAERS) was also discussed at the meeting. In a presentation to the committee, Robert Chen, the Center of Disease Control's Division of Immunology, reported that VAERS information would be sent out to "22,000 physicians in target groups who frequently administer vaccines" this month, and public health facilities are targeted for mailing next month. Chen predicted that the reporting system should be fully operational by November 1. Since September 1989, CDC has been working in conjunction with the firm ERC BioServices to create VAERS, "a single, nationwide system for reporting and analyzing information and adverse events occuring after receipt of a vaccine," Chen said. The purpose of the system is "to correct the problems of having two separate systems -- FDA and CDC -- one for the public and one for the private sector" that deal with the reporting of vaccine-related adverse events. The new VAERS system attempts to correct these problems by supplying all physicians and public health clinics with a simple vaccine injury table, a single form for reporting adverse events, and by making an "800" number available to interested parties. All reports will be processed by the ERC BioServices.
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