Sunday, November 1, 2009

Lawsuit filed to HALT release of H1N1 vaccine

By Sarah Foster
Posted 1:00 AM Eastern
October 14, 2009
© 2009
WASHINGTON – With the U.S. Food and Drug Administration scheduled to begin nationwide delivery this week of swine flu vaccine to 90,000 government-approved locations, attorney James Turner filed a complaint Friday in federal court in the District of Columbia for a Temporary Restraining Order to halt the distribution, licensing and use of four controversial vaccines -- including their use under an existing Emergency Use Authorization (EUA) -- until there has been adequate safety testing and a full opportunity for public hearings.
The suit challenges the Sept. 15 licensing of four swine flu vaccines, alleging that the FDA violated the law in its hurried approval by failing to determine the safety and efficacy of the vaccines as required by law since 1964.
Turner told NewsWithViews that none of the procedures that should have been done, and that make up a formal administrative record, had been done.
“Our argument is that they’re required to follow the law that says how you determine something is safe and effective,” he said. “They did not follow that law. They did not have any public hearings; they did not have any notice and comments. Their core argument is that this is such a unique and significant problem that they must move forward immediately and vaccinate everybody if they can. The way they’re doing that is to argue that the virus itself is so similar to the ordinary, routine flu [virus] that they do not have to go through the regular process of safety approval for this new drug.”

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