Court ruling again stops anthrax shots for US soldiers

Oct 28, 2004 (CIDRAP News) – The Department of Defense (DoD) has suspended its anthrax vaccination program in response to a federal court ruling that military personnel should not have to accept the shots against their will unless the president orders them to do so.

US District Judge Emmet G. Sullivan of Washington, DC, ruled yesterday that the Food and Drug Administration (FDA) failed to follow proper procedures in approving use of the anthrax vaccine to prevent inhalational anthrax.

"By refusing to give the American public an opportunity to submit meaningful comments on the anthrax vaccine's classification, the agency violated the Administrative Procedure Act," Sullivan wrote in the conclusion of a 41-page opinion.

Asserting that the vaccine amounts to "either a drug unapproved for its intended use or an investigational new drug," Sullivan said the vaccination program is illegal unless the shots are voluntary or the president waives the requirement for informed consent.

In response, DoD issued a statement yesterday saying it would "pause giving anthrax vaccinations until the legal situation is clarified." The statement added, "DoD remains convinced that the anthrax immunization program complies with all the legal requirements and that the anthrax vaccine is safe."

More than 1 million military personnel, mostly those serving in the Middle East, have had to receive anthrax shots since 1998. Because of worries about side effects, some troops have refused the shots and been punished or forced out of the military.

Sullivan's ruling came in a suit filed by six military members and civilian contractor employees. In an initial ruling in December 2003, the judge ordered DoD to stop requiring the shots on the ground that the FDA had never specifically approved the vaccine for inhalational anthrax, as distinguished from cutaneous anthrax.

The FDA quickly responded with a statement, based on the findings of an expert panel in 1985 and on subsequent research, that the vaccine is safe and effective for all forms of anthrax. Sullivan then lifted his injunction in January 2004, little more then 2 weeks after he had issued it.

In the latest ruling, Sullivan said the FDA failed to follow its own rules in approving use of the vaccine for inhalational anthrax. He explained that the agency took over licensing of drugs and vaccines from the National Institutes of Health (NIH) in 1972. The FDA subsequently set up formal procedures for reviewing products that had been licensed by the NIH. The procedures included reviews by an expert panel and soliciting public comments before confirming the product approvals.

In 1985, the expert panel recommended confirming the approval of the anthrax vaccine and certain other products, saying the vaccine was effective against cutaneous anthrax in at-risk workers. The FDA then proposed to issue the approval and called for public comments, Sullivan wrote. Only four comments were received by the 1986 deadline, none of them specific to the anthrax vaccine.

The judge said the FDA took no further action until December 2003, shortly after his initial ruling in the lawsuit. In confirming the vaccine's license at that time, and saying it was effective for all forms of anthrax disease, the FDA relied partly on post-1986 research findings, on which the public never had a chance to comment, according to Sullivan.

As in his previous ruling, Sullivan cited a 1998 law barring DoD from forcing its personnel to take investigational new drugs or drugs not approved for their intended use. Under the law, only the president can waive the requirement for informed consent.

"This court will not permit the government to circumvent this requirement," the judge wrote. "The men and women of our armed forces deserve the assurance that the vaccines our government compels them to take into their bodies have been tested by the greatest scrutiny of all—public scrutiny. This is the process the FDA in its expert judgment has outlined, and this is the course this Court shall compel FDA to follow."

According to a Washington Post report today, Mark Zaid, a lawyer for the six plaintiffs, said he would take steps to reverse all penalties inflicted on soldiers who refused to take the vaccine. He also promised to seek compensation for those who claim they were harmed by the vaccine.

See also:

DoD news release
http://www.defense.gov/releases/release.aspx?releaseid=7878

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