FOR IMMEDIATE RELEASE: December 30, 2003

FOR FURTHER INFORMATION CONTACT

Mark S. Zaid, Esq.

(202) 454-2809

(202) 498-0011 (cell)

John J. Michels, Jr., Esq.

(312) 750-2770

WASHINGTON, D.C. --

In the wake of a December 22, 2003, Court-imposed Preliminary Injunction prohibiting the government's use of the anthrax vaccine for protection against inhalation exposure without informed consent, the Food & Drug Administration (FDA) today issued a Final Rule and Order concerning the alleged safety and effectiveness of the vaccine. Relying upon a 1985 proposed rule, the FDA now claims that "the efficacy of the vaccine includes all cases of anthrax disease regardless of the route of exposure or manifestation of disease."

The Honorable Emmet G. Sullivan of the United States District Court for the District of Columbia had ruled that the vaccine "is an investigational drug and a drug being used for an unapproved purpose...Absent an informed consent or presidential waiver, the United States cannot demand that members of the armed forces also serve as guinea pigs for experimental drugs."

"This alleged Final Rule is nothing more than after-the-fact gamesmanship to overrule the Court's findings. It appears reflective of policy duress than independent analysis given that the 1985 proposed rule has existed for nearly 20 years without FDA action", said co-counsel Mark S. Zaid, Esq. In fact, the 1985 Panel determined that "no meaningful assessment of [the vaccine's] value against inhalation anthrax is possible..." added Zaid.

The Expert Panel limited the scope of the license when it stated "this product appears to offer significant protection against cutaneous anthrax in fully immunized subjects." Zaid also noted that the DoD has not been providing its service members or civilian contractors with the full series of shots required by the FDA.

In examining the merits of the case, Judge Sullivan concluded that the "DoD's administration of the inoculation without consent of those vaccinated amounts to arbitrary action." He further opined that "the right to bodily integrity and the importance of complying with legal requirements, even in the face of requirements that may potentially be inconvenient or burdensome, are among the highest public policy concerns one could articulate."

"The FDA pronouncement is not retroactive and, at best, means that the FDA has issued a ruling that makes the vaccine properly licensed from this point forward," said co-counsel John J. Michels, Jr., of McGuire Woods LLP.  "It is clear that the FDA believes that its Final Rule alters the landscape regarding how the vaccine is categorized, and therefore, all persons vaccinated to this point were inoculated with an unlicensed or investigational vaccine," added Michels.

Internal government documents, many of which were placed before the Court, reveal a history of regulatory violations and scientific concerns regarding the DoD's Anthrax Vaccination Immunization Program ("AVIP"). A 1994 report by the Senate Veterans Affairs Committee concluded that the vaccine could not be expected to protect troops against airborne anthrax and should be considered experimental. In February 2000, the House of Representative's Committee on Government Reform recommended the termination of the mandatory AVIP.

"In addition, FDA regulations indicate that the investigational status of a vaccine is not determined solely by its license status. The anthrax vaccine manufacturer has a current investigational new drug application pending before the FDA for inhalation anthrax; this application places the vaccine in IND status when the vaccine is used as a preventative for inhalation anthrax," said Michels.  The Court noted that vaccines and drugs may be licensed for one application and investigational for another. 

The lawsuit was filed under pseudonyms on March 18, 2003, by six plaintiffs (and other similarly situated individuals) who are either members of the active duty and selected National Guardsmen components of the Armed Forces or civilian contract employees of the Defense Department. Each of the plaintiffs had been ordered to take the anthrax vaccine. The government has indicated it will shortly seek to vacate the injunction based on the FDA's Final Rule.

The plaintiffs were represented by John J. Michels, Jr., a partner in the Chicago office of McGuire Woods LLP (www.mcguirewoods.com), who previously represented Major Sonnie Bates and Captain John Buck, the highest military officers to refuse the anthrax vaccine, and Mark S. Zaid, Managing Partner of the Washington, D.C. law firm of Krieger & Zaid, PLLC, which routinely represents individuals employed within the United States Intelligence and Military communities.

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