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FDA asked to regulate advertising of anthrax vaccine

By Chris Strohm
GOV Exec

Two lawyers have asked the Food and Drug Administration to prevent the Defense Department and a private contractor from advertising that the government's anthrax vaccine is fully licensed.

The lawyers claimed the Pentagon and BioPort Corporation of Michigan should be prevented from saying the anthrax vaccine -- BioThrax -- is an FDA-licensed product. Mark Zaid, managing partner of Krieger & Zaid in Washington, and John Michels, a partner in the Chicago law firm of McGuireWoods, said the FDA is required to take such action in response to a recent court ruling.

Zaid and Michels represent six anonymous plaintiffs who filed a lawsuit against the military's anthrax vaccine program.

A federal judge decided Oct. 27 that the military must stop administering BioThrax, also known as Anthrax Vaccine Adsorbed, to service members.

Judge Emmet Sullivan of the U.S. District Court for the District of Columbia ruled that the vaccine was not properly licensed for protecting against inhaled anthrax.

"Unless and until FDA properly classifies AVA as a safe and effective drug for its intended use, an injunction shall remain in effect prohibiting [the military's] use of AVA on the basis that the vaccine is either a drug unapproved for its intended use, or an investigational new drug," Sullivan wrote.

The FDA previously issued a final rule and order in December 2003 saying the anthrax vaccine was licensed and safe and effective for the prevention of anthrax disease, regardless of the route of exposure. The judge, however, vacated that final rule and order in his ruling and told the FDA to get more public input and to reevaluate the vaccine.

Zaid and Michels sent a letter to the FDA last week stating that BioPort and the Defense Department continue to advertise that the anthrax vaccine is fully licensed for use against inhaled anthrax, despite the recent court ruling.

"The FDA is legally obligated per its statutory mandate to enforce the court's ruling and prevent the marketing of unlicensed vaccines," the lawyers wrote. "Yet, the FDA is permitting BioPort and others to openly advertise the AVA as a licensed vaccine for use against inhalation anthrax."

The letter added: "The FDA must take immediate and aggressive steps to ensure BioPort, its paid proxies and the Department of Defense accurately characterize AVA as an unlicensed and investigational vaccine for purpose of inhalational exposure."

FDA spokeswoman Lenore Gelb said the judge's ruling is "under review" and the agency is evaluating whether to reopen the public comment period for the anthrax vaccine. She said the FDA has no intention of directing BioPort or the Defense Department to alter their marketing materials for the vaccine, however, because the agency still considers AVA to be a fully licensed vaccine. Gelb declined to comment further.

BioPort did not return telephone calls for comment.

Zaid and Michels noted that BioPort recently dedicated a new facility in Maryland for producing 100 million anthrax vaccine doses when it becomes fully operational in two years.

"If BioPort wishes to continue to ignore the current legal climate concerning the status of the AVA, it does so at its own commercial risk," they concluded in the letter. "However, so long as the FDA continues to fail to exercise its authority to oversee the manufacturing and marketing of biological products, it seems clear that BioPort and others will take advantage of the FDA's dereliction of its duties."