FDA Condones False Advertising about anthrax vaccine

FDA Condones False Advertising about anthrax vaccine

Thu, 9 Dec 2004

The FDA and the Pentagon are flagrantly violating the law and a U.S. Court ruling.

On October 27, 2004, a US Court ordered the Pentagon to suspend its forced anthrax vaccination of military personnel, and the Court ordered the FDA to “follow the law in order to carry out its vital role in protecting the public’s health and safety.” See: http://www.govexec.com/dailyfed/1204/120804c1.htm

The case involves six anonymous service members who challenged the legality of the military’s Anthrax Vaccination Immunization Program because the anthrax vaccine has not undergone appropriate clinical trials to determine its safety and effectiveneness. Thus, the vaccine is an investigational drug, requiring voluntary, informed consent by those who choose to be human test subjects.

In its ruling, the Court stated: “This court will not permit the government to circumvent this requirement. 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.”

Lawyers for plaintiffs complained in a letter to the FDA that: “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.”

According to GovExec.com, “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. ”

This is another example of the culture of arrogance and disregard for US law, under which the highest officials at the FDA operate. The FDA is no longer an agent of the lawful government, but an agent of the drug / biologics industry. Congress must act if we are to restore public trust in anything the FDA gives US seals of approval for.

Contact: Vera Hassner Sharav
212-595-8974

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FDA asked to regulate advertising of anthrax vaccine
By Chris Strohm

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.”

http://www.govexec.com/dailyfed/1204/120804c1.htm

Court stops Defense Department anthrax vaccinations
October 27, 2004
By David McGlinchey

The Defense Department suspended anthrax vaccinations for the second time in a year after the U.S. District Court for the District of Columbia ruled that more public input was required on the dangers of the controversial inoculation.

“This court has an obligation to ensure that [the Food and Drug Administration] follow the law in order to carry out its vital role in protecting the public’s health and safety,” according to the court’s ruling, which was issued Wednesday. “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.”

A Pentagon spokesman said the suspension of anthrax vaccinations would not have any effect on the deployment of personnel to conflicts overseas. A memo from Defense Secretary Donald Rumsfeld also defended the existing policy, saying that Pentagon officials “remain convinced” that the “anthrax vaccine is safe and effective.”

Last December, U.S. District Judge Emmet Sullivan ordered the Pentagon to stop administering the vaccine because the FDA did not specifically declare the immunizations to be effective against inhaled anthrax. The ruling was prompted by a lawsuit brought by six anonymous service members who challenged the legality of the Anthrax Vaccination Immunization Program. As part of the AVIP, military personnel are required to receive a series of anthrax immunizations over the course of 18 months, followed by annual booster shots.

Ten months ago, Sullivan said the vaccine should have been classified as an investigational drug. On Dec. 30, 2003, the FDA released a final rule that officially classified the anthrax vaccine as effective for dealing with inhaled anthrax. Sullivan lifted the injunction shortly after. In Wednesday’s ruling, Sullivan vacated the final rule and ordered the FDA to “properly” classify the vaccine.

“This court will not permit the government to circumvent this requirement,” the ruling stated. “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.” Pentagon spokesman James Turner said it was unclear how long the current injunction would remain in place. According to Turner, officials are reviewing the injunction but it is “too soon to tell” when the immunizations will resume. He expects to know more by the middle of next week.

Anthrax vaccines have caused controversy in the military, with hundreds of service members refusing the immunizations because of concerns over side effects. Some personnel have faced disciplinary actions or have been forced out of the military for their refusal.

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