News of the Day ... in Perspective10/28/2004
Court renders military forced anthrax vaccination program illegal
On Oct. 27, U.S. District Judge Emmet G. Sullivan ordered the military to stop requiring anthrax vaccinations.
In December, 2003, the Court had issued a temporary restraining order against mandatory anthrax vaccinations, but this was lifted eight days later, when the FDA issued a Final Rule and Order classifying anthrax vaccine adsorbed (AVA) a Category I drug (a drug that is safe, effective, and not misbranded).
Judge Sullivan found that the Final Rule was issued in violation of the Administrative Procedure Act, which requires a public notice-and-comment period. The comment period for the Proposed Rule was closed on March 18, 1986, 18 years before the Final Rule was issued.
In issuing the Final Rule, the FDA relied on studies and data that were not in existence at the close of the comment period. Thus, there was no opportunity for “meaningful commentary.”
The Court observed that “if the status of the anthrax vaccine were open for public comment today, the agency would receive a deluge of comments an analysis that might inform an open-minded agency.” The Rule has been remanded for reconsideration following an appropriate notice-and-comment period.
The Pentagon noted that the Court did not question the safety or effectiveness of the vaccine. The Judge observed that Courts are required to be highly deferential to federal agencies. He was specifically ruling on the issue of whether the Agency complied with its own procedures.
The Department of Defense is not allowing soldiers the opportunity to be vaccinated against anthrax voluntarily, according to Dr. Meryl Nass.