Emergency-Use Authorization for Anthrax Vaccine Issued by FDA

The FDA issued an emergency-use authorization (EUA) Jan. 31 for military use of anthrax vaccine, marking the first time the agency has used its EUA power since it was granted the emergency authority last summer with the passage of Project BioShield.

Under the BioShield legislation, the FDA can authorize the use of an unapproved drug or medical product when it is determined that the treatment can be used to protect public health during a military, public health or domestic emergency declared by the secretary of defense, the HHS secretary or the secretary of homeland security.

In the case of the anthrax vaccine, the FDA's EUA authority was triggered recently by a order by outgoing HHS Secretary Tommy Thompson, who declared an emergency justifying the use of anthrax vaccine adsorbed. Thompson's order came at the recommendation of Deputy Secretary of Defense Paul Wolfowitz, who on Dec. 10, 2004, determined there is a significant chance of an anthrax attack on U.S. military personnel.

To view the EUA, go to http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0040-nad0001.pdf (http://www.fda.gov/OHRMS/DOCKETS/98fr/05n-0040-nad0001.pdf).