Appeals Court Pursues Unexpected Inquiry In DOD Anthrax Shots Case
Inside the Pentagon
By Elaine M. Grossman
A federal appeals court considering a Bush administration request to restart mandatory anthrax inoculations for selected military personnel this week ordered both sides in the case to submit written arguments on a point of law neither party has emphasized to date.
The government appeal seeks to reverse a 2004 decision by U.S. District Court Judge Emmet Sullivan, who declared the Pentagon anthrax inoculation program "illegal" because the Food and Drug Administration had not properly approved the vaccine for protection against inhaled spores.
On Monday (Dec. 5), the DC Circuit Court directed the government to submit a brief by Dec. 12 on the question of whether the anthrax vaccine is a "drug unapproved for its applied use" under the law governing the armed services, because the vaccine was originally licensed in a manner unrecognized by Title 10 of the U.S. Code.
The drug's license was approved by the National Institutes of Health for individuals such as veterinarians, laboratory workers and others exposed to potentially infected animals.
During Dec. 1 oral arguments before the appeals court, Judge David Tatel asked if the government was relying on a Title 10 provision that requires drug labeling approved by the FDA under the terms of the Federal Food, Drug and Cosmetic Act.
Justice Department attorney Michael Raab replied that the Public Health Service Act extended the coverage of the Federal Food, Drug and Cosmetic Act to NIH-approved biological products like the anthrax vaccine.
What is unusual is that this is not an argument that those who brought the case against the Defense Department have emphasized to date.
Another member of the three-judge appeals panel, A. Raymond Randolph, asked a plaintiffs' attorney to address the issue.
John Michels -- who filed the suit with co-counsel Mark Zaid in 2003 on behalf of five anonymous military personnel and one civilian who refused the shots -- said he did not question the validity of the NIH anthrax vaccine license itself. Rather, he asserted the Defense Department wants to use the anthrax vaccine in a manner "not described in the approved labeling" to protect against inhaled spores, as opposed to less risky skin contact with anthrax.
If so, the anthrax vaccine would be considered an "investigational new drug" and inoculations would require either a service member's consent or a presidential waiver based on national security considerations, Michels said. This is the argument upon which Sullivan's decision -- and his ban on DOD's mandatory shots program -- was based.
Appeals Judge Thomas Griffith also questioned whether there is a legal basis to ban anthrax inoculations across the Defense Department, rather than apply such a remedy solely to the six plaintiffs. But since the status of the vaccine applies to any military personnel, it is a "logical outgrowth" to decide the case Pentagon-wide, Michels argued.
On the question of the anthrax vaccine license validity, the appeals court directed Michels and Zaid to respond to the government brief by Dec. 19. The administration will have an opportunity to reply with another short written brief of its own by Dec. 22.
