Please submit your comments, via the links at the bottom of this email, to the FDA public docket for anthrax vaccine. 

Please submit your comments, via the links at the bottom of this email, to the FDA public docket for anthrax vaccine.  This docket opened on December 29, 2004, and closes on March 29, 2005.  This public docket is a court ordered requirement based on the FDA's December 2003 previous improper and illegal attempt to finalize the anthrax vaccine license.  The Agency was found to have broken the law and the DoD's program was rendered illegal.  The FDA is now attempting to accept public comments, but is once again short cutting the normal process by failing to form an expert panel to review the new data that the DoD has generated to support full and final licensure of the anthrax vaccine.

 
The federal judge's October 27, 2004 ruling (http://www.dcd.uscourts.gov/Opinions/2004/Sullivan/03-707c.pdf) specifically delineated that the FDA "must" follows their own rules.  According to the court, when the FDA experts "review the labeling" of a vaccine the Agency follows a "two-stage" process whereby an expert review panel reviews the scientific data and submits a report to the FDA Commissioner prior to a proposed rule.  Currently the FDA is circumventing their normal requirement for an expert review panel, moving directly to a proposed ruling for full vaccine licensure.
 
On page 30, footnote 9, of the judge's ruling about the illegality of the anthrax vaccine mandate, the judge also captured the DoD's attorney's admitting that the original proposed, and never finalized, licensure of the anthrax vaccine in 1985 didn't contemplate the vaccine's mass use for inhaled anthrax.  Attorney for the DoD and FDA:  "But itís absolutely right, Your Honor, that the possibility of weaponized anthrax was not in the minds of the advisory panel and probably not in the minds of the FDA."  The judge also transcribed the FDA's original 1985 review of the vaccine, published in the federal Register:  "Anthrax vaccine poses no serious special problems other than the fact that its efficacy against inhalation anthrax is not well documented."  Considering these facts and admissions, the FDA "must" reform an expert panel to review all new data, never "contemplated" by the original 1985 experts, that the DoD has generated to support a final license.
 
The federal court also cited a Citizen Petition filed on October 15, 2001 (Docket: 01P-0471 Issue the NFR Placement of Anthrax Vaccine as Category II), in which we identified to the FDA the never finalized state of the anthrax vaccine, while respectfully requesting the Agency do so properly.  The FDA did not act on the Petition, instead having to be ordered to do so by a federal judge four years later.  Additionally, the FDA has never held the DoD or the manufacturer accountable for the illegal and adulterating manufacturing changes that the vaccine underwent prior to the first Gulf War. These illegal alterations may have made the vaccine up to one-hundred times more potent, though the changes and the vaccine have been excluded from study by the DoD as a possible cause of Gulf War Illness. These unapproved alterations were reported in our Petition, and also to the Government Accountability Office (GAO) who validated the concerns in a report, http://www.gao.gov/new.items/d02181t.pdf.  Curiously, the GAO also has reported that adverse reactions to the anthrax vaccine are one-hundred times higher than DoD first acknowledged.
 
If you concur that the FDA's conduct in previously illegally attempting to improperly licensing the anthrax vaccine for the DoD is unacceptable, and that the most recent attempt to re-license the vaccine without appropriate independent expert panel review is similarly improper, please submit your comments to the public docket via the links, address or fax number below.
 
Sincerely,
 
Major Thomas L. "Buzz" Rempfer
860-680-8452
 
Comments Due: March 29, 2005
How to Comment: Submit a Comment on this Regulation
You may submit comments, identified by Docket No. 1980N-0208, by any of the following methods: Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the instructions for submitting comments on the agency Web site. E-mail: fdadockets@oc.fda.gov. Include Docket No. in the subject line of your e-mail message. FAX: 301-827-6870. Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the agency name and Docket No. for this proposal. All comments received will be posted without change to http://www.fda.gov/ohrms/dockets/default.htm