Update On the Citizen Petition to the FDA -- Oct. 24, 2002
                                
Three major revelations presented by FDA's interim response to the Citizen Petition, Docket
#01P-0471, follow. Links and background are included at the end.

1.  FDA admits the licensing rule for anthrax vaccine has not been finalized, and further that they
are required by law to accomplish this task.  Since the original approval of anthrax vaccine in
1970 was not based on the Brachman data, yet their proposed rule in 1985 is, this means that the
anthrax vaccine license has never been finalized based on the supporting scientific data the DoD,
FDA, and the manufacturer rely upon today.  This is an important admission which renders
anthrax vaccine without a proper finalized license today.

2.  FDA admits they do not intend on releasing any anthrax vaccine held in strategic stockpiles
that are cited in the Petition, essentially any vaccine made prior to the initial launch of the AVIP
in 1998.  These stockpiles resulted in every punishment and every illness on record to date.  The
importance of this admission can only be logically followed by the commonsense
acknowledgment that no service man or woman should have ever been punished over these
unreleasable lots and any such punishments should be rescinded ASAP. 

3.  Finally, despite the fact that FDA maintains that everything is "currently" OK, they also
acknowledge that they did not enforce their own policy guidance by ensuring that the
government "must" disapprove all contracts with manufacturers that are not in compliance with
current good manufacturing practices.  BioPort and her predecessors were not in compliance
throughout the life of the AVIP, and therefore the logical conclusion follows that the very
vaccine contracts that found so many soldiers punished and ill were not allowed by government's
own guidance.  FDA dismisses their responsibility to enforce their own guidance because they
maintain they were not bound to by law.