FDA Citizen Petition--Anthrax Vaccine
Posted: Fri Feb 01, 2002 6:11 am
Are you aware of the FDA Citizen Petition concerning the Anthrax Vaccine?
With the recent attacks of the anthrax mailings, we should all be concerned
that this is yet another vaccine to add to the list of many more to come.
This vaccine has been mandatory to all military, with many members leaving
the service or facing court-marial. Federal workers have been given this
vaccine and now the postal workers. Recent articles state it causes birth
defects.
In a hearing before congress, Dr. JOHNSON-WINEGAR states, "We certainly view
most of these vaccines in three tiers, tier 1 being the military, the
core military, whether that is active duty or active duty and Reserve, I
defer to people who have expertise in that area. The second area would be
our
allies and host nation civilians and certainly critical DOD civilians would
be the second tier. And the third tier would be something larger that could
extend potentially to the entire population of the United States. Also in
that second tier I would include people that we classify as the first
responders, the police, the fire, the medical people who would be the ones
to
come and respond to an incident."
The absence of valid statistical data has been a stumbling block for those
interested in understanding how safe - or unsafe - the anthrax vaccine
really
is.
Now, the patients themselves are initiating scientific studies to gather the
information. Women appeared to experience a higher systemic rate than men.
We would like your support and forward this to anyone on your list.
Directions are listed below. Thank you for your time in this crucial matter.
The writers of this petition are experts on the AVIP.
If you have any questions, you may contact:
Major Tom Rempfer at 860-668-1512, or 1513
Major Russ Dingle at 860-568-8767
Sincerely,
Jane Tier
* * * *
FDA Citizen Petition/Anthrax Vaccine
I would like to ask that you please take a short minute or two to submit a
comment to the FDA in support of the FDA citizen petition .
This petition is a valid and legal instrument that has been filed with FDA.
It seeks action by the FDA commissioner concerning the anthrax vaccine. By
law, FDA is required to respond to this petition. Their response to our
requests then becomes their legally binding position on the anthrax vaccine.
All that you need to do is write something on the order of "I support this
petition, docket number 01P-0471" Of course, more detailed comments are
welcome. (Emphasis in future docket entries should be placed on the
verification by GAO in their 23 OCT 01 testimony to Congress of the
unapproved manufacturing changes to the anthrax vaccine filters, and the
subsequent unreported chemical changes caused as a result.)
Below is a summary of the petition. To read the Citizen Petition in full
please go to http://www.enter.net/~jfsorg/ • Link: Anthrax Vaccine Risks (the petition
is above the web site counter)
Here you will be able to read official documents of the General Accounting
Office (GAO) Reports (the latest 10/01: Changes to the Manufacturing Process
), FDA Reports and Congressional Testimony.
*When corresponding to the FDA please use the address below and insert in
the
subject area the following:
Address: fdadockets@oc.fda.gov
Subject: RE: Docket No. 01P-0471
* * * * * * *
Dockets Management Branch
Department of Health and Human Services
Food and Drug Administration; Room 1-23
12420 Parklawn Drive
Rockville, Maryland 20857
CITIZEN PETITION:
The undersigned submit this petition under Section 360bbb-2 of the Federal
Food, Drug and Cosmetic Act, section 553(e) of the Administrative Procedures
Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to
request the Commissioner of Food and Drugs to take the administrative
actions
listed below regarding anthrax vaccine adsorbed.
A. Action requested
(1) Issue a Final Rule on the drug category placement of anthrax vaccine as
Category II (unsafe, ineffective, or misbranded) amending the as yet to be
finalized Proposed Rule as published in the Federal Register 13 December
1985.
(2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in the
possession of BioPort Corporation and all doses in private, public, U.S. or
foreign government possession.
(3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent
Application of CGMP Determinations (CPG 7132.12) with respect to anthrax
vaccine adsorbed (license #1260).
(4) Revoke the anthrax vaccine adsorbed license (license #1260) held by
BioPort Corporation.
Other links of interest:
ANTHRAX VACCINE HOME PAGE
Anthrax Vaccine Network
[Non-text portions of this message have been removed]
With the recent attacks of the anthrax mailings, we should all be concerned
that this is yet another vaccine to add to the list of many more to come.
This vaccine has been mandatory to all military, with many members leaving
the service or facing court-marial. Federal workers have been given this
vaccine and now the postal workers. Recent articles state it causes birth
defects.
In a hearing before congress, Dr. JOHNSON-WINEGAR states, "We certainly view
most of these vaccines in three tiers, tier 1 being the military, the
core military, whether that is active duty or active duty and Reserve, I
defer to people who have expertise in that area. The second area would be
our
allies and host nation civilians and certainly critical DOD civilians would
be the second tier. And the third tier would be something larger that could
extend potentially to the entire population of the United States. Also in
that second tier I would include people that we classify as the first
responders, the police, the fire, the medical people who would be the ones
to
come and respond to an incident."
The absence of valid statistical data has been a stumbling block for those
interested in understanding how safe - or unsafe - the anthrax vaccine
really
is.
Now, the patients themselves are initiating scientific studies to gather the
information. Women appeared to experience a higher systemic rate than men.
We would like your support and forward this to anyone on your list.
Directions are listed below. Thank you for your time in this crucial matter.
The writers of this petition are experts on the AVIP.
If you have any questions, you may contact:
Major Tom Rempfer at 860-668-1512, or 1513
Major Russ Dingle at 860-568-8767
Sincerely,
Jane Tier
* * * *
FDA Citizen Petition/Anthrax Vaccine
I would like to ask that you please take a short minute or two to submit a
comment to the FDA in support of the FDA citizen petition .
This petition is a valid and legal instrument that has been filed with FDA.
It seeks action by the FDA commissioner concerning the anthrax vaccine. By
law, FDA is required to respond to this petition. Their response to our
requests then becomes their legally binding position on the anthrax vaccine.
All that you need to do is write something on the order of "I support this
petition, docket number 01P-0471" Of course, more detailed comments are
welcome. (Emphasis in future docket entries should be placed on the
verification by GAO in their 23 OCT 01 testimony to Congress of the
unapproved manufacturing changes to the anthrax vaccine filters, and the
subsequent unreported chemical changes caused as a result.)
Below is a summary of the petition. To read the Citizen Petition in full
please go to http://www.enter.net/~jfsorg/ • Link: Anthrax Vaccine Risks (the petition
is above the web site counter)
Here you will be able to read official documents of the General Accounting
Office (GAO) Reports (the latest 10/01: Changes to the Manufacturing Process
), FDA Reports and Congressional Testimony.
*When corresponding to the FDA please use the address below and insert in
the
subject area the following:
Address: fdadockets@oc.fda.gov
Subject: RE: Docket No. 01P-0471
* * * * * * *
Dockets Management Branch
Department of Health and Human Services
Food and Drug Administration; Room 1-23
12420 Parklawn Drive
Rockville, Maryland 20857
CITIZEN PETITION:
The undersigned submit this petition under Section 360bbb-2 of the Federal
Food, Drug and Cosmetic Act, section 553(e) of the Administrative Procedures
Act, and Title 21 Subsection 10.30 of the Code of Federal Regulations to
request the Commissioner of Food and Drugs to take the administrative
actions
listed below regarding anthrax vaccine adsorbed.
A. Action requested
(1) Issue a Final Rule on the drug category placement of anthrax vaccine as
Category II (unsafe, ineffective, or misbranded) amending the as yet to be
finalized Proposed Rule as published in the Federal Register 13 December
1985.
(2) Declare as adulterated all stockpiles of anthrax vaccine adsorbed in the
possession of BioPort Corporation and all doses in private, public, U.S. or
foreign government possession.
(3) Enforce FDA Compliance Policy Guide, Section 400.200 Consistent
Application of CGMP Determinations (CPG 7132.12) with respect to anthrax
vaccine adsorbed (license #1260).
(4) Revoke the anthrax vaccine adsorbed license (license #1260) held by
BioPort Corporation.
Other links of interest:
ANTHRAX VACCINE HOME PAGE
Anthrax Vaccine Network
[Non-text portions of this message have been removed]