Progress of FDA Citizens Petition

[Guest guest]

To All:

If you have filed the FDA Citizens Petition/Anthrax Vaccine, I would like

to thank you. If you have not had the chance to do so, here is your

opportunity!

The web site at the FDA can search to see if your name has been posted. I

can assure you most have not! There are only 27 postings to date. In

frustration and knowing the importance, I called the FDA. I spoke with

in Dockets. She assured me that the postings would be updated by next

week. Lets make sure she does!

We can not drop the ball, so I am asking you to call Ms. and ask

if your name has been received and posted, if you can not find your name

posted. The FDA does not post comments, only names. And when calling,

REMEMBER, the FDA works for US! The toll free number is 1-888-463-6332. Of

course, the frustration of automated phone systems are at play, but if you

hit a button and get to talk to a person, have them transfer your call. I had

to be firm in my transfer! I was not given the direct number to Ms. .

Have the docket number with you, when and if you call. It also helps to have

the date in which you sent it.

Also, there may be some confusion on the petition. There are two listed

at Sorg's web site. Both are equally important! The first one listed,

above the counter, is with the direct link for e-mailing to the FDA. The

second one is an on-line petition to Destroy Quarantined Stockpiles. Again,

both are important.

I believe BioPort will be going for their inspection this week and your

action is needed. The FDA's business hours are M-F, and I believe 8-4. I

called during lunch hour and had no real problem.

Again, thank you and if you forwarded this petition to anyone, please

inform them. Sorry if you receive duplicates on this current mailing.

Sincerely,

Jane

* * * *

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.

The folks who administer these petitions have told us that any petition

receiving 100 comments is given an expeditious review and increased

exposure, as 100 comments is very rare in the FDA regulatory world.

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: <A

HREF= " http://www.enter.net/~jfsorg/ " >Anthrax Vaccine Risks</A> (the petition

is above the web site counter)

Here you will also 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@...

Subject: RE: Docket No. 01P-0471

Thank you for your time and concerns regarding the anthrax vaccine. If you

need more information or having difficulty please e-mail me at:

DaRocksMom@...

Sincerely,

Jane Tier

* * * * * * *

Dockets Management Branch

Department of Health and Human Services

Food and Drug Administration; Room 1-23

12420 Parklawn Drive

Rockville, land 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.