My letter to the FDA

[Guest guest]

To All:

Today I went to my state reps office and faxed a letter (plus cc's to listed

below) to the Acting Commissioner at the FDA. I had no problem. I realize

that no one will read this letter, so I just decided to " go for it " . Check

out my first carbon copy! I am sure the list could go on with cc, but did not

what to push my luck. Maybe others on the list will follow addressing it to

perhaps someone else. I tried to remain professional, as I am just a mom!

DaRocksMom [DA:) ]

Jane

p.s. yes my real name is Janet and I hate it!

December 18,2001

Food and Drug Administration

5630 Fishers Lane

Rockville, MD 20852

Dear (Acting) Commissioner Schwetz:

I would like to bring to your attention a Citizens Petition filed with

the FDA concerning the

anthrax vaccine (Docket No. 01P-0471).

It is my understanding any petition receiving 100 comments is given an

“expeditious review

and increased exposure”.

There are well over 200 current comments for this petition. It appears,

while BioPort is

going for inspection, that the FDA is not giving the “expeditious review and

increased exposure.”

It appears “Domestic Marketing & Importation of Transgenic Fish” has

received priority over

this crucial issue. I have personally talked to in Dockets at

the FDA and she assures

me she will be posting by the end of next week. She was “out a couple of

weeks and well – with the

holidays, I am backlogged.” Outrageous oversight, due to clerical priorities

is intolerable to the

signees representing the American public.

According to the media, BioPort’s quarantined drug stockpile has been

released.

The latest GAO Testimony before the Subcommittee on National Security,

Veterans’ Affairs, and

International Relations, Committee on Government Reform, and the House of

Representatives

that was released October 23, 2001, concerning the “Changes to the

Manufacturing Process”,

highlights the petitions importance. I hope it has not reached the point of

no return or lost

“trust and good faith” with this public health controversy and I hope you

will be instrumental

in its resolve.

With your authority and the “mission of the FDA”, I encourage your

immediate attention

in this matter; Citizens Petition, Docket No. 01P-0471.

Sincerely,

Janet Tier

23 Rambler Rd.

Glenolden, PA 19036

cc:

The Honorable W. Bush, President of the United States

The Honorable Congressman Burton, Chairman, Government Reform Committee

The Honorable Congressman Shays

A. Suydam DPA, Senior Associate Commissioner

Dockets Management Branch