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Re: CoMeD's Petition In Response To FDA Letter

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To All,

As promised CoMeD's in-depth response (under

21 CFR 10.35) to the FDA's letter to CoMeD

date-stamped " SEP 26 2006 " has been posted

to the CoMeD website on the documents page:

http://www.mercury-freedrugs.org/docs/

beginning with the the document link titled,

" CoMeD's Petition to FDA for a STAY under

21 CFR Sec 10.35. "

Would like to thank Kathleen Seidel of

neurodiversity.com for her assistance in

framing the CoMeD response.

Factually, the FDA's letter failed to address:

a. The key " safety not proven " issue (a non-

dischargeable responsibility of the drug

industry and the FDA - NOT a CoMeD

responsibility),

b. Related issues of the failure to comply

with all applicable policies, laws,

statutes and court decisions, and

c. The violation of bodily integrity by,

among other things, making false claims

of " safety " without the requisite

toxicological proofs to back up their

claims of safety.

- issues that were clearly addressed in the

original petition.

Based on the FDA's knowing failure to address

the issues raised in the original CoMeD citizen

petition (filed 4 August 2004), CoMeD started

a lawsuit that sought to compel the FDA to

answer the CoMeD petition in a manner that

complied with all applicable law.

To address the FDA letter, CoMeD e-filed an

answer to the government's motions and an

amended lawsuit on 25-27 October 2006.

For those interested, the federal lawsuit and

all related documents have been filed in the

U.S. District Court for the District of

Columbia under case: 1:06CV01357.

Hopefully, after thoroughly reviewing CoMeD's

petition for a stay and all of the supporting

documentation:

1. The FDA will address the original citizen

petition (filed in FDA's Public Docket as:

2004P-0349) in a manner that fully complies

with all applicable policies, laws, statutes,

and fedreal court decisions governing the

FDA's actions and the limits thereon as well

as the manufacturers' absolute duty to prove

drug safety, or

2. The federal court will compel the Secretary

of Health and Human Services and the FDA to

comply with all applicable policies, laws,

statutes, and fedreal court decisions governing

the FDA's actions and the limits thereon as

well as the manufacturers' absolute duty to

prove drug safety for all drugs, including

vaccines that contain Thimerosal or any

other mercury-based compound, at any level

above that which has been proven to be " safe, "

in the appropriate toxicological studies, to

be sufficiently nontoxic to those recipients

who are the most susceptible to mercury

poisoning.

Respectfully,

Dr. King

http://www.dr-king

CoMeD Science Advisor

http://www.mercury-freedrugs.org

+++++++++++++++++++++++++++++++++++++++++++++++

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