Guest guest Posted November 4, 2006 Report Share Posted November 4, 2006 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 +++++++++++++++++++++++++++++++++++++++++++++++ Quote Link to comment Share on other sites More sharing options...
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