This is in line with our (Public Health and Medical Fraud Research) previous assessment and regulatory information on some of the vaccine safety issues.
My research regulatory group and I also feel the vaccines in question are in violation of the federal Food, Drug, & Cosmetic Act, Ch. 3 Section 301 General Adulteration of material in Interstate Commerce, Ch. 5 Sec. 501 Adulterated Drug/Devices (a) related to safety, and Sec. 505 (new Drugs) (a) related to safety, and the Public Health Service Act - Biologicals, Sec. 351as related to the target of specified and realistic results expected from product.
We put this together to help us focus on the various rulings, regulations, and exemptions, designated to vaccines. In which case, kindly see ATTACHED notes of 21 CFR related to FDA "work-arounds" that might potentially allow adulterated or unsafe product to enter into interstate commerce, thereby negating any safety precautions.
The specific entries, near end of each document, that are of interest are "highlighted" for your ease of your review. ~ Dr. E
Historically, FDA either has violated its own rulings against adulterated or unsafe products (ie: The Delaney Clause , then followed by the Deminimus Act allowing specified carcinogens in foods, thereby relieving themselves [FDA or Mfr.] from judicial intervention)... so, in conclusion, FDA has effectively disregarded safety, and as such, has also pre-empted tort actions against the vaccine mfr.s regarding conditions of safety, effectiveness, et al.
Further investigation is required to determine specific violations of regulations and U.S. laws by DHHS/PHS/FDA and/or NIH or CDC relevant to this particular issue of the 2009 Novel Flu Virus and subsequent vaccine development.
This is another FDA issue that occurred last week : http://abcnews.go.com/Business/story?id=8322658&page=1
And these moronic criminals are in charge of the extremely delicate vaccine safety issues ? - How, by protecting the Pharmaceutical cartel from liability. Heck, the ENTIRE system is criminally liable !!!!!
Lock 'em all up, and toss the key into Crater Lake !!
Arthur Evangelista, Ph.D.
FDA SUED OVER UNCLEAR GMP RULES
By Shane Starling, 12-Aug-2009
The Food and Drug Administration is being sued over its controversial and much-amended GMP regulations on the grounds the 1000-page rule is ambiguous where it should be clear, according to the attorney mounting the action.
The action accuses the FDA of being in breach of a Fifth Amendment requirement against vague laws and asks for areas of the rule to be rewritten so that dietary supplement manufacturers understand when they are in breach of the law which the action argues is not currently the case.
The action, mounted in the same Washington DC District Court where the FDA is being challenged over its treatment of qualified selenium health claims, seeks to make the FDA clarify actions companies are required to take under the GMP (Good Manufacturing Practices) regulations to be in compliance.
These include record-keeping requirements and testing standards and methods.
The FDA has 60 days to respond to the action which was lodge on Friday.
The agency was not available for comment by the time of publication.
Adequate and sufficient
The GMP rule is enormous in length but flawed in development in that it gives the agency unbridled discretion to act when it perceives a company to be in breach of standards that are not clear, said Jonathan W Emord of Virginia-based law firm, Emord & Associates, which is heading the action.
It is an unacceptable law, he told NutraIngredients-USA.com. If parties do not know what they are required to do to avoid prosecution then that is a bad law and that is the case with the GMP rule. Words like "sufficient" and "adequate" that appear in its text are themselves not sufficient or adequate in lawmaking.
Emord emphasized that the action does not challenge the right of the FDA to administer GMPs, or call for the law to be scrapped. He said the action had the support of "significant industry players" that preferred to remain in the background for fear of falling foul of regulators.
The other plaintiffs in the case are the Alliance for Natural Health US, the Coalition to End FDA and FTC Censorship, and Durk Pearson and Sandy Shaw, two supplement formulators.
One industry observer who was involved in the writing of the 1994 DSHEA (Dietary Supplements and Health Education Act) said the action had "next to no chance" of succeeding.
If you would like to comment on this action, click on the 'Have Your Say' button below.
They should keep the darn investigation going into all their activities, including the vaccine issues - ever notice how these morons always stop short of doing real good for the American people ??? ~ Dr. E (former federal investigator for FDA -Investigations Branch)
HEPARIN CONFLICT-OF-INTEREST INVESTIGATION OF FDA DRUG DIRECTOR; FDA DEVICE CHIEF RESIGNS
Shelley Wood
August 14, 2009 (New York, New York) - The Wall Street Journal is reporting that Dr Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, is being investigated by the inspector general of the Department of Health and Human Services for alleged conflicts of interest related to the approval of generic versions of enoxaparin (Lovenox, Sanofi-Aventis), a low-molecular-weight-heparin (LMWH) with a blockbuster record for sales [1].
According to Journal reporter Alicia Mundy, the investigation stems from an "ethics complaint" from Amphastar Pharmaceuticals, which "says it has been delayed in its six-year effort to win approval" for a generic version, at the same time that a competing company--Momenta Pharmaceuticals--has had "special access" to Woodcock.
Contacted by heart wire, office of the inspector general spokesperson Dee Ellison would not confirm that such an investigation was under way; likewise, an FDA spokesperson told heart wire that the agency "does not confirm that any investigations are even taking place" but added, "we take all conflict-of-interest allegations seriously and deal with them appropriately." The Journal article comes within days of another high-profile shake-up at the FDA: on Tuesday, an FDA-wide email sent by agency commissioner Margaret A Hamburg announced that Dr Dan Shultz, Director of the Center for Devices and Radiological Health (CDRH), was resigning from the post.
Schultz's resignation, first reported by the Gray Sheet [2], came "following talks with Hamburg."
Woodcock Allegedly Worked With Competitor
The Woodcock investigation, according to the Journal, stems from the fact that Woodcock coauthored a paper with scientists at Momenta at a time when both companies were seeking FDA approval of their generic LMWHs. Amphastar also points out that Woodcock was in contact with one of Momenta's founders and collaborated with him on an FDA task force looking into the tainted heparin crisis. Amphastar is calling these interactions a conflict of interest and has asked that Woodcock recuse herself from any involvement with these applications--something the FDA has said she won't be doing, the Journal reports.
According to Mundy, Amphastar's application for its generic LMWH was submitted in 2003, two years before Momenta's. Amphastar's application was rejected in November 2007; both companies have submitted additional data and are still awaiting a formal decision.
Schultz News Follows a Year of Controversy in Device Sector
In the case of Schultz, Gray Sheet reporter Jessica Bylander quotes Schultz saying that he and Hamburg came to a "mutual agreement" that his resignation "would be in the best interest of the center and the agency."
Bylander also points out that Schultz had been "under fire from Congress and the public following a series of letters from internal FDA whistleblowers alleging corruption in the agency."
Neurologist Dr Jeff Shuren will serve as acting CDRH director while the FDA conducts a national search to fill the position.
References