To kill or to ill. Even if the pillmaker *faked* the clinical studies, they can't be held liable if they pass the approval process. And we know what the oversight is on product safety today; it's a cheaper bribe than ever to beat it- Big Pharm appointees crowd the FDA . Vote fraud, mine safety, torture: this administration's modus operandi is to make it the obligation of the courts to enforce the law. They think that you won't fight back every time, so they're guaranteed a certain number of victories or short-term regulatory relief.
news target dot com wrote wrote:June 30, 2006 is a day that will be long remembered as a dark milestone in the history of FDA and its campaign against health consumers. On June 30, an FDA "Final Rule" goes into effect, establishing a regulatory power grab of such scale and scope that it attempts to bypass all laws, the will of Congress and fundamental protections for consumers. This "Final Rule," which may as well be called a "Final Solution" for drug consumers, claims that consumers can no longer sue drug companies for the harm caused by any FDA-approved drug, even if the drug's manufacturer intentionally misled the FDA by hiding or fabricating clinical trial data.
In one blatantly illegal act, the FDA is attempting to pull off the greatest Big Pharma coup of all: The outright elimination of any responsibility whatsoever for the suffering and death caused by deadly pharmaceuticals.
In the preamble of the FDA's new "Final Rule" to take effect on June 30, the agency asserts that FDA approval of prescription drugs -- and their implied safety -- may no longer be second-guessed by consumers or organizations of any kind. The FDA's stamp of approval, the agency claims, is an absolute declaration of safety of all such drugs, for any use whatsoever, including off-label use (the use of drugs on health conditions that were never tested in clinical trials).
But such a position has no basis in law. During a June 6, 2006 hearing, a New Jersey state court judge Carol E. Higbee characterized the FDA's preamble as, "a political statement by the FDA" and explained that the ploy has, "...nothing to do with science. ...It is contrary to the U.S. Supreme Court's decisions. It is contrary to all the law on preemption. ... In addition to being contrary to the law of the land, it is also contrary to the Constitution of the United States."
complete article here