The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity

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."

FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year, according to peer-reviewed published studies, and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone (see Death By Medicine for detailed statistics). Vioxx, according to senior FDA drug safety researcher Dr. David Graham, appears responsible for the deaths of over 60,000 Americans, and further deaths due to beta blockers, antidepressant drugs, statins and other medications continue to mount by the hour.

Here is a copy of the FDA's Final Rule. It is 77 pages long, but if you search for "preemption" and "liability" you should find all the sad and scary parts.

The Raw Truth About the War on Drugs