Why would Americans trust the FDA to regulate the pharmaceutical industry? Since the Bush administration took office the FDA has become the industry's partner in crime.
The most notorious protection scheme put in place by the FDA and Big Pharma is the preemption policy that bans private lawsuits against drug companies in state courts once a drug and its label have been approved by the FDA.
On January 18, 2006, the FDA issued new rules for the labeling of prescription drugs, and in the preamble to the rules on page 43, the FDA says, State law actions "threaten FDA's statutorily prescribed role as the expert Federal agency responsible for evaluating and regulating drugs," requiring lay persons to second-guess its expert assessments of a drug's risks and benefits.
So, after all of the concerns raised about the FDA's failure to protect consumers against dangerous products over the last several year, by top experts from all over the world, the FDA has hereby declared itself the sole authority on decisions regarding prescription drugs, including whether a drug's label contains adequate descriptions of indications for use, risks and benefits.
In an October 6, 2006, articled titled, "The Doctrine of Preemption," Stan Kaufman aptly refers to the new policy as the "Doctrine of Preemptive Crony Capitalism." When announcing this multi-billion dollar immunization gift to Big Pharma, the FDA told drug makers:
"We think that if your company complies with the FDA processes, if you bring forward the benefits and risks of your drug, and let your information be judged through a process with highly trained scientists, you should not be second-guessed by state courts that don't have the same scientific knowledge."
A statement saying the complete opposite was made in 1996, by the FDA's Chief Counsel in a speech that said the FDA had a "longstanding presumption against preemption" and that "FDA's view is that FDA product approval and state tort liability usually operate independently, each providing a significant, yet distinct, layer of consumer protection."[
The preemption claim reverses a long-standing policy of permitting State actions intended to protect consumers and undermines the States' ability to protect their citizens, yet State and local entities were given no opportunity to object to it.
Under Executive Order 13132, issued first by President Reagan, and then reissued by President Clinton, the FDA is supposed to consult with State and local authorities about the effects of each regulation it issues that affects the States.
Nowhere in the proposed rule did the FDA provide notice or seek comment on the preemption provisions added to the preamble. In the only proposed rule known to State and local officials, the FDA said that the regulation would not preempt State law. In fact, the language published in the Federal Register on December 22, 2000, explicitly stated that "this proposed rule does not preempt state law."
The rule requested comment on products liability issues, but only by asking whether the new "Highlights" section raised liability concerns and, if so, how the FDA might alleviate those concerns without eliminating the Highlights section. This request can hardly be called "notice" of the preemption statement that suddenly appeared in the preamble in 2006.
By relying on this false representation, State and local authorities were robbed of any opportunity to object to the preamble. In a January 2006, letter to Michael Leavitt, Secretary of Health and Human Services, the National Conference of State Legislators called the regulation a "thinly veiled attempt on the part of FDA to confer upon itself authority it does not have by statute."
The NCSL also stated the failure to allow for an appropriate comment period constitutes "an abuse of agency process and complete disregard for dual system of government."
Ken Suggs, president of the Association of Trial Lawyers of America, was quoted in the January 19, 2006 Washington Post, as saying, the "fact that the drug industry can get the FDA to rewrite the rules so that CEOs can escape accountability for putting dangerous and deadly drugs on the market is the scariest example yet of how much control these big corporations have over the political process."
Legal experts point out that it was never the intent of Congress to preempt private lawsuits in State courts, and that in fact, when Congress was considering the Food, Drug, and Cosmetic Act of 1938, it specifically rejected a proposal to include a private right of action for damages on the ground that such a right already existed under State common law.
According to Houston attorney, Robert Kwok, who handles complex pharmaceutical litigation involving drugs such Fosamax, Norvasc and SSRI antidepressants like Celexa:
