"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," said Scott Gottlieb, the FDA's deputy commissioner for medical and scientific affairs.
The agency's assertion of "federal preemption" was included as a preamble to its new drug labeling guidelines.
The claim of preemption was quickly attacked by trial lawyers and members of Congress as another effort by the Bush administration to limit the public's ability to bring and win lawsuits, according to the January 19, 2006 Washington Post.
"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 our political process," Mr Suggs told the Post.
In response to the FDA's announcement, Senator Kennedy issued a statement that said: "It's a typical abuse by the Bush Administration -- take a regulation to improve the information that doctors and patients receive about prescription drugs and turn it into a protection against liability for the drug industry."
Over the past several years, lawmakers have been turning up the heat on both the FDA and the pharmaceutical industry in response to their combined failure to reveal problems found during studies conducted on top selling drugs like Vioxx.
At one point, Senator Charles Grassley (R-Iowa), Chairman of the Senate Finance Committee, came right out and accused the FDA of suppressing studies in order to protect pharmaceutical industry profits and the careers of certain FDA officials.
"The Vioxx example showed that the FDA and Merck were too close for comfort," Senator Grassely told Health News on March 12, 2005. "Testimony and documents at our Finance Committee hearing showed that the FDA allowed itself to be manipulated by Merck," he said.
Based on a trial that took place in 2000, both the FDA and Merck were aware that heart attacks were five times more likely in patients taking Vioxx than among those taking a similar drug, Sen Grassley pointed out, but the FDA did nothing to change the labeling on the drug for nearly two years, while Merck aggressively marketed its product on nightly TV.
Back on November 18, 2004, he generated enormous media attention when he held hearings on Vioxx, and FDA scientist, Dr David Graham, who works in the FDA Office of Drug Safety, testified that Vioxx may have been responsible for tens of thousands of heart attacks and strokes but that his superiors had pressured him to keep silent about his findings.
"The estimates range from 88,000 to 139,000 Americans," Dr Graham told the committee. "Of these, 30 to 40 percent probably died," he advised.
"For the survivors," he added, "their lives were changed forever."
To put this large number of injuries into perspective, Dr Graham told members of the committee that instead of a serious side-effect of a prescription drug, to think of it as if they were talking about jetliners.
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