FDA Shields Drug Companies From Lawsuits February 27, 2006. By Evelyn Pringle Last month, the FDA revealed its latest protective policy for drug companies in a statement that said people who believe they have been injured by drugs approved by the FDA should not be allowed to sue drug companies in state courts. "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. "Eliminating the rights of individuals to hold negligent drug companies accountable puts patients in even more danger than they already are in from drug company executives that put profits before safety," said Ken Suggs, president of the Association of Trial Lawyers of America. "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 â 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." The National Conference of State Legislatures, a bipartisan group that represents state lawmakers, accused the FDA of trying to seize authority that it did not have. 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. "If there were an average of 150 to 200 people on an aircraft," he said, "this range of 88,000 to 138,000 would be the rough equivalent of 500 to 900 aircraft dropping from the sky." "This translates to 2-4 aircraft every week," he noted, "week in and week out, for the past 5 years." "If you were confronted by this situation," Dr Graham asked the committee, "what would be your reaction, what would you want to know and what would you do about it?" He condemned the FDA's failure to acknowledge the risks that Vioxx posed to millions of people in the 5 years it was allowed to remain on the market. "I strongly believe that this should have been, and largely could have been, avoided," Dr Graham told the committee. The Vioxx matter caught the attention of the Senate Finance Committee basically because of the Vioxx related costs to government programs like Medicaid and Medicare. The committee is responsible for oversight of the two programs. At the November 18, 2004 hearing, Senator Max Baucus said: "In the 5 years that Vioxx was on the market, Medicaid spent more than $1 billion on the drug." "And Medicaid bears the cost of any additional medical care necessary when drugs cause injury," he pointed out.