FDA wants to limit lawsuits against drug manufacturers

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http://www.bmj.com/cgi/content/full/332/7535/196-dNews roundupUS agency wants to limit lawsuits against drug manufacturersNew York Jeanne Lenzer The US Food and Drug Administration has issued a policy statement that will make it harder for people to sue drug manufacturers. The statement, supporting an arrangement known as "pre-emption," was inserted into the agency’s new guidelines on drug labelling. It asserts that complying with the FDA’s labelling requirements should preempt or supersede individual states’ liability statutes. The new statement means that, in the FDA’s opinion, as long as a drug company complies with federal labelling laws, the company should not be found in violation of statutes on "failure to warn." The statement does not have the force of law but may be considered by the courts. The statement sparked an angry reaction from Edward Kennedy, the Democrat senator for Massachusetts. "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," he said. Scott Gottlieb, the FDA’s deputy commissioner for medical and scientific affairs, said, "What we are saying is that if a sponsor brings us all their evidence, everything they know about a drug, and we decide what should and should not be included in the label based on our scientific review, then that federal process should have some merit in these ‘failure to warn’ cases in the state courts.In our view," said Dr Gottlieb, "state courts should not be able to add additional warnings to the label that are not supported by science. We have learned in our research that the public health risks associated with over warning are as great as—if not greater than—the health risks associated with under warning. Over warning can cause patients not to take beneficial drugs and doctors not to prescribe them. "We need to make sure the warnings approved by FDA scientists to promote the public health are not obscured by warnings that are added simply to avoid litigation. Labels should be written with patients in mind, not lawsuits." Proponents of pre-emption argue that lawsuits are threatening the financial stability of drug companies and create expenses that are passed on to consumers. The Pharmaceutical Research and Manufacturers of America, an industry trade association, said that the risks and benefits of drugs as determined by the companies and the FDA should "not be undone by 50 different sets of product liability laws" in various states. The FDA has previously joined with the industry in support of the pre-emption defence (BMJ 2004;329:189). In a move that provoked controversy at the time, the agency filed a brief in 2002 in the case of Motus versus Pfizer. The case was brought by the widow of a man who killed himself while taking the antidepressant sertraline. The FDA argued that the claim was pre-empted because the company had used an FDA approved label. The agency went further, asserting that Pfizer would have misbranded sertraline if they had warned that suicide was a potential side effect of the drug. Allison Zieve, an attorney with Public Citizen, a non-profit consumer advocacy organisation based in Washington, DC, said the FDA’s position is "a huge gift from the agency to the companies it is supposed to be regulating." She said the new language on pre-emption is the FDA’s attempt to make a single statement in support of pre-emption instead of filing separately in individual cases. Companies, in turn, will be able to point to the FDA’s position. However, the statement will not have the force of law, said Ms Zieve. "Courts can decide how much weight to give it." Ms Zieve said that liability suits are "the sole means for compensation for people who are injured." She said, "Not even the FDA argues that the patient has done something wrong, so the question is who should bear the burden of what went wrong? Our country has left that decision to state law and, for the most part, charged companies with the cost of injuries caused by their products." Neither the FDA nor drug companies are "angels or perfect," said Ms Zieve, "and the hazards of a drug are not always known until patients start taking it." She added: "The FDA has stated that it supports pre-emption if the company used an FDA approved label at the time of the patient’s injury, even if the agency later determined that the warning was inadequate and required it to be strengthened." The FDA’s statement is at www.fda.gov/bbs/topics/news/2005/NEW01272.html.