New FDA policy would insulate Big Pharma from lawsuits through federal preemption

• People who believe they were injured by drugs approved by the Food and Drug Administration should not be allowed to sue drug companies in state courts, the agency said yesterday in a formal policy statement.
• The FDA's controversial assertion of "federal preemption" was included as a preamble to long-awaited guidelines designed to make drug labeling information more accessible and readable for doctors and consumers.
• Agency officials said that though the preemption policy does not have the weight of law or formal regulation, they hope state judges will accept their position.
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• "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 new labeling rules require drugmakers to highlight the most important advisory information in the "package insert" issued with every prescription and to cut back on the often-technical legal language that officials said is included more to protect drugmakers from lawsuits than to inform doctors and patients.
• Without state product liability laws, the critics said, drug companies could escape responsibility for injuries and deaths caused by drugs such as Merck & Co.'s Vioxx, which an FDA medical officer estimated had killed as many as 55,000 Americans.
• "Americans are overwhelmed with the complexity of health information.
• This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information."