Last Wednesday, top scientists and career employees at the Food and Drug Administration (FDA) opposed agency regulations that weaken consumers’ ability to file lawsuits against drug manufacturers.
The disputed issue has to do with language in a drug-labeling rule from 2006, which puts restrictions on when someone can sue in state court over injury claims involving medications. According to the FDA’s position, federal regulations take precedent over state law when there is a conflict, which is known as preemption.
A report released by Rep. Henry Waxman, chairman of the House Oversight and Government Reform Committee, internal agency documents revealed that career officials criticized this approach. Previously, the FDA had viewed private lawsuits as extra security against unsafe drugs, according to the report.
Dr. John Jenkins, who oversees FDA’s new drug reviews, was quoted in the report as saying, “Much of the argument for why we are proposing to invoke preemption seems to be based on a false assumption that the FDA approved labeling is fully accurate and up-to-date in a real time basis. We know that such an assumption is false.”
The report showed that the FDA has not given a complete set of documents that would reveal important communications between the White House and the agency. However, some of the documents alluded that the FDA and the White House would not move ahead with a rule on drug labeling until the preemption changes were included.
Over the years, patients have successfully sued drug manufacturers for failing to provide adequate warnings against certain dangers. Currently, there is a case being heard by the U.S. Supreme Court against the drug manufacturer, Wyeth. The plaintiff claims that she lost her right arm below the elbow after she was injected with the drug, Phenergan.
In the FDA’s 2006 and 2008 rule, the agency stated that lawsuits could encourage drug manufacturers to propose unnecessary labeling. This type of labeling could cause scientifically unsubstantiated warnings and could result in less use of helpful treatments.
