Report Claims Politics Shaped FDA Preemption Policy

The FDA’s reversal of its long-held position against federal preemption of device or drug safety lawsuits was a response to pressure from the Bush administration and went against the views of its senior career staff, according to internal agency documents cited in a House committee’s Democratic majority staff report.

The report states that key FDA officials expressed concern about changes in the labeling rules and that regulatory changes were based on a false assumption.

“High-ranking career officials repeatedly warned that the central factual justifications for the agency’s new positions were false,” the report stated. “They also expressed concern that the changes in the labeling rules would harm patients by significantly delaying the addition of important safety information to drug labels.”

The White House, according to the report, pressured the FDA to reject the concerns of career experts to shield drug manufacturers from liability.

“The FDA has an obligation to ensure the safety and effectiveness of drugs. In this case, however, internal documents indicate that the Bush Administration weakened important drug safety regulations to shield manufacturers from liability. That is a serious abuse of the agency’s public health authorities,” the report concluded.

SOURCE: FDA NEWS