LawyersUSA

Just days before the U.S. Supreme Court takes up a highly-anticipated case on FDA- preemption of state court actions, a congressional report shows that scientists and career staffers at the agency objected to the preemption policies implemented under President George W. Bush.

The report by the House Committee on Oversight and Government Reform, which was released on Wednesday, found that historically the Food and Drug Administration has not sought to preempt state law claims, and that the agency "viewed lawsuits brought by persons injured by a drug as a valuable complement to the agency's regulatory efforts."

But during the Bush administration the FDA made a dramatic reversal, rewriting drug labeling regulations to make it more difficult for manufacturers to alter labeling without agency approval and adding preemption language that has become "a cornerstone of drug industry preemption arguments."

The report states, "Internal agency documents obtained by the Committee show that these regulatory changes were made by FDA over the objections of key career officials. … "According to [these] documents, high-ranking career officials repeatedly warned that the central factual justifications for the agency's new positions were false. 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."

In a statement, an FDA spokesperson said that "in any organization, there is rarely unanimity of opinion."

"In proposing the rules, FDA carefully considered dissenting viewpoints," the statement said. "Many employees of FDA participated in the development and review of the rules."

The American Association for Justice, a trial attorneys group, the blasted the FDA over the report, noting that the findings were similar to those in an AAJ report released earlier this month.

"In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency's history of respect for litigation and put consumer safety on the backburner," said Gerie Voss, Director of Regulatory Affairs at AAJ, in a statement.

Next Monday, the Supreme Court will hear oral arguments in Wyeth v. Levine, which considers whether FDA approval of a drug impliedly preempts state regulation and state law tort claims.

-Kimberly Atkins