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New Congressional Report Finds that FDA Career Staff Objected to Preemption
Washington, DC—The Bush Administration’s efforts to ignore and override the objections of career Food and Drug Administration (FDA) staff to include complete immunity preemption in FDA regulations is further confirmed in a report released today by the U.S. House Committee on Oversight and Government Reform. American Association for Justice (AAJ) released a comprehensive report this month with similar findings, detailing the Bush regulatory strategy called preemption.
Today’s report highlights internal FDA documents which show high-ranking career officials repeatedly warning about the dangers of not allowing drug companies to add additional warnings to their labels without FDA approval. Prior to this the FDA had asserted through a rule on drug and device labeling that manufacturers should not be held accountable for failing to update their label with additional risks, if the original label was approved by the FDA.
Prior to the rule being issued one FDA career official asserted that the rule “is not as it purports to be, consistent with the agency’s role in protecting the public health.”
“This is just further evidence of what we have been saying all along, the Bush Administration put politics above consumer safety by insisting complete immunity preemption be included in federal regulations,” said Gerie Voss, Director of Regulatory Affairs at AAJ.
AAJ’s report shows how the Office of Management and Budget (OMB) had direct involvement in the placement of the “complete immunity” preemption language at seven federal agencies in over 60 proposed or final rules. For a full copy of “Get Out of Jail Free: A Historical Perspective of How the Bush Administration Helps Corporations Escape Accountability” go to: www.justice.org/getoutofjailfree
“In a gift to big negligent corporations, the Bush Administration overrode the advice of career professionals, ignored the agency’s history, and put consumer safety on the backburner.” said Voss.