(WASHINGTON, D.C.) – U.S. Senators Patty Murray (D-Wash.) and Hillary Rodham Clinton (D-NY) today said that the release of a Government Accountability Office report confirms that the Food and Drug Administration’s 2004 decision not to approve over-the-counter sales of Plan B emergency contraceptives was politically motivated.
The Senators, who requested the GAO investigation on June 15, 2004, have repeatedly called on the FDA to restore credibility to the agency by moving ahead with a ‘yes’ or ‘no’ decision on the over-the-counter application of Plan B.
“This long-awaited report leaves no question that science was compromised in the FDA’s decision making process on Plan B. The GAO has confirmed what we have always suspected, that this was a politically motivated decision that came down from the highest levels at the FDA,” Murray and Clinton said.
“It is particularly disturbing that the decision to deny the application of Plan B appears to have been made before the agency’s own scientific panels completed their reviews. How can American consumers regain confidence in the FDA if science is so clearly overlooked by its leading officials? Despite overwhelming evidence that Plan B is safe and effective, politics at the upper echelons of the agency trumped science in this case.”
Murray and Clinton called on Health and Human Services Secretary Michael O. Leavitt to renounce political obstructionism at the FDA and to move forward with a scientific-based decision on Plan B.
“American consumers deserve an FDA that sets the gold standard in drug approval. Today’s report shows that unusual and highly suspect decision-making has played a role in the drug approval process. We call on Secretary Leavitt to renounce this suppression of science and help restore credibility to the agency by moving forward with a yes or no decision on Plan B.”
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