WASHINGTON, D.C. – U.S. Senators Patty Murray (D-WA) and Hillary Rodham Clinton (D-NY) today expressed their outrage at both the Department of Health and Human Services and the FDA for breaking their promise to issue a decision on the over-the-counter application of Plan B emergency contraceptives.
In a letter dated July, 13, 2005, Health and Human Services Secretary Michael Leavitt, promised Health, Education, Labor and Pensions Committee Chairman Michael Enzi that a decision would be made by September 1:
“I have spoken to the FDA, and, based on the feedback I have received, the FDA will act on this application by September 1, 2005.”
The Senators, who have repeatedly called for a yes or no answer from the agency and who dropped their hold on the nomination of Lester Crawford to head the FDA based on Secretary Leavitt’s promise, issued the following statement:
“Secretary Leavitt and the FDA not only broke their promise to Congress, they broke their promise to the American people.
For two years and four months, the FDA has dragged its heels. Today, the FDA had a chance to restore the confidence of American consumers and increase women’s access to safe and effective treatments, but it failed in this mission.
A delay is not a decision. For six months we have asked for a simple answer – yes or no. It is a breach of faith to have this Administration give us their word that a decision would be made, and have that promise violated. FDA’s only criteria for approval should be safety and efficacy, not politics and ideology.
The FDA is claiming there are unanswered questions about this drug’s effect on girls under 17. The fact is the pending application would have no impact on girls under 17. Today, they may only receive this drug with a prescription and that would remain the case if the FDA approves the application.
Today’s move serves only to increase questions about FDA’s status as an independent agency. This delay goes against what FDA’s own advisory panel found nearly two years ago – that Plan B is safe and effective and should be available over-the-counter. There is no credible scientific reason to continue to deny increased access to this safe health care option.
Indeed, in today’s statement the FDA acknowledged that the application has scientific merit, but still refused to approve it. We can only infer that FDA – and its newly confirmed administrator, Lester Crawford – are working to put ideological beliefs ahead of women’s health.
The FDA has shirked its duty to serve as an independent agency beholden to no other goal than the promotion of sound science and the well-being of the American people.
Chairman Enzi promised that he will hold a hearing if there were further delays in this application. We are calling on him to honor this promise and promptly schedule a hearing to look into FDA’s approval process for this drug and to ensure that American patients are receiving access to safe and effective treatments in a timely manner.”
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