August 30, 2005
The Honorable Michael O. Leavitt
Secretary of Health and Human Services
Washington, D.C. 20201
Dear Secretary Leavitt,
As U.S. Senators we make a commitment to protect the safety and well-being of the American public and we take this responsibility seriously. It is both disappointing and frustrating that our job has been hindered by the disingenuous actions of HHS and FDA with regard to Plan B emergency contraceptives.
In a July 13th letter to Senate HELP Committee Chairman Mike Enzi, you gave your word that a decision on Plan B’s over-the-counter application 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.”
Based on your promise that FDA would deliver a yes or no answer by September 1, we entered into a good faith agreement and lifted our hold on the President’s nominee to head the agency.
The President now has his FDA administrator, but the American public still does not have an answer on Plan B.
And now - according to press accounts - you are claiming to have fulfilled your commitment to us and that the FDA’s new delays are actually “a step forward in the process.”
Mr. Secretary, for six months we have asked for a simple yes or no answer on Plan B and you clearly understood this. A delay is not a decision, and no amount of semantics can change that. You can play word games all you want, but it is time for the FDA to stop playing games with the health and well being of millions of American women.
It is a breach of faith to have you give us your word that a decision would be made, only to violate that promise.
We find it curious that the FDA is now raising questions about Plan B’s impact on girls under the age of 17. The FDA has known since last July that the application under consideration only allowed over-the-counter access for girls 16 and older. Yet, it waited a year and one month to start a process for determining how to implement such an age restriction. These concerns should have been dealt with within the normal FDA review process, not at the eleventh hour.
FDA’s only criteria for approval of Plan B should be safety and efficacy, not politics or ideology. Unfortunately your broken promise calls into question the independence of both the agency and its newly inaugurated administrator.
Day-by-day the public’s confidence in the FDA’s ability to make decisions based on scientific evidence of safety and efficacy is eroding. We urge you to allow science, not politics, to guide this agency and we insist that a decision be brought swiftly on Plan B’s application.
U.S. Senator Patty Murray
U.S. Senator Hillary Rodham Clinton