Senators Patty Murray and Hillary Rodham Clinton yesterday sent a letter to Secretary of Health and Human Services, Michael Leavitt, expressing outrage over further delays in a decision over the emergency contraceptive Plan B and questioning the credibility of the US Food and Drug Administration. At the end of last week, the US drug regulator said plans to make the emergency contraceptive available over the counter represent “profound regulatory decisions that cut to the heart of our work” and called for a decision to be made via an open public forum. A decision on Plan B’s status had been expected by September 1 [[18/07/05c]].
In their letter, the Senators state: |”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. 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.”
Parry and Clinton also reveal that, because of the promise of a decision by September 1, they lifted their hold on the President’s nominee to head the agency, Lester Crawford [[16/06/05d]]. “The President now has his FDA administrator, but the American public still does not have an answer on Plan B,” they note, adding that they find it curious the agency is only now raising questions about the impact of having an emergency contraceptive available over the counter for young girls. “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.”
“The 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,” they concluded.