Chalk up a win for science. Federal Judge Edward Korman today ordered the Food and Drug Administration (FDA) to make “Plan B” emergency contraception available to women of all ages without a prescription, calling efforts to stop the FDA from doing so “arbitrary, capricious, and unreasonable.”
A federal judge has accomplished what two administrations failed to do: make a decision about access to a drug based on medical evidence. It’s just common sense for the government to make drug approval and access decisions solely based on the best available science, not on hunches or political calculations. The decision brings a decade of politics trumping science to an end.
The saga began during the Bush administration, when officials within the FDA defied scientific staff and an independent advisory committee in refusing to make the drug available without a prescription. The problem continued after President Obama took office, when Department of Health and Human Services Secretary Kathleen Sebelius went back on a promise to ensure that FDA decisions were scientifically supportable when she ordered the agency to refrain from approving Plan B for over-the-counter access, despite a clear statement from FDA that such access was warranted.
Medical experts and leading medical organizations have overwhelmingly said that emergency contraception is safe for use over the counter–safer, in fact, than some of the products already on drugstore shelves.
Congratulations should go to the science and health advocates who have worked tirelessly for the past ten years to show how the government was politicizing the science of emergency contraception and to hold officials accountable for undermining the authority of the FDA. This includes Dr. Susan Wood, a scientist who resigned from the agency in 2005 in protest during the Bush administration and has done much since to raise the profile of this issue. This also includes the Reproductive Health Technologies Project, which has done much to educate the public about the science of emergency contraception, and many other public health organizations and advocates who have recognized that when it comes to any drug approval or access decision, we should put the science first.
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