Just for a minute put aside your feelings about emergency contraception and rather than thinking about Plan B, consider Plan E. That’s E like in Ephedra. During my tenure at FDA, one of the agency actions I was most proud of was the banning of dietary supplements containing Ephedra. All the scientific evidence supported the decision. Politicians and the media were laudatory. There was broad public support — especially among parents of high school athletes — some of whom had tragically died because of these dangerous snake oil supplements. I am convinced that lives were saved because of the FDA’s decision. And then, in April of this year, a federal judge in Utah — Ground Zero for the dietary supplement industry, overturned the agency’s ban. The judge’s ruling was based on the legal argument that FDA hadn’t really proven Ephedra was dangerous. Yes, that is absurd. But sometimes the law really is an ass. That’s why it’s so important that FDA decisions be based not only on sound science but also on a sound legal foundation.
Which brings me to Plan B. Considering the highly charged environment surrounding female reproductive issues, legal maneuvering to overturn a potential “behind the counter” decision wouldn’t be based on science, but rather on the agency’s authority to make such a split decision. And making public health decisions through litigation is not in the best interests of the public health. An action on Plan B, absent a definitive and public rule making process would, rather than making emergency contraception more widely available, very likely delay OTC availability due to prolonged and protracted legal actions. And if legal action is the most effective route, you can be sure it will be pursued.