Advocates Argue Obama Administration’s EC Appeal Filed on Shaky Legal, Factual Basis


On Wednesday afternoon, the Center for Reproductive Rights (CRR) filed its opposition to a request by the Obama administration to stay an April federal court order that required the Food and Drug Administration (FDA) to make levonorgestrel-based emergency contraception available without a prescription and without point-of-sale or age restrictions within 30 days. The request for a stay was filed as part of an appeal to the Second Circuit Court of Appeals of the April order. A judge will hear arguments on the request for a stay on Tuesday.

In order to see a stay of the order, the Obama administration must convince the judge that it is likely the administration will succeed on the merits of its appeal—in this case, arguing that the judge overstepped his grounds in ordering the restrictions lifted instead of sending the matter back to the FDA for additional rulemaking. The argument is misguided and cynical and, as the Center for Reproductive Rights argues, avoids the reality of bad faith politics before the court. “In pressing this argument, Defendants are in effect using their own misconduct in delaying action on the Citizen Petition to deny women the benefit of advances in medicine that have occurred over the last decade,” CRR argues in its brief. “Over the course of this protracted litigation, and due directly to Defendants’ bad faith conduct and undue delays, while the precise relief that Plaintiffs seek has had to change, the fundamental nature of that relief has not.”

CRR also takes issue with the Obama administration’s argument that the primary harm to stem from this case will be a tarnishing of faith in the FDA’s review and approval process, rather than hardship for the thousands of citizens who need access to emergency contraception but can’t get it. “In arguing that Plaintiffs and the women they represent will not be irreparably injured by a stay, Defendants suggest that by approving the Plan B One-Step amended SNDA, they have somehow simplified the regulatory regime for emergency contraception, thereby making levonorgestrel-based drugs more readily accessible to women of all ages. Defendants are mistaken,” CRR notes. In fact, according to the brief, the Obama administration’s appeal on the heels of the Plan B approval has only complicated matters further, causing greater harm to those in need in the meantime: “In eliminating the dual-marketing regime for Plan B One Step, Defendants have replaced it with a convoluted triple-tiered marketing scheme that will only increase the confusion that already prevents women from obtaining timely access to levonogestrel-based products.”

The Tuesday hearing won’t settle the Obama administration’s appeal of the ruling, but will determine whether or not it has to comply with the May 10 deadline set by the judge. In the event that the judge denies the administration’s request, it can file an immediate appeal of that denial with the Second Circuit Court of Appeals. That means it is highly unlikely that emergency contraception will be widely available as of this week. It also means that just like the fight over contraception coverage in Obamacare, the fight over access to emergency contraception will be tied up in the courts.

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