In support of its appeal and request to stay the April 5 district court order directing the Food and Drug Administration (FDA) to make emergency contraception (EC) available by May 5, and without a prescription and without point-of-sale or age restrictions, the Obama administration incredulously insists a stay is necessary to protect against politics infecting the rule-making process.
The administration filed its appeal just days before the FDA was supposed to comply with the order and right after announcing one specific product, Plan B, would be made available over-the-counter for people age 15 and older, but only with identification. The administration lays out its legal arguments avoiding a simple truth: the first-of-its-kind decision by the Department of Health and Human Services (HHS) to overrule the FDA on emergency contraception in 2011 was a brazen political move that could only produce a brazenly political rule. Instead, the administration accuses the judiciary of politics here, arguing the April 5 order was effectively rule-making from the bench and that it was the court, not the administration that was over-reaching in ordering the FDA to lift the EC restrictions.
The Court’s Order interferes with and thereby undermines the regulatory procedures governing FDA’s drug approval process. A drug approval decision involves scientific judgments as to whether statutory and regulatory factors are met that warrant deference to those charged with the statutory responsibility to make those decisions. The agency alone has the necessary information and scientific expertise to assess the data and information required to make a determination that a drug is safe and effective.
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Here, the proper course of action should have been to remand for further agency consideration, or for elaboration of the basis for a decision not to proceed with rulemaking as to Plan B.
Nevertheless, the Court declined to remand to the agency. Instead, it stepped into FDA’s shoes, directed the scientific conclusions that the agency must draw from the record before it, and granted relief beyond the scope of the Citizen Petition.
The only way the administration can make this argument is to act as though the entire history of emergency contraception approval did not happen. It’s dizzying and the kind of argument one expected during the Bush years. Yet here we are.
Had Judge Korman remanded the matter back to the agency as the administration argues he should have, then the FDA would have undertaken yet another review of evidence to issue a new, different rule on EC availability. Of course, as Korman detailed in the April 5 order, in this case a general remand was necessary because the agency had already done this in 2011 when it originally recommended that EC be universally available. “We supplied, and the court accepted, the legal authority that in this case no more rule-making necessary,” Janet Crepps, senior legal counsel for the Center for Reproductive Rights (CRR), told Rewire.
As Crepps explained, Judge Korman relied on that authority and the extensive factual record before him on the rule-making process to hold that giving the administration more time would only create more harm: “The judge cited the administrations unreasonable pattern of delay to say they don’t get the benefit of the doubt any longer. How many tries do they get when they’ve shown a pattern of bad faith in dealing with this issue?”
In support of their motion for a stay, the administration argues the harm that would come from implementing the April 5 order would be a breach of the public trust because they could no longer be confident that “FDA approved” meant the agency actually approved a product and not the courts. “Their public trust argument is misplaced,” Crepps said. “Look at the end of 2011 when the FDA said emergency contraception is safe and effective for over the counter use for everyone. It was the political influences that have derailed the public trust on this issue. Politics has infused and contaminated the process. If the administration wants to restore trust it should follow the FDA’s original recommendations.”
Had Korman told the agency to issue a new rule, what would that rule look like? On this point the administration has conveniently offered up, ahead of its appeal, its “compromise” with Plan B. “Indeed, over the past eight years, FDA has invested thousands of hours reviewing and acting upon multiple iterations of SNDAs, generic competitors, as well as the Citizen Petition,” the administration argued in its brief. “On remand, FDA would reconsider, consistent with any governing legal ruling by the Court, the Citizen Petition regarding Plan B and its generics in light of the applicable scientific data or information.”
The problem is this “compromise” is hardly a model of politics-free rule-making, and while the administration insists the Plan B announcement is separate and distinct from this broader legal challenge, it is impossible not to look at them together. This is especially true when the administration itself uses the Plan B approval process to hold up its legal argument for overturning the April 5 order. Currently if a person under age 15 needs to access emergency contraception that person will still need a prescription and will have to find an open pharmacy—one that stocks the drug. Those 15 and older will need to have an ID to purchase, and the product must also be sold only in stores that have a pharmacy. This is of course to allow “conscience” refusals and reflects the ever-present force of the religious right in dictating women’s health policy.
Thursday afternoon U.S. District Judge Edward Korman gave the Obama administration until May 10 of this year to comply and said that he will hold a hearing on the government’s motion for a stay on Tuesday, May 7 at 11 am. Whether it’s granted or not, the administration has just guaranteed the issue of emergency contraception remain convoluted and infected by politics and tied up in litigation for years to come.