Regulatory Focus™ > News Articles > Government Outlines Case on 'Plan B' Appeal, Argues Violations of Proper Process

Government Outlines Case on 'Plan B' Appeal, Argues Violations of Proper Process

Posted 28 May 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) on Friday filed a motion to stay an earlier decision by a New York circuit court judge that would have required it to approve Teva Women's Health's Plan B One Step, an emergency contraceptive pill that has long been at the center of legal battles between the agency and women's health groups.

The little-noticed appeal, made right before a holiday weekend on 24 May 2013, serves to outline the agency's case in support of a motion to stay an earlier decision made by Judge Edward Korman, who slapped down FDA's original arguments and a subsequent appeal in a series of scathing remarks that called into question whether FDA was acting in good faith during the appeals process.


FDA initially approved Teva's proposal to make Plan B One-Step available over the counter (OTC) in December 2011, but was immediately overturned by US Department of Health and Human Services Secretary Kathleen Sebelius, who said the decision lacked the necessary data to show the drug would be safe for use in its youngest potential users.

Several days after that decision, FDA-acting on the same reasoning provided by Sebelius in regard to the earlier decision-denied a citizen petition filed by Teva to make its original, two-pill formulation of Plan B available OTC as well.

Women's health groups then filed a lawsuit against FDA and DHHS seeking to compel a reversal of the decision. Korman agreed with their argument, and on 5 April 2013 ruled that both agencies should permit the drug to be made available OTC. The decision, scathing in its treatment of Sebelius, ordered FDA to re-approve Teva's citizen petition regarding Plan B and make the drug available OTC to all women of reproductive age.

The weeks after that decision were momentous for two reasons. On 30 April 2013, FDA approved an amended application submitted by Teva in the aftermath of the original denial that allows Plan B One Step to be given to all women aged 15 and older, on the condition that they show valid identification. Then, on 1 May 2013, the Department of Justice, acting on behalf of FDA, appealed Korman's decision, arguing that he lacked standing to overturn a regulatory decision.

The two actions reportedly enraged Korman, who lambasted government lawyers in a hearing, allegedly saying they were "lying" to him. In early May 2013, Korman would again deny FDA's request to appeal his decision, saying he was not entirely persuaded by the agency's arguments that he had overstepped his authority and that the appeal seemed to be "frivolous and taken for the purpose of delay."

Korman did, however, give FDA time to file an appeal with an appeals court, which FDA did in May 2013.

A New Appeal

The substance of that appeal was released on Friday in a document supporting its motion for a stay pending its appeal.

Its arguments are similar to the ones it made in its appeal to Korman, including the principal argument that "the district court exceeded its authority by ordering FDA to change" its determination that Teva Plan B One Step should not be approved for OTC use. FDA argued that Korman had in effect ordered it to approve a supplemental new drug application submitted by Teva.

The crux of FDA's argument is that Korman conflated the Plan B One Step application, which was submitted as an SNDA, with a Citizen Petition for Plan B two-step, which had been submitted to FDA before the former had even been invented, resulting in a confusing and often conflicting web of logic. Because the two drugs are not equivalent, Korman should not be using the safety profile of one drug to support the other, FDA argued.

"Anomalously, the court's order thus requires action with respect to the one-pill drug that was not the subject of the citizen petition but does not likewise require action with respect to the two-pill drug that was the subject of the citizen petition," the agency explained in its petition.

FDA also cried foul at Korman not remanding the decision back to it for consideration, particularly as Congress has vested review power in the agency. Korman said such a move would be "utterly futile," but FDA said he had been unable in their estimation to prove that this was indeed the case. "There is no basis for predicting the outcome of a remand in advance," it added.

"Such a course would be extraordinary in any controversy; it is particularly anomalous when a court purports to dictate the terms on which a drug should be sold to the public," FDA explained. The agency said the court had also erred by ordering it to acting "outside of its statutorily-required procedures" by ordering it to change the status of a drug without initiating proper regulatory changes.

Given the complexity of the issues, FDA's arguments, and a purported lack of harm to plaintiffs, FDA said the court should stay the decision until "final resolution of the government's appeal."

That review could be "lengthy," explained Lyle Denniston of the Bloomberg-supported legal publication SCOTUS Blog. "If the courts ultimately rule that Judge Korman should have sent the question of access to the two-pill Plan B back to the FDA, the issue of access to the generic version of that contraceptive might remain quite uncertain for some time," wrote Denniston. That could culminate in months or years of additional delays, perhaps ultimately being decided by the Supreme Court.

FDA Motion to Stay

SCOTUS Blog Summary

Tags: Plan B

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