In an unexpected reversal, the US Department of Justice (DOJ)-acting on behalf of the US Food and Drug Administration (FDA)-has announced that it will allow Teva Women's Health's Plan B One-Step (levonorgestrel) to be marketed over the counter (OTC) without age or point-of-sale restrictions, in effect dropping its appeal of an order issued earlier this year by Judge Edward Korman.
FDA initially approved Teva's proposal to make Plan B One-Step available 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, a justice on the New York circuit court, 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 reapprove Teva's citizen petition regarding Plan B and make the drug available OTC to all women of reproductive age.
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. Korman rejected FDA's arguments in its appeal, but stayed his decision to allow FDA to appeal to a higher court, which it did in late May 2012.
Conceding the Arguments
Despite FDA's arguments, the appeals court issued the agency a major setback when it said it would only allow the agency to appeal Korman's decision on Plan B One-Step, but would not hear arguments regarding the original two-pill Plan B formulation, in effect approving it for sale.
As a result, FDA said it plans to comply with the court's order, allowing Plan B One-Step to be marketed OTC to women of all ages. The original formulation of Plan B will continue to be sold to so-called "older adolescents," and not to those of all ages based on FDA's understanding that there are "significant differences" between the two products and how they are used.
DOJ's 11 June 2013 letter notes that FDA has already called on Teva Women's Health to submit a supplemental new drug application (SNDA) with the new proposed labeling that would allow the drug to be sold without age or point-of-sale restrictions.
"Upon receipt of this SNDA, FDA will approve it without delay," DOJ wrote.
"After FDA receives and approves Teva's supplement, we expect the sponsors of the generic versions of PBOS to submit appropriate amendments to their abbreviated new drug applications," DOJ added. "If FDA grants Teva marketing exclusivity, the scope of that exclusivity may affect the labeling that could be approved for generic equivalents of PBOS."
All of this, however, is contingent upon Korman accepting DOJ's understanding of the case, which isn't necessarily a given. If Korman determines that FDA's understanding of differences between Plan B One-Step and the two-step version of Plan B is incorrect, he could order the agency to approve the latter for wider distribution as well. That possibility is a tantalizing one for women's health advocates, who note that such a decision would make generic versions of the drug more widely available.
Analysis: Outstanding Questions
But a lingering question remains for FDA: Why did it suddenly concede the case after months of legal wrangling and enduring withering publicity?
The answer could have to do with the agency's assessment of an expected outcome and its effect on legal precedence. FDA's appeal to Korman's decision was predicated on the argument that no judge should have the authority to order it to make an approval decision.
"It is particularly anomalous when a court purports to dictate the terms on which a drug should be sold to the public," FDA wrote. The agency said the court had also erred by ordering it to act "outside of its statutorily-required procedures" by ordering it to change the status of a drug without initiating proper regulatory changes.
But facing a potential loss in appeals court after judges there essentially discarded half of its arguments without even so much as a hearing, FDA's litigators may well have determined that the best course of action would be to limit the precedence of Korman's decision.
FDA has long noted the effects of precedent-setting decisions on its regulatory authority, noting that legal decisions on its compounding authority have left it with different authority in different parts of the country. In the same vein, it may have decided that by containing Korman's decision to the circuit court of New York, that might allow it to argue that the Plan B decision was a legal anomaly that should not be held up as a precedent-setting decision.
DOJ Letter to Korman