In a scathing ruling issued on 10 May 2013, US District Court Judge Edward Korman has ordered the US Food and Drug Administration (FDA) to approve Teva Women's Health's citizen petition to approve its Plan B (levonorgestrel) product for women as young as 10, blasting the regulator for engaging in what he called a "filibuster through the appellate process."
The court case revolves around a long-running and complicated approval decision made by FDA in December 2011. FDA initially approved Teva's proposal to make Plan B One-Step available over the counter (OTC), 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.
While FDA Commissioner Margaret Hamburg blasted that decision, saying she agreed with her reviewers' determination that the drug was supported by "adequate and reasonable, well-supported and science-based evidence" to show its safety and efficacy, Sebelius' decision-unprecedented in the history of FDA-was final.
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.
Women's health groups, however, took strong issue with the decision, and 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.
A New Decision
Korman's behavior left little doubt as to how he would rule on the government's arguments, and the release of his response to the government's appeal, issued on 10 May 2013, confirms his low regard for FDA's contention that his earlier decision was improper.
As explained in the original decision, there are two separate but related entities within the case: The Plan B One Step supplemental new drug application, which FDA ultimately denied after DHHS exerted pressure, and a related citizen petition, which was denied based on pressure against the former. Korman noted he did "not have any authority to review the denial of the Plan B One-Step SNDA for the purpose of granting relief." Thus, his order to reverse the denial applied only to the Citizen Petition, which covered the two-pill version of Plan B.
"The case is remanded to the FDA with the instruction to grant the Citizen Petition and make levonorgestrel-based emergency contraceptives available without a prescription and without point-of-sale or age restrictions within thirty days," Korman wrote in the original order. "On remand, the FDA may determine whether any new labeling is reasonably necessary. Moreover, if the FDA actually believes there is any significant difference between the one- and two-pill products, it may limit its over-the-counter approval to the one-pill product."
Korman: Sebelius was 'Politically Motivated'
In his 10 May decision, Korman added further detail to his rationale for the decision, saying he "did so because the Secretary's action was politically motivated, scientifically unjustified, and contrary to agency precedent, and because it could not provide a basis to sustain the denial of the Citizen Petition."
But FDA's appeal of the decision was predicated on the argument that, logical or not, Korman lacked standing to determine whether regulators acted properly in approving a product, regardless of whether it was in a Citizen Petition or in an SNDA or whether Sebelius herself had violated that principle.
The argument, said Korman, was basically that public confidence in FDA would be harmed if a drug was alleged to be"FDA approved," but had instead been approved by a judge, and not FDA. Korman said that argument did not apply here in light of FDA's previous finding that the drug was safe and effective for use, adding that the public "can have confidence that the FDA's judgment is being vindicated."
On the contrary, Korman continued, "If a stay is granted, it will allow the bad-faith, politically motivated decision of Secretary Sebelius, who lacks any medical or scientific expertise, to prevail-thus justifiably undermining the public's confidence in the drug approval process."
'Sugarcoating' an SNDA
Korman also blasted FDA's decision to approve Teva's new SNDA just a day before its appeal was filed, noting that its effect was to try to undermine the argument that a further appeal would harm the plaintiff-"a sugarcoating for FDA's appeal," Korman noted. The judge added that there was no apparent rhyme or reason for the application to have been approved the day before the appeal, observing that it had been under FDA review for more than a year at that point, and also noted that 15- and 16-year-old girls would likely have difficulty meeting the identification requirements called for by FDA, adding little benefit.
"If I was operating in ignorance of the fact that Teva was negotiating a sweetheart agreement with the FDA, it was because nothing happened in this regard from December 2011 until April 30, 2013, 25 days after I issued my opinion in this case," Korman wrote.
Korman goes on to note that, "This case presents the kind of 'rare circumstances' where a remand to the agency is not only unnecessary, but would constitute an abuse of discretion" on the part of the court. "The FDA is not the problem," he continued. "The cause of the rejection of over-the-counter sale of levonorgestrel-based emergency contraceptives was the Secretary of Health and Human Services," and a remand to FDA would be "futile" because of this.
Conclusion: Appeal Denied, Stay Granted
Korman thus concluded that FDA's appeal was denied on grounds that it is "frivolous and is taken for the purpose of delay."
The agency will, however, be given a courtesy stay while the Court of Appeals considers the decision. FDA has until 13 May 2013 to file an appeal with that court.
Read Korman's decision here.