Regulatory Focus™ > News Articles > FDA Says 'Plan B' Ruling Overstepped Judicial Authority, Endangering Regulatory Process

FDA Says 'Plan B' Ruling Overstepped Judicial Authority, Endangering Regulatory Process

Posted 02 May 2013 | By Alexander Gaffney, RAC

Just hours after approving an application from Teva Women's Health allowing the company to market its product over-the-counter (OTC) to women as young as 15 years of age, the US Food and Drug Administration (FDA)-by way of the US Department of Justice-filed an appeal in the US District Court of New York seeking to overturn an earlier ruling that ordered the agency to approve the drugs for girls as young as 10 years of age.


In December 2011, Kathleen Sebelius, secretary of the US Department of Health and Human Services (DHHS), became the first DHHS secretary in history to overturn a decision by FDA, ordering it to reverse an earlier but tentative decision to approve Teva's Plan One-Step (levonorgestrel) for use in girls as young as 10.

"It is commonly understood that there are significant cognitive and behavioral differences between older adolescent girls and the youngest girls of reproductive age, which I believe are relevant to making this determination as to non- prescription availability of this product for all ages," Sebelius wrote in a memo to FDA Secretary Margaret Hamburg at the time of her decision.

Sebelius' memo went on to say that if Teva wanted its application to move forward, it would be required to submit additional data establishing that prescription dispensing requirements should be eliminated for "all ages."

"The label comprehension and actual use studies submitted to FDA do not include data on all ages for which the drug would be approved and available over-the-counter," Sebelius wrote.

FDA was ordered to issue Teva a complete response letter, which it did, and the agency approved the company's subsequent application on 30 April 2013, making the drug available OTC to women as young as 15 years of age.

Subsequent Lawsuit

But that decision still left the matter of a lawsuit to deal with. In the wake of the initial decision, the Center for Reproductive Rights sued FDA in the Eastern District Court of NY. On 5 April 2013, that court issued a decision, authored by Judge Edward Korman, slamming Sebelius for her interference and ordering FDA to approve the initial application submitted by Teva and tentatively approved by FDA in 2011.

Korman's ruling noted that he had little doubt as to the drug's safety. "Indeed, the drug is currently available to the youngest girls of reproductive age with a prescription," Korman wrote.

Korman's decision frequently slammed Sebelius, saying that her directive had "forced the agency to ride roughshod over the policies and practices that it has consistently applied in considering applications for switches in drug status to over-the-counter availability." Korman added that Sebelius' intervention was a "significant departure from agency practice" and observed that the intervention "fell within the scope of the authority that the Secretary expressly delegated to the Commissioner of the FDA."

"In doing so, she failed to take cognizance of a host of FDA policies that the agency would be forced to override in order to comply with her directive," Korman wrote, adding that her decision amounted to "political interference."

"Even with eyes shut to the motivation for the Secretary's decision, the reasons she provided are so unpersuasive as to call into question her good faith," Korman continued. "While the Secretary has strung together three factual statements in her memorandum to Commissioner Hamburg, she has failed to offer a coherent justification for denying the over-the-counter sale of levonorgestrel-based emergency contraceptives to the overwhelming majority of women of all ages who may have need for those drugs and who are capable of understanding their correct use."

The decision goes on to order FDA to approve the citizen petition filed by Teva, and gave it 30 days in which to either approve the drug or appeal the ruling.

A New Appeal

Now the agency has exercised the latter of its two options, announcing on 1 May 2013 that it would appeal the ruling. In the case filed in the US District Court of the Eastern District of New York, the Department of Justice argues that Korman's ruling was "erroneous for at least two reasons."

The first, they said, was that the court "exceeded its authority" by ordering FDA to approve a product that was not the focus of a citizen petition, but was rather the focus of a supplemental new drug application (SNDA), which a court cannot-in theory-overrule.

The second reason, they said, was that Korman issued a timeline by which the agency would need to issue an opinion. Instead, Korman should have ordered the agency to take further administrative action resulting in either a reconsideration of the decision or a more complete explanation.

"The Court cannot pretermit the rulemaking process and foreclose public participation in that process by instead immediately mandating a particular substantive outcome," the Department of Justice wrote.

In a statement to the New York Times, one justice department official said the appeal was less about the outcome, which FDA agreed with in 2011, but rather the process by which Korman came to his conclusion. "What we're focused on is that the remedies that the judge ordered were beyond his authority," the anonymous official said. The precedent for the action could in theory lead to other judicial officials usurping the regulatory process, in effect overruling FDA's authority to make final decisions.

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