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| 05 April 2013 | By Alexander Gaffney, RAC
In a stunning reversal of a 2011 order by US Department of Health and Human Services Secretary Kathleen Sebelius, a federal judge has ordered the US Food and Drug Administration (FDA) approve an application by Teva Pharmaceuticals that would permit their Plan B (levonorgestrel) morning after pill to be made available as an over-the-counter product instead of by prescription, saying Sebelius likely lacked the authority to make such a decision, and that regardless of her authority the decision was arbitrary and unreasonable.
In 2011, Sebelius became the first DHHS Secretary in history to reverse a decision by FDA, ordering it to reverse an earlier but tentative decision to approve Teva's product. The decision was seen by some as reflecting the desire of the Obama administration to avoid a likely political firestorm during the election season.
"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.
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, and as of February 2012 Hamburg said she was awaiting a response from the company. "We're waiting to hear back from the sponsor company to hear what steps they want to take next," said Hamburg in an interview with Michael Krasney, host of the National Public Radio program Forum.
In subsequent statements, Obama had expressed support for Sebelius' decision, saying that he was concerned about whether regulators could have "confidence" that 12- or 13-year-old children could use Plan B properly.
"The reason Kathleen made this decision is that she could not be confident that a 10-year-old or an 11-year-old going to a drugstore should be able - alongside bubble gum or batteries - be able to buy a medication that potentially, if not used properly, could have an adverse effect," Obama said in remarks to the White House press pool.
"[Sebelius'] judgment was that there was not enough evidence that this potentially could be used improperly in a way that had adverse health effects on those young people," Obama added. When asked if he supported her decision, he said, "I do."
But the decision earned rare public rebukes from Hamburg, who was clearly irked by the decision.
"The science supported the decision to move forward," said Hamburg in her interview with Krasney. However, "the secretary of Health and Human Services, to whom Congress has given the actual authority for decision-making in these matters […] determined that there wasn't sufficient data to support the younger ages," added Hamburg.
Under the new legal opinion, FDA would be ordered to approve Teva's original request. The decision, by US District Court judge Edward Korman, orders the reversal of FDA's denial of Teva's citizen petition seeking OTC access to Plan B.
Korman said that, "The reader will observe that Secretary Sebelius did not say that, "if not used properly," levonorgestrel-based emergency contraception could have an "adverse effect" on the youngest girls of reproductive age, nor did she include within that group girls as young as 10."
"Indeed, the drug is currently available to the youngest girls of reproductive age with a prescription," Korman noted, significantly weakening her case.
Korman also had harsh words for Sebelius, saying 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."
Korman's case opinion goes on to offer a-literally-sentence-by-sentence deconstruction of Sebelius' arguments, dismissing each in turn.
Korman also found that FDA's consideration of the data was largely appropriate, saying that FDA had, in fact, appropriately considered adequate data, and that this data was sufficient to support approval.
"More significantly, the FDA did engage in extrapolation in considering the Plan B OneStep SNDA; otherwise, it would not have announced its intention to approve that SNDA and expand access to Plan B One-Step to all women of childbearing age," he wrote. "In sum, the defendants' motion for summary judgment does not provide any evidence to contradict a record which shows that the FDA has engaged in extrapolation at the very least from older to younger adolescents with respect to the issues of actual use and label comprehension."
The opinion goes on to note similar precedence for supplemental OTC-switch approvals, such as Alli, a weight loss product, and dextromethorphan, a cough suppressant Korman observed is "regularly abused by teenagers."
Korman argued that is FDA could rely on clear labeling restrictions to make those products available to the general public on an OTC basis, so too should it have done the same for Plan B.
"The FDA's willingness to rely on labeling to make these drugs available for sale over-the-counter without any age or point-of-sale restrictions, even though they are unsafe for unsupervised use by young adolescents, stands in stark contrast to its refusal to make equally available concededly safe and timesensitive levonorgestrel-based emergency contraceptives."
"While the FDA complied with Secretary Sebelius's order, it is clear that the decision to deny the SNDA was not that of an agency to which "Congress has entrusted the responsibility of making the necessary scientific assessment . . . [and which] must have the latitude to make that decision properly," Korman stated.
Korman called into question Sebelius' authority to issue the decision, saying it was "hardly clear that the Secreary had the power to issue the order, and if she did have that authority, her decision was arbitrary, capricious and unreasonable."
Even if Teva has been able to present data sufficient to show evidence of adequate labeling and actual use studies for younger girls, "the FDA would still have been forced to deny their petition on the grounds articulated by the Secretary," Korman argued.
"Thus, the suggestion that the plaintiffs need to provide "additional data" comparable to that in the Plan B One-Step application "to support a switch of Plan B for women younger than 17 years of age" is simply a complete pretext-another example of the bad faith that has permeated the FDA's consideration of the Citizen Petition from beginning to end."
Korman concluded that Sebelius' decision was "arbitrary, capricious and unreasonable," and ordered FDA to approve Teva's Supplemental new drug application to make Plan B available "without point-of-sale restrictions within thirty days."
Tags: Kathleen Sebelius, Margaret Hamburg, Sebelius, DHHS, Hamburg