In a major announcement made late Tuesday, the US Food and Drug Administration (FDA) announced that it had expanded the approved indications for Plan B One Step, a birth control medication manufactured by Teva Women's Health and the subject of ongoing, complex and contentious litigation.
Teva submitted an application to FDA in 2012 to allow it to market Plan One-Step (levonorgestrel) for use without a prescription to women 15 years of age and older-the same application approved on 30 April 2013.
But that application hides an unusual history, and one unprecedented in the history of FDA.
In December 2011, Kathleen Sebelius, secretary of the US Department of Health and Human Services (DHHS), 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 for use in girls as young as 10. 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 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, 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.
Those new developments seemed to be designed by Teva to avoid the majority of the criticism leveled against it by Sebelius and others on the right of the US cultural spectrum. Under the new application, only females 15 years of age and over would be permitted to purchase Plan B One-Step without a prescription, and those individuals would be required to show proof of age in the form of identification.
"A customer who cannot provide age verification will not be able to purchase the product," FDA said. "In addition, Teva has arranged to have a security tag placed on all product cartons to prevent theft."
Teva's data also seemed tailored to addressing Sebelius' original complaints-namely, that there was not sufficient data to show that young women understood how the drug works, how to properly use the product, and its limitations.
"The approval of Plan B One-Step for use without a prescription by women 15 years of age and older is based on an actual use study and label comprehension data submitted by Teva showing that women age 15 and older understood that the product was not for routine use and would not protect them against sexually-transmitted diseases," FDA wrote. "These data also established that Plan B One-Step could be used properly within this age group without the intervention of a health care provider."
"We welcome the FDA's decision to provide extended and improved access to this important product, a significant milestone for women," Teva said in a statement,
What of other Litigation?
But the approved age is different than the one called for recently by Judge Edward Korman, who ordered FDA to approve Teva's original request, which would have allowed access to the drug for females as young as 10.
Korman's decision was scathing in its treatment of Sebelius' decision to overrule FDA, 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."
That decision still has not been appealed by FDA, but neither does the new approval placate Korman's order for the agency to approve the drug under the terms of the original application, raising the prospect that the agency will file a last-minute appeal against the case.
"The FDA's approval of Teva's current application for Plan B One-Step is independent of that litigation and this decision is not intended to address the judge's ruling," the agency wrote. "The Department of Justice is considering next steps in the litigation."
FDA Approval Notice
Teva Statement on Approval