Court Accepts Government’s Plan B Proposal With Caveats

The court has issued a memorandum approving the proposal by the Food and Drug Administration (FDA) and HHS to resolve the Plan B litigation by approving a supplemental new drug application (SNDA) “without delay” when the manufacturer submits it. In response to plaintiffs’ concerns about continued delay, the court noted that they “will have a remedy available” if the government fails to do so.

The Government’s Position

The letter from the government’s attorney to Judge Korman stated that it had invited the manufacturer Teva Branded Pharmaceuticals R & D, Inc. (Teva) to submit an SNDA and proposed labeling for Plan B One Step (PBOS). The government’s decision was to make Plan B One Step available to anyone without prescription or other restrictions but not to do so with the original Plan B, which requires two doses. The effect is to continue the requirement for prescriptions for original Plan B for women under age 17 indefinitely. Apparently, the current prescription requirements for PBOS will continue until the SNDA is approved.

Continued Concerns About Access

The plaintiffs objected to the FDA’s proposal not to expand the availability of the original, less expensive Plan B for two reasons. First, the words “without delay” did not bind the FDA to any specific time frame. In addition, it would allow Teva to charge an inflated price for PBOS, depriving low-income women of access to the drug. However, the court responded that its order of April 5, 2013, specified that the FDA could take this action “if it really believed” there was a difference between the two forms of administration and that the agency was presumed to act in good faith. Nevertheless, the plaintiffs “will have a remedy” if the FDA does not comply.

Marketing Exclusivity

Counsel also noted that the decision whether to give Teva three years of market exclusivity would affect the labeling and the rights of manufacturers of generic versions. Although Judge Korman could not order the FDA not to grant marketing exclusivity, the memorandum discussed in detail arguments against it. The purpose of granting exclusivity with approval of an SNDA is to reward developers for the effort and expense of conducting necessary clinical trials, but the court had ruled that the plaintiffs’ 2001 Citizen Petition should have been granted without any further studies. The FDA’s panel of scientists, convened in 2003, had overwhelmingly supported approval of over-the-counter (OTC) sales of Plan B without age restrictions.

The FDA’s requirement for additional study was based on the lack of data on the ability of 10- or 11-year old girls to follow the instructions on the label. However, the court noted that the study would not have been necessary if the FDA had followed its usual practices, i.e., extrapolation to preteens from the data about teenagers, and reliance on labeling to assure appropriate use. Its departure from the usual practice was the result of political interference.

The Efforts That Led to Approval

The court emphasized the political nature of the agency’s actions. It noted that Teva never appealed the agency’s denial of approval for OTC sale of PBOS. Rather, the plaintiffs, not the manufacturer, spent 12 years pursuing their Citizen’s Petition, and their efforts were responsible for the OTC availability of the drug.