CRR Files to Re-open FDA Plan B Suit

                Teva, the pharmaceutical company that manufactures Plan B has been attempting to get Plan B approved for over the counter status for over a decade. The Center for Reproductive Rights has been assisting them as they pursued lawsuits seeking interventions from the court system when it became clear that the FDA was putting political ideologies above science. The full background is a little complex so if you want the long version read our earlier posts regarding this topic.

                The long and short of it was that the FDA under former President George W. Bush’s administration was under orders to decline Teva’s application for OTC status. This information came out so Teva and the CRR sought a court injunction regarding it. The judge who presided over it ordered the FDA to re-examine the evidence and make the decision based on science instead of ideology. They did this but it took them a while so Teva and the CRR filed a motion of contempt against the FDA. While all this was going on President Obama got elected and appointed Kathleen Sebelius to be Secretary of the Department of Health and Human Services.

                While the contempt hearing was pending, the FDA announced its intention to approve the OTC status of Plan B. Sadly, Secretary Sebelius decided to step in and (for the first time in American history) overrode the FDA’s decision. The contempt hearing was still scheduled and Judge Korman (the same judge who ordered the re-examination) dismissed the contempt charges because the FDA tried to follow science. He also recommended Teva and the CRR file to have their original suit re-opened and to add Secretary Sebelius as a defendant.

                Last week, they did exactly that. According to the press release on the CRR website “The new suit asks U.S. District Court Judge Edward Korman to issue a preliminary injunction that would allow all levonorgestrel-based emergency contraceptives —both the single-dose Plan B One-Step and the two-dose generic brands — to be immediately approved for unrestricted over-the-counter sale.” Specifically, they want it available in 30 days.

                During all of this, President Obama and his administration have pushed forward regulations that will require all women with health insurance get birth control without a co-pay. This includes Plan B so his seems to have a two-sided view of Plan B; he wants people to have it as long as they are over 17.

                Judge Korman has been demonstrably clear in his support for the greater access to Plan B given that science supports it. It is possible he will grant the CRR’s petition, but we will keep you posted.


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