Yesterday, an FDA advisory panel was tasked with examining the safety record of and advisability of approving HRA Pharma’s new drug Ulipristal, to be marketed in the United States as an “emergency contraceptive” called “Ella” (known as “EllaOne” in Europe). During the meeting, HRA Pharma repeatedly admitted that they did not have sufficient data to answer the panelists’ questions regarding both the safety and the mechanism of action for the drug. However, at the conclusion of the meeting, the panel inexplicably and unanimously voted to recommend the drug’s approval, with no special recommendations or restrictions.
The new drug is being promoted as an “emergency contraceptive,” effective for up to five days after intercourse. However, Dr. Scott Emerson, a professor of Biostatistics at the University of Washington and panelist, repeatedly raised the point that the low pregnancy rate for women taking Ella four or five days after intercourse suggests that the drug must have an “abortifacient” quality. Even if Ella’s primary mechanism of action is to delay ovulation, it cannot be so successful at “preventing” pregnancy four to five days after intercourse unless it also works to interfere with (or kill) a developing embryo. The study results regarding Ella’s effectiveness, presented to the panel by HRA Pharma, clearly do not make sense otherwise.
In response, HRA Pharma said, in part, that the sample size of their studies were too small to adequately answer Dr. Emerson’s questions.
Yet, that Ella would act as an abortifacient is not surprising. It is the “next generation” of the abortion drug, RU-486. Ella, like RU-486, is a selective progesterone receptor modulator (SPRM). A progesterone blocker, an SPRM works to interfere with the developing human embryo, causing it to die by either interfering with the uterine lining and preventing implantation, or by starving an implanted embryo.
Women deserve to be fully informed that Ella may interfere with and kill a developing embryo and does not simply prevent conception. However, the panel voted unanimously to approve marketing of this drug as a contraceptive without acknowledging its abortifacient capacity.
Several members of the advisory panel raised the concern that there was insufficient data to show the effect Ella would have on a pregnancy and a developing embryo or fetus. However, when it came time to vote they did more than ignore this concern for women and their unborn children. Not only did they vote unanimously in favor of the drug, they specifically recommended that the FDA not require a pregnancy test before dispensing Ella.
Minors were also done an injustice by the panel. The safety profile of the new drug does not address specific risk factors Ella may present to girls and younger women. The safety studies conducted in the US were only on women 18 and older. A British study included some 16 and 17 year old women, but the sample size of that study was small. Even with knowledge that Ella’s potential risk to minors is unknown, the advisory panel made a special point of noting that minors should be considered no differently than adults in gaining access to this new drug.
Planned Parenthood’s Dr. Vanessa Cullins boasted at the meeting about their off-label use of Plan B, the most common “emergency contraceptive” currently in use in the U.S. The organization’s deadly misuse of RU-486 is also well known. We can expect they will be a major provider of Ella, and yet the committee found no cause for concern about their admitted off-label use of similar drugs. Instead, the committee unanimously agreed that no recommendations were necessary to protect against Ella’s potential off-label use.
The panel’s biggest point of contention was whether or not there should be any recommendations regarding women with high body mass indexes (BMIs) because studies have shown Ella to be less effective in very obese women. The panel’s consensus, however, was it was more important not to discourage women from taking Ella than to raise concerns about its efficacy.
The panel’s discussion surrounding their unanimous vote of approval showed they were not concerned with the risks the new drug may pose and how it actually works, but only with how not to discourage women from taking Ella. They ignored their job, put women at risk, and recommended that the FDA keep women in the dark about the truth about Ella.