On Friday the 13th of this year, the FDA approved a new abortion drug to be marketed under the name “ella.” Now there may be protests at my labeling it an abortion drug, but I do so deliberately and with solid evidence. [Not for young readers.]
First, both those who support and those who oppose women’s “reproductive rights” have acknowledged the approval of ella as marking a shift in ideology at the FDA, with proponents hailing it as the restoration of “scientific integrity.” This is the same reaction they have had to every Obama policy shift away from the evidence-based and life-affirming decisions of the previous administration. On the contrary, as with the Obama administration’s handling of what was known as the President’s Bioethics Council, ideology trumps ethics, caution, bipartisanship and, yes, science. If the Obama administration was truly concerned about “science,” the FDA might still release the drug, but it would do so only under the same regulatory restrictions regarding distribution and “black box warnings” as those for RU-486.
Second, since ella is in the same drug class as RU-486 (selective progesterone receptor modulator – SPRM), it is certain that it can cause abortion if the right conditions exist. Unlike “Plan B”, ella acts to block progesterone activity via three separate and distinct mechanisms. Because progesterone is critical for the endometrium’s ability to receive the growing embryo (implantation) and maintain the pregnancy, ella can act to destroy the already implanted embryo.
Critics will cry that ella is only approved for use within five days, so it cannot interfere with a pregnancy already established, since implantation does not occur until 6-10 days after sexual intercourse. Of course, of course. Then we are wrong to be concerned about the potential of OHSS (Ovarian Hyperstimulation Syndrome) in young women undergoing preparation for egg donation, since Lupron is not approved for that use. The proponents of ella must think pro-life activists are remarkably naive if they don’t think we can foresee the misuses to which the drug will be put. Nothing prevents a woman from doing something such as gaining several prescriptions from different doctors and taking them all at once in hopes of inducing an abortion. Lack of FDA approval will not prevent men from using it against their girlfriends when they learn they are about to become a father — it doesn’t take long to search for news stories of men surreptitiously administering “Plan B” to their girlfriend after an “oops” night.
In addition, ella is being released on an unsuspecting public for use in that population of women who are precisely the ones most likely to already be pregnant without knowing it. No studies have been undertaken which look at the safety of taking the drug as prescribed when the woman is already pregnant. Such studies are required by commonly accepted ethical guidelines such as those of the International Conference on Harmonisation. Nor have any studies been conducted which look at the safety of multiple uses in the same menstrual cycle.
Also worrying is the possibility that ella’s approval as emergency contraception will pave the way for covert federal funding of abortion. Planned Parenthood Federation’s own Fact Sheet delineates off-label uses of RU-486, including “evidence-based” use of the drug a week longer into pregnancy than the current labeled usage. Given PPF’s record of flouting the laws and lies about the development of a baby during pregnancy (see LiveAction’s website for video of various hidden camera investigations), it is hard to keep from expressing outright astonishment in the face of claims that ella is only approved for use within five days!
ella is no friend to women.