On September 28, 2000, the Food and Drug Administration (FDA) approved the abortion drug RU-486 for use in the United States. A look at the facts surrounding the FDA approval of the drug and its 10 years of use in the U.S. is sobering. Women’s health has been sacrificed and countless lives have been taken to advance the agenda of the abortion industry. A decade later, the FDA has again put politics above women’s health, approving a new abortion drug, ella, in August, and allowing the drug to be deceptively marketed as a contraceptive.
In the last days of the Clinton Administration, RU-486 was pushed through the FDA’s expedited approval process. These “Accelerated Approval Regulations” were designed for drugs “that have been studied for their safety and effectiveness in treating serious or life threatening illnesses and that provide meaningful therapeutic benefit to patients over existing treatment.”
RU-486 was not adequately tested for its safety and effectiveness and it does not provide any meaningful therapeutic benefit over surgical abortions already available. In one study, RU-486 failed in 18.3 percent of patients, while surgical abortions failed in only 4.7 percent of patients. (Taken alone, RU-486 fails in one-third of cases, so the regimen includes a second drug – a prostaglandin – that must also be taken.) Moreover, pregnancy is not a serious or life-threatening illness. RU-486 was wrongly fast-tracked for approval.
RU-486 is known to cause serious adverse health risks such as severe bleeding, ruptured tubal pregnancies, serious infections, and even death. Women who take RU-486 report “significantly longer bleeding” and “significantly higher levels” of pain, nausea, vomiting, and diarrhea than women who have surgical abortions. In addition, the long term effects of RU-486 on women, such as on fertility and future pregnancy, are not known. And an improper regimen of RU-486, as pushed by Planned Parenthood, has proven fatal for women – including four women who died in one week alone after a California Planned Parenthood facility provided them with RU-486.
In August 2010, the FDA approved the drug ella. Like RU-486, ella is a selective progesterone receptor modulator (SPRM). By blocking progesterone, an SPRM can either prevent a developing human embryo from implanting in the uterus, or it can kill an implanted embryo by starving it to death. The FDA’s prescribing instructions acknowledge that ella may “affect” implantation and advise that the drug should not be taken if there is a “known or suspected pregnancy.” However, the FDA is allowing the drug to be deceptively labeled as a contraceptive.
In addition, there are serious concerns about the lack of studies regarding the drug ella. The FDA’s prescribing instructions for ella note among the things that have not been studied are:
– The safety and efficacy of repeated use of ella
– How ella may interact with hormonal contraceptives
– The effects of ella on minors
– The risks to a fetus when ella is administered to a pregnant woman
– The risks to an infant when ella is taken by a nursing mother
Moreover, since ella’s chemical make-up and mode of action are very similar to RU-486, concerns exist that the drug will be similarly dangerous to women’s health, particularly if it is used off-label.
September 28, 2010 is a somber anniversary. Ten years ago today the FDA put politics above women’s health. Unfortunately, it was not an isolated incident. The approval of ella demonstrates that when it comes to chemical abortion, advancing the abortion industry’s agenda is more important to the FDA than protecting women’s health.