Today, August 13, 2010, the Food and Drug Administration approved the application for a new abortion drug, ulipristal acetate, under the label “ella.”
Ella is the first selective progesterone receptor modulator (SPRM) available in the United States for the indication of “emergency contraception (EC).” According to the European Medicines Agency, SPRMs block progesterone which is necessary to maintain a pregnancy. This effectively deprives the unborn child in the womb of the nutrients he or she needs to live.
Today’s approval labeling ella as emergency contraception is deceptive and dangerous to women and their unborn children. Women deserve to know that ella can cause an abortion and the FDA is deliberately misleading women by mislabeling ella as contraception and not an abortion drug.
Until today, the only SPRM approved in the United States is the medical abortion drug, mifepristone (RU-486), which is approved for use to induce an abortion through Day 49 of pregnancy. Prior to today’s decision, FDA approved “emergency contraception” available in the U.S. (Plan B & Next Choice) prevents ovulation, fertilization and implantation. Many pro-life Americans oppose emergency contraception because it can kill an embryo by preventing implantation in the womb. Ella also prevents ovulation, fertilization and implantation. However, ella’s strong similarity to mifepristone indicates it could also cause an abortion after implantation days, weeks, or months into pregnancy.
On August 2, 2010, Congressman Joe Pitts (R-Penn.) sent a letter signed by 90 Members of Congress to FDA Commissioner Hamburg regarding the application for this new abortion drug. The letter raises concerns regarding the similar chemical makeup of ella to RU-486, the absence of research to demonstrate that the drug does not cause abortion, the failure to address the dangers of off-label use, and the lack of information about health risks for a woman or her unborn child.
Pro-life leaders are also concerned that approval of this new abortion drug could result in taxpayer subsidies for abortion. Approved as an emergency contraceptive, ella could be purchased using taxpayer funds through Medicaid, Title X, and international family planning programs. In addition, it would be eligible for funds appropriated in the Patient Protection and Affordable Care Act, (P.L. 111-148 and insurance companies could be forced to cover ella under the requirements of P.L. 111-148. Pro-life groups are concerned that this approval creates a loophole to existing prohibitions on abortion funding since ella can cause abortions when used off-label or when prescribed to women who are not yet aware that they are pregnant. This could also pose significant conscience concerns as pharmacists would not be protected from being forced to dispense this new abortion drug.