.- After the Federal Drug Administration recently approved the new drug ella, which is being marketed as emergency contraception, numerous pro-life groups reacted strongly to the move, claiming that the pill acts as an abortifacient.
On Aug. 13, the FDA released a statement announcing the approval of ella for distribution in the United States, explaining that in June, an advisory committee âunanimously voted that the application for ella provided compelling data on efficacy and sufficient information on safety for the proposed indication of emergency contraception.â Ella has been approved for distribution in Europe since May of this year.
Although the drug is being marketed internationally as a morning after pill, the FDA statement also noted that âwomen with known or suspected pregnancy and women who are breastfeeding should not use ella.â
Numerous pro-life critics denounced the FDA's approval of the pill, with many arguing that the drug is mislabeled and misleading because it acts as an abortifacient.
Rep. Chris Smith (R-N.J.) wrote on Friday that rather âthan doing its due diligence on the impact this harmful drug will have on women and developing unborn children, the FDA has turned a blind eye to the serious dangers posed by ella.â
âBy misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion through Medicaid, Title X, and international family planning programs,â he noted.
Explaining how the drug works, the American Association of Pro Life Obstetricians and Gynecologists (AAPLOG) said that ella âis the first selective progesterone receptor modulator (SPRM) available in the United States for the indication of 'emergency contraception (EC).'â
âThis class of drug (SPRM) blocks progesterone which is necessary to maintain a pregnancy. It disables the uterine lining, compromising it's (sic) ability to form 'secretory' endometrium â the lining which nourishes the fertilized, implanting new human baby.â
âThis effectively deprives the brand new human child of oxygen and nutrients, and the child dies,â AAPLOG underscored. âThis is abortifacient action.â
Dr. Charmain Yoest of Americans United for Life cited concerns on the potentially harmful effects that the drug will have on women.
âThe chemical make-up and mechanism of action of ella are very similar to RU-486, which is known to cause serious adverse health risks such as severe bleeding, ruptured tubal pregnancies, serious infections, and even death,â Yoest wrote on Aug. 13.
The Americans United for Life leader also said that several members on the FDA advisory panel in June raised concerns about the effect that the drug would have on pregnancy, noting that there was âinsufficient data.â
âHowever, at the end of the meeting,â Yoest said, âthe panel inexplicably voted unanimously in favor of approving the drug as a contraceptive, and specifically recommended that the FDA not require a pregnancy test before dispensing ella.â
Family Research Council Jeanne Monahan, director of the organization's Center for Human Dignity, echoed Yoest's criticisms, saying that the âFDA advisory panel largely ignored important questions, including impacts on women's health and the abortifacient capacity of Ella.â
âBy approving this drug quietly on a Friday afternoon when most of Washington was on vacation,â Monahan added, âthe Obama Administration and the FDA once again placed politics above science, women's health and informed consent.â