FDA Approves Ella Drug; Pro-Life Groups Say It's Untested and Can Cause Abortions

The Food and Drug Administration today approved the controversial ella drug that supporters label a morning after pill but pro-life groups point out will cause very early abortions. They say the drug is untested and women will be misinformed about how it works as an abortion agent.

Billed as a better morning after pill, because it can be used longer after sexual intercourse than the traditional Plan B drug, the drug would almost always cause an abortion because it would begin working days after conception, which confers into existence a new, unique human being.

Supporters of the drug have gotten around that fact by redefining the beginning of pregnancy as implantation rather than conception, or fertilization.

"The prescription-only product prevents pregnancy when taken orally within 120 hours (five days) after a contraceptive failure or unprotected intercourse. It is not intended for routine use as a contraceptive," the agency said.

The FDA approved the drug with prescription-only status and Erin Gainer, the CEO of drug-maker HRA Pharma, said previously "We currently have no plans to request over-the-counter status for this drug."

In June, the FDA Advisory Committee for Reproductive Health Drugs gave its approval to the early abortion drug on two 11-0 votes.

Watson Pharmaceuticals Inc. will sell the abortion drug under teh name ella starting in the last three months of the year.

Wendy Wright, the president of Concerned Women for America led off a conference call today with reporters in advance of the decision, saying that the FDA is misleading American women.

"The FDA underscored the point that this decision was driven by politics by releasing it late on a Friday when people are not paying attention," she said.

"The meager trials done on ella indicate it may cause miscarriages and birth defects. Yet the FDA allowed the HRA Pharma to avoid fully testing the drug so women will be kept in the dark on what kind of serious complications it may cause to her and her baby," she added. 

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.