The Food and Drug Administration (FDA) has approved "Ella", a new morning-after contraceptive pill effective up to five days after unprotected sex or contraceptive failure, despite the lack of adequate clinical trials.
Erin Gainer, CEO of HRA Pharma of Paris, which produces Ella (ellaOne as it is known in Europe), says Ella is "an effective and well-tolerated new generation emergency contraceptive that fulfills a significant and previously unmet need in this field by reducing pregnancy risk up to five days after intercourse."
However, the FDA itself warned that it was unsafe for women to use Ella more than occasionally because they did not have any data on long-term safety. The FDA also warned that women should be ruled out as being pregnant before taking the drug, indicating that it could cause fetuses already in development to be aborted.
"By 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," said U.S. Rep. Chris Smith (R-N.J.), co-chairman of the Congressional Pro-Life Caucus, a bi-partisan organization.
"The FDA is supposed to protect people from dangerous drugs and deceptive marking. Instead, today they have proven they are willing to be complicit in this abortion cover-up," said Smith. "At a minimum the drug should be classified as an abortion drug. Women deserve to know that these pills, that they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death."
"The FDA's irresponsible approval of Ella (Ulipristal), without adequate safety studies, places women's health and lives at risk. The chemical make-up and the 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. Further study is necessary to ensure Ella is safe for women, particularly if it is used off-label." Americans United for Life president Charmaine Yoest told the LifeNews website.
"Make no mistake about it, Ella is a dangerous abortion drug," said Kristan Hawkins, Executive Director of Students for Life of America (SFLA), which has called on the FDA to review and reverse its decision. "The FDA's approval of Ella for sale within the U.S. shows that the FDA has not done its job protecting women, particularly young women whom SFLA serves on a daily basis."
"By approving this drug quietly on a Friday afternoon when most of Washington was on vacation, the Obama Administration and the FDA once again placed politics above science, women's health and informed consent," said Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council.