By Susan Brinkmann, OCDS
Staff Journalist
The Food and Drug Administration (FDA) has approved the use of Ella, a drug currently being marketed in Europe as a “morning after pill”, even though it has not undergone rigorous testing in the U.S. and has been known to cause birth defects in children who survived after their mothers used the drug.
The FDA announced its approval of the drug late Friday afternoon, an indication that it is aware of the controversy surrounding use of Ella, a so-called morning-after-pill that can be taken up to five days after unprotected sex.
The drug is known as a selective progesterone receptor modulator (SPRM) which acts by blocking progesterone, the hormone necessary to maintain a pregnancy, thereby causing an abortion by depriving the unborn child of the nutrients it needs to survive. It is the first SPRM approved for use in the United States.
The FDA Advisory Committee for Reproductive Health Drugs voted 11-0 to approve the drug which will be sold by Watson Pharmaceuticals beginning in the fourth quarter of this year. It will be sold by prescription only.
Ella is considered a better morning-after-pill than the one currently on the market in the U.S., Plan B, because it acts over a longer period of time.
“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.
According to LifeNews.com, supporters of the drug are able to deny the drug’s abortifacient properties only by using a contrived definition of pregnancy which states that a woman does not become pregnant until a fertilized egg implants in the womb – which occurs several days after conception.
Opponents of the drug are wasting no time exposing the politics behind the FDA’s decision. During a conference call with reporters, Wendy Wright, president of Concerned Women for America, accused the FDA of 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.
Apparently, the FDA advisory panel made its decision based on data from two phase III clinical trails sponsored by HRA Pharma. These studies showed that 1.51 percent of women using Ella (or EllaOne in Europe) became pregnant when using the drug 72 hours after intercourse while 2.81 percent became pregnant when using the Plan B drug.
Another study, conducted by Anna Glasier, of NHS Lothian in Edinburgh and published in The Lancet medical journal, found fewer pregnancies occurring in women who used Ella than in those who used traditional morning after pills. Among women who took the drug between three to five days of unprotected sex, only women taking traditional pills became pregnant, indicating that those who used Ella during the same time period had abortions.
Wright said that in regards to Ella, the FDA appears to be following the same course it took with during the Clinton administration when it approved the dangerous RU 486 abortion drug without adequate testing. To date, RU-486 has killed at least 13 women, and potentially dozens more, and injured more than 1,100 in the United States alone according to FDA reports.
“Though called an ’emergency contraceptive,’ the drug operates the same way as the abortion drug RU-486, which has caused numerous deaths and over 1,000 reported adverse events,” Wright said during the conference call.
Another concern is the high rate of birth defects for unborn children who are born after failure of the Ella pill.
“Incredibly, despite evidence that Ella may cause birth defects in babies that survive, members of an FDA Advisory Committee recommended against long-term studies to determine if it does, preferring that women be kept in the dark,” Wright said.
Although the manufacturer of the drug claims it is safe for women, “The drug sponsor should prove it,” Wright said.
New Jersey Congressman Chris Smith echoed Wright’s concerns, adding that the new drug could qualify for federal funding under the new health care reform law because it’s being classified as a contraceptive rather than as an abortion-causing drug.
“Ella might even be mandated as a preventive service under Obamacare thus forcing insurance companies to cover this new abortion drug,” Rep. Smith told LifeNews.com.
“I call on President Obama to issue an Executive Order prohibiting any federal agency from providing funding for Ella or insurance coverage that includes Ella,” he said.
“Rather than 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. 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,” Smith continued.
The FDA is supposed to protect people from dangerous drugs and deceptive marketing, he said, and should not be complicit in an “abortion cover-up” such as this one.
“At a minimum the drug should be classified as an abortion drug. Women deserve to know that these pills they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death.”
He added: “Moreover, this drug should never have been approved without significant evidence that children who survive Ella will not suffer from serous birth defects and the FDA should have insisted on adequate testing to determine the drug is safe for teenage girls.”
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