By Peter J. Smith
WASHINGTON, D.C., August 13, 2010 (LifeSiteNews.com) – The U.S. Food & Drug Administration (FDA) approved Friday afternoon HRA Pharma’s “ella,” a new drug billed as an advanced form of "emergency contraception," for sale and distribution in the United States. However, pro-life advocates have raised the alarm on the drug’s safety and testing, and say ella is little more than a chemical abortion drug similar to RU-486, remarketed to the public as contraception.
The FDA’s unanimous decision allows the drug to be marketed in the United States as an “occasional” emergency contraception, taken by a woman up to five days after sexual intercourse. The FDA warned, however, that it was unsafe for women to use ella more than occasionally, as they had no data on its safety over the long term. They also warned that women should be ruled out as pregnant before being prescribed ella, and women experiencing lower abdominal pain or who become pregnant after taking ella should be checked by their health care providers for ectopic pregnancy. (see release)
Pro-life leaders, however, were upset with the federal regulatory agency’s decision to approve the drug, pointing out that ella chemically works the same as RU-486. Therefore it not only can cause an abortion, but may also pose a risk to a woman’s health and life, and even have an adverse effect on later pregnancies.
“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,” said Wendy Wright, President of Concerned Women for America. “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.”
The chemical name for ella is ulipristal acetate, which functions as a progestin-blocker, or "selective progesterone receptor modulator (SPRM)."
Other forms of emergency contraception work by releasing massive amounts of progesterone into a woman's body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. This can also have an abortifacient effect if the influx of progesterone changes the lining of the womb, preventing an already conceived embryo from implanting.
But ulipristal acetate works far differently, with far more effective abortifacient results. As a SPRM, it turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but its continuance.
Mifeprostone, the drug taken in the two step RU-486 regimen, is also a SPRM, which also has been found to have had thousands of "adverse event reports" related to its use. Since the FDA approved it for sale in 2000, Mifepristone has been tied to 13 confirmed deaths, 9 of which were reported in the U.S. As of May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1,070 events were recorded, including six deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.
Wright added that the best regulatory defense for women may be trial lawyers: the FDA, she said, appears to hold reproductive drugs to a lower standard than other drugs, and “treats serious complications and even death as preferable to pregnancy.”
“Make no mistake about it, ella is a dangerous abortion drug,” said Kristan Hawkins, Executive Director of Students for Life of America, in a statement calling upon 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.”
Students for Life of America and the “ella Causes Abortions Coalition” released a video Friday afternoon highlighting their concerns with ella’s possible effects and other questions unanswered by HRA Pharma.
Unfortunately, little data currently exists to answer these questions. Ulipristal acetate was studied by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), but they admitted they lacked any concrete information as to the effects of the drug on women who do get pregnant. In 29 cases of women who became pregnant while testing ulipristal, 16 chose to have an induced abortion, six miscarried, another six said they were going to carry their babies to term, but they received no information regarding the status of their pregnancies.
But the labeling of ella as an emergency contraceptive, rather than an early abortion-inducing drug, may actually have another financial motive for HRA Pharma: the U.S. federal government may end up its biggest single customer.
“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 bipartisan Congressional Pro-Life Caucus. Given President Barack Obama’s ideological commitment to abortion, said Smith, it was no surprise.
The congressman urged another Executive Order from President Obama preventing the federal government from funding ella or forcing insurance companies to cover it as an essential benefit.
“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 they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death.”
See related coverage by LifeSiteNews.com:
FDA Readies Public Hearing for Next Generation Abortion Drug
Pro-life blogger concerned after RU-486 abortion Tweeter goes silent
Oregon Planned Parenthood Offers RU-486 Abortion in 'Privacy of Their Home'
Planned Parenthood Implicated in RU-486 Deaths of Four Women
Leading Researcher Proves RU-486 Causes Septic Shock Deaths