Coalition of Pro-Life Groups Tell FDA to Not Approve Ella Abortion Drug
by Steven Ertelt
July 28, 2010
Washington, DC (LifeNews.com) — A coalition of pro-life groups is sending a letter to the FDA and Drug Administration asking it to not approve the new abortion drug Ella that backers have mislabeled as a morning after pill. The drug works days after conception to essentially cause an abortion of a unique human being.
In June, the FDA Advisory Committee for Reproductive Health Drugs gave its approval to the early abortion drug on two 11-0 votes.
The panel said the "investigational emergency contraceptive pill" known as ulipristal, that would potentially be sold under the name ella in the United States, is safe and effective at preventing pregnancy.
Kristan Hawkins of Students for Life of America has organized the Ella Causes Abortions coalition — a collection of national pro-life groups and leaders (LifeNews.com is also a member) designed to inform the FDA, lawmakers, and the public that ella acts as an abortion drug and not a contraceptive.
Make no mistake about it, ella is a dangerous abortion drug. The FDA advisory panel which approved it for sale within the U.S. has not done its job protecting women and is planning on intentionally misleading women by calling ella a mere contraceptive," Hawkins told LifeNews.com today.
She said she hopes the coalition "will help educate Americans about ella and encourage the FDA Commissioner not to give final approval for the new abortion drug.
The letter says the "drug is deceptively portrayed as a five day ’emergency contraceptive’ preventing ovulation, fertilization, or implantation however, there is evidence that Ulipristal Acetate (ella) may also kill or injure an unborn child after implantation."
"Ulipristal Acetate and the abortion drug Mifepristone (RU-486) are both selective progesterone receptor modulators (SPRM). SPRMs block progesterone, which is necessary to maintain pregnancy — thus starving an unborn baby of the nutrients it needs to continue life," it explains.
"Given ellas similar chemical makeup to RU-486, women deserve to see evidence demonstrating that ella will not destroy or harm an unborn child and that ellas modes of action do not include abortion, especially in light of studies that show ella causes abortions in animal studies," it adds.
The letter to the FDA says its own materials on the drug admit data is too limited to draw any definitive conclusions regarding the effect of ulipristal on an established pregnancy or fetal development.
The letter also references the advisory committee meeting and points out that a representative from Planned Parenthood openly admitted the abortion business distributes PlanB/NextChoice beyond the time frame approved by the FDA and its web site indicates Planned Parenthood distributes RU-486 past the time frame approved by the FDA.
"So there is a compelling indication that ella could be provided off-label to either intentionally or unintentionally induce an abortion," the letter says.
The letter says the FDA also has an obligation to inform women of the risks ella poses.
"Since ellas chemical make-up and mode of action are very similar to RU-486, which causes 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," the letter says. "The FDA summary indicates that the clinical study was too limited to draw any meaningful conclusions about risks associated with tubal pregnancy. Limited to no data is available about ellas effect on minors or its interaction with other drugs, such as hormonal birth control."
The coalition letter also points out that the FDA advisory panel did not address the cases in which women who used ella subsequently gave birth.
One woman who carried her baby to term after taking ella gave birth to a child with optic nerve hypoplasia and developmental delay.
Finally, the letter points out that women who take ella and eventually decide to give birth could be passing along the harmful drug to their children via breastfeeding.
"Research in animals showed that traces of ella could be found in breast milk. Little is known of the effects that it could have on infants who are breastfeeding and the FDA must also ensure proper research and labeling to inform nursing mothers of the risks involved," the letter reads.
Ultimately, the risks and problems — both known and potential — are sufficient for the FDA to deny approval to the abortion drug, the pro-life groups conclude.
"In light of these serious concerns, we believe that ella should not be approved and should not be categorized as ’emergency contraception,’" they say.
If the drug is approved, the letter concludes: "At a bare minimum, the FDA must provide women with informed consent and ensure transparent labeling about the serious risks associated with off-label use clearly indicated, specifically, with the label including a ‘black box warning.’ Women deserve to know the truth about the harm that ella can cause to themselves and their unborn children."
Related web sites:
Ella Causes Abortions – https://www.ellacausesabortions.com
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