FDA Panel Decision to OK New Abortion Drug Ella Panned by Pro-Life Groups
by Steven Ertelt
LifeNews.com Editor
June 18, 2010
Washington, DC (LifeNews.com) — A unanimous decision Thursday by a Food and Drug Administration advisory committee to recommend for approval a new abortion drug called ella is not setting well with pro-life groups. They are also upset that mainstream media outlets are falsely presenting the drug as an improved morning after pill.
The Advisory Committee for Reproductive Health Drugs cast two 11-0 votes saying women could use the drug to prevent pregnancy when taken up to five days after intercourse.
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.
Wendy Wright, the president of Concerned Women for America who testified before the committee yesterday, expanded on her initial comments to LifeNews.com.
She said members of the panel ignored the fact that the dug clearly works as an abortion pill by terminating the life of a newly-conceived human being.
"One committee member pressed in the morning for an answer on what action other than delayed ovulation is happening on the later days. The drug sponsor’s answer :delayed ovulation. Clearly what would make the drug more effective on later days than earlier days is that it’s causing an abortion," Wright said.
Wright noted that as the female panel member voted for the drug, another committee member noted the high number of miscarriages and said, "You’re going to have a problem with those miscarriages."
"Animal studies showed nearly all pregnancies ended in stillbirths," she said.
Wright said the FDA panel wouldn’t even go as far as considering publishing a warning label on the drug to inform women about potential problems or its abortifacient properties.
"Members voted for no negative info on the drug label because it would bias people against the drug. They even argued against doing studies on whether surviving babies have birth defects because, as one member said, negative outcomes are more likely to be reported than positive," she said.
"While researchers may be interested in statistics, women care about whether a drug can cause a birth defect, regardless of the ‘statistical risk’. The drug sponsor and committee members displayed no concern whatsoever about women and their babies," Wright added.
Meanwhile, Jeanne Monahan, the Family Research Council’s Director of the Center for Human Dignity, also opined on the FDA panel’s decision.
She told LifeNews.com she’s upset the committee voted against recommending any precautions or labeling that would inform women of the drug’s abortifacient capabilities as well as health risks.
"The FDA is placing politics above science, women’s health and informed consent," she said.
Monahan says FRC "calls upon the Obama Administration and the FDA to make good on their promise of transparency and honesty."
"Women deserve to know that this drug can take a life that has already been implanted as well as the serious health risks it imposes, including infection and bleeding. Women’s health should not be jeopardized just to advance the agenda of the abortion industry," she said.
At the same time, Erin Gainer, CEO of HRA Pharma, the maker of the Ulipristal abortion drug, applauded the decision.
"HRA Pharma is pleased with the outcome of the Advisory Committee’s votes on the safety and effectiveness of ulipristal acetate," she said. "We look forward to working with the FDA to obtain approval for this new drug and offering a next-generation emergency contraceptive to women in the U.S."
And abortion advocates also lauded the decision, with Planned Parenthood president Cecile Richards saying on twitter, "Great news yesterday" that the panel approved "new emergency contraception for women."
Nancy Keenan, president of NARAL, added, "Emergency-contraception options like ella are a safe, effective back-up method when something goes wrong such as if a condom breaks, or in tragic situations when a woman is sexually assaulted."
But Wright said ella subjects women to problems after sexual assault as men obtain it in an attempt to cover their tracks by stopping the pregnancy.
Donna Harrison, MD, president of the American Association of Pro-Life Obstetricians and Gynecologists, also testified at the FDA hearing.
According to MedPage today, she said the ella abortion drug should not be approved "because there is insufficient data in the company’s trials to conclude what effect, if any, ulipristal has on pregnancy outcomes if a woman becomes pregnant despite taking the drug."
The FDA will likely approve prescription-only status for the ella drug and Erin Gainer, the CEO of HRA Pharma, said, "We currently have no plans to request over-the-counter status for this drug."
But that was the case with the Plan B drug until abortion advocates pushed for over the counter sales and then pushed to sell the drug to minors without a physician visit or parental consent or notification.
Before the hearing, Wright informed LifeNews.com her group had a host of concerns about the ella pill.
Earlier this week, the Food and Drug Administration declared Ella safe and effective for women and released documents saying ella, made by French drugmaker HRA Pharma, appears to work with no unexpected side effects.
Wright also says anyone billing the new Ella abortion drug as a means of preventing abortions is misleading the public.
"Advocates for the morning-after pill claimed that it would dramatically reduce pregnancies and abortions. Now they admit that’s not true. They also admit that morning-after pills are not as effective as previous studies — which the FDA relied on — claimed," she said.
"The same advocates claim that RU-486 is safe, but the families of the women who died from that drug will beg to differ," she continued.
In fact, at least 13 women around the world — and potentially dozens more — have died from using the RU 486 (or mifepristone) abortion drug. Another 1,100 in the United States alone have been injured by it, with some women having such severe problems it required a hospital visit and complete blood transfusion.
Americans United for Life and the American Association of Pro Life Obstetricians & Gynecologists told the FDA a study in England confirms the pro-life perspective that ulipristal acts as an abortion drug.
Anna Glasier, of NHS Lothian in Edinburgh, led a study of more than 5,500 women in the UK published online in The Lancet medical journal. It found fewer pregnancies among those women given the ellaOne drug within five days of intercourse.
And for women who took the drug between 3-5 days after having sex, only women taking the traditional morning after pill became pregnant. They’s because all of the women using ulipristal during that time period had abortions.
The FDA is currently reviewing HRA Pharma’s New Drug Application (NDA) for ulipristal acetate. While it normally follows the recommendations of its advisory committees, it is not bound by them.
Ulipristal acetate was approved in May 2009 by the European Commission for marketing as an emergency contraceptive within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. The product was launched in October 2009 and is marketed today in 22 European countries under the brand name ellaOne.
HRA Pharma is a privately-held European pharmaceutical company.
Related web sites:
Sign a Petition Against Ella – https://www.ellacausesabortions.com
Sign Up for Free Pro-Life News From LifeNews.com
Daily Pro-Life News Report Twice-Weekly Pro-Life
News Report Receive a free daily email report from LifeNews.com with the latest pro-life news stories on abortion, euthanasia and stem cell research. Sign up here. Receive a free twice-weekly email report with the latest pro-life news headlines on abortion, euthanasia and stem cell research. Sign up here.
