FDA Readies Public Hearing for Next Generation Abortion Drug

While the US Food & Drug Administration (FDA) readies a June public hearing for a new drug billed as an advanced form of “emergency contraception,” pro-life advocates are warning that ulipristal acetate is in fact the “next generation” of the abortion drug RU-486. Ulipristal acetate functions similarly to RU-486, which has been related to a number of maternal deaths both in the U.S. and abroad.

Americans United for Life filed testimony with the FDA’s Advisory Committee for Reproductive Health Drugs, urging the federal drug oversight agency not to approve ulipristal acetate for sale in the U.S. or make it available over-the-counter.

“The FDA and abortion proponents are misrepresenting Ulipristal as an ’emergency contraception’ drug — it’s simply the next generation of RU-486,” said Dr. Charmaine Yoest, President and CEO of Americans United for Life. “The American people need to know that Ulipristal is a dangerous drug that will place women’s lives in danger.”

The FDA advisory committee will hold a public hearing on ulipristal as the first step of the approval process. The drug, which would be marketed under the names “ella” or “ellaOne,” could be taken by a woman five days after sexual intercourse.

However, a letter sent by AUL to the FDA argues that the drug does not function like other “emergency contraception” such as Plan-B, which is taken within 72 hours of intercourse. Rather, ulipristal is a much more potent abortifacient, chemically similar to the abortion drug mifepristone, the first step in the two part regimen for RU-486.

Emergency contraception works by releasing massive amounts of progesterone into a woman’s body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. The drug can act as an abortifacient if the progesterone changes the lining of the womb, preventing a newly conceived embryo from implanting.

Ulipristal is far more effective abortifacient, being a progestin-blocker, or “selective progesterone receptor modulator (SPRM),” which turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but its successful continuance.

The AUL letter written by William L. Saunders, Senior Vice President of Legal Affairs, states that “[i]n addition to suppressing ovulation, [ulipristal], prevents the implantation of the embryo in the womb, but it directly interferes with the development of a human embryo, by blocking the genes that synthesize proteins necessary for maintaining its survival.”

AUL said that the drug’s chemical similarity to mifepristone, another SPRM, is reason enough for the FDA to prevent its importation into the United States.

Mifepristone has had thousands of “adverse event reports” related to its use since the FDA approved it for sale in 2000, including 13 confirmed deaths, 9 of which were reported in the U.S. AUL pointed out that by May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1070 events were recorded including “six deaths, nine life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection.”

A number of the victims were women with no reported prior health risk factors. AUL explained that medical literature had found that the chemical composition of mifepristone “can prevent the proper functioning of the immune system and cause fatal shock.”

“Ulipristal is subject to similar risks, and unsupervised, over-the-counter access would put countless women’s lives in danger,” wrote Saunders.

He added that with over-the-counter availability “there will be no physician oversight or assurance of proper administration,” and that the RU-486 regimen has been repeatedly abused by abortion providers in complete disregard for FDA guidelines and women’s health. (See related coverage here and here)

Ulipristal was studied by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), who admitted they lacked any concrete information as to what the effects of the drug would be 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 and one was not followed up. However, five of the six were still underway with no other information offered regarding the status of their pregnancies.

CHMP also reported that they have no data as to whether the drug has any carcinogenic effects.
Read the AUL testimony provided to the FDA.

Read the CHMP report on ulipristal acetate.

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