After reviewing the results of a study conducted by HRA Pharma, the European company producing the drug, and following testimony from both proponents and opponents of the drug in question, the FDA panel determined that Ulipristal, the “investigational emergency contraceptive pill” already being used in other countries under the trade name EllaOne, would be a safe and effective pregnancy preventing option for women in the United States.
Proponents are pressing the FDA for final approval of EllaOne because it can be used to end a pregnancy up to five days after intercourse, an “improvement” over the so-called Plan B “morning after pill” now widely used in America, which only stops pregnancy up to 72 hours after sex.
Cecile Richards, president of Planned Parenthood, called the panel’s decision to move the drug to the next step toward full FDA approval a “commonsense recommendation” based on expert scientific counsel. “There are many reasons why a woman may face the risk of unintended pregnancy,” Richard’s said, “from failure or improper use of birth control, to sexual assault, and every woman deserves every option available to prevent an unplanned pregnancy.”
But opponents of the drug say that contrary to the descriptions by its manufacturer that it prevents pregnancy, Ulipristal is really no different than the notorious abortion pill RU-486, which has been in use as an abortifacient in the United States since 2000.
“It kills embryos, just like the abortion pill,” Donna Harrison, president of the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG), said in a statement. “It prevents the fertilized egg, the embryo, from implanting in the uterus. And if the embryo has already implanted, it will destroy the embryo.”
In a letter to the FDA, AAPLOG, which represents over 2,000 pro-life physicians across the nation, said that it had concluded “from publicly available information that ulipristal acetate is an abortifacient of the same type as mifepristone (RU 486) and that its approval as an emergency contraceptive raises serious health and ethical issues.” The letter added that “ulipristal’s potential effects on women who used the drug off-label and upon ongoing pregnancies are essentially unexamined and untested.”
Opponents also say that EllaOne’s manufacturer has downplayed the potential side-effects and health risks of the drug, including fatigue, dizziness, nausea, headaches, increased danger of infection, and bleeding. “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,” said Jeanne Monahan, director of the Center for Human Dignity at the Family Research Council. “Women’s health should not be jeopardized just to advance the agenda of the abortion industry.”
Cardinal Daniel DiNardo, chairman of the U.S. Conference of Catholic Bishops’ Committee on Pro-Life Activities, said that mislabeling EllaOne as an “emergency contraceptive” is a dishonest move meant to deceive women who would never consider abortion as an option. “Millions of American women, even those willing to use a contraceptive to prevent fertilization in various circumstances, would personally never choose to have an abortion,” the Cardinal wrote in a letter to Dr. Margaret Hamburg, commissioner of the FDA. “They would be ill served by a misleading campaign to present Ulipristal simply as a ‘contraceptive.’”
Wendy Wright of Concerned Women for America said that in addition to being deceptive about the true function of Ella, its maker has not provided detailed information about the potential for the drug to cause birth defects, or its impact on women who are pregnant. “And yet the committee strongly recommended not giving a woman a pregnancy test,” said Wright, adding, “In Europe, Ella is not to be used in pregnancies, but the FDA committee voted not to test women to detect if they’re pregnant. They are telling doctors to be willfully blind when giving the drug.”
While the FDA has said studies indicate that EllaOne poses no danger of death or harmful side-effects to women taking it, Wright said that there is simply not enough data to make such a determination. “There have not been adequate trials done to find out what happens when women take it more than once,” she said, “or when girls under 18 take it.”
EllaOne was approved in Europe as an “emergency contraceptive” over a year ago, and is now in use in 22 European countries. Following final FDA approval, EllaOne is expected to be distributed in the United States through California-based Watson Pharmaceuticals.
Photo: AP Images