A European doctor who supplies drugs for inducing abortion to American women online has filed a lawsuit against the Food and Drug Administration (FDA).
Dr. Rebecca Gomperts, and her organization Aid Access, are seeking the relaxation of U.S. abortion drug safety regulations in order to expand their mail-order drug sales to American women who, they claim, are unable to readily access abortions.
Gomperts is the founder and director of both Women on Waves and Women on Web, states the complaint.
The Charlotte Lozier Institute (CLI), the research arm of the pro-life Susan B. Anthony List, describes Women on Web as “a pro-abortion activist group that illegally sends abortion drugs by mail to women in countries where abortion is prohibited or limited, without any in-person evaluation by a doctor.”
Women on Waves, CLI states, is “an abortion boat that sails around performing abortion in international waters.”
In her lawsuit, Gomperts complains of the “significant restrictions imposed by the FDA” on the distribution of abortion drugs online or by mail-order.
Specifically, she complains that “only healthcare providers who have been certified by Mifeprex’s distributor may prescribe Mifeprex,” and that those providers who wish to be certified must prove they can “date a pregnancy and diagnose an ectopic pregnancy,” and demonstrate their “plans for the patient to receive surgical abortion care in cases of incomplete abortion or severe bleeding.”
Gomperts also complains of the FDA requirement that providers must ensure “the patient has access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.”
Additionally, Gomperts objects to the fact that certification to provide Mifeprex requires the healthcare provider to discuss the medication guide and patient agreement with the woman.
According to NPR, Gomperts’ attorney, Richard Hearn, said the lawsuit is seeking to force the FDA to stop what Gomperts says is the seizure of abortion drugs she has prescribed through Aid Access and the blocking of payments to her organization from patients.
Hearn claims online and mail-order abortion drugs are necessary for women who want to have abortions but live in rural areas.
“[W]omen in Idaho and other rural states, especially conservative states … cannot exercise that right,” he said.
However, Students for Life of America (SFLA) spokesperson and chief media strategist Kristi Hamrick said it is “good and safe policy” to protect women in the U.S. from “the known dangers of abortion-inducing drugs.”
“Risking women’s lives so that an international sales team for abortion pills can more easily operate is not in the interests of American women,” Hamrick said. “It’s easy to understand why a profit-driven industry for chemical abortion pills wants fewer health and safety standards, but protecting women from the known dangers of the pills is the right public policy.”
The FDA states about the dangers of Mifeprex:
As of December 31, 2018, there were reports of 24 deaths of women associated with Mifeprex since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (also called sepsis), including some that were fatal. The adverse events cannot with certainty be causally attributed to mifepristone because of concurrent use of other drugs, other medical or surgical treatments, co-existing medical conditions, and information gaps about patient health status and clinical management of the patient. A summary report of adverse events that reflects data through December 31, 2018 is here.
The FDA also advises that “all providers of medical abortion and emergency room healthcare practitioners should investigate the possibility of sepsis in women who are undergoing medical abortion and present with nausea, vomiting, or diarrhea and weakness with or without abdominal pain.”
“These symptoms, even without a fever, may indicate a serious infection,” cautions FDA.
Dr. Tara Sander Lee, senior fellow and Director of Life Sciences at CLI, said Gomperts’ lawsuit against the FDA is “ludicrous,” noting that the FDA is charged with assuring the safety of drugs and that the abortion drugs provided through her organization have already been shown to be “damaged and contaminated.”
Sander Lee said:
Far from being safe and effective, abortion pills from Aid Access have been shown to be damaged and contaminated, and these tainted drugs have caused serious—and sometimes even fatal—bacterial infections and excessive bleeding in women. It is fully within the FDA’s jurisdiction to protect women from harm and prevent these dangerous abortion pills from getting into the hands of any more women. That Aid Access is attempting to stop the FDA from doing their job proves they have no intention of ensuring the health and safety of women in the U.S.
A study released in June by researchers at Franciscan University of Steubenville uncovered the potential dangers of drug-induced abortion.
The study investigated the effects of the abortion-inducing drugs mifepristone (RU-486) and misoprostol in rats in a controlled environment.
Based on the animal models, the researchers found significant and harmful behavior changes in pregnant rats who were given the abortion-inducing drugs, compared to rats that did not receive the drugs and those that received the drugs but were not pregnant.
Dr. Stephen Sammut, psychology professor at Franciscan who led the study, said the research is “breaking new ground” in the area of the mental health effects of abortion on women.
“In the animal model, we observed depression-like behaviors, and we saw anxiety-like behaviors,” he explained in a statement. “The biochemistry indicated potentially long-term effects.”
Dr. Donna Harrison, executive director of the American Association of Pro-life OB-GYNs, said in a statement about the study:
Medical abortion researchers focused on how fast the drug could kill the baby and how much effort it would take on the part of the abortionists to handle complications. This study (the first not performed by the abortion industry) raises serious concerns about mental health effects of drug-induced abortions and the differences between spontaneous and induced abortion. Such studies should have been performed long before drug-induced abortion was allowed on the market.
According to data available at the Centers for Disease Control and Prevention (CDC), in 2015, 24.6 percent of all abortions in the United States were drug-induced.
Sammut told Breitbart News that, given all the “many complex changes that take place in the woman to prepare her for the pregnancy,” ending the pregnancy with drugs is, therefore, “a serious issue and its repercussion must reverberate throughout all the physiological systems.”
He addressed the question of downplaying the potential for serious effects of drug-induced abortion:
Additionally, we all know about the importance of hormones in regulating the functioning of our body, brain and behavior … so, would it not be reasonable to expect that interfering with natural changes associated with pregnancy would cause serious consequences? The trivialization of the use of these drugs at any age, but even more so when a person is still young, is very dangerous. Even an aspirin has its side effects….and the consequences of the administration of these drugs is significantly greater than many an aspirin.
Sammut further expressed concern that women may not receive enough information about the potential for physiological and psychological repercussions as a result of the procedure.
“We absolutely should be concerned about the trivialization of the potential dangers,” he said. “It is the obligation of a caregiver to inform their patient of every potential consequence. The administration of these drugs has a significant impact on the body – should a person not be informed of the potential for physiological and ultimately psychological effects? Is that not part of the care that a patient deserves?”
The case is Gomperts v. Azar, U.S. District Court for the District of Idaho.
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