September 9, 2019 (LifeSiteNews) – The European physician behind an organization that circumvents medical regulations by sending abortion pills through the mail has filed a federal lawsuit against the U.S. Food & Drug Administration (FDA) over actions it has taken to block their activities.
Created by Dutch abortion activist Rebecca Gomperts, “Aid Access” sends women the abortion-inducing drugs mifepristone and misoprostol after just an online consultation with a “doctor,” for the express purpose of getting around the costs and unavailability of abortions in their area, as well as regulations such as waiting periods or parental involvement requirements. The group claims it’s safe to take the pills at home, without medical supervision.
The FDA opened an investigation into Aid Access last October, and in March warned the organization that it was “facilitating the sale of…unapproved and misbranded” products, and to “promptly cease” doing so or face regulatory action potentially “including seizure or injunction, without further notice.”
On Friday, Gomperts filed a suit in U.S. District Court for the District of Idaho against the FDA and Health and Human Services (HHS) Secretary Alex Azar for seizing up to ten doses of abortion drugs Aid Access had “prescribed” since that letter, NPR reports, as well as allegedly blocking some payments to the group. The suit seeks to stop what Gomperts calls “bullying” and “intimidation” by the FDA.
Gomperts' attorney Richard Hearn claims that Aid Access merely helps women carry out the so-called “right” to abortion. “Some women in the United States can exercise that right just by going down the street if those women happen to live in New York or San Francisco or other major metropolitan areas on either one of the coasts,” he told NPR. “But women in Idaho and other rural states, especially conservative states…cannot exercise that right.”
“FDA remains very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet or via other channels for illegal importation, because this bypasses important safeguards designed to protect women's health,” the agency responded in a statement to NPR. It didn’t comment on potential future actions against Aid Access, but said it “generally does not take enforcement action against individuals” who receive such unapproved drugs.
Part of the FDA’s March warning to Aid Access was that its business circumvents federal requirements that the approved prescription version of mifepristone, Mifeprex, be only made available via a Risk Evaluation and Mitigation Strategy (REMS) program and obtainable only from REMS-certified healthcare providers. This, it said, ensures that providers can “assess the duration of the pregnancy accurately, diagnose ectopic pregnancies, and provide surgical intervention in cases of incomplete abortion or severe bleeding, or to have made arrangements for others to provide such care”; give women “access to medical facilities for emergency care”; and more.
Pro-lifers also warn that even when “properly” taken, abortion pills are not only lethal to preborn children but more dangerous to women than advertised.
“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 FDA warns, on top of 2,740 cases of severe complications from 2000 to 2012.
“Protecting women from the known dangers of abortion-inducing drugs is good and safe policy,” Students for Life of America spokesperson Kristi Hamrick said in a statement about the lawsuit. “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. 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.”