Washington D.C., Sep 10, 2019 / 06:06 pm (CNA).- Pro-life groups are decrying an effort by a European doctor to sue the United States Food and Drug Administration in order to continue selling medical abortion pills online.
Dr. Rebecca Gomperts is a licensed physician in Austria and the founder of Aid Access, a European company that prescribes and mails misoprostol and mifepristone, the drugs required for a medical abortion, to women in the United States.
In March, the FDA issued a cease-and-desist to Aid Access, ordering the group to stop prescribing and mailing the drugs to patients in the United States because they were unregulated.
On Monday, Gomperts, through attorney Richard Hearn, filed a civil action lawsuit in federal court in Idaho against the FDA, seeking the protection of the women who have received the prescriptions, and the protection of her group to continue selling the abortion drugs online.
In the suit, Gomperts claims that the FDA has seized up to 10 doses of the abortion drugs sent through the mail by Aid Access, and blocked some payments from patients made to Aid Access, since March.
Dr. Tara Sander Lee, a senior fellow and the director of life sciences with pro-life research group Charlotte Lozier Institute, said in a statement that it was “ludicrous” of Gomperts to sue the FDA, “a government agency charged with protecting the public health of women by assuring the safety and efficacy of any drug.”
“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,” Lee said.
“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.,” Lee added.
FDA-approved versions of the medical abortion drugs have been available to US consumers since 2000, but may only be prescribed by a certified health care provider in a hospital, clinic, or medical office setting. They may not be sold online or in a retail pharmacy.
The health care provider must inform patients about the serious risks associated with use of the medications, and sign a waiver certifying the patient has access to emergency care or a surgical abortion in the case of complication.
These requirements are part of an FDA risk mitigation program called REMS, which is used for all higher-risk medications. The March letter to Aid Access stated that the FDA-approved version of mifepristone, called “Mifeprex,” is under the REMS program because “the drug carries a risk of serious or even life-threatening adverse effects, including serious and sometimes fatal infections and prolonged heavy bleeding, which may be a sign of incomplete abortion or other complications.”
“The sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products,” the FDA stated in the letter. “Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”
Hearn told NPR that Gomperts is operating out of a desire to provide abortions to women in remote parts of the U.S. who may not have easy access to a clinical 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,” Hearn told NPR. “But women in Idaho and other rural states, especially conservative states…cannot exercise that right.”
Women who request medical abortions through Aid Access are seen by Gomperts in an online consultation, and if they are approved for the drugs, they are instructed on how to request them from a pharmacy in India.
According to the suit, between March 30, 2018 and August 27, 2019, Aid Access received thousands of requests for chemical abortions from women in the U.S. Gomperts claims that of these women, 7,131 have been prescribed misoprostol and mifepristone through Aid Access.
In its March letter, the FDA said that “by facilitating the sale of unapproved mifepristone and misoprostol to consumers in the U.S., Aidaccess.org causes the introduction of unapproved new drugs into U.S. commerce in violation of the FD&C Act.”
Gomperts told NPR that Aid Access briefly stopped prescribing the drugs after the FDA letter, but resumed the practice in May.
“The FDA is a huge institution. It’s very powerful, and it’s a form of intimidation that is quite severe,” Gomperts told NPR. “I would say a form of bullying. And so I think it’s very important to stand up against it.”
Aid Access is the sister organization of Women on Web, which sends medical abortion drugs to women seeking abortion in countries in which the practice is illegal, and Women on Waves, a boat that performs abortions in international waters in order to circumvent legal issues women may face.
The lawsuit comes just after Planned Parenthood announced an expansion of its telemedical services through its app, through which users can request birth control delivery, UTI treatment prescriptions, and appointments at Planned Parenthood.
According to its website, Planned Parenthood has also used telemedicine to prescribe mifepristone and misoprostol, the two drugs used in medical abortions. According to the Guttmacher Institute, 18 states require that a licensed physician be physically present during medical abortions, effectively banning abortions prescribed via telemedicine in those states.
Kristan Hawkins, president of pro-life organization Students for Life of America, recently testified to the dangers of RU-486, or medical abortions, in California. In her testimony, she noted that the FDA had previously updated its notes on the dangers of medical abortions.
“As of December 31, 2018, there were reports of 24 deaths of women associated with RU-486 since the product was approved in September 2000, including two cases of ectopic pregnancy resulting in death; and several cases of severe systemic infection (sepsis), including some that were fatal,” the updated FDA note states.
“To date, the report documents nearly 4,200 reported adverse effects, including hospitalization and other serious complications,” Hawkins said at the time.
Hawkins said in a Sept. 9 statement that Aid Access appears to want to prioritize profits over the safety of women.
“Protecting women from the known dangers of abortion-inducing drugs is good and safe policy,” Hawkins said.
“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.”
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