This Doctor Won’t Stop Mailing Abortion Pills to the U.S. — Even Though the FDA Ordered Her to
One of the most prominent abortion providers in the world announced Friday that she will not stop sending pills that trigger abortions to the United States — even though the FDA has ordered her to close up shop.
“I tried to go to a local Planned Parenthood but my boyfriend tracked my location and showed up at the clinic to take me home,” one woman, begging for help, wrote to Rebecca Gomperts, an Austria-based physician. “I cannot have a baby at this time, and I need to please find a way to safely end this pregnancy.”
“It was assault. I’m homeless and trying to get off the street,” somebody else wrote. “This is going to ruin anything I have spent the last year trying to get together.”
“I have three disabled children already. I cannot financially or emotionally support one more child,” yet another wrote. “The three I have already require so much, and I have no help at all.”
These women sent their messages to Aid Access, an online service founded by Gomperts that ships abortion-inducing pills to American women. Gomberts’ attorney detailed the requests in a letter to the FDA on Friday, just days after Alabama passed a law to ban almost all abortions within the state.
Under the law, which is not yet in effect, abortions would only be permitted if the pregnancy posed a “serious health risk” to the mother. There are no exceptions for rape or incest, and doctors who perform the procedure could be imprisoned for 99 years.
“I will not be deterred,” Gomperts said in a statement Friday. “When U.S. women seeking to terminate their pregnancies prior to nine weeks consult me, I will not turn them away. I will continue to protect the human and constitutional right of my patients to access safe abortion services.”
Gomperts first launched Aid Access in 2018, more than a decade after starting Women on Web, a similar service for people who live in countries where abortion is illegal. Women who log onto Aid Access are screened online for their eligibility for medication abortions. (If they’re more than nine weeks pregnant, the pills may not work.)
Gomperts consults with prospective patients remotely, then fills their prescriptions for misoprostol and mifepristone. The abortion-causing pills are ultimately shipped to the United States by an India-based pharmacy.
Last year, Gomperts said 11,108 women, who lived in all 50 states and Washington, D.C., consulted her about abortions. She ended up prescribing 2,581 medication abortions. More than one in four women could not afford to pay for Aid Access’ services, which cost 80 euros. (Aid Access helps women cover the cost, if necessary.)
Right now, FDA guidelines dictate that pills to induce medication abortions in the U.S. must be prescribed by a certified health care provider in a clinic, medical office, or hospital. Those abortions currently account for about one third of all abortions in the United States.
In October 2018, the FDA announced that it was investigating Aid Access. Six months later, the FDA sent Gomperts a letter, warning her that the agency had determined she introduced “misbranded and unapproved new drugs” into the United States. This violates the Federal Food, Drug, and Cosmetic Act, according to the FDA.
“Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight,” the FDA’s letter said. “Drugs that have circumvented regulatory safeguards may be contaminated; counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.”
The response from Gomperts’ attorney alleges that the doctor is not aware of any hospitalizations, deaths, or complications related to the pills Aid Access provides. A 2017 study also found the abortions facilitated by Women on Web, whose service is very similar to Aid Access, to be as safe as abortions performed in clinics — which is to say, they’re safe. Furthermore, the letter argues that the FDA does not have jurisdiction over Gomperts, and that the agency is making it unconstitutionally difficult for her patients to get abortions.
“The right of a woman to terminate a pregnancy prior to viability is guaranteed in the U.S. Constitution,” the letter reads. “Unfortunately, many women in the U.S. can only exercise that right by seeking medical care from Dr. Gomperts.”
In a statement to VICE News, the FDA said that drugs purchased from "foreign internet sources" are not subject to FDA manufacturing regulations or facility inspections.
"Failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice," the agency said. "We cannot comment on a potential future action at this time, but we remain very concerned about the sale of unapproved mifepristone for medical termination of early pregnancy on the Internet, because this bypasses important safeguards designed to protect women’s health."
Attached, as an exhibit, to the end of the letter from Gomperts' attorney, the testimonies from Aid Access’ patients spanned 12 pages.
“You guys literally saved my life,” one person wrote, according to the letter. “I have heart failure and would not be able to go through a child birth.”
“I just want to say thank you for guiding me through this entire process, and following up with me whenever I needed any help,” another added. “I can never thank you enough. Thank you.”
This Doctor Won’t Stop Mailing Abortion Pills to the U.S. — Even Though the FDA Ordered Her to
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May 20, 2019
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