“It is very important to continue … because it is the only safe abortion alternative for some of the most vulnerable people,” Dr. Rebecca Gomperts said in an emailed statement. “As a physician, I have the obligation to provide medical care to people in need.”
A letter drawn up by Gomperts’ attorney was sent to the FDA late last week, offering a formal response to the federal agency, which had asked the doctor in March to “immediately cease causing the introduction of these violative drugs into U.S. Commerce.”
“The effect, if not the purpose,” of the warning and restrictions is to “place a substantial burden in the path of U.S. women” who’ve “been forced to attempt to exercise their right to a medical abortion by way of the internet,” he wrote.
Included with Hearn’s letter was a 12-page list of 145 notes sent to Gomperts.
“It was assault, I’m homeless and trying to get off the street,” one woman wrote. “I can’t afford to get set back anymore. I can’t do this and I don’t want to. … I want it to be over ASAP so please help me.”
“The father had taken off the condom without informing me,” wrote another woman, who said in her thank you note that she lives in the Bible Belt and worried that her family would shun her. “There’s no way I could have gotten to the local clinic. Abortions are only available on a few days a week, and they’re always at times I work. I also don’t drive, so discreetly visiting the clinic wasn’t an option.”
“You all prepared me, answered my questions so quickly, I will always be grateful for you,” a third woman said. “Between heart issues and the pregnancy hormones setting off my depression again to the point I wanted to die you guys saved my life.”
How abortion pills by mail work
The first drug taken in the protocol is mifepristone, which blocks progesterone, a hormone that allows the pregnancy to continue. The second drug, misoprostol, stimulates the uterus, causing it to cramp, bleed and contract — ending the pregnancy in what is “very similar to a spontaneous miscarriage,” Gomperts explained.
Obtaining the drugs in the United States, however, can be challenging. Many states have laws that require patients to first be shown ultrasounds or sit down with doctors. For women who can’t get to or afford a clinic visit, medication abortion might not be an option.
Plus, the FDA has imposed restrictions, such as requiring that providers have special certification to distribute the medication and that the medication be dispensed only in health-care settings.
Rules like these are celebrated by anti-abortion groups, which expressed outrage when they first learned of Aid Access.
But clinicians and researchers often balk at these fears.
Why Aid Access
Gomperts suggested in an email that the federal restrictions amount to hypocrisy.
“In direct opposition to its mission — to protect the public health by ensuring the safety, efficacy, and security of drugs — the FDA has so severely restricted access to these safe and effective pills that few doctors are willing or able to prescribe mifepristone and misoprostol,” she wrote.
“I realized it was time,” she said last fall. “Something had to be done.”
She has consulted “with women in all 50 states and the District of Columbia,” attorney Hearn said in his letter to the FDA. “Of the 11,108 women who consulted with Dr. Gomberts in 2018, 2,581 were prescribed medicine approved by the FDA to induce a medical abortion during the early stages of their pregnancies.”
Of those she’s served, Hearn said, Gomperts is “not aware of a single death, hospitalization or serious complication attributed to the prescriptions she prescribed for her patients in the U.S.”
Aid Access is the only one of eight suppliers to receive a grade of A.
What happens next
Hearn outlined further points of comparison to illustrate the safety of these abortions.
“Medical abortions have the same mortality rate as natural miscarriages, (approximately 1 death per 234,000 prescriptions),” he wrote. “That means that medical abortions are significantly safer than natural childbirth, (1 death per 3,788 births), penicillin (1 death per 100,000 prescriptions) and Viagra (1 death per 20,000 prescriptions).”
US women “have a 60-fold higher risk of death from childbirth than from a medical abortion,” he wrote.
The FDA, however, maintains its concern that drugs purchased online from foreign sources “are not the FDA-approved versions of the drugs” and, if unregulated, “may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether,” according to an email from the office of media affairs.
The federal agency would not comment on its next steps, in light of Hearn’s insistence that his client would continue her work and not turn US women away. But its media relations department recounted its warning from the March letter, saying, “failure to correct the violations of the law may result in FDA regulatory action, including seizure or injunction, without further notice.”
What that would look like in Gomperts’ case is unclear, but Hearn is not concerned. He said that the FDA rarely enforces its warning letters, isn’t in the business of regulating doctors and that it would be up to the Department of Justice to try to prosecute Gomperts.
Because Gomperts lives in Europe, he suspects that the Department of Justice wouldn’t bother. But if it ever comes to that, he insists, he’s prepared to stand and fight for her and her patients.