By Randall K. O’Bannon, Ph.D. NRL Director of Education & Research
In a development which surprised absolutely no one, the U.S. Food & Drug Administration (FDA) yesterday “suspended” regulations on the dispensing of the abortion pill mifepristone for the duration of the pandemic. This means that abortionists can meet with women by video conference and have pills shipped to the women’s homes without ever having to visit the clinic.
The abortion industry has been calling for at-home abortions for years and has used the pandemic as an excuse to demand that the government allow “contactless” abortion pill distribution.
Several state attorneys general, led by then-California AG (and now HHS Secretary) Xavier Becerra , signed a letter in March of 2020 petitioning the FDA to relax its Risk Evaluation and Mitigation Strategy (REMS) regulations on mifepristone. Those regulations were put in place more than a decade ago. The FDA felt mifepristone was one of those “medications with serious safety concerns” that required special safety regulation “to help ensure the benefits of the medication outweigh its risks.”
The FDA’s REMS for mifepristone included several requirements. First, that distribution of the drugs be limited to prescribers who certified that they were aware of and prepared to handle certain complications (e.g., hemorrhage, infection, incomplete or failed abortion, the rupture of undetected ectopic pregnancy) associated with the drug and would screen and counsel patients regarding these risks. Second, these pills would “only be available to be dispensed in a clinic, medical office, or hospital, by or under the supervision of a specially certified prescriber.”
This last provision was the one that really stuck in the craw of abortion “providers.” It effectively prohibited them from doing their screening “visits” virtually –not in person–and shipping their pills by mail without ever actually meeting, much less conducting a physical examination of their “patient” in person.
Lobbyists for the pro-abortion medical society American College of Obstetricians and Gynecologists (ACOG) filed suit in court to force the FDA to drop its REMS regulations. They found a sympathetic ear in District Court Judge Theodore Chuang, who temporarily blocked enforcement of the regulations in July 2020. In March of 2021, the Supreme Court reinstated those restrictions. The justices wrote that the lower court judge had no authority to overrule the decisions of experts at the government agency specifically charged with overseeing the safety of drugs sold and used in the U.S.
Undaunted by their lack of success under the Trump administration, abortion advocates renewed their push when pro-abortion Joe Biden took office and installed Xavier Becerra to head the Department of Health and Human Services. HHS is the federal agency which oversees the FDA.
Their persistence has paid off with this latest announcement.
What was the basis for the FDA’s change? In its letter announcing the “suspension” of the REMS regulations, the FDA cited a number of studies by abortion advocates claiming to have demonstrated that these at-home telemedical, “no-test” abortions were safe.
Not surprisingly, the letter mentions nothing about the two dozen mifepristone patients who have died after taking the drugs, nor the thousands of women who suffered “adverse events.” Those included life-threatening hemorrhages, infections, or ruptured ectopic pregnancies. Nor did the letter address how dropping the in-person screening, physical exam and counseling and having the abortion at home far from any medical assistance may exacerbate these risks.
As NRL News Today addressed in numerous posts, a common feature of many of these studies touting the alleged “safety” of at-home chemical abortions is that they typically fail to consider the outcome of those women who are lost to follow up, those of whom the study loses track. Especially if the clinic or abortionist shipping the pills is hundreds of miles away, in another state, or even in a foreign country, the woman suffering from copious, uncontrollable bleeding or excruciating abdominal cramps (which could be signs of a serious infection or a rupturing ectopic pregnancy) is probably more likely to visit the closest emergency room, where she may or may not inform the doctors of her attempted chemical abortion.
These risks are known and are real. However, when these women’s experience is left out of the calculations, at home use of the drug will appear much safer than it actually is.
Though offered as a temporary measure during the time of the beginning of the COVID-19, expect the pro-abortion lobby to seek to have these restrictions permanently lifted once the pandemic is officially over, no matter what the actual safety record shows. That is clearly what abortion advocates have been angling for, and what they hope to have achieved with yesterday’s announcement.
Expect efforts to set up webcam abortions in every state with pills shipped overnight directly to women’s homes. States with laws requiring the physical presence of the prescribing physician will be tested.
Despite their best promotions and political efforts, abortions have dropped in the United States over the past thirty years. They have continued to fall since chemical abortions (or “medication abortions,” as abortion advocates call them) were first approved by the government in September of 2000. Women who have taken mifepristone and its companion misoprostol have found that the drugs were nowhere near as easy, safe and effective as advertised.
The FDA’s announcement is a setback. However, so long as we keep emphasizing truth out about the dangers of these drugs and what they actually do to mothers and their unborn children, we have reason to believe we will continue to see the abortion curve trending downward.