As the Abortion Pill Becomes More Widespread, FDA Warns of Grave Dangers

Pro-life experts point out that these concerns also apply to mail-order and telehealth abortions, for which the FDA lifted its restrictions in December 2021.

Mifepristone (Mifeprex), one of the two drugs used in a medication abortion, is displayed at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 15, 2022.
Mifepristone (Mifeprex), one of the two drugs used in a medication abortion, is displayed at the Women's Reproductive Clinic, which provides legal medication abortion services, in Santa Teresa, New Mexico, on June 15, 2022. (photo: Robyn Beck / AFP/Getty)

WASHINGTON — In the aftermath of the Supreme Court’s overturning of Roe v. Wade, abortion advocates have been pushing for the widespread use of abortion pills in telehealth abortions without an in-person doctor visit — including before a woman actually becomes pregnant.

A representative from the Food and Drug Administration told Politico Oct. 31 that there are significant safety concerns, including missing a potentially life-threatening ectopic pregnancy or inaccurately assessing how far along the woman is, if abortion pills are provided to women before pregnancy.

Pro-life experts point out that these concerns also apply to mail-order and telehealth abortions, for which the FDA lifted its restrictions in December 2021.

The abortion pill accounts for more than half of U.S. abortions, according to the latest estimate from the pro-abortion Guttmacher Institute, made before the Dobbs decision overturned Roe in June.

The FDA representative anonymously told Politico that the abortion pill mifepristone is “not approved for advance provision of a medical abortion,” because if mifepristone “were prescribed before a patient is pregnant, providers wouldn’t be able to properly oversee care to ensure safety and effectiveness.” The spokesman expressed concern that “if patients were to take mifepristone weeks or months after getting a prescription filled, a medical professional may not be able to assess if a pregnancy is intrauterine or ectopic or date pregnancies properly. The drug is only approved through 70-days gestation for abortions.”

Dr. George Delgado, medical director of Culture of Life Family Healthcare in San Diego, told the Register that for any telehealth or “mail-order medical abortions,” where there is no in-person visit with a doctor, the risks “will be the same as if you buy it ahead of time.”

Those risks include “the possibility of an erroneous diagnosis of pregnancy because a woman is just taking it and not confirming her pregnancy with anybody else” or “inaccurate dating of pregnancy.”

The FDA did not respond by press time to the Register’s questions regarding whether the federal health agency believes the concerns over advance prescription of mifepristone also apply to telehealth prescriptions of the drug and receiving it via mail, particularly in the cases of ectopic pregnancy or ensuring the correct dating of a pregnancy.

Delgado pointed out that even the American College of Obstetricians and Gynecologists, a pro-abortion-rights group that advocates for the FDA to remove regulations for mifepristone, has recommendations that an ultrasound “is the most accurate method to establish or confirm gestational age” and noted in those recommendations that about half of women get the timing of their pregnancy wrong.

He said that another issue with unsupervised use of the abortion pill, whether prescribed via telehealth or in advance, is missing “a diagnosis of an ectopic pregnancy,” a potentially life-threatening condition in which the unborn baby implants outside the uterus in the fallopian tube. He said a woman might take the pill, “have some bleeding, think that she’s done with her abortion, but, actually, the bleeding is from her tube starting to bleed, and then her tube ruptures. She doesn’t go get medical treatment because she doesn’t think it’s out of the ordinary. She could die.”

Delgado said, in these unsupervised cases, a woman could miss an assessment of the woman’s blood type to determine Rh status. Most people have the Rhesus or Rh factor protein on the surface of red blood cells, but if a woman lacks the protein or is Rh negative, as about 15% of women in the U.S. are, and has an Rh-positive unborn baby and does not receive treatment, they will be Rh incompatible, and she will be at great risk for future miscarriages.

He said that, in this case, too, despite their advocacy for unregulated at-home abortions, the American College of Obstetricians and Gynecologists recommends a test to rule out Rh incompatibility during a prenatal care visit, noting that “if treatment is not given during the first pregnancy and the woman later gets pregnant again with an Rh-positive fetus, she can make more antibodies. More antibodies put a future fetus at risk.”

In addition to the host of medical issues, Delgado pointed out that mifepristone “could get into the wrong hands” and be used by an abusive partner or sex traffickers. Concerns over the potential for coerced abortions have a solid foundation: A BBC poll of more than 1,000 women in the U.K. revealed that 15% said that in their lives they had felt pressured to have an abortion, and 3% had been given an abortifacient like a pill or a tablet without their knowledge or consent.

Continued Push for Unregulated Abortion

Delgado was unsurprised by the FDA’s handling of mifepristone guidelines, given the political considerations at play. “Even if you look back at how mifepristone was approved, it was really pushed through without the usual safeguards,” he said. “There were no placebo-controlled studies when mifepristone was approved.”

The pro-abortion nonprofit Population Council, which obtained the rights to sell mifepristone in the U.S. in 1994, gave the rights to manufacture it in 1997 to Danco Laboratories, a group formed for the purpose of bringing the drug to the U.S. after larger drug companies refused to manufacture it. The group made the drug for the U.S. in a partnership with China after being unable to find manufacturers in the U.S. or Europe.

The FDA had formerly required that the abortion industry report complications from the abortion pill after its approval in 2000 up until 2016, but, under the Obama administration, it removed that requirement, and the only thing that had to be reported was deaths from the pill.

The socially conservative group Judicial Watch sued the FDA recently after their Freedom of Information Act request was ignored, regarding “correspondence between FDA and the manufacturers of Mifeprex, the brand name for the drug, about the drug’s stability, along with company tests on stability, which relates in part to how long the drug remains effective after its manufacture,” Fox News reported Nov. 7.

Abortion proponents are angry about the FDA’s recent comments on the matter. Several Democratic senators complained to HuffPost about the FDA representative’s remarks.

“It’s important that the FDA take into account the public-health crisis that the Supreme Court and radical Republicans have caused and now do everything in its power to ensure that providers can act with proper authorization to prescribe advance provision of medication abortion,” Sen. Ed Markey, D-Mass., commented. “For policymakers, supporting reproductive freedom means clearing the path for health care providers — who best understand what is safe and accessible for their patients — to do their job without FDA interference.”

Ushma Upadhyay, a professor in the Department of Obstetrics, Gynecology and Reproductive Science at the University of California San Francisco’s Bixby Center for Global Reproductive Health, told CNN that the FDA is “not acknowledging people’s ability to understand their own bodies and know what’s right for them” when it comes to taking abortion pills. “Patients should also be trusted to know when it is appropriate for them and when it is not to seek help from a provider.”

ER Deception?

Rachel Morrison, an attorney at the Ethics and Public Policy Center’s HHS Accountability Project, told the Register that in the comments to Politico, “the FDA rightly recognized that access to abortion drugs pre-pregnancy poses serious safety-and-health risks to women, and that practice must be stopped.” She added that the FDA “has been trying to loosen safety protections when it comes to abortion drugs, but the fact that this is a step too far for them speaks volumes.”

She said that the health-and-safety concerns for pre-pregnancy prescriptions “still exist when prescribed to a woman via telehealth and there is no ultrasound or in-person examination.”

In this case, she said abortion “is not a decision between a woman and her doctor,” but “between a woman and some person she has never met and will never talk to again. When there are complications, it’s not the person who prescribed the abortion drugs who the woman will go to. She’ll go to the ER and is actively encouraged by a lot of abortion providers to lie about receiving the abortion drugs and say it’s just a miscarriage, which inhibits the medical professionals from being able to understand and treat the woman most efficiently and accurately.”

The international abortion group Aid Access, which distributes the abortion pill by mail, tells women who experience complications, “if you think you might have a complication, you should go to a doctor immediately. You do not have to tell the medical staff that you tried to induce an abortion; you can tell them that you had a spontaneous miscarriage. Doctors have the obligation to help in all cases and know how to handle a miscarriage.”

A May 2022 study of Medicaid data by the pro-life Charlotte Lozier Institute found that when abortion-pill complications are miscoded as a natural miscarriage, women are “twice as likely to be admitted for surgery for retained products of conception” and are “at significantly greater risk of multiple hospital admissions for treatment of complications.”

Morrison said that more and more women are turning to abortion pills post-Dobbs because “it’s a lot easier to evade state laws protecting the lives of unborn children than having to actually go to an abortion provider.” In this climate, she said, “it’s all the more important that women are informed about these risks.”