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An illegal decision and its decades of harm

Women and girls have paid the price of the FDA’s politicized approval of abortion drugs in 2000

The Food and Drug Administration campus in Silver Spring, Md. Associated Press/Photo by Andrew Harnik, file

An illegal decision and its decades of harm
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The Food and Drug Administration has one key duty: to ensure that the drugs available to Americans are safe. But in 2000, under political pressure from President Bill Clinton’s administration, the FDA failed in that job by approving chemical abortion drugs.

For years, doctors and citizens have submitted evidence, including multiple peer-reviewed studies, that chemical abortion drugs are harmful, but the FDA has ignored the truth. Now, four medical organizations and four individual doctors represented by Alliance Defending Freedom are acting to speak out and to protect women and girls.

The FDA never had the authority to approve these drugs for sale, and it approved them without examining whether they are safe under their labelled use. Instead, the FDA claimed that pregnancy is an “illness” and that these drugs offer “meaningful therapeutic benefits.”

In the 22 years since then, the FDA has removed safeguard after safeguard on these drugs, so that anyone can get them without ever seeing a doctor in person or being examined for life-threatening conditions. The reality—that the FDA ignores—is that, all across America, doctors are treating women and girls who have been seriously harmed by chemical abortion drugs.

Dr. Regina Frost-Clark is a hospital OBGYN and is often called to the emergency room for consultations. She writes in the lawsuit that, “In at least a dozen cases, I have treated women who were suffering significant bleeding after taking chemical abortion drugs.” Some of these women were admitted to the hospital because the bleeding was so severe. She notes that, quite often, women and girls don’t know what drugs they have been given or how much, and many of them are totally unaware of the risk of complications from chemical abortion drugs.

Chemical abortions have a complication rate at least four times higher than surgical abortions. Dr. George Delgado, a family practice doctor, attests in the lawsuit that “the risk of severe bleeding with chemical abortion is five times higher than surgical abortion.” Dr. Shaun Jester treated a woman who obtained a chemical abortion, bled for two weeks, and then developed a uterine infection. She required intravenous antibiotics and a dilation and curettage; had she waited only a few more days to go in, he says, the infection could have become septic and killed her.

The FDA failed American women and girls by caving to political pressure and recklessly sending dangerous drugs into the market.

Dr. Frost-Clark notes that most of the women she treats received chemical abortion drugs from an abortion facility before experiencing health emergencies. But there is an even more dangerous scenario: More and more women are obtaining these drugs from online pharmacies and taking them without any medical supervision at all.

That is possible because, in 2021, the FDA suspended a requirement that chemical abortion drugs be dispensed in person. This means that women can obtain these harmful drugs without even one in-person visit to check for contraindications or to verify gestational age. This is a serious problem, because the risks skyrocket beyond seven weeks of pregnancy. (The FDA permits the drugs for use up to 10 weeks.)

This led to a nightmare scenario for one woman, who received chemical abortion drugs after a virtual appointment and took them at home alone. She went into full labor and delivered a child later determined to be between 30 and 36 weeks gestation. The woman suffered lacerations, heavy bleeding, and extreme pain, as well as grievous emotional and mental trauma, from delivering a baby at home by herself with no medical assistance.

Ending the in-person dispensing requirement also increased the chances of other grave situations going unnoticed, such as an ectopic pregnancy (which chemical abortion drugs will not end). But even among women who take chemical abortion drugs before 10 weeks and who do not experience an emergency, many later report grief and shock when they expel a tiny person, with discernable arms and legs, and even fingers and noses.

In 2000, the FDA failed American women and girls by caving to political pressure and recklessly sending dangerous drugs into the market. In the years since, it has only doubled down. The Bible encourages us to expose such things as we have opportunity—to bring it out into the light (Ephesians 5:11-13), especially for the purpose of protecting the innocent (Proverbs 31:8-9).

The healthcare professionals who have sued believe enough is enough. For them, it is time for the FDA to be held accountable for its illegal, irresponsible approval of chemical abortion drugs. And they simply believe it’s time for the courts to rein in the FDA to its mission, which is to protect the health and safety of Americans—including American women and girls.

Editor’s note: This column has been corrected to reflect that the Bible verse about protecting the innocent is Proverbs 31:8-9.

Christiana Kiefer

Christiana Kiefer is senior counsel at Alliance Defending Freedom.

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