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4 Things You Need to Know about the Abortion Drug Lawsuit

May 11, 2023

On May 17, the U.S Court of Appeals for the Fifth Circuit will hear Alliance for Hippocratic Medicine v. FDA, the case determining whether the U.S. Food and Drug Administration’s (FDA) approval of the abortion drug, mifepristone, will be reversed. Since this lawsuit was filed, the abortion lobby has spread lies, telling people that the reversal of mifepristone’s approval would jeopardize the use of birth control (it doesn’t), make miscarriage management dangerous (another lie), and attack women’s health (which is straight-up dishonest).

Let’s look at the basic facts of this case. 

  1. What Is the Case About?

In the year 2000, the FDA approved the abortion drug, mifepristone, without adequately studying the drug’s safety. Because this drug, which was originally produced by a subsidiary of the chemical company that manufactured the Zyklon-B poisonous gas for Nazi death camps, is dangerous for women, physicians from across the country filed a petition challenging the decision. For over 6,000 days, the FDA failed to adequately reply. In 2021, after permanently removing many safety requirements for the drug, the FDA finally responded by dismissing the doctors’ safety concerns, and so the Alliance for Hippocratic Medicine filed a lawsuit seeking to reverse FDA approval for mifepristone.

That is what this case is about. It is not about birth control. It is not about the morning-after pill. It is not about preventing women who have had miscarriages from safely passing their already deceased unborn baby. It is not about repealing “women’s rights.” 

It is about reversing the approval of one drug — mifepristone — a drug that is intended to kill an unborn child, is incredibly dangerous for women, and was approved by the Clinton administration’s FDA through a highly politicized irregular process. 

  1. Who Are the Major Players in the Lawsuit?

The U.S. Food and Drug Administration and the Alliance for Hippocratic Medicine. 

The FDA is a federal agency of the Department of Health and Human Services. The FDA’s mission is to protect public health by “ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices” as well as the “nation’s food supply, cosmetics, and products that emit radiation.”

The Alliance for Hippocratic Medicine (AHM) is a nonprofit representing nearly 30,000 health care professionals. This organization “upholds and promotes the fundamental principles of Hippocratic medicine. These principles include protecting the vulnerable at the beginning and end of life, seeking the ultimate good for the patient with compassion and moral integrity, and providing healthcare with the highest standards of excellence based on medical science.” Members of AHM practice according to the Essential Hippocratic Oath. They partner with the Catholic Medical Association, the Coptic Medical Association of North America, the American College of Pediatricians, American Association of Pro-Life OBGYNs, and the Christian Medical and Dental Associations. 

  1. Why Should the FDA Approval of the Abortion Drug, Mifepristone, Be Reversed?

While every abortion is tragic because it takes the life of an unborn child, mifepristone is especially heinous because of the risk it also poses to the unborn child’s mother. 

Between 2000 and 2021,4,207 adverse events related to mifepristone were reported to the FDA. It may be tempting to think 4,207 isn’t many, BUT this number only includes those voluntarily reported, as in 2016 the FDA removed the requirement for prescribers to report non-fatal adverse events. Furthermore, the FDA itself admits that their adverse events reporting typically includes 1 to 10% of the adverse events that occur. 

The FDA also admits there is reporting bias that leads to the inaccuracy of their statistics. For example, while the FDA classifies all complications that require intervention to prevent permanent damage as “serious,” a New York Times article on mifepristone classified needing a procedure after mifepristone or heading to the ER as merely a moderate complication. 

Still, the NYT’s own reporting shows that after taking mifepristone, 3 to 5% of patients need an additional procedure to remove remaining tissue or terminate the pregnancy. Three to 5% is one in 20 to one in 33 women.

Furthermore, most states do not require abortion complication data to be broken down based on abortion type, but Arkansas passed legislation in 2019 requiring this breakdown. The 2020 data shows that 88.9% of abortion complications in Arkansas are the result of the use of the abortion drug, mifepristone.

The FDA approval of mifepristone should be reversed because its approval violates the FDA’s commitment to ensuring public health safety. Mifepristone, the abortion drug, is not safe for anyone. 

  1. Where Is This Case Now?

On April 7, a U.S. district court judge in Texas issued a decision that when the FDA used fast-tracked provisions to approve mifepristone in 2000, it did so illegally. The Biden administration appealed, and the Fifth Circuit issued a ruling partially affirming the district court decision. The Fifth Circuit rule prohibited the distribution of mifepristone through the mail, protected women and unborn babies after seven weeks gestation from the chemical abortion drug, and reinstated in-person visits with a physician who can detect contraindications and follow-up to assess complications after the drug has been taken.

The Biden administration then appealed to the U.S. Supreme Court, and the Supreme Court opted to pause the Fifth Circuit’s decision while the lawsuit proceeds. So, as it stands, the abortion drug — mifepristone — is available without an in-person consultation with a physician though 10 weeks of pregnancy. It is important to note that Planned Parenthood advertises using chemical abortions up to 11 weeks, and more important to note that by 10 weeks gestation, incomplete abortions occur up to 10% of the time. The further along in gestation a woman is, the more likely she will have an incomplete abortion requiring surgery.

On May 17, a panel of three Fifth Circuit judges will hear the case. We must pray that the Fifth Circuit will decide to place the health and safety of women and their unborn children ahead of the bank accounts of the abortion industry.

Mary Szoch is the Director of the Center for Human Dignity at Family Research Council.