Medical groups file lawsuit over FDA authorization of chemical abortion pills

In this photo illustration, a person looks at an Abortion Pill (RU-486) for unintended pregnancy from Mifepristone displayed on a smartphone on May 8, 2020, in Arlington, Virginia.
In this photo illustration, a person looks at an Abortion Pill (RU-486) for unintended pregnancy from Mifepristone displayed on a smartphone on May 8, 2020, in Arlington, Virginia. | OLIVIER DOULIERY/AFP via Getty Images

Multiple medical professionals and organizations have filed a lawsuit alleging that the U.S. Food and Drug Administration overstepped its authority by approving and repeatedly loosening restrictions on chemical abortion pills. 

The Alliance Defending Freedom, a legal group involved in the U.S. Supreme Court case that overturned Roe v. Wade, filed the lawsuit last Friday in the U.S. District Court for the Northern District of Texas Amarillo Division on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations and four individual doctors.

"The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy an 'illness' and argue that these dangerous drugs provide a 'meaningful therapeutic benefit' over existing treatments," the lawsuit reads.

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"But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion," the legal filing continues. "In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs."

The chemical abortion drug regimen requires two drugs — mifepristone and misoprostol. Mifepristone, also known as RU-486, is a synthetic steroid endocrine disruptor that blocks progesterone receptors in the uterus and chemically destroys the environment in the uterus and starves the baby to death. 

According to the lawsuit, mifepristone alone works less than 25% of the time to complete the abortion, and the FDA mandates using misoprostol to induce cramping and contractions to expel the baby from the mother's womb.

The FDA originally approved use of mifepristone as a method for abortion in 2000. According to the pro-choice research organization Guttmacher Institute, chemical abortions now account for more than half of all abortions in the United States.

The lawsuit comes after the FDA's decision last December to permanently eliminate the in-person dispensing requirements for abortion pills, a measure initially enacted during the COVID-19 pandemic to allow pregnant women to obtain the drugs by mail and end their pregnancy without seeing a doctor first.

"[T]he FDA failed America's women and girls when it chose politics over science and approved chemical abortion drugs for use in the United States," the lawsuit contends. "And it has continued to fail them by repeatedly removing even the most basic precautionary requirements associated with their use." 

ADF Senior Counsel Julie Marie Blake told The Christian Post Monday that ADF's clients have challenged the FDA's approval of chemical abortion pills for the last 20 years. 

The FDA requires those who seek to challenge one of its decisions to file a petition before the case can go to court. In March 2016, 14 years after ADF's clients filed their first petition with the FDA, the agency rejected the petition on the same day it extended the pill's usage limit from seven weeks gestation to 10 weeks. 

In 2016, the FDA also reduced other abortion pill restrictions, allowing non-medical doctors to prescribe the drug and eliminating the requirement for abortionists to report non-fatal chemical abortion complications.

The latter change, Blake said, has made the data surrounding abortion pill complications "incomplete and unreliable." 

The FDA rejected another petition that plaintiffs filed in December 2021, which asked the agency to, at minimum, restore safeguards.

In April 2021, due to the COVID-19 pandemic, the FDA temporarily lifted the ban on mail-order abortion pills, making the decision permanent in December

"And so, our clients are finally able to go to court, having tried to exhaust our administrative remedies with the FDA," Blake said. "And to finally get a judge to rule on whether it is illegal to approve these drugs in the first place, as well as to remove all the safeguards on them."

A 2018 report published by the National Academies of Sciences, Engineering, and Medicine states that "complications after a medication abortion, such as hemorrhage, hospitalization, persistent pain, infection, or prolonged heavy bleeding, are rare — occurring in no more than a fraction of a percent of patients."

The report cited research purporting that chemical abortions have an "overall effectiveness rate of 96.7 percent for gestations up to 63 days (9 weeks)." 

Blake cited a 2015 study, "Incidence of Emergency Room Department Visits and Complications After Abortion," which assessed the abortion complication rate for California women who paid for abortions through Medicaid, using data from 2009 and 2010. 

Researchers found that the complication rate was 5.2% for women who took the abortion pill compared to 1.3% for women who had a first-trimester surgical abortion. The major complication rate for the abortion pill was .31%, in contrast to .16% for first-trimester surgical abortions.

Earlier this month, the FDA warned about healthcare providers providing women advance abortion pill prescriptions in light of the Supreme Court's reversal of Roe this June. 

The decision allowed states to once again ban and restrict abortion, with several outlawing or severely restricting the procedure following the ruling.

In response, various telemedicine and in-person providers have offered abortion pills to non-pregnant women in case they plan to have an abortion and their state outlaws it. 

The FDA noted that a woman could take the first dose of the regimen weeks or months after the prescription is filled, which means a physician likely will not have had the chance to screen the woman for an ectopic pregnancy or other potential complications, which could endanger patients.

Samantha Kamman is a reporter for The Christian Post. She can be reached at:

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