Fifth Circuit Court Rules FDA Must Restore Vital Safeguards for Abortion Pill

Tierin-Rose Mandelburg | August 17, 2023
Text Audio
00:00 00:00
Font Size

Represented by Alliance Defending Freedom (ADF), a group of medical professionals condemned the negligence of the U.S. Food and Drug Administration (FDA) and said it should be “illegal” to distribute the abortion pill. ADF claimed the FDA didn’t adequately evaluate the abortion drug's safety and urged officials to take it off the market. On August 16, the 5th Circuit Court of Appeals ruled that the FDA must restore crucial safeguards around chemical abortion drugs. 

ADF is representing four different medical associations and four different doctors with experience caring for pregnant and post-abortive women. When the FDA permitted the distribution of mail order abortion pills, these medical professionals spoke up against the dangers of said drugs and sued the administration back in November 2022.

First of all, if the drug, mifepristone, works, it ends the life of at least one human being. Second of all, it poses significant risks to the health and even life of the mother who takes it. The drug can cause the mother to experience a month of cramping, bleeding and severe pain. According to Sen. James Lankford (R-Texas), the drug is “four times more dangerous” than surgical abortions and has reportedly increased abortion-related ER visits by “500 percent” from 2002-2015. Yet in April, the Supreme Court ruled that it would stay on the market.

ADF claimed that the FDA did not adequately research the effects the abortion drug had on women when it was released more than 20 years ago and when it loosened laws on how to obtain the drug in 2016. The ADF wanted to make it clear that there is no “safety” with this drug. 

Luckily, New Orleans Fifth Circuit ruled to end the mail-order abortion regime, insisting that it was not safe and insisted that the FDA should restore safeguards that were removed in 2016. 

Related: FDA Sued Over Dangerous Abortion Drug

The court noted that the data the FDA cited its 2000 approval of the drug indicated that “thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.”

The court’s ruling will prohibit abortion providers from sending abortion drugs via the mail where women can take them without any medical support or knowledge. It also ruled that the 2016 move by the FDA, which allowed the abortion drug to be taken from seven to 10 weeks gestation and loosened restrictions on obtaining said drugs, was a violation of the Administrative Procedure Act. The Fifth Circuit reinstated “the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation,” ADF reported. 


ADF Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory doctors, stated the following in a release about the case:

The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen. The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.

Keep in mind, however, that this is just one step. The new regulations won’t go into effect until after the Supreme Court decides whether or not to take the case. Presently, the SCOTUS stay that was upheld in April is still in effect, but the Fifth Circuit ruling is progress and has the potential to protect women and save countless lives.


Follow us on Twitter