What the 5th Circuit ruling does to the abortion drug mifepristone

What the 5th Circuit ruling does to the abortion drug mifepristone

The U.S. Court of Appeals for the 5th Circuit issued a long-awaited ruling on Wednesday on the fate of the abortion pill mifepristone that would restore several restrictions and revoke order-by-mail prescriptions of the controversial medication if it were not for a stay order issued by the Supreme Court.

“There’s no immediate effect for the 5th circuit decision, but I do think it puts the FDA on notice as well as gives women a reason to maybe think twice about taking mifepristone, unsupervised [and] certainly through the mail,” said Alliance Defending Freedom Senior Counsel Erin Hawley, representing the Alliance for Hippocratic Medicine, one of the litigants in the controversial case.


The FDA initially approved mifepristone in 2000 under several restrictive conditions, such as requiring a physician examination to obtain the pill, an in-person administration of the agent, and a post-abortion follow-up appointment with a physician. Under the original approval, physicians were also required to report nonfatal adverse effects of the medication.

In 2016, the FDA loosened these restrictions, including raising the gestational age from seven weeks to 10 weeks. In response to the COVID-19 pandemic, the FDA approved mail-order dispensing of mifepristone under emergency orders, which were codified in January.

The Supreme Court issued an emergency ruling in April blocking the enforcement of a ban on the abortion agent after U.S. District Judge Matthew Kacsmaryk suspended the FDA’s 2000 approval of mifepristone.

Wednesday’s ruling upholds in part Kacsmaryk’s ruling by stopping mail-order prescriptions of mifepristone but also invalidates Kascmaryk’s ruling by restoring the pre-2016 restrictions on the drug, including the seven-week gestational limit.

“The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to dangerous drug regimen without regard to women’s health, or the rule of law,” Hawley said.

Sen. Bob Menendez (D-NJ) responded by calling the ruling an “all-out assault on women’s reproductive healthcare.”

“This moment must serve as a clarion call in the fight to ensure that everyone has access to comprehensive reproductive care, including abortion care,” Menendez said.

Today’s decision from the U.S. Court of Appeals for the 5th Circuit is yet another affront to basic reproductive rights in our country.

Read my full statement on their decision to limit access to Mifepristone: pic.twitter.com/ebiGgHxvK0

— Senator Bob Menendez (@SenatorMenendez) August 16, 2023

Planned Parenthood also stepped in on social media to say that the 5th Circuit’s ruling is not immediately applicable due to the Supreme Court’s emergency stay.

Today’s 5th Circuit Court of Appeals ruling does NOT affect the availability of mifepristone, one of the two medicines commonly used in medication abortion. It remains FDA-approved and available in many states across the country, including via telehealth.

— Planned Parenthood (@PPFA) August 16, 2023

“The Fifth Circuit rightly required the FDA to do its job and to restore crucial safeguards for women and girls, including ending illegal mailorder abortions,” Hawley said. “The FDA will finally be made to account for the damage that is caused to the health of countless women and the rule of law by unlawfully removing almost every meaningful safeguard from the chemical abortion drug regimen.”

Susan B. Anthony Pro-Life America also took Wednesday’s announcement as a victory for the anti-abortion movement.

5th Circuit issues rebuke of Democrats’ mail-order abortion extremism: FDA probably broke the law by allowing mail-order abortions without an in-person doctor visit. pic.twitter.com/x08UtIJ5E7

— SBA Pro-Life America (@sbaprolife) August 16, 2023

When asked by reporters if the Alliance for Hippocratic Medicine would seek to appeal the decision to attempt to remove complete approval for mifepristone, Hawley said the ADF legal team is “fully assessing this decision” but that it has “not finalized any plan as to an appeal.”


The Center for Reproductive Rights and NARAL both made statements on social media platform X, formerly known as Twitter, that Wednesday’s ruling will certainly be challenged at the Supreme Court level.

“This appeals court decision sets up a showdown at the Supreme Court over baseless attacks on medication abortion, which has been a lifeline since the high court reversed Roe last year,” said Nancy Northup, president and CEO of the Center for Reproductive Rights. “This order, if allowed to take effect, could jeopardize the FDA’s entire scientific system of drug approvals and would leave patients panicked and confused about their health and safety.”