Dueling lawsuits could decide the fate of abortion drug mifepristone

by Jacob Fuller

Lauren C. Moye, FISM News

Dueling lawsuits against the Federal Drug Administration (FDA) led by opposing sides of the aisle will determine the fate of medical abortions — that is, abortions induced by medication, rather than a procedure — in the United States.

Since Dobbs v. Jackson overturned nationwide federal protection of abortion access in the U.S., Democrats and Republicans have been battling each other over the legality of abortion on a state-by-state basis. Now, drug-induced medical abortions are the latest battleground in the war.

While opponents of abortion see inherent risk in easing restrictions to medical abortion drugs, pro-abortion activists are now claiming the FDA has not gone far enough to increase access.

“These advocates say they will not be content until the federal government mandates abortion access in all fifty states,” Erin Hawley, senior counsel at Alliance Defending Freedom (ADF) wrote.

Proving Hawley correct, twelve Democrat-led states announced a lawsuit on Friday against the FDA over mifepristone restrictions.

Mifepristone was first approved in 2000 as the first step in a two-drug chemical abortion process. Mifepristone prevents the woman’s body from producing the hormone progesterone, which is necessary for the healthy and continued development of a fetus.

Mifepristone is then followed by misoprostol to cause uterine contractions so that preterm labor is triggered.

Medical abortions now comprise over half of the abortions performed in the U.S.

In recent years, the FDA has authorized corner pharmacies to dispense these abortion drugs. However, the FDA has also permanently removed an in-person dispensing requirement, which allows for the drugs to be mailed to a recipient.

Sometimes a simple survey is enough to secure access to these drugs.


ADF is leading the fight in a Texas-based lawsuit filed on behalf of four medical associations and four frontline doctors who claim to have seen first-hand the damage that medical abortions can cause to women and young girls.

Conservative District Judge Matthew Kacmaryk is expected to rule soon, since the Feb. 24 filing deadline has passed. If Kacmaryk rules in favor of the plaintiffs, then the supply of mifepristone to all 50 states will be halted.

However, a positive ruling will most likely be swiftly appealed.

ADF’s lawsuit claims that the FDA erroneously approved mifepristone and misoprostol under an emergency ‘life or death’ ruling that should not apply to pregnancy. This circumvented necessary safety studies, including the impact of an estrogen-reducing drug on the reproductive development of teenagers.

ADF claims that 1 out of 5 will have an “adverse event” after taking the chemical abortion regimen.

“One study found that, after nine weeks’ gestation, almost four times as many women and girls experience an incomplete abortion, nearly twice as many suffer an infection, and over six times as many women and girls require surgical abortion after consuming the chemical abortion drugs,” ADF lawyers wrote in the brief.

However, among other changes made in 2016, the brief says that the FDA “eliminated the requirement for abortionists to report non-fatal complications from chemical abortion drugs” which means important stats are now missing in the conversation. This is significant because emergency room visits from resulting complications after the use of the two-drug medical abortion procedure have not been measured in nearly seven years.

While ADF is arguing that mifepristone was approved without thorough safety vetting there are additional risks with allowing women to access the drugs through the mail without proper counseling and vetting.

For example, there is potential harm when a woman or girl with a negative blood type aborts a positive blood type baby without also being given the medication Rhogam. The baby’s blood could activate the mother’s immune system to treat the positive blood type as an illness.

Once this happens, the mother’s future ability to carry a baby to term will be impacted. The mother’s body will attack future positive-blood-type babies.

Twenty-two Democrat-led states have weighed into this lawsuit, claiming that ending mifepristone access would be “nothing short of catastrophic.”

A large number of Republican states have also filed briefs supporting a reversal of the FDA approval.


In the Democrat-led lawsuit against the FDA, plaintiffs allege that restrictions remaining on mifepristone are “unduly burdensome, harmful and unnecessary, and expose providers and patients to unnecessary privacy and safety risks,” according to the Washington attorney general’s office.

Restrictions include a special certification needed for a pharmacy to dispense mifepristone and that patients and providers must sign a statement that the drugs are intended to end a pregnancy.

“The federal government has known for years that mifepristone is safe and effective,” Washington state Attorney General Bob Ferguson said in a statement. “In the wake of the Supreme Court’s radical decision overturning Roe v. Wade, the FDA is now exposing doctors, pharmacists, and patients to unnecessary risk. The FDA’s excessive restrictions on this important drug have no basis in medical science.”

The lawsuit asks for a preliminary injunction to be placed against remaining FDA restrictions on the drug.

The lawsuit was filed in federal court in the Eastern District of Washington state. Other states involved in the case include Oregon, Arizona, Colorado, Connecticut, Delaware, Illinois, Michigan, Nevada, New Mexico, Rhode Island, and Vermont.

Conflicting rulings between the two cases could send the decision to the Supreme Court.