Reproductive rights advocates are on edge over a lawsuit to revoke the decades-old Food and Drug Administration (FDA) approval of mifepristone, which, if successful, would end legal access to abortion pills nationwide.
Advocates and legal experts say the suit has no merit, but they fear conservative courts will think otherwise.
Abortion pills have become one of the next major fronts in the fight over reproductive health care in the wake of the Supreme Court’s decision overturning Roe v. Wade, and the lawsuit is seen by both sides as the start of the battle to come.
Mifepristone, a drug that blocks hormones necessary for pregnancy, was approved by the FDA in 2000. It is used with a second drug called misoprostol, which causes contractions and essentially induces a miscarriage.
Jenny Ma, senior counsel for the Center for Reproductive Rights, said she anticipates seeing challenges in the courts as well as laws coming out of state legislatures that would either ban medication abortion outright or institute restrictions so significant it may as well be a ban.
“The anti-abortion activists are pushing the boundaries of what that [Dobbs] decision could lead to,” Ma said. “This does not end with the Dobbs decision, and that there will be so many more restrictions and laws and lawsuits that follow because of it.”
Katie Glenn, state policy director for SBA Pro-Life America, said limiting the availability of abortion pills is a major priority for her organization. They want states to crack down on the ability to order the drugs online and then have the pills shipped across state lines.
“We see this as a huge danger to American women,” Glenn said.
In 2020, medication abortion accounted for 54 percent of all pregnancy terminations in the U.S. Since the Supreme Court’s decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to terminate a pregnancy.
Health officials and major groups including the American Medical Association and the American College of Obstetricians and Gynecologists say mifepristone is safe and effective.
Mifepristone has been used by more than 3 million women in the United States since FDA approval, the groups said in a June letter to the Biden administration, “and robust evidence exists regarding the safety of mifepristone for medication induced abortion.”
The lawsuit was filed two weeks ago in Amarillo, Texas, by the Alliance Defending Freedom (ADF), a powerhouse conservative legal group that has helped draft and defend states’ anti-abortion laws, including in Mississippi in the case that led the Supreme Court to overturn Roe v. Wade.
The lawsuit argues the FDA unlawfully fast-tracked the approval of mifepristone through a process intended for treatments of life-threatening illnesses. The group alleged the agency failed to protect the health, safety and welfare of girls and women and never studied the safety of the drugs under the labeled conditions of use.
This lawsuit “is the culmination of decades-long efforts by ADF’s clients to hold the FDA accountable for its irresponsible actions,” the group said.
FDA said it does not comment on litigation.
ADF first filed a citizen petition in 2002 to challenge the FDA’s approval. It was rejected. The group filed another petition in 2016 when FDA expanded availability of mifepristone and said it was safe to use through the first 10 weeks of pregnancy.
“The FDA never had the authority to approve these dangerous drugs for sale. We urge the court to listen to the doctors we represent who are seeking to protect girls and women from the documented dangers of chemical abortion drugs,” ADF senior counsel Julie Blake said in a statement.
The lawsuit asked for the court to immediately pause the FDA’s approval of the drug while the case proceeds, which would effectively make all medication abortions illegal.
Susan Wood, former assistant commissioner for women’s health at FDA and current director of the Jacobs Institute of Women’s Health Services at George Washington University, said the ADF’s arguments aren’t valid.
She said the approval process that mifepristone went through over 20 years ago was appropriate for the time. After approval, the agency put guardrails in place that some even saw as too strict.
“If a court rules allowing these factually incorrect arguments to go forward … it would put FDA authority at risk, and I think in a fairly serious way,” Wood said.
But the lawsuit was strategically filed in district court in Amarillo, where Judge Matthew Kacsmaryk presides over all new cases.
Prior to being appointed by former President Trump in 2017, Kacsmaryk was deputy general counsel at the First Liberty Institute, a Christian legal advocacy group.
In that role he helped businesses fight against contraceptive mandates and represented an Oregon bakery that refused to bake a cake for a same-sex wedding.
Should Kacsmaryk prove to be sympathetic to ADF’s arguments, the government would likely appeal. The case would go to the Fifth Circuit Court of Appeals, which has jurisdiction over Texas, Louisiana and Mississippi.
Abortion has been banned in all three of those states.