Reproductive rights advocates are nervous about a lawsuit to revoke the Food and Drug Administration’s (FDA) approval of mifepristone, which, if successful, would end legal access to the drugs. abortion pills across the country.
Advocates and legal experts say the lawsuit is without merit, but fear conservative courts will think otherwise.
Abortion pills have become one of the next major fronts in the fight for reproductive health care in the wake of the Supreme Court decision overturning Roe v. Wade, and both sides view the lawsuit as the start of the battle to come.
Mifepristone, a drug that blocks hormones needed 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 adviser at the Center for Reproductive Rights, said she anticipates seeing challenges in the courts, as well as laws emerging from state legislatures that would ban medical abortion altogether or institute restrictions so significant that they may well be a ban.
“Anti-abortion activists are pushing the boundaries of what [Dobbs] decision could lead to,” Ma said. “This does not end with the Dobbs decision, and there will be many more restrictions, laws and lawsuits because of that.”
Katie Glenn, state policy director for Susan B. Anthony Pro-Life America, said limiting the availability of abortion pills is a top priority for her organization. They want states to crack down on the ability to order the drugs online and then ship the pills across state lines.
“We see this as a great danger to American women,” Glenn said.
In 2020, medical abortion accounted for 54 percent of all pregnancy terminations in the US since the Supreme Court decision overturning Roe v. Wade in June, women have increasingly turned to abortion pills if they need to end a pregnancy.
Health officials and major groups such as 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 there is strong evidence that mifepristone is safe for the medication-induced abortion.
The lawsuit was filed two weeks ago in Amarillo, Texas, by the Alliance Defending Freedom (ADF), a powerful conservative legal group that has helped draft and defend anti-abortion laws in states, including Mississippi in the case that brought it to court. Supreme. overturn Roe v. Wade.
The lawsuit alleges that the FDA illegally expedited the approval of mifepristone through a process intended for treatments of life-threatening diseases. The group alleged that the agency failed to protect the health, safety, and well-being of girls and women and never studied the safety of drugs under labeled conditions of use.
This lawsuit “is the culmination of decades-long efforts by ADF customers to hold the FDA accountable for its irresponsible actions,” the group said.
The FDA said it does not comment on litigation.
The 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 the FDA expanded the availability of mifepristone, saying it was safe to use during the first 10 weeks of pregnancy.
“The FDA never had the authority to approve the sale of these dangerous drugs. We urge the court to listen to the doctors we represent who seek to protect girls and women from the documented dangers of chemical abortion drugs,” ADF lead attorney Julie Blake said in a statement.
The lawsuit asked the court to immediately halt FDA approval of the drug while the case progressed, effectively making all medical abortions illegal.
Susan Wood, a former FDA assistant commissioner for women’s health and current director of the Jacobs Institute for Women’s Health Services at George Washington University, said the ADF’s arguments are invalid.
He said the approval process mifepristone went through more than 20 years ago was appropriate for the times. After the approval, the agency put in place security measures that some even considered too strict.
“If a court rules that it allows these factually incorrect arguments to go forward … it would jeopardize the authority of the FDA, and I think in a pretty serious way,” Wood said.
But the suit was strategically filed in the Amarillo district court, where Judge Matthew Kacsmaryk presides over all new cases.
Before 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, she helped companies fight contraceptive mandates and represented an Oregon bakery that refused to bake a cake for a same-sex wedding.
If Kacsmaryk shows sympathy for the ADF’s arguments, the government is likely to appeal. The case would go to the Court of Appeals for the Fifth Circuit, which has jurisdiction over Texas, Louisiana and Mississippi.
Abortion has been banned in all three states.
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