Reproductive rights advocates are on edge over a lawsuit seeking to revoke the decades-old Food and Drug Administration (FDA) approval of mifepristone, which, if successful, would end the drug. legal access to abortion pills nationwide.
Lawyers and legal experts say the lawsuit has no merit, but they fear conservative courts may think otherwise.
Abortion pills have become one of the next major fronts in the fight for reproductive health care following the Supreme Court’s decision overturning Roe v. Wade, and the trial is seen by both sides 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 miscarriage.
Jenny Ma, senior counsel for the Center for Reproductive Rights, said she expects to see challenges in the courts as well as laws from state legislatures that would ban medical abortion outright or institute such far-reaching restrictions. that it might as well be a ban.
“Anti-abortion activists are pushing the boundaries of what [Dobbs] decision could lead to,” Ma said. “It doesn’t end with the Dobbs decision, and there will be so many more restrictions and laws and lawsuits that will follow because of it.”
Katie Glenn, director of state policy 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 have the pills shipped across state lines.
“We see this as a huge danger to American women,” Glenn said.
In 2020, medical abortion accounted for 54% of all pregnancy terminations in the United States. Since the Supreme Court decision overturning Roe v. Wade in June, women are increasingly turning to abortion pills if they need to terminate 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 strong evidence exists regarding the safety of the drug. mifepristone for medical 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 state anti-abortion laws, including in Mississippi in the case that led the Supreme Court. to overturn Roe v. Wade.
The lawsuit argues 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 the drugs under the stated 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 challenging the FDA approval. It was rejected. The group filed another petition in 2016 when the FDA expanded the availability of mifepristone and said it was safe to use during the first 10 weeks of pregnancy.
“The FDA has never had the authority to approve the sale of these dangerous drugs. We urge the court to listen to the physicians we represent who seek to protect girls and women from the documented dangers of chemical abortion drugs,” a ADF senior counsel Julie Blake said in a statement.
The lawsuit asked the court to immediately suspend FDA approval of the drug while the case progresses, which would effectively make all medical abortions illegal.
Susan Wood, former assistant commissioner for women’s health at the FDA and current director of the Jacobs Institute of Women’s Health Services at George Washington University, said the ADF’s arguments are not valid.
She said the approval process for mifepristone more than 20 years ago was appropriate for the times. After approval, the agency put in place guardrails that some even considered too strict.
“If a court decides to allow these factually incorrect arguments to proceed…it would put the authority of the FDA at risk, and I think in a pretty serious way,” Wood said.
But the lawsuit was strategically filed in Amarillo District Court, where Judge Matthew Kacsmaryk presides over all new cases.
Before being appointed by former President Trump in 2017, Kacsmaryk was assistant general counsel at the First Liberty Institute, a Christian legal advocacy group.
In that role, he helped companies fight contraceptive mandates and represented an Oregon bakery that refused to bake a cake for a gay wedding.
If Kacsmaryk proves sympathetic to the ADF’s arguments, the government is likely to appeal. The case would go to the 5th Circuit Court of Appeals, which has jurisdiction over Texas, Louisiana and Mississippi.
Abortion has been banned in all three states.
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