Three States Renew Lawsuit Against FDA Over Abortion Pill Regulations
Missouri, Idaho, and Kansas renewed their lawsuit against the U.S. Food and Drug Administration (FDA) over the abortion pill mifepristone months after the Supreme Court refused to invalidate approval of the pill.
Access to abortion is a political issue in the current election cycle. Abortion-related initiatives are on the ballot next month in 10 states, including Arizona, Florida, Missouri, and South Dakota.
Bailey said that by removing safety precautions such as a requirement for doctor visits during the medication abortion process, the federal government abdicated its responsibility to protect women.
When the lawsuit was before U.S. District Judge Matthew Kacsmaryk in Amarillo, he found in April 2023 that the FDA shouldn't have approved mifepristone for public use in 2000. He said the agency was under political pressure to get the pill on the market and then, after that, had deliberately dragged out legal challenges to its approval of the drug for years. He issued an order retroactively staying the approval.
In 2016, the FDA changed the drug's official label, extending the cutoff for use from 49 days of gestation to 70 days. At the same time, the agency allowed the drug to be prescribed with only one in-person visit and halted the requirement that prescribers report nonfatal adverse events.
In 2021, the agency allowed patients to receive the drug by mail instead of having to pick it up in person from a specially certified health care provider.
The U.S. Court of Appeals for the Fifth Circuit refused to block most of Kacsmaryk's ruling, holding that the FDA's actions in 2016 and 2021 were probably unlawful. The Supreme Court blocked the injunction over the original approval of the drug, allowing mifepristone to remain on the market.
The nation's highest court did not issue a ruling on the merits but held that those challenging the status of the pill lacked legal standing to do so.
Standing refers to the right of someone to sue in court. The parties must show a strong enough connection to the claim to justify their participation in a lawsuit.
That decision came two years after the court's landmark 2022 ruling in Dobbs v. Jackson Women's Health Organization, which overturned Roe v. Wade and returned the regulation of abortion to the states.
In the amended legal complaint, which is currently pending before Kacsmaryk, the three states argue that the FDA must protect public health "by putting commonsense safeguards on high-risk drugs."
The agency, which has acknowledged that about "one in 25 women who take abortion drugs will visit the emergency room," has not lived up to its responsibilities "by removing many of the safety standards it once provided to women using abortion drugs," the complaint says.
The agency's decisions in 2021 and 2023 "to allow these drugs to be sent by mail and dispensed online or at pharmacies" jeopardize women, according to the complaint.
During oral argument before the Supreme Court in March, U.S. Solicitor General Elizabeth Prelogar told the justices that the FDA has determined across five presidential administrations that mifepristone is "safe and effective" and that "millions of Americans have used mifepristone to safely end their pregnancies."
Medication abortions have become increasingly common since Roe v. Wade was overturned in 2022, according to the Guttmacher Institute, a pro-abortion organization.
The Epoch Times reached out to the FDA for comment but no reply was received by publication time.
