Lawsuit seeks to block access, reverse approval for abortion pill

A coalition of anti-abortion medical groups and providers sued the Food and Drug Administration (FDA) Friday, challenging the agency’s decades-old approval of mifepristone, a pill that is used in medicated abortions.

The lawsuit was filed in Amarillo, Texas, by the Alliance for Defending Freedom, a conservative legal group that has helped author states’ anti-abortion laws and defended 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.

“The U.S. Food and Drug Administration chose politics over science when it pushed for the legalization of the chemical abortion drugs mifepristone and misoprostol in 2000,” the group said. 

“But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs,” the lawsuit claimed.

The FDA said it does not comment on pending litigation. 

In 2000, the FDA approved mifepristone for medication abortion. The drug is used in combination with a second pill, misoprostol, during the first 10 weeks of pregnancy.

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.

Research has shown the process is safe and effective, and the agency has put certain guardrails in place to ensure the drug’s safety.

Mifepristone is regulated under a Risk Evaluation and Mitigation Strategy (REMS), a safety program the agency required for certain drugs to ensure that their benefits outweigh their risks. The mifepristone REMS requires pharmacies that dispense the drug to be certified and mandates that patients sign an agreement acknowledging the drug’s risks.

But with Roe v. Wade overturned, abortion pills are becoming the newest battleground. 

Following the decision, many states passed laws that severely restrict or outright ban medication abortion. Attorney General Merrick Garland in June indicated the Justice Department will take action against states that ban abortion pills, though it’s unclear if the federal government has that power.

The FDA in recent years has taken some steps to ease access to the drugs, though abortion advocates say there are still too many barriers in place.

The FDA temporarily lifted a requirement that mifepristone be dispensed in person at a clinic or hospital because of the COVID-19 pandemic, and the Biden administration made the change permanent in December 2021, paving the way for doctors to prescribe the drug digitally and then mail the pills to patients.