Today : Oct 02, 2025
Health
01 October 2025

FDA Review And Lawsuit Intensify Abortion Pill Debate

Federal regulators and a California lawsuit bring new urgency to the battle over abortion pill access, religious directives, and emergency care for women.

The national debate over abortion access and safety has reached a fever pitch as both federal regulators and state courts grapple with the complex intersection of healthcare, law, and personal belief. In a series of high-profile developments this week, the U.S. Food and Drug Administration (FDA) launched a formal review of safety rules for abortion pills—rules that were recently loosened under the Biden administration—while a California woman filed a landmark lawsuit against a major Catholic hospital chain, alleging denial of emergency abortion care.

At the heart of the FDA review is mifepristone, a medication used for more than two decades to end pregnancies and manage miscarriages. According to The Center Square, the review comes after the Biden administration relaxed restrictions, allowing increased mail-order access to the drug. This move has sparked fierce debate among lawmakers, advocacy groups, and medical professionals, each bringing their own deeply held convictions to the table.

During a recent U.S. Senate Finance Committee hearing, Senator Steve Daines of Montana pressed U.S. Health and Human Services Secretary Robert F. Kennedy Jr. about the ongoing studies into mifepristone’s safety profile. Kennedy assured the committee that research was “progressing and ongoing,” adding, “I will keep your office informed at every stage.” His remarks underscored the administration’s intent to base decisions on evolving scientific evidence, though critics argue that the process is anything but apolitical.

One of the most vocal critics of the Biden administration’s approach is Mark Lee Dickson, director of Right to Life Across Texas and founder of the Sanctuary Cities for the Unborn Initiative. Dickson lambasted the decision to loosen safeguards on mail-order abortion pills, telling The Center Square, “For years we saw an administration that didn’t look for the health and safety of Americans. They looked for the health and safety of the pockets of the abortion industry.”

Dickson also invoked the long-standing Comstock Act of 1873, a federal law prohibiting the mailing of abortion-inducing drugs and paraphernalia. “We actually have a law that was passed by Congress in 1873 known as the Comstock Act that prohibits the mailing of abortion-inducing drugs and abortion paraphernalia. If it was enforced, it would shut down every abortion facility in America regardless of the state,” he emphasized, pointing to the ways in which historical legal frameworks continue to shape present-day policy debates.

On the other side of the aisle, Planned Parenthood of Illinois strongly defended the use of mifepristone, highlighting its decades-long safety record and vital role in both abortion and miscarriage care. Dr. Katie Sisco, chief medical officer of Planned Parenthood of Illinois, stated in an email to The Center Square, “More than half of our patients choose this option for its privacy and affordability. The FDA’s politically motivated review undermines trust in proven health care and spreads harmful misinformation.” Sisco added, “PPIL firmly supports our patients and providers. We will continue to offer clear, accurate information and fight for every person’s right to make informed decisions about their bodies, their health, and their futures, without interference or intimidation.”

The FDA’s review comes amid mounting pressure from advocacy groups on both sides. Dickson, for his part, participated in a coalition letter urging federal regulators to reinstate the safety protections for mifepristone. Citing data from the Ethics and Public Policy Center, he asserted, “What we’ve realized, based on data from the Ethics and Public Policy Center, is that about 11% of women who take these abortion-inducing drugs end up in emergency rooms across the United States. When you see a reality like that, something has to be done. That is why I think the FDA is taking this so seriously, they can’t ignore the fact that 11% of women are ending up in emergency rooms.”

Planned Parenthood, however, sees these calls for stricter oversight as a thinly veiled attempt to roll back reproductive rights. Dr. Sisco’s remarks reflect a broader concern among abortion-rights advocates that the FDA’s actions may be driven by politics rather than public health. “The FDA’s politically motivated review undermines trust in proven health care and spreads harmful misinformation,” she reiterated.

Meanwhile, the real-world consequences of these policy battles are playing out in hospitals and homes across the country. On September 30, 2025, Rachel Harrison, a California woman, filed a lawsuit against Dignity Health, claiming that two of its Catholic hospitals denied her emergency abortion care during two separate pregnancies. As reported by Getty Images and detailed in court documents, Harrison’s water broke at 17 weeks in both pregnancies—a condition known as previable preterm premature rupture of membranes (PPROM). This condition carries significant risks to both fetus and mother, and medical professionals recommended termination to prevent serious complications.

However, the hospitals—Mercy San Juan Medical Center and Mercy General Hospital—refused to provide an abortion due to the presence of a fetal heartbeat, despite the medical recommendation. During her second pregnancy, Harrison developed life-threatening sepsis and had to seek care outside her insurance network to receive a blood transfusion. The lawsuit alleges that the hospitals prioritized religious directives over patient safety and violated California’s Emergency Services Law, which mandates treatment for emergency medical conditions such as PPROM.

Harrison and her partner, Marcell Johnson, are seeking an order requiring Dignity Health to comply with state law, as well as compensatory and punitive damages. The case shines a spotlight on the ongoing tension between religious healthcare providers—which, in Dignity Health’s case, operate under a set of Ethical and Religious Directives—and state laws designed to guarantee emergency care regardless of religious doctrine. Dignity Health, which operates 24 Catholic hospitals, defended its practices through a spokesperson: “When a pregnant woman’s health is at risk, appropriate emergency care is provided. The well-being of our patients is the central mission for our dedicated caregivers.”

This lawsuit is only the latest in a string of legal challenges nationwide, as patients, providers, and advocacy groups test the boundaries of state and federal law. The clash between religious freedom and access to emergency reproductive care is likely to intensify as more states impose restrictions or expand protections in the wake of shifting federal guidance.

Amid all the legal wrangling and political posturing, the lived experiences of women like Rachel Harrison and the patients served by organizations like Planned Parenthood remain at the center of the storm. As the FDA continues its review and courts weigh the merits of cases like Harrison’s, the nation’s approach to abortion access—and the delicate balance between individual rights, medical judgment, and religious belief—hangs in the balance.

For now, the only certainty is that the debate will continue, with high stakes for patients, providers, and policymakers alike.