Is the abortion pill above challenge?

On Tuesday, the Trump administration urged a federal court to dismiss a lawsuit brought by three states over the removal of crucial protections for women taking the abortion drug mifepristone. The administration took no position on the merits of the Biden administration’s rolling back of vital safeguards protecting women but wrongly suggested that the states do not have standing to litigate their claims.

Last year, the Supreme Court sided with the Biden administration and found that pro-life emergency room doctors lacked standing to challenge the FDA’s removal of crucial protections for women. That didn’t spell the end to the case, however. Three states—Missouri, Kansas, and Idaho—moved to intervene in the district court and proceeded with the litigation. To show standing, the three states argue that they have a sovereign interest in protecting women and enforcing their laws protecting life. The Biden administration’s actions allow abortion drug providers to ship drugs nationwide—leaving states powerless to protect life and enforce state law.

Louisiana, for example, has indicted an abortion drug provider who allegedly illegally mailed drugs into the state, where a teenage girl was coerced into taking the drugs, experienced a serious complication, and needed to call an ambulance to take her to the emergency room. But New York leaders refuse to extradite the drug provider, hiding behind a state shield law that precludes Louisiana from obtaining any justice for the girl. The states also suffer economic harm when women who are on Medicaid take the abortion drug, suffer complications, and end up in the emergency room or hospital. With abortion drugs flooding all 50 states by mail daily, these unwanted complications are far from a remote possibility.

When it originally approved mifepristone, the FDA put a Black Box warning on the label notifying women that serious adverse events, including sepsis, infection, hemorrhaging, and death, could occur. The FDA’s label notes that roughly one in 25 women who take the abortion drug end up in the emergency room. Given that the drug is particularly high-risk, the FDA mandated certain protections for women, including in-person dispensing by a physician who could ensure emergency medical attention for complications, and limited the drug to seven weeks gestation.

Fast forward, and the Obama administration took away most of the protections for women taking the abortion drug, removed the requirement that abortion providers report complications (aside from death), and expanded the gestational age to ten weeks. Then, under the guise of COVID-19, the Biden administration removed the initial doctor visit where the drug would be dispensed in-person—–the only opportunity for women to be screened for dangerous complications like ectopic pregnancy and to accurately assess gestational age. This opened the door to mail-order abortions. Online providers have filled that void with the help of shield laws.

There’s no question that the Biden administration’s action violated federal law. The Administrative Procedure Act requires a reasoned explanation for the change, but the administration took away the opportunity to screen for dangerous conditions based on data it conceded was “not adequate” to find mifepristone safe. And the FDA relied on the absence of reported complications—despite the fact that the FDA had years before stripped away the requirement that abortion providers report such complications. Worst of all, the FDA’s own studies noted that more women would end up in hospitals and emergency rooms because they were not being screened in-person by a medical professional. That’s not reasoned decision-making.

The consequences are enormous. Two-thirds of the one million abortions in the United States are chemical abortions. A recent Ethics and Public Policy Center report compiled from real-world insurance data found that the actual complication rate was roughly 22 times higher than the FDA estimates. The study shows that nearly 11% of women who took the abortion drug experienced a serious adverse event within 45 days. For example, the study shows that 3,062 women were treated for ectopic pregnancy after taking the abortion drug. That is over 3,000 women whose lives were placed in imminent danger by the removal of the only opportunity for a doctor to screen for ectopic pregnancies.

The Biden administration avoided review of its unlawful removal of safeguards for women based on a legal technicality. In so doing, the administration made the unpalatable argument that no one could challenge the removal of protections on abortion drugs. In its first significant filing in the case, the Trump administration appears to agree with the Biden administration, noting that any injuries to the states were too far removed from any FDA action. The startling proposition that no one can challenge an agency’s decision to remove safeguards on a high-risk drug taken by hundreds of thousands of women every year cannot be right. America has a government of laws, after all, and not of men.

The Biden Administration prioritized politics over women’s health. The current administration shouldn’t make the same mistake.

Editor's note: Alliance Defending Freedom, where Erin Hawley works, represented the plaintiffs in FDA v. Alliance for Hippocratic Medicine.