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Court provides tough pill to swallow at FDA

The 5th Circuit keeps substantial portion of District Court ruling in place that halted agency’s approval of chemical abortion drugs

The 5th U.S. Circuit Court of Appeals in New Orleans Associated Press/Photo by Jonathan Bachman, file

Court provides tough pill to swallow at FDA

“It’s as safe as taking an ibuprofen for pain relief.”

This false statement regarding the chemical abortion drug mifepristone has been peddled for years in the mainstream media, by elected officials, and certainly by the pharmaceutical companies and manufacturers that subsist on the drug’s sales.

Safe? There’s a “Black Box” death or serious injury warning that comes on every package of mifepristone.

Twenty-three years ago, the Food and Drug Administration illegally expedited and approved the use of mifepristone and its companion chemical abortion drug, misoprostol, by characterizing pregnancy as an “illness” and arguing that chemical abortion provides a “meaningful therapeutic benefit.” Now, for the first time, a federal court of appeals has called out the agency on its reckless disregard for the law and for putting women and girls in harm’s way.

In a landmark ruling, the U.S. Court of Appeals for the 5th Circuit upheld a substantial portion of a district court ruling, putting many of the FDA’s unlawful actions regarding chemical abortion on ice. The court explained that when the FDA approved mifepristone it “imposed a ‘Black Box’ warning.” FDA requires “Black Box” warnings “when a drug ‘may lead to death or serious injury.’” Rejecting the often-heard argument that chemical abortion is as safe as Advil, the court explained that ibuprofen’s label “bears no resemblance to the ‘Black Box’ warning on mifepristone’s label.” That label “says nothing” about “surgery, emergencies, emergency rooms, or death.”

This isn’t news to the doctors and medical groups I and other attorneys at Alliance Defending Freedom represent in the first lawsuit to hold the FDA accountable for its endangerment of women and girls by illegally approving chemical abortion drugs, and then eliminating the critical safeguards that were in place. These doctors, who often treat women suffering the devastating consequences from chemical abortion gone wrong, first petitioned the FDA back in 2002 challenging the agency’s approval of the drugs.

Following the 5th Circuit’s decision, crucial safety measures that prioritize women’s health are back in place.

The 5th Circuit agreed that their concerns were valid. The FDA, for example, never studied the safety of the drugs under the labeled conditions of use. The court compared the FDA’s actions to an agency that determined whether a car equipped with safety belts was safe and then took those safety belts away based on existing data of how cars perform with those safety belts.

Equally troubling, the court found, was the FDA’s “ostrich’s-head-in-the-sand approach” to the data it relied upon to remove nearly every safeguard from the drug and allow mail-order abortions. The court found it entirely unreasonable for the agency to eliminate the reporting requirement for non-fatal adverse events “and then use the resulting absence of data to support its decisions” to remove safeguards and allow for abortion by mail.

While the 5th Circuit did not remove chemical abortion drugs from the market entirely because it found that the doctors we represent might not have filed suit in time, it suggested that the FDA’s initial approval was deeply flawed. It also agreed that the FDA’s approval of generic mifepristone was unlawful, and that the manufacturer must cease production by today.

Following the 5th Circuit’s decision, crucial safety measures that prioritize women’s health are back in place. Abortionists are no longer allowed to send chemical abortion drugs through the mail, which the FDA had been allowing since 2021, in direct violation of longstanding federal law. Additionally, the court’s decision moved back the time period in which chemical abortion can be used to seven weeks’ gestation, protecting the mother from adverse complications that increase with gestational age, reinstated necessary doctor visits, and brought back the requirement that abortionists must check women for complications after their chemical abortions.

Politics should never come before the health, safety, and welfare of women and girls facing an unplanned pregnancy. Federal agencies that act lawlessly and evade responsibility must be held accountable. In this post-Roe era of our nation, our policies and laws must reflect that life is a human right more than ever before.

Every woman deserves access to real health care, not a chemical drug that comes through the mail, ends an unborn child’s life, and puts the mother’s own safety at risk. Every pregnant woman deserves dignity, respect, and empowerment to help her be the best mother to her children. True support for women in this situation includes speaking the truth about the potential harms of chemical abortion drugs, and then walking alongside mothers-to-be through care, practical resources, prayer, and the loving community of the body of Christ.

The author works for Alliance Defending Freedom and represents plaintiffs in this case.

Erin Hawley

Erin Hawley is a wife, mom of three, senior counsel at Alliance Defending Freedom, and a law professor at Regent University School of Law.

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