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FDA endangered women's health by removing key safeguards for high-risk abortion drugs

In new brief, ADF attorneys provide detail on why US Supreme Court should require the FDA to restore safety standards for abortion drugs

Thursday, Feb 22, 2024

WASHINGTON – Alliance Defending Freedom attorneys filed their brief Thursday with the U.S. Supreme Court, asking it to hold the Food and Drug Administration accountable for unlawfully removing crucial safeguards for the use of abortion drugs. The FDA recklessly removed in-person doctor visits, ongoing care, and other protections for women’s health either based on studies it conceded were inadequate or without ever studying the safety of the drugs with all the safeguards removed.

ADF attorneys are asking the court to affirm the U.S. Court of Appeals for the 5th Circuit’s decision holding that the FDA acted unlawfully by removing its original safety standards like doctors’ visits to check for ectopic pregnancies, severe bleeding, and life-threatening complications, as well as reporting requirements so women are better informed about the serious risks associated with abortion drugs.

“Women should have the ongoing care of a doctor when taking high-risk drugs. The FDA’s own label for abortion drugs says that roughly one in 25 women who take them will end up in the emergency room. But the FDA recklessly removed essential safeguards like the ongoing care of a doctor leaving women to suffer serious complications all alone,” said ADF Senior Counsel Erin Hawley, vice president of the Center for Life and regulatory practice. “It is appalling that the FDA eliminated in-person doctor visits based on studies that the agency admitted were inadequate. Women deserve better.”

In the case, U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine, ADF attorneys represent doctors, medical associations, and their members who are witnessing firsthand the harms inflicted by the FDA’s recklessness and are regularly called upon to treat emergencies caused by abortion-drug complications. As the brief notes, “That OB/GYNs, OB/GYN hospitalists, and emergency-room physicians will often be called upon to treat abortion-drug complications is not a bug in FDA’s abortion-drug plan but part of its very design.”

The brief explains the importance of women receiving in-person doctor visits, noting that the FDA violated the Administrative Procedure Act when it removed requirements—including that doctors provide follow-up visits to check for complications—without evaluating the changes as a whole. This is “akin to an agency no longer requiring seatbelts and airbags based on studies that evaluated the risk of removing just one of those protections.” The brief also highlights that the FDA’s own materials cite studies showing that the removal of the initial in-person doctor visit significantly increases the number of women seeking emergency medical attention. One cited study “‘suggests a pre-abortion examination may decrease the occurrence of procedural intervention and decrease the number of unplanned visits for postabortion care.’” Despite this, the FDA still removed the in-person requirements and chose to put women at greater risk of serious complications.

The brief argues, “No agency is above the law. Congress gave federal courts the authority—and obligation—to review the actions of agencies that regulate nearly ‘every nook and cranny of daily life.’ FDA’s insistence that [the Supreme] Court cannot check its work runs counter to the Administrative Procedure Act. Judicial review ensures that an agency doesn’t ‘become a mon­ster which rules with no practical limits.’ Giving such unfettered power to FDA—an agency whose actions ‘affect every citizen,’—is particularly problematic. Turning a blind eye to FDA’s patently unreasonable actions here, which jeopardize women’s health throughout the nation, would be unprecedented.”

Alliance Defending Freedom is an alliance-building, non-profit legal organization committed to protecting religious freedom, free speech, parental rights, and the sanctity of life.

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