U.S. Food and Drug Administration v. Alliance for Hippocratic Medicine
Description: By eliminating necessary safeguards for pregnant girls and women who undergo the dangerous mifepristone abortion drug regimen, the U.S. Food and Drug Administration failed to abide by its legal obligations to protect the health, safety, and welfare of girls and women.
FDA endangered women's health by removing key safeguards for high-risk abortion drugs
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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Erin Morrow Hawley serves as senior counsel and vice president of the Center for Life and regulatory practice at Alliance Defending Freedom. Before joining ADF, Hawley practiced appellate law at Kirkland and Ellis LLP, Bancroft LLP, and King & Spalding LLP. Hawley has litigated extensively before the U.S. Supreme Court as well as numerous federal courts of appeals and state courts of last resort. She also worked at the U.S. Department of Justice, serving as counsel to Attorney General Michael Mukasey. As an academic, Hawley served as an associate professor of law at the University of Missouri and she also taught constitutional law as a senior fellow at the Kinder Institute for Constitutional Democracy. Hawley is a former law clerk to U.S. Supreme Court Chief Justice John G. Roberts and Judge J. Harvie Wilkinson of the U.S. Court of Appeals for the 4th Circuit. Hawley received her bachelor’s degree in Animal Science from Texas A&M University and her law degree from Yale Law School where she served as a Coker Fellow in Constitutional Law and on the Yale Law Journal. She is an active member of the Missouri and District of Columbia bars and is admitted to practice before the U.S. Supreme Court and various federal courts of appeals.
Erik Baptist serves as senior counsel at Alliance Defending Freedom, focusing on administrative litigation and regulatory advocacy. Before joining ADF, he was a partner at Wiley Rein LLP—one of the largest law firms in Washington, D.C.—where he employed his expertise in administrative and environmental law to represent clients on litigation, regulatory, and enforcement matters. Prior to working at Wiley, Baptist served as a senior executive service political appointee at the U.S. Environmental Protection Agency. As the senior deputy general counsel and deputy assistant administrator, he directed EPA’s litigation, implemented groundbreaking rulemakings and policies, represented EPA and defended witnesses in response to congressional inquiries, and collectively helped oversee the work of more than 1,100 EPA lawyers, scientists, and staff. He earned his B.A. from Vanderbilt University and his J.D. from The George Washington University Law School. Baptist is an active member of the D.C. Bar and is admitted to practice before the U.S. Supreme Court and various federal courts of appeal.