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Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration

Description:  By illegally approving chemical abortion drugs, 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. The FDA never studied the safety of the drugs under the labeled conditions of use, ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls, disregarded the substantial evidence that chemical abortion drugs cause more complications than surgical abortions, and eliminated necessary safeguards for pregnant girls and women who undergo this dangerous drug regimen. After the U.S. Court of Appeals for the 5th Circuit ruled that the FDA must restore critical safeguards to chemical abortion drugs, the Biden administration appealed to the U.S. Supreme Court, asking the high court to take this case.

Dr. Christina Francis, Dr. Shaun Jester, Dr. Donna Harrison, and Dr. Tyler Johnson, doctors experienced in caring for pregnant and post-abortive women who joined the lawsuit challenging the FDA's illegal approval of chemical abortion drugs.
Wednesday, Aug 16, 2023

NEW ORLEANS – In a victory for women’s health, a unanimous panel for the U.S. Court of Appeals for the 5th Circuit ruled Wednesday that the Food and Drug Administration must restore critical safeguards for chemical abortion drugs and disallow their shipment by mail. Alliance Defending Freedom attorneys representing four medical associations and four doctors experienced in caring for pregnant and post-abortive women asked the 5th Circuit to uphold a federal district court’s decision protecting the health and safety of women and girls against chemical abortion drugs.

“The 5th Circuit rightly required the FDA to do its job and restore crucial safeguards for women and girls, including ending illegal mail-order abortions,” said ADF Senior Counsel Erin Hawley, vice president of the ADF Center for Life and Regulatory Practice, who argued before the court on behalf of the medical associations and doctors. “The FDA will finally be made to account for the damage it has caused to the health of countless women and girls and the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen. The FDA’s unprecedented and unlawful actions did not reflect scientific judgment but rather revealed politically driven decisions to push a dangerous drug regimen without regard to women’s health or the rule of law. This is a significant victory for the doctors and medical associations we represent and, more importantly, the health and safety of women.”

The court’s ruling prohibits abortion providers from sending chemical abortion drugs through the mail, which the FDA had been allowing since 2021 in direct violation of longstanding federal law. Additionally, in 2016, the FDA extended the permissible gestational age of the baby for which a girl or woman may take chemical abortion drugs—from seven to 10 weeks’ gestation—removed two of three required office visits, allowed non-doctors to prescribe the drug regimen, and eliminated the requirement that providers report non-fatal adverse events to the FDA Adverse Event Reporting System. The 5th Circuit held that the FDA’s 2016 action violated the Administrative Procedure Act and upheld the district court’s conclusion reinstating the original 2000 safeguards, including the seven weeks’ gestational limitation, necessary office visits, non-fatal adverse event reporting, and physician dispensation.

“In loosening mifepristone’s safety restrictions, FDA failed to address several important concerns about whether the drug would be safe for the women who use it,” the court wrote in its opinion in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. “It failed to consider the cumulative effect of removing several important safeguards at the same time. It failed to consider whether those ‘major’ and ‘interrelated’ changes might alter the risk profile, such that the agency should continue to mandate reporting of non-fatal adverse events. And it failed to gather evidence that affirmatively showed that mifepristone could be used safely without being prescribed and dispensed in person.”

With respect to the 2021 decision to allow mail-order abortion, the court criticized the FDA for giving dispositive weight to the adverse-event data in FAERS after eliminating the provider-reporting requirement, noting that “it’s unreasonable for an agency to eliminate the reporting requirement for a thing and then use the resulting absence of data to support its decision.”

The court further noted that the data the FDA cited in its 2000 approval of mifepristone shows “that thousands of women, and as many as hundreds of thousands, have experienced serious adverse effects as a result of taking the drug, and required surgery or emergency care to treat those effects.”

ADF attorneys filed the lawsuit against the FDA in November 2022 on behalf of the Alliance for Hippocratic Medicine, the American Association of Pro-Life Obstetricians and Gynecologists, the American College of Pediatricians, the Christian Medical & Dental Associations, and doctors Shaun Jester, Regina Frost-Clark, Tyler Johnson, and George Delgado. It is the first lawsuit to challenge federal government officials for their illegal approval of chemical abortion drugs that harm women and girls.

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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ABOUT Erin Morrow Hawley

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.

ABOUT Erik Baptist

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.