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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.

Thursday, Nov 9, 2023

The following quote may be attributed to Alliance Defending Freedom Senior Counsel Erin Hawley, vice president of the Center for Life and regulatory practice, regarding a brief in opposition ADF attorneys filed with the U.S. Supreme Court Thursday in Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration. The brief asks the high court to deny the Biden administration’s and Danco Laboratories’ request for the court to hear the case and instead let stand the U.S. Court of Appeals for the 5th Circuit’s ruling that restored critical safeguards for chemical abortion drugs:

“Every court so far has agreed that the FDA acted unlawfully in removing crucial safeguards for women and authorizing dangerous mail-order abortions. The FDA’s recent actions on chemical abortion drugs have harmed the health of women and undermined the rule of law by unlawfully removing every meaningful safeguard from the chemical abortion drug regimen. The FDA, like any federal agency, is required to rationally explain its decisions. Yet its unprecedented actions here did not reflect scientific judgment but rather a politically-driven decision to push a dangerous drug regimen without regard to women’s health. We are urging the Supreme Court to deny the Biden administration’s request to overrule the decision of the 5th Circuit.”

The brief explains how the administration’s and Danco’s petitions wrongly insinuate that the lower court’s decision takes mifepristone off the market when it does not. The brief notes that, “the modest decision [from the 5th Circuit] merely restores the common-sense safeguards under which millions of women have taken chemical abortion drugs. Women will still have access to chemical abortion under the same protections that existed for the first 16 years of mifepristone’s use, including crucial examinations and ongoing monitoring for complications by a prescribing physician…. If this litigation involved a drug unrelated to abortion, there would not even be a debate as to whether this Court should intervene mid-litigation stream.”

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.