SCOTUS Reinstates FDA Abortion Drug Rule

WASHINGTON, D.C. -- The United States Supreme Court reinstated a requirement enacted by the U.S. Food and Drug Administration (FDA) that women seeking to obtain abortion drugs must pick them up in person from a hospital or medical office rather than receiving them by mail. The High Court ruled 6-3 in Food and Drug Administration v. American College of Obstetricians and Gynecologists (FDA v. ACOG) that the FDA abortion drug rule may go into effect and lifted a nationwide injunction against it. It granted the FDA request to reinstate enforcement for the “Elements to Assure Safe Use” in the Risk Evaluation Mitigation Strategy (REMS) for the chemical abortion pill mifepristone.

This removes a lower court’s preliminary injunction on the FDA rule that requires women to pick up the abortion medication mifepristone from a hospital, clinic, or medical office and to sign a disclosure form. Mifepristone, also known as Mifeprex, is usually taken together with the medication misoprostol in order to end pregnancies up to 10 weeks after conception. The Trump administration appealed the initial ruling and said it would be safer for women to see a doctor first because the drug can kill or injure women in certain medical situations. Last July, U.S. District Judge Theodore Chuang ruled to temporarily block enforcement of the FDA rule requiring the abortion pill to be administered only in clinics, medical offices or hospitals. Chuang’s ruling allowed the abortion drug to be mailed to women without seeing a doctor. The Justice Department then asked Judge Chuang to suspend his July 13 order pending an appeal to the Fourth Circuit Court of Appeals, but the judge refused. Chuang concluded that the “in-person requirements” for patients seeking abortion drugs impose a “substantial obstacle” to abortion patients and are likely unconstitutional under the circumstances of the pandemic. Chemical abortions account for approximately 40 percent of all abortions committed, and the risk of death for the woman appears to be 10 times greater than from surgical abortions. A recent study published in the journal Frontiers in Neuroscience provides additional evidence of the harmful biological and behavioral effects of drug-induced abortion. The FDA specifies that chemical abortion pills should never be given to a woman if she cannot go to a follow up visit to check on possible complications. As of December 31, 2018, there have been 24 reported deaths of women in the United States associated with mifepristone since U.S. Food and Drug Administration approved the drug in September 2000. This includes two cases of ectopic pregnancy resulting in death and eight fatal cases of severe systemic infection (also called sepsis). There have also been nearly 600 women who experienced such severe blood loss that they required transfusions. Liberty Counsel Founder and Chairman Mat Staver said, “Abortion drugs are not safe. Abortion harms women and kills children.”