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The Supreme Court, Medication Abortion, and the FDA: What's at Stake?
The Supreme Court, Medication Abortion, and the FDA: What’s at Stake?On March 26, 2024, the Supreme Court is scheduled to hear oral arguments in Food and Drug Administration (FDA) v. Alliance for Hippocratic Medicine (AHM), and Danco Laboratories LLC v. AHM. While the Supreme Court stated in the Dobbs decision that it “returns the issue of abortion to the people’s elected representatives,” the outcome of this case could limit access to medication abortion throughout the country, including in states where abortion is legal and protected. The interest in this case expands far beyond the issue of access to mifepristone and abortion; many people are watching whether the Court will block the FDA’s independence in determining the conditions required to assure a drug’s safe use— something the Court has never done before.
What Is the Case?
In the case, AHM v. FDA, the plaintiffs contend the FDA did not act within its authority when it approved mifepristone (one of the two drugs used in the medication abortion regimen) and also when it revised the protocol for prescribing and dispensing the medication in 2016 and 2021 (See Table 1). The plaintiffs also claim that the approval violated an 1873 anti-obscenity law, the Comstock Act, which prohibits the mailing of any medication used for abortion. The plaintiffs claim they have legal standing, arguing they are injured because they must treat patients who present to the emergency room after taking mifepristone, forcing them to divert time from their other patients and violating their conscience rights.
Danco, the manufacturer of Mifeprex, the brand name of mifepristone, has intervened in this case and is a defendant along with the FDA. The FDA and Danco claim the FDA approved changes in the Risk Evaluation and Mitigation Strategies (REMS) (special conditions FDA applies to some drugs) and other conditions for mifepristone use in 2016 after extensively reviewing the scientific evidence and 15 years of data reflecting the drug’s safety profile. Based on numerous studies, the FDA concluded mifepristone was safe to use up to 70 days gestation, misoprostol was effective and safe to use at home, and the efficacy and safety was the same with physicians and non-physician providers. The FDA also determined that the continued reporting of non-fatal adverse events by prescribers under the REMS was not warranted because of mifepristone’s safety record. During the COVID-19 public health emergency, the in-person dispensing requirement for mifepristone was enjoined by a court order for 6 months from July 2020 to January 2021. Based on the research and data collected during this period, the FDA found no indication that modification of the in-person dispensing requirement had increased adverse events. In April 2021, the FDA notified the American College of Obstetricians and Gynecologists (ACOG) that the agency would exercise enforcement discretion of the in-person dispensing requirement. In January 2023, the FDA formally amended the REMS, to permanently remove the in-person dispensing requirement, and adding a requirement that certified pharmacies can dispense mifepristone.
What Is the Case?
In the case, AHM v. FDA, the plaintiffs contend the FDA did not act within its authority when it approved mifepristone (one of the two drugs used in the medication abortion regimen) and also when it revised the protocol for prescribing and dispensing the medication in 2016 and 2021 (See Table 1). The plaintiffs also claim that the approval violated an 1873 anti-obscenity law, the Comstock Act, which prohibits the mailing of any medication used for abortion. The plaintiffs claim they have legal standing, arguing they are injured because they must treat patients who present to the emergency room after taking mifepristone, forcing them to divert time from their other patients and violating their conscience rights.
Danco, the manufacturer of Mifeprex, the brand name of mifepristone, has intervened in this case and is a defendant along with the FDA. The FDA and Danco claim the FDA approved changes in the Risk Evaluation and Mitigation Strategies (REMS) (special conditions FDA applies to some drugs) and other conditions for mifepristone use in 2016 after extensively reviewing the scientific evidence and 15 years of data reflecting the drug’s safety profile. Based on numerous studies, the FDA concluded mifepristone was safe to use up to 70 days gestation, misoprostol was effective and safe to use at home, and the efficacy and safety was the same with physicians and non-physician providers. The FDA also determined that the continued reporting of non-fatal adverse events by prescribers under the REMS was not warranted because of mifepristone’s safety record. During the COVID-19 public health emergency, the in-person dispensing requirement for mifepristone was enjoined by a court order for 6 months from July 2020 to January 2021. Based on the research and data collected during this period, the FDA found no indication that modification of the in-person dispensing requirement had increased adverse events. In April 2021, the FDA notified the American College of Obstetricians and Gynecologists (ACOG) that the agency would exercise enforcement discretion of the in-person dispensing requirement. In January 2023, the FDA formally amended the REMS, to permanently remove the in-person dispensing requirement, and adding a requirement that certified pharmacies can dispense mifepristone.
