Recent Court Decisions Concerning Chemical Abortion Pills
Background on FDA Law and Regulations Regarding Mifepristone (Mifeprex):
- In 1906 the Congress passed the Federal Food and Drug Act creating a federal agency to ensure the safety of drugs manufactured and marketed in the U.S.
- In 1962 Congress amended the law to require manufacturers to show that a drug is safe before it is marketed. The FDA will approve or deny approval of the drug. The law also stated that state laws are not preempted unless there is a direct conflict with federal law.
- Through regulation, the FDA established requirements for new drug applications submitted for approval and within its authority could evaluate and approve drugs with conditions of restricted use or distribution.
- In 2007, Congress gave the FDA the authority to create a REMS (a risk evaluation and mitigation strategy) to ensure that the benefits outweigh the risks of a drug. Part of that authority includes the FDA’s authority to require additional restrictions for drugs that have “inherent toxicity or potential harmfulness.” The law did not address preemption of state laws.
- In 2000 FDA approved Mifeprex, the brand name of mifepristone. Under the original restrictions, the drug had to be provided by or under the supervision of a physician. The physician had to be able to accurately assess the duration of the pregnancy and rule out an ectopic pregnancy, provide surgical intervention if necessary, give a patient a medication guide and have the patient sign an agreement; fully explain the procedure and report any hospitalizations or serious adverse events. Patients had to take the medication in the provider’s office and had to agree to return for a follow-up appointment.
- In 2015, the manufacturer of Mifeprex proposed modifications for the REMS.
- In 2016, the FDA decided that individuals other than a physician could prescribe mifepristone. The requirement that the patient take the drug in the doctor’s office and the requirement of a follow-up appointment was removed as well. Physicians still needed to assess the duration of the pregnancy and diagnose an ectopic pregnancy, provide surgical intervention if necessary, give patients the medical guide and obtain a signature for the patient agreement.
- In 2019, the FDA approved a generic version of Mifeprex subject to the same requirements of mifepristone.
- In December 2021, FDA removed the in person dispensing requirement and required a pharmacy certification requirement and pharmacy agreement form. Pharmacies were now authorized to dispense the drug.
- In 2023, the REMS eliminated the requirement that a physician prescribe mifepristone and allowed a health care provider to do so. The health care provider had to be able to assess the duration of the pregnancy, ensure that the pregnancy was not ectopic, give the patient a patient agreement form with a patient’s signature; be able to explain the procedure and report any deaths. The drug could be taken at a location of choice.
F.D.A. v. Alliance for Hippocratic Medicine (March 26, 2024):
- In Nov. 2022, four pro-life medical associations and several individual doctors moved for a preliminary injunction to require the F.D.A. to rescind the 2000 approval of mifepristone or remind the FDA’s 2016 and 2021 regulatory rollbacks of previous restrictions on the medicine. In April 2023, a federal district court sided with the plaintiffs but, on appeal, the 5th Circuit upheld only part of the lower court ruling. The court upheld the 2000 approval but agreed with the lower court’s decision to stay the FDA’s 2016 and 2020 regulatory rollbacks.
- The Supreme Court, on March 26, 2024, overruled the lower courts and found that the plaintiffs did not have “standing” meaning that they did not have a constitutional right to bring the case before the court.
- In effect, the 2000 approval and the F.D.A.’s loosening of safeguards for the prescribing and dispensing of mifepristone remain in effect.
Bryant v. Stein (April 30, 2024):
- Overview of SB20:
- On May 16, 2023, the North Carolina Legislature enacted SB20. The law was designed to protect women who choose abortion and provide additional care for women and babies brought to term.
- The bill includes the following:
- Limits abortion to 12 weeks
- Requires in-person counseling by a physician or a qualified professional
- Retains the requirement of an ultrasound, an in-person examination and blood testing
- Retains the requirement that the first abortion pill (mifepristone) be given by the physician in person
- Strengthens informed consent requirements for both surgical and chemical abortions
- Retains the 72 hour waiting period after counseling
- Requires reporting of adverse events including non-fatal events
- Requires that a physician prescribe the chemical abortion pills
- Requires the doctor to schedule a follow-up appointment to ensure that the abortion is complete and that the woman is in sound physical health
- Bryant v. Stein Decision:
- Amy Bryant, a UNC Health System abortionist, challenged SB20 provisions relating to the dispensing of the chemical abortion pill arguing that the federal laws and the federal FDA regulations regarding the chemical abortion pills preempt provisions of SB20 which affect the prescribing and administering of chemical abortion pills.
- Decision:
- The court struck down parts of SB20 and retained others.
- The provisions which remain in effect:
- In-person counseling 72 hours in advance of the abortion
- Ultra-sound requirement
- Blood testing requirement
- Reporting of non-fatal adverse events to the State
- The provisions which have been struck down:
- The scheduling of in-person follow-up appointments
- The requirement that only a physician can prescribe chemical abortion drugs
- The requirement that prescribing be done in person
- The requirement that the dispensing of the abortion pill be done in person
- The requirement that the abortion pill be administered in person
- Reporting to the FDA of all non-fatal adverse events. Deaths must still be reported
