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Federal Judge Strikes Restrictions on Chemical Abortion Drug in N.C.

Woman holding white pill and a glass of water

In an opinion filed April 30, U.S. District Court Judge Catherine Eagles struck down portions of North Carolina’s law restricting use of the chemical abortion drug mifepristone. The ruling also upheld several provisions of the law that the judge determined did not conflict with the Food and Drug Administration’s (FDA) authority to regulate the drug.

Mifepristone is a chemical abortion drug that starves an unborn baby of its mother’s progesterone, causing its death. A second drug, misoprostol, is taken up to 48 hours later and causes the uterus to contract in order to expel the dead baby.

The FDA initially approved the use of mifepristone in 2000 with numerous restrictions and labeling requirements including: allowing only physicians to prescribe the drug; administering the drug in-person at the physician’s office, having the patient agree to return for a follow-up appointment to “confirm the pregnancy has ended and the patient is well,” and reporting of any adverse events from the use of the drug to the FDA. Over time, the FDA significantly loosened these restrictions and ultimately eliminated them altogether.

In response, and over concerns about women’s health and safety, the North Carolina General Assembly subsequently passed legislation to essentially reinstate these provisions into state law. Dr. Amy Bryant, an abortionist from Chapel Hill, then challenged those laws in court.

As stated in Judge Eagle’s opinion, the U.S. Congress has specifically authorized the FDA to regulate drugs with an “inherent toxicity or potential harmfulness,” and mifepristone is one of those drugs. According to Judge Eagles, “This case thus raises the question of whether and when a state can impose additional requirements on the distribution of an FDA-approved drug.”

According to the opinion, “The Court finds and concludes that to the extent North Carolina law imposes safety restrictions on the distribution of the drug that the FDA has implemented and then later affirmatively rejected and removed, those laws frustrate the congressional goal of establishing a comprehensive regulatory framework under which the FDA determines conditions for safe drug distribution that do not create unnecessary burdens on the health care system or patient access.”

More specifically it states, “The provisions of the North Carolina law that prohibit health care providers other than physicians from prescribing the drug, require in-person prescribing, dispensing, and administering, mandate the scheduling of an in-person follow-up appointment, and require non-fatal adverse event reporting to the FDA stand as obstacles to Congress’ purpose and are preempted.”

With respect to other related laws, the opinion clarifies, “But to the extent North Carolina law imposes requirements that have not been expressly considered and rejected by the FDA or that focus more on the practice of medicine and a patient’s informed consent, these provisions do not interfere with Congress’ purpose and are not preempted. This includes the state’s requirements for an in-person advance consultation, use of an ultrasound, an in-person examination, blood type testing, and adverse event reporting to state health authorities.”

In an unfortunate commentary early in the opinion, Judge Eagles writes, “While this case concerns the distribution of a drug used to terminate a pregnancy, a similar case could arise over any drug, from FDA-approved thyroid or diabetes medications, drugs for cancer treatment, vaccinations, contraceptives, or opioids for pain management.”

This statement sadly fails to recognize the gravity of this decision based on the fact that mifepristone, unlike the other drugs mentioned, not only poses a significant risk to the mother but also destroys the life of an unborn child. According to the pro-abortion Guttmacher Institute, “medication abortions” (i.e. chemical abortions) accounted for 63% of all abortions in the United States in 2023.

Incidentally, North Carolina Attorney General Josh Stein was named as a defendant in this case but has refused to defend North Carolina’s pro-life statutes and has largely sided with the plaintiff. As a result, Speaker of the N.C. House Tim Moore and N.C. Senate President Pro-Tempore Phil Berger sought and were approved by the court to intervene as defendants.


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