In a recent ruling, a judge declared that certain restrictions on the distribution of abortion pills in North Carolina are illegal. The ruling was based on arguments surrounding the use of the drug mifepristone, which have raised concerns about bypassing federal regulatory protocols.
U.S. District Judge Catherine Eagles in Greensboro has granted a partial victory to the plaintiff, a physician who filed a lawsuit against the state regarding the regulations for the pill. The concerns raised were not addressed by the Food and Drug Administration (FDA), as reported by The Associated Press.
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According to Eagles, the FDA has not specifically reviewed and rejected certain restrictions on the drug. These restrictions include the need for an in-person consultation 72 hours before an abortion, an in-person examination, and an ultrasound before prescribing the drug. Despite not being expressly reviewed, these restrictions are allowed to remain in the state.
The judge observed that the existing state laws are also impeding Congress from enacting a federal regulation for mifepristone.
In her ruling, Judge Eagles stated that the safety restrictions imposed by North Carolina law on the distribution of the drug contradicted the FDA’s decisions and actions. The FDA had initially implemented these safety restrictions but later rejected and removed them. According to the judge, these laws hinder the congressional objective of establishing a comprehensive regulatory framework in which the FDA determines conditions for safe drug distribution without imposing unnecessary burdens on the healthcare system or limiting patient access.
Dr. Amy Bryant filed a lawsuit on January 25, 2023, claiming that North Carolina’s government was infringing on constitutional rights by imposing regulations on medication abortion. Dr. Bryant argued that such regulations were redundant as the federal government had already addressed the issue through the FDA.
In response to Eagles’s ruling, Bryant expressed her satisfaction with the judge’s recognition that the state cannot impose all restrictions on FDA-approved medication.
Bryant argued that the state’s regulations on mifepristone go against the FDA’s expert opinion and unnecessarily interfere with their judgment. He stated that several restrictions in North Carolina, such as the in-person prescription, dispensing, and administration of mifepristone, as well as the mandatory follow-up appointments, are preempted. Additionally, he emphasized the limitations placed on nurse practitioners in prescribing the drug.
“We are currently reviewing the ruling and assessing its implications for our ability to provide quality care to patients in North Carolina,” she expressed in a written statement.
North Carolina Attorney General Josh Stein (D) has been named a legal party in the case, as he is a gubernatorial candidate who has consistently advocated for abortion access. Stein places the blame on GOP legislators who implemented the law, stating that they have made it more challenging for women, particularly those in rural areas of North Carolina, to obtain medication abortion.
North Carolina’s Republican-led General Assembly recently implemented new legislation in 2023, aiming to restrict abortion rights further. This move comes in the wake of the Supreme Court’s decision to overturn Roe v. Wade in June 2022, effectively eliminating federal protection for abortion access. As part of these new laws, the ban on abortions has been reduced from 20 weeks of pregnancy to just 12 weeks.
The AP highlighted that medication abortions faced restrictions, with potential criminal, civil, and professional penalties for violating certain rules.
In 2000, the FDA granted approval to mifepristone as a medication capable of terminating pregnancy, in combination with misoprostol. Earlier this year, the FDA introduced a new policy allowing women to obtain the drug through online consultations and mail delivery. However, in March, the Supreme Court considered arguments from advocates seeking to impose additional limitations on the drug.
