A federal judge struck down some of North Carolina’s restrictions on access to abortion medications on Monday, saying they conflict with the authority of the U.S. Food and Drug Administration (FDA).
The judge also struck down the requirement that “non-fatal adverse events” related to mifepristone be reported to the FDA.
“This case thus raises the question of whether and when a state can impose additional requirements on the distribution of an FDA-approved drug,” the 46-page ruling reads.
“While this case concerns the distribution of a drug used to terminate a pregnancy, a similar case could arise over any drug, from FDA-approve thyroid or diabetes medications, drugs for cancer treatment, vaccinations, contraceptives, or opioids for pain management.”
In the ruling, the judge upheld some of the state requirements for prescribing mifepristone, which include an in-person advance consultation, the use of an ultrasound, an in-person examination, blood type testing, and the reporting of adverse events to state health authorities.
Judge Eagles said that these requirements had “not been expressly considered and rejected by the FDA” or that they “focus more on the practice of medicine and a patient’s informed consent.”
The FDA first approved mifepristone in September 2000 for “medical termination of pregnancy through seven weeks gestation.” This was later extended to 10 weeks gestation in 2016.
Dr. Amy Bryant, the plaintiff in the case, filed the lawsuit against Josh Stein in his capacity as attorney general of North Carolina in January 2023. She argued that North Carolina’s laws conflicted with federal law.
Mr. Stein, a Democrat running for governor, announced in February 2023 that he would not defend the state restrictions in court because he argued that they are preempted by federal laws.
“Their sloppy, chaotic law violated women’s constitutional rights and made it harder to get a safe, effective medication abortion. I fought back against the unconstitutional parts of the law that made it harder for women – especially in rural parts of the state – to get the health care they need,” Mr. Stein said.
“I’m proud to defend women’s reproductive freedoms and pleased that this ruling helps women regain some control over their personal health care decisions. Politicians need to stay out of the exam room and leave these decisions to a woman and her medical provider,” he added.
