Requirements such as a consultation and ultrasound before prescription can remain
By Gary D. Robertson
Associated Press
RALEIGH, N.C. (AP) — Some of North Carolina government’s restrictions on dispensing abortion pills — such as requiring only doctors prescribe and provide the drug to the patient in person — are unlawful because they frustrate the goal of Congress to use federal regulators to ensure the drug is distributed safely, a judge ruled on Tuesday.
U.S. District Judge Catherine Eagles in Greensboro granted a partial victory to a physician who performs abortions and who last year sued state and local prosecutors and state health and medical officials on state medication abortion regulations beyond those addressed by the U.S. Food and Drug Administration.
Other restrictions on the drug mifepristone that were challenged, however, such as requiring an in-person consultation 72 hours in advance, an in-person examination and an ultrasound before prescribing, are not preempted and can remain, Eagles wrote. That is because they have not been expressly reviewed and rejected by the FDA, or because they focus more on the practice of medicine or on general patient health, she added.
Yet some “statutory requirements of the state’s Abortion Laws stand as obstacles to Congress’ clear and manifest purpose of providing a comprehensive regulatory framework for safe use and distribution of higher-risk drugs run by the FDA,” Eagles wrote. She asked the parties to propose written judgments and injunctions for the case within a few weeks.
Spokespeople for plaintiff Dr. Amy Bryant and GOP legislative leaders didn’t immediately provide comments requested Tuesday on the decision. The ruling could be appealed.
Democratic Attorney General Josh Stein, an abortion-rights supporter and candidate for governor, was a named legal party in the case. But he didn’t defend the additional restrictions in court because Stein’s office believed they were preempted by the FDA.
“The court held that parts of North Carolina’s anti-abortion law that make it harder for women, especially in rural North Carolina, to get medication abortion are unconstitutional,” Stein said in a written statement. “Republican legislators enacted the law to control, not protect, women.”
Following the overturning of Roe v. Wade, the Republican-led General Assembly enacted new abortion laws in 2023 that carried onward or expanded many abortion restrictions, such as moving the ban on most abortions from after 20 weeks of pregnancy to 12 weeks. Restrictions also applied specifically to medication abortions. Violating some rules can result in criminal, civil and professional penalties.
Republican legislative leaders permitted to join the lawsuit to defend the restrictions argued the FDA hadn’t received specific powers to set regulations on abortion drugs across the nation. While Eagles agreed, she added there was nothing to indicate that Congress had given the FDA less authority to regulate the use and distribution of mifepristone compared to any other drug upon which it had power to alter and reduce restrictions if found to be safe.
The FDA approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The pills are now used in more than half of all abortions in the U.S. The U.S. Supreme Court heard arguments in March from lawyers for anti-abortion doctors who asked the court to restrict access to mifepristone, but the justices didn’t sound ready to do so.
Some of North Carolina’s restrictions on the books already had been removed by federal regulators as unnecessary, Eagles wrote, including that the drug be prescribed only by a physician and dispensed in person. The FDA announced in 2021 that women would be able to get a prescription via an online consultation and receive the pills through the mail. Eagles also said the state’s requirement that a woman schedule an in-person follow-up appointment also has been found by the FDA to be unnecessary.
When the FDA creates a program for a higher-risk drug and expressly imposed and removed a limit, “the state cannot reimpose that restriction based on drug safety concerns.,” Eagles wrote, but requirements “directed to broader health concerns and informed consent to the termination of a pregnancy” are not preempted.
Associated Press
RALEIGH, N.C. (AP) — Some of North Carolina government’s restrictions on dispensing abortion pills — such as requiring only doctors prescribe and provide the drug to the patient in person — are unlawful because they frustrate the goal of Congress to use federal regulators to ensure the drug is distributed safely, a judge ruled on Tuesday.
U.S. District Judge Catherine Eagles in Greensboro granted a partial victory to a physician who performs abortions and who last year sued state and local prosecutors and state health and medical officials on state medication abortion regulations beyond those addressed by the U.S. Food and Drug Administration.
Other restrictions on the drug mifepristone that were challenged, however, such as requiring an in-person consultation 72 hours in advance, an in-person examination and an ultrasound before prescribing, are not preempted and can remain, Eagles wrote. That is because they have not been expressly reviewed and rejected by the FDA, or because they focus more on the practice of medicine or on general patient health, she added.
Yet some “statutory requirements of the state’s Abortion Laws stand as obstacles to Congress’ clear and manifest purpose of providing a comprehensive regulatory framework for safe use and distribution of higher-risk drugs run by the FDA,” Eagles wrote. She asked the parties to propose written judgments and injunctions for the case within a few weeks.
Spokespeople for plaintiff Dr. Amy Bryant and GOP legislative leaders didn’t immediately provide comments requested Tuesday on the decision. The ruling could be appealed.
Democratic Attorney General Josh Stein, an abortion-rights supporter and candidate for governor, was a named legal party in the case. But he didn’t defend the additional restrictions in court because Stein’s office believed they were preempted by the FDA.
“The court held that parts of North Carolina’s anti-abortion law that make it harder for women, especially in rural North Carolina, to get medication abortion are unconstitutional,” Stein said in a written statement. “Republican legislators enacted the law to control, not protect, women.”
Following the overturning of Roe v. Wade, the Republican-led General Assembly enacted new abortion laws in 2023 that carried onward or expanded many abortion restrictions, such as moving the ban on most abortions from after 20 weeks of pregnancy to 12 weeks. Restrictions also applied specifically to medication abortions. Violating some rules can result in criminal, civil and professional penalties.
Republican legislative leaders permitted to join the lawsuit to defend the restrictions argued the FDA hadn’t received specific powers to set regulations on abortion drugs across the nation. While Eagles agreed, she added there was nothing to indicate that Congress had given the FDA less authority to regulate the use and distribution of mifepristone compared to any other drug upon which it had power to alter and reduce restrictions if found to be safe.
The FDA approved mifepristone in 2000 to end pregnancy, when used in combination with a second drug, misoprostol. The pills are now used in more than half of all abortions in the U.S. The U.S. Supreme Court heard arguments in March from lawyers for anti-abortion doctors who asked the court to restrict access to mifepristone, but the justices didn’t sound ready to do so.
Some of North Carolina’s restrictions on the books already had been removed by federal regulators as unnecessary, Eagles wrote, including that the drug be prescribed only by a physician and dispensed in person. The FDA announced in 2021 that women would be able to get a prescription via an online consultation and receive the pills through the mail. Eagles also said the state’s requirement that a woman schedule an in-person follow-up appointment also has been found by the FDA to be unnecessary.
When the FDA creates a program for a higher-risk drug and expressly imposed and removed a limit, “the state cannot reimpose that restriction based on drug safety concerns.,” Eagles wrote, but requirements “directed to broader health concerns and informed consent to the termination of a pregnancy” are not preempted.
