RALEIGH, N.C. (AP) — A federal judge has permanently blocked some efforts in North Carolina to restrict how abortion pills can be dispensed, saying they are unlawfully in conflict with the authority of the U.S. Food and Drug Administration. But she allowed other state laws to remain in effect, granting only a partial victory to a doctor who sued.
The injunction entered Monday by U.S. District Judge Catherine Eagles in Greensboro gives permanence to her April 30 ruling that some of North Carolina’s regulations on medication abortion have been preempted by decisions of federal drug regulators that determined they were not needed.
The order Monday means North Carolina cannot require that only doctors prescribe the pills; that the drugs be provided to the patient only in person; and that the patient schedule a follow-up appointment. It also prohibits state and local prosecutors, state health and medical officials and other defendants from enforcing such rules or penalizing people who don't follow them with criminal, civil and professional penalties.
Congress delegated authority to the FDA to scrutinize the use of mifepristone, which the agency approved in 2000 to end pregnancy when used in combination with a second drug, misoprostol. The FDA expressly determined that restrictions similar to North Carolina's were no longer necessary, based on evaluations of their safe distribution and use, Eagles wrote in April.
Her order appears to mean patients in North Carolina can now receive the pills through pharmacies — prescribed through someone like a nurse practitioner or physician assistant or using telehealth — and take them at home, in keeping with FDA decisions.
But Eagles also upheld some challenged restrictions, such as requiring an in-person consultation 72 hours in advance, an in-person examination and an ultrasound before obtaining a prescription. She said these rules had either not been expressly reviewed and rejected by the FDA, or focus more on the practice of medicine or on general patient health.
Dr. Amy Bryant, who provides abortions and raised this legal challenge last year, said in a prepared statement that the permanent injunction will “allow for increased access to safe and effective medication abortion care throughout North Carolina.”
The challenged regulations on medication abortion are in a 2023 law enacted by the Republican-controlled General Assembly that carried onward or expanded many previous abortion restrictions. One change reduced the time frame for most abortions from after 20 weeks of pregnancy to 12 weeks.
Tami Fitzgerald, executive director of the conservative North Carolina Values Coalition, said Tuesday that the ruling “lowers the standard of care for women.” She also criticized the order for stopping a state requirement that “non-fatal adverse events” related to mifepristone be reported to the FDA, saying it would conceal “dangerous complications and side effects of abortion drugs.”
Democratic Attorney General Josh Stein, an abortion rights supporter now running for governor, didn’t defend the restrictions in court because he already contended they were preempted by the FDA's decisions. He blamed Republican lawmakers on Tuesday for the unlawful provisions and said, “this ruling helps women regain some control over their personal health care decisions.”
The offices of House Speaker Tim Moore and Senate leader Phil Berger, who joined the case to defend the laws, didn’t immediately respond Tuesday to an email seeking comment. They could appeal Eagles' order. An upcoming ruling in a separate case at the U.S. Supreme Court brought by anti-abortion doctors who want the justices to restrict access to mifepristone could affect the results of the North Carolina litigation.
http://accesswdun.com/article/2024/6/1246175