Doctor argues North Carolina overshoots federal medication abortion rules

The preemption case — how far states can go in regulating certain medications without trampling on FDA authority — could have far-reaching impacts on high risk drugs.RICHMOND, Va. (CN) — A doctor told a Fourth Circuit panel Wednesday that North Carolina can’t impose restrictions and requirements rejected by the Food and Drug Administration on an abortion-inducing drug.Dr. Amy Bryant filed suit in January 2023, challenging the southern state’s adoption of additional steps for patients to use mifepristone. The requirements go beyond the FDA’s risk assessment of drugs to ensure they are regulated and don’t burden patient access, Bryant argues.“Under well-settled principles of preemption that preserve American federalism, a state cannot impose laws that conflict with and frustrate the objectives of federal law,” she wrote in her complaint.Legislative defendants U.S. Representative Tim Moore and state Senator Phil Berger argue if states are unable to impose additional regulations — like requiring in-person prescribing and administering — they could be “handcuffed” from strengthening safeguards on high risk drugs. State tort remedies for drugs could also be eliminated, the Republican politicians say.Erin Hawley, counsel for Moore and Berger, said Wednesday, “At most, plaintiffs can point to statements by the FDA finding certain provisions to be ‘not necessary.’ That is not the same thing as forbidding states from regulating.”A federal judge partially affirmed Bryant’s claims in 2024, finding the state can’t impose safety restrictions on medications the FDA specifically rejected, and laws that do just that “frustrate the congressional goal of establishing a comprehensive regulatory framework.”U.S. District Judge Catherine Eagles found the state’s requirements for in-person prescribing, dispensing, administering and an in-person follow-up appointment are obstacles to Congress’ purpose and are preempted by federal law, permanently preventing the state from enforcing the laws.However, Eagles upheld certain requirements: an in-person 72 hour advance consultation, the use of ultrasound, an in-person examination, blood testing and reporting adverse side effects. Those requirements “deal with informed consent and broader health and safety matters and are not preempted," she said.Bryant is asking the appeals court to go further and hold all of North Carolina’s restrictions are preempted by federal law.Nicholas Brod, solicitor general of North Carolina, argued on behalf of Democratic Attorney General Jeff Jackson Wednesday that the FDA has spent 25 years trying to “achieve a precise calibration between patient access burdens on the healthcare delivery system and safety.”“The state is trying to essentially turn back the clock to an earlier version of regulations that FDA had once imposed, and that seems to me to be a very unusual situation and why I think our preemption theory here is actually quite narrow,” Brod said.The office argues the state can’t enforce regulations designed by the legislature that frustrated a balance the FDA reached to provide patient access to mifepristone, echoing previous Attorney General Josh Stein’s brief.U.S. Circuit Judge Julius Richardson, a Donald Trump nominee, asked Brod Wednesday whether the FDA is in charge of abortion policy.“States have broad authority to regulate FDA approved drugs,” Brod said. “They can pass laws that complement FDA regulations. They can pass laws that fill gaps in FDA regulations, and they can pass laws that seek to exceed FDA regulations that are designed to set minimum safety standards. What states can’t do is seek to reimpose regulations on REMS drugs that the FDA once itself imposed and then made a deliberate choice to withdraw.”REMS drugs, including mifepristone, are those that require additional risk evaluation and mitigation strategies to alleviate safety concerns.Moore and Berger say there’s no indication Congress intended the FDA to be the exclusive authority regulating drugs, just to ensure high-risk drugs are regulated enough to bring to market. Congress did not mean to decrease states’ ability to protect their citizens, they argue.But Bryant says a ruling against federal regulations preempting state ones would apply to over 20,000 FDA-regulated drugs and create a patchwork of state safety regulations. A decision in favor of preemption could be limited to the roughly 70 drugs in the REMS programs, she says.Moore and Berger claim Bryant’s argument can’t be limited to mifepristone. A decision finding state regulation of high-risk drugs is preempted would affect 14 states that limit opioid dosage for chronic pain.Bryant’s attorney, Paul Alessio Mezzina, said the defendants haven’t identified a single state regulation of opioids in conflict with an FDA determination.In addition to Richardson, U.S. Circuit Judge Robert Bruce King, a Bill Clinton appointee, and U.S. Circuit Judge Henry Floyd, a Barack Obama appointee, served on the panel.In North Carolina, abortion is legal for any reason during the first 12 weeks of pregnancy. Beyond that, it is illegal except in cases of rape or incest through the 20th week, if there is a severe fetal anomaly through 24 weeks, or to protect the life of the mother at any point.Subscribe to our free newslettersOur weekly newsletter Closing Arguments offers the latest about ongoing trials, major litigation and rulings in courthouses around the U.S. and the world, while the monthly Under the Lights dishes the legal dirt from Hollywood, sports, Big Tech and the arts.Additional Reads