Appeals court hears drugmaker's challenge to abortion restrictions

A federal appeals panel expressed skepticism Tuesday during oral arguments in a case challenging West Virginia’s abortion laws, arguing they effectively limited access to a commonly used medication abortion drug.

Medication abortions refer to a two-step regimen in which a patient takes mifepristone, which ends a pregnancy, followed by a second drug, misoprostol, which expels the pregnancy. The drugs are used for the majority of U.S. abortions. They’re also used for miscarriage management.

West Virginia in 2022 banned almost all abortions and required a mandatory waiting period and counseling requirements before receiving the procedure. GenBioPro, which manufactures generic mifepristone, sued two West Virginia prosecutors in January 2023 over that ban, arguing that state law makes it impossible for residents to access the drug and for the company to do business in the state.

In August, a district judge dismissed GenBioPro’s case, ruling that West Virginia’s law supersedes the Food and Drug Administration’s approval of the drug. The case was appealed to the U.S. Court of Appeals for the 4th Circuit in Richmond, Va., which heard oral arguments Tuesday.

The case, GenBioPro v. Raynes, is one of several recent lawsuits regarding regulations and access to mifepristone, which has become a front in the battle over abortion access.

The FDA approved mifepristone in 2000 and GenBioPro’s generic version in 2019. Abortion opponents have repeatedly challenged regulations to and the approval of the drug.

In June, the Supreme Court upheld access to mifepristone in a case that said challengers did not have standing to challenge the FDA’s approval and regulation of mifepristone. The attorneys general of Kansas, Missouri and Idaho filed an amended complaint against the FDA over its regulation of mifepristone on Oct. 11.

Arguments

GenBioPro v. Raynes was heard before a three-judge panel composed of 4th Circuit Judges J. Harvie Wilkinson, a Ronald Reagan appointee, and DeAndrea Gist Benjamin, a Joe Biden appointee, as well as District Judge Rossie D. Alston Jr. of the Eastern District of Virginia, a Donald Trump appointee.

GenBioPro’s attorney — David Frederick of Kellogg, Hansen, Todd, Figel & Frederick — told the panel that the FDA’s authority over the drug and its post-market safety protocols should preempt the state’s abortion laws. Frederick cited the 2007 FDA user fee reauthorization law that he said imposes more restrictions and grants more powers to the FDA over post-marketing surveillance than a set of drug safety amendments from 1962 to the Federal Food, Drug, and Cosmetic Act.

“Congress entrusted the balancing on these factors to the FDA,” he said.

If every state is able to separately supersede FDA’s regulations on drugs, “it would be impossible for the FDA to do the periodic evaluation that Congress mandated” to ensure that safeguards for drugs are up to date.

Benjamin questioned the counseling language required under West Virginia law, which includes a protocol different from what was approved by the FDA.

“Isn’t that exactly what Congress does not want to happen under this uniformity of regulation of this drug?” she asked.

Frederick said current state law prohibits the drugmaker from selling its FDA-approved product, which is why GenBioPro should have standing in this case.

The 2022 Supreme Court decision overruling Roe v. Wade “concerned an individual right,” Frederick said. “Our case concerns an FDA-approved medication where there is a clash between the balancing that the states are seeking to impose and what the federal government chose to impose.”

Erin Hawley, the attorney speaking on behalf of the state of West Virginia, said Congress’ intent with the 2007 law was to provide a floor rather than a ceiling for regulation. States should be allowed to implement additional safety measures but could not disregard the minimum set by the FDA, she argued.

“We want to make it crystal clear, we are not in any way intruding upon the state’s traditional authority to regulate the practice of medicine,” Hawley said.

Wilkinson asked Hawley why Congress and the FDA would go into great detail if they did not intend to preempt state regulation.

“They looked at this issue and they addressed it in the most meticulous way possible. So why isn’t that an important issue of congressional intent?” he asked.

Hawley said the state law is intended to complement existing FDA regulations.

“The reason there is detail in the statute is because Congress and the FDA are dealing with the most dangerous, the highest-risk drugs on the market,” she said.

Let me “make sure I just understand what the respective positions are. You’re not seeking to put the FDA out of business,” said Wilkinson.

“Not at all, your Honor,” said Hawley.

Hawley, senior counsel for the Alliance Defending Freedom and vice president of the ADF Center for Life and regulatory practice, also argued the separate case challenging FDA’s regulation of mifepristone before the Supreme Court earlier this year. She is married to Missouri Republican Sen. Josh Hawley.

Wilkinson seemed skeptical of the precedent the case could set.

“I really worry about just kind of being in a sort of a semi-rogue position vis-à-vis the Supreme Court,” he said to Frederick.

Questioning Hawley, Wilkinson asked if this could be the first U.S. court to mandate access to a drug. Wilkinson also asked if this was due to a lack of other cases or because courts had rejected the standing of similar cases.

“I think there’s a reason that there’s a paucity of cases. It’s because, precisely because no one, including the FDA, has ever thought that Congress in 2007 was mandating nationwide abortion access instead of the 2007 amendments,” said Hawley. “They were passed by a bipartisan Congress.”

Frederick countered that ruling in favor of the state would actually be precedent-setting — the first case allowing a state to restrict access to an FDA-approved drug.

“No court has upheld a state restriction of the type that West Virginia is asserting here,” said Frederick.

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