West Virginia abortion ban cannot block use of pills, GenBioPro tells court
By Brendan Pierson
Oct 29 (Reuters) -GenBioPro, which sells a generic version of the abortion pill mifepristone, on Tuesday urged a federal appeals court to rule that West Virginia's near-total ban on abortion does not apply to use of the pill under circumstances approved by the U.S. Food and Drug Administration.
"The issue in this case is whether West Virginia can interfere with a balance between access and safety Congress entrusted to the FDA for mifepristone," David Frederick, a lawyer for GenBioPro, told a three-judge panel of the 4th U.S. Circuit Court of Appeals on Tuesday. "The answer is no."
The Nevada-based company, which sued the state in 2022, argues that the federal Food, Drug and Cosmetic Act (FDCA) gives the FDA the authority to regulate when mifepristone can be used. The agency has approved the drug for medication abortion in the first 10 weeks of pregnancy, subject to certain safety requirements including special certifications for the prescriber and pharmacy.
Mifepristone is part of a two-drug regimen along with misoprostol used in medication abortion, which accounts for more than half of U.S. abortions, according to the Guttmacher Institute, a research group that supports abortion rights.
GenBioPro says that federal law preempts, or overrides, West Virginia's 2022 abortion law, which bans abortion except in cases of rape or incest before 14 weeks, non-viable pregnancies or when the mother's life is at risk.
The company is asking the court to reverse a ruling last year by U.S. District Judge Robert Chambers in Huntington, West Virginia. Chambers found that the U.S. Supreme Court in its 2022 ruling overturning its 1973 Roe v. Wade precedent, which had guaranteed abortion rights nationwide had "made it clear that regulating abortion is a matter of health and safety upon which states may appropriately exercise their police power."
Erin Hawley of the conservative legal group Alliance Defending Freedom, arguing for the state on Tuesday, urged the 4th Circuit panel to affirm Chambers' ruling. She said that the FDA, on its website, tells healthcare providers to check their own states' laws about whether they can prescribe mifepristone.
"The FDA itself acknowledges what has always been true under the FDCA, and that is that states get to regulate the healthcare field," she said.
The panel appeared skeptical of GenBioPro's argument. Circuit Judge J. Harvie Wilkinson said federal regulation was a floor, not a ceiling, for state regulation of drugs, and that states had the right to go further.
"I think the theory that's propounded here could potentially put the states in handcuffs as far as health and safety of their citizens is concerned," he said.
Both Wilkinson and U.S. District Judge Rossie Alston of West Virginia, sitting on the panel by designation, said that the Supreme Court seemed to leave regulation of abortion to states.
"The bottom line is Supreme Court seems to suggest generally that these types of questions on abortion...should be best left to the states, and because we live in the United States of America, if you want to access certain things you can move to a state that allows it," Alston said.
Wilkinson and Alston were appointed by former presidents Ronald Reagan and Donald Trump, both Republicans. Circuit Judge DeAndrea Benjamin, an appointee of Democratic President Joe Biden, asked few questions during the argument.
Mifepristone is at the center of another high-profile lawsuit brought in 2022 in Texas by anti-abortion groups seeking to undo the drug's FDA approval, who are also represented by the Alliance Defending Freedom.
A trial judge ruled in their favor, but the Supreme Court ruled that they lack standing, keeping the drug on the market for now. A group of conservative states are pressing forward with their challenge to the drug's approval.
The case is GenBioPro v. Raynes, 4th U.S. Circuit Court of Appeals, No. 23-2194.
For GenBioPro: David Frederick of Kellogg, Hansen, Todd, Figel & Frederick
For the state: Erin Hawley of Alliance Defending Freedom
Read more:
Abortion pill maker loses bid to block West Virginia's abortion ban
US Supreme Court preserves access to abortion pill mifepristone
Abortion pill still under legal threat despite US Supreme Court ruling
U.S. Supreme Court overturns Roe v. Wade, ends constitutional right to abortion
(Reporting By Brendan Pierson in New York)
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