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Health Law
Can Mississippi trump FDA regulations to restrict abortion pills? Federal judge considers the issue
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A federal judge in Mississippi is considering whether abortion-pill regulations by the Food and Drug Administration preempt Mississippi’s restrictions on dispensing the medication.
U.S. District Judge Henry T. Wingate of the Southern District of Mississippi will hear arguments on Mississippi’s motion to dismiss the case June 8.
Bloomberg Law and Reuters have coverage.
According to Bloomberg Law, the pending lawsuit “could set a roadmap for the Biden administration and others seeking to ease access to the medication across the country as the U.S. Supreme Court considers overturning Roe v. Wade.”
GenBioPro, the manufacturer of the abortion drug mifepristone, challenged Mississippi’s restrictions in a lawsuit filed in October 2020. Mifepristone is combined with the medication misoprostol for abortions at up to 10 weeks of pregnancy.
Mississippi requires a licensed physician to prescribe the abortion pill in person. The FDA, however, lifted the in-person requirement in December. And the FDA allows the drug to be prescribed by any certified health provider, including physician assistants and nurse practitioners.
According to statistics from the Guttmacher Institute cited by the articles, Mississippi is among 32 states that require licensed physicians to prescribe the medication and among 19 states that ban the use of telehealth prescriptions. If the Supreme Court overturns Roe, more than a dozen states will almost totally ban abortion, according to Reuters.
“In a world without Roe, medication abortion becomes the big challenge for these states that want to regulate abortions out of existence,” said Greer Donley, a professor at the University of Pittsburgh School of Law, who spoke with Reuters.
Reuters called the GenBioPro lawsuit “a long shot,” however. The conservative-dominated Supreme Court has shown skepticism to abortion rights and to federal preemption claims, according to Reuters. And Congress hasn’t explicitly indicated that FDA approval of the drug trumps state law.
But Bloomberg Law sees promise in the litigation.
“Constitutional and FDA policy attorneys say [the preemption] argument may have legs and could serve as a basis for any future lawsuits against state mifepristone restrictions,” the article said.
Experts told Bloomberg Law that courts have generally given states leeway when regulating the practice of medicine, which could aid the state’s arguments in favor of its restrictions. But state arguments may not be as clear cut if they totally ban the drug, said Wendy Parmet, director of Northeastern University’s Center for Health Policy and Law, who spoke with Bloomberg Law.
A state saying, “‘You can only prescribe it from an in-person visit in the first six weeks of pregnancy,’ becomes a very different case than just saying, ‘You can’t sell a drug that’s on the interstate market,’” Parmet told Bloomberg Law.
Donley, who specializes in reproductive health care law, told Bloomberg Law that challengers would have “a solid case” for preemption if a state seeks to explicitly ban mifepristone.
“It gets more complicated when the state bans abortion generally, and by effect, these drugs are essentially banned,” Donley said.
Mississippi is making other arguments in its motion to dismiss, according to Bloomberg Law. The state says GenBioPro doesn’t have standing because it is asserting the rights of third-party health care providers and women. The state also argues that GenBioPro has failed to allege a concrete injury.
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