Two separate lawsuits filed Wednesday provide the latest evidence that the next front in the battle over abortion access will be the availability of medication used to administer abortions.
The cases include a district court challenge from a North Carolina physician who argues that federal regulations should override state laws requiring the abortion drug mifepristone to be dispensed in person in surgical facilities and a mandatory 72-hour waiting period to receive the drug.
The second case, filed by GenBioPro, challenges West Virginia’s ban on most abortions and ban against using telemedicine to prescribe mifepristone.
Both lawsuits come after the Biden administration earlier this month announced it would allow retail pharmacies to sell the abortion drug mifepristone and eliminate in-person requirements for dispensing the drug. Separately, the Justice Department also defended the mailing of mifepristone across state lines.
The Biden administration changes will ease how mifepristone, approved by the Food and Drug Administration in 2000 and used in more than half of all abortions, can be dispensed to patients.
Mifepristone, which ends a pregnancy, is generally used with misoprostol, a miscarriage management drug used to empty the uterus.
The changes come after the June 2022 Supreme Court Dobbs v. Jackson Women’s Health Organization decision, which overturned Roe v. Wade and unleashed a flurry of state — and some federal —legislation alternately limiting abortion access and expanding it.
“We know from years of research and use that medication abortion is safe and effective – there’s no medical reason for politicians to interfere or restrict access to it, or for states to force doctors to comply with mandates not supported by medicine or science,” said Amy Bryant, a plaintiff in the North Carolina case.
GenBioPro, one of two U.S. makers of mifepristone, wrote in its court filing that federal law preempts West Virginia’s ban on using telemedicine to provide the drug.
“These laws impermissibly restrict patients’ access to mifepristone and GenBioPro’s opportunity and ability to market, promote, and sell the medication in the State,” the company wrote in a court filing. “In “deem[ing]” mifepristone to be one of the few drugs subject to heightened FDA regulation, Congress authorized FDA, and only FDA, to impose restrictions on access to mifepristone.”
The new suits follow a third case filed by abortion opponents last year that challenges federal approval of mifepristone in 2000. West Virginia Attorney General Patrick Morrisey, who is named as one of two case defendants, said the state will not “relent in our defense of this clearly constitutional law.”
“We are prepared to defend West Virginia’s new abortion law to the fullest,” he said in a statement. “While it may not sit well with manufacturers of abortion drugs, the U.S. Supreme Court has made it clear that regulating abortion is a state issue.”
Congress has also indicated interest in the broader issue.
Last week, Republican Study Committee Chairman Kevin Hern of Oklahoma and Rep. Diana Harshbarger, R-Tenn., introduced a bill that would rescind recent changes by FDA to expand the drug’s access.
Looking ahead
Of the three cases, the third — Alliance for Hippocratic Medicine v. U.S. Food and Drug Administration — could have the broadest impact.
In November, conservative legal advocacy group Alliance Defending Freedom challenged the FDA’s approval of mifepristone, citing concerns about its safety.
ADF is seeking an emergency ruling to pull approval of the drug nationwide.
“If the FDA were forced to withdraw its approval that would mean that mifepristone would be taken off the shelves nationwide and would therefore decimate access to abortion to people across the country regardless of where they live or the laws of their state,” said Jennifer Dalven, director of the reproductive freedom project at the American Civil Liberties Union, speaking in a press call last week.
Challenging the FDA’s approval for a longstanding drug is unusual. Drug approval changes typically originate either voluntarily from the drugmaker itself or in conjunction with the agency.
“In any rational universe, this case would be laughed out of court on multiple grounds. Mifepristone was approved over 20 years ago, it’s been used safely and effectively by millions of people for early abortion care and to treat miscarriages. But unfortunately, in a world we are living in today, we have to take this case seriously,” said Dalven.
On Jan. 13, the Justice Department filed its brief with the court arguing that “the public interest would be dramatically harmed by effectively withdrawing from the marketplace a safe and effective drug that has lawfully been on the market for twenty-two years.”
That same day Danco Laboratories, the other company that produces mifepristone, filed a motion to intervene in the case stating that 5 million women have used Mifeprex, its brand name version of the drug, since 2000.
ADF is expected to file its brief by Feb. 10, meaning a preliminary ruling could be issued as early as Feb. 13. The judge may or may not choose to hear oral arguments. Any decision would likely be appealed to the U.S. Court of Appeals for the 5th Circuit — known for controversial decisions seeking to overturn the 2010 health law .
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