Legal experts say generics maker GenBioPro’s case against Mississippi for rules hindering use of its abortion drug could prove to be a bellwether if the Supreme Court winds up overturning Roe v. Wade.
In its 2020 civil suit, GenBioPro took aim at a Mississippi law hindering the use of its approved drug mifepristone, including barring women from nearby access to the pill and requiring a licensed doctor to prescribe it in-person. The state’s legislation defies federal law, the company argued, and is thus trumped by the Food and Drug Administration.
More than two dozen states are certain or likely to ban abortion if Roe v. Wade is overturned, according to the Guttmacher Institute. But there’s one thing potentially standing in the way of their plans: women would likely still be able to get the pills online or in other states.
And that’s why lawsuits like GenBioPro’s are significant. With various state laws leading to confusion over medication abortion access, attorneys believe, such legal challenges could make a post-Roe world a little more predictable.
“In a world without Roe, medication abortion becomes the big challenge for these states that want to regulate abortions out of existence,” one reproductive rights expert explained to Reuters.
Mifepristone, also known as RU486, blocks the hormone progesterone, which is needed for a pregnancy to continue. It’s the only medication approved in the U.S. for the medical termination of a pregnancy and the only generic version approved for this indication. It’s used together with misoprostol, which causes uterine contractions that expel the pregnancy from the uterus, in a two-drug regimen through 70 days of pregnancy.
Under Mississippi law, women cannot receive the pill without visiting the state’s sole licensed abortion facility and must take the pill in the presence of a doctor. Eighteen other states have the in-person rule on their books. But the FDA endorses no such requirement.
As such, the state’s laws “frustrate the FDA’s purpose in regulating mifepristone, upsetting the balance that the FDA has struck to protect the public safety, and causes real harm for [GenBioPro] by hindering [its] ability to provide mifepristone in Mississippi,” the lawsuit states.
A hearing, set for June 8, will take up a motion by Mississippi State’s health officer, Thomas Dobbs, to toss out GenBioPro’s case on the grounds that the company has failed to establish that it’s actually been harmed by the restrictions.
Some attorneys say there is a basis in case law whereby GenBioPro or Danco Laboratories – which has sold the brand-name version of the drug, Mifeprex, since 2000 – could prevail. In a 2014 case involving opioid drug Zohydro, manufacturer Zogenix convinced a federal judge that a Massachusetts law, which had tried to prohibit the drug, was preempted by federal approval.
In deciding under what conditions a drug can be used safely and effectively, “Courts have routinely granted deference to FDA,” one attorney specializing in FDA regulations told Bloomberg Law.
The Biden administration could also step in, suing through the Department of Justice or filing a brief in support of a manufacturer’s legal challenge.
Others contend that GenBioPro’s suit is a long shot. For one, Mississippi could argue that Congress didn’t give the FDA explicit authority to regulate abortion or that cases like Zogenix’s don’t deal with an FDA-approved drug per se.
Then there’s the Supreme Court itself, which has generally viewed with skepticism the argument that state law is superseded by FDA approval.
“I do think there is some basis to think that states can’t ban an FDA-approved drug,” the reproductive rights expert told Reuters. But if the Supreme Court overturns Roe v. Wade and a state then bans abortion, she added, “It gets a lot more complicated.”