WASHINGTON — Efforts in states to further restrict medication abortion face legal questions over potential conflicts with federal drug regulations.
And experts are noting the potential federal court precedent set in a regulatory case from 2014 in Massachusetts that declared: “If the Commonwealth were able to countermand the FDA’s determinations and substitute its own requirements, it would undermine the FDA’s ability to make drugs available to promote and protect the public health.”
That statement is from a federal district court order that blocked Massachusetts from banning the sale of a prescription painkiller, despite concerns that the drug in question, Zohydro, could lead to addiction and overdose fatalities.
In her order blocking the ban, Judge Rya Zobel was talking about a powerful opioid — but could her logic also apply to abortion pills?
In the aftermath of the Supreme Court’s June 24 ruling in Dobbs vs. Jackson Women’s Health, which overturned its landmark 1973 ruling in Roe vs. Wade that established a constitutional right to abortion, many states that have already banned — or are in the process of banning — the procedure are looking to restrict the use of medication abortion next.
Texas, which significantly restricted access to abortion in the state after its six-week ban under Senate Bill 8 went into effect on Sept. 1, already has a law on the books to further curtail access to abortion pills.
Legal experts are predicting the fight over medication abortion, which involves taking a pair of pills to terminate an early pregnancy, is just getting started. But the 2014 Zohydro case in Massachusetts could set an important precedent for how courts evaluate state laws that clash with federal drug regulations.
The Food and Drug Administration, responsible for evaluating and regulating drugs approved for public use, signed off on Zohydro in 2013 despite concerns from an advisory panel over the drug’s potential for abuse.
Massachusetts was seeing a spike in opioid-related deaths at the time, and former Gov. Deval Patrick formally declared a public health emergency that included the ban on Zohydro.
In 2000, the FDA approved a drug called Mifeprex — known as mifepristone, generically — for use, in conjunction with another drug called misoprostol, to end an early pregnancy through 70 days gestation, or until the 10-week mark.
In 2021, amid COVID concerns, the FDA scrapped a requirement it had in place that mifepristone had to be dispensed in-person, allowing the option to receive the pills in the mail. This change, still in place today, significantly expanded access to medication abortion — studies show a majority of abortions in the U.S. now happen medically.
“The FDA, based on the evidence, right — it’s not like they’re just picking and choosing, it’s based on the evidence — they’re kind of lifting some of those restrictions over time,” said Katie Keith, Director of the Health Policy and the Law Initiative at the O’Neill Institute at Georgetown University Law Center.
“But it is subject to kind of a heightened standard of regulation by the FDA, which I think makes it a stronger argument why some of these state restrictions are unnecessary, not science-based,” Keith said.
Texas’ law limiting access to abortion medication, Senate Bill 4, outlaws providing abortion-inducing drugs to Texans after seven weeks of pregnancy, three weeks earlier than the 10-week cutoff the FDA has approved.
In Mississippi, where the drug manufacturer GenBioPro makes a generic version of mifepristone, the state is now set to ban nearly all abortions under a 2007 “trigger law” following the Supreme Court’s decision in Dobbs.
GenBioPro, through an ongoing lawsuit against Mississippi, is seeking to preserve access to abortion pills in light of the statewide ban — using the same logic the Massachusetts district court judge used when she blocked the New England commonwealth from banning Zohydro.
“Mississippi’s current restrictions on mifepristone already upset the balance the FDA struck between risk mitigation and ensuring access to a safe and effective medication,” GenBioPro’s lawyers argued in a letter to the presiding judge on June 30. “A ban would further distort that balance and run farther afoul of the Supremacy Clause [of the Constitution].”
The lawyers also cited Attorney General Merrick Garland, who said in a statement after the Dobbs decision came down that “states may not ban mifepristone based on disagreement with the FDA’s expert judgment about its safety and efficacy.”
Keith said she thinks the state vs. federal fight over regulating medication abortion will be the “next frontier, for many reasons.”
“A lot of this, I think, is going to run headlong into arguments about federal preemption,” she said, referring to the idea that federal law supersedes conflicting state law. “The federal government is in charge of the mail, the federal government is in charge of approving drugs, and it’s just gonna be a matter of litigating that out and sort of bringing legal challenges.”
