Pair of lawsuits kick off state-federal battle over abortion pills

The cases come as both supporters and opponents of the right to terminate a pregnancy are increasingly focusing on abortion pills — which recently became the most popular method of abortion in the United States and a common way patients are circumventing state bans on the procedure.

Anti-abortion advocates and their allies in state and federal office are pushing more states to adopt laws like North Carolina’s — including states that already have near-total bans — hoping to prevent patients from ordering the pills online.

The North Carolina case, filed in federal district court in Greensboro, challenges the state’s law requiring that abortion pills may only be provided in person by a physician in a certified surgical facility after a mandatory counseling session and a 72-hour waiting period.

Eva Temkin, the lead attorney in the suit, said those restrictions are hampering physicians, including her client Amy Bryant, as they attempt to serve patients in the state and those coming from other southeastern states that have implemented near-total bans on abortion since the Supreme Court overturned Roe v. Wade last summer.

“The restrictions in North Carolina that our plaintiff and medical providers generally are grappling with have created a lot of inflexibility and inefficiency,” she said. “Since Dobbs there has been a significant increase in the number of patients needing abortion care and these rules impose unnecessary delays and travel costs. Because of these restrictions, providers can’t see the number of patients they’d like to see, for instance, by telehealth.”

A spokesperson for Democratic Attorney General Josh Stein, who recently announced his bid for governor, told POLITICO the office is reviewing the lawsuit, declining to comment further.

The case has echoes of a previous legal fight between the FDA and Massachusetts over that state’s efforts to restrict an opioid medication, Temkin noted, a battle in which federal rules prevailed.

“It’s a well-settled principle that a state can’t implement a policy that conflicts with and frustrates the objectives of a federal law,” Temkin said.

“But in some ways, this is the first case of its kind,” she added. “And that’s because this is the first drug on which states have imposed restrictions on access that the FDA has determined are not appropriate.”

The FDA lifted the in-person dispensing requirement for the drugs in 2021 — at first, just for the duration of the Covid-19 pandemic and then permanently after determining the pills were safe to prescribe via telemedicine and send-by-mail. The agency loosened its rules for the medication again earlier this month, allowing them to be dispensed by certified retail pharmacies to patients with a prescription.

In West Virginia, GenBioPro, the company that manufactures the generic version of the abortion pill, is arguing in federal court that the state cannot impede the regulation or sale of a federally approved medication without violating the supremacy and commerce clauses of the Constitution.

The drugmaker’s lawsuit also challenges the state’s previous restrictions on medication abortion — including a ban on telehealth prescription of the drug, mifepristone. Those restrictions were superseded by the September 2022 prohibition on the procedure at all stages of pregnancy.

The state laws “constrict GenBioPro’s ability to market its FDA-approved product to West Virginians who need it,” the company said in the lawsuit. “West Virginia cannot override FDA’s determinations about the appropriate restrictions on a medication that FDA approved for use and Congress subjected to this enhanced regulatory regime.”

Meanwhile, anti-abortion groups, which filed a lawsuit in Texas in November are challenging the FDA’s two-decade old approval of the abortion pill, mifepristone, a case that could halt access to it nationwide.

Anti-abortion groups are also mounting a campaign to pressure Walgreens and CVS pharmacies not to carry the drugs in states where they are legally allowed to do so, with lawsuits, protests and boycotts planned for the coming weeks.

Over the weekend, marking what would have been the 50th anniversary of Roe v. Wade, President Joe Biden signed a memo directing his health secretary to “consider new guidance to support patients, providers, and pharmacies who wish to legally access, prescribe, or provide mifepristone — no matter where they live.”