A pair of lawsuits start a state-federal battle over abortion pills

The cases come as both supporters and opponents of the right to terminate a pregnancy increasingly focus on the abortion pill, which recently became the most popular method of abortion in the United States and a common way that patients circumvent state bans on the procedure.

Abortion advocates and their allies in state and federal offices are pushing more states to adopt laws like North Carolina’s, including states that already have near-total bans, in hopes of preventing patients from asking the pills online.

The North Carolina case, filed in federal district court in Greensboro, challenges a state law that requires abortion pills can only be provided in person by a doctor at a certified surgical center after a session of mandatory counseling and a 72-hour waiting period.

Eva Temkin, the lead attorney for the lawsuit, said those restrictions make it difficult for doctors, including her client Amy Bryant, as they try to treat patients in the state and those from other southeastern states that have implemented bans almost total abortions since the Supreme Court reversed Roe v. Wade last summer.

“The restrictions in North Carolina that our claimants and medical providers generally face have created a lot of inflexibility and inefficiency,” he said. ‚ÄúSince Dobbs There has been a significant increase in the number of patients requiring abortion care and these rules impose unnecessary delays and travel costs. Because of these restrictions, providers cannot see the number of patients they would like to see, for example, through telehealth.”

A spokesman for Democratic Attorney General Josh Stein, who recently announced his run for governor, told POLITICO that the office is reviewing the lawsuit, and would not comment further.

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

“It is a well-settled principle that a state may not implement a policy that conflicts with and frustrates the objectives of a federal law,” Temkin said.

“But in a way, this is the first case of its kind,” he added. “And that’s because this is the first drug on which states have imposed access restrictions that the FDA has determined are inappropriate.”

The FDA lifted the in-person dispensing requirement for the drugs in 2021, initially only during the Covid-19 pandemic and then permanently after determining that the pills were safe to be prescribed via telemedicine and sent by mail. The agency loosened its rules for the medication again earlier this month, allowing certified retail pharmacies to dispense it to patients with a prescription.

In West Virginia, GenBioPro, the company that makes the generic version of the abortion pill, is arguing in federal court that the state cannot prevent the regulation or sale of a federally approved drug without violating the Supremacy Clause and commerce of the Constitution.

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

State laws “restrict GenBioPro’s ability to market its FDA-approved product to West Virginians in need,” the company said in the lawsuit. “West Virginia cannot overrule the FDA’s determinations of appropriate restrictions on a drug that the FDA approved for use and that 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 the entire country

Anti-abortion groups are also waging 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, commemorating what would have been the 50th anniversary Roe v. WadePresident Joe Biden signed a memorandum directing his health secretary to “consider new guidance to support patients, providers and pharmacies who want to legally access, prescribe or provide mifepristone, no matter where they live.”

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