Two lawsuits filed this week challenge state restrictions on medication abortion, which plaintiffs argue are not in line with the U.S. Food and Drug Administration’s updated Risk and Evaluation Management Strategy (REMS) requirements. These are just the first of what is expected to be a growing wave of lawsuits that aim to expand access to medication abortion in a post-Dobbs era.
Nationally, the tide has been changing in medication abortion, which comprises at least half of all abortions in the United States, according to the Guttmacher Institute. Recently, the Food and Drug Administration loosened restrictions on the two-drug regimen by making the pills available to retail pharmacies, meaning that patients no longer have to go to a clinic or a health-care facility specifically for the drugs. This is progress from the federal agency’s initial approval of mifepristone in 2000, which, taken with misoprostol, a medication that has long been used to treat ulcers, makes up the drug combination that is referred to in casual conversation as “abortion pills.”
In North Carolina, Dr. Amy Bryant, a board-certified and licensed OB-GYN, has gone to the Middle District court to push back on the state’s onerous restrictions on medication abortion, which she argues are not in line with federal regulations.
“Rejecting the regulatory framework imposed by Congress and FDA, North Carolina has imposed a complex web of requirements relating to the provision of mifepristone that apply to all patients and medical providers in the state, including Plaintiff,” the lawsuit says.
And in West Virginia, GenBioPro, one of two American manufacturers of mifepristone, filed a lawsuit in the southern district of West Virginia to challenge the state’s abortion ban, which, of course, includes medication abortion.
“Congress has empowered the FDA as the authority on prescription drug medication,” Skye Perryman, president of Democracy Forward and a lawyer for GenBioPro, told Reckon in an interview last week. “And so what we saw with the announcement earlier this year is the agency, after considering all the evidence before it, striking what it believes is its balance with respect to medication abortion access.”
In North Carolina, the state requires that the medication be dispensed in person, directly by a physician. Additionally, the patient must undergo state-mandated counseling and then wait 72 hours before they can acquire the medication, which is a nontrivial burden in abortion care, where time is of the essence. In some circumstances, a patient must also undergo an ultrasound in advance. “These restrictions,” the complaint says, “impose significant costs and burdens on both the Plaintiff and her patients.”
Of course, there is plenty of effort from anti-abortion advocates to restrict medication abortion access as much as possible. Last year, Alliance Defending Freedom, a conservative Christian legal advocacy group, filed a lawsuit in Texas that directly challenges the FDA’s guidance on medication abortion, claiming that the agency unlawfully fast-tracked the approval for mifepristone back in 2000.
The group was strategic in its filing, making sure the case would go before U.S. District Judge Matthew Kacsmaryk, who was appointed to the bench by President Donald Trump. Judge Kacsmaryk previously served as legal counsel for Alliance Defending Freedom, and is openly sympathetic to their anti-abortion and anti-LGBTQ causes. In a court filing earlier this month, the FDA argued 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.”
“Certainly Congress has bestowed upon FDA the authority and obligation to regulate prescription drugs in the United States that you see that there are special interests that are seeking to deprive FDA of that authority or to question that authority to the detriment of patients, to the detriment of medical professionals, and to the detriment of all Americans,” Perryman said.