By: David Ostrowsky

For a quarter century, Mifepristone, the medication used to block a hormone necessary for pregnancy development, has been widely used throughout America. If anything, over the past few years, since the Supreme Court overturned Roe vs. Wade and permitted individual states to outlaw abortions, the pill, used in conjunction with Misoprostol, has become even more popular among women seeking to terminate their pregnancies. And yet, despite its far-reaching popularity and well-documented efficacy, the Food and Drug Administration (FDA) has maintained stringent restrictions on Mifepristone.

Restrictions that, in the eyes of attorneys general from California, New Jersey, New York, and Massachusetts, have become excessively stringent.

Earlier this month, the quartet of liberal, pro-abortion states filed a citizen petition to lift such restrictions and mandate that the FDA acknowledge the copious amount of scientific research that has invariably found Mifepristone to be safe and effective. Per the filing, the FDA would also not be allowed to alter Mifepristone regulations while the petition is pending.

“The FDA must follow the science and lift these unnecessary barriers that put patients at risk and push providers out of care,” Letitia James, the attorney general of New York, remarked after the petition was filed.

Perhaps the most prominent barrier is the regulatory framework called Risk Evaluation and Mitigation Strategy, or REMS, which the FDA imposed on Mifepristone. REMS is essentially a drug safety program that the FDA uses on medications for which it has considerable safety concerns. Within the context of Mifepristone, REMS requires prescribers to have the necessary qualifications to evaluate whether patients are proper candidates for the drug and ensure that the abortion pill is only dispensed by certified pharmacies or under the auspices of certified prescribers. Also, another requirement under REMS is that patients must sign an agreement acknowledging that they are taking Mifepristone because they decided to terminate their pregnancy.

In the citizen petition, the aforementioned states have advocated for a complete evisceration of the REMS framework, positing that “given mifepristone’s well-established, 25-year safety record, FDA’s current restrictions on mifepristone are no longer justified by science or law.” Furthermore, the states’ filing cites new studies in stating that “mifepristone’s safety has remained stable even as its restrictions have been lessened” and that continuing the restrictions “cannot be squared with the FDA’s lack of REMS programs on drugs that have significantly more risks than mifepristone.” In short, the four states filing the petition believe that these restrictions amount to unnecessary red tape and have discouraged some providers from offering the medication. It should be noted that in addition to the attorneys general of New York, New Jersey, Massachusetts, and California, prominent medical organizations have called for the removal of these restrictions.

The FDA has to respond to the petition within 180 days by granting or denying the request, or saying it needs an extension. In its responses, the agency must document its position, which could be used in lawsuits, including one that the four states could file should their petition be denied.

Surely, Americans’ unfettered access to Mifepristone, a drug that was approved for abortion in America in 2000, remains a contentious issue nationwide. Three Republican-led states (Idaho, Missouri, Kansas) have filed a lawsuit against the FDA challenging the agency’s prior approval of Mifepristone. While the Supreme Court dismissed the case last year, arguing that private parties did not have legal grounding to oppose access to the drug, a Texas federal judge ruled in January that Idaho, Missouri, and Kansas could resume their lawsuit. Meanwhile, the medication continues to be shipped across state lines into states that outlaw abortion, making it more complicated for said states to regulate the practice.

For sponsors of self-insured plans, it bears monitoring how such legal proceedings play out in the ensuing months. Many of their respective participants inclined to terminate their pregnancies may have limited resources and the inability to easily access Mifepristone could have a profound impact on their decisions. And from a legal perspective, there is a very important consideration: as self-insured plans governed by the Employee Retirement Income Security Act (ERISA) are generally exempt from a given state’s insurance laws due to ERISA preemption, plan sponsors—even those with plan participants residing in states with restrictive abortion laws—can typically elect whether or not to cover abortion medication, such as Mifepristone. Alternatively, non-ERISA plans, such as self-insured non-federal governmental plans or church plans, would not have the same flexibility in coverage and must comply with state insurance mandates to the extent they apply to self-insured plans.