The remote island of Kauai boasts pristine beaches, jewel-toned tides, and the dubious distinction of being a federally designated “medically underserved area.” In a pandemic that means an unnervingly finite number of ICU beds and ventilators, but even before Covid, women on the island knew the designation meant a crushing number of obstacles to navigate if they discovered an unwanted pregnancy. There’s the cost of airfare, hotel, and local transportation, at a minimum, and often taking time off of work or finding child care, too.
Because there is no abortion provider on Kauai, women who live on the island — and on its even more isolated neighbor, Ni’ihau — are left with no option but to fly to O’ahu in order to terminate a pregnancy. It’s a frustrating reality not only for the women themselves, but for one of the island’s doctors, who in 2017 sued the federal government over a set of arbitrary rules that made it difficult to prescribe mifepristone, the first of the two-pill regimen that together constitute a medication abortion, the method by which almost 40 percent of pregnancies are terminated. The suit was delayed by the pandemic, but in May, the FDA announced it would review its restrictions on mifepristone. It declared on Thursday that it will modify the current restrictions on medication abortion.
Mifepristone was first approved by the FDA more than 20 years ago, but it has been subject to a number of arbitrary restrictions, known as a risk evaluation and mitigation strategy, or REMS, since 2007. Under those rules, doctors were not allowed to write a prescription unless they obtained an additional certification specifically for prescribing mifepristone, and patients were forced to pick-up the mifepristone from that provider in person. The burden the FDA’s rules placed on doctors — to acquire both a separate certification and the drug itself — inevitably meant that mifepristone was only available at abortion clinics, the number of which has been rapidly dwindling in recent years.
In a letter to the plaintiffs in the case, the FDA said it would remove the “in-person dispensing requirement,” meaning women from Kauai and other underserved areas around the United States will no longer be forced to travel hundreds miles to a certified clinic in order to pick up the pills.
Experts have long held that the requirement was medically unnecessary. “The risks of mifepristone are just totally independent of the regulatory burdens the FDA placed on the drug,” says Greer Donley, assistant professor at the University Pittsburgh Law School, who has studied FDA policy. “Even though it has risks, it’s not risky by any means compared to other drugs that are on the market without any REMS.”
The fatality rate for the erectile dysfunction drug Viagra, for example — which is not subject to REMS — is six times higher than mifepristone’s. According to the ACLU, which represented the plaintiffs in the case, mifepristone was the single medication — out of 20,000 FDA-approved drugs — that required patients pick it up at a medical facility, regardless of where they ultimately took the drug.
In the same letter, the FDA noted that it will require pharmacies that dispense the drug to be specially certified to dispense the drug, rather than doctors themselves. The agency is leaving in place a requirement that patients sign a special form before they can be prescribed mifepristone. In a statement, Georgeanne Usova, senior legislative counsel at the ACLU, said it was “disappointing that the FDA fell short of repealing all of its medically unnecessary restrictions on mifepristone.”
The FDA did not specify when the rule will take effect. Even when it does, the decision will not have an immediate effect in 19 states, including Texas, where there are additional restrictions on the administration of mifepristone. But in states that do not have those restrictions, Donley says, “the significance could be quite enormous.”
Because of the pandemic, Donley says, “We’ve already seen the proliferation of virtual abortion clinics. My guess is that virtual abortion clinics in those 31 states [that do not have additional restrictions on mifepristone] will become almost the standard of care for many women who need early abortion … Not only do women not have to deal with the administrative or logistical hurdles of traveling to a clinic, finding child care, taking time off work — all that stuff — they don’t have to face protesters, they don’t have to worry about their privacy being [violated] because of protesters, and virtual clinics are actually offering abortion for hundreds of dollars less than clinic-based care.”
The FDA’s decision is especially crucial now, as a conservative Supreme Court contemplates overturning Roe v. Wade. In a statement, Julia Kaye, staff attorney with the ACLU Reproductive Freedom Project and lawyer for plaintiffs, called it “critical progress, though far from complete.”
She added, “We will continue to fight every day for a world where we can all control our reproductive destinies, regardless of where we live, how much money we make, or the color of our skin.”