Mifepristone: FDA eases restrictions on abortion pill


The isolated island of Kauai has pristine beaches, jewel-toned tides, and the dubious distinction of being a federally designated “medically underserved area”. In a pandemic that means an incredibly limited number of intensive care beds and ventilators, but even before Covid, women on the island knew the designation meant an overwhelming number of hurdles to overcome if they found out about an unwanted pregnancy. There is the cost of the plane ticket, hotel and local transportation, at a minimum, and often also taking time off from work or finding child care.

Because there is no abortion provider in Kauai, women who live on the island – and on its even more isolated neighbor, Ni’ihau – have no choice but to take the plane to O’ahu 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 an arbitrary set of rules that made it difficult to prescribe mifepristone, the first of the two-tablet regimen which together constitutes a medical abortion, the method by which nearly 40 percent of pregnancies are terminated. The lawsuit was delayed by the pandemic, but in May the FDA announced it would reconsider its restrictions on mifepristone. He said Thursday he would change current restrictions on medical abortion.

Mifepristone was first approved by the FDA over 20 years ago, but it has been subject to a number of arbitrary restrictions, known as the Risk Assessment and Mitigation Strategy, or REMS, since 2007. Under these rules, doctors were not allowed to write a prescription unless they obtained additional certification specifically for prescribing mifepristone, and patients were forced to withdraw mifepristone from this supplier in person. The burden that FDA rules placed on doctors – to acquire both separate certification and the drug itself – inevitably meant that mifepristone was only available in abortion clinics, the numbers of which quickly grew. decreased in recent years.

In a letter to the plaintiffs in the case, the FDA said it would remove the “in-person delivery requirement,” meaning women in Kauai and other underserved areas of the United States will no longer be forced to travel hundreds of kilometers to a certified clinic to pick up the pills.

Experts have long argued that the requirement was medically unnecessary. “The risks of mifepristone are completely independent of the regulatory constraints the FDA places on the drug,” says Greer Donley, an assistant professor at the University of Pittsburgh School of Law, who has studied FDA policy. “Even though it comes with risks, it is by no means risky compared to other drugs on the market without REMS.”

The death rate for the erectile dysfunction drug Viagra, for example – which is not subject to REMS – is six times that of mifepristone. According to the ACLU, which represented the plaintiffs in the case, mifepristone was the only drug – of 20,000 drugs approved by the FDA – that required patients to collect it from a medical facility, regardless of where they were. eventually took the drug.

In the same letter, the FDA said it would require pharmacies that dispense the drug to be specially certified to dispense the drug, rather than the doctors themselves. The agency is leaving in place the requirement that patients sign a special form before they can be prescribed mifepristone. In a statement, Georgeanne Usova, senior legislative advisor at the ACLU, said it was “disappointing that the FDA has not repealed all of its medically unnecessary restrictions on mifepristone.”

The FDA has not specified when the rule will take effect. Even then, the decision will not have immediate effect in 19 states, including Texas, where there are additional restrictions on the administration of mifepristone. But in states that don’t have these restrictions, says Donley, “the importance could be pretty huge.”

Due to the pandemic, Donley says, “We have already seen the proliferation of virtual abortion clinics. I guess the virtual abortion clinics in these 31 states [that do not have additional restrictions on mifepristone] will become almost the standard of care for many women who need an early abortion … don’t have to face the protesters, they don’t have to worry about their privacy [violated] because of the protesters, and virtual clinics actually offer abortion for hundreds of dollars less than clinic care.

FDA ruling especially crucial now, as conservative Supreme Court considers overturning Roe vs. Wade. In a statement, Julia Kaye, an attorney for the staff of the ACLU’s Reproductive Freedom Project and an attorney for the plaintiffs, called it “critical progress, although far from over.”

She added, “We will continue to fight every day for a world where we can all control our reproductive destiny, no matter where we live, how much money we make or what color our skin is. “


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