Medication Abortion Care Is Safe Yet Still Obstructed After 20 Years

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EMAA Project and advocates call to remove the barriers to medication abortion care on its 20th anniversary

Today marks the 20th anniversary of the FDA’s approval of medication abortion care in the U.S., yet because of the 20-year-old restrictions the FDA still imposes on the medication, it’s only available from a limited number of health care professionals and telehealth options are limited — not because it’s not possible, but because of state laws and politics.

“Given its 20-year long safety record in the U.S., there is no medical justification for the over-regulation of medication abortion care. It’s time for the FDA to lift these antiquated regulations, so that more providers and pharmacies can offer it. Over-regulating medication abortion care harms patients and limits their ability to access the care that they need,” said Kirsten Moore, Director of the EMAA Project.

Medication abortion care is a safe, effective option for ending an early pregnancy. Over the past 20 years, almost 4 million pregnant people in the U.S. have used it to end their pregnancies. In 2014, 45% of women seeking abortion up to 9 weeks chose medication abortion care. Despite this track record, many face barriers to obtaining it from their health care provider—or can’t get it at all—due to restrictions the FDA still imposes on the medication, called REMS. Because of these outdated rules, women struggle to access medication abortion care, and most cannot receive it from their own health care provider, the professional who knows their health needs best.

“We have amassed twenty years of data that show medication abortion care is safe and effective,” said Angel Foster, Professor at the University of Ottawa. “Tens of millions of women around the world have used medication abortion care—including 4 million here in the U.S. Yet, in 2020, patients and providers are still required to jump through the same hoops that they did twenty years ago. It’s past time to remove these outdated restrictions on medication abortion care.”

The restrictions on medication abortion care fall hardest on those who are struggling to make ends meet, live in rural areas, are women of color, undocumented, or are young. These communities are often already facing exacerbated health circumstances from the pandemic, and can’t afford risking unnecessary exposure to COVID-19. They also might be hit by lost employment, wages, and childcare for the children they are already parenting.

“With over seven million COVID-19 cases in the U.S., it is critical to make medication abortion care more available,” said Dr. Bhavik Kumar, Medical Director, Primary & Trans Care. “As a primary care physician, I can tell you that patients should not have to travel to get one of the safest medications that I can prescribe. Instead, my patients should have care that works for them and their families, and they need to be able to make their own health care decisions without politics getting in the way.”

Professional medical societies, including the American College of Obstetricians and Gynecologists and the American Academy of Family Physicians, have called on the FDA to remove restrictions on medication abortion care. Even former FDA Commissioner Dr. Jane Henney, who oversaw the original approval of medication abortion care, has called on the FDA to reevaluate the restrictions in light of the medication’s positive safety record.

Research shows that medication abortion care through telehealth is just as safe and effective as seeing a provider in person, and it could alleviate many barriers to care during the pandemic and beyond. In fact, telehealth has expanded widely for many health services throughout the pandemic, but too many restrictions on medication abortion care have still remained. The FDA refused to lift restrictions during the pandemic, and the ACLU and advocates had to sue in court to temporarily allow it to be mailed by providers to patients. However, the Trump Administration elevated the case to the Supreme Court just last month.

The 20th anniversary of medication abortion care comes as the Supreme Court is set to rule on whether to keep suspending this barrier during the pandemic and Republican senators are urging the FDA to ban medication abortion care entirely.

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Chrissy Faessen