After a flurry of national headlines over Texas’ so-called “heartbeat bill” that bans abortion after about six weeks of pregnancy—before many women even know they’re pregnant—the case has rapidly reached the United States Supreme Court. Oral arguments in that case begin today.
But amid somewhat less public fanfare, the U.S. Food and Drug Administration (FDA) has undertaken a substantive review of its restrictions on mifepristone, a progesterone blocker and one of the drugs commonly used in medication abortion.
An interim update on that review could come as early as this week. Though the FDA may simply provide a status update on the process, along the lines of “the review is still underway,” the final guidance could significantly reduce barriers to medication abortion, the primary method for abortions in the first ten weeks of pregnancy.
Though medication abortion has been FDA approved in the U.S. for more than 20 years, mifepristone continues to be subject to stringent FDA restrictions known as the Risk Evaluation and Mitigation Strategies (REMS).
Under the REMS, the FDA requires that mifepristone can only be dispensed in specific healthcare facilities by specially certified prescribers, though patients still typically take the drug at home without direct medical supervision. The REMS also prohibit retail pharmacies from stocking and dispensing mifepristone.
“That might’ve made sense back in 2000 when mifepristone was first approved,” said Dr. Daniel Grossman, professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California San Francisco (UCSF) and director of Advancing New Standards in Reproductive Health (ANSIRH), a program of the UCSF Bixby Center for Global Reproductive Health.
At that time, according to Grossman, though there was plenty of safety data from outside the United States, there was little data from within the U.S. Today, though, there is extensive evidence that medication abortion itself is safe and effective, as is telemedicine as a means for dispensing the medications.
“Really at this point, it makes absolutely no sense,” Grossman said. “It seems like it’s more political motivations that keep the drug tightly restricted.”
The REMS typically apply to medications deemed to have “serious safety concerns,” according to the FDA’s own description, but experts suggest that description doesn’t fit mifepristone.
“[Abortion medications are] safer than Tylenol,” said Carrie N. Baker, a contributing editor at Ms. Magazine and chair of American studies and professor of the study of women and gender at Smith College. “They’re six times safer than Viagra, which is handed out like candy and people buy Viagra all the time online without even using a doctor.”
Prompted by a lawsuit brought by the American Civil Liberties Unition (ACLU) on behalf of the American College of Obstetricians and Gynecologists among others, the FDA suspended the requirement that mifepristone must be dispensed in person during the Covid-19 public health emergency.
This temporary easing of restrictions paved the way for mail-order medication abortion through telemedicine. And scientific studies ensued.
New research in the journal Contraception suggests that dispensing mifepristone via mail-order, rather than in person, is safe, effective, and feasible, with few adverse events.
Patients in the study, who sought medication abortions during the pandemic and agreed to receive the medications by mail, had comparable outcomes to patients who received mifepristone in person. Virtually all (97%) participants had a complete abortion, consistent with results in prior studies.
“It’s really quite clear that in-person dispensing is not necessary to safely and effectively provide the service,” said Grossman, a lead author on the study.
Notably, the study found several measures of patient satisfaction with the mail-order abortion medications.
Most participants (82%) reported receiving the medication in the mail within three days and another 17% received the drugs within a week.
Overall, 88% reported being very satisfied with the experience and 90% said they would want to get the pills by mail again if they had an unwanted pregnancy in the future and chose to have a medication abortion. Additionally, 94% said they would recommend mail-order medication abortion to a friend.
Among a small subset of study participants who had had a previous medication abortion where the medication was dispensed in a clinic setting, more than half (55%) reported that the mail-order experience this time was better.
This study adds to a large body of evidence that shows medication abortion without in-person dispensing is safe and effective.
Despite this evidence, women in 19 states—including Texas—are already effectively banned from using telemedicine or mail-order pharmacies to access medication abortion services due to state-level restrictions. Whatever happens with the REMS requirements will not help women in those states.
Grossman says he doesn’t know what the FDA will do with its interim update or in its final determination. But, he says, the science is clear.
“I am still very confident that the FDA is going to review this evidence and look at the science objectively and determine that there is no benefit of this in-person dispensing requirement,” Grossman said. “If they review the science and look at it objectively, they will determine that there is no medical need for this.”