As FDA Considers Easing Restrictions on Medical Abortion, New Study Finds Patients Prefer Flexibility

After an avalanche of national headlines on Texas’ so-called “heartbeat bill” which prohibits abortion after about six weeks of pregnancy, before many women even know they are pregnant, the case quickly reached the United States Supreme Court. Oral arguments in this case begin today.

But amid somewhat less public fanfare, the U.S. Food and Drug Administration (FDA) has undertook a thorough review of its restrictions on mifepristone, a progesterone blocker and one of the drugs commonly used in medical abortion.

An interim update on this review may be released as early as this week. While the FDA may just provide an update on the process, in the sense of “review is still ongoing,” the final guidelines could significantly lower barriers to medical abortion, the main method for abortions in the first ten weeks of pregnancy.

Although medical abortion has been approved by the FDA in the United States for more than 20 years, mifepristone continues to be subject to strict FDA restrictions known as Risk Assessment and Mitigation Strategies (REMS).

Under REMS, the FDA requires that mifepristone can only be dispensed at specific healthcare facilities by specially certified prescribers, although patients generally take the drug at home without direct medical supervision. REMS also prohibits retail pharmacies from stocking and dispensing mifepristone.

“It might have made sense in 2000, when mifepristone was first approved,” said Dr. Daniel Grossman, a professor in the Department of Obstetrics, Gynecology and Reproductive Sciences at the University of California. in 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, although there was a lot of safety data from outside the United States, there was little data from the United States today, however, there is lots of evidence that medical abortion itself is safe and effective, as is telemedecine as a means of drug delivery.

“Really at this point it makes absolutely no sense,” Grossman said. “It seems to be more political motivations that keep the drug strictly restricted.”

REMS generally applies to drugs considered to have “serious safety concerns,” according to the FDA’s own description, but experts suggest that description doesn’t match mifepristone.

“[Abortion medications are] safer than Tylenol,” said Carrie N. Baker, editor of Ms. Magazine and chair of American Studies and professor of women’s and gender studies at Smith College. “They’re six times safer than Viagra, which is being handed out like candy and people are buying Viagra all the time online without even going to a doctor.”

prompted by a trial filed by the American Civil Liberties Union (ACLU) on behalf of the American College of Obstetricians and Gynecologists, among others, the FDA suspended the requirement that mifepristone be dispensed in person during the public health emergency of Covid-19.

This temporary easing of restrictions paved the way for mail-order medical abortion through telemedicine. And scientific studies followed.

New to research in the journal Contraception suggests that distributing mifepristone by mail, rather than in person, is safe, effective, and feasible, with few adverse events.

Patients in the study, who requested medical abortions during the pandemic and agreed to receive the drugs by mail, had outcomes comparable to patients who received mifepristone in person. Almost all (97%) of the participants had a complete abortion, which is consistent with the results of preliminary studies.

“It’s really very clear that in-person distribution is not necessary to deliver the service safely and efficiently,” said Grossman, one of the study’s lead authors.

Notably, the study found several measures of patient satisfaction with mail order abortion medication.

Most participants (82%) reported receiving the medications in the mail within three days and 17% received the medications within a week.

Overall, 88% said they were very satisfied with the experience and 90% said they would want to receive the pills in the mail again if they had an unwanted pregnancy in the future and chose to have a medical abortion. Additionally, 94% said they would recommend mail-order medical abortion to a friend.

Among a small subset of study participants who had previously had a medical abortion where the medication was administered at a clinic, more than half (55%) said the mail order experience was this time better.

This study adds to a large body of evidence that shows medical abortion without distribution in person is safe and effective.

Despite this evidence, women in 19 states– including Texas – are already effectively prohibited from using telemedicine or mail-order pharmacies to access medical abortion services due to state-level restrictions. Whatever happens with the REMS requirements will not help women in these states.

Grossman says he doesn’t know what the FDA will do with its interim update or in its final decision. But, he says, the science is clear.

“I’m still very confident that the FDA is going to look at this evidence and look at the science objectively and determine there’s no benefit to this in-person delivery requirement,” Grossman said. “If they look at the science and look at it objectively, they’ll determine there’s no medical need for it.”