Consumer group urges FDA to crack down on unapproved ‘Abortion Reversal’ procedure

anti-abortion protestors in 'march for life' protest at U.S. Supreme Court in 2019
Jan 18, 2019: Anti-abortion protesters at the U.S. Supreme Court, Jan. 18, 2019.
Photo: Jeff McCoy /

By Stephanie Russell-Kraft, FairWarning

A consumer watchdog group is asking the U.S. Food and Drug Administration to shut down a group of websites advertising a so-called abortion pill reversal, a potentially dangerous treatment that is not FDA-approved.

One of the sites, called Abortion Pill Rescue, markets what it calls “an effective process called abortion pill reversal that can reverse the effects of the abortion pill.” The site, run by Heartbeat International, a Christian anti-abortion organization, directs visitors to a hotline that can guide them through the procedure. “If you have taken the first dose of the abortion pill and regret it, you are not alone,” the website reads. “We can help you!”

The group claims that “medical professionals have been able to save 64-68% of pregnancies through abortion pill reversal.”

But the experimental procedure, first proposed in 2012, has not been evaluated by the FDA and could harm patients, according to the nonprofit Campaign for Accountability, which called on the agency to shut down Abortion Pill Rescue  and at least two other websites advertising the procedure.

“Women should not be used as guinea pigs unknowingly, and Americans have the right to expect that the FDA will take action when false, unlawful, and potentially dangerous health treatments are being peddled,” Alice C.C. Huling, counsel for the Campaign for Accountability, wrote in a May 20 letter.

Huling said FDA officials acknowledged her letter and referred it to the agency’s Office of Drug Security, Integrity, and Response. An FDA spokesperson told FairWarning that the agency doesn’t have “anything to share at this time.”

Abortion pill

The abortion pill is actually a combination of two medications—a dose of mifepristone, followed one to two days later by a dose of misoprostol. The “reversal” procedure calls for skipping the second, misoprostol pill and instead taking progesterone.Want more stories like this? Sign up here to get news alerts.

Anti-abortion groups have aggressively marketed the procedure since 2012, when it was first proposed. More than half a dozen states have passed laws requiring health care providers to counsel patients about the reversal process, according to the Guttmacher Institute, a reproductive rights research organization. Public and reproductive health experts have argued that these laws interfere with doctor-patient relationships, particularly since the pill reversal is an unproven therapy. Judges in North Dakota and Oklahoma have agreed, blocking the laws in those states that require mandatory pill reversal counseling.

When researchers at the University of California, Davis ran a trial of the procedure in 2019, they were forced to end the study early because three women suffered severe vaginal bleeding and wound up in the hospital. “Patients in early pregnancy who use only mifepristone may be at high risk of significant hemorrhage,” they found.

Alice C.C. Huling, legal counsel for the Campaign for Accountability, a nonprofit advocacy group.

Huling hopes the FDA will step in to warn consumers about what she believes is misleading language on websites that advertise abortion reversals. “It is discussed as if it has been proven safe and effective, and it hasn’t been,” she said.

For their part, anti-abortion groups have tried to turn the tables. In a letter to the FDA last month, Heartbeat International and other groups called on the agency to shut down websites marketing information about at-home medication abortion. One of those sites, AidAccess, received a warning letter from the FDA last year for selling an unapproved off-brand abortion pill.

“It should concern everyone when a website markets drugs to vulnerable women in violation of FDA standards designed to protect women,” Andrea Trudden, director of communications for Heartbeat International, said in an email to FairWarning.

‘Massive hypocrisy’

Huling and other abortion advocates believe the FDA has unfairly restricted access to safe abortion medication while turning a blind eye to untested “reversal” methods. “It’s massive hypocrisy that needed to be addressed,” said Huling.

The FDA’s current regulations on abortion medication are far stricter than what is medically necessary, according to many of the country’s top OB-GYNs.

Medication abortion was first approved by the FDA in 2000. According to the agency, the treatment is “safe and effective when used to terminate a pregnancy.”

And yet, the agency has subjected mifepristone to additional regulations that limit where and how the drug is dispensed. Even if it is prescribed remotely, patients must travel to a hospital or medical office and physically sign a form in the presence of their health care provider in order to obtain the pill. These regulations don’t apply to mifepristone when it is prescribed for uses other than abortion.

Anti-abortion groups have cited violations of these regulations in their calls to take down websites that advertise the abortion pill. “These requirements also protect women and unborn children from predators who would force or trick pregnant women into taking [mifepristone],” the groups, including Heartbeat International, wrote in their May 4 letter to the agency.

The American College of Obstetricians and Gynecologists has long opposed the FDA’s restrictions on mifepristone, arguing that they are not based on any medical requirement.

A lawsuit

Last month, the group sued the FDA, arguing that the in-person pick-up requirements are likely to put more patients in danger because of the ongoing Covid-19 pandemic. Traveling to a clinic could put patients at a greater risk of contracting the illness if they have to use public transportation, for example.

The doctors claim the FDA has “singled out” abortion patients “for a special barrier to telehealth care.” They’ve received support in an amicus brief from attorneys general of 22 states and the District of Columbia.

The FDA has denied these claims. “Nothing in the Constitution compels the federal government to make it easier for women to obtain an abortion by approving a particular drug, much less ensure that the dispensing of that drug is left unregulated,” the agency said in a June 10 court filing.

Dr. Daniel Grossman, director of Advancing New Standards in Reproductive Health, a research group at the University of California, San Francisco, believes those restrictions might have made sense in 2000, when the abortion pill procedure was still new.

“But now, after 20 years of experience demonstrating the safety of this medication, it really doesn’t make sense,” he said.

“Regulatory bodies have been very quick to overregulate abortion care,” Grossman added. “It’s clear that abortion is treated differently.”

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