Pro-Lifers Raise Safety Concerns, Push Back at the State Level Following FDA’s Removal of Restrictions on Abortion Pill

The Biden administration’s permanent lifting of restrictions on at-home abortions could cause serious harm to women, let alone the unborn.

In this photo illustration, a person looks at an Abortion Pill (RU-486) for unintended pregnancy from Mifepristone displayed on a computer on May 8, 2020, in Arlington, Virginia.
In this photo illustration, a person looks at an Abortion Pill (RU-486) for unintended pregnancy from Mifepristone displayed on a computer on May 8, 2020, in Arlington, Virginia. (photo: Olivier Douliery / AFP/Getty)

WASHINGTON — Pro-life advocates and physicians are warning of serious risks to women arising from the Biden administration’s Dec. 16 permanent lifting of in-person dispensing requirements on the abortion pill mifepristone, which allows for widespread at-home abortions through telemedicine. 

The FDA’s move “puts countless women and unborn children in danger,” Sue Liebel, policy director at the pro-life Susan B. Anthony List, warned. “Women who take chemical abortion pills are significantly more at risk of serious complications and more likely to require a visit to the emergency room.” 

Safety concerns include serious side effects that could arise from the use of the pill too far along in pregnancy or in the case of an ectopic pregnancy, both issues that could be missed when using the pill without an in-person consultation.

Many states already have some form of restriction on the use of mifepristone and now that the pill will be more widely available, others are looking to address issues that could arise.

Since 2000, the FDA had restricted mifepristone under its “Risk Evaluation and Mitigation Strategies” (REMS) drug-safety program, only permitting that it be prescribed to induce an abortion by a certified health-care provider and dispensed in a clinic, hospital or medical office. 

FDA guidelines still state that women should not take mifepristone if it has been more than 70 days since their last menstrual period or if they’ve had an ectopic pregnancy, problems with adrenal glands, are currently being treated with long-term corticosteroid therapy or have an intrauterine device (IUD) in place. 

In April, the FDA announced that it would temporarily exercise “enforcement discretion” during the COVID-19 pandemic regarding the in-person-dispensing requirement for mifepristone. Last week, the FDA made two permanent changes to the requirements on the abortion pill, first “removing the requirement that mifepristone be dispensed only in certain health-care settings, specifically clinics, medical offices, and hospitals,” and “adding a requirement that pharmacies that dispense the drug be certified.”

Abortion activists were elated by the announcement. Planned Parenthood President Alexis McGill Johnson called the move a “long-overdue step toward expanding people’s access to safe medication abortion.” However, pro-life advocates called attention to the numerous safety concerns that have arisen from the use of the abortion pill. 

Jeanne Mancini, president of the March for Life, said in a statement that “the FDA itself has documented thousands of adverse events caused by chemical abortion, including hundreds of women hemorrhaging, being hospitalized and, in the case of some women, even death.” She warned that the FDA “has lowered the standards for women’s health in name of greater access to abortion, a truly political move that will have grave consequences.” 


Deadly Complications

Complications from mifepristone can turn deadly, as some recent studies have noted. One study, titled “Deaths and Severe Adverse Events After the Use of Mifepristone as an Abortifacient from September 2000 to February 2019,” was conducted by pro-life physicians and looked at all of the adverse events that had been reported to the FDA since the drug’s approval, finding 24 deaths and nearly 1,000 life-threatening complications. 

Dr. Donna Harrison, an OB-GYN and executive director of the American Association of Pro-Life Obstetricians and Gynecologists, was among the authors of that study. She told the Register that there are “huge safety concerns” with telemedicine abortion, including the possibility of an ectopic pregnancy, which could lead to “massive internal hemorrhaging” after taking mifepristone. She added that the risks from taking the abortion drug “dramatically increase” the farther along a woman is in her pregnancy, which is why an in-person ultrasound is so necessary. 

“If she is seven weeks after her last period, she has about a 1 out of 20 chance of needing emergency surgery to clean out her womb,” Harrison said. “But if she is really 14 weeks after her period, she has a 1 out of 3 chance of hemorrhaging and/or needing emergency surgery to clean out her womb. Studies have shown that half of women who come for a first prenatal visit are more than a month off from how far pregnant they think they are.” 

A November study from the Charlotte Lozier Institute found that “the rate of abortion-related emergency room visits following a chemical abortion increased over 500% from 2002 through 2015, according to an analysis of Medicaid claims data,” and “over the same period, chemical abortions within the study population increased from 4.4% to 34.1% of total abortions.” Dr. James Studnicki, vice president of data analytics at the Charlotte Lozier Institute and an author of the study, wrote in Newsweek that the study’s “most unexpected finding was an increasing trend of women being treated in the emergency room for a miscarriage within 30 days of a confirmed chemical abortion — a sequence of events which is impossible, and was therefore either mistakenly or purposefully miscoded. By 2015, fully 60.9% of abortion-related emergency room visits following a chemical abortion were miscoded as treatment for a miscarriage.” 

In regard to the FDA’s decision to remove the in-person requirement, Studnicki said the agency “should review publicly available Medicaid data and act to strengthen rather than eliminate medical oversight of the chemical abortion process.”


Data and Reporting Gaps

Melanie Israel, a policy analyst at the DeVos Center for Religion and Civil society at the Heritage Foundation, told the Register that, given the Lozier Institute’s findings, it’s “really shocking to think that here the FDA is saying we should make these pills even more widely available and subject more women to having complications and having to go to the emergency room.” She said a serious concern in the decision to lift the in-person requirements is that the FDA “is not collecting good, robust data and looking at that when they’re making these decisions.”

She pointed out that, prior to 2016, “as a condition of somebody being a certified prescriber, they had to report serious adverse events and deaths to the abortion pill manufacturer who in turn shares that information with the FDA,” but the Obama administration “changed that reporting requirement so that only deaths have to be reported.” 

She said reporting requirements also had the weakness that the abortion doctor prescribing the pills to a woman is not necessarily going to be the person in the emergency room who’s dealing with the complications. 

Israel noted there “have now been 26 deaths associated with the drug that we know of since 2000.” She referenced the “patchwork of policies” in the states when it comes to reporting requirements. Consequently, she is encouraging state legislatures to look at what data is being collected to ensure they have the full picture of the complications that women are experiencing. 

Dr. Harrison pointed out that currently there is not an easy way for women to report adverse events after taking the abortion pill. 

“There is an online reporting system by the FDA, but as of a year ago, there was no ‘submit’ button,” she said. “So after you fill out the extensive form, you have to print it off and physically mail it to the FDA. From my team’s review of over 4,000 adverse events reported to the FDA, less than a dozen were submitted by patients.” 

She added that since the FDA stopped requiring the manufacturer to submit information on adverse effects in 2016, “no one is systematically collecting information on adverse effects from the abortion pill,” and “by not collecting data on the bad effects of the abortion pill, the FDA can say, as the FDA director said in a recent letter: We haven’t had an increase in adverse event reports so it must be safe.” This constitutes “willful negligence on the part of the FDA,” she said.

Harrison also pointed out that when ordering abortion pills and receiving them in the mail, “there is no possible way to adequately screen someone for domestic violence or sex trafficking,” because “when an abortionist has a telemedicine visit with a woman, the abortionist cannot see who is standing behind the computer or who else is in the room.” She said that since anyone can order abortion drugs online, including abusive partners or parents coercing a minor daughter to abort her child, “the potential for coerced abortion is massive.”

Katie Glenn, government affairs counsel at Americans United for Life, told the Register that websites selling the abortion pill via telemedicine did not have enough regulation, citing the recent case of a married U.K. official on trial for slipping mifepristone to his mistress. 

She also referenced a 2019 article by New York Times columnist Farhad Manjoo, who highlighted how easy it was to get abortion pills in the mail. He wrote that while one website “sent me an email asking me if I really am pregnant, as I have a man’s name and ‘the woman must confirm’ that she is ordering the drugs of her own accord,” he said that “most of my orders came through fine.”


State Restrictions 

Glenn said that several states really strengthened their laws “to explicitly outlaw telemedicine abortion,” including Texas, where a new law was enacted this month with harsher penalties of jail time and a $10,000 fine for anyone who prescribes abortion pills via telemedicine. She said Texas is sending “a message that other states need to adopt this so that they can prosecute and enforce their own laws, but also that these companies need to take state law seriously.”

She said that states should “look at their options as far as what existing prosecution power they have and what private rights of action exists for their citizens” when it comes to complications arising from telemedicine abortion. In the case of an ectopic pregnancy, which occurs in about 2% of pregnancies, women receiving abortion pills through the mail could “end up in the hospital with a rupture” if they are not screened, and “women and their families need to have legal recourse against abortion-pill websites in such cases.” 

There are 21 states, according to Glenn, with some sort of in-person requirement when it comes to abortion, whether it’s for counseling, an ultrasound or the abortion itself. Eight states — Arizona, Montana, Ohio, Oklahoma, South Dakota, Texas, West Virginia and Wisconsin — have explicitly passed bans on telemedicine abortion. 

Glenn added that “there are other states, like Maine, Maryland, Massachusetts, Minnesota, Nevada, Virginia and Washington, that license facilities or state that only a doctor licensed in state may do abortions in state, so any provider sending drugs into the state is violating state law.” The pro-abortion Guttmacher Institute noted that 19 states currently require “the clinician providing a medication abortion to be physically present when the medication is administered, thereby prohibiting the use of telemedicine to prescribe medication for abortion.”

Israel said that, given the Dobbs v. Jackson Women’s Health case before the Supreme Court and the possibility that Roe v. Wade would be overturned with abortion policy returning to the states, “on the pro-abortion side they see chemical abortion as really being the answer that they’re going to be looking towards; and, of course, on the pro-life side, folks see it as a very real challenge, because if states are able to enact more pro-life laws than they currently can because of Roe, some of that progress could be undercut if we have telemedicine abortions causing abortions to happen in these states that are trying to protect life.”