The Biden administration permanently rescinded a longstanding federal safety protocol requiring that dangerous chemical abortion drugs be administered in person.
The FDA's REMS (Risk Evaluation Management Strategy) has been in place for the abortion pill since its release in 2000, and has required that the abortion drugs only be prescribed by a certified health-care provider and dispensed in a clinic, hospital or medical office. An in-person exam by a physician is necessary to properly determine the gestation of a woman's pregnancy, and to also screen for ectopic pregnancy, as well as for other conditions - all significant factors in ensuring the woman's safety.
The REMS, reserved for drugs with serious safety concerns, no longer includes the requirement that mifepristone (the abortion pill) "be dispensed only in certain healthcare settings, specifically clinics, medical offices, and hospitals," as of the Biden's administration's announcement Thursday. The FDA is adding a requirement that pharmacies that dispense the drug be specially certified.
Ultimately, women will be able to obtain abortion drugs through the mail without important medical oversight to keep them safe.
Writing to the abortion advocacy group that had sued over the REMS, the FDA said it was eliminating the in-person requirement "to minimize the burden on the healthcare delivery system" and "to ensure that the benefits of the drug outweigh the risks."
This explanation fails to address the issue of safety for women with chemical abortion pills, said Heartbeat International President Jor-El Godsey.
"To “minimize the burden on the healthcare delivery system…” the FDA is willing to permanently subject women to the whims of Big Abortion instead of good healthcare," Godsey said. "They care more for the system than for women."
Dr. Brent Boles, medical director for the Abortion Pill Rescue® Network (APRN), criticized the move as putting the abortion industry's priorities before the safety of women.
"The predictable decision by the FDA in the lifting of REMS restrictions on the use of mifepristone is a victory, but not for women," Boles said. "The victors are those in the abortion industry and the victims are women and their babies."
Tweet This: The predictable FDA decision to lift the mifepristone REMS restriction is a victory- but not for women - for the abortion industry
Christa Brown, director of Medical Impact for Heartbeat International, echoed the safety concerns
"Of the more than 20,000 prescription drugs approved by the FDA, there are just 74 medications deemed so dangerous to warrant a REMS restriction and one of these was mifepristone," Brown said. "The REMS restriction was one last safety barriers in place of a process that’s been shown to be four times more dangerous than surgical abortion."
"The REMS restriction for mifepristone was intended to minimize the significant risk of hemorrhage, retained fetal tissue, and infection – symptoms that can quickly become life-threatening for women," said Brown. "This requirement was not restrictive – it was protective. Sadly, the FDA has chosen to ignore the thousands of women in need of emergency care who were damaged by chemical abortion and has caved to the pressures of ACOG, World Health Organization, the American Medical Association and Big Abortion."
Chemical abortion, also known as medical abortion, medication abortion, “the abortion pill,” RU-486, or mifepristone/Mifeprex, is a two-drug regimen legal up to 70 days (10 weeks) in the U.S., but which sometimes is prescribed even later into pregnancy. The first drug blocks the natural hormone progesterone, starving the developing baby of nutrients, while the second drug, taken a day or so later, induces labor to expel the deceased baby from the womb.
There are numerous possible complications associated with chemical abortion - including an incomplete abortion, potentially resulting in the need for a follow-up surgical abortion - heavy and prolonged bleeding, infection, fever and digestive system discomfort. Numerous additional negative side effects have also been reported.
In April the Biden FDA announced that during the declared COVID-19 public health emergency, it would no longer enforce the in-person doctor visit requirement. Abortion activists had been pushing for a relaxing of the REMS and using the pandemic as the reason.
According to national pro-life group Susan B. Anthony List, Ohio, Oklahoma, Montana, Indiana, Arkansas, Arizona and Texas have enacted state-level safeguards against mail-order abortion drugs, and at least seven other states are expected to enact protections in the new year.
SBA List State Policy Director Sue Liebel also condemned the move to eliminate the REMS safeguard.
“The Biden administration’s reckless move puts countless women and unborn children in danger," Liebel said. "Abortion activists’ longtime wish has been to turn every post office and pharmacy into an abortion center. They promote abortion drugs as easy, painless and private. Science says otherwise."
"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," she said. "Some women even die. Already-exhausted ER doctors and nurses will be forced to ‘clean up after’ an abortion industry that puts profits before safety and won’t regulate itself – all to please Biden’s radical base and pay back political allies."
Live Action President and founder Lila Rose offered strong reaction on Twitter.
"Despite the abortion pill killing 24 mothers and 3,700,000 children, The Biden FDA just permanently removed in-clinic dispensing requirements for abortion pills, allowing the deadly drugs to be sent by mail, prescribed by "doctors," & fulfilled by pharmacies," Rose tweeted. "Horrific."
Other pro-life leaders criticized the move as well.
"The #Biden administration continues to put women’s health in jeopardy," Priests for Life National Director Father Frank Pavone said.
"Surprise," tweeted Judicial Watch President Tom Fitton. "Extremists running @FDA push dangerous abortion-by-mail with additional authorization for at home chemical abortions."
A recent study from SBA List's research arm the Charlotte Lozier Institute found that chemical abortion is a “serious public health threat” as abortion-related ER visits had jumped over 500% in 13 years.
Another national study, written in part by CLI scholars, analyzed reported complications from chemical abortions in the U.S. over a 20-year period and found nearly 2,000 “severe” complications, more than 500 life-threatening complications, and more than 20 deaths. The study authors estimated that complications are significantly underreported.
The FDA has documented at least 4,000 cases of serious adverse events associated with the abortion pill, including more than 1,000 women who required hospitalization. As of December 31, 2018, there had been 24 reported deaths of women in the United States related to abortion pills.
In addition to keeping women safe with a medical exam, Boles said the in-person prescribing requirement also meant better screening for abuse.
"The in-person requirement also ensured that the person being given the mifepristone actually sought the service, and was not being coerced into aborting her child by an abusive partner, domineering parents, or sex traffickers and perpetrators of incest," he said. "It ensured that mifepristone was not being given covertly to women who would otherwise not have chosen abortion. These protections are now gone."
Help is available for women who have taken the first abortion pill and experience regret. The Abortion Pill Rescue® Network offers the chance to reverse the effects of the chemical abortion pill and save their children if quick action is taken. Statistics show that the safe, effective Abortion Pill Reversal (APR) protocol has saved more than 2,500 babies.
Editor's note: Heartbeat International manages the Abortion Pill Rescue® Network and Pregnancy Help News. This article has been updated with additional comment.