The Biden administration has permanently reversed a long-standing federal safety protocol requiring that abortion-safe chemical 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 requires that abortion drugs be prescribed only by a certified healthcare provider and dispensed in a clinic, hospital or a doctor’s office. . An in-person examination by a doctor is necessary to correctly determine the gestation of a woman’s pregnancy and to also screen for an ectopic pregnancy, as well as other conditions – all important factors in ensuring a 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 establishments, in particular clinics, doctors’ surgeries and hospitals ,” from the Biden administration’s announcement on Thursday. The FDA adds a requirement that pharmacies dispensing the drug must be specially certified.
Ultimately, women will be able to get abortion drugs through the mail without significant medical oversight to ensure their safety.
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Writing to the abortion advocacy group that sued REMS, the FDA said it was eliminating the in-person requirement “to minimize the burden on the health care delivery system” and “to ensure that the benefits of the drug outweigh the risks”.
This explanation does not answer the question of the safety of women using chemical abortion pills, said Heartbeat International President Jor-El Godsey.
“To ‘minimize the burden on the health care delivery system…’, the FDA is prepared to permanently subject women to the vagaries of Big Abortion instead of good health care,” Godsey said. “They care more about the system than women.”
Dr. Brent Boles, medical director of the Abortion Pill Rescue® Network (APRN), criticized the move as putting the priorities of the abortion industry ahead of women’s safety.
“The FDA’s predictable decision to lift REMS restrictions on the use of mifepristone is a victory, but not for women,” Boles said. “The victors are those of the abortion industry and the victims are the women and their babies.”
Tweet this: FDA’s predictable move to lift REMS restriction on mifepristone is a win — but not for women — for the abortion industry
Christa Brown, director of Medical Impact for Heartbeat International, echoed safety concerns
“Of the more than 20,000 prescription drugs approved by the FDA, there are only 74 drugs deemed so dangerous to warrant REMS restriction and one of them was mifepristone,” Brown said. “The REMS restriction was a final safety barrier in place of a process that was found 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,” Brown said. “This requirement was not restrictive – it was protective. Unfortunately, the FDA chose to ignore the thousands of women in need of emergency care who were damaged by chemical abortion and bowed to pressure from ACOG , the World Health Organization, the American Medical Association and major abortion.”
Chemical abortion, also known as medical abortion, medical abortion, “the abortion pill”, RU-486, or mifepristone/Mifeprex, is a two-drug regimen legal for up to 70 days (10 weeks) in the United States, but which is sometimes prescribed even later in pregnancy. The first drug blocks the natural hormone progesterone, depriving the developing baby of nutrients, while the second drug, taken a day or two later, induces labor to expel the dead baby from the womb.
There are many possible complications associated to chemical abortion – including a incomplete abortionpotentially leading to The need to a followed surgical abortion – heavy and prolonged bleeding, infection, fever and discomfort in the digestive system. Many additional negative side effects have also been reported.
Often presented as “at home”, “self-directed” or “do-it-yourself” abortion, chemical abortion often means that when complications occur, the woman is largely left to care for them at homepotentially alone.
In April the Biden FDA announced that during the declared COVID-19 public health emergency, it would no longer enforce the in-person medical visit requirement. Abortion activists had pushed for a relaxation of REMS and used the pandemic as the reason.
According to the national pro-life group Susan B. Anthony List, Ohio, Oklahoma, Montana, Indiana, Arkansas, Arizona and Texas have adopted state-level safeguards against mail-order abortifacients, and at least seven other states are expected to enact protections. in the new year.
SBA List Director of State Policy Sue Liebel also condemned the decision to eliminate the REMS backup.
“The Biden administration’s reckless decision puts countless women and unborn children at risk,” Liebel said. “The long-standing wish of abortion activists is 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 at much higher risk for serious complications and more likely to require an emergency room visit,” she said. “Some women are even dying. 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 the Biden’s radical base and reimbursing political allies.”
The president and founder of Live Action, Lila Rose, reacted strongly on Twitter.
“Although the abortion pill kills 24 mothers and 3,700,000 children, the Biden FDA has just permanently removed in-clinic distribution requirements for abortion pills, allowing deadly drugs to be mailed, prescribed by “doctors “and filled by pharmacies,” Rose tweeted. “Horrible.”
Other pro-life leaders also criticized the decision.
“The #Biden administration continues to put women’s health at risk,” said Father Frank Pavone, National Director of Priests for Life noted.
“Surprise,” tweeted Judicial Watch President Tom Fitton. “Extremists who run @FDA pushing unsafe abortion through the mail with additional clearance for chemical home abortions.”
A recent study from SBA List’s research arm, the Charlotte Lozier Institute, found that chemical abortion is a “serious threat to public health” as abortion-related ER visits jumped more than 500% in 13 years.
another national to study, written in part by CLI academics, analyzed reported complications of chemical abortions in the United States over a 20-year period and found nearly 2,000 “serious” complications, more than 500 life-threatening complications, and more than 20 deaths. The study authors felt 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 deaths reported of women in the United States linked to abortion pills.
In addition to keeping women safe through medical screening, Boles said the in-person prescription requirement also meant better screening for abuse.
“The in-person requirement also ensured that the person receiving the mifepristone was genuinely seeking the service and was not coerced into aborting their child by an abusive partner, overbearing parents, or sex traffickers and incest perpetrators,” said he declared. “This ensured that mifepristone was not secretly administered to women who otherwise would not have chosen abortion. Those protections are now gone.”
Help is available for women who have taken the first abortion pill and have regrets. the Abortion Pill Rescue® Network offers the possibility of reversing the effects of the chemical abortion pill and saving their children if prompt action is taken. Statistics show that the Abortion Pill Reversal (APR) protocol is safe and effective saved more than 2,500 babies.
Editor’s note: Heartbeat International operates the Abortion Pill Rescue® Network and Pregnancy Help News. This article has been updated with an additional comment.