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FDA Rule On Chemical Abortion Drugs Challenged in Court

Attorneys general of 23 states have filed two amicus briefs in support of a lawsuit seeking the withdrawal of FDA approval of the drugs mifepristone (RU-486) and misoprostol for use in chemical abortions. Unfortunately, Illinois Attorney General Kwame Raoul is not one of them. Success in this suit could make chemical abortion illegal even in states where abortion access remains legal.

Our friends at Alliance Defending Freedom filed the original suit in November 2022 and represent over 30,000 medical professionals from four national medical associations, and several more independent doctors. ADF argues that because the FDA has never tested the drug on the pediatric population, there is no science backing its safety for use in young women.

Dr. Christina Francis, the CEO-Elect of the American Association of Pro-Life Obstetricians and Gynecologists and a party in the suit, stated in an interview that Mifepristone is not only untested, but dangerous. She reports that 1 in 5 women have serious complications following chemical abortions including hemorrhage, life-threatening infection and fertility issues.

The AGs Arguments Against Mifepristone

In their brief, the attorneys general argue in part that the FDA’s approval of mifepristone for abortion has two legal flaws. The first is that it defies the agency’s own regulations since the section the FDA first approved the drug under, Subpart H, “does not permit the agency to greenlight elective abortions on a wide scale.”

The second is that allowing abortion medication to be sent via the mail is in direct contrast to a federal law that prohibits “using the mail to send or receive abortion-inducing drugs such as mifepristone.” They go on to state, “The FDA and the Administration as a whole have no intention to respect the Constitution, the Supreme Court, or the democratic process when it comes to abortion.”

The lawsuit is asking the court to revoke the FDA’s approval of mifepristone completely. If this does not happen, they are asking that laws and regulations be followed at all stages in regard to reviewing, approving, prescribing, dispensing, and administering chemical abortion drugs. If the judge doesn’t rule against mifepristone entirely, the lawsuit asks that current laws and regulations be followed in regard to these chemicals.

Where The Case Stands

The State of Missouri filed its own brief on Friday, February 10th, while Mississippi Attorney General Lynn Fitch filed a brief on behalf of her state as well as Alabama, Alaska, Arkansas, Florida, Georgia, Idaho, Indiana, Iowa, Kansas, Kentucky, Louisiana, Montana, Nebraska, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, and Wyoming.

The U.S. Justice Department argued in its court filing this lawsuit “is extraordinary and unprecedented.” The United States District Court for the Northern District of Texas will hear the case first.  After this, an appeal would likely go to the 5th U.S. Circuit Court of Appeals, and if a ruling in that court were to be appealed, it could go to the U.S. Supreme Court.

Here in Illinois

Illinois Attorney General Kwame Raoul has made it clear that his office will not support efforts to restrict abortion or abortion-inducing drugs in our state.

Based on data from 2020 when there were 46,243 abortions reported in the state, and according to the Illinois Right to Life, “1,180 abortions were performed on minors and 88 were performed on girls younger than 15 years-old.”

Planned Parenthood’s own Guttmacher Institute released a report admitting that chemical abortions accounted for the majority of all abortions in the U.S.. According to this report, in 2020, abortion pills accounted for 54 percent of all U.S. abortions, an increase from 44 percent in 2019.

The Charlotte Lozier Institute reports that the percentage of chemical abortions in Illinois as of 2020 was 19.2 percent and trending higher. If this lawsuit results in the revocation of the approval of mifepristone, many lives will be saved. (20 percent of 46k abortions is 9,200.)





Death Coming Soon to A Pharmacy Near You

As of early January 2023, Danco Laboratories, the U.S. manufacturer of the abortion pill, announced that the FDA has made changes to its guidelines surrounding the abortion pill. These changes allow pharmacies, from large chains like CVS or Walgreens to small, locally owned businesses, to dispense the pill to anyone with a prescription.

Many women choose the abortion pill (also known as a chemical abortion) because they assume it’s safer and more natural. However, complications occur during chemical abortion four times more frequently than during surgical abortion. According to Dr. Christina Francis, “approximately one in five women will experience a significant complication,” which often must be treated by emergency surgery.

The abortion pill is actually a two-pill regimen made up of different drugs:  Mifepristone, also known as Mifeprex or RU-486, and Misoprostol. When a woman chooses to abort her pre-born baby through a chemical abortion, she first takes Mifeprex. This blocks progesterone, starving the pre-born baby of the nutrients needed to continue developing. One to two days later, she takes Misoprostol, which causes her to deliver her now-dead baby. This part frequently happens in the woman’s own home, so she is responsible for disposing of her pre-born baby’s body, often by flushing it down a toilet.

Unsurprisingly, this causes significant trauma for the woman involved in an abortion. Aside from the moral harm it does to her conscience, seeing her dead child covered in blood and floating in the toilet, often awakens her to the reality of what just happened, causing insurmountable emotional problems she will struggle with for years.

But the emotional trauma resulting from the use of the abortion pill isn’t why it was under guidelines that prevented it from being sold in retail pharmacies. Mifeprex, the first drug in the regimen, is dangerous enough that the FDA gave it REMS status. REMS stands for Risk Evaluation and Mitigation Strategy, which is described by the FDA as, “a drug safety program that the U.S. Food and Drug Administration (FDA) can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication… REMS focus on preventing, monitoring and/or managing a specific serious risk by informing, educating and/or reinforcing actions to reduce the frequency and/or severity of the event.”

Mifeprex is often dangerous. A few of the possible side effects include:

Under the previous REMS guidelines for Mifeprex, women could only receive the pill in person at approved clinics or hospitals that could provide certain medical and safety procedures. But as of January 3rd, 2023, the guidelines have been amended by the FDA so that retail pharmacies who “become certified in the Mifepristone REMS Program” can dispense this highly dangerous pill to anyone with a prescription.

Women in hopeless situations, who believe the lie that the abortion pill is a safe and effective way to deal with a difficult circumstance, are unwittingly walking into a deadly situation. These women desperately need Jesus. This world desperately needs Jesus. The culture of death is so insatiable in its thirst for blood that it’s willing to bypass any concern for human life, and any idea of the sacredness of human life, solely to make death easier, more accessible, and more desirable.

Read more:

Four Doctors Groups Tell Federal Court to Pull Abortion Pill From Market, It’s Dangerous for Women (LifeNews.com)





Is Abortion More Important than Safety? The Case Now Before the U.S. Supreme Court

In 1986, Missouri became the first state to pass an abortion law requiring abortion doctors to have admitting privileges at a hospital “in the community” to ensure the health and safety of women undergoing abortion.

Later, I was horrified to find out that a doctor was doing abortions just a few miles from my home in St. Louis. It turned out that his admitting privileges were in another country! The abortion clinic was closed.

As I wrote last August in “Pro-abortion Desperation in Missouri” :

“the last abortion clinic in Missouri lost its license because of numerous health and safety violations. The Planned Parenthood abortion clinic continues to operate only because of several temporary injunctions by a judge.”

While the Missouri case is still ongoing, now the U.S. Supreme Court is considering the June Medical Services v. Russo case concerning whether Louisiana’s law requiring abortion providers to have admitting privileges at a local hospital conflicts with the Court’s 2016 Whole Woman’s Health v. Hellerstedt decision along with a second issue about “whether abortion providers can legally represent the interests of women seeking an abortion when those providers sue to overthrow laws protecting those women’s health and safety.”

IS ABORTION MORE IMPORTANT THAN SAFETY?

In a powerful commentary titled “The OB-GYNs Who Play Politics With Women’s Lives-Abortion is more important than safety to the American College of Obstetricians and Gynecologists” in the March 3, 2020 Wall Street Journal, Dr. Christina Francis calls out the American College of Obstetricians and Gynecologists (ACOG) for “offering a medically unsound recommendation in the furtherance of its extreme position on abortion”.

Dr. Francis, a board-certified obstetrician-gynecologist and the chairman of the board of the American Association of Prolife OB/GYNS, refutes ACOG’s friend of the court brief arguing that the admitting privileges requirement for abortionists is not “‘medically justified’ and therefore constitutes an ‘undue burden’ on a woman’s right to abortion’” by stating:

“Yet every second counts in an obstetric emergency. A pregnant woman experiencing severe uterine hemorrhage can bleed to death in as little as 10 minutes. That’s why its essential that anyone performing an abortion have the ability to admit a patient to a nearby hospital—preferably one closer than 30 miles away.”

ACOG routinely puts politics ahead of medicine by adopting the most extreme positions on abortion. It has lobbied and briefed against parental notification of minors and informed-consent laws, and in favor of taxpayer-funded abortion. It has advocated for laws restricting speech around clinics and compelling pro-life pregnancy centers to tell women where they can go to obtain state-subsidized abortions. ACOG’s work has gotten so political that in 2008 it added a lobbying arm. I was refused when I asked if I could direct our dues only to the organization’s nonlobbying arm.

Eighty-six percent of OB-GYNs don’t perform abortions, but ACOG’s position is that you either support the most extreme abortion lobbying or you’re off the island. Most of ACOG’s abortion advocacy is undertaken free of consultation with its almost 60,000 members. Physicians who’ve left the organization, like me, support its general work but don’t want to support abortion lobbying, especially when it comes to watering down or eliminating safety standards(Emphasis added)

Dr. Ford also notes that:

“In any practice area other than abortion, a doctor performing an operation would have hospital-admitting privileges. In the case of complications that doctor would, at a minimum, call ahead to fast-track the patient to the appropriate emergency care. Abortion-clinic patients, on the other hand, are frequently kicked to the curb and told to make their own way to the emergency room.”

CONCLUSION

Those of us in Missouri have seen the problems and attempted coverups at the hopefully last Planned Parenthood clinic in St. Louis.  Just last year, it was reported that:

“Operation Rescue, with the help of Missouri pro-life activists, has documented 74 medical emergencies that have occurred at RHS Planned Parenthood in the past ten years, including three emergencies that required ambulance transport for women to a local hospital within a 22-day period ending on May 15, 2019.” (Emphasis added)

The U.S. Supreme Court decision is not expected until June and is likely to have an enormous impact on the state of abortion in our country, especially since pro-abortion groups have now abandoned the old rhetoric about keeping abortion “safe, legal and rare’” in favor of tax-payer funded abortion on demand up to birth and even leaving babies to die after failed abortions.

In the meantime, considering choosing and supporting pro-life health care professionals and their professional organizations such as the American Association of Pro-life Obstetricians and Gynecologists (AAPLOG) and the National Association of Pro-life Nurses (NAPN).


This article was originally published at NancyValko.com.