AHM v. FDA

AHM v. FDA Messaging Guide

Summary of the Case

In response to the 5th U.S. Circuit Court of Appeals decision today in Alliance for Hippocratic Medicine v. FDA, Susan B. Anthony Pro-Life America affirmed the Court’s finding that the FDA likely violated the law when it loosened safety standards on abortion pills and allowed them to be sent through the mail.

Four Top Messages

The FDA failed to review the safety of the abortion pill.

  • Federal data show that the rate of abortion pill-related emergency room visits is up more than 500% since Mifepristone was approved.
  • Major international studies show that the abortion pill regimen carries four times the risk of complications as surgical abortion.
  • Peer-reviewed research from the Lozier Institute found a 53% greater risk for an ER visit for abortion pill complications than after a surgical abortion.
  • Don’t just take our word for it, to learn more visit AbortionDrugFacts.com.

The FDA approved DIY abortion drugs for political reasons, jeopardizing the health and safety of women and girls.

  • The FDA fast-tracked the abortion pill regimen using its accelerated drug approval authority, designating pregnancy as an “illness.”
  • The FDA ignored its own rules, performing no focused studies on girls under 18 before approving the abortion pill for use on them.
  • In 2021, the FDA permanently eliminated the in-person dispensing requirement, allowing mail-order abortion pills without any in-person exam.
  • Through telehealth appointments it is impossible to screen for complications, such as ectopic pregnancy, which affects one in 50 women.

The FDA approved telehealth/mail-order abortions by relying on studies that used in-person medical visits.

  • The FDA approved telehealth or mail-order abortion based on studies that used physical exams, ultrasounds, and labs to screen for known risks. All forms of care that are not possible over the Internet.
  • At 63%, a majority of Americans oppose mail-order abortion.
  • The FDA has made a young woman or teenage girl the administrator of her own abortion and her home the abortion center. By eight weeks’ gestation the body of an unborn baby – her baby – delivered into a toilet would be visible and recognizably human.
  • Biden’s FDA and abortion activists seek to turn every home into a dangerous abortion center, leaving women and girls to deal with serious complications and emotional trauma themselves.

The FDA puts women and girls in grave danger by recklessly allowing mail-order abortion pills with no in-person doctor visit.

  • A majority of women who had abortions, over 60%, reported pressure to abort including from boyfriends, family or more, according to data from the Lozier Institute.
  • Without in-person medical exams, doctors can’t screen pregnant women or girls for coercion and abuse.
  • Telehealth exams can’t account for abusers who may be just out of view of the computer screen.
  • There’s only one side financially profiting off a young woman’s coerced choice and that’s “pro-choice” activists enabled by Biden’s FDA.
  • DIY abortion pills are not empowering – women describe feeling isolated, silenced and regretful.

Q&A – Answering Tough Questions

  • Major international studies show that the abortion drug regimen has four times the risks of surgical abortion. As many as one in five women will suffer a complication. Furthermore, this case does not have any impact on the legality of surgical abortion.
  • Federal Medicaid data show that the rate of ER visits related to chemical abortion has gone up more than 500% since mifepristone was approved.
  • Compared to surgical abortions, the science shows chemical abortion puts women at over 50% greater risk of an ER visit for complications within 30 days, affecting one in 20 women.
  • Three to seven out of every hundred women who have a chemical abortion early in pregnancy will need surgery to finish the abortion. As many as 15% will experience hemorrhage, and 2% will have an infection.

Judge Kacsmaryk (Kaz-MAIR-ik) made a public commitment to apply the law fairly and I am confident he understands his role. Speaking of this country, I’d like to point out that the majority of our country, 63% of Americans, oppose the mail-order of dangerous abortion drugs.

You’re referring to the “Comstock Laws” (18 USC 1461-2), which make it illegal to send abortion pills in the mail. It’s worth noting that longstanding federal law was updated under President Clinton, in the 1994 Crime Bill and the 1996 Telecommunications Act. So even while Clinton made it a priority to bring the abortion pill to market, Congress was passing and Clinton was signing laws that had the effect of strengthening federal safeguards against abortion-by-mail. 

The FDA ignoring federal law is yet another example of the agency putting politics over people. The law aligns with the majority (63%) of Americans who oppose mail-order abortion drugs. It’s clearly in the public interest. Like the plaintiffs, we’re not aware of any case that says the FDA can just pick and choose which federal laws it doesn’t want to follow. 

No. This is simply suspending FDA approval of a dangerous abortion drug that was approved through a politicized process. It never should have been approved the way it was, and a majority of Americans oppose abortion pills through the mail.

The FDA should not be taking shortcuts to appease the abortion lobby. The law mandates the FDA protect the safety of Americans, not approve dangerous drugs in a politicized process. What we need is for the FDA to stop sidestepping safety and ignoring its own rules. The FDA’s commitment should be to the American people.

This case has no impact on the availability of surgical abortion for those seeking one. In fact, the data shows complications are four times more likely after the abortion pill regimen compared to surgical abortion. The FDA should do its job to protect women and girls from life-threatening complications. Medicaid data show the rate of ER visits related to chemical abortion is up 500% since mifepristone was approved, and in 2016 the FDA stopped requiring adverse event reports for anything other than death, of which we know there have been at least 28. U.S. abortion data and maternal mortality data are so poor, those deaths are likely just the tip of the iceberg. The FDA is ignoring the science and its duty and needs to be held accountable. Moreover, it’s offensive to suggest the solution to maternal mortality is to tell women not to have babies.

This case is about the dangerous, controversial and politicized approval of chemical abortion. In every instance chemical abortion is aimed at ending the life of an unborn child. Birth control has been on the market much longer and is approved to prevent, not end, pregnancy. There is no law anywhere in the U.S. that bans birth control.

This case is not about the morning-after pill, which is a form of emergency contraception. It is about an unsafe abortion drug regimen that is now being mail-ordered to women and young teens, with no in-person doctor visit, no comprehensive collection of complications and no accountability of the FDA.

Again, this case is about mifepristone, an abortion drug that’s designed to end a human life on purpose. The abortion pill is never safe for unborn babies, and the data show it’s four times as dangerous for women as surgical abortion.

That said, it’s true the FDA hasn’t always followed science or its own rules. Here are some examples of why we shouldn’t have blind trust:

  • Look at Vioxx, which was taken off the market after 20 million Americans had used it and many died.
  • Look at the historic settlements over opioids and the Biden administration bringing back in-person doctor visits for certain medications.
  • One controversial opioid known as Zohydro ER (hydrocodone) was pulled from the market last year, almost a decade after it was first approved. 
  • And just recently, the FDA approved a pricey new Alzheimer’s drug that may not even work. An independent committee had voted against approval, and just weeks ago the FDA official responsible resigned.

It’s disturbing that the FDA has escaped accountability on abortion drugs for 20 years. Necessary corrections won’t cause the system to collapse, not when the alternative is taking unsafe drugs. No American should have to worry that the FDA is breaking its rules and putting politics over patients. Their job is to keep Americans safe, not to be pals with the pharma companies.

If the FDA had done its job properly, we wouldn’t be having this discussion today. Instead, they put politics first and ignored their own rules to fast-track these abortion drugs for approval, jeopardizing the health and safety of women and girls. Then they intentionally stopped collecting data on complications. Now they say the drug must be safe, despite clear evidence. The FDA’s “see no evil, hear no evil, report no data on evil” approach does not mean these drugs are safe. There were no focused studies on girls under the age of 18. Multiple women have died and the rate of ER visits due to these drugs is up 500% since mifepristone was approved. The FDA approved sending mail order pills based on studies that used in-person exams, ultrasounds and labs. It’s time to correct these egregious decisions of the past 20 years.

The FDA actually has been challenged about their approval of abortion drugs going all the way back to the late ‘90s, but they have ignored opposition and multiple citizen petitions for decades now while the science and data on the dangers of these drugs have piled up. Unfortunately, this is their M.O. They wield the legal system to their benefit and have kept unsafe drugs on the market for years. Accountability is long overdue.

This case ONLY has to do with mifepristone as part of a two-drug regimen for abortions, not miscarriages.  Doctors are still allowed to prescribe mifepristone or misoprostol for another medical condition, like preventing ulcers or managing a miscarriage, and their patients aren’t in trouble.

  • Ironically, the FDA is reinstating in-person visits for ADHD medications, pain medications and other drugs but not for these dangerous abortion pills. Shouldn’t a drug that kills and expels an unborn child require an in-person doctor visit?
  • This question seems to be part of an intentional effort to conflate abortion and miscarriage. Miscarriage management happens when the unborn child dies of natural causes. The abortion pill intentionally blocks the hormones needed to keep the baby alive to end his or her life and then expels him or her from the womb. Two entirely different things.

By sidestepping safety, the FDA was the one who turned a blind eye and failed communities of color. To best help vulnerable communities, we must link them with financial and physical resources. Right now, there are nearly 3,000 pregnancy centers and maternity homes across the United States that serve women and families of all races, creeds and socioeconomic backgrounds. Community-based health clinics and pregnancy centers outnumber Planned Parenthoods 14 to one and provide quality medical, material and emotional support services – typically at no cost. So while the abortion industry profits from unsafe abortion pills, life-affirming nonprofits are getting financial and physical resources into the hands of communities in need.

The pro-life movement unequivocally rejects penalizing the woman or girl who undergoes an abortion. Abortionists and chemical abortion suppliers who exploit them for profit should be the ones held accountable.

Unsafe mail-order abortion drugs under the FDA’s approval are the “chemical coat hanger” putting women and young teens at risk. Abortion activists are playing a dangerous game with the lives of women and girls. By putting the act of abortion over the needs of the woman, they have persuaded the Biden FDA to approve dangerous mail-order abortion pills. Based on Medicaid data, these pills send women to the ER at alarming rates. And now they say if mifepristone is pulled, they will push misoprostol-only abortion, downplaying documented failure rates as high as 39% and requiring surgery for approximately one in four women (22%) who use it for abortion.

The FDA’s job is to protect all Americans by ensuring that our drugs and our food are safe. Their mission statement promises to help us “get accurate, science-based information” to make informed decisions about our health care. With mail-order abortion drugs, they’ve failed to do that and they must be held accountable.

The contrast is clear: Democrats want to mandate abortion on demand up to birth for any reason across the country requiring less safety controls for mail-order abortion drugs and Republicans stand with young women and girls advocating for better healthcare and safety.

If the FDA did its job by looking at the available data, conducting focus studies on minors and charting drug side effects (other than death) it would see that mifepristone is not safe.

Abortion Pill Reversal (APR) uses the natural hormone progesterone to reverse the effects of mifepristone when a woman changes her mind after starting the chemical abortion process. Progesterone has been used safely to support healthy pregnancies since the 1950s – it is commonly used today to reduce the risk of premature birth and multiple miscarriages. Pro-abortion researchers with a vested interest have tried to discredit APR, but even their biased studies demonstrate that it works. One doctor from the Yale School of Medicine even told the New York Times it “makes biological sense” and he would recommend it for his own daughter.

APR offers a second chance at choice and is credited with saving at least 4,000 babies in the last decade. Women deserve to know that safe, effective treatment exists that could save their child if quick action is taken.

This statistic created by abortion advocates has been thoroughly debunked and doesn’t even make logical sense. Abortion is a violent act that kills the unborn child and harms the mother. In Scandinavian countries with far more accurate and complete data on pregnancy outcomes, including abortion and childbirth, study after study shows that a woman is almost four times more likely to die from abortion than childbirth.

In America, medical care is so advanced that even in high-risk pregnancies, it’s rare not to have a safe delivery of a healthy baby alongside a healthy mother. Meanwhile abortion on demand is so unpopular, the abortion lobby has to use fear to sell its agenda. The FDA did their bidding by redefining pregnancy as an illness to fast-track approval of the abortion pill. Pregnancy isn’t a disease and abortion isn’t health care.

We’re talking about the federal government. The length of time indicates nothing about the quality of the work. We know that during those four years the FDA was not doing focused studies on how the drug affects minors, like they are required to do. They were finding an excuse to misuse the accelerated approval process by calling pregnancy a “life-threatening illness.” This is politics at its worst.

  • Every year dozens of FDA-approved products have some kind of status change – just search “FDA drug recalls.” The idea that agency decisions are set in stone and no one can ever question them is not just inaccurate but undemocratic, and in the case of mail-order abortion pills it’s downright dangerous.
  • Both sides of the aisle have challenged FDA decisions. It was a Massachusetts Democrat Governor who sued to block Zohydro (an opioid) in Massachusetts due to concerns about abuse. The FDA left it on the market for almost a decade before it was finally pulled for not being safe.
  • Not many drug companies only sell one product that ends a human life by design. But the drug manufacturer for mifepristone – that’s all they do, one drug. Do you really think a company that banks all its revenue on one drug will regulate itself? No! They’re too busy protecting their profits from their one money maker.

The FDA is an unelected bureaucracy. Where else would the checks and balances be when they ignore the lawmaking branch? It’s appropriate for the courts to remind them that they’re required to follow existing laws. What’s hypocritical is pro-abortion Democrats continually using the courts to impose partisan policy agendas and fight tooth and nail against the will of the people who want commonsense protections for women and babies.

The majority of Americans don’t trust the FDA or believe their claims that mail-order abortion pills are safe. Accountability has to be the first step toward repairing the damage to the public’s trust.

The FDA ignored the law and their own policies again and again – first when they fast-tracked approval of the abortion pill by designating pregnancy as an “illness,” second when they failed to conduct any focused studies on minors, third using COVID-19 as the reason, they did away with the need for medical visits, ultrasounds and lab work and just started letting pills be shipped straight to people’s homes (sometimes without parental notification or consent). All of these add up to an elimination of crucial safety guardrails.

It’s not the first time the FDA has failed at due diligence and been too cozy with drug makers – just look at the many opioid scandals. It’s time to start holding them accountable and repairing the public’s broken trust. “Agency deference” can’t be a license to ignore Congress and other actual lawmakers. For the safety of Americans, the FDA can’t just be let off the hook for violating the law.

Most doctors want to help their patients heal and live healthy lives, not end their lives. Around 90% of OB-GYNs don’t perform elective abortions. For them nothing changes about the way they practice, except that we hope fewer women will suffer emergencies from complications of abortion pills, like bleeding, infection and the need for surgery.

What would help recruit new students is not kicking OB-GYNs who represent the majority out of major educational conferences. We need more inclusion – prospective medical students deserve to hear their fact- and science-based perspective.

Let’s see them. The New York Times hasn’t been transparent. They didn’t publish the list and haven’t provided it to independent researchers even after repeated request. If they stand behind their journalism, then release the study names.

The little information they did publish shows a heavy pro-abortion bias. Most of their “experts” have financial ties to abortion pill manufacturers and some are abortionists themselves. They even went to Planned Parenthood to double check their work. In contrast, a major U.S. study of over 400,000 confirmed abortions used 17 years of paid Medicaid claims records – not voluntary surveys cherry-picked by the abortion industry – and found the rate of abortion pill-related ER visits spiked 500%. Analysis shows that when women show up in ERs after taking abortion pills, their complications are miscoded as a miscarriage over 60% of the time, and this puts them at twice the risk of being admitted for surgery.

Abortion advocates are exaggerating. Around 90% of OB-GYNs don’t perform elective abortions yet they are still able to care for women experiencing a miscarriage. Mifepristone (the abortion pill) is rarely used for miscarriage management because it requires a special certification that most OB-GYNs don’t have. All OB-GYNs have several effective options available for miscarriage management that don’t depend on the availability of this one abortion drug – which carries a “Black Box” warning, the strongest possible safety warning. The bottom line is, regardless of what happens with the abortion pill, women will still receive appropriate and safe miscarriage care.

Pro-abortion groups like ACOG just petitioned the FDA to change the label and add miscarriage management in October, four months after Dobbs. Ask them what took them so long.

Polling

75% agree (52% strongly agree) that the FDA should have performed studies focused on girls under the age of 18 before approving the abortion pill for minors. 

62% feel not very confident (26%) or not at all confident (35%) in the claim that the abortion pill is safe after being on the market for two decades, when they know that the FDA tracks no side effects other than death. 

61% disagree that it is safe to distribute abortion pills through the mail with little to no supervision (41% strongly disagree), in light of the increased risk to women of coercion and abuse. 

56% consider the FDA untrustworthy (31% very untrustworthy) when they learn that the FDA fast-tracked the abortion pill regimen using its accelerated drug approval authority by calling pregnancy a “life-threatening illness. 

By a double-digit margin (51%-39%), Americans disagree that the abortion pill has been vetted carefully enough to protect women’s health and safety, based on what they know about the FDA (10% were unsure or did not respond). 

Background Information

Abortion Lobby Fights Dobbs with “Mail Order Abortion”

The Abortion Lobby views chemical abortion as the future of their industry because it is cost-effective for them and hard to regulate. In the Dobbs era, they are fighting back by creating the Amazon of Abortion, making chemical abortion pills available through the mail, and turning pharmacies and post offices into abortion dispensers.

19 States Have Already Taken Action to Stop the Distribution of Dangerous Mail-Order Abortion Drugs

18 states have already acted to stop the distribution of dangerous chemical abortion drugs by mail, and litigation is pending in three others to protect women from mail-order abortion pills.

19

Alabama, Arkansas, Arizona, Florida, Indiana, Kansas, Kentucky, Louisiana, Mississippi, Missouri, Nebraska, North Carolina, North Dakota, Oklahoma, South Carolina, Tennessee, Texas, West Virginia, and Wisconsin

3

Ohio, Montana, and South Dakota

What is the FDA’s Risk Evaluation Mitigation Strategy (REMS)?

Mifepristone is a dangerous drug, and ever since it was first approved, it has had safety restrictions which became formalized as a Risk Evaluation Mitigation Strategy (REMS), an FDA protocol for drugs with serious potential risks, requiring physicians to dispense the drug directly to the patient.

However, the abortion lobby steadily has worked to undermine these protections. In 2021, they used the COVID-19 pandemic as an excuse to roll back a key portion of the REMS – the requirement that abortion facilities administer drugs in person. Now, abortion pills are available through the mail and in any pharmacies that choose to participate after FDA certification.

As a result, women and girls can now go online and order dangerous drugs that have potentially extreme risks of infection and hemorrhage, without ever being examined by a physician. They are left to take these drugs at home in isolation, without medical care, and will deliver their tiny, unborn child all alone. Women are in danger of significant harm or even death:

  • Failure to screen for ectopic pregnancy can put women’s lives at risk.
  • Many women don’t accurately date their pregnancies, and with no physical exam or ultrasound can accidentally take drugs too late in pregnancy, when they are even more dangerous.
  • There is no oversight of where abortion pills end up, making them the perfect tool for traffickers and abusers.
  • As many as 15% of women undergoing chemical abortion suffer hemorrhage.
  • One in 50 will have an infection.

These risks increase as pregnancy advances. Pro-life laws on the state and federal level are no longer adequate to save women’s lives. Abortion restriction laws, parental consent laws, informed consent laws and more will be circumvented by the ability of anyone to order abortion drugs from anywhere for any reason.

AHM v. FDA could be the most significant pro-life battle since Dobbs. For in-depth resources, visit AbortionDrugFacts.com and LozierInstitute.org.

Social Media

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Doctors have sued the FDA for illegally approving the chemical abortion drug regimen & failing to meet its legal obligation to protect girls & women.

It is clear that the FDA has put politics over the health and safety of women.


Did you know that to approve the abortion pill regimen with its accelerated drug approval authority, the FDA classified pregnancy as an “illness” and the abortion pills as a treatment?

Pregnancy is not an illness. Death is not a treatment.


The FDA has been challenged about their approval of abortion drugs going all the way back to the late ‘90s, but they have ignored opposition & citizen petitions for decades now while the data on the dangers of these drugs has piled up.

Accountability is long overdue.


If the FDA did its job by looking at the available data, conducting focus studies on minors and charting drug side effects (other than death) it would see that mifepristone is not safe.

Learn more  ➡️ https://lozierinstitute.org/abortion-drug-facts/


How dangerous is the abortion pill regimen?

Federal data show that the rate of chemical abortion related emergency room visits is up more than 500% since Mifepristone was approved.

Post last modified: August 21, 2023