Explainer: FDA's Dangerous Chemical Abortion Drug Expansion
Explainer: FDA's Dangerous Chemical Abortion Drug Expansion
What did the FDA just do?
When the FDA first approved chemical abortion in 2000, it required safety standards for prescribing because of the inherent risks of serious complications for the mother. One of these safeguards is called “in-person dispensing,” meaning that a certified provider who is qualified to counsel patients and treat complications must physically hand the medications to the patient after screening her to prevent unauthorized use. This ensures that the physician sees the patient and provides an adequate screening prior to prescribing the drug. These protections were weakened under the Obama administration, and again after Joe Biden took office. In 2021, at the request of the abortion industry, the FDA loosened its requirements on in-person dispensing, allowing certified providers to send abortion drugs through the mail.
On January 3, 2023, the FDA made this change formal, meaning that now abortion drugs can be prescribed over the phone or online and sent through the mail across the country—or even from overseas—without the pregnant woman ever being seen by a physician in-person. Further, for the first time, they can now be dispensed at certified brick-and-mortar pharmacies without the pregnant woman ever being seen in-person by a physician.
What is chemical abortion?
Chemical abortion, sometimes called “the abortion pill,” is a two-drug regimen approved by the U.S. Food and Drug Administration (FDA) to cause an abortion during the first 70 days, or 10 weeks, of pregnancy. First, mifepristone blocks progesterone, the natural hormone which helps maintain a healthy pregnancy. A day or two later, misoprostol induces labor to expel the baby from the womb.
How common is chemical abortion?
Chemical abortion is now the most common method of abortion in the United States, comprising over 54% of all abortions in 2020. Unfortunately, this number is expected to climb as the abortion industry promotes “pills by mail” to avoid common-sense protections like medical screening, informed consent, and parental involvement for minors. And now because of the FDA’s most recent actions, these dangerous chemical abortion drugs will be available at neighborhood pharmacies unless state regulators intervene.
Is chemical abortion safe?
No, in fact chemical abortion is extremely dangerous. Chemical abortion is four times more likely than surgical abortion to result in complications, including hemorrhage, infection, and even death. A recent peer-reviewed analysis of state Medicaid data led by CLI scholars found that since FDA approval, there has been a 500% increase in the rate of emergency room visits following chemical abortions and that the risk of multiple hospitalizations is greater if the abortion is miscoded as a natural miscarriage, which is increasingly common as the abortion industry tells patients to “avoid mentioning abortion” in the ER—putting their interests ahead of women’s health.
Analyses of adverse event data, collected by the FDA, show that the abortion pill has resulted in more than 20 deaths and thousands of serious complications. Comparisons with Planned Parenthood complications data reveal that FDA’s data is sorely lacking, and researchers estimate that the FDA data is missing as much as 95% of all serious adverse events. Despite these data flaws, the FDA changed its regulations in 2016 to no longer require abortion pill prescribers to report most complications – now, only deaths are reported. The FDA then used this meaningless data to claim that the abortion pill is “safe.”
Why does “in-person dispensing” matter?
In-person dispensing is necessary to screen a woman for medical contraindications, such as taking certain medications, which mean that she is not a good candidate for the drugs. It is also the only way to ensure that she is not being coerced, abused, or trafficked, which cannot be determined on a video call because the abuser may be nearby. In-person screening means the patient can receive an ultrasound, which is medically necessary to make sure the pregnancy is not ectopic (which requires immediate treatment and is made more dangerous by chemical abortion drugs) and that she is still within the 70-day gestational window, after which complications significantly increase. That ultrasound also gives her a chance to see her baby and recognize his or her humanity, a feature of informed consent.
In-person dispensing prevents drugs from being slipped to someone else by an abuser, and it creates the opportunity for a woman to be offered alternatives and receive help. Remove the sidewalk, remove the sidewalk counselor. Remove the clinic, remove legal liability for medical malpractice. That is why the abortion industry has worked so hard to eliminate an in-person doctor visit.
How can we fight back?
In the States: Many states have already enacted their own protections to ensure that women receive medical screenings, give informed consent, and can access follow up care and additional resources for parenting, adoption, or post-abortive counseling. Twenty-one states explicitly prohibit “telemed” abortions. These safeguards are critical in states that still permit legal abortion. Beyond this, states can end chemical abortion by passing laws that protect unborn children throughout pregnancy and then strongly enforcing these laws. States must act boldly to ensure that they protect women and babies even if federal agencies will not. SBA Pro-Life America has been sounding the alarm on chemical abortion for years and continues to work with state lawmakers to enact the strongest safeguards possible.
In Congress: The newly-elected House GOP majority must exercise their oversight authority, demanding answers about the politicization of chemical abortion regulations and what the FDA and Postal Service are doing, in order to stop illegal pill distribution. Pro-life senators should block executive branch nominees who support the Biden administration’s abortion-on-demand agenda.
In Our Communities: Learn more about this critical issue at abortiondrugfacts.com and about abortion in your state at lozierinstitute.org/state-abortion-reporting. Then share this information with your family and friends and tell your local lawmakers that you oppose dangerous pills by mail and demand safeguards for women and girls.