Last week, the FDA implemented changes that allow Mifepristone, also known as RU-486, to be dispensed by regular pharmacies, a change from the requirement that the drugs be dispensed by a doctor after an in-person visit that has been in place since the drug was approved for chemical abortions in 2000 under the Clinton administration.
During the second special session in 2021, the Texas Legislature passed Senate Bill (SB) 4 by Sen. Eddie Lucio Jr. (D-Brownsville), which states that only a physician may dispense the abortion drug after examining the woman in person, verifying her pregnancy is less than 49 days gestation, and obtaining her informed consent.
Informed consent includes an ultrasound and probable gestation age of the preborn child, a 24-hour waiting period, and information about the medical risks and assistance available to the woman.
“The action taken by the FDA is discouraging, but not surprising,” Texas Right to Life’s Legislative Director Rebecca Parma told The Texan. “We are thankful that the Texas Legislature had the foresight to put protections in place to make sure preborn children are protected in Texas.”
She described the Texas laws as “layers of protection.”
If a person violates SB 4, they are subject to a state jail felony. The woman obtaining the abortion is not criminally liable.
If a chemical abortion were to take place after the detectable heartbeat, a civil action could be brought under the Texas Heartbeat Act (SB 8).
The drug falls under the Risk Evaluation and Mitigation Strategy (REMS) of the FDA, a drug safety program “for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks.”
According to the Charlotte Lozier Institute, a pro-life research organization, chemical abortions have four times the rate of complications for women as surgical abortion. “As many as one out of five women will suffer a complication,” its fact sheet states.
Under the revised REMS for Mifepristone, the drug “must be dispensed by or under the supervision of a certified prescriber or by certified pharmacies for prescriptions issued by certified prescriber in-person or by mail.”
In 2020, during the COVID-19 pandemic, “emergency measures” were in place that allowed the drug to be dispensed via a telemedicine appointment and sent through the mail. Now, those measures have been adopted as standard by the FDA.
The drugs will be even more accessible, widely used, and possibly abused, Parma explained, because instead of only being dispensed by a doctor after an in-person visit, it can be filled by local pharmacies like CVS and Walgreens, who have announced they plan to dispense the drug.
Removing the more restrictive dispensing requirements could allow chemical abortions to be prescribed without knowing whether the abortion is sought voluntarily or under duress or whether the patient is under the legal age, Parma emphasized.
However, pharmacies in Texas are not permitted to carry the drugs and fill prescriptions for the purpose of ending a pregnancy, Texas Right to Life pointed out in a press release.
As an added layer of protection for women and their unborn children, Texas prohibits telehealth abortion providers in the Texas Occupations Code.
Drugs inducing chemical abortions are approved by the FDA for use through 10 weeks gestation.
But SB 4, passed before the Dobbs v. Jackson Women’s Health Organization decision reversing Roe v. Wade, removed any references to the FDA and limited chemical abortion drugs to seven weeks gestation.
The Texas ”trigger ban” and pre-Roe laws ban abortion entirely except for procedures done to save the mother from death or substantial bodily impairment. They carry criminal and administrative penalties for any abortions that take place in Texas.
If a chemical abortion were to take place after the detectable heartbeat, usually at six weeks, a civil action could be brought under the Texas Heartbeat Act.
The Alliance Defending Freedom (ADF), a conservative legal defense fund, has brought an action on behalf of doctors and doctor associations in the U.S. District Court for the Northern District of Texas in Amarillo. The lawsuit seeks to set aside and vacate the “FDA’s actions to approve chemical abortion drugs.”
The plaintiffs argue in the suit that the FDA never had the authority to approve the chemical abortion drugs because they were given “accelerated approval” as drugs meant to treat “life-threatening illnesses” and provide “meaningful therapeutic benefit,” characterizations of the drug disputed in the filing.
It goes on to claim the “agency has also eliminated the few safeguards it initially established to protect women and girls who go through the chemical abortion drug regimen.”
The suit also points out that federal law prohibits the delivery of chemical abortion drugs.
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Kim Roberts is a regional reporter for the Texan in the DFW metroplex area where she has lived for over twenty years. She has a Juris Doctor from Baylor University Law School and a Bachelor's in government from Angelo State University. In her free time, Kim home schools her daughter and coaches high school extemporaneous speaking and apologetics. She has been happily married to her husband for 23 years, has three wonderful children, and two dogs.