TDD #17: The Texas Abortion Pill Case
Alliance for Hippocratic Medicine et al v. U.S. Food and Drug Administration (Texas Federal Court)
Suing the FDA
On November 18, 2022, the Alliance Defending Freedom, on behalf of several medical associations and physicians in the OBGYN field (the “Plaintiffs”), filed a lawsuit against the Food and Drug Administration (FDA) (the “Defendant”) regarding what the Plaintiffs claim was their rushed and non-compliant approval of chemical abortion drugs that have never been deemed safe for women and girls.
The Plaintiffs are asking the court to order the FDA to:
withdraw FDA approval of chemical abortion drugs, and
to comply with with federal law regarding clinical studies and investigations required to ensure a drug is safe and effective for use under the conditions prescribed before providing its approval
Who are the Plaintiffs?
What is the Food and Drug Administration?
The FDA, a division of the executive branch of government (under the President, not Congress or the Courts) exists to protect the health, safety, and welfare of all Americans by setting and complying with safety standards for the food and drugs we consume. This includes rejecting or limiting the use of what are classified as dangerous drugs.
What is the Alliance Defending Freedom?
The Alliance Defending Freedom is a non-profit law firm that takes on what they believe are important cases that have a widespread impact on Americans and their unalienable rights to life, liberty, and the pursuit of happiness, all of which are codified in the United States Constitution.
Think of the ADF as the “counter” to the American Civil Liberties Union (ACLU), which is also a non-profit law firm. The ACLU, however, supports what they describe as social justice issues, including reproductive justice, transgender rights to live freely, LGBTQIA+ rights, causes, police brutality issues, and many others.
What is Chemical Abortion?
Before getting into the details of the lawsuit, let’s look at what chemical abortion drugs are and how they work.
Chemical abortion is a two-drug cocktail taken within 24 - 48 hours of each other.
Mifepristone
First, a pregnant woman takes mifepristone (also known as RU-486 and Mifeprex) a synthetic hormone that stops the production of progesterone. Progesterone is required to build the uterine lining, which is required for the fetus to receive nutrition and develop in the womb. By blocking progesterone, mifepristone causes chemical destruction of the uterine lining, resulting in fetal demise. Once nutrition is withdrawn, the fetus cannot survive.
Misoprostol
Second, after the progesterone has been blocked via mifepristone, the FDA requires physicians to prescribe misoprostol (also known as Cytotec) and direct it to be administered within 24-48 hours of taking mifepristone. Misoprostol causes the uterus to contract, cramp, and push out the uterine lining, which includes the expired fetus and related pregnancy tissue. While mifepristone is what terminates the pregnancy and can be taken alone, it only works in isolation is less than 25% of chemical abortions, hence the need for misoprostol to complete the abortion.
A Short History of Chemical Abortion Drugs
The complaint, the document filed that initiates a lawsuit, does an excellent job summarizing the history of chemical abortion in the United States and it’s written in plain English. I highly recommend you read it in full.
Here are a few highlights:
1980: RU-486 (initial name for mifepristone), was developed by French pharmaceutical company Roussel-Uclaf (hence the name RU-486) as a progesterone antagonist, or a synthetic hormone that blocks natural production of progesterone in women’s bodies.
1981: Roussel-Uclaf tested RU-486 for use in medical abortion on 11 women in Switzerland.
1982: Rousel-Uclaf announced that RU-486 had performed successfully.
1987: After clinicial trials on approximately 20,000 women, Roussel-Uclaf sought approval for RU-486 (in France), which is used in connection with a second drug to remove the placenta from the uterus. Initially, RU-486 was paired with sulprostone or gemeprost, now it is paired with misprostol.
1988: France approved RU-486 for use in medical abortion on September 23, 1988. One month later, on October 21, 1988, Roussel-Uclaf’s executives voted to stop distributing the drug in response to anti-abortion protests and misgivings of Hoechst AG of Germany, the majority shareholder of Roussel-Uclaf whose chairman was a devout Roman Catholic and against abortion.
Hoescht AG was formerly known as I.G. Farben and was the company that manufactured the poison gas used in the Holocaust. This was not public news Hoescht wanted to broadcast.
1993: Just a day into his first term, President Bill Clinton order his cabinet to secure the legal rights to RU-486 so chemical abortion drugs could be approved by the FDA and made available to the American public.
1994: Roussel-Uclaf donates rights in RU-486 to The Population Council, a non-profit established by John D. Rockefeller in 1952. The Population Council’s mission is medical population control through reproductive health initiatives.
Shortly after receipt of the rights from Roussel-Uclaf, The Population Council licensed manufacturing and distribution rights to a newly formed private company, Danco Laboratories, for the sole purpose of securing FDA approval for mifepristone.
Note that Danco Laboratories does not disclose its investors, but has indicated they are wealthy individuals and organizations that support abortion. The article discussing this is behind a paywall, but if you subscribe to the Washington Post, you can access it here.
1996: The Population Council submits its application for FDA approval for mifepristone.
2000: The Population Council, while working in close concert with the FDA under Clinton’s administration, secures FDA approval for mifepristone, ironically without studying the drug’s use under the labeled conditions (there are no age restrictions so it’s also available to young girls) and just one month before the 2000 presidential election.
The complaint explains these issues well in paras. 7 - 9:
The only way the FDA could have approved chemical abortion drugs was to use its accelerated drug approval authority, necessitating the FDA to call pregnancy and ‘illness’ and argue that these dangerous drugs provide a ‘meaningful therapeutic benefit’ over existing treatments.
But pregnancy is not an illness, nor do chemical abortion drugs provide a therapeutic benefit over surgical abortion. In asserting these transparently false conclusions, the FDA exceeded its regulatory authority to approve the drugs.
What’s more, the FDA needed to disavow science and the law because the FDA never studied the safety of the drugs under the labeled conditions of use despite being required to do so by the Federal Food, Drug, and Cosmetic Act (FFDCA). The agency also ignored the potential impacts of the hormone-blocking regimen on the developing bodies of adolescent girls in violation of the Pediatric Research and Equity Act (PREA). And the FDA disregarded the substantial evidence that chemical abortion drugs cause more complications than even surgical abortions
2002: The American Association of Pro-Life Obstetricians and Gynecologists, together with the Christian Medical Association, and Concerned Women for America files a Citizen Petition with the FDA requesting revocation of the Mifeprex (RU-486) approval on the grounds the FDA approved the drug in violation of its own regulations and the harm Mifeprex causes.
2016: The FDA denies the 2002 Citizen Petition - 14 years after it was filed - that requested it take Mifeprex off the market until it conducted proper studies.
2016: On the same day it denied the 2002 Citizen Petition, and without any additional testing and without acknowledging the complications of chemical abortion that do not exist in surgical abortion, the FDA took several actions which constituted major changes in the administration of the abortion drug cocktail:
It approved use of mifepristone up to 70 days, or 10 weeks gestation, as opposed to the previous 59 days, or 7 weeks gestation, despite the fact that the surface area of the placenta and fetus grow significantly during that 3 week period.
It changed the dosage and route of administration (oral to buccal, or cheek pouch).
Original Requirements (2002):
Required three office visits by the patient:
Appointment 1: 600 mg of Mifeprex administered to the patient by the physician or under the supervision of the physician in a clinic, medical office, or hospital.
Appointment 2: Patient returns on day three for examination with physician; if termination of pregnancy is not complete, physician administers 400 mcg of misoprostol for patient to take orally.
Appointment 3: Patient returns to physician for follow up visit approximately 14 days after administration of Mifeprex to confirm complete termination of the pregnancy occurred.
Revised Requirements (2016):
Requires one office visit by the patient:
Appointment 1: 200 mg of Mifeprex administered to the patient by the healthcare provider who prescribes, or under the supervision of a healthcare provider who prescribes, in a clinic, medical office, or hospital.
No Appointment Required: Patient takes 800 mcg of misoprostol by buccal route 24 to 48 hours after Mifeprex administration. Since there is no office visit requirement, the healthcare provider who prescribes discusses with the patient an appropriate location for her to be when she takes the misoprostol.
No Appointment Required: Patient should (but is not required to) follow up with the healthcare provider who prescribed the abortion drugs approximately 7 to 14 days after administration of the drugs to confirm complete termination of pregnancy has occurred and to evaluate the degree of bleeding.
If the pregnancy has ended, but complete expulsion did not occur after the initial dose of misoprostol, the patient may be prescribed an additional 800 mcg of misoprostol to take buccally; women who choose to take a repeat dose of misoprostol should (but are not required to) have a follow-up visit with the prescribing healthcare provider in approximately 7 days to assess for complete expulsion.
In sum, the 2016 Major Changes eliminated …
the in-person dispensing requirements (from a doctor in a doctor’s office, instead of a regular pharmacy) and post-abortion follow-up visit requirements
the need for an ultrasound to confirm the gestational age of the fetus (mifepristone is increasingly dangerous as the pregnancy progresses),
safeguards that would ensure it’s not an ectopic pregnancy (mifepristone is NOT approved for ectopic pregnancies)
safeguards to ensure there aren’t any contraindications for mifepristone (reasons a woman shouldn’t take it due to dangerous or deadly side effects given other medications she takes, such as anticoagulants, or because she has a certain blood type)
the requirement that only medical doctors could prescribe chemical abortion drugs (expansion of qualified subscribers is highly unusual with drugs with the dangerous classification).
the requirement for reporting non-fatal complications from use of chemical abortion drugs - unless the mother dies, all reporting requirements are eliminated
Effects of these eliminations …
By eliminating the need for in-person distribution by a physician, patients must go to the nearest emergency room on their own to address any complications or to seek reversal treatment.
Absent emergency treatment, patients may develop sepsis and die given that all of the fetal issue was not expelled after taking misoprostol.
The requirements of the Federal Food Drug and Cosmetic Act FFDCA and the Pediatric Research Equity Act PREA for safety assessments on how these changes affect age groups, in this instance the bodies of young girls (under 18), to determine if pediatric labeling is necessary, are completely ignored.
2019: Danco Laboratories, a generic drug distributor, filed an Abbreviated New Drug Application seeking approval to sell a generic form of Mifeprex. Here also, without any new studies or evaluations, the FDA approved distribution of the generic form of Mifeprex.
2019: The American Association of Pro-Life Obstetricians and Gynecologists and American College of Pediatricians filed a Second Citizen Petition in response to the 2016 Major Changes. The Petition requested the FDA to:
restore and strengthen the elements of the Mifeprex regimen and prescriber requirements approved in 2000, and
retain the Mifeprex Risk Evaluation and Mitigation Strategy (REMS) which required Mifeprex only be dispensed to patients in clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber
2021: In April of 2021, the FDA under the Biden Administration, issued a temporary “Non-Enforcement Decision” when meant that abortion providers would no longer have to see abortion patients and dispense chemical abortion drugs in person, but can send the chemical cocktail by mail due to COVID-19. It was intended to be a temporary decision as there are well-known and well-documented dangers and complications of medication abortion that don’t exist in surgical abortion.
2021: In December 2021, 2.5 years after it was filed, the FDA denied the Second Citizen Petition challenging the 2016 changes. On the same day, the Biden Administration made the temporary decision to authorize abortion providers to send abortion drugs to patients by mail a permanent one, even though it violates federal postal service laws declaring “[e]very article or thing designed, adapted, or intended for producing abortion … is nonmailable matter…” (18 U.S.C. §§ 1461, 1462). Until 2021, mailing dangerous drugs was prohibited.
Per the lawsuit, this is a huge win for sex-traffickers who can force their victims to terminate their pregnancies, regardless of the age of the fetus, without any physical touchpoint with medical service providers. This means that not only will girls be denied access to healthcare, but they won’t have an opportunity to confide in a medical provider that she is being harmed so that the medical provider can call 911 or otherwise have law enforcement intervene.
2022: The Alliance Defending Freedom filed the lawsuit, on behalf of its clients, in federal court against the FDA (a federal agency, hence filing in the federal court). As stated above, the lawsuit asks the court to:
withdraw the FDA’s approval of mifepristone and misoprostol as FDA-approved drugs, and
withdraw the FDA’s efforts to deregulate these drugs by requiring them to comply with federal law regarding clinical studies and investigations required to ensure a drug is safe and effective for use under the conditions prescribed before providing its approval
Here is the specific relief requested as stated in the complaint:
After two decades of engaging the FDA to no avail, Plaintiffs now ask this Court to do what the FDA was and is legally required to do: protect women and girls by holding unlawful, setting aside, and vacating the FDA’s actions to approve chemical abortion drugs and eviscerate crucial safeguards for those who undergo this dangerous drug regimen.
2023: At President Biden’s direction, the FDA approved distribution of chemical abortion drugs through retail pharmacies, such as CVS or Walgreens, which eliminates the need for a pregnant woman to receive the drugs directly from a medical provider.
2023: TODAY, March 15, 2023. The parties are arguing the case before the Texas court.
A decision can come at anytime after oral arguments.
I’ll cover the legal aspects of this case in a separate edition of The Dobbs Digest.
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This summary just scratches the surface of this very complicated and emotionally intense issue. Chemical abortion drugs account for about half of abortions in the United States so the threat of restricting access to these drugs is very real for abortion supporters.
The Tug-of-War
As is the case with the abortion debate writ large, the tug-of-war usually comes to down to the question … “at what cost.”
The pro-life movement focuses on the pro-choice movement’s seemingly cavalier attitude regarding the physical, medical, emotional, and mental cost to women from increasing access while removing important safeguards that protect women from dangerous side effects.
The pro-choice movement focuses on the pro-life’s seemingly cavalier attitude regarding the physical, medical, emotional, and mental cost to women from being denied easy access to abortion, regardless of the dangerous side effects.
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This issue isn’t going away any time soon, and it’s going to get a lot more complicated. I’ll be tracking this case and providing updates along the way.
Regardless of your position on abortion, it does no one any good to deny reality. Chemical abortion is a serious procedure with significantly more side effects that surgical abortion. Per the lawsuit …
Approximately 10% of women who take the drug combo will need follow up treatment for an incomplete or failed chemical abortion and approximately 39% of women will require surgery if the drugs are taken in the second trimester. Chemical abortions are also 50% more likely than surgical abortions to result in an ER visit within 30 days of the procedure.
Women with a certain blood type who don’t receive additional medication at the time of the chemical abortion have increased risk of unsuccessful pregnancies in the future, such as resulting in stillbirths or suffering neonatal death (baby dies w/in first 28 days) or brain injury. They account for approximately 15% of women.
There is no use in pretending these numbers don’t exist. The facts are what the facts are. The truth is what the truth is.
And, the sooner I started dealing with this in my personal life, the happier I became and the easier my life was to manage. It’s not always fun, but it’s honest. And there’s a lot to be said for an honest life.
Next Up?
Here we go …. we’re entering a full-fledged fight over the most polarizing topic of our time: abortion.
It’s about to get a lot messier as we head into the 2024 election cycle: legally, culturally, and politically.
I’ll be here to break it down.
Thank you, as always, for your support.
- Kelley
March 15, 2023
This is interesting and I pray the Supreme Court does the right thing. It seems there have been some.dangerous decisions made about the use of this drug.
I had no idea there was so much going on recently -- especially this year! It seems much of this is kept out of the news. Is that because uninformed people present fewer objections? Glad to know the FDA and Brandon are looking out for women and girls.🤦🏼♀️