Playing Politics with the Abortion Pill: A Quarter Century of Abuse of Power at the FDA
Introduction
Quis custodiet ipsos custodes? (Juvenal, Satire VI, lines 347–348). For some 2,000 years, the problem of “who guards the guardians” has challenged good governance. The fundamental rights of every person, including the right to life, depend on a government properly constrained. The history of the FDA’s approval of the abortion drug mifepristone is a cautionary tale of what happens without such constraints.
Congress has delegated its regulatory authority over the medical field to the Food and Drug Administration (FDA), a responsibility it is required to fulfill on the basis of sound science. In the case of the chemical abortion drug mifepristone, the FDA approved it not because doing so was supported by the evidence but because it advanced the pro-abortion political agenda.1 Further, the statutory mechanism used by the FDA to approve mifepristone for abortifacient use clearly did not permit the drug’s approval. The deaths of young mothers like Candi Miller, Amber Thurman,2 and Alyona Dixon3 are among the tragic consequences of the FDA’s reckless approval of chemical abortion drugs.4 The danger those drugs pose to women’s health was clear at the time of their approval by the FDA and has not abated in the intervening decades. Yet, the agency has repeatedly reduced the restrictions it had once implemented to mitigate some of the risk.
In 2006, the United States House of Representatives Government Reform Committee’s Subcommittee on Criminal Justice, Drug Policy, and Human Resources culminated a year-long investigation with a hearing on mifepristone entitled RU-486: Demonstrating a Low Standard for Women’s Health?5 (“Congressional Hearing”). One of the witnesses was Monty Patterson, the father of Holly Patterson, who was killed by mifepristone just after her eighteenth birthday.6 At the hearing, Mr. Patterson testified that:
[T]welve days after Holly’s 18th birthday, on September 10, 2003, she walked into a Planned Parenthood clinic to be administered an RU-486 medical abortion regimen. By the 4th day, she was admitted to the emergency room of a local hospital. She was examined.
She was given pain killers. She complained of bleeding, cramping, constipation, and pain, but subsequently, she was sent home. Seven days after taking RU-486, Holly returned to the same emergency room hospital complaining of weakness, vomiting, abdominal pain. Hours later, I was called to the hospital, where I found her surrounded by doctors and nurses, barely conscious and struggling to breathe. Holly was so weak she could barely hold onto my hand. Feeling utter disbelief and desperation, I watched Holly succumb to a massive bacterial infection as a result of a drug-induced abortion with RU-486.7
The resulting report, also entitled The FDA and RU-486: Lowering the Standard for Women’s Health8 (“Congressional Report”), summarized the congressional investigation into the scandalous scientific flaws in the FDA’s clearly political September 28, 2000, approval of RU-486 (“mifepristone”) as a chemical abortifacient.9 Following upon years of political pressure from Democratic congressional chairmen Ron Wyden, Ted Weiss, and Henry Waxman in the early 1990s, the Congressional Report showed the deep Clinton White House involvement in pushing the FDA to find a way to get mifepristone introduced into the American market even before a new drug application was received.10 The Congressional Report details the uncontroverted dangers of chemical abortions—dangers of which the FDA was aware when it approved mifepristone as an abortifacient under the Subpart H approval process. The House Commerce Committee Subcommittee on Oversight and Investigations sent two letters to the FDA seeking documents on the data integrity in clinical trials of the safety and efficacy of mifepristone sponsored by the Population Council, and a third letter related to the FDA’s unusual consideration of mifepristone. There is no record that the FDA or the Department of Health and Human Services (HHS) ever responded to these oversight letters, and neither agency has produced them under the Freedom of Information Act (FOIA). Judicial Watch is representing Advancing American Freedom in a FOIA lawsuit in federal court to obtain copies of these records first requested by Congress in 1996. Thus far, neither agency has been forthcoming.11 Finally, however, after years of stonewalling Congress and complainants, the FDA is being called to account and states are exercising their authority to safeguard the well-being of both mothers and their preborn children by restricting the use of chemical or surgical abortion.12 Further, the new presidential administration presents the opportunity for the FDA to take a more serious look at the dangers of chemical abortion. Secretary of Health and Human Services Robert F. Kennedy Jr. testified in his confirmation hearing that President Trump had asked him to “study the safety of mifepristone” and committed to following the President’s lead on life.
The FDA has spent decades avoiding public and judicial review. Just as pro-mifepristone partisans tried to withhold FDA documents over months from Congress, and just as Danco, the company that sponsored mifepristone for approval, declined to testify under oath,13 FDA senior bureaucrats have manipulated the agency to extend a 180-day review to nearly two decades. Clearly, as the federal court for the Northern District of Texas explained, the “FDA [has] stonewalled judicial review,” Alliance for Hippocratic Medicine v. FDA, 2:22-CV-223-Z at *1 (N.D. Tex. 2023), because it knows that approving mifepristone for abortifacient use violated its own rules in 2000. Too many victims, named and unnamed, have been harmed as a result.
I. The FDA Approved Mifepristone Without Regard for the Significant Safety Concerns Apparent at the Time of Approval.
The FDA approved mifepristone for use as an abortifacient under Subpart H. To be approved under Subpart H, a drug must provide a “meaningful therapeutic benefit over existing treatments.” 21 CFR § 314.500. But there was ample evidence prior to the FDA’s approval of mifepristone in 2000 that chemical abortions provided no such benefit over the existing procedure, surgical abortions.
In 1981, human trials of mifepristone took place in Geneva, Switzerland, after seventeen months of animal research.14 Even those initial human trials indicated the dangers of mifepristone when used as an abortifacient. Those trials resulted in two unsuccessful abortions out of eleven attempts. Two additional women required further medical intervention, including, in one case, emergency surgery and a blood transfusion.15 The next round of trials, conducted in several different countries, produced widely varied success rates from as low as 54 percent to as high as 90 percent.16 That success rate increased to 94 percent in one trial when doctors in Sweden began to administer prostaglandin alongside mifepristone, though it remained significantly lower than the 99 percent success rate of surgical abortion at the time.17 Id.
After mifepristone was approved in France,18 a committee of experts reviewed data on 30,000 women who had used mifepristone as an abortifacient and found numerous significant risks associated with use of the drug.19 Further, the World Health Organization released a study in 1991 finding that just under 3 percent of women with completed abortions and almost 30 percent of those with incomplete abortions “had to be given ‘antibiotic therapy to prevent or cure suspected genitourinary infection’ during the six-week follow-up period.”20
Writing before mifepristone’s approval, the FDA’s medical reviewer found that chemical abortions were of limited value given the short time period during which they were available, the need for three visits to a medical facility during the process, the need for a follow-up visit to ensure that surgical intervention was not required, and the shortcomings of chemical abortion in comparison to surgical abortion.21 In particular, the reviewer noted the higher failure rates, greater frequency of symptoms (including cramping, nausea, and vomiting), and increased blood loss associated with chemical as opposed to surgical abortions.22
Further, the FDA medical officer’s review found that for women with pregnancies up to seven weeks, the original gestational limit approved by the FDA, the failure rate was almost 8 percent, with the percentage increasing at longer gestational periods, up to 23 percent for pregnancies between eight and nine weeks.23 Because these failure rates were higher and the symptoms associated more frequent, and because chemical abortion provided no significant benefits over the alternative—surgical abortion—improved efficacy and safety could not have justified the FDA’s approval of mifepristone for abortifacient use under its own regulation.
II. The FDA’s Approval of Mifepristone for Use as an Abortifacient Violated the Plain Language of Subpart H of CFR Part 314.
Federal executive agencies derive whatever power they may have from Congress by legislation empowering them to exercise legal control over a particular policy domain. Subpart H, an FDA regulation promulgated to address the AIDS crisis and entitled Accelerated Approval of New Drugs for Serious or Life-Threatening Illnesses, allows the FDA to approve new drugs to treat “serious or life-threatening illnesses” if the drugs provide a “meaningful therapeutic benefit to patients over existing treatments.” 21 CFR §314.500. Further, the FDA may approve the new drug only “on the basis of adequate and well-controlled clinical trials.” 21 CFR § 314.510. Thus, the purpose of Subpart H is to allow for expedited approval of new drugs when doing so would improve treatment of patients whose illnesses are serious and who need better treatment options. The FDA, in approving the mifepristone regimen for chemical abortions, acted outside of this clear purpose and violated the plain requirements of the regulation’s text. The language of Subpart H is unambiguous, and the FDA’s interpretation of that language is just as clearly contrary to that language in several ways.
As explained, Subpart H exists to allow for the approval of new drugs for the treatment of “serious or life-threatening illnesses.” 21 CFR § 314.500. But pregnancy is not an illness. As noted by the Subcommittee report, the FDA’s letter to the Population Council24 (which licensed mifepristone to Danco) referred to “the termination of an unwanted pregnancy” as the “serious condition” to be addressed by the approval of mifepristone.25 However, the language of the regulation does not provide for approval of drugs for serious conditions but rather for illnesses. Although pregnancy may occasionally result in serious or life-threatening conditions, pregnancy itself is neither serious nor life-threatening.
Subpart H requires that new drugs approved through its process “provide [a] meaningful therapeutic benefit to patients over existing treatments.” 21 CFR § 314.500. The regulation gives examples of such therapeutic benefits as the “ability to treat patients unresponsive to, or intolerant of, available therapy, or improved patient response over available therapy.” Id. Even if abortion constituted a treatment with therapeutic benefits, it was clear from the evidence at the time of approval in 2000 that chemical abortion was both more dangerous for the woman and less effective than surgical abortion.
The Congressional Report quotes the FDA’s Approval Memo to the Population Council describing the supposed therapeutic benefit of chemical over surgical abortions as the “avoidance of a surgical procedure.”26 The Congressional Report identifies four problems with this idea.
First, the report notes that mifepristone was not approved only for use for women intolerant of surgical abortions, as would be expected for a less safe, less effective form of abortion.27 According to the report, “[the] FDA baldly asserted that there was a clinical benefit for chemical abortion and made no effort to produce statistical evidence of an actual benefit.”28
Second, the report notes that a substantial portion of women using mifepristone to induce an abortion ultimately required surgical intervention, casting doubt on the supposed benefit of chemical abortions, because “women must be able to tolerate the surgical procedure” if they are going to attempt a chemical abortion.29 As the report notes, the FDA must show that there is, in fact, some clinical benefit to an approved drug, which they did not do in this case. Id.
Third, the report notes that the fact that some patients may prefer one form of treatment over another is not itself a clinical benefit.
Finally, the report notes that the FDA medical officer, prior to approval of mifepristone, commented that bleeding was a significantly more prevalent and serious issue in multiple studies comparing chemical to surgical abortions. “Given these comments,” the report summarizes, “it is impossible to conclude that [mifepristone] medical abortions provide a meaningful therapeutic benefit over surgical abortion.”30
Subpart H also requires the FDA’s approval of a drug to be “on the basis of well-controlled clinical trials.” Further, 21 CFR 314.126(e) says, “Uncontrolled studies or partially controlled studies are not acceptable as the sole basis for the approval of claims of effectiveness.” In this case, the data relied on by the FDA was not concurrently controlled.31 As the Congressional Report notes, the trials the FDA relied on were not concurrently controlled against first-trimester surgical abortion.32 As part of the investigation for the report, the subcommittee held a hearing in which the FDA Deputy Commissioner for Operations, Dr. Janet Woodcock, explained that a historical control was used in assessing the trials of mifepristone.33 In other words, the trials were controlled against the existing data on pregnancy, miscarriage, and abortion.
The Congressional Report points out three problems with the FDA’s assertion of non-concurrent control as a basis for the approval of mifepristone. First, the “FDA’s assertion that the French and U.S. trials were historically controlled appears to be a post hoc assertion.”34 The study that reported on the American trials did not mention a control group, and a statement from an FDA statistician who reviewed the French trials suggested a lack of concurrent control groups in those trials as well.35
Second, the American studies of mifepristone excluded women with numerous medical issues, but the FDA acknowledged that the historical data, the control group, was drawn from the general population and thus did not exclude women with those health problems.36 As a result, the apparent safety of mifepristone relative to surgical abortion was likely inflated, because the data on chemical abortions was gathered from relatively healthy women, while the data on surgical abortions included women with health problems who would have been excluded from the studies of chemical abortion. Regardless, because the trial and control groups were not matched in terms of their health background, they are not a “meaningful control.”37 As the report concludes, “If it was not possible to match the populations with the historical data set, then a concurrent control should have been used.” Id.
Finally, the report notes that using historical data rather than a concurrent control group results in “defining the clinical endpoint too restrictively.”38 In other words, surgical abortions and miscarriage are not binary; they do not “produce only simple zero or one outcomes.” Id. As the report notes, “A control should have been used in the [mifepristone] trial that compared different methods of producing the experimental outcome—first-trimester pregnancy termination—while assessing each method’s ability to manage highly predictable, regular complications of medical abortion (i.e., hemorrhage, incomplete abortion).” Id.
In sum, the FDA only claimed that its studies were controlled after approval, the American cherry-picked studies of mifepristone excluded women with numerous medical issues, potentially inflating the apparent safety of chemical as opposed to surgical abortion, and the historical data that was used as a non-concurrent control provided at best a low-resolution picture of the safety and effectiveness of chemical as opposed to surgical abortions. Mifepristone, therefore, clearly did not meet the strict requirements for approval under Subpart H.
III. Chemical Abortion Continues to Pose a Significant Safety Risk for Women, Made Worse by the Lax Reporting Requirements Approved by the FDA.
As discussed above, the FDA knew about the significant negative health consequences of mifepristone before approving it for abortifacient use in the United States. Despite the continued danger of chemical abortion since its approval, the FDA has simultaneously removed protective limitations on the prescription of chemical abortion drugs and weakened the reporting requirements for adverse events caused by those drugs, casting doubt on its claims about the safety of mifepristone.
Currently, adverse events are widely underreported because the FDA requires prescribers to report only deaths, not other less-than-lethal adverse events associated with mifepristone. Back in 2000, the FDA approved mifepristone with certain safeguards and requirements to decrease the dangers mifepristone could pose to women, consistent with Subpart H. See 21 C.F.R. § 314.520. Although compliance with them was still insufficient to prevent adverse events, those requirements were much more stringent than the ones imposed today. Among those earlier requirements was one obligating prescribers to report non-fatal but serious adverse events to the drug manufacturer.39 Beginning in 2016, prescribers need report only deaths associated with the drug, not other serious adverse events.40 The FDA’s intentional blinding of itself and the public from accurate knowledge of the full range and extent of adverse events associated with mifepristone, along with its claims that chemical abortion is safe because there are so few reports of adverse events, is a through-the-looking-glass approach to public health that obscures mifepristone’s true dangers. Such reckless disregard for women’s well-being is politics, not science.
The FDA’s inexplicable removal of most adverse event reporting requirements forces researchers to look overseas for data on mifepristone’s harm to women. Even recent experience with mifepristone indicates that it continues to be more dangerous than surgical abortion, contrary to the requirements of Subpart H. As British researcher and medical doctor Calum Miller explains:
During the COVID-19 pandemic, a small minority of countries permitted abortion providers to send abortion pills—usually Mifepristone and misoprostol—by post to women after a remote consultation by video or telephone (hereafter, “telemedicine” refers to either)—that is, without any in-person contact throughout the process. This was an unprecedented move since full telemedicine had not been studied in legal, experimental conditions prior to this . . . In the United Kingdom . . . ambulance calls and responses relating to medical abortion also increased dramatically between 2018 and 2021, following the introduction of [chemical abortion] at home and then full telemedicine.41
Further, according to British researchers:
Data obtained from five NHS Ambulance Trusts in England, show that emergency ambulance responses for complications arising after a medical abortion are three times higher for women using pills-by-post at home, compared to those who have their medical abortion in a clinic.42
Not only did the FDA remove the adverse event reporting requirement, but it also removed the previously required in-person doctor assessment. At the time of the FDA’s initial approval, a woman seeking a chemical abortion was required to visit the doctor three times to receive a chemical abortion prescription. In 2016, that number of visits dropped to one.43 Then in 2021 the FDA removed the in-person visit requirement altogether, meaning that a woman can obtain mifepristone through the mail without in-person examination, sonogram, or laboratory analysis.44
Prescribing chemical abortion drugs via telemedicine exposes women to several risks, one of the most significant of which is a ruptured ectopic pregnancy. Ultrasounds, which require an in-person assessment, are critical in identifying gestational age and ruling out ectopic pregnancies. Chemical abortion is ineffective in cases of ectopic pregnancy, yet, as the federal court for the Northern District of Texas explained, “there is simply no requirement that any procedure is done to rule out an ectopic pregnancy—which is a serious and life-threatening situation.” Alliance for Hippocratic Med. v. FDA, 2:22-CV-223-Z at *51 (N.D. Tex. Apr. 7, 2023). The current REMS require only that the prescriber have the “[a]bility to diagnose ectopic pregnancies,” not that a doctor actually assess whether the patient has one.45
Finally, telemedicine may not allow for a thorough discussion of the patient’s medical history or assessment of her needs, potentially missing important details that could impact the procedure’s safety. Telemedicine also leads to uncertainty and the inability to confirm that a woman is not being coerced into undergoing an abortion. Further, “We can expect that 1-in-17 women using the abortion pills at home, will subsequently need hospital treatment for complications arising from the medical abortion treatment failure, presenting with retained products of conception and/or hemorrhage.”46 Thus, the FDA’s loosening of standards puts women at greater risk of harm without any counterbalancing interest to justify that increased risk.
By 2006, the dangers of chemical abortion had become even more evident than they were in 2000, when the FDA approved the drugs for that use. In her testimony in a Congressional Hearing in May of 2006, Dr. Donna Harrison said,47
In my experience as an ob-gyn, the volume of blood loss seen in the life-threatening cases is comparable to that observed in major surgical trauma cases like motor-vehicle accidents. This volume of blood loss is rarely seen in early surgical abortion without perforation of the uterus, and it is rarely seen in spontaneous abortion.
Dr. Harrison added that no risk factors predicted such hemorrhage, and that it was life threatening for women without access to immediate medical care.48 Such dangers have been ignored by the FDA in its effort to push mifepristone over the past 24 years.
Information that has become available since the publication of the Congressional Report in 2006 is no more encouraging. Several studies have shown the medical risk associated with the use of chemical abortion. One study found that 10 percent of women, after use of chemical abortion, require followup medical treatment for failed or incomplete abortion,49 and 20 percent of women who use mifepristone to induce abortions will have an adverse event, including hemorrhaging and infections.50 This rate of adverse events is four times greater than the adverse event rate of surgical abortion. Id.
Abortion, including chemical abortion, also risks harm to the woman’s mental health. A comprehensive review of the literature on abortion and mental health found that at least some women experienced negative mental health outcomes as a result of their abortions and that “[t]he ability to identify women who are at greater risk of negative reactions has resulted in numerous recommendations for abortion providers to screen for these risk factors in order to provide additional counseling both before an abortion, including decision-making counseling, and after an abortion.” 51 The dangers to women posed by chemical abortion are many. Yet the FDA, despite consistent evidence of these dangers, has repeatedly reduced the safety measures it had initially put in place to protect against those harms.
Conclusion
The question at the heart of this issue is what is of greater importance to government regulators: the health and safety of women and the unborn or the political advantage of greater abortion “access.” Surgical abortion is safer than chemical abortion, at least for the mother. Yet the FDA has repeatedly loosened safety requirements for mifepristone’s prescription. It’s time for the government to prioritize safety and science over politics. Until it does so, women like Amber Thurman and Candi Miller will continue to suffer the consequences.
NOTES
1. The FDA’s approval of mifepristone for abortifacient use demonstrates the danger of bureaucracy and its tendency to hide politics behind a veil of supposed expertise. Advancing American Freedom (AAF) has repeatedly drawn attention to the danger. This testimony summarizes AAF’s work on this issue and the work of others to call attention to the FDA’s prioritization of politics over women’s safety. AAF’s own work and other important resources on this issue can be found at the links below. The Judicial Watch Special Report provides some of the most striking evidence that the approval of mifepristone for abortifacient use was a political, not a scientific, decision.
Amicus Briefs
• Bryant v. Moore (Fourth Circuit) (August 2024): https://tinyurl.com/52k345f6
• GenBioPro Inc. v. Kristina Raynes (Fourth Circuit) (April 2024): https://tinyurl.com/bdh73fth
• FDA v. Alliance for Hippocratic Medicine (Supreme Court) (February 2024): https://tinyurl.com/vzszsubm
• FDA v. Alliance for Hippocratic Medicine (Fifth Circuit) (May 2023): https://tinyurl.com/678zz8xd
• Alliance for Hippocratic Medicine v. FDA (Supreme Court) (April 2023): https://tinyurl. com/3j9d98cm
• Alliance for Hippocratic Medicine v. FDA (Fifth Circuit) (April 2023): https://tinyurl.com/ yskwk5wf
• Alliance for Hippocratic Medicine v. FDA (District Court) (February 2023): https://tinyurl. com/4ccjmwdy
AAF Memos
• How Chemical Abortion Harms American Women and Children (Feb 2024): https://tinyurl. com/4xsy9ybr
• The Truth About the Georgia Abortion Death (Sept 2024): https://tinyurl.com/yc5ftebj
AAF Letter to Congress on Mifepristone
• Restore Safeguards on Mifepristone in Agriculture Appropriations Bill (Sept 2023): https://tinyurl. com/5acjw2rr
FOIA Requests
• FOIA Request for FDA Records on Mifepristone: https://tinyurl.com/2n85njv6
• FOIA on FDA Approval of Mifepristone: https://tinyurl.com/yfz2f9k7
Online Resources
• Judicial Watch Special Report: The Clinton RU-486 Files: https://tinyurl.com/2hzbncm3
• Congressional staff report “The FDA and RU-486: Lowering the Standard for Women’s Health”: https://tinyurl.com/48pdx2hn
• Congressional Hearing “RU-486: Demonstrating A Low Standard for Women’s Health?”: https:// tinyurl.com/3bxr5mdy
2. Kavitha Surana, Abortion Bans Have Delayed Emergency Medical Care. In Georgia, Experts Say This Mother’s Death Was Preventable, ProPublica (Sept. 16, 2024) https://www.propublica.org/ article/georgia-abortion-ban-amber-thurman-death
3. Carole Novielli, Woman’s Death from ‘Septic Abortion’ Days After Obtaining Abortion Pill Sparks Lawsuit, Live Action (September 25, 2023) https://www.liveaction.org/news/womans-deathseptic-abortion-pill-lawsuit/
4. The Truth About the Georgia Abortion Death: https://advancingamericanfreedom.com/aaf-thetruth-about-the-georgia-abortion-death/
5. RU-486: Demonstrating a Low Standard for Women’s Health? Hearing before the House Subcommittee on Criminal Justice, Drug Policy and Human Res., Committee on Government Reform, 109th Cong. (May 17, 2006), available at https://archive.org/details/gov.gpo.fdsys.CHRG109hhrg31397. Video available at https://www.c-span.org/video/?192580-1/ru-486-health-safetystandards#
6. “I said I wanted to show you a picture of my daughter so at least you see what I have lost and actually what she lost. I owe and dedicate my presence here to those who have no voice and particularly to my daughter, Holly, who died at 18, and the other women who have died or have been seriously hurt by taking the RU-486 medical abortion drug regimen as a solution to their unplanned pregnancy. I am here to testify about my personal experience as the father of a victim of this drug and my consequent knowledge, experiences, and views pertaining to RU-486, the drug.” Congressional Hearing at 120.
7. Id.
8. The FDA and RU-486: Lowering the Standard for Women’s Health, House of Representatives Government Reform Committee; Subcommittee on Criminal Justice, Drug Policy, and Human Resources (Oct. 2006), available at https://www.liveaction.org/news/wp-content/uploads/2020/08/ SouderStaffReportonRU-486.pdf
9. Hannah Levintova, “The Abortion Pill’s Secret Money Men: The untold story of the private equity investors behind Mifeprex—and their escalating legal battle to cash in post-Dobbs,” Mother Jones (March/April 2023), available at https://www.motherjones.com/politics/2023/01/abortion-pillMifepristone-mifeprex-roe-dobbs-private-equity/
10. Congressional Hearing at 3-66.
11. Copy of the lawsuit and the Congressional oversight letters are available at https:// advancingamericanfreedom.com/aaf-foundation-files-foia-lawsuit-against-hhs-on-Mifepristone/
12. The states’ legitimate interest in protecting the life of the unborn and the safety and health of the mother is recognized by the Court today and was recognized at the time of the FDA’s approval. See Dobbs v. Jackson Women’s Health Organization, 142 S. Ct. 2228, 2284 (2022); Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 846 (1992). See AAF amicus briefs defending state laws to restore FDA protections on mifepristone in West Virginia (https://advancingamericanfreedom. com/genbiopro-inc-v-kristina-raynes/) and North Carolina (https://advancingamericanfreedom.com/ bryant-v-moore).
13. Congressional Hearing at 68.
14. Congressional Report at 10.
15. Congressional Report at 10.
16. Congressional Report at 10-11.
17. Success was defined as fetal death without the need for further medical intervention.
18. A French manufacturer handed over the technologies and patent rights to Population Council. The plan for this donation was first recommended to president-elect Clinton by Ron Weddington (co-counsel with his wife Sarah in Roe v. Wade) in a 1992 letter where he proposed expanding access to cheap chemical abortions “to eliminate the barely educated, unhealthy and poor segment of our country” since “26 million food stamp recipients is more than the economy can stand.”[54] Weddington JR. Letter to President-To-Be Clinton, Jan 6 1992. In: Rasco C, editor. OA/Box OA7455, File Folder: RU486 [Internet]. Clinton Library; 1992. p. 54–8. Available from: https://clinton.presidentiallibraries.us/ files/original/f8977047aefa0c1f90a24665cabf95bc.pdf
19. Congressional Report at 11-12.
20. Congressional Report at 12, n. 63.
21. Congressional Report at 29-30.
22. Congressional Report at 29-30.
23. Congressional Report at 31.
24. “The Population Council is a nonprofit founded in 1952 by John D. Rockefeller III to address supposed world overpopulation.” Population Council, https://www.influencewatch.org/non-profit/ population-council/ (last visited Feb. 9, 2023). As pro-abortion activist Lawrence Ladar noted, “In a larger sense, each woman who decides whether or not a fetus should become a child affects the population charts.” Lawrence Lader, Abortion, Indianapolis, Indiana: Bobbs-Merrill; 1966. 212 p.
25. Congressional Report 19, n. 99.
26. Congressional Report at 21, n. 106 (internal quotation marks omitted).
27. Congressional Report at 22.
28. Congressional Report at 22.
29. Congressional Report at 22.
30. Congressional Report at 23.
31. See Congressional Report at 15-19.
32. Congressional Report at 14.
33. Congressional Hearing at 92.
34. Congressional Report at 17.
35. Congressional Report at 17.
36. Congressional Report at 18.
37. Congressional Report at 18.
38. Congressional Report at 18.
39. Food and Drug Administration, Approved Labeling Text for Mifeprex (Sept. 28, 2000), https:// www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.htm
40. Food and Drug Administration, Risk Evaluation and Mitigation Strategy (March 2016), https:// www.fda.gov/media/164649/download. Food and Drug Administration, Risk Evaluation and Management Strategy (May 2021), https://www.fda.gov/media/164651/download.
41. Calum Miller, “Telemedicine Abortion: Why It Is Not Safe for Women,” in Nicholas Colgrove, ed., Agency, Pregnancy and Persons: Essays in Defense of Human Life at 288, 296 (forthcoming, 2023). ProQuest Ebook Central, http://ebookcentral.proquest.com/lib/wfu/detail.action?docID=6998328 Even the most zealous advocates for mifepristone did not countenance that: “Prescribing RU 486 will maintain the same doctor-patient relationship that accompanies the use of an antibiotic or any drug.” Lader 1995 at 17.
42. Id.
43. Information on Mifeprex Changes and Ongoing Monitoring Efforts, Government Accountability Office at 7 (Mar. 2018) https://www.gao.gov/assets/gao-18-292.pdf
44. Information about Mifepristone for Medical Termination of Pregnancy Through Ten Weeks Gestation, U.S. Food and Drug Administration (Mar. 2023) https://www.fda.gov/drugs/postmarketdrug-safety-information-patients-and-providers/information-about-Mifepristone-medicaltermination-pregnancy-through-ten-weeks-gestation
45. Risk Evaluation and Mitigation Strategy (REMS) Singla Shared System for Mifepristone 200MG, Food and Drug Administration at 1 https://www.fda.gov/media/164651/download?attachment
46. FOI Investigation into Medical Abortion Treatment Failure, Percuity at 4 (Oct. 2021). https:// percuity.files.wordpress.com/2021/10/foi-ma-treatment-failure-211027.pdf
47. Congressional Hearing at 142.
48. Id.
49. Maarit Niinimaki et al., Comparison of rates of adverse events in adolescent and adult women undergoing medical abortion: population register based study, BMJ, April 20, 2011, at 4.
50. Maarit Niinimaki et al., Immediate complications after medical compared with surgical termination of pregnancy, 114 Obstetrics & Gynecology 795 (2009).
51. David C. Reardon, The abortion and mental health controversy: A comprehensive literature review of common ground agreements, disagreements, actionable recommendations, and research opportunities, 6 Sage Open Medicine 1, http://journals.sagepub.com/doi/10.1177/2050312118807624.
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Original Bio:
J. Marc Wheat is General Counsel of Advancing American Freedom (AAF), a non-profit organization founded by former vice president Mike Pence to advocate for conservative values in public policy. Timothy Harper is Counsel at Advancing American Freedom (AAF).
