On December 16th, 2021, the Food and Drug Administration (FDA) permanently removed the “in-person dispensing requirement” under the Risk Evaluation and Mitigation Strategy program for mifepristone, the first pill in the two-part abortion process.[1] Practically speaking, this means that abortion providers will no longer be required to provide women with an in-person visit before starting the abortion process. Instead, mifepristone is now available by mail. This has become a goal of abortion activists in recent years whose ears only faintly catch “safe, legal, and rare,” from previous generations of abortion activists, and have all but forgotten the rallying cries against do-it-yourself abortions. How difficult and traumatic can delivering a very premature baby at home be anyway? One woman described the process as “savage” and “horrific.” She felt that she “was going to give birth to death.”[2] How dangerous could it be to prematurely induce labor and deliver a deceased infant at home alone? According to a recent study based on 17 years’ worth of Medicaid claims data, the rate of abortion-related emergency room visits increased by over 500% after a chemical abortion during the years 2002-2015.[3] The FDA is making a risky gamble, not for themselves, but for the countless unborn lives that will be lost, and for countless women who are trusting that chemical abortion is safe and effective.

​

Before moving to the history of chemical abortion it is important to discuss the term chemical abortion. What is a chemical abortion? Abortion by chemical means is discussed in many ways and referred to by different terms:

 

“Many abortion providers euphemistically refer to chemical abortion as “medication abortion,” misrepresenting pregnancy as an illness to be treated with medication. A more accurate description of “medication abortion” is chemical abortion. A chemical abortion is just that: an abortion induced by chemicals. To “self-manage” a chemical abortion means to induce an abortion on oneself without formal medical supervision, most commonly using the drugs mifepristone and misoprostol.”[4]

​

The above definition is important to point out both because the process of chemical abortion is not therapeutic, and because the process of inducing labor on oneself through chemical means obviously invokes the reality of the situation.

 

History

 

2000

The FDA approved the use of mifepristone (brand name “Mifeprex”), in conjunction with misoprostol, to end early-stage pregnancies in late 2000.[5] The FDA’s letter of approval to the Population Council, whose application dated back to 1996, cited the Code of Federal Regulations regarding drug distribution and safety and restricted mifepristone distribution based on dispensing physicians meeting the following criteria:

​

• “Ability to assess the duration of pregnancy accurately.”

• “Ability to diagnose ectopic pregnancies.”

• “Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through other qualified physicians, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.”

• “Has read and understood the prescribing information of Mifeprex.”

• “Must provide each patient with a Medication Guide and must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and Patient Agreement, give her an opportunity to read and discuss both the Medication Guide and the Patient Agreement, obtain her signature on the Patient Agreement and [provider] must sign it as well.”

• “Must notify the sponsor or its designate in writing as discussed in the Package Insert under the heading DOSAGE AND ADMINISTRATION in the event of an ongoing pregnancy, which is not terminated subsequent to the conclusion of the treatment procedure.”

• “Must report any hospitalization, transfusion or other serious events to the sponsor or its designate.”

• “Must record the Mifeprex package serial number in each patient’s record.”[6]

• ​

The above requirements illustrate the FDA’s past understanding of when and how mifepristone can adversely affect women’s health, and how to adequately prepare for those circumstances and how sponsors can take responsibility for adverse events.

​

2004

In September 2003, an 18-year-old woman by the name of Holly Patterson who was undergoing a chemical abortion tragically died after calling a clinic hotline with symptoms of “severe abdominal cramping.” She was told to take a painkiller and if her symptoms did not improve then to go to the ER. Soon after, she went to the ER and was given a narcotic shot and sent home. Days later, and still in severe pain, she was readmitted to the same hospital, where she died later that afternoon. It was later “discovered by the CDC and the FDA that Holly had tested positive for Clostridium sordellii toxic shock syndrome following medical abortion.”[7] 

​

On November 15th, 2004, the FDA issued the following announcement:

​

The Food and Drug Administration will announce today important new safety changes to the Danco Laboratories, LLC's labeling of mifepristone (trade name Mifeprex, also known as RU-486). Mifeprex was approved in 2000 for the termination of early pregnancy, defined as 49 days or less. FDA and Danco Laboratories have received reports of serious bacterial infection, bleeding, ectopic pregnancies that have ruptured, and death, including another death from sepsis that was recently reported to FDA. These reports have led to the revision of the black box labeling.

​

The new warnings to health care providers and consumers include changes to the existing black box on the product to add new information on the risk of serious bacterial infections, sepsis, and bleeding and death that may occur following any termination of pregnancy, including use of Mifeprex. While these risks are rare, the new labeling and Medication Guide will provide the latest available information to all.

​

 The following day the SFGate published an article opining that the “move was in part a response to the case of an East Bay 18-year-old, Holly Patterson who died in September 2003 after seeking to end her 7-week pregnancy with RU-486,” although the FDA did not mention her case directly. The article further went on to describe a phone interview with Holly’s father during which he conveyed his belief that “his daughter would still be alive had the revised label been in place when she was prescribed RU-486 at a Planned Parenthood clinic in Hayward: ‘I think Holly would have been able to recognize her symptoms early on.’”[8]

​

The 2004 FDA announcement further clarifies that symptoms of an adverse event following a chemical abortion can be confusing and health care providers need to be on the lookout:

​

The new information reminds health care providers that serious bacterial infection and sepsis may occur without the usual signs of infection, such as fever and tenderness on examination. Health care providers should be aware that prolonged, heavy bleeding may warrant surgical interventions. The label also warns that health care providers should be vigilant for patients with undiagnosed ectopic pregnancies (tubal pregnancies) as this condition may be missed by physical examination and ultrasound. Some of the symptoms of an ectopic pregnancy may mimic the expected symptoms of a medical termination of pregnancy. Mifepristone is not effective for termination of these pregnancies.[9]

​

The announcement takes special care to point out that even under the best of circumstances, a physical exam and an ultrasound, ectopic pregnancies can be very difficult to diagnose.

​

2005

In 2005 the FDA became aware of the deaths of other women following chemical abortions who tested positive for Clostridium sordellii. This spurred the FDA to make further label changes to mifepristone to warn providers about the dangers of infection following chemical abortion:

​

This update provides additional information about four septic deaths in women following medical abortion that were first described by the Food and Drug Administration (FDA) in July 2005. At that time, FDA alerted health care providers that it was aware of four reports of septic death that had occurred in the United States between September 2003 and June 2005 in women following medical abortion with mifepristone (Mifeprex) and misoprostol. Since July 2005, FDA has learned that all four cases of fatal infection tested positive for Clostidium sordelli.

​

The FDA further recommended, “Physicians should have a high index of suspicion for sepsis so that patients can be immediately treated with antibiotics that include coverage of anaerobic bacteria such as Clostridium sordellii.”

​

2006

On March 17th, 2006, the FDA issued another health advisory after learning of “two additional deaths following medical abortion with mifepristone (Mifeprex).” The agency said the following:

​

The Agency received verbal notification of the deaths in the United States from the manufacturer, Danco Laboratories.  At this time, we are investigating all circumstances associated with these cases and are not able to confirm the causes of death.  However, all providers of medical abortion and their patients need to be aware of the specific circumstances and directions for use of this drug and all risks including sepsis when considering treatment.  In particular, physicians and their patients should fully discuss early potential signs and symptoms that may warrant immediate medical evaluation.[10]

​

At the time the above announcement was made the FDA and CDC were unaware whether the deaths were caused by Clostidium sordelli or sepsis.

 

2011

In 2011 the FDA converted its regulations on Mifeprex into a Risk and Mitigation and Strategy (REMS) program. REMS are put in place for certain medications with serious safety concerns. In 2011 the FDA released a report containing instances of adverse events following a chemical abortion. The categories included death, hospitalization (excluding death), ectopic pregnancies, blood loss requiring transfusions, infections, and severe infections.  The REMS tightened requirements for sponsors and physician dispensers requiring providers and patients to be more aware of the risks associated with the drug. In addition to the REMS already being in place for mifepristone, the FDA also implemented a more stringent set of requirements called Elements to Assure Safe Use (ETASU). “According to the FDA, ETASU are “required medical interventions or actions by healthcare professionals prior to prescribing or dispensing the drug.” In the case of mifepristone, ETASU includes the following:

​

1) Providers prescribing mifepristone must be specially certified.

​

2) Mifepristone may only be dispensed at approved facilities by certified prescribers.

​

3) Patients receiving mifepristone must present ‘evidence or other documentation of safe use conditions.’”[11]

​

2016

In 2016, the FDA updated the Mifeprex REMS and labeling to loosen certain restrictions on the drug. In accordance with the new labeling Mifeprex was able to be used in conjunction with misoprostol to terminate pregnancies “70 days or less since the first day of a woman’s last menstrual period,” up from the 49 days allowed previously.[12] The FDA also relaxed the reporting requirements for adverse events, requiring that only deaths be reported rather than all serious adverse events associated with mifepristone.

​

2019

In 2019, the FDA approved an application from drug company GenBioPro to market a generic version of mifepristone. The Mifeprex REMS were converted into a shared REMS that covers both Mifeprex and generic mifepristone.

 

2020

In July 2020, the abortion industry used the COVID-19 pandemic to obtain a court order allowing abortion providers to distribute mifepristone through the mail.

​

2021

In April 2021, the FDA announced it was exercising “enforcement discretion” regarding the in-person requirement, which allowed the abortion pill to be distributed online and through the mail, and that it was reviewing the mifepristone REMS.

​

In December 2021, the FDA announced that it was revising the REMS to formally remove the in-person requirement and create a certification for pharmacies to distribute mifepristone.

​

Just a little over 20 years ago in response to the question “Is mifepristone distribution restricted?” the FDA responded, “Yes, mifepristone is supplied directly to doctors who meet certain qualifications. It is not and will not be available in pharmacies.”[13] Despite years of increasing safeguards on mifepristone in response to adverse events, the FDA has caved to political, certainly not scientific, pressures to loosen restrictions on mifepristone. A recent study found that not only had the rate of abortion-related emergency room visits increased astronomically following chemical abortions (500%), but that a majority of the visits had been miscoded as miscarriages, potentially covering up just how many adverse events following chemical abortion are dealt with in an ER setting.[14]

​

The recent decision by the FDA signals that chemical abortion is safe, which opposes current peer-reviewed research from several countries that suggests just the opposite. In the United States the following data regarding hospitalization and chemical abortion was published in 2021:

​

• “The rate of abortion-related ER visits following a chemical abortion increased 507% from 2002-2015.

​

• Chemical abortion significantly increased the risk of an emergency room visit. Within 30 days of a chemical abortion, when compared to rates following a surgical abortion:

  • 22% greater risk of ER visit for any reason.

  • 53% greater risk of ER visit for an abortion-related reason.

​

• Over 60% of abortion-related ER visits following a chemical abortion in 2015 were miscoded as treatment for a miscarriage.

  • The sequence of confirmed chemical abortion, subsequent pregnancy, and subsequent miscarriage within 30 days is impossible to know. The high rate of miscoded chemical abortion visits suggests the FDA’s data on adverse events is flawed.”[15]

 

Additionally, the following data was found from California:

​

“A retrospective observational cohort study using California[16] Medicaid data found a major complication rate of 5.2% for chemical abortion but just 1.3% for first-trimester aspiration abortion, or a complication rate for the abortion pill that is four times greater than surgical abortion.”[17]

​

Finally, the following research was published out of Finland and Sweden:

​

· “A study of 42,619 abortions in Finland[18] found that chemical abortion has a complication rate four times greater than surgical abortion and that a fifth of all chemical abortions result in complications.

​

· A study from Sweden[19] found that complications related to chemical abortions at less than 12 weeks gestation ‘increased significantly during 2008-2015 without any evident cause.’”[20]

​

Many additional risks are present for woman who ingest chemical abortion pills without the proper clearance from their physicians. Physician Ingrid Skop points to the dangers of miscalculating gestational age:

​

“If a woman miscalculates her gestational age and has entered the second trimester when she ingests mifepristone and misoprostol, the likelihood that she will require surgery increases dramatically.  A Finnish records-linkage study of over 18,000 women comparing first-trimester to second-trimester chemical abortions found 38.5% of second-trimester abortions required surgical completion (versus 7.9% in the first trimester).  Additionally, 4% of the later abortions were complicated by infections (versus 1.9% of the earlier ones).”[21]

​

Additionally, Dr. Skop warns of the dangers of a misdiagnosed ectopic pregnancy:

​

“Even with routine pre-abortion ultrasound, ectopic pregnancies are sometimes missed… A woman who experiences ectopic warning symptoms, such as pain or bleeding, while undergoing a chemical abortion may be less likely to report them to a health care provider, because she has been warned to expect just such symptoms as a sign that the abortion drugs are working.  A woman is 30% more likely to die from an ectopic while undergoing an abortion than if she had an ectopic but had not sought an abortion.”[22]

​

Dr. Skop also points out the importance of women seeing a provider in person due to the prevalence of women coerced into abortions:

​

“Current FDA regulations require a woman seeking abortion to consume the mifepristone in the presence of the abortionist.  One reason for this limitation is to make sure a woman has been counseled and desires the abortion.  Potential for misuse and coercion is high when there is no way to verify who is consuming the drug and whether she is doing so willingly…. It has been documented that many women experiencing sex trafficking have been forced into multiple abortions.  Interaction with the health care system is an opportunity for these women to be identified and helped, but ready availability of chemical abortion pills to their abusers will remove this opportunity for intervention.”[23]

​

Only time will tell what the coming years will bring for mifepristone distribution, but if previous years are any indication of what lies ahead, then loosening safeguards on the drug is a defeat for women and babies everywhere. Physicians must prepare for the new world of loosened restrictions on chemical abortion and find new ways to treat their patients in the most effective way possible since the FDA has failed to protect women against the dangers of chemical abortion, even in the face of countless data sets showing its dangers.

​

__________________

[1] Food and Drug Administration, Mifeprex (Mifepristone) Information, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information, Content current as of 12/16/2021 (Accessed January 5, 2022).

[2] Life Issues Institute, A Closer Look at the Chemical Abortion Pill, https://www.youtube.com/watch?v=CJyx_VKH-J8, 2019. (Accessed January 5, 2022).

[3] James Studnicki, et al, A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015, https://doi.org/10.1177%2F23333928211053965, First Published November 9, 2021 (Accessed January 5, 2022).

[4] Hannah Howard, Medical and Social Risks Associated with Unmitigated Distribution of Mifepristone: A Primer, https://lozierinstitute.org/medical-and-social-risks-associated-with-unmitigated-distribution-of-mifepristone-a-primer/ (October 1, 2020) (Accessed January 20, 2022).

[5] FDA, Letter to Population Council, Dated September 28, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf (Accessed January 6, 2022).

[6] FDA, Letter to Population Council, Dated September 28, 2000, https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf (Accessed January 6, 2022).

[7] Patient Safety Movement, Holly Patterson: As told by Holly’s father, Monty L. Patterson, https://patientsafetymovement.org/patient-safety/patient-stories/holly-patterson/ (Accessed January 6, 2022).

[8] www.SFGate.com, FDA to issue abortion drug warning / RU-486 caution partly in response to local teen's death, https://www.sfgate.com/health/article/FDA-to-issue-abortion-drug-warning-RU-486-2635903.php, 11/16/2004 (Accessed January 6, 2022).

[9] FDA, FDA To Announce Important Labeling Changes for Mifepristone, http://wayback.archive-it.org/7993/20161022130208/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2004/ucm108373.htm, 11/15,2004 (Accessed January 6, 2022).

[10] FDA, Public Health Advisory: Sepsis and medical abortion with mifepristone (Mifeprex), http://wayback.archive-it.org/7993/20161024174900/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm051298.htm, 3/17/2006 (Accessed January 6, 2022).

[11] Hannah Howard, Medical and Social Risks Associated with Unmitigated Distribution of Mifepristone: A Primer, https://lozierinstitute.org/medical-and-social-risks-associated-with-unmitigated-distribution-of-mifepristone-a-primer/ (October 1, 2020) (Accessed January 20, 2022).

[12] FDA, Mifeprex (mifepristone) Information, https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/mifeprex-mifepristone-information, Content current as of 12/16/2021 (Accessed 1/6/2022).

[13] FDA, Questions and Answers about Mifepristone - 9/28/2000, http://wayback.archive-it.org/7993/20161024033541/http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111359.htm (Accessed January 7, 2022).

[14] James Studnicki, et al, A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999–2015, https://doi.org/10.1177%2F23333928211053965, First Published November 9, 2021 (Accessed January 5, 2022).

[15] Charlotte Lozier Institute, Chemical Abortion: FDA Ignores ‘Inconvenient’ Science and Data Confirming Public Health Threat, https://lozierinstitute.org/chemical-abortion-fda-ignores-inconvenient-science-and-data-confirming-public-health-threat/ (December, 16, 2021) (Accessed January 20, 2022).

[16] See https://pubmed.ncbi.nlm.nih.gov/25560122/.

[17] Ibid.

[18] See https://pubmed.ncbi.nlm.nih.gov/19888037/.

[19] See https://pubmed.ncbi.nlm.nih.gov/30253769/.

[20] Ibid.

[21] Ingrid Skop, M.D., F.A.C.O.G., The “No-Test Medication Abortion” Protocol: Experimenting with Women’s Health, https://lozierinstitute.org/the-no-test-medication-abortion-protocol-experimenting-with-womens-health/ (July 30, 2020) (Accessed January 20, 2022).

[22] Ibid.

[23] Ibid.

​

​