AAPLOG Responds to ACOG’s Advocacy and Health Policy statement “Understanding the Practical Implications of the FDA’s December Mifepristone REMS Decision”

ACOG recently released a document on “Understanding the Practical Implications of the FDA’s December Mifepristone REMS Decision,” as well as a statement on the importance of facts with respect to ectopic pregnancy. [1] [2]  Although ACOG claims to represent more than 60,000 medical professionals and to maintain the “highest standards of clinical practice for women’s health care”, these latest statements promote an agenda, that is not only out of step with the views of most OB/GYNs, but is a departure from quality healthcare for women. [3] Not only did ACOG initiate the push for the demedicalization of medication abortions by suing the FDA to remove the in-person visit requirement during the COVID-19 pandemic, but their recent statement on the FDA’s Mifepristone REMS decision encourages practices that interrupt the physician-patient relationship and removes key protections for women seeking medication abortions.

AAPLOG recognizes several significant concerns in ACOG’s recommendation.  First, ACOG claims that the in-person requirement, still maintained by some states, has disproportionate adverse effects on women of color and women in rural settings who are far from a healthcare facility.  The truth is that providing access without a medical examination, ultrasound, and in-person counseling does just the opposite.  An in-person visit and ultrasound are needed in order to determine pregnancy location and provide adequate in-person informed consent. The in-person requirement also helps to protect women from forced abortions by traffickers or partners.  Though ACOG has recently changed their recommendations to say that screening for ectopic pregnancies can be done by asking about risk factors and symptoms,  approximately 50% of women with this potentially life-threatening condition will not have risk factors and may present for abortion prior to experiencing symptoms.[4]  Since black women have not only a higher risk of ectopic pregnancy but also a higher risk of mortality from ectopic pregnancy, missing this diagnosis poses a disproportionate risk to women of color. [5] [6]  Delay of care for an ectopic pregnancy poses a grave and unnecessary risk to women. There may be further delay of care because symptoms of vaginal bleeding and pain can be signs not only of the abortion process, but of an ectopic pregnancy. 

One study showed that 20% of women had an adverse event related to their medication abortions and many of these will need to seek emergency medical care.[7]  AAPLOG has serious concerns for the women who will hemorrhage from an incomplete abortion obtained online yet are hours away from the closest hospital with emergency obstetrical services.  The REMS clearly state that the prescriber must ensure that women have access to medical facilities that can provide resuscitation and transfusion and have the ability or have made plans to provide surgical intervention for incomplete abortion or severe bleeding.[8] Providing medication abortion without providing adequate care for the possible complications is not medical care, but a disservice to women.

By circumventing an in-person visit, women cannot be guaranteed confidential counseling on all of the risks of medication abortion, nor have a safe space to be able to confide in a trusted physician about being forced or coerced into having an abortion, something that has been reported to occur in more than 60% of women obtaining abortions in the US.[9]  One study found that 53% of trafficked women had one or more abortions forced on her. An in-person visit with a physician may be her only chance to discuss this and potentially be helped out of an abusive situation.  One of the reasons for why the UK restricted their “pills by post” program was concerns over domestic violence.[10]  Robbing women of the opportunity to receive fully informed consent and have a safe space to share their concerns is not good medical practice and serves only the abortion industry. [11] 

ACOG also claims that the combination of mifepristone and misoprostol is safe, even beyond the first trimester.  This claim completely ignores the fact that first trimester medication abortions have a four times higher complication rate than surgical abortions in the same time frame.[12]  Even worse, medication abortions done in the second trimester were much more likely to require surgical intervention due to incomplete abortions than those done in the first trimester (38.5% vs. 8%). [13] Without requiring an ultrasound prior to a woman receiving the chemical abortion drugs, not only will ectopic pregnancies potentially be missed (occur in approximately 2% of all recognized pregnancies), but women will likely take the medicines beyond the 10 week gestational age cutoff, increasing the risk of complications. 

Though ACOG claims that ultrasounds are not needed to confirm gestational age, their own Committee Opinion entitled “Methods for Estimating the Due Date” states that 40% of women will be wrong about their gestational age based on last menstrual period (LMP) alone.  If LMP alone is used to determine gestational age and if women are able to obtain these medications online, a significant number of women will take these medications beyond 10 weeks gestation resulting in higher risk of complications. If there is no doctor-patient relationship, they will be left to find care on their own and present to their local emergency room if they have one.

These advocacy statements from ACOG not only ignore the wealth of scientific evidence that clearly shows the dangers of what they are advocating for, but they are also out of step with how the majority of OB/GYN’s in this country practice. Advocating for less medical oversight of a potentially dangerous drug like mifepristone is medical malpractice and it is time for ACOG to return to recommendations based on what is safest and best for women.

AAPLOG provides further information on the dangers of the FDA’s recent decision on the mifepristone REMS in the Committee Opinion, “Dangers of Relaxed Restrictions on Mifepristone.”[14]