At NARAL Pro-Choice Maryland, we believe in the right to choose abortion care as it is essential to ensuring all childbearing individuals can decide for themselves if, when, and how to form their families. While we’re hard at work advancing reproductive rights in Maryland, anti-choice advocates have been hard at work on the federal level fighting this progress. Recently, the American Association of Pro-Life Obstetricians and Gynecologists (AAPLOG) and the American College of Pediatricians have filed a Citizen Petition with the FDA with the goal of restricting the use and dispensing of Mifeprex (mifepristone) and misoprostol.
These drugs are essential components of medical abortion care, and these organizations aim to reinstate regimen and prescriber requirements from 2000. Not only are these organizations looking to roll-back the current regulations on the dispensing of mifepristone, but the petition would also implement the following:
- Limiting Mifeprex use to 49 days instead of 70 days gestation
- Requiring a physician to provide Mifeprex, not a health care provider (i.e. nurse practitioner, clinician, etc).
- Using a sonogram prior to Mifeprex dispensation to rule out ectopic pregnancy
- Requiring the patient physically come to the clinic, medical office, or hospital on three separate occasions
- Televisits and telemedicine appointments/consultations are prohibited for Mifeprex dispensation
- Requiring the patient to have easy access to emergency care
- “Adverse event” reporting should be enhanced and published to the FDA’s MedWatch Program (a public alert platform)
- Requesting the FDA provides guidance to emergency health care facilities about how to distinguish complication following abortion versus spontaneous miscarriage
- Requesting additional studies be conducted for “ at-risk populations”, including patients under the age of 18; patients with repeat use of Mifeprex; patients who have limited access to emergency room services; and patients who self-administer misoprostol
- Mandating the administration of Rh-negative drugs
Mifeprex has been used by millions of individuals seeking medical abortion care and has found to be safe and effective during the first nine weeks of pregnancy. Since its FDA approval in 2000, studies on mifepristone have proven not only is it more than 97% effective, but the side-effects are mild (i.e. cramping, fatigue, nausea) and the rate of severe adverse side-effects (i.e. hemorrhage, infection, and ongoing pregnancy) is very low. This petition suggests that not only is mifepristone and misoprostol ineffective, but both cause severe health complications and death. These new proposed requirements will jeopardize current abortion care in Maryland by limiting where, when, and how one can access Mifeprex and medical abortions. The outcome: pushing abortion care access out of reach for even more people in our state. We’ll never stop fighting to protect and expand this fundamental human right, but we need you!
If you support access to abortion care and want your voice to be heard, please submit a personalized comment to the FDA encouraging them to expand access to Mifeprex and to remove restrictions that would hinder abortion care. You can find comment instructions and suggested language below.
FDA Comment Regulations and Instructions
The more letters of support for Mifeprex the better as the FDA notes single, well-supported comments may carry more weight in the decision making the process. To comment on the current anti-choice petition or restrictions on Mifeprex in general, please be sure to follow these and other FDA comment regulations:
- Address your comments with the following: “Acting Commissioner of Food and Drug, Norman Sharpless, M.D.”
- Be concise in your comments, but be sure to support your claims
- Base your justification on sound reasoning and scientific evidence
- Tell your story! Communicate how you will be impacted by these regulation changes
- Identify credentials and experience that may distinguish your comments from others. If you are commenting in an area in which you have relevant personal or professional experience (e.g., scientist, attorney, health practitioner, etc.) say so.
Original comments on your experience with medical abortion, Mifeprex, and why you believe it is important to expand access to Mifeprex are essential. To assist you in crafting scientifically informed comments for the agency to consider, we have included a number of quick facts that you can choose to include within your comments. Be sure to include the citations!
To submit your comments, follow this link and drop your comments into the text box provided or attach your document. Click the “Continue” tab on the bottom of the screen to review and submit your final comments.
Fact #1: Mifeprex and its use in medical abortion procedures have been proven to be safe and effective with little adverse outcomes. The mortality rate for medication abortion is approximately 1 per 100,000, which is significantly lower than the maternal mortality rate for women bringing their pregnancies to term at 9.8 per 100,000.
- Beal, M. W. (2007). Update on medication abortion. Journal of Midwifery & Women’s Health, 52(1), 23–30.
In a study examining the experiences of patients using mifepristone, 91% of women reported they would choose the mifepristone regimen again if they had another abortion and 97% would recommend the medical abortion method to others.
- Jensen, J.T., et al. (2000). Acceptability of Suction Curettage and Mifepristone Abortion in the United States: A Prospective Comparison Study. American Journal of Obstetrics & Gynecology, 182(6), 1292–9
- Hollander, Dore. (2000). Most Abortion Patients View Their Experience Favorably, But Medical Abortion Gets a Higher Rating than Surgical. Family Planning Perspectives, 32(5), 264.
Among the over 13,000 women who completed a mifepristone regimen in a 2015 study, over 97% reported it effective. The rates of mifepristone effectiveness remained over 95% at all days of gestation with rates of infection requiring hospitalization and rates of transfusion reaching 0.01 and 0.03%, respectively.
- Gatter, M., et al. (2015) Efficacy and safety of medical abortion using mifepristone and buccal misoprostol through 63 days. Contraception. 91(4), 269-73.
In an analysis of medical abortion at Planned Parenthood health centers between 2009 and 2010, significant adverse events or outcomes were reported in less than 1% of the over 200,000 medical abortions provided.
- Cleland, K., et al. (2013). Significant adverse events and outcomes after medical abortion. Obstetrics and Gynecology, 121(1), 166–171.
Telemedicine is an important access point for individuals living in rural or remote areas. Telemedicine availability has resulted in access to abortion services at earlier gestational time periods resulting in fewer health risks and lower costs for patients.
- Grossman D, et al. (2011). Effectiveness and acceptability of medical abortion provided through telemedicine. Obstetrics and Gynecology. 118(2), 296-303.
- Grossman D, et al. (2013). Women’s and providers’ experiences with medical abortion provided through telemedicine: A qualitative study. Women’s Health Issues. 23(2), 117-22
More than 2.75 million women in the United States have used Mifeprex.
- Danco Laboratories, LLC. (2016, March 30). “Mifeprex® (mifepristone): FDA Approves Updated Labeling” [Online]. http://www.earlyoptionpill.com/wp-content/uploads/2016/03/Mifeprex-Label-Update_Press-Release_March302016-1.pdf
Since it’s approval by the FDA in 2000, Mifeprex usage in the United States has grown from 14% of non-hospital medical abortion procedures in 2005 to 23% in 2011.
- Jones, R. K., & Jerman, J. (2014). Abortion Incidence and Service Availability In the United States, 2011. Perspectives on Sexual and Reproductive Health, 46(1), 3–14
Mifeprex and misoprostol have similar safety and efficacy results regardless of who provides it (e.g. nurse practitioners (NPs), certified nurse-midwives (CNMs), physician assistants (PAs), or gynecologists (GYNs)). Restricting its use to physicians only decreases access to safe abortion services in areas without these individuals or resources. It also increases costs for both patient and providers.
- Barnard, S., et al. (2015). Doctors or mid-level providers for abortion. The Cochrane Database of Systematic Reviews, 7, CD011242.
- Taylor, D., et al. (2009). When politics trumps evidence: legislative or regulatory exclusion of abortion from advanced practice clinician scope of practice. Journal of Midwifery & Women’s Health, 54(1), 4–7.
- Yarnall, J., et al. (2009). Non-physician clinicians can safely provide first-trimester medical abortion. Reproductive Health Matters, 17(33), 61–69.