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FDA Mifeprex Comment Action Page

Instructions     Template     Quick Facts

At NARAL Pro-Choice Maryland, we believe in the right to choose abortion care as it is essential to ensuring that 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 medication 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 that only a physician is authorized to provide Mifeprex, not other advanced medical 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 complications 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 medication abortion care and has found to be safe and effective during the first nine weeks of pregnancy. These new proposed requirements will jeopardize current abortion care in Maryland by limiting where, when, and how one can access Mifeprex and medication 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.  Please submit your comments by SEPTEMBER 28th, 2019!

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 FDA comment regulations:

  1. Be concise in your comments, but be sure to support your claims
  2. Base your justification on sound reasoning and scientific evidence
  3. Tell your story!  Communicate how you will be impacted by these regulation changes
  4. Identify credentials and experience that may distinguish your comments from others. If you are commenting on an area in which you have relevant personal or professional experience (e.g., scientist, attorney, health practitioner, etc.) say so.

Comments on your experience with medication abortion, Mifeprex, and why you believe it is important to expand access to Mifeprex are essential.  To assist you in crafting comments, we have crafted a template as well as 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.

Petition Comment Template

The following language may be used in constructing your statements:

Acting Commissioner of Food and Drug, Norman Sharpless,

My name is [insert name here]. I am a [insert profession/credentials] in the State of Maryland, a state that has recognized the importance of Mifeprex and its role in abortion coverage. Because I am a supporter of reproductive rights and freedom, I am deeply concerned about the changes proposed in this petition and the impacts this would have on abortion access in my state.

[Insert Your Thoughts Here]

These new proposed requirements will jeopardize individual health and current abortion care in by limiting where, when, and how one can access Mifeprex and medication abortion. There are many reasons why regulations on mifepristone and misoprostol should not be rolled back.

[Insert Your Thoughts Here]

The freedom to make one’s own family planning and health decisions is important and will adversely impact those in my community should these restrictions be enacted. I encourage you to consider expanding access to Mifeprex and to remove restrictions that would hinder its use in the future.

Sincerely,

[Insert Signature]

Quick Facts

Fact #1: Mifeprex and its use in medication abortion protocols 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.

Fact #2: 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.  97% would recommend the medication 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.

Fact #3: 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% throughout the 63 days 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.

Fact #4: Significant adverse events were reported in less than 1% of the over 200,000 medication abortions provided at Planned Parenthood health centers between 2009 and 2010.

  • Cleland, K., et al. (2013). Significant adverse events and outcomes after medical abortion. Obstetrics and Gynecology, 121(1), 166–171.

Fact #5: 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

Fact #6: 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

Fact #7: Since it’s approval by the FDA in 2000, Mifeprex usage in the United States has grown from 14% of non-hospital medication abortion protocols in 2005 to 23% in 2011.  More people rely on medical abortion over the last decade.

  • 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

Fact #8: Mifeprex and misoprostol have similar safety and efficacy results regardless of who provides it.  Nurse practitioners (NPs), physician assistants (PAs), and gynecologists (GYNs) can administer Mifeprex.  Restricting this to physicians only decreases access to abortion services in areas without these individuals or resources.  It also increases costs for both patients 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.

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We fight for a future that includes access to all reproductive health care no matter your zip code or employer. Maryland must lead the charge. Are you with us?