The Availability and Use of Medication Abortion
Medication abortion, also known as medical abortion or abortion with pills, is a pregnancy termination protocol that involves taking two different drugs, Mifepristone and Misoprostol, that can be safely used up to the first 70 days (10 weeks) of pregnancy. Since the U.S. Food and Drug Administration (FDA) first approved the drug in 2000, its use in the United States has quickly grown, with over a third of abortions at 8 weeks gestation or less being medication abortions. While this protocol involves taking two medications and does not involve a medical procedure, it is subject to many of the same abortion-specific provider restrictions as other abortion methods, at both the state and federal levels. This factsheet provides an overview of medication abortion, with a focus on federal and state regulations pertaining to its provision and coverage, and the role of the drug in self-managed abortions.
What is a Medication Abortion?
The most common medication abortion regimen in the United States involves the use of two different medications: mifepristone and misoprostol. Mifepristone, sold under the brand name Mifeprex and also known as the abortion pill, RU-486, blocks progesterone, a hormone essential to the development of a pregnancy, and thereby prevents an existing pregnancy from progressing. Misoprostol, taken 24-48 hours after mifepristone, works to empty the uterus by causing cramping and bleeding, similar to an early miscarriage. A follow-up visit is typically scheduled a week or two later, to confirm that the pregnancy was terminated via ultrasound or blood test. Medication abortion is a safe and highly effective method of pregnancy termination if the pills are administered at 9 weeks’ gestation or less, the pregnancy is terminated successfully 99.6% of the time, with a 0.4% risk of major complications, and an associated mortality rate of less than 0.001 percent (0.00064%).
Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. The FDA first approved Mifeprex in 2000, and in 2016, the FDA approved a new evidence-based regimen and drug label, which guides current clinical practice. This regimen approves use of medical abortions for up to 70 days (10 weeks) of pregnancy (Table 1).
|Table 1: FDA Mifepristone and Misoprostol Regimen|
|Max. gestational age||Up to 70 days LMP* (10 weeks)|
|Mifepristone dosage||200mg (one pill), taken orally|
|Mifepristone administration||Dispensed in office; Where the medication must be taken (home or clinical setting) is not specified|
|Misoprostol dosage||800µg (4 pills), taken buccally (placed in cheek) or vaginally|
|Misoprostol timing||24-48 hours after mifepristone buccally, or 6-72 hours after mifepristone vaginally|
|Misoprostol administration||Taken at home|
|Follow-up visit||7-14 days after mifepristone, no location specified|
|Prescriber requirements||By or under the supervision of a prescriber that has been certified by the manufacturer|
|Note: *LMP – Last Menstrual Period|
|Source: FDA, Mifeprex (mifepristone) Information, February 2018.|
Risk Evaluation and Mitigation Strategies (REMS)
Mifepristone cannot be dispensed by retail pharmacies like most other medications; rather pregnant patients can only obtain the drug directly from a certified medical provider who has filled out a prescriber agreement form from the manufacturer about the proper use of the drug. This is because the FDA has applied a Risk Evaluation and Mitigation Strategy (REMS) for Mifeprex since 2011 (See Box 1).
Box 1: What are REMS and ETASU?
|Since 2007, the FDA has had the authority to require Risk Evaluation and Mitigation Strategy (REMS) programs from drug manufacturers for specific drugs to ensure that its benefits outweigh its risks. The FDA must consider a variety of factors when determining the necessity of a REMS including: the seriousness of the disease or condition to be treated, the size of the population expected to use the drug, expected duration of treatment, and the seriousness of adverse events. There are currently 61 FDA approved REMS programs are typically required for drugs known to be associated with potential serious complications or contraindications, such as antipsychotics, opioids, testosterone, and drugs used to treat cancer, acne, and multiple sclerosis. These programs may include a medication guide, a patient package insert, and/or a communication plan to educate providers on the safe use of the drug.
If the FDA decides these measures are not sufficient to safely allow the drug on the market, the agency may require a more stringent version of REMS, including one or more Element to Assure Safe Use (ETASU). More than half of the currently approved REMS programs have one or more ETASU. FDA guidelines stipulate that an ETASU “must be commensurate with the specific serious risk listed in the drug’s labeling, and must not be unduly burdensome on access to the drug, especially for patients with serious or life-threatening diseases and who have difficulty accessing healthcare.”
A variety of organizations, such as the American College of Obstetricians and Gynecologists (ACOG), support the elimination of REMS regulations for mifepristone, which they maintain are medically unnecessary and impede access to medical abortion. The former FDA commissioner, Jane Henney, and physician Helene D Gayle published a perspective arguing that the FDA should reevaluate the REMS regulations, in light of studies that show mifepristone as safe and effective. Some advocates suggest that the REMS process limits the pool of providers and consequently delay care for pregnancy patients, as they must search for certified providers. Finally, some providers are challenging the REMS designation for mifepristone in court.
The FDA guidelines and label for Mifeprex apply equally to the approved generic. The FDA-approved REMS program for Mifeprex, and now, the generic mifepristone, also includes Element to Assure Safe Use (ETASU), a stronger version of REMS, and contains three provisions:
- Mifepristone must be dispensed to patients only in certain healthcare settings, specifically clinics, medical offices, and hospitals, by or under the supervision of a certified prescriber;
- A provider must become a certified prescriber by completing and sending a Prescriber Agreement Form to the specific distributor, Danco Laboratories or GenBioPro, which confirms they are able to assess the duration of a pregnancy, diagnose ectopic pregnancies, and provide surgical abortion in the case of an incomplete abortion;
- The certified prescriber must obtain a signed Patient Agreement Form from the woman before dispensing the drug, as documentation of safe use conditions.1
In October 2017, the American Civil Liberties Union (ACLU) filed a lawsuit, on behalf of a group of providers, against the FDA challenging the REMS requirements for mifepristone. These plaintiffs cite the low rate of complications associated with medical abortions and assert that other drugs with similar or more serious risks do not have REMS restrictions, and are unduly burdensome on patients trying to access the drug, particularly patients in rural or medically underserves areas. The case is still pending in front of the District Court of Hawaii.
In May 2020, ACOG and other provider groups filed a subsequent lawsuit challenging the REMS requirement that mifepristone be dispensed in person in response to the need to have an alternative to the in-person requirement because of the pandemic. In July of 2020, the federal district court ruled that the FDA was required to temporarily suspend the REMS in-person requirement during the pandemic emergency while the case worked its way through the courts. The Trump Administration appealed this lower court’s ruling and in January of 2021, the Supreme Court ruled in favor of the Trump FDA, allowing them to again enforce the in-person dispensation of mifepristone during the pandemic. This action effectively blocked the ability of nearly all providers to dispensing medication abortion pills by mail during the COVID-19 emergency, as many providers had temporarily been able to do since July of 2020.
On April 12th, 2021, the FDA’s Center for Drug Evaluation and Research (CDER) notified ACOG that they will “exercise enforcement discretion” during the ongoing public health emergency with respect to in-person dispensing requirements of mifepristone based on a safety review. Effectively, this will allow providers in states that do not have laws that would otherwise ban this practice to dispense mifepristone using the telehealth protocol for medication abortion.
On May 7th, 2021, in response to the ACLU lawsuit, the FDA announced in a court filing that a review of the REMS is currently underway. An update to the FDA review is expected in December 2021.
Federal and state-level regulations have effectively limited the use of mifepristone, particularly in underserved areas without a nearby clinic. Studies show providers of medication abortion are mostly concentrated where surgical abortion is already available. Many state laws regulating abortion providers apply to all types of abortion procedures. For example, 17 states require the clinic to meet structural standards comparable to ambulatory surgical centers, such as maintaining standard operating rooms, surgical examination tables, and more. Seven states require that abortion providers have hospital admitting privileges or an alternative arrangement in place. Many states have also passed laws specifically pertaining to medication abortion, such as specific counseling and provider requirements. Currently, 33 states permit only licensed physicians to dispense mifepristone pills (Figure 1). Research demonstrates that advanced practice clinicians (APCs), such as nurse practitioners, physician assistants, or nurse-midwives, can dispense provide abortion pills as safely as physicians can, but they are only permitted to do so in 17 states and DC.
Arkansas, Idaho, Kentucky, Nebraska, Oklahoma, South Dakota, and Utah have enacted laws that require providers to counsel patients that medication abortion may be reversed if given a high dose of progesterone after taking mifepristone despite a lack of scientific evidence to support this claim. Similar laws were passed in Arizona, North Dakota, and Kansas, with courts blocking the laws in Arizona and North Dakota, and the Governor vetoing the bill in Kansas.
Insurance Coverage and Costs
Insurance coverage for abortion is heavily regulated at both the federal and state level. Since 1977, the federal Hyde Amendment has banned the use of any federal funds for abortion, unless the pregnancy is a result of rape, incest, or if it is determined to endanger the woman’s life. After the FDA approved Mifeprex in 2000, this law also applied to medication abortions. However, a 2019 study from the U.S. Government Accountability Office (GAO) found that 14 state Medicaid programs do not cover mifepristone even in the cases of rape, incest, and life endangerment as is required by the Hyde amendment.
States also regulate fully insured private insurance, including plans on the Affordable Care Act (ACA) Marketplaces. 11 states limit abortion coverage in private insurance plans – some of these states follow the Hyde exceptions, while others are more restrictive. In 2020, 33 states had no ACA Marketplace plans that offered abortion coverage, with 26 states categorically banning it. Several plans that offered coverage for abortion procedures did not cover medication abortion, and some plans that did offer abortion coverage had differences in gestational limits, annual/lifetime caps on claims, and coverage of mifepristone. Conversely, six states (California, Illinois, Maine, New York, Oregon, and Washington) require all state-regulated private health plans (including Marketplace plans) to include abortion coverage. Self-insured plans are not regulated by state insurance law, and federal law does not ban or require abortion coverage in self-insured plans. Although there has been no recent research on abortion coverage offered by fully insured plans in the remaining 33 states and the District of Columbia, Danco Laboratories offers a collection of state payer policies and how they relate to Mifeprex.
In 2014, the average amount paid for a medication abortion up to 10 weeks was $535, while the average amount paid for an abortion in a clinic and local anesthetic was $508. Although Danco Laboratories does not make the cost of Mifeprex public, providers report that Mifeprex costs them around $90 a pill. GenBioPro, the manufacturer of the generic mifepristone drug also does not report the cost of their pill, but has stated that they want to drive down costs for those who choose medication abortion.
For those who do not have abortion coverage, there are other a limited means of financial support, promoted on both Danco and GenBioPro’s website. The National Abortion Federation, as well as local abortion funds are sometimes able to cover some of the cost of an abortion (including travel) for a pregnant person. Outside of these funding sources or a sliding fee scale clinic, there are few options to help with abortion costs.
Although the overall rate of abortion has continued to decline, the use of medication abortion has greatly increased over the years, and now makes up roughly 41% of all abortions at 8 weeks gestation or less (Figure 2).
According to Danco Laboratories, by 2016, over 2.75 million women in the United States have used Mifeprex since its FDA approval in 2000. Data from the Centers for Disease Control and Prevention (CDC) shows that from 2007 to 2016, reported abortions at 8 weeks gestation or less increased by 2.5%, while reported abortions between 9-13 weeks decreased by 7.9%. A 2017 Guttmacher Institute Report found that medication abortion performed up to 9 weeks gestation accounted for 39% of all nonhospital abortions.
Telemedicine, or telehealth, can be used to expand access to health services in areas where the number of providers is limited. Many women, particularly those who live in rural communities, have to travel long distances to obtain abortion services, which has raised interest in the potential of telemedicine to expand access medication abortion. Because the newest FDA label allows women to take the pills after leaving the clinic, telemedicine has emerged as a viable option to expand the availability of abortion to women who are either unable to travel to clinic or for other reasons wish to have an abortion in the privacy of their own home.
As part of efforts to limit abortion access, many states have taken action to block the use of telemedicine for abortion. Five states, Arizona, Arkansas, Missouri, Louisiana, and West Virginia, have passed laws specifically banning telemedicine for abortion provision. In addition, 15 other states have enacted laws that require the clinician providing a medication abortion to be physically present during the procedure, effectively prohibiting the use of telemedicine to dispense medication for abortion remotely (Figure 3).
Self-managed abortion, sometimes referenced as “self-induced” or “at-home” abortion, is when a person ends a pregnancy outside the medical care setting, typically by ordering abortion pills online. This practice is illegal in the U.S., but is permitted in some other countries. Women may seek to manage their own abortion for many reasons, including clinic access barriers, cost, transportation, and privacy. The median cost of mifepristone-misoprostol products ordered online is approximately $205, about half of the average charge for a clinic abortion. Legal barriers, such as the threat of criminal charges, to self-managed abortion affect pregnant people as well as those who help them in ending their pregnancy.
Women Help Women, which already operates to provide pills to women in other countries, recently launched Self-managed Abortion; Safe and Supported (SASS), to provide information about self-managed medication abortion to women in the United States. However, due to legal barriers, they do not ship pills to women in the United States. A few projects, such as the Plan C Campaign, are now working to inform women in the US about self-managed abortions, including how to appropriately take the drugs, how they might access funds to pay for them, and a list of online retailers with reviews on price, ship time, product quality, and physician oversight. The FDA has issued warning letters to some of these organizations, including Aidaccess.org and RAblon, asking them to immediately cease the introduction of abortion medications into the U.S., as mifepristone may only be legally dispensed using the REMS protocol.
Even as overall rates of abortion decline, the use of medication abortion has grown significantly since its approval by the FDA in 2000. The drug’s availability may have shifted the average time abortions occur to earlier in pregnancy. Its uptake, however, has been limited by federal and state regulations, including the FDA REMS requirement, bans on telemedicine and requirements for in-person dispensation of mifepristone, and requirements for in-person counseling visits and other tests that are not medically recommended for safety. While some states continue to impose regulations that restrict access, others are exploring ways of increasing access by allowing non-physician clinical providers to prescribe mifepristone and testing the effectiveness of telemedicine to expand access to abortion services for those who seek them.
Following the 2016 label change, the provider no longer is required to give each woman a copy of the Mifeprex Medication Guide.