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 half 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 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%).

FDA Protocol

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). Until 2019, mifepristone was only sold under the brand name Mifeprex, manufactured by Danco Laboratories. In 2019, the FDA approved GenBioPro, Inc.’s application for generic mifepristone.

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 Can be dispensed via mail or by pharmacy; Dispensed in office in states that ban telehealth for medication abortion.
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)

In 2011, the FDA added a Risk Evaluation and Mitigation Strategy (REMS) to the dispensing requirements for mifepristone permitting only medical providers who had obtained  certification from the manufacturer to prescribe and directly dispense the drug. This requirement not only limited the number of clinicians able to prescribe medication abortions, but also necessitated an in-person visit to a health care setting and meant patients could not obtain the medication from a retail pharmacy or by mail.

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. During the pandemic, ACOG and other provider groups filed a lawsuit challenging the REMS requirement that mifepristone be dispensed in person in response to the importance of having an alternative to the in-person requirement because of the public health emergency.

On May 7th, 2021, in response to the ACLU lawsuit, the FDA announced in a court filing that a review of the REMS was underway. On December 16, 2021, the FDA removed the in-person dispensing requirement for mifepristone and expanded the distribution to certified pharmacies in addition to certified clinicians. This change allows for distribution of medication abortion by mail in states that do not restrict telehealth for medication abortion. This change to the dispensing requirement came after an extensive scientific review of the safety of medication abortion as prompted by the ACLU and ACOG lawsuits. Despite the change to the in-person requirement, prescribers are still required to be certified by the manufacturers. In April of 2022, Danco Laboratories and GenBioPro (the two manufacturers of mifepristone) are expected to submit proposed protocols to the FDA to describe how they certify pharmacies, after which the FDA has 180 days to review or modify the submissions. Pharmacies may be able to dispense mifepristone by late 2022. Box 2 shows the change in REMS from 2011 to 2021.

Box 2: Risk Evaluation and Mitigation Strategy (REMS) 
REMS 2011-2021  REMS as modified December 16, 2021 
The prescribing clinician had to be certified by one of the two mifepristone distributors (Danco Laboratories and GenBioPro).   Broadens to Certified Pharmacists: The prescribing clinician or pharmacist must be certified by one of the two mifepristone distributors (Danco Laboratories and GenBioPro).  
The prescriber had to obtain a patient agreement form from the patient before dispensing mifepristone.  No change: The prescriber must obtain a patient agreement form from the patient before dispensing mifepristone. 
The prescriber could only dispense to patients in health care settings.   Removed health care setting dispensing requirement: mifepristone may be dispensed by certified pharmacies and through the mail. 

Availability

Federal and state-level regulations have effectively limited the use of mifepristone, particularly in underserved areas without a nearby clinic. Studies show clinicians providing medication abortion are mostly concentrated where surgical abortion is already available. Many state laws regulating clinicians who provide abortion care 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 clinicians who provide abortion care, including those that offer only medication abortion, to 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 clinician 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 18 states and DC.

ArkansasIdahoKentuckyNebraskaOklahomaSouth Dakota, and Utah have enacted laws that require patients to be counselled 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 ArizonaNorth 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 (CaliforniaIllinoisMaineNew YorkOregon, 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 with 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 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.

Use

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 54% 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 2004 to 2019, reported medication abortions at 9 weeks gestation or less increased by 219.6%. A  2021 Guttmacher Institute Report found that medication abortion accounted for 54% of all nonhospital abortions.

Telehealth

Telehealth can be used to expand access to health services in areas where the number of clinicians who provide abortion care is limited. Many patients, particularly those who live in rural communities, must travel long distances to obtain abortion services, which has raised interest in the potential of telehealth to expand access medication abortion. Because the updated FDA label now allows for telehealth, mifepristone has emerged as a viable option for patients who are either unable to travel to clinic or for other reasons wish to have an abortion in the privacy of their own home, if permitted by state law.

As part of efforts to limit abortion access, some states have taken action to block the use of telehealth for abortion. Six states, ArizonaArkansasMissouriLouisiana, Texas, and West Virginia, have passed laws specifically banning telehealth for abortion provision. In addition,14 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 telehealth to dispense medication for abortion remotely (Figure 3).

Self-Managed Abortion

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. Patients may seek to manage their own abortion for many reasons, including clinic access barriers, cost, transportation, and privacy. 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 patients in other countries, recently launched Self-managed Abortion; Safe and Supported (SASS), to provide information about self-managed medication abortion to patients in the United States. However, due to legal barriers, they do not ship pills to patients in the United States. A few projects, such as the Plan C Campaign, are now working to inform patients 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.

Conclusion

The use of medication abortion has grown significantly since its approval by the FDA in 2000. The FDA update of the REMS has the potential to expand the availability of medication abortion and broaden the use of telehealth dispensing. However, state bans on telehealth and requirements for in-person dispensation of mifepristone, and requirements for in-person counseling visits and ultrasounds that are not medically recommended will continue to restrict access in many states.

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