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Con gressionaI
Research Service
Medication Abortion: New Litigation May
Affect Access
Updated August 28, 2023
The Supreme Court's decision in Dobbs v. Jackson Women 's Health Organization has spurred significant
debate over federal and state regulation of medication abortion-a pregnancy termination method
involving the use of prescription drugs. Recent attention has centered on how these drugs may provide
broader access to elective abortion, particularly for those residing in areas with few or no abortion
providers. The scope of federal and state authority to regulate medication abortion is the subject of a
number of high-profile lawsuits that raise questions about the future availability of these products. This
Legal Sidebar explores federal and state regulation of medication abortion drugs, ongoing litigation
concerning medication abortion access, and selected legal considerations for Congress.
Background on FDA and State Regulation of Medication Abortion
According to recent data, medication abortions represent roughly half of all U.S. abortions. The
medication abortion regimen typically involves using the prescription drug mifepristone (the only drug
approved by the Food and Drug Administration [FDA] as an abortifacient), followed by a second drug,
misoprostol, to terminate an early pregnancy. Like other prescription drugs available on the market, FDA
evaluated and approved the medication abortion drugs pursuant to Federal Food, Drug, and Cosmetic Act
(FD&C Act) requirements. Under current law, to market a new brand-name drug, a manufacturer must file
a new drug application with FDA, which must include full reports of investigations which have been
made to show whether or not such drug is safe for use and whether such drug is effective in use. FDA
may approve an application if the application's sponsor (e.g., a drug manufacturer or marketer)
demonstrates, among other things, that the drug is safe and effective under the conditions prescribed,
recommended, or suggested in the product's labeling.
As a condition of mifepristone's approval, FDA currently requires compliance with distribution controls
pursuant to a risk evaluation and mitigation strategy, or REMS. In general, a REMS is a drug safety plan
that FDA may impose upon a determination that, among other things, the plan is necessary to ensure that
the benefits of the drug outweigh its risks. While the mifepristone REMS has been modified over time,
the most recent version compels health care professionals who prescribe the drug to be certified; meet
specified qualifications (e.g., the ability to assess the duration of a pregnancy accurately); and ensure that
patients receive and sign a patient agreement form relating to mifepristone use. Earlier REMS versions
Congressional Research Service
https://crsreports.congress.gov
LSB10919
CRS Legal Sidebar
Prepared for Members and
Committees of Congress](ViewImageLocal?handle=hein.crs/govemri0001&div=1&collection=&method=preview&ext=.png&size=3)