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Congressional_______
R esearch Service
Medication Abortion: New Litigation May
Affect Access
Updated April 19, 2023
After the Supreme Court's decision in Dobbs v. Jackson Women 's Health Organization, there has been
greater focus on federal and state regulation of medication abortion-a pregnancy termination method
involving the use of prescription drugs. Recent attention has centered on how medication abortion 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 high-profile litigation that raises questions about the future availability of these products. Recently, two
federal district courts issued conflicting decisions in litigation over current federal requirements for
medication abortion drugs. At the time of this writing, the Supreme Court is considering whether to stay
enforcement of an order issued by a district court in one of those cases. The lower court's order would
effectively reinstate earlier, more rigorous federal controls on medication abortion drugs while litigation
over the current federal requirements continues. This Legal Sidebar explores federal and state regulation
of medication abortion drugs, 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 requirements of the Federal Food,
Drug, and Cosmetic Act (FD&C Act). 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
Congressional Research Service
https://crsreports.congress.gov
LSB10919
CRS Legal Sidebar
Prepared for Members and
Committees of Congress](ViewImageLocal?handle=hein.crs/govelip0001&div=1&collection=&method=preview&ext=.png&size=3)