HeinOnline is a subscription-based resource containing thousands of academic and legal journals from inception; complete coverage of government documents such as U.S. Statutes at Large, U.S. Code, Federal Register, Code of Federal Regulations, U.S. Reports, and much more. Documents are image-based, fully searchable PDFs with the authority of print combined with the accessibility of a user-friendly and powerful database. For more information, request a quote or trial for your organization below.
![handle is hein.crs/govelji0001 and id is 1 raw text is:
SCon gressionaI
R.fesearch Service
Medication Abortion: New Litigation May
Affect Access
Updated April 24, 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. On April 21, 2023, the Supreme Court stayed enforcement of an order issued by a
district court in one of those cases, leaving the current federal regulatory framework in place as the
litigation proceeds. 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
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,
Congressional Research Service
https://crsreports.congress.gov
LSB10919
CRS Legal Sidebar
Prepared for Members and
Committees of Congress](ViewImageLocal?handle=hein.crs/govelji0001&div=1&collection=&method=preview&ext=.png&size=3)