Medication Abortion: A Changing Legal Landscape

Medication Abortion: A Changing Legal Landscape

Legal Sidebari

Medication Abortion: A Changing Legal
Landscape
Updated October 5, 2022
Following the Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, questions
have been raised about continued access to medication abortion, a pregnancy termination method
involving the use of prescription drugs. Recent attention has centered on the availability of these drugs, as
their availability may allow those residing in areas with few or no abortion providers to access an elective
abortion. The Food and Drug Administration (FDA) regulates the distribution of mifepristone (sold under
the brand name Mifeprex) pursuant to its authority under the Federal Food, Drug, and Cosmetic Act
(FD&C Act), and the agency’s current policies may permit the drug to be dispensed to patients without an
in-person visit to a health care provider. At the same time, state legislatures have taken steps to restrict
access to medication abortion, including bans on medication abortion drugs under particular
circumstances. Prior to Dobbs, such restrictions may have been subject to legal challenge based on the
Court’s abortion-related decisions in Roe v. Wade, Planned Parenthood of Southeastern Pennsylvania v.
Casey, and other cases that recognized a woman’s constitutional right to terminate a pregnancy. Now that
Roe and Casey have been overruled, a state’s ability to restrict or prohibit access to these drugs may
depend on the interplay between state and federal law. This Legal Sidebar explores federal regulations of
medication abortion drugs under the FD&C Act, state efforts to regulate access to medication abortion,
issues related to federal preemption of state law, and related legislation in the 117th Congress.
FDA Regulation of Medication Abortion
According to recent data published by the Centers for Disease Control and Prevention, medication
abortions represented approximately 42% of all U.S. abortions by 2019. The medication abortion regimen
involves using the prescription drug mifepristone, followed by a second drug, misoprostol, to terminate an
early pregnancy. Similar to other prescription drugs available on the market, FDA evaluated and approved
the medication abortion drugs in accordance with requirements of the FD&C Act. As a condition of
mifepristone’s approval, FDA requires compliance with a risk evaluation mitigation strategy, or REMS. In
general, a REMS is an FDA-imposed drug safety plan designed to ensure that the benefits of a drug with
serious potential safety concerns outweigh its risks. While the mifepristone REMS has been modified
over time, the current version requires health care professionals who prescribe the drug to be certified,
meet particular 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.
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The 2019 version of the REMS also specified that mifepristone could only be dispensed in certain clinics,
medical offices, and hospitals, or under the supervision of a certified prescriber (although a patient could
take the drug in a different location, including the patient’s home). After a lawsuit was filed over the
enforcement of the REMS in-person dispensing requirements during the Coronavirus Disease 2019
(COVID-19) pandemic, FDA stated that it would suspend enforcement during the public health
emergency. As enforcement remains currently on hold, FDA announced that data support long-term
modifications to the REMS. As FDA indicated, future modifications would remove the REMS in-person
dispensing requirements and add a new certification requirement for pharmacies that dispense
mifepristone. While the REMS modifications have not been finalized, it appears FDA’s decision to
modify the REMS is intended to allow patients to obtain medication abortion drugs without an in-person
visit to a clinician and through the mail from certified prescribers or retail pharmacies.
State Restrictions on Medication Abortion
Aside from mifepristone regulation under the FD&C Act, numerous states have enacted laws that aim to
restrict access to medication abortion drugs. Using their police powers to regulate for public health,
safety, and welfare, these states have established requirements related to the types of health care providers
who may prescribe mifepristone and the conditions under which it must be prescribed. According to one
recent report, 33 states provide that medication abortion drugs may only be prescribed by a licensed
physician. In addition, the report identifies 19 states requiring the physician to be in the physical presence
of the patient when prescribing these drugs, or place restrictions on the use of telehealth.
State restrictions on medication abortion have occasionally been subject to legal challenge. In 2012, the
Supreme Court of Oklahoma invalidated Oklahoma’s law barring persons in the state from using
mifepristone in ways that contravened FDA’s protocol on dosage and use of the drug. The court held that
the state law impermissibly infringed on a person’s right to obtain an abortion. The U.S. Supreme Court
agreed initially to review Oklahoma Coalition for Reproductive Justice v. Cline, but it later dismissed the
state’s petition for certiorari as improvidently granted, preserving the state Supreme Court’s judgment.
Following the Dobbs decision, a court reviewing a medication abortion law like the one at issue in Cline
may now reach a different conclusion. In overruling Roe and Casey, the majority opinion in Dobbs not
only held that the U.S. Constitution does not guarantee a right to abortion, but also changed the standard
under which laws restricting abortion are to be evaluated. Abortion restrictions will now be evaluated
under a rational basis review standard that is generally more deferential to lawmakers. Applying rational
basis review, a court might conclude that a law prohibiting the use of mifepristone in ways that
contravene FDA protocol is rationally related to a legitimate government interest, such as an interest in
promoting patient safety and maternal health.
The Court’s decision in Dobbs is also likely to have an impact on the availability of medication abortion
in states that broadly prohibit all abortion methods. For instance, 13 states adopted so-called trigger laws
that prohibit abortion and take effect once a constitutional right to abortion is no longer recognized. Other
states have enacted measures in the wake of Dobbs restricting abortion. Because many of these laws seem
to apply to both surgical and medication abortions, the availability of mifepristone could be restricted in
these states.
Medication Abortion After Dobbs: Preemption of State Law
Following the Court’s decision in Dobbs, the evolving legal landscape surrounding medication abortion is
increasingly complex. The mifepristone REMS and federal requirements relating to the conditions under
which the drug may be prescribed and dispensed to patients remain in effect. Against this backdrop, state
provisions that limit the availability of these drugs (e.g., through telehealth or other measures) aim, in at
least some instances, to restrict the drug’s access beyond what federal law would otherwise permit. Some

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states are seeking to take these restrictions further and prohibit medication abortion generally. Questions
may arise about federal preemption of these state laws and the extent to which states may impose
requirements on medication abortion drugs that are subject to FDA regulation.
Pursuant to the Constitution’s Supremacy Clause, federal preemption occurs when a validly enacted
federal law supersedes an inconsistent state law. Preemption may occur in a variety of circumstances,
including when it is “impossible for a private party to comply with both state and federal requirements,”
or if implementation of state law “stands as an obstacle to the accomplishment and execution of the full
purposes and objectives of Congress.”
With respect to medication abortion drugs, a preemption inquiry may involve an analysis of the
relationship between a state’s police power to regulate health and safety matters and FDA’s federal
oversight role in determining the safety and efficacy of prescription drugs. In a 2014 case that addressed
these issues, Zogenix, Inc. v. Patrick, a federal district court examined a Massachusetts order that
generally barred prescribing and dispensing an opioid medication based on concerns about diversion,
overdose, and abuse. Despite the Commonwealth’s argument that the order was a permissible exercise of
its traditional state police powers, the district court issued a preliminary injunction against implementation
of the order, concluding that Massachusetts’s ban on the drug was an “obstruction” that undermined
FDA’s authority to make “drugs available to promote and protect the public health.” Massachusetts later
established requirements for prescribers to take certain actions when prescribing the opioid and for
pharmacies to take specified steps to prevent diversion of the drug, and the district court declined to
enjoin the new requirements.
In one recent federal district court case, Genbiopro, Inc. v. Dobbs, a pharmaceutical company that markets
and sells mifepristone challenged Mississippi state provisions that, among other things, direct physicians
authorized to prescribe an “abortion-inducing drug” to perform a physical examination of the pregnant
patient and compel patients to ingest the medication in a physician’s presence. The company argued, in
part, that federal law preempts Mississippi’s requirements, as they impermissibly conflict with FDA’s
established regimen for mifepristone and frustrate Congress’s objectives in giving FDA authority to
determine measures to address prescription drug risks. Mississippi, on the other hand, contended that
Congress did not give FDA the power to override a state’s authority to regulate the circumstances under
which an abortion may be performed. In August 2022, the company voluntarily dismissed its lawsuit, but
reports suggest that future preemption challenges to state laws restricting access to medication abortion
may be forthcoming.
Related Federal Legislation in the 117th Congress
In Dobbs, the majority opinion maintained that it was returning the authority to regulate abortion “to the
people and their elected representatives.” Following the Court’s decision, additional state abortion
restrictions seem likely, and Congress may also consider federal legislation to regulate the procedure.
Legislation that specifically addresses medication abortion has been in introduced in the 117th Congress.
For instance, the Teleabortion Prevention Act of 2021 (H.R. 5136 and H.R. 626) would require an
abortion provider to be “physically present at the location” of a medication abortion. A provider who
violates the Act would be fined not more than $1,000 or imprisoned for not more than two years, or both.
Those who support a right to abortion and access to medication abortion may promote legislation that
would establish such a right in federal statute. If enacted, the Women’s Health Protection Act of 2021
(WHPA) (H.R. 3755/S. 4132), introduced in the 117th Congress, would guarantee health care providers a
statutory right to provide abortion services and preempt any state law that would limit or restrict that
right. The bill would also establish a corresponding right for patients to obtain abortion services
unimpeded by state law restrictions, such as pre-viability abortion prohibitions. The House passed the
WHPA in September 2021, but the Senate has twice rejected cloture motions to proceed with

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consideration of the bill. A second bill introduced this Congress, the Reproductive Choice Act (S. 3713),
would codify the “essential holdings” of Roe and Casey, and would provide that a state may not impose
an undue burden on a woman’s ability to have an abortion before fetal viability. If enacted, it appears that
the bill would allow abortion restrictions to be evaluated under the standard established in Casey.
Questions involving the relationship between existing state medication abortion requirements and FDA’s
mifepristone regimen may also prompt additional federal legislation that aims to clarify the degree to
which federal regulation of medication abortion drugs preempts state or local measures inconsistent with
federal policy. It appears that at least one proposal of this nature, H.R. 8976, the Protecting Reproductive
Freedom Act, has been introduced.

Author Information

Jennifer A. Staman
Jon O. Shimabukuro
Legislative Attorney
Legislative Attorney

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