Legal Sidebari

Medication Abortion: A Changing Legal
Landscape
Updated July 8, 2022
Following the Supreme Court’s recent 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 regulated under the Federal Food, Drug, and Cosmetic Act
(FD&C Act). Recent attention has centered on the availability of these drugs, as the drugs’ availability
may allow those residing in areas with few or no abortion providers to have access to an elective abortion.
The Food and Drug Administration (FDA) regulates the distribution of mifepristone (sold under the brand
name Mifeprex), and the agency’s current policies allow the drug to be prescribed via telehealth and sent
to patients through the mail under specified conditions. At the same time, state legislatures have taken
steps to regulate access to medication abortion, including, since the Court’s decision in Dobbs, proposing
specific 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 decisions in Roe v.
Wade and Planned Parenthood of Southeastern Pennsylvania v. Casey, as well as other cases that
recognized a woman’s constitutional right to terminate a pregnancy. Now that the Court’s majority
opinion in Dobbs has overruled Roe and Casey, a state’s ability to restrict or prohibit access to these drugs
may solely 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 and issues regarding federal preemption, and considerations for 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 pursuant to the agency’s authority under 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,
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meet particular qualifications (e.g., the ability to accurately assess the duration of a pregnancy), and
ensure that patients receive and sign a patient agreement form relating to mifepristone use.
The 2019 version of the REMS 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 COVID-19 public
health emergency. As enforcement remains currently on hold, FDA announced that data support long-term
modifications to the REMS and that future modifications would remove the in-person dispensing
requirements and add a new certification requirement for pharmacies that dispense mifepristone. While
this REMS modification has not been formally implemented, it appears FDA’s decision to modify the
REMS was 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. Additionally, on July 8,
2022, President Biden issued an Executive Order directing the Secretary of Health and Human Services to
submit a report within 30 days identifying possible actions to protect and expand access to medication
abortion and other types of abortion care.
State Restrictions on Medication Abortion
Aside from mifepristone regulation under the FD&C Act, numerous states have enacted laws that aim
specifically 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 rational basis review 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, as of the date of this Sidebar, 13 states
have adopted so-called trigger laws that prohibit abortion and take effect once a constitutional right to
abortion is no longer recognized. Because many of these laws seem to apply to both surgical and
medication abortions, the availability of mifepristone could be severely restricted in these states.

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Medication Abortion After Dobbs: Considerations for Congress
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
states are seeking to take these restrictions further and prohibit use of 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 central
oversight role in determining the safety and efficacy of prescription drugs that are marketed in the United
States. 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,
ZohydroER, 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’ ban
on the drug was an “obstruction” that undermined FDA’s authority in making “drugs available to promote
and protect the public health.” Massachusetts later established other requirements for ZohydroER
prescribers to take certain actions when prescribing the drug and pharmacies to take specified steps to
prevent diversion of the drug, and the district court declined to enjoin the new requirements.
Other state requirements governing medication abortion may also be examined by courts. In an ongoing
federal district court case, Genbiopro, Inc. v. Dobbs, a pharmaceutical company that markets and sells
mifepristone is challenging 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 argues, 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, contends 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 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.
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

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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
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 provides 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 by Casey.
Questions involving the relationship between existing state medication abortion requirements and FDA’s
mifepristone regimen may also prompt additional federal legislation that clarifies the degree to which
federal regulation of medication abortion drugs preempts state or local measures inconsistent with federal
policy. To date, it appears that this kind of legislation has not been introduced.

Author Information

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





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LSB10706 · VERSION 3 · UPDATED

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