Legal Sidebari

Medication Abortion: New Litigation May
Affect Access
Updated April 14, 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. 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 sponsor of the application (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
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. Earlier REMS versions
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also imposed other controls on prescribing and dispensing mifepristone, including three mandatory in-
person office visits to health care providers in certain specified health care settings (reduced to one in-
person visit in 2016). In January 2023, an update to the REMS allowed patients to obtain the drug without
an in-person visit to a clinician, including through the mail from certified prescribers or pharmacies.
Aside from the FDA’s regulation of mifepristone, several states have enacted measures to limit access to
medication abortion drugs. Using their police powers to regulate for health, safety, and welfare, states
have established requirements related to the types of health care providers who may prescribe
mifepristone and the conditions under which the drug may be available. For instance, according to one
recent report, numerous states provide that only licensed physicians may prescribe medication abortion
drugs. The report also identifies many states that require health care providers to be in the physical
presence of the patient when prescribing these drugs or otherwise restrict the use of telehealth.
Additionally, some states have adopted more stringent requirements on medication abortion, including
measures that prohibit access to these drugs except under narrow circumstances (e.g., following rape or
incest). These types of state provisions aim, at least in some cases, to impede medication abortion access
beyond what federal law would otherwise permit. Questions have arisen about the interaction between
these federal and state regulatory regimes.
Litigation over Medication Abortion Access
In recent months, plaintiffs have filed at least four cases that target the regulation of medication abortion.
Two of the lawsuits concern federal mifepristone regulation and assert claims that FDA’s actions relating
to the drug are unlawful. The other two cases challenge the validity of state medication abortion
restrictions.
Challenges to Federal Regulation of Mifepristone
Two lawsuits making their way through the court system contest FDA’s actions with respect to
mifepristone, the basis for their claims are widely inconsistent. While one suit alleges that FDA
unlawfully approved the use of mifepristone for terminating a pregnancy, the other suit claims that 2023
mifepristone REMS unlawfully restricts access to the drug.
In Alliance for Hippocratic Medicine v. FDA (Alliance), plaintiff medical organizations and doctors sued
FDA and Biden Administration officials, asking the U.S. District Court for the Northern District of Texas
to vacate FDA’s mifepristone approval in an effort to take the drug off the market. Plaintiffs made several
arguments about the agency’s initial approval and subsequent administrative actions related to the drug,
including that FDA violated the Administrative Procedure Act (APA) when it (1) impermissibly used the
so-called Subpart H regulations, a regulatory approval pathway that is only available for treating serious
or life-threatening illnesses (and that pregnancy is not such an illness); (2) failed to examine or
inappropriately disregarded scientific evidence in approving and setting distribution controls for the drug;
and (3) improperly ignored the so-called Comstock Act, federal criminal provisions that restrict the
distribution of drugs or other abortion-related articles through the mail or other carriers. Danco
Laboratories, the company that sells the brand-name version of mifepristone, moved to intervene in the
litigation and is also a defendant in the case.
In response to these arguments, FDA countered that the plaintiffs lack standing to sue, the majority of
their claims are untimely, and that the agency properly exercised its FD&C Act authority and applied its
scientific expertise to make determinations about mifepristone that are entitled to “substantial deference.”
The agency also stressed the lawsuit’s uniqueness, noting that FDA identified no other example “where a
court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-
approved drug to be removed from the market.” Additionally, FDA maintained that the agency need not
consider the Comstock Act in regulating mifepristone, and that, in accordance with earlier judicial

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decisions and as addressed in a recent Justice Department memorandum, the Act is inapplicable when the
sender of the product intends for the product to be used lawfully.
On April 7, 2023, the Texas district court issued a preliminary injunction in the plaintiffs’ favor and
ordered a stay of FDA’s approval of mifepristone, thus suspending the legal basis for the drug’s sale and
distribution nationwide. The court held, among other things, that in initially approving mifepristone under
the Subpart H regulations, FDA overstepped its authority and improperly relied on “plainly unsound
reasoning and studies that did not support its conclusions.” The court also determined that the Comstock
Act’s restrictions on mailing abortion drugs prevent FDA from removing the in-person dispensing
requirement, as included in the REMS. Defendants filed a notice to appeal with the U.S. Court of Appeals
for the Fifth Circuit, as well as emergency motions to stay the district court’s order while the appeal is
ongoing.
On April 12, 2023, the Fifth Circuit granted the defendants’ motions in part. Noting that the court may
only grant emergency stays in “extraordinary circumstances,” the appeals court found that the defendants
successfully made this “extraordinary” showing with respect to FDA’s approval of mifepristone in 2000.
The court suggested that because of a six-year statute of limitations provision, the plaintiffs’ challenge to
the approval of the drug may be time-barred. However, the court declined to stay the district court’s order
relating to FDA’s 2016 REMS change and subsequent actions on mifepristone. In other words, under the
Fifth Circuit’s order, FDA’s approval of mifepristone remains in effect pending appeal, along with the
more stringent, pre-2016 distribution controls in place (including in-person dispensing requirements). The
Justice Department issued a statement indicating that it would petition the Supreme Court for emergency
relief in the case.
In contrast, attorneys general of 17 states and the District of Columbia filed suit in State of Washington v.
FDA, alleging, in part, that FDA’s imposition of the 2023 mifepristone REMS unlawfully hampers access
to the drug and is “arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law”
in violation of the APA. The state plaintiffs contend that the REMS restrictions are unduly burdensome to
patients and unwarranted, particularly in light of what the plaintiffs describe as ample evidence regarding
the drug’s safety and effectiveness. In response, FDA and other federal defendants countered that FDA
met its FD&C Act and APA obligations in concluding that the REMS is scientifically justified, necessary
to ensure the benefits of the drug outweigh its risks, and not unreasonably burdensome.
On April 7, 2023, approximately 20 minutes after the Texas district court handed down its order, the U.S.
District Court for the Eastern District of Washington issued a preliminary injunction barring FDA from
“altering the status quo and rights as it relates to the availability of Mifepristone under the current
operative January 2023 [REMS] in Plaintiff States.” The Washington district court determined that FDA
failed to appropriately consider the drug’s safety profile in imposing the REMS. Given the conflicting
nature of the Alliance and Washington opinions, FDA quickly filed a motion for clarification of the ruling,
asking the district court to clarify the agency’s obligations assuming the order in the Alliance case takes
effect. On April 13, district court granted the motion, reiterating that regardless of a ruling in the Fifth
Circuit, FDA cannot alter the “the status or rights of parties” under the 2023 mifepristone REMS in the
plaintiff states. The district court’s ruling in Washington may be appealed to the U.S. Court of Appeals for
the Ninth Circuit (or potentially the Supreme Court).
Challenges to State Law Restrictions
In late January 2023, plaintiffs filed separate cases in North Carolina and West Virginia federal district
courts, alleging that the FD&C Act preempts state restrictions on medication abortion. Under federal
preemption doctrine, federal law may implicitly override state law when, for instance, it is “impossible for
a private party to comply with both state and federal requirements” or if implementation of state law
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Congress.” In Bryant v. Stein, a North Carolina physician sued North Carolina’s Attorney General and
others, asserting that federal law preempts the state’s medication abortion controls, including an in-person
dispensing requirement and a 72-hour waiting period. In the complaint, the physician claims that FDA
developed a precise, data-driven set of regulatory controls for mifepristone and that the state “cannot
stand in the shoes of FDA to impose restrictions on medication access . . . that upset the careful balance
FDA was directed by Congress to strike.” After the North Carolina Attorney General sided with the
plaintiffs in Bryant and argued that federal law preempts the state’s abortion restrictions, two North
Carolina legislators intervened in the case to defend the state’s medication abortion laws.
In GenBioPro v. Sorsaia, a pharmaceutical company that sells the generic version of mifepristone sued
West Virginia officials, challenging state provisions that, among other things, ban abortion generally
(including access to mifepristone) except under limited circumstances. The company claims, in part, that
federal law preempts West Virginia’s requirements, as they are alleged to 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. Defendants in these cases have generally argued
that state restrictions on medication abortion drugs, even bans, are permissible as a way to promote and
protect public health and that nothing in the REMS negates state laws that prohibit the prescription,
administration, or use of medication abortion. District courts have not yet issued a ruling on the
preemption issues raised in these lawsuits.
Considerations for Congress
Judicial decisions in the Alliance, Washington, Bryant, and GenBioPro lawsuits could potentially
transform the legal landscape surrounding medication abortion regulation and affect the conditions under
which medication abortion drugs are accessible to pregnant patients. Most immediately, the conflicting
decisions in Alliance and Washington have created uncertainty as to the current availability of
mifepristone. While the Fifth Circuit’s partial stay order in Alliance generally installs more rigorous
controls on mifepristone nationwide that existed pre-2016, pending appeal of the Texas lower court
decision, the Washington district court’s order in the Ninth Circuit directs FDA to maintain the “status
quo” with respect to the current operative 2023 mifepristone regulation in 17 states and D.C. while the
plaintiff states’ suit is litigated. However, if the Supreme Court chooses to stay the Fifth Circuit’s order
pending appeal, the immediate consequences of the decisions may be minimal. Congress may choose to
await further legal developments in the litigation or may enact legislation that could affect the outcome of
these cases.
Among possible legislative options, Congress could pass legislation that addresses the status of
mifepristone as an FDA-approved drug or otherwise codifies federal standards for the prescribing or
dispensing of medication abortion drugs. An example of this type of bill is the Protecting Life from
Chemical Abortions Act (H.R. 384), which would, among other things, reinstate in-person dispensing
requirements as part of the mifepristone REMS. Another example takes a different approach: the
Protecting Access to Medication Abortion Act (S. 237 and H.R. 767) would generally require FDA to
maintain the mifepristone REMS to allow patients to access prescriptions for mifepristone via telehealth
and certified pharmacies to dispense the drug through the mail to patients (though the REMS would be
able to be modified or removed based on “sound scientific evidence”).
Congress could also clarify the degree to which federal regulation of medication abortion drugs preempts
state measures inconsistent with federal policy. Such legislation could speak to the extent to which states
may set controls on medication abortion drugs subject to FDA oversight. For example, the Protecting
Reproductive Freedom Act from the 117th Congress (H.R. 8976) would have limited states’ ability to
impose restrictions on mailing medication abortion drugs across state lines or requirements that would
compel the in-person prescribing or dispensing of the drugs. Additionally, at the end of the 117th
Congress, the House passed H. Res. 1434. This resolution does not have the force of law but “reaffirms”

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that FDA can regulate reproductive health care products; that those federal requirements have a
preemptive effect on state or local laws that limit access to those products; and that the U.S. Attorney
General has the authority to take legal action against states or localities that restrict access on these
products.
Alternatively, Congress may choose to pass legislation that expressly preserves a state’s ability to regulate
medication abortion drugs. For instance, the Protecting Pain-Capable Unborn Children from Late-Term
Abortions Act (117th Congress, S. 4840) would have prohibited abortion, through the use of drugs or
otherwise, under certain circumstances. The bill also would have specified that it could not be “construed
to preempt or limit any Federal, State, or local law that provides greater protections for an unborn child”
as compared to the relevant provisions under the legislation.

Author Information

Jennifer A. Staman

Legislative Attorney




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LSB10919 · VERSION 3 · UPDATED

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