Innovations-Magazine-February-2024 - 4

REGULATORY PERSPECTIVES
Let's Talk About: Speech vs. Conduct
Dale J. Atkinson, Esq
The Atkinson Firm
Author's Note:
Let me express my
thanks to NABP for
involving me in its
member magazine.
It is an honor to
provide periodic
articles relevant to the
pharmacy regulatory
community. I hope
that readers benefit from these submissions
written from the perspective of a regulator.
Too often, regulators conflate
regulation and public protection with the
profession and professional promotion.
Recognizing this distinction is critical to
understanding government regulation
and the rights bestowed upon all those
involved in a profession, including the
consumers and licensees themselves.
In the realm of professional regulation,
one of the most addressed legal issues in
recent times relates to the First Amendment
and speech versus conduct. Numerous cases
have been litigated related to mental health
services, veterinary practice, dieticians,
and more, each challenging activity that
was alleged to constitute limitations on
speech. Free speech is a fundamental right
in the United States protected by the First
Amendment of the Constitution. When the
government interjects itself into regulation
and attempts to limit the rights of a licensee
to speak, the First Amendment may be at
issue if the statute in question is challenged.
But what distinguishes speech from conduct?
Consider the following case.
In 2022, the state of Missouri enacted
an amendment to the pharmacy practice
act. The newly enacted statute, signed
on June 22, 2022, and effective in late
August 2022, states:
The [Missouri Board of Pharmacy]
shall not deny, revoke, or suspend, or
otherwise take any disciplinary action
against, [sic] a certificate of registration
or authority, permit, or license required
by this chapter for any person due to
the lawful dispensing, distributing,
2 | FEBRUARY 2024
or selling of ivermectin tablets or
hydroxychloroquine sulfate tablets for
human use in accordance with prescriber
directions. A pharmacist shall not contact
the prescribing physician or the patient to
dispute the efficacy of ivermectin tablets
or hydroxychloroquine sulfate tablets for
human use unless the physician or patient
inquires of the pharmacist about the efficacy
of ivermectin tablets or hydroxychloroquine
sulfate tablets [emphasis added].
Missouri Revised Statutes (MRS)
§338.055.7 (2022)
A pharmacist (plaintiff) is a Missourilicensed
pharmacist in good standing
employed by a pharmacy in St Louis.
As a retail pharmacist, the plaintiff
had recently received prescriptions for
hydroxychloroquine and ivermectin to
fill and dispense to patients. During the
relevant time period, the plaintiff engaged
in numerous discussions with various
doctors and patients disputing the efficacy
of hydroxychloroquine and ivermectin
to treat COVID-19. Indeed, the plaintiff
contacted prescribing physicians expressing
these concerns for their efficacy.
Consistent with the American
Pharmacists Association Code of Ethics, the
plaintiff is said to believe that " counseling
patients and doctors to the best of her
professional judgment is required as a
matter of ethics, even when that means
contacting the patient or doctor to dispute
the efficacy of a given medication. " Based
upon her status as a licensee subject to
regulation by the Missouri Board of
Pharmacy, the plaintiff filed a lawsuit in
the US District Court for the Western
District of Missouri. Arguing violations
of the First Amendment and her right
to free speech, she sought a preliminary
injunction prohibiting the enforcement
of the newly enacted statute, specifically
the second sentence cited and emphasized
previously. The defendants were the
officers and members of the Board in
their official capacities (collectively
referred to as " the defendants " ).
A preliminary injunction is a judicially
imposed remedy that, in this case, would
prohibit the enforcement of the statute
pending a ruling on the merits of the
dispute. In order to justify the imposition
of a preliminary injunction, the court
considers the following elements:
* the threat of irreparable harm to the
moving party;
* the balance between this harm and any
injury that granting the injunction will
inflict on the non-moving party;
* the probability the moving party will
succeed on the merits; and
* the public interest.
In its defense, the defendants first argued
that the plaintiff did not have standing
to assert these claims. The court quickly
disposed of this argument, finding that
the plaintiff and other similarly situated
pharmacists were subject to administrative
adverse action for noncompliance. As part of
this initial assessment, the court held that the
complaint could be interpreted as a " facial "
challenge to the law in spite of the failure to
specify as such. A facial challenge implicates
unlawful application to all affected parties
rather than simply the plaintiff.
Moving to the substantive allegations,
the court found that the plaintiff was likely
to succeed on the merits, justifying the
imposition of the preliminary injunction.
In short, the court found that the second
sentence of the statute " infringes the
free speech rights of the Plaintiff and
other Missouri-licensed pharmacists by
threatening to impose liability based
upon the viewpoint of their speech. " That
liability, based upon the authority of the
Board of Pharmacy, involves the threat
of an adverse licensure action through an
administrative proceeding.
In its analysis, the court reviewed the
drugs in question, hydroxychloroquine
and ivermectin, and their history and
relationship to COVID-19. It cited Food
and Drug Administration, the World
Health Organization, testimony from
experts, lawmaker positions, and the
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