The White House released the long-awaited Make America Healthy Again (MAHA) Strategy Report (the Strategy) on September 9, 2025 to much fanfare, though the report itself was rather lackluster.1 The accompanying U.S. Food and Drug Administration (FDA) and U.S. Department of Health and Human Services (HHS) communications2 were, however, of more consequence.
This week's actions follow President Trump's February 13, 2025 Executive Order, "Establishing the President's Make America Healthy Again Commission," and the subsequent May 22, 2025 assessment from the MAHA Commission (the MAHA Report) focused on childhood chronic disease.3 The MAHA Commission identified four potential drivers of childhood chronic disease in the MAHA Report: poor diet and ultra-processed foods, chemical exposure (referred to as the cumulative load of chemicals in our environment), lack of physical activity and too much screen time causing chronic stress, and overmedicalization from vaccines and other drugs.4 The Strategy is one part of the administration's efforts to address these drivers, though, as we note, it does so with little detail.
Direct-to-Consumer Advertising: Presidential Memorandum to FDA and "Sweeping Reforms" at FDA
President Trump sent a memorandum to FDA on September 9, 2025
with the subject, "Addressing Misleading Direct-to-Consumer
Prescription Drug Advertisements."5 This
administration has not been shy about its dislike for
direct-to-consumer (DTC) prescription drug advertisements, so the
memorandum and subsequent announcement by FDA that it is initiating
rulemaking on the subject are not surprising.6 What is
surprising is FDA's announcement that it is sending thousands
of general "cease-and-desist" letters warning
pharmaceutical companies to remove misleading ads (though this is
actually one template letter, signed by Commissioner Makary, sent
to all prescription drug sponsors) along with around 100 untitled
letters to companies that have, in FDA's view, deceptive
ads.7
The Trump DTC memorandum suggested that FDA should increase the
amount of risk information required in these DTC prescription drug
advertisements "to the extent permitted by applicable
law." At the same time, Secretary Kennedy and Commissioner
Makary announced FDA's plan to initiate rulemaking to close
what the agency views as the "adequate provision
loophole" through which they argue drug companies
"conceal critical safety risks in broadcast and digital ads,
fueling inappropriate drug use and eroding public
trust."8
The administration took the position that "the lack of
appropriate patient safety information in direct-to-consumer
pharmaceutical ads has directly led to negative health and economic
impacts," including what it terms the overmedicalization of
children for chronic conditions.9 Thus, the
administration explicitly stated that it wants to return DTC
prescription drug advertising to the pre-1997 regime, meaning that
FDA should increase "the amount of information regarding any
risks associated with the use of any such prescription
drug."10
During the interim period, i.e., before the time-consuming
rulemaking process concludes, FDA apparently intends to rely on its
"current authorities" to take an aggressive enforcement
posture with respect to DTC prescription drug advertisements. Here,
too, FDA has indicated that it will return to the 1990s, when the
agency issued over 100 Warning Letters each year and
"misleading ads were rare," until it sees what it views
as compliant advertisements. Thus, irrespective of the rulemaking
process, FDA is keen on steering sponsor behavior to align with its
new interpretation of what "fair balance" and "major
statement" means.11 FDA also notes that the agency
has implemented an artificial intelligence tool to proactively
surveil and review drug ads.
This enforcement will come not just for the TV, radio, and print
advertisements specifically enumerated in the Federal Food, Drug,
and Cosmetic Act (FDCA) and implementing regulations, but also for
other forms of advertising, including social media
advertisements.12 In fact, the administration is clear
that "egregious violation demonstrating harm from current
practices will be prioritized, including by social media
influencers and DTC telehealth companies."13
However, FDA's communications do not specifically target
telehealth companies and appear keenly focused on social media
platforms and the rise of influencers to promote prescription
drugs.
We will continue to monitor the fall-out from these September 9,
2025 DTC-related actions, including updating clients as more
information comes out about the Commissioner's cease-and-desist
letters — a potentially new form of FDA communication. DTC
advertisements that target children, or conditions commonly
diagnosed in childhood, may be the early target, though the
administration's concurrent statement about using AI to
identify potentially violative ads could signal a less metered
approach. In addition, we are monitoring several open questions,
including how Federal Trade Commission enforcement plays into these
announcements and the types of promotional materials targeted by
FDA. For example, we do not yet know whether FDA intends to examine
unbranded disease awareness or "help seeking" content
through this new enforcement philosophy.
Companies concerned about these developments should consider
proactively reviewing their DTC promotional materials for
compliance with required safety communications to reduce the risk
of further enforcement activity. As FDA continues its campaign
focused on DTC advertising, including likely attempting to revert
to onerous requirements that were abandoned long ago in an attempt
to deter industry DTC communications, we anticipate that litigation
over the agency's actions in this area will likely ensue.
Aspects of the MAHA Strategy of Interest to the Life Sciences Industry
More generally, the Strategy also provides additional insights into the administration's thinking about prescription drug and other product development research and incentives. Though lacking specificity, the Report focuses on ending childhood chronic disease by advancing research, fostering private sector collaboration, realigning incentives, and increasing public awareness. To accomplish these goals, the Strategy outlines steps that each agency under HHS should or will take, though the Strategy largely leaves the details on how to implement these steps to each agency.
I. Advance Research
The Strategy's objective is to advance critical research by pursuing rigorous, gold-standard sciences to drive innovative solutions. None of the tasks specified in this objective are a surprise; many highlight recent talking points by Secretary Kennedy and others in the Trump administration, including topics like the use of real-world data and AI, moving away from animal studies, researching the root causes of autism, investigating vaccine injuries, and assessing prescribing patterns concerning serotonin reuptake inhibitors and other mental health drugs.
New Approach Methodologies
Concerning animal study use, this Strategy echoes, and is
perhaps a more formal announcement of, FDA's earlier blueprint
concerning New Approach Methodologies (NAMs). NAMs are
human-relevant methods used to evaluate immunogenicity, toxicity,
and pharmacokinetics in humans without using traditional animal
models.14 While researchers have supported developing
new approaches to preclinical testing in an effort to make early
testing faster, low-cost, and more humane, FDA's NAMs
Blueprint, which acknowledges these potential benefits, does not
answer a number of key questions which are critical if drug and
device developers are to eventually adopt these models, and the
Strategy likewise provides limited regulatory insight.
As background, in 2022, Congress amended the FDCA and the Public
Health Service Act (PHSA) to allow nonclinical studies to support a
new drug application or biologics licensing
application.15 This change (replacing "preclinical
tests (including tests on animals)" with "nonclinical
tests") expanded the types of tests sponsors may use before or
during the clinical trial phase of an investigation into a new
drug. Tests identified by FDA as being permissible were cell-based
assays, organ chips and micro physiological systems, computer
modeling, other nonhuman or human biology-based test methods such
as bioprinting, and animal tests, i.e., NAMs.16
FDA's NAMs Blueprint takes the first step in advancing the goal
of reducing reliance on animal testing by describing the
agency's short- and long-term implementation plan. Within the
next three years (i.e., by 2028), FDA intends to explore
pre-existing international data, encourage sponsors to submit NAM
data, and develop an open-access repository, with the goal of
reducing animal toxicity testing across new drugs. The eventual aim
is "to make animal studies the exception rather than
the norm for pre-clinical safety/toxicity testing" within the
next three to five years.17
To assist in this effort, the Strategy announces a new office
within the National Institutes of Health, called the "Office
of Research Innovation, Validation, and Application." This
office will be responsible for developing, validating, and scaling
NAMs, and will coordinate all-things NAMs across HHS, including
with FDA. Examples of NAMs included in the Strategy include
organoids, computational simulations, and real-world data
integration.
Gold Standard Science
The Strategy also emphasizes "Gold Standard Science," a term that has been circulating throughout this administration since before the inauguration and has been used by Commissioner Makary and Secretary Kennedy to rebuke data about vaccine safety and effectiveness, among other product types. In late May of this year, President Trump issued Executive Order 14303, "Restoring Gold Standard Science" which was followed by a June 23, 2025 memorandum from the Office of Science and Technology Policy instructing agency heads to implement Gold Standard Science in the conduct and management of scientific activities. Most recently, FDA issued a new Staff Manual Guide (9001) instructing FDA staff on the tenets of Gold Standard Science. While none of these actions have changed the way clinical trials are conducted, they suggest that FDA will scrutinize protocols more closely and is likely — at least for certain drug classes — to require additional data assessing the effects of placebos, co-administration (i.e., concomitant use), and to require longer-term post-approval studies.
II. Realigning Incentives
This section of the Strategy likewise does not provide any novel
or new information relevant to life sciences manufacturers. Rather,
it also emphasizes previous themes, like increasing oversight and
enforcement of DTC prescription drug advertising, addressing what
it views as conflicts of interest, and promoting deregulatory
actions that will speed drug and device approval without
jeopardizing patient safety. We discuss the Presidential Memoranda
on DTC advertising (also released on September 9, 2025)
above.
With respect to conflicts of interest, the Strategy explicitly
calls out FDA user-fee processes. Those renegotiation efforts have
recently begun, and while there have not been reported derivations
thus far, the Strategy emphasizes transparency and efficiency. We
will continue to monitor this point.
III. Private Sector Collaboration and Increasing Public Awareness
The Strategy is concise on these points relative to
FDA-regulated drugs and medical devices, but provides a couple of
key insights into this administration's thinking. Namely, the
Strategy states that FDA "will" revise certain drug
labeling, including the labeling of "older" generic
drugs, and drugs with abuse potential such as OxyContin and
7-hydroxymitragynine (7-OH).
And, finally, perhaps indicative of its true intentions, the
Strategy provides little in the way of steps to achieve private
sector collaboration. The most interesting steps included in this
section are a MAHA education campaign designed to influence
adolescent behaviors in a way that promotes fertility in order to
improve maternal and infant health outcomes "and ensure a
brighter future for parents and infants across the
U.S."18 As part of this strategy, HHS will partner
with the Infertility Training Center to educate Title X clinics on
underlying causes of infertility. There are, however, no strategies
for collaborating with pharmaceutical manufacturers.
* * *
As noted, as with other recent FDA actions (see our CRL Advisory), a court challenge is only a matter of time. In addition to possible litigation, we will keep an eye on emerging trends and whether this signals a significant shift in the way pharmaceutical manufacturers do business. If you have any questions or would like more information, please reach out to one of the authors of this Advisory or your existing Arnold & Porter contacts.
Footnotes
1 The MAHA Strategy, last accessed Sept. 10, 2025.
2 The White House, Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs, Sept. 9, 2025.
3 The MAHA Report, last accessed Sept. 10, 2025; Arnold & Porter, A First Look at the MAHA Era: Initial Thoughts for Industry Based on the MAHA Commission EO, Feb. 17, 2025.
4 The MAHA Commission membership includes Secretary Kennedy, FDA Commissioner Makary, and several other agency appointees in addition to Stephen Miller, President Trump's Deputy Chief of Staff for Policy. All members are part of the Trump administration.
5 The White House, Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs, Sept. 9, 2025.
6 Secretary Kennedy states in the corresponding FDA press release that "Pharmaceutical ads hooked this country on prescription drugs." FDA, FDA Launches Crackdown on Deceptive Drug Advertising, Sept. 9, 2025.
7 FDA, FDA Launches Crackdown on Deceptive Drug Advertising, Sept. 9, 2025; FDA Letter to Industry, Sept. 9, 2025.
8 FDA, FDA Launches Crackdown on Deceptive Drug Advertising, Sept. 9, 2025.
9 HHS, Fact Sheet: Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies, Sept. 9, 2025.
10 The White House, Memorandum for the Secretary of Health and Human Services the Commissioner of Food and Drugs, Sept. 9, 2025; see also, HHS, Fact Sheet : Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies, Sept. 9, 2025.
11 FDA Letter to Industry, Sept. 9, 2025.; 21 C.F.R. § 202.1.
12 HHS, Fact Sheet : Ensuring Patient Safety Through Reform of Direct-to-Consumer Pharmaceutical Advertisement Policies, Sept. 9, 2025.
13 MAHA Strategy, at 9.
14 FDA News Release, "FDA Announces Plan to Phase Out Animal Testing Requirement for Monoclonal Antibodies and Other Drugs" (Apr. 10, 2025); FDA, Roadmap to Reducing Animal Testing in Preclinical Safety Studies (Apr. 2025) (hereinafter "NAM Blueprint").
15 Pub. Law. 117-328 Sec. 3209 (Dec. 29, 2022) (amending section 505 of the FDCA (21 U.S.C. § 355) and section 351(k)(2)(A)(i)(I) of the PHSA).
16 Id.
17 NAMs Blueprint, at 6.
18 MAHA Strategy, at 18.
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