DTC Reforms and MAHA Proclamations: The MAHA Agenda and Its Focus on Prescription Drugs Continues To Take Shape

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.

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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.

© Arnold & Porter Kaye Scholer LLP 2025 All Rights Reserved. This Advisory is intended to be a general summary of the law and does not constitute legal advice. You should consult with counsel to determine applicable legal requirements in a specific fact situation.