A First Look at the MAHA Era: Initial Thoughts for Industry Based on the MAHA Commission EO

Swiftly following the confirmation of Robert F. Kennedy Jr. as Secretary of the Department of Health and Human Services (HHS), the White House issued an executive order (EO) establishing the Make America Healthy Again (MAHA) Commission,¹ whose policies and actions could reshape the life sciences industry.

MAHA is a term that has been percolating for some time now, spurred mainly by comments Kennedy made during his presidential campaign and after President Trump announced his intention to nominate him as Secretary of HHS. True to Kennedy’s campaign promise and other public statements, the stated mission of the MAHA Commission is to combat lagging American life expectancy and rising rates of chronic disease by focusing on the food and pharmaceutical industries. The EO emphasizes that there is a need for “fresh thinking” on issues affecting “over-reliance on medication and treatments” and “food and drug quality and safety.” We summarize the EO below, along with some of the potential and anticipated impacts on life sciences and other U.S. Food and Drug Administration (FDA)-regulated industries. A forthcoming Advisory will discuss the implications of the MAHA agenda on the food industry in more detail.

Summary of the MAHA EO

The EO announces that the policy of the federal government is to combat rising rates of mental health disorders, obesity, diabetes, and other chronic diseases in the United States by directing federally funded research to focus on transparency, open-source data, and the root causes of chronic illness in the country. In addition, the EO directs agencies to ensure the flexibility of health insurance benefit designs in covering expanded treatment options that support lifestyle changes and disease prevention. Such policy will be carried out by cabinet members and other government officials who will comprise the MAHA Commission.²

Childhood chronic disease is the main focus of the EO, though we would not be surprised if the Commission’s policies and other potential actions affect other populations. At its foundation, however, the EO points to rising rates of children with at least one health condition, imbuing the policy goal with a sense of urgency based on fear. Specifically, the EO states that 77% of “young adults” are ineligible for the military mainly because of their health scores and that the pervasiveness of chronic childhood illness causes health burdens that harm the economy and national security. Chronic conditions such as mental health conditions, autism, and attention deficit disorder/attention deficit hyperactivity disorder — and the percentage of children being prescribed medication to treat such conditions — are highlighted as major changes in the U.S. youth population in the past 10 years compared to the 1980s.³

In response to these concerns, the EO requires that within 100 days, the MAHA Commission must submit an assessment to the President, detailing, among other things, (1) what it terms potential “threats” such as over-utilization of medication and certain food ingredients, as well as the prescription of selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs; and (2) its plans to establish a framework for increasing transparency and ethics and “eliminating undue industry influence.” Based on the assessment, the Commission must then submit, within 180 days of the EO, a strategy for eliminating undue industry influence and restoring the “integrity of science” through transparency, among other actions.

Impacts on Industry

On its own, the EO does not change FDA’s authorities or approach to targeted products, but it obviously sends strong signals to the industry about what categories of products will be under the microscope. And even negative callouts like those in the EO (which points to “absorption of toxic material” and “medical treatments” as bases of disease) can necessitate careful consideration of regulatory and product liability strategies.

Additionally, considering Kennedy’s statements, we anticipate several changes affecting the FDA-regulated industry may be forthcoming as first the EO’s and then the MAHA Committee’s recommendations are put into action. For example:

• The MAHA Commission may push for or recommend increasing scrutiny of data submitted to support marketing applications to FDA — notwithstanding FDA’s longstanding disclosure regulations and statutory preclusions on disclosure. There may also be changes to ethics and transparency requirements related to persons involved in medical product reviews, advisory committees, and related activities.
• There may be changes proposed to FDA’s approach to certain classes of drugs, including in particular those therapeutic areas the EO alleges are “threats.” The Commission may call for additional studies, safety label changes, risk evaluation and mitigation studies, indication modifications, and other measures that may affect patient access to medication, particularly in pediatric populations. The MAHA Commission could also propose statutory changes that, with the acquiescence of Congress, would enhance or limit FDA authorities for certain classes of products.
• Medical devices may also receive safety-related scrutiny as part of the MAHA effort, although the regulation of digital health, including tools and systems incorporating artificial intelligence, may be liberalized.
• Kennedy has been a proponent of restricting (or even eliminating) direct-to-consumer (DTC) advertising, so the Commission may consider ways to enhance FDA’s enforcement related to advertising and promotion of prescription drugs — and DTC broadcast ads in particular — as a way to reduce reliance on medication to manage chronic disease. This may include attempting to impose onerous additional disclosures intended to make DTC broadcast advertising untenable.
• Increased scrutiny over proposals for the studies of food and cosmetic ingredients and/or revocation of food additive approvals and scrutiny of food ingredients generally recognized as safe, as well as other substances in food and cosmetic products and food packaging.
• There may also be a focus on increased access to nontraditional products such as dietary supplements, including exploring existing or new authorities to cover such products under federal healthcare programs.

These potential changes go hand-in-hand with what we expect will also include pressure on FDA to release raw data and, in general, more information submitted by sponsors concerning the safety and effectiveness of a product — as well as FDA correspondence such as complete response letters. Releasing information without context certainly has the potential to disrupt the market by encouraging the spread of misinformation or the release of confidential commercial or trade secret information closely held by sponsors.

Further, we may see a push for additional studies based on Kennedy’s and the EO’s policy that the National Institutes of Health (NIH) and health-related federally funded research should prioritize “gold-standard” research on root causes. During his confirmation hearings, Kennedy explained that his gold standard is “real scientific research with replication of studies.””⁴ Specifically, Kennedy stated that he believes at least 20% of NIH’s budget should be given to replication and that “all of the science [should be] published with the raw data.”⁵ And on top of this, there are additional questions concerning the orphan drug pathway and COVID-19 vaccines — particularly boosters and mandates — based on comments by the presumptive nominee for FDA Commissioner, Dr. Martin Makary,⁶ and several EOs weakening COVID-19 vaccine mandates in schools and other settings.⁷ 

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We are still in the early days of the second Trump administration, and we await the confirmation of the new FDA Commissioner. However, as in other areas, the string of actions by the administration, including both the MAHA EO and abrupt layoffs of FDA personnel in certain areas, make clear that regulated industry will need to engage and ensure that MAHA initiatives are well grounded in science and law.

Arnold & Porter is closely monitoring the Trump administration’s EOs as they are issued, with a keen eye toward potential impacts on our Life Sciences clients. If you have any questions about the content discussed in this Advisory or would like more information, please reach out to one of the authors or your existing Arnold & Porter contact. 

© 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.