Trump establishes MAHA Commission, with medicines – and maybe user fees – in its crosshairs

Hours after ROBERT F. KENNEDY JR. was confirmed as Secretary of Health and Human Services, President DONALD TRUMP issued an Executive Order establishing a Make America Healthy Again (MAHA) commission, with Kennedy at the helm. The order makes clear that the MAHA commission will take aim at the role of medicines in chronic illness, and its eventual recommendations could have an impact on the FDA’s user fee reauthorization process as well.

President DONALD TRUMP’s latest executive order establishes a Make America Healthy Again commission

• Make America Healthy Again (MAHA) was a core component of Robert F. Kennedy Jr.’s presidential campaign during the 2024 election. Then-candidate Kennedy coined and promoted the idea of a MAHA movement, focused on concerns about rising rates of chronic and childhood illnesses in the U.S. and citing factors like the food and health care systems as key contributors. As AgencyIQ previously discussed, the MAHA agenda, together with Kennedy’s personal bent against FDA-regulated products such as vaccines and certain food products, and the life sciences industry in general, raise concerns about Kennedy’s impact in a federal leadership role. [Read AgencyIQ’s full analysis of Kennedy’s MAHA agenda here.]
• Today, the Senate confirmed Kennedy as secretary of the Department of Health and Human Services (HHS), the parent department for the FDA. Kennedy was confirmed by a 52-48 Senate majority. Sen. MITCH MCCONNELL (R-Ky.), who formerly served as the Republicans’ Senate leader, was the lone Republican senator who opposed Kennedy’s confirmation. [ Read AgencyIQ’s analysis of Kennedy’s confirmation here.]
• Hours after Kennedy’s confirmation as HHS Secretary, Trump issued an executive order formally establishing MAHA as a federal commission. The MAHA Commission will be helmed by Kennedy in his role as HHS Secretary, along with leadership from other departments including Education, Housing and Urban Development and Agriculture. Agencies to be involved include the FDA, National Institutes of Health (NIH), Centers for Disease Control and Prevention (CDC), and the Environmental Protection Agency (EPA).
• What will the commission be doing? The EO sets the MAHA Commission’s role: To “aggressively combat critical health challenges facing our citizens, including the rising rates of mental health disorders, obesity, diabetes, and other chronic diseases.” The MAHA agenda appears primarily focused on childhood illnesses related to lifestyle factors, including the food system and disease prevention over treatment.
• Federally funded research: The order lays out a series of specific actions, including directing NIH and other “health-related research funded by the Federal Government” to prioritize research into the “root causes” of illnesses, and directing that all federally funded research should employ “transparency and open-source data” to “avoid or eliminate conflicts of interest that skew outcomes and perpetuate distrust.” NIH funding for research programs would be largely frozen under other Trump administration EOs that are currently being challenged in the courts, and federal appropriations for such research will likely be reduced under the current legislative budget proposal. While the order doesn’t specify, it’s possible that “conflicts of interest” in federally funded research could be interpreted to limit access to federal research funds for the life sciences industry.
• Alternatives to medical treatment: The order directs agencies to “work with farmers” to improve food availability and quality, and also to “ensure the availability of expanded treatment options and the flexibility for health insurance coverage to provide benefits that support beneficial lifestyle changes and disease prevention.” This wording may mean expanded wellness benefit offerings such as meal delivery services, exercise and health education programs; these are among the types of “health related” benefits offered as “supplemental benefits” under some Medicare Advantage (MA) plans (see an explainer on the supplemental benefit system in Health Affairs here).
• The “initial mission of the Commission” will be to “address the childhood chronic disease crisis” by “study[ing] the scope of the childhood chronic disease crisis” and the role of potential contributing factors including “toxic material, medical treatments, lifestyle, environmental factors, Government policies, food production technologies, electromagnetic radiation, and corporate influence or cronyism [emphasis added],” and to make recommendations about mitigating these issues.
• Within 100 days (i.e., late May 2025), the MAHA Commission will compile a report on their findings for the president. The report will include information on “over-utilization of medication, certain food ingredients, certain chemicals, and certain other exposures post to children” and provide evaluations and recommendations on education and federal programs to prevent childhood health issues. The order calls out some specific items it indicates are threats to children, including “selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, stimulants, and weight-loss drugs.” Within 180 days (i.e., mid-August 2025) the Commission will publish a strategy on “appropriately restructuring the Federal Government’s response to the childhood chronic disease crisis, including by ending Federal practices that exacerbate the health crisis or unsuccessfully attempt to address it, and by adding powerful new solutions that will end childhood chronic disease.”

Analysis and what’s next

• While the life sciences industry isn’t the sole target of the MAHA Commission, it is clearly a primary target. The executive order specifically calls out “medical treatments,” entire classes of medications, “the over-utilization of medication,” employing a host of other phrases that could easily encompass life sciences companies given the MAHA movement leaders’ past statements (“undue industry influence” and “cronyism” are of particular interest). Given that MAHA movement leaders like CASEY MEANS and CALLEY MEANS have previously pointed to the FDA’s acceptance of industry-paid user fees as being evidence of industry corruption, the Commission’s ultimate recommendations – due shortly before the start of the Prescription Drug User Fee Act (PDUFA) reauthorization negotiations in Fall 2025 – could pose a concern to the life sciences industry.
• The MAHA report due in May, for example, should include a “framework for transparency and ethics review in industry-funded projects.” While it doesn’t specify the types of projects subjects to the framework, it seems likely that industry-funded research into medical products would be in scope. It could also include industry’s user fee funding covering the costs of FDA review. The order also calls for specific safety-related reviews “to assess the prevalence of and threat posed by” specific behavioral and mental health drugs, as well as weight-loss products. Though the does not mention vaccines, they will likely be of particular interest to Kennedy in his role as MAHA Commissioner and HHS Secretary.
• The MAHA commission’s work could lead to an overhaul in federal systems for health care, clinical research and the food system. However, it’s not clear what such a proposal would look like – or how seriously the commission’s eventual recommendations will be received. While a directive from the White House to the FDA to increase its efforts in a specific therapeutic area is not uncommon (e.g., President JOE BIDEN’s Cancer Moonshot project), that typically comes with additional funding for research and staffing. Based on the text of the order, it doesn’t seem that the MAHA commission will be targeted at medical management of chronic illnesses in the traditional sense. Further, the MAHA commission is being established as the White House is also calling for overall reductions in the federal workforce, including at health agencies. Hefty reductions could impact what the “restructuring” of the agencies looks like based on the MAHA strategy and plans, as directed by the order.
• In short: The EO is brief and light on details, but impacts could be significant for the FDA, which could face new directives – and thus for the life sciences industry in the way they engage with federal funding and regulators.

To contact the author of this item, please email Laura DiAngelo ( ldiangelo@agencyiq.com).
To contact the editor of this item, please email Kari Oakes ( koakes@agencyiq.com).

Key Documents and Dates

• Presidential Actions: Establishing the President’s Make America Healthy Again Commission