MAHA Clinical File
Rx Only

Department of Pharmacy Services | Pharmacy and Therapeutics Committee

Formulary Review

PHARMACY &
THERAPEUTICS
Committee

Formulary Addition Request: MAHA (Make America Healthy Again), a novel policy compound with no established therapeutic indication

Review DateMarch 2026
RequestorDept. of Health and Human Services
PriorityUrgent (per requestor)
Review IDPT-2026-MAHA-001
Formulary review clipboard with DO NOT ADD stamp, pharmacy mortar and pestle, and vote tally showing 0-12

1Drug Identification

Product Information

Generic NameMake America Healthy Again (MAHA)
Brand NameMAHA
Therapeutic ClassUnclassified (no therapeutic class assigned)
ManufacturerRobert F. Kennedy Jr., JD (HHS)
FDA Approval StatusNot submitted. Not reviewed. Not approved.
DEA ScheduleN/A (not a controlled substance, though its effects are uncontrolled)
NDC NumberNone

2Proposed Indications

Requested Indications

Primary IndicationChronic disease epidemic in the United States
Secondary IndicationFood supply toxicity (food dyes, seed oils, preservatives)
Off-Label UseVaccine skepticism, fluoride removal, supplement promotion, raw milk advocacy, institutional dismantlement

Committee note: The primary indication (chronic disease) is valid. The proposed treatment does not address the primary drivers of chronic disease (obesity, smoking, alcohol, physical inactivity) and instead targets factors with no documented mortality burden (food dyes, seed oils).

3Mechanism of Action

Proposed Mechanism

MAHA operates through multiple pathways:

1.

Executive order pathway: Bypasses standard regulatory review. Onset of action: immediate. Duration: until court injunction.

2.

Institutional depletion pathway: Reduces capacity of regulatory agencies through workforce reduction. Half-life: years to decades (institutional knowledge, once lost, is slow to rebuild).

3.

Public messaging pathway: Delivered via podcast, social media, and press conference. Bioavailability varies by audience credulity.

4Clinical Efficacy (Pivotal Trials)

Evidence Assessment

Phase III TrialsNone
Phase II TrialsNone
Phase I TrialsNone
Observational StudiesNone submitted
Systematic ReviewsNone
Meta-AnalysesNone
Case Reports1 (the United States of America, March 2026, outcomes unfavorable)

Manufacturer's Evidence Statement

“[The evidence] hasn't been fully gathered.”

Kennedy, Joe Rogan Experience, March 2026

Committee note: “The evidence hasn't been fully gathered” is not a standard of evidence recognized by this committee or any pharmacopoeia.

5Safety and Adverse Reactions

Documented Adverse Events (March 2026)

Adverse Event
Severity
Outcome
Measles outbreak (1,300+ cases, 2025)
Serious
Ongoing
DTaP coverage below herd immunity (92.1%)
Serious
Worsening
26 states rejecting CDC guidance
Serious
Ongoing
160 clinical trials terminated
Serious
Irreversible
20,000 HHS workers fired
Serious
Ongoing
ACIP panel ruled illegal by federal court
Serious
Under appeal

“The destruction that Kennedy has wrought in one year might take generations to repair.”

The Lancet, editorial, March 2025

6Cost Analysis

Direct Costs

NIH Grant Terminations~$3 billion in approved funding cut
mRNA Contracts Terminated$500 million+
HHS Workforce Reduction20,000 positions (25% of agency)
Proposed NIH Budget Cut40% reduction from current levels

Cost-Effectiveness Assessment

For comparison, the programs MAHA is dismantling have documented cost-effectiveness:

Childhood vaccination (1994-2023)$780 billion in direct costs saved
Water fluoridation$6.5 billion/year saved. ROI: $20 per $1 invested.
Clean water systems (1900-1940)ROI: $23 per $1 spent

MAHA has provided no cost-effectiveness data. Its primary policy action has been to defund programs with proven ROI.

7Formulary Alternatives

Available Alternatives with Superior Evidence

Alternative
Evidence Base
Documented ROI
Vaccination programs
Thousands of RCTs. 508M illnesses prevented.
$780B direct savings (1994-2023)
Tobacco regulation
50+ years. 8 million lives saved.
Prevalence: 42% to 12%
Water fluoridation
80+ years. 25%+ decay reduction.
$20 per $1 invested
Obesity prevention (systemic)
Sugar taxes, food reformulation, access programs
Addresses #1 modifiable risk factor
Evidence-based policy
200+ years of epidemiological science
The entire modern public health system

All listed alternatives have established evidence bases, documented cost-effectiveness, and decades of real-world outcomes data. MAHA has none of these.

8Committee Discussion and Vote

Committee Discussion Summary

The committee reviewed all available evidence for MAHA, which took approximately 45 seconds, as no evidence was submitted.

The committee noted that MAHA's manufacturer described the evidence as “not fully gathered” and the FDA's own assessment was “we don't have sufficient data to establish efficacy.”

The committee further noted that the product's primary mechanism of action (institutional dismantlement) is the opposite of what a health system should stock, and that every documented outcome has been adverse.

Pharmacy and Therapeutics Committee

DO NOT ADD TO FORMULARY

0

In Favor

12

Against

0

Abstain

Unanimous. No evidence of efficacy. Unfavorable risk-benefit ratio. Active harm documented. Superior alternatives available.

Basis for Rejection

Insufficient evidenceNo clinical trials submitted
Unfavorable risk-benefitAll documented outcomes adverse
Cost concerns$3B+ in defunded programs with proven ROI
Superior alternativesEvidence-based public health policy (200+ years of data)
Manufacturer credibilityFounded anti-vaccine advocacy group; conflict of interest undisclosed

A hospital would not stock a drug with no trials, no evidence, and only adverse outcomes. A country should not either.

This page is satire formatted as a pharmaceutical document. It is not medical advice. The pharmacology, however, is real.