FDA

The audit

Who controls it

FDA issues its communications, which are subject to agency leadership; FDA and EPA jointly develop the fish advice. FDA's 2025 acetaminophen physician notice was signed by Commissioner Makary.

Money

FDA's FY2025 Prescription Drug User Fee Act (PDUFA) program had $1.458 billion in net collections, $1.360 billion in user-fee obligations, and $1.759 billion in total obligations, of which 77% came from user fees and 23% from appropriations. These figures apply to the human-drug-review program, not FDA as a whole; no separate page-level budget for fish advice was identified.

Conflict rules

The reviewed press releases and advice pages do not show author-by-author financial disclosures. FDA is subject to government ethics rules, while the fish method describes technical inputs and external review; no company sponsor controlling that advice was identified.

Method

FDA's September 2025 acetaminophen release discusses reported associations, contrary studies, and the fact that causation has not been established, but it does not present a new systematic review or evidence-grade table. The FDA/EPA fish method publishes its mercury equation, reference dose, uncertainty factor, data sources, fish categories, and confidence ranges, and underwent external review.

Dates on its pages

The FDA acetaminophen safety page is dated August 14, 2025, the announcement and physician notice September 22, 2025, and the fish chart October 2021, while the technical page includes entries through June 2024.

Political exposure

Leadership changed from Commissioner Makary (March 25, 2025 to May 13, 2026) to Acting Commissioner Diamantas beginning May 15, 2026. On September 22, 2025 FDA started an acetaminophen label-change process while stating that causation was not established and contrary studies existed; ACOG and SMFM publicly differed on the precaution and retained acetaminophen as an appropriate option. The audit treats this as documented disagreement, not proof that a position was politically or commercially dictated.

Money exposure

Pooled PDUFA fees fund allowable human-drug-review costs under statutory limits and alongside appropriations; the fees are not paid for a particular decision. FDA/EPA fish advice uses public mercury-surveillance data and technical analysis, and the audit identified no direct industry sponsor or sponsor-driven change.

Track record

The topiramate backtest found different rates in FDA's March 2011 notice (1.4%) and July 2011 label (1.2%); the figures have distinct comparisons and remain tied to their source. The 2017 codeine notice recommended against use while breastfeeding, while the later label says breastfeeding is not recommended during treatment, not that it is a formal contraindication. In 2025 FDA said an acetaminophen label-change process had started; the backtest found no neurodevelopment-specific OTC order through October 14, 2026, and the selected product labels had no neurodevelopment warning.

Where this comes from

• FDA FY2025 PDUFA financial report
• FDA acetaminophen announcement
• FDA acetaminophen physician notice
• FDA/EPA fish technical information
• FDA/EPA fish questions and answers
• ACOG acetaminophen advisory