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CLINICAL TRIAL SPONSORS:

(1) KEEP RESULTS SECRET,

(2) DON’T PAY $62 Billion to $122 Billion in FINES, and

(3) HARM PATIENTS

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Lawrenceville, NJ (Dr Charles Simone) – The Food and Drug Administration and the National Institutes of Health wrongly allow clinical trial sponsors: (1) to keep their results secret, (2) escape from paying between $62 billion to $122 billion* in fines since the law was enacted in 2007 requiring disclosure of results, and (3) harm patients.  This is more than $13,000 per day in fines for not reporting results. Any group that conducts clinical trials are required to record their results within one year of trial completion on the NIH’s website ClinicalTrials.gov.  Because of its common format, this site, that has 215 million monthly page views, allows for easy comparison of results.  Physicians and patients rely on trial results to see whether new treatments are safe and effective.

According to the FDAAA Trials Tracker, an independent monitoring initiative run by the Evidence-Based Medicine Data Lab at the University of Oxford, the total cumulative amount of statutory fines that could have been imposed under the law exceeds:

~$122 Billion

According to another analysis (below): Given the trajectory (~$500M in 2018 → ~$11B in 2020 → ~$23.2B in 2021 → ~$62B in 2024)

higher than $62 billion

The total amount owed to the U.S. taxpayer as of August 2026 ranges from $62 billion to $122 billion.* 

The FDA and NIH can enforce the law at any time – but they have not.  The FDA can impose the daily fine that amounts to between $62 billion to $122 billion* owed to the American taxpayer.  And the NIH can stop funding those who ignore the law – but they have not.

More than 4700 clinical trials were reviewed in the journal Science: 45% reported results on time, 32% did not report at all, and 23% reported late.  They include universities, NIH itself, and more than 20 Big Pharma companies.  https://www.science.org/content/article/fda-and-nih-let-clinical-trial-sponsors-keep-results-secret-and-break-law.  In April 2026, the FDA sent more than 2,200 warning letters involving over 3,000 clinical trials that appeared noncompliant.

Failure to report negative or inconclusive studies distorts medical evidence, influences prescribing patterns, and undermines informed patient care.  Some top offenders:

Major Organizations Cited in Reporting Analyses

1).  Academic / Nonprofit Institutions

• • • • MD Anderson Cancer Center

      • Massachusetts General Hospital

      • Mayo Clinic

      • Memorial Sloan Kettering Cancer Center

      • University of California San Francisco

      • Duke University

      • University of Pennsylvania

2). Federal Agencies

• • • • National Cancer Institute

      • National Institute of Allergy and Infectious Diseases

      • National Heart Lung and Blood Institute

      • VA Office of Research and Development

3). Big Pharma

• • • • Pfizer

      • Novartis

      • Gilead Sciences

      • GlaxoSmithKline (GSK)

      • AstraZeneca

      • Eli Lilly and Company

      • Amgen

      • Bristol Myers Squibb

      • Merck and Company

      • Hoffman LaRoche

Science analyzed ClinicalTrials.gov records of all clinical trials with results legally required to be reported between 18 January 2018 and 25 September 2019. The chart, covering trial sponsors with 15 or more results due in that window or reported early, shows that some results deposited were not posted due to quality lapses.

Critics of the mandatory reporting law say that physicians can learn from peer-reviewed medical/scientific journals.  But thousands of trials are not published because the treatments have been shown to be ineffective.

ClinicalTrials.gov was created by Congress in 1997 because patients said they were harmed since Big Pharma did not disclose information that their medicines were ineffective or harmful. One case often cited in legal filings and a report in the British Medical Journal is of Paxil, GlaxoSmithKline’s antidepressant, in which the company kept secret that the drug was not effective and caused suicidal ideation in teenagers.  And yet their sales force encouraged physicians to prescribe it to teenagers.

We need an NIH Director and an FDA Commissioner who will enforce the law, collect the billions of dollars in fines, and stop funding non-compliant trial sponsors.

Physicians and patients rely on trial results to see whether new treatments are safe and effective.  Patients volunteer for clinical trials with the expectation that their participation will advance medical knowledge. Keeping results hidden undermines scientific integrity, physician decision-making, and public trust in medicine.

The total amount owed to the U.S. taxpayer as of August 2026 ranges from $62 billion to $122 billion.* 

*From Gemini (July 31, 2026)

Under Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) and its 2017 Final Rule, trial sponsors are legally required to report summary results to ClinicalTrials.gov within 12 months of study completion. Noncompliance carries civil monetary penalties of over $10,000 to $13,000+ per day per violation.

According to the FDAAA Trials Tracker, an independent monitoring initiative run by the Evidence-Based Medicine Data Lab at the University of Oxford, the total cumulative amount of statutory fines that could have been imposed under the law exceeds:

~$122 Billion

(Calculated continuously based on thousands of non-compliant/overdue clinical trials since statutory enforcement provisions took effect under the Final Rule).

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Key Context & Enforcement Breakdown

• • • • Total Fines Claimed/Collected by FDA: $0

        Despite having the authority to levy daily civil money penalties and seek federal injunctions or criminal prosecution, the FDA has virtually never collected monetary fines against non-compliant pharmaceutical companies or academic research institutions.

      • Notices of Noncompliance: The FDA rarely issues formal Notices of Noncompliance. Instead, it relies on sending informal “Pre-Notice” letters for voluntary corrective action, resulting in years of missing data remaining largely unpenalized.

      • NIH Grant Withholding: While the NIH technically holds the authority to suspend or withhold grant funding from non-compliant institutions, this penalty is virtually never exercised to recover funds or penalize secret trials.

© 2020-2026 Charles B. Simone, M.MS., M.D.