FDA demands missing trials
The FDA has sent more than 2,200 notices urging companies and researchers to publish missing clinical‑trial results, highlighting widespread non‑reporting of outcomes. The New York Times and The Center Square report that many unfavourable findings remain unpublished, creating gaps in the public record of trial evidence. ( )
The Food and Drug Administration said on April 13 that it contacted more than 2,200 companies and researchers about missing clinical-trial results that should have been posted publicly. (fda.gov) The agency said the messages went out on March 30 to sponsors and investigators tied to more than 3,000 registered trials, including some publicly funded studies. The Food and Drug Administration said the records either appeared to be missing required results or had not cleared the National Library of Medicine’s quality-control review. (fda.gov) ClinicalTrials.gov is the federal database where many drug, biologic, and device studies must be registered and later updated with summary results. For trials covered by the Food and Drug Administration Amendments Act and its 2017 final rule, the standard deadline is one year after the study’s primary completion date. (clinicaltrials.gov) The Food and Drug Administration said 29.6 percent of studies “highly likely” to fall under mandatory reporting rules had no results information submitted. The agency said the missing studies were interventional trials with a United States nexus and an agency-regulated product, while Phase 1 drug trials and device feasibility studies were excluded. (fda.gov) Missing results can skew the public record because failed or unfavorable studies disappear while positive ones stay visible. Commissioner Marty Makary said companies were too often suppressing unfavorable findings and said doctors “deserve to have the best data” when deciding whether to prescribe a medicine. (fda.gov) The notices were framed as a push for voluntary compliance, not a final penalty action. The Food and Drug Administration said it used a risk-based approach and sent the reminders before deciding whether to pursue regulatory action. (raps.org) The agency already has a formal enforcement ladder for trials that are not properly registered or reported. Its ClinicalTrials.gov compliance pages say a pre-notice can be followed by a notice of noncompliance and then civil money penalties if a violation is not corrected. (fda.gov) Food and Drug Administration training materials say penalties can reach up to $10,000 per day after the 30-day correction period that follows a notice of noncompliance. A separate agency page listing enforcement actions showed named notices sent in 2025, indicating the government has used the process before this broader reminder campaign. (fda.gov, fda.gov) Outside watchdogs have tracked the same problem for years. TrialsTracker, a project that monitors reporting under the 2007 law, says the Food and Drug Administration is not publicly tracking overall compliance and estimates thousands of required trial results remain overdue. (fdaaa.trialstracker.net) The immediate test is whether the March 30 notices turn missing entries into public records. If they do not, the next step is no longer a reminder but an enforcement case. (fda.gov, fda.gov)
