The Food and Drug Administration is urging pharmaceutical companies to make public data from clinical trials.
About three in 10 studies deemed highly likely to fall under mandatory reporting requirements have no results filed with the government’s clinical trial website, the FDA said on April 13. That is in line with historical estimates.
The FDA sent more than 2,200 companies and researchers messages in late March that reminded them of the requirements, the agency said on April 13.
“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community. Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data’s influence on the company’s share price,” FDA Commissioner Dr. Marty Makary said in a statement.
“Too many clinical trial sponsors and researchers are failing to report their results, leaving important information unavailable to clinicians and other researchers. If you are a doctor deciding whether or not to prescribe a medication to a patient, you deserve to have the best data about clinical studies on that medication.”
Sponsors of many clinical trials, and researchers involved with them, are required by federal law to report at least a summary of results within one year of completion. Phase 1 trials are among those excluded from the requirements.
The FDA can initiate a process when the people responsible for submitting the information fail to do so, which can lead to fines of up to $10,000. The process includes sending notices of noncompliance.
Only two such notices were sent in 2025, and the agency is declining to issue any, at least for now.
“The messages issued on March 30, 2026, represent an extra step the agency is taking to provide the relevant responsible parties with the opportunity to comply with federal law before the agency considers whether to take further regulatory action,” the FDA stated.
The agency, under Makary, has favored pressing companies to voluntarily meet its demands, including the removal of synthetic dyes from food.
“I fully support this new initiative to increase the prompt publication—as required by law—of results information from interventional studies of the medical products we regulate,” Dr. Tracy Beth Hoeg, acting director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
“We hope that the thousands of messages sent to sponsors and investigators reminding them to publicly report their findings will improve patient safety and keep researchers and the public better informed of benefits and risks of new and investigational products.”
Hellbound and Down 