FDA crackdown targets unpublished research results

Although the initial effort was described as a reminder, it noted possible civil fines of up to $10,000 a day. The FDA reminded companies and researchers of the requirements to submit certain clinical trial results information to ClinicalTrials.gov.

The federal agency, which has its own criminal investigations branch, said that companies and researchers often fail to disclose negative trial results. That creates gaps in the public record, overrepresenting successes and underrepresenting failures.

"Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community," FDA Commissioner Dr. Marty Makary said in a statement. "Those sponsoring clinical trials have an ethical obligation to make results public regardless of the data's influence on the company's share price."

The Center Square reached out to the Pharmaceutical Research and Manufacturers of America for comment on Monday.

Almost 30% of studies likely to fall under mandatory reporting have not submitted results to ClinicalTrials.gov, according to an internal FDA analysis. These studies include interventional studies with a U.S. nexus and an FDA-regulated product that are past the reporting deadline. Phase 1 and device feasibility studies are excluded.

At the end of March, the agency sent messages to more than 2,200 companies and researchers associated with over 3,000 clinical trials, including some publicly funded trials. These entities did not appear to have submitted required results to ClinicalTrials.gov or may not have completed the National Library of Medicine's quality review process. The messages seek voluntary compliance with requirements.

The FDA said it could also send Pre-Notices of Noncompliance and Notices of Noncompliance as part of compliance efforts. The agency said messages issued on March 30 "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."

"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," said Dr. Tracy Beth Hoeg, the acting director of the Center for Drug Evaluation and Research. "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 the benefits and risks of new and investigational products."

The FDA has issued eight Notices of Noncompliance since 2021 and 232 Pre-Notices of Noncompliance since 2013. None of those have resulted in a civil penalty so far, according to agency reports.