FDA Urges Pharma to Publish Trial Data, Warns of ‘Distorted’ Evidence Base

The FDA said it reminded more than 2,000 pharmaceutical companies and researchers about legal requirements to publish clinical trial data, warning that a publication preference for positive trials could be skewing the available evidence on therapies.

“Far too often, companies are suppressing unfavorable clinical trial results and keeping them secret from patients and the scientific community,” FDA Commissioner Marty Makary, MD, MPH, 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.”

Federal requirements created under the FDA Amendments Act of 2007 require reporting to ClinicalTrials.gov within a year for many interventional studies, but an internal FDA analysis found that 29.6% of studies considered highly likely to require reporting had no results posted.

“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,” said Makary.

A publishing bias toward positive results “obscures the true landscape of drug development outcomes,” according to the agency. “This gap can also create a distorted perception of the safety and efficacy of medical products.”

It’s not only drug companies that fail to report, with top U.S. universities often falling short as well, according to an analysis from Universities Allied for Essential Medicines.

Overall, the FDA said on Monday, more than 2,200 companies and researchers (stemming from over 3,000 clinical trials) had data gaps and were sent letters on March 30. The messages seek voluntary compliance with the trial reporting requirements, but the agency can also impose fines.

An op-ed published by MedPage Today in 2023 that called for more aggressive enforcement of the data reporting law said the agency could have issued $45 billion in fines for reporting lapses. “In spite of the thousands of trials violating the law, the FDA has not yet collected any fines,” the authors wrote at the time.

The FDA said the messages it sent “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.”