FDA to Announce Letters Urging Disclosure of Unreported Clinical Trial Data

FDA Sends Letters on Unreported Trial Data The Food and Drug Administration will announce on Monday that it has sent over 2,200 letters to drug manufacturers, medical device makers, and researchers.

The letters press these entities to publish clinical trial data that they have failed to report, according to The New York Times. The FDA action asked researchers and companies to voluntarily submit their results.

Experts note that unreported results can include negative outcomes, though companies maintain that reporting decisions align with legal and strategic priorities.

Legal Requirements for Reporting Drug developers are legally required to post results from many studies on ClinicalTrials.

gov, a federal database. Roughly 30 percent of studies examined in an internal FDA analysis had not reported their results to the database. The FDA can make drug developers pay over $10,000 a day if they do not disclose their results within a mandated time frame.

The National Institutes of Health could cut funding to institutions that do not comply. An expert petitioned the FDA to ramp up enforcement of universities and companies that did not report trial results, The New York Times reported. The expert is the director of the Science, Health and Information Clinic at the New York University School of Law.

Expert Views on the Initiative An expert said he was concerned that the effort might be “more symbolic than substantive.” The initiative addresses non-compliance identified in the FDA's internal analysis. The letters target entities responsible for the roughly 30 percent of unreported studies.