Analysis recommends greater transparency in FDA reporting of negative trials

The process that led to the Food and Drug Administration's (FDA's) eventual approval of gepirone extended release (ER) for the treatment of major depressive disorder illustrates that the agency's regulatory flexibility can result in approval of drugs with questionable benefits, stated authors of a newly published special communication. The academicians suggested that the FDA should include in product labeling for approved drugs information on all of a drug's efficacy trials, including negative trials. Their report was published online June 24, 2026 in JAMA Psychiatry .