Radical transparency in post-market oversight of medicine safety

When medicines are first marketed, knowledge of rare serious harmful effects is limited, because generally too few people are exposed, trials are too brief, and vulnerable groups such as elderly people have been excluded.1 Harm from medicine use is an important public health concern, leading to many potentially preventable hospital admissions and deaths.234 Early signals of serious harm, supported by evidence and acted on promptly, could lead to improved patient and public health.

In a linked paper (doi:10.1136/bmj-2022-071752), Dhodapkar and colleagues analysed 12 years of safety signals identified within the US Food and Drug Administration’s Adverse Event Reporting System (FAERS).5 They asked how often these signals resulted in regulatory actions and whether they were corroborated by additional research. The 2007 FDA Amendments Act requires that the FDA publish quarterly reports of safety signals identified in FAERS.6 This requirement is a welcome step, ensuring ongoing data mining for signals and rapid public …