Experts say that for the public to have confidence in medicines, regulators must be completely open about drug safety. According to a study that was recently published in The BMJ, less than one-third of the regulatory decisions made by the US Food and Drug Administration (FDA) are supported by publ
The study indicates that either the FDA is basing its regulatory decisions on information that has not been made publically accessible or that when possible safety signals are identified, more thorough safety evaluations may be required.
Monitoring a medicine’s safety after it is made accessible to patients is critical for monitoring drug safety. A team of US researchers, therefore, decided to analyze safety signals identified within the FAERS database. They asked how often these signals resulted in regulatory actions and whether they were corroborated by additional research.
However, less than a third of regulatory actions were corroborated by at least one relevant published research study, and none of the regulatory actions were corroborated by a public assessment, reported by the Sentinel Initiative. In a linked editorial, experts argue that regulators should publish all evidence underlying their responses to drug safety signals to reduce harm and ensure public trust in medicines.
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