Regulatory judgments for toxicity signals of medicinal products: in search of accountability

Mintzes and Fuller’s call for “radical transparency” about available evidence of regulatory judgments based on Dhodapkar and colleagues’ article analysing the “safety signals identified within the US Food and Drug Administration’s Adverse Event Reporting System” is a cul-de-sac.12The lack of concordance of regulatory agency judgments about drug toxicity issues among four similar countries (Australia, Canada, the United States, and the United Kingdom) has already shown that judgments are not reliable.3 The problem is systemic, poor regulatory judgments for toxicity signals being the tip of an iceberg.Finding a prudent middle ground to protect patient interests represents an immense tension for drug regulators. But the system is out of control, having been on a slippery slope for a long time. It is accelerating drug approval, while remaining too slow for drug withdrawal,4 despite the rise in big data technology. Since 2015, for example, the French independent drug bulletin Prescrire has been blowing…
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