The Rise of Regulatogens: A Crisis of Insouciance and Dilettantism in the Regulatory DART World-And How We Must Fix It.

Developmental and reproductive toxicity testing (DART) safety tests are expensive and time-consuming. The future of DART testing is trending toward in vitro and in silico systems (and potentially artificial intelligence). Forward-looking academic programs have embraced the new test systems, but regulatory decisions remain based on decades-old, whole-animal testing. Many regulatory scientists have neither whole-animal DART testing experience nor academic training in embryology/developmental biology, comparative anatomy, and epidemiology. Consequently, some new medicines and chemicals have been misidentified as developmental toxicants by those eager to protect the public but lacking requisite in-depth DART/epidemiology training/experience to make informed interpretations. Additionally, some unqualified individuals have been appointed to health leadership roles. Sadly, their mandates are often accepted forthwith, foregoing independent evaluation by experts, resulting in misclassification of substances as "teratogens by fiat"-Regulatogens. Potential long-term remedies to address this crisis are discussed, but implementation and effective results will take years. Immediate remedies require qualified scientists/experts to step forward and challenge the validity and interpretation of poor science/improper interpretation underlying decisions that lack rigor, and proffer appropriately interpreted data with conclusions that are explainable to all stakeholders, including the public.