There is currently considerable debate in many countries over the effects of public policy — in particular, governmental regulation — on the development of innovative pharmaceuticals. Regulators must balance patients' access to therapies with ensuring the safety of drugs. The consequences of poor decisions can be dire: if access is promoted at the expense of safety, a dangerous product can cause incalculable harm; conversely, if safety is over-emphasized at the expense of access, patients can suffer from the absence of life-saving and life-enhancing medications. Using the United States as an example, we discuss the influence of governmental bodies such as the US Food and Drug Administration (FDA), as well as recent legislative initiatives, on pharmaceutical innovation. We argue for a balanced approach to governmental interventions.
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Miller, H., Henderson, D. Governmental influences on drug development: striking a better balance. Nat Rev Drug Discov 6, 532–539 (2007). https://doi.org/10.1038/nrd2323
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