2019, Academic Paper

Pharmaceutical Drug Regulation in the United States and United Kingdom: Assessing Consumer Drug Availability and Pricing


The regulation of medical drugs, devices and therapies involves competing goals of assuring safety and efficacy while providing rapid movement of innovative therapies through the investigative and regulatory processes. There is a trade-off between affordability and accessibility of the remedy (patient quality of life) and associated risk (toxicity of the drug). While both the United States and the United Kingdom have similar regulatory priorities and missions, the approaches to drug and device approval are distinct. Approval and regulation of novel medical drugs, devices and therapies poses complexities. Extensive research and development, clinical trials, lengthy regulatory review requirements, and funding are all factors that should be considered in the analysis of drug and device evaluation. Common concerns between the US and UK approval requirements highlight the need for mutual cooperation, stronger regulations, and increased transparency in the pharmaceutical sector.


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