Pharmaceutical regulation risk-benefit

The safety of a diet could be defined as the overall risk-benefit of consuming that diet over a lifetime. This concept is not one that is applied in determining the safety of a chemical in food. Safety is almost invariably considered as the absence, or minimisation, of risk and not as the maximisation of benefit. Consequently, the scientific basis for regulating food chemicals is based on principles that were developed for assessing the risks posed by pharmaceuticals and industrial chemicals, and minimising these, rather than for maximising the benefits. 

Benefit-risk, then, is a central part of the practice of pharmaceutical medicine and its regulation. It can almost never be reduced to a numerical exercise. Benefit-risk assessments of clinical trial data are an important part of all new drug applications. Good people will differ in their benefit-risk assessment even when using the same body of clinical trials data. 

The comparative evaluation or balancing of risks and benefits of pharmaceutical products is inevitable, although there are no standard, widely accepted definitions used in medicine. Definitions and terms depend on the context in which they are used, or on the user. Patients, physicians, formularies, pharmaceutical companies, ethics committees, regulatory authorities, and other public health bodies, insurers, consumer groups, and others may have very different perspectives, e.g. the perspective of regulators and companies usually in-... 

On this basis, a programme can be developed to accurately assess the potential toxicity of biotechnologically-derived pharmaceuticals and ultimately establish a benefit to risk ratio. Such a programme will provide the clinician with scientifically relevant data to support clinical trials of potentially greater complexity than those undertaken for conventional pharmaceuticals. At the same time, the data will be sufficient to allow regulators to approve applications for clinical trial programmes and marketing. 

---