Raising the bar for market authorisation of new drugs

What’s the hype?

Various components of drug development, including experimentation, evidence generation, and marketing are already subject to regulation. However, there is interest in expanding the remit of regulatory agencies in Europe and the United States in order to make drug manufacturers more accountable and market authorisation more stringent.3 Recent proposals include making the raw data collected in pivotal randomised controlled trials of new drugs publicly available and developing a framework for independent appraisal of evidence.

One particularly important aspect is the standards of evidence for marketing authorisation.4 Currently, each new product is evaluated on its own merit, without being assessed against other available treatments. As a result, many drugs are approved on the basis of placebo controlled trials without showing their equivalence, non-inferiority, or superiority to existing alternatives. There are proposals in the United States and Europe to require evidence on comparative efficacy at the time of licensing.1 5 This is because the current regulatory environment crowds the marketplace with products that offer marginal, if any, improvements in therapeutic value over existing options. …