EU Drug Approvals 'Should Require Comparative Efficacy Evidence'

An article in the BMJ argues that demonstrating a new drug's lack of inferiority to existing alternatives should be a formal requirement of the approvals process.

Evidence on a new drug's efficacy in comparison to existing therapies should be required for approval in Europe, experts have claimed.

Writing in the British Medical Journal, Corinna Sorenson and colleagues at the London School of Economics and Political Science say that this type of evidence should play a formal part of the approvals process, enabling decision-makers to determine whether a new drug is superior to existing alternatives.

At present, pharmaceutical companies are only required to demonstrate a drug's safety and efficacy in relation to existing therapies when use of a placebo is deemed unethical.

However, Ms Sorenson and her colleagues argue that comparative efficacy evidence is "important", and that there are methodological tools available to provide this type of information.

"When one or more treatment alternatives are available, demonstrating lack of inferiority through compar