Professor John Abraham (Department of Sociology, University of Sussex)
Key Challenges of Pharmaceutical Development, Regulation and Public Health
I begin by examining the distinction between the regulatory and policy definitions of pharmaceutical innovation with what public health needs from pharmaceuticals, namely, therapeutic advance. The response to the ‘innovation crisis’ in terms of shortening and loosening regulatory assessment within the standard approval process is discussed, including streamlining of safety standards. I then shift to examine regulatory provisions for drugs to treat serious or life-threatening conditions under ‘accelerated approval’ or ‘exceptional circumstances’ regulations. Specifically, the shift to use of non-established surrogate endpoints is scrutinised. Do these regulatory changes give us more confidence that new drugs are efficacious and safe? Finally, I examine the question of the ‘independence’ of the regulatory agencies: funding, performance targets, and conflicts of interest of regulatory advisers.
