Unmet need has turned pharma toward specialty meds. Yet every success reduces unmet need, raising the bar. In this landscape, how do you ensure that a small-audience drug has a compelling value proposition at launch?
A McKinsey Center for Government analysis shows that in the period 2001-2010, FDA approved 88% of NDAs and BLAs that were supported by advisory committees and did not approve 86% of those not endorsed by the committees.
Big pharma marketers who’ve been complaining to Washington for decades about the unregulated nibbling at their market shares won historic relief when the Drug Quality and Security Act was signed into law on Nov. 27.