Monday, March 19, 2012
While proposals to create "progressive"
approval pathways have been in the spotlight, a movement to create a "staged"
approval pathway is gaining momentum in Washington. The idea would permit
abbreviated development of therapies for well-defined populations with serious
unmet medical needs while limiting off-label use.
The concept has emerged as a
tool to speed the development of therapies for multi-drug resistant pathogens.
But its supporters envision a much wider application to include conditions -
such as obesity - in which the sickest patients are unable to get new drugs
because regulators are unwilling to expose larger, healthier populations, or
patients with acceptable therapeutic options, to known or potential adverse