No Refills - Magazine - The Atlantic
Megan McArdle's article on why there are fewer drugs approved is well taken and is actually not new, just lost in the stupid way the media reports on the FDA. I also take strong exception to the claim that conservatives blame the FDA. Five years ago I chaired a task force, established by the late Joshua Lederberg, to look at how the FDA was using regulatory science based on new genetic and clinical insights used to discover new targets to change medical product development. The Critical Path initiative was established to create a new set of tools for this purpose, tools that would help individualize risk and benefits. Those who use Big Pharma to attack commercialization have sought to undermine the Critical Path because it eliminates unexpected fear as a political weapon. Those who attack "biomarkers" as another way companies can market new, ineffective drugs willfully fail to grasp the fact that the principal barrier to approval is the absence of well validated markers. And the attack comes from the right and the left.
The report can be found here: www.manhattan-institute.org/pdf/CMP_FDA_Task_Fo...
