Christopher Viehbacher, chief executive of Sanofi and chairman of PhRMA on PDUFA reauthorization:
"To make sure we're not ignoring unmet needs in primary care, we need a lot more clarity around the risk-benefit so there's predictability when we invest in these products.”
Predictability is the philosophical core of PDUFA. And risk/benefit is at the heart of the FDA process.
To make PDUFA V a public health victory, the most important thing is to remove (or at best minimize) the politics.
Easier said than done? Perhaps.
“PDUFA without the Politics” speaks to the issues inside PDUFA minus the slings and arrows of partisan politics.
But judge for yourself. Click here for the full paper.
Caveat Emptor
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
