At CMPI’s “PDUFA without the Politics” Capital Hill Briefing, Dr. Tim Franson (President, USP Convention, former Vice President, Global Regulatory Affairs, Eli Lilly & Co., and one of the “father’s of PDUFA”) mentioned the Hawthorne Effect – “that which is measured gets accomplished.”
Which begs the question – should more things in PDUFA V be measured or measured with more robust deliverables?
Are “meetings” sufficient promises – or are actions more desirable? Specifically – are meetings about a benefit/risk grid enough or should there be a date-certain for a regulatory instrument to be operational?
Should PDUFA V be exclusively about process? What about provision?
Speech is conveniently located midway between thought and action, where it often substitutes for both. – John Andrew Holmes
