By Jim Robinson, President, Astellas Americas
When the Information Technology and Innovation Foundation (ITIF) published a report on the importance of the Prescription Drug User Fee Act (PDUFA) last month, one particular sentence caught my attention.
PDUFA is a significant part of the reason why the FDA leads peer agencies in the timeliness of drug application determinations and is widely recognized as one of the best drug-regulatory agencies in the world.
I couldn’t agree more.
This statement also reflects the fact that industry-driven science is leading to treatments that didn’t exist just a few years ago. We’re fundamentally changing, improving and saving lives. Today, there are more than 7,000 new medicines in development. Each holds the potential to be a breakthrough for diseases that afflict millions, a few hundred or a few dozen.
A state-of-the-art FDA helps shepherd innovations from clinical trials to the patient’s bedside, while incorporating unique approaches to drug development and regulatory decision-making. The sixth iteration of PDUFA, which Congress must pass by late summer to avoid disruptions of new drug reviews and approvals, will play a critical role in shifting the mindset of both the public and private sectors.