After all the non-stop claptrap about there being too many new drugs comes a sobering fact: even as pharmaceutical companies poured a record $43 billion into research and development in 2006, U.S. Food and Drug Administration statistics show that the agency approved only 18 new drugs last year. That's down from 36 in 2004 and nearly as low as it's been at any time during the past decade.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
According to Dr. Scott Gottlieb, the agency's former deputy commissioner for medical and scientific affairs, "Our concern is that the development process itself is not keeping up at a fast enough pace to match the progress on the discovery end."
Which begs the question—wither the 21st century drug development tools that would make possible a swifter path from bench to bedside? More importantly, where's the outrage? Where are the scathing articles about the "critical path gap?" Where's the outcry from the halls of Congress about "who lost the critical path?"
Here's the rest of the story from The Journal of Life Sciences:
http://www.tjols.com/commentary/jun13_fda.jsp
Thoughts and comments most welcome.
