FDA drugs director Janet Woodcock predicted in October that the next 25 years could bring scientific and technological advances with the potential to make drug development more “reliable and predictable and understandable,” consequently decreasing “regulatory oversight in the manufacturing sector.”
Addressing the American Association of Pharmaceutical Scientists, she said that if science can make things clearer, safety and efficacy questions will not be so difficult. Woodcock also cited the need to “establish international standards” and “move toward quality by design.”
The current worldwide economic crisis has resulted in calls for deregulation, with calls for everything up to and including abolishing U.S. drug regulation in order to let the industry maintain productivity and jobs. “This will be a heck of a fight,” Woodcock observed.
In the postmarketing area, she predicted that “we will look back with horror at how we managed drug safety in the early part of the 2000s.” With the coming of electronic medical records networks such as Sentinel and vigilance systems in other countries, people could discover what’s happening with medicine in the real world far more effectively, she asserted.
From the December 01, 2011 Issue of MM+M - Medical Marketing and Media
