Monday, January 28, 2013
FDA is asking the public to consider whether it should
supplement the current all-or-nothing approval structure with a system that
would couple approval of selected new drugs with measures designed to
discourage off-label use.
The agency says it could
approve drugs for conditions such as antibiotic-resistant infections and
life-threatening obesity based on small, fast trials if it were confident use
would be limited to well-defined populations.