Tag Archives: Margaret Hamburg

FDA’s Only Getting Tougher

It’s been quite a year or two at the FDA since Commissioner Hamburg took over.  Of particular interest to me is their increasingly tough stance on inspections and marketing issues.  Here are some highlights:

  • The FDA wants to prosecute pharma and device execs should their firms engage in off-label marketing.  With what is known as the Park Doctrine, execs could face up to a year in jail + $100,000 fines.  This would be on top of the billion-dollar+ fines the companies have paid (which have not dissuaded them from trying to get away with things). Continue reading