FDA looks to prosecute 'two-legged defendants'

FDA and Justice Department officials have been talking up possible prosecution of individual managers, rather than just their companies.

We've heard a lot of talk lately about the feds cracking down on pharma executives. In the wake of a series of off-label marketing settlements, FDA and Justice Department officials have been talking up possible prosecution of individual managers, rather than just their companies.

FDA's litigation chief Eric Blumberg gave perhaps the most direct warning in a speech earlier this month, when he told the Food and Drug Law Institute that the agency is looking for an opportunity to go after individual executives. Now, in an interview with the Philadelphia Inquirer, he reiterates that warning, saying, "[O]ne thing that will get executives' attention is a few cases in which we have convicted two-legged defendants."

Why the new approach? Blumberg says it's because fines and settlements aren't working. Companies are repeatedly mismarketing their drugs, despite promises to the contrary. And investors appear to be shrugging off those fines--even the record-setting $2.3 billion s