FDA looks to prosecute 'two-legged defendants'

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 settlement with Pfizer--as if they're just part of pharma's operating strategy. "We need to put something else on the scale to make people think twice, three times, before they promote drugs for unapproved uses," Blumberg tells the Inquirer

The repeated warnings haven't fallen on deaf ears; the Inquirer also talked to a pharma consultant who says his clients are doing some fact-finding--and strategizing--to make sure they don't give the FDA cause. And that's exactly what Blumberg advises: Drugmaker executives should "find out what is going on in the marketing and sales divisions of their companies," he says, presumably so they can fix any problems they find. Or else.

- read the Inquirer story