• 
• 

December 2010

FDA official wants to prosecute pharma execs

This article is excerpted from a Bloomberg News story.

FDA to pharma: Review your marketing to make sure it’s not breaking the rules, or else. In the second headsup from an agency official since March, FDA Deputy Chief Eric Blumberg said yesterday that pharma execs may be criminally prosecuted for offlabel marketing violations.

Big settlements with the Department of Justice aren’t cutting it, Blumberg said. Take Pfizer--after settling claims that it had mismarketed the epilepsy drug Neurontin, the company promised the government to stay in between the lines. Then came Bextra (and three other drugs). The company last year agreed to pay a record-setting $2.3 billion to settle claims that it marketed the drugs for offlabel uses. The settlement was so large in part because Pfizer was a repeat offender, prosecutors said at the time.

“It’s clear we’re not getting the job done with large, monetary settlements,” Blumberg told a conference audience. “Unless the government shows more resolve to criminally charge individuals at all levels in the company, we cannot expect to make progress in deterring off-label promotion.” For its part, Pfizer says it has made institutional changes designed to make sure the whole company follows the rules.

Blumberg’s comments follow FDA Commissioner Margaret Hamburg’s promise that her agency would go after individual executives for marketing infractions. In a letter to Sen. Charles Grassley, whose Finance Committee has dogged the pharma industry over the last several years, Hamburg said FDA would charge company execs with misdemeanor violations of the Food, Drug and Cosmetic Act, but that hasn’t happened yet.

You can read the Bloomberg story here.

Add Comment