Off-Label Promo Could Be First FDA Target of Corporate Prosecutions

The FDA may turn next to misdemeanor prosecutions of pharmaceutical company executives for off-label promotion of their products — based on new agency standards that are being fine-tuned. Off-label promotion is so rampant that “very soon, some corporate executive is going to be first,” Eric Blumberg, deputy chief for litigation in the Office of Chief Counsel, said at the 2010 Food and Drug Law Institute Annual Conference in Washington, D.C. He advised industry executives to monitor marketing departments for off-label promotion.
Drug Industry Daily