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FDA threatens pharma executives with individual penalties for off-label marketing

By Phillips & Cohen LLP

A round of applause for Food and Drug Administration Deputy Chief for Litigation Eric Blumberg. He said yesterday at a conference in Washington that executives of pharma companies that promote off-label marketing of drugs could be prosecuted for misdemeanors under what?s known as the ?Park Doctrine,? Bloomberg reported.

?It?s clear we?re not getting the job done with large, monetary settlements,? Blumberg said. ?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.?

The Park Doctrine, named after a 1975 Supreme Court case, allows the government to prosecute chief executive officers and other executives for violations of the federal Food, Drug and Cosmetic Act. They could be fined up to $100,000 and sentenced to one year in jail, with the possibility of being barred from working in the pharma industry.

Full post as published by False Claims Act - Qui Tam on October 14, 2010 (boomark / email).