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US drug company executives could face criminal charges for off-label promotion

BMJ 2010; 341 doi: (Published 19 October 2010) Cite this as: BMJ 2010;341:c5808
  1. Jeanne Lenzer
  1. 1New York

Executives of drug companies may face charges in a criminal court if their companies promote the off-label use of drugs, an attorney for the US Food and Drug Administration has said.

The agency’s deputy chief for litigation, Eric Blumberg, speaking at a conference in Washington, DC, said, “It’s clear we’re not getting the job done with large, monetary settlements. 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.”

Blumberg cited Pfizer, the world’s largest drug manufacturer, for violating regulations forbidding the promotion of drugs for conditions other than those approved by the FDA.

Monetary settlements have reached record highs …

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