Wednesday, November 26, 2008

"This isn't Candy?"

Drug manufacturer Cephalon recently settled a claim of a misdemeanor violation of the U.S. Food, Drug and Cosmetic Act. The company must pay $425 million to settle criminal and civil charges filed against the company for the way it marketed three of its drugs - Actiq (a painkiller), Gabitril (an epilepsy drug) and Provigil (a sleeping drug). "These are potentially harmful drugs that were being marketed as if they were, in the case of Actiq, actual lollipops instead of a potent pain medication intended for a specific class of patients,” said acting United States Attorney Laurie Magid in a statement.
The first part of the settlement is for $50 million (criminal charges) and the second part is for $375 million (civil charges). Implementing a company code of ethics and following the PhRMA Code looks pretty cheap by comparison.
The civil complaint was brought by a former sales rep who, on the government’s request, agreed to wear a wire to a company sales conference. Three other individuals (two of them also former Cephalon sales reps), later filed suit as well. The four whistle-blowers will share $46.5 million from the settlement. Pretty "sweet" for the honest sales reps. What's disturbing from an ethics perspective is that you can't be in the pharma industry and not be aware of FDA's regulations of how drugs may be marketed. The tone was set at the top of Cephalon and it was waaay off pitch.

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