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FDA Enforcement Against Pharmaceutical Companies in the Product Promotion Arena

By Alan Minsk

In his “Reason in Common Sense, The Life of Reason (Vol. 1)”, George Santayana wrote: “Those who cannot remember the past are condemned to repeat it.”

We all can benefit from reviewing the lessons learned from past mistakes, whether committed by ourselves or others. The medical device industry would be well-served in heeding Santayana's warning; review of the Food and Drug Administration's enforcement in the pharmaceutical promotion area could offer insight into how it might minimize its regulatory risk. The device industry need only review recent FDA enforcement actions against its pharmaceutical brethren to understand better the types of governmental concerns. While the promotional rules might differ slightly for pharmaceutical and medical device firms, the basic rules apply equally.

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