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Subpoenas Over Promotional Activities Continue

Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite adamant (as it should be) about the differences between drugs and devices, litigation is one area where we're beginning to see similarities. Experts at device conferences during the past year have emphasized that we're next and that it would be wise to look at what's happening to drug companies to see if these problems are present in your organization.

Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional "and other" activities. While not much details were given, it noted that the subpoena sought documents from Amgen's sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a device conference a couple of months ago told attendees that the government has been looking at these very same documents at device companies in efforts to find evidence of a violation. Their strongest advice--conduct audits and make sure you respond to them appropriately.

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