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Off-Label Marketing Investigations

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BRG experts assisted outside counsel for a global pharmaceutical company accused of fraudulent promotion of several of its products for indications that were not Food and Drug Administration approved (so-called “off-label” uses). The Department of Justice and several U.S. Attorney offices pursued these off-label promotion allegations. 

The BRG team took a data-driven approach to understanding the prescribing and sales of the products at issue in order to develop our analysis. Specifically, we:

  • Analyzed the relevant client sales and marketing practices, documents, and data
  • Analyzed brand plans and internal company sales projections and return-on-investment calculations
  • Analyzed third-party data regarding prescribing patterns for the products at issue, by prescriber specialty
  • Performed detailed financial analysis of the products using data dumps of the company’s transaction-level sales, rebate, and general ledger data
  • Created product-specific profit and loss statements
  • Identified changes in the various compendia regarding approved product uses

BRG professionals developed liability and damages analyses that incorporated numerous data sources and estimated the financial impact of the alleged off-label promotion activity while excluding off-label sales that were independent of the alleged off-label promotion activity. This matter was resolved in a settlement with the Department of Justice.

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