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ARTICLE · 07 MARCH 2018

DOJ Issues Guidelines For Enforcement Related To Off-Label Promotion

Foley & Lardner LLP
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On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion.

United StatesConsumer Protection
Nathan Beaver
Nathan Beaver
Rebecca Bradley
Rebecca Bradley
Thomas Carlucci
Thomas Carlucci
Monica R. Chmielewski
Monica R. Chmielewski
Melissa B. Coffey
Melissa B. Coffey
Kyle Y. Faget
Kyle Y. Faget
David Goroff
David Goroff
Adrian L. Jensen
Adrian L. Jensen
Pamela Johnston
Pamela Johnston
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On February 28, 2018, Ethan P. Davis, the Deputy Assistant Attorney General for the Consumer Protection Branch, addressed the life sciences community regarding off-label promotion. In his remarks, Deputy Assistant Attorney General Davis outlined the key factors DOJ takes into consideration when deciding to pursue enforcement related to off-label promotion, spoke to the DOJ's new policy on guidance documents, and listed the current top enforcement priorities for the division.

Key Considerations

The Department of Justice considers the following factors when deciding whether to pursue enforcement against pharmaceutical companies for off-label promotion.

  • Was the speech at issue false or misleading, or was it truthful?

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