DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

05 March 2018 Legal News: Government Enforcement Defense & Investigations Publication
Author(s): Nathan A. Beaver Thomas F. Carlucci Pamela L. Johnston Rebecca S. Bradley Monica R. Chmielewski Melissa B. Coffey Kyle Y. Faget David B. Goroff Adrian L. Jensen Katy E. Koski James W. Matthews Lisa M. Noller Eileen R. Ridley David L. Rosen Michael J. Tuteur

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?
  • Did the off-label use injure patients, or did it help patients?
  • Did the company’s actions materially mislead the FDA?
  • Did the company lie or mislead doctors and patients?
  • Did the conduct involve improper inducements or kickbacks?

DOJ Policy on Guidance Documents

The Justice Department has stated it will no longer use guidance documents to impose binding rules on private parties. Consequently, enforcement divisions will no longer be permitted to consider violations of guidance documents as violations of the law.

Off-Label Promotion Settlements and Prosecutions

Deputy Assistant Attorney General Davis outlined a few recent and notable off-label settlements and prosecutions, including the following:

  • Celgene Corporation

    In 2017, Celgene Corporation agreed to pay $280 million to settle allegations regarding false and misleading statements they made about two of their cancer drugs.
  • Aegerion Pharmaceuticals

    Aegerion Pharmaceuticals recently pled guilty to violations of the Food, Drug and Cosmetics Act related to their promotion of a drug for the treatment of high cholesterol. The company misled providers about appropriate candidates for the drug and failed to comply with the drug’s Risk Evaluation and Mitigation Strategy (REMS).

Top Enforcement Priorities

The Consumer Protection Branch has named the following as their top priorities for enforcement:

  • Combatting the opioid crisis

    The division will focus on ensuring that companies comply with REMS requirements for opioids.
  • Noncompliance with current Good Manufacturing Practices (cGMPs)

    The division will vigorously pursue enforcement against companies that do not comply with cGMP regulations.


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