January 19, 2021

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January 19, 2021

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DOJ Issues Guidelines for Enforcement Related to Off-Label Promotion

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.

Rebecca S. Bradley, Monica R. Chmielewski, Kyle Y Faget, David B. Goroff, Andrew L. Hurst, Adrian L. Jensen, Pamela L. Johnston, Alexandra M Kitson, Katy E. Koski, James W. Matthews, Lisa M. Noller, Eileen R. Ridley, David L. Rosen, Michael J. Tuteur, and Torrey K. Young, contributed to this article. 

© 2020 Foley & Lardner LLPNational Law Review, Volume VIII, Number 64



About this Author

Nathan A. Beaver, Foley Lardner, FDA Enforcement Lawyer, Regulatory Attorney,

Nathan A. Beaver is a partner and food and drug lawyer with Foley & Lardner LLP, where his practice focuses on the representation of manufacturers whose products and activities are regulated by the Food and Drug Administration (FDA), Drug Enforcement Administration (DEA), and the Federal Trade Commission (FTC). He advises clients on regulatory issues affecting prescription and over-the-counter drug products (including animal drugs), medical devices, dietary supplements, cosmetics, and foods with special emphasis on the strategic considerations involving the approval...

Thomas F. Carlucci, Foley Lardner, Health Care Fraud Lawyer, Off Label Marketing Attorney,

Thomas F. Carlucci is a partner and litigation attorney at Foley & Lardner LLP where he is managing partner of the San Francisco office. Mr. Carlucci represents corporations, organizations and individuals in white-collar matters and internal investigations with an emphasis on potential health care fraud, tax fraud, off-label marketing, and false claims. He also focuses on civil state and federal tax litigation.

Melissa Coffey, Partner

Melissa Coffey is a partner with Foley & Lardner LLP, where she is vice chair of the Government Enforcement Defense & Investigations Practice. Her practice concentrates on representing companies and individuals in investigations and proceedings involving the Securities and Exchange Commission (SEC), the Public Company Accounting Oversight Board (PCAOB), the Department of Justice (DOJ), and other regulators. Ms. Coffey also has extensive experience conducting internal investigations.

Ms. Coffey has experience with False Claims Act qui tam...