The Garland Memorandum reinstates the long-standing understanding of regulated industries.
On July 1, 2021, U.S. Attorney General Merrick Garland published a memorandum that rescinds two previous memoranda―the Sessions Memorandum and Brand Memorandum―that prohibited Department of Justice (DOJ) attorneys from using noncompliance with federal agency guidance documents as a basis for civil and criminal enforcement cases. These memoranda reasoned that since guidance documents do not undergo the notice-and-comment rulemaking process, they should not bind the public or require regulated entities to go beyond what is required by law. For example, the Brand Memorandum stated a failure to comply strictly with a guidance document would not result in DOJ seeking criminal or civil enforcement.
Garland’s memorandum states these previous policies were “overly restrictive,” “discouraged the development of valuable guidance” and hindered DOJ’s litigation of cases when relevant agency guidance was available. See Garland Memorandum, at 2. While it underlines the lack of “force and effect of law” guidance documents hold, it also emphasizes the “many valuable functions” these documents serve, including: advising the public on how the agency will likely apply its binding regulations; explaining an agency’s programs and policies; communicating other important information to persons and regulated entities in clearer and more accessible language than regulations; and promoting transparency, fairness and efficiency. Id.
In enforcement, DOJ attorneys “are free to cite or rely” on guidance documents “[t]o the extent guidance documents are relevant to claims or defenses in litigation.” Id. However, agency guidance documents themselves cannot form “the basis for an enforcement action” since they cannot “impose any ‘legally binding requirements’ on private parties.” Id. (citing Kisor v. Wilkie, 139 S. Ct. 2400, 2420 (2019) (plurality opinion)).
The Garland Memorandum reinstates the long-standing understanding of regulated industries. That is, deviations from guidance documents should be well supported by internal documentation, and in some cases, “guidance” from outside counsel.
For More Information
If you have any questions about this Alert, please contact Frederick R. Ball, Brittany Pagnotta, any member of the Life Sciences and Medical Technologies Industry Group, any member of the Trial Practice Group or the attorney in the firm with whom you are regularly in contact.
Disclaimer: This Alert has been prepared and published for informational purposes only and is not offered, nor should be construed, as legal advice. For more information, please see the firm's full disclaimer.