On January 25, 2018, the Associate Attorney General directed the Department of Justice (DOJ) not to rely on agency guidance documents to establish a violation in affirmative civil enforcement (“ACE”) cases. Agency guidance documents include letters to industry, policy manuals, handbooks and FAQs.
Affirmative Civil Enforcement (“ACE”) refers to filing civil lawsuits on behalf of the United States. The purpose of these civil actions is to recover government money lost to fraud or other misconduct or to impose penalties for violations of Federal health, safety, or environmental laws.
Under the January 25 directive, DOJ “may not use its enforcement authority to effectively convert agency guidance documents into binding rules,” and “may not use noncompliance with guidance documents as a basis for proving violations of applicable law in ACE cases.”
Clients should be aware of situations where DOJ or agencies cite guidance documents in the context of compliance actions and consider whether the January 25 directive may be applicable. Although the directive applies to DOJ, it may have broad impact across the federal government, as DOJ litigates enforcement actions for most federal agencies, including U.S. Department of Health and Human Services (HHS) agencies like the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS). The directive applies to both future ACE actions and ACE actions pending as of January 25, 2018.
Sources: Aiken Gump and DOJ