On Thursday, January 25th, the Associate Attorney General issued a memorandum that prohibits the Department of Justice from using civil enforcement authority to “convert agency guidance documents into binding rules.” According to the Memorandum published on the Department of Justice website, Justice Department civil litigators are prohibited from using guidance documents – or noncompliance with guidance documents – to establish violations of law in affirmative civil enforcement actions. Further, in that same news release, DOJ Associate Attorney General Brand stated “Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking.”
PLEASE NOTE: IACP currently is reviewing this information and determining what impact this has for current FDA Guidance for Industry (GFI) documents. IACP will send you additional updates as they become available.
Please see the Department of Justice’s press release below.
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Thursday, January 25, 2018
Associate Attorney General Brand Announces End To Use of Civil Enforcement Authority to Enforce Agency Guidance Documents
Today, as a follow-up to a memo issued by Attorney General Jeff Sessions in November, the Office of the Associate Attorney General issued a new policy that prohibits the Department of Justice from using its civil enforcement authority to convert agency guidance documents into binding rules. Under the Department’s new policy, Department civil litigators are prohibited from using guidance documents-or noncompliance with guidance documents-to establish violations of law in affirmative civil enforcement actions.
On November 17, 2017, Attorney General Jeff Sessions issued a memo prohibiting the Department of Justice from issuing guidance documents that have the effect of adopting new regulatory requirements or amending the law binding on persons or entities outside the Executive Branch. The memo prevents the Department of Justice from evading required rulemaking processes by using guidance memos to create de facto regulations. In the past, the Department of Justice and other agencies had blurred the distinction between regulations and guidance documents.
“Although guidance documents can be helpful in educating the public about already existing law, they do not have the binding force or effect of law and should not be used as a substitute for rulemaking,” Associate Attorney General Rachel Brand said. “Consistent with our duty to uphold the rule of law with fair notice and due process, this policy helps restore the appropriate role of guidance documents and avoids rulemaking by enforcement.”
NOTE: The new policy can be found here.
Office of the Associate Attorney General
Press Release Number:
18 – 96