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News & Press: Breaking News

Assoc Atty Gen Brand Ends Use of Civil Enforcement Authority to Enforce Agency Guidance Documents

Friday, January 26, 2018   (0 Comments)
Posted by: Dagmar Anderson
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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 click here to view the Department of Justice's press release.

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