Beaver Addresses Effect of New DOJ Policy on FDA Enforcement Actions

Partner Nate Beaver was quoted in an article for Food Quality & Safety, “What DOJ’s Policy on FDA Guidance Really Means,” about the impact that a new Justice Department policy prohibiting government litigators in civil cases from using noncompliance with guidance documents to prove violations of federal law will have on FDA enforcement actions.

Beaver said the change will make it more challenging for the FDA to pursue violations, especially where the agency has chosen to issue guidance documents rather than set rules. He also pointed out that one of the first steps the Trump administration took was an executive action that requires agencies to eliminate two rules for every new rule they finalize. Given that, he said, the FDA is likely to continue to avoid rulemaking except where absolutely necessary.