7 Things To Do (and 7 Not To Do) During an FDA Investigation

 

The U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI), “protects the American public by conducting criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible, and bringing them before the Department of Justice for prosecution.”

These investigations are very different from routine audits and inspections—although all FDA inquiries can potentially lead to the same outcomes if they produce evidence of criminal misconduct. When facing an FDA investigation, there are both steps companies need to take and mistakes they need to avoid, and knowing what to do (and what not to do) is critical for achieving a favorable outcome.

The FDA OCI has a number of stated priorities. However, these priorities are broad in scope; and, as such, they encompass virtually all activities falling within the FDA’s enforcement jurisdiction. As identified by OCI, the Office’s priorities include:

“Breaches in the legitimate medical supply chain by individuals and organizations dealing in unapproved, counterfeit, and substandard medical products;”

“Criminal violations in situations where the normal regulatory process has been unable to remedy the problem;”

“Criminal violations where the risk of harm to the public health is particularly significant and the only remedy appears to be through the criminal process;” and,

“Criminal conduct that prevents the FDA from being able to properly regulate. This includes false statements to the FDA during the regulatory process and obstruction of justice.”

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