Jon B. Cole, MD
FDA issued a warning letter to Dr. Jon B. Cole, MD, of Hennepin County Medical Center, regarding two clinical investigations of ketamine, haloperidol, and midazolam for severe agitation in the pre-hospital setting conducted without required Investigational New Drug Applications (INDs). The investigations (Protocols HSR 14-3841 and HSR 17-4306) were found to be clinical investigations rather than standard medical practice because they pre-specified drug interventions, limited EMT-P clinical judgment, and removed alternative treatments from ambulances. FDA further found the studies did not qualify for IND exemption because they failed to adequately exclude pregnant women, pediatric patients, and intoxicated subjects, and lacked specific safety measures for the pre-hospital setting. Dr. Cole was required to respond within 15 business days with corrective actions to prevent future violations.
Flagged claims (3)
the drugs were used "essentially in accord with their approved labeling"
an IND was not needed for either Protocol HSR 14-3841 or Protocol HSR 17-4306 because the drugs administered in these clinical investigations were not research interventions
all three of the drug products were part of the standard of care used routinely by local EMT-Ps in the pre-hospital setting
Required actions (2)
Within 15 business days of your receipt of this letter, you should notify this office in writing of the actions you have taken to prevent similar violations in the future.
You should address these deficiencies and establish procedures to ensure that any ongoing or future studies comply with FDA regulations.
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