The FDA has turned down a citizen petition seeking that the investigators and the institutional review board (IRB) at Minneapolis, Minn.-based Hennepin County Medical Center (HCMC) be barred from conducting clinical trials.

The petition, filed by Public Citizen in November, asked the FDA to disqualify two principal investigators (PIs) at HCMC, Jon Cole and Lauren Klein, as well as their co-investigators, for running multiple trials of investigational drugs without filing or possessing investigational new drug applications (IND). The center’s IRB was also in the crosshairs of the advocacy group, which argued that the board should be disqualified based on noncompliance (CenterWatch Weekly, Nov. 22, 2021).

Although the PIs contended that they did not need to get IND approvals for the trials in question because the trials involved noninvestigational drugs, the agency did not agree, issuing a pair of warning letters. In addition, the FDA sent a Form 483 to the medical center’s IRB, citing it for approving waivers of consent for the trials and approving research “in a situation where some or all of the subjects were likely to be vulnerable to coercion or undue influence” without ensuring safeguards were in place.

The agency appears to believe that the warning letters issued to the PIs in May 2021 and the Form 483 issued to the IRB in August 2018 are sufficient enforcement actions for now, though it noted it plans “to continue to consider all the options available to the agency as we determine whether to pursue additional compliance actions.”

Read the FDA’s final response to the citizen petition here: https://bit.ly/3yggyeO.