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May 10
2010
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No. 1: May 10-14, 2010
Faulty Transfer Triggers IND Termination
Scenario:
Dr. Armstrong submits an investigator-initiated Investigational New Drug (IND) application while on the faculty of a university medical center. On Form FDA 1572 (Statement of Investigator), he is listed as sponsor-investigator and Dr. Brown, his departmental colleague, is listed as sub-investigator.
Six months later, Dr. Armstrong leaves to join a distant teaching hospital, handing over his IND file to Dr. Brown to continue the research.
Three years pass. One day a colleague reminds Dr. Brown that an IND annual report should be submitted to the Food and Drug Administration (FDA), and he does so at once.
FDA Shakes Things Up
One week later the annual report is returned to Dr. Brown from the FDA, unaccepted. A telephone inquiry reveals, “This IND was terminated last year because annual reports were never submitted.”
The FDA representative warily adds, “Please do not tell me that this study is still in progress.” The researcher replies “OK, I won’t tell you that.” And gracefully ends the call.
The university’s IRB is immediately notified and places the study on hold. Review of the research records shows that long-gone Dr. Armstrong is still listed as the sponsor on Form FDA 1571 (IND application) of this now-terminated IND.
What Went Wrong?
Dr. Armstrong assumed that, because he had left and because Dr. Brown, a sub-investigator, was willing to continue the study, he had no further obligations to the old IND. When the FDA sent reminders to Dr. Armstrong at the original address it had on file, these were forwarded, unopened, to him at his new post. However, he paid them no attention, thinking that he no longer had any responsibility there. He even ignored the letter from the FDA stating that if an annual report were not submitted in 30 days the agency would terminate the IND.
Pertinent Rule/Regulation
IND sponsorship can be transferred only after the current sponsor sends a letter to the FDA stating that the IND is to be transferred and the new sponsor sends a letter to the FDA indicating that responsibility for the IND is accepted and all pertinent regulations will be followed. (21 CFR 314,72, Change in ownership of an application)
Outcome
The FDA reactivated the IND after Dr. Armstrong sent them the transfer letter and his successor, Dr. Brown, provided his acceptance letter. The school’s IRB removed the hold it had placed on the study.
Comments by Harvey M. Arbit, PharmD, MBA, president of Arbit Consulting, LLC. He specializes in FDA regulatory affairs related to investigator-initiated IND and IDE research.
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