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May 10

No 1: Faulty Transfer Triggers IND Termination

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No. 1: May 10-14, 2010

Faulty Transfer Triggers IND Termination


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)


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.

Comments (6)
written by Dr Deek, April 30, 2010
Let me see if I have this right! Dr. Armstrong submits a NDA, lists himself as sponsor/investigator and Dr Brown as "sub-investigator". Apparently the NDA was approved and was approved to the applicants' institution, who clearly holds responsibility over the entire matter (and who stood in the best position to benefit from the NDA research study). Armstrong leaves, it doesn't matter where or why, but he leaves and leaves the "NDA file" in the hands of Dr Brown. Three years later, someone, presumably at the behest of the University's administration, tells Dr. Brown to submit a report tothe FDA regarding the IND. He does and the report is returned, with a statement that the study was closed because of failure to submit reports. However, apparently the study was still in progress; Dr Brown didn't deny that, he simply agreed with the FDA rep to not state this. The University "places" the study on hold, only when it comes to their attention that the FDA closed the study, which is a fact that the University administrators are paid to know, keep track of and ensure compliance with. Further, present review of the study shows Dr Armstrong as the sponsor on FDA form 1571, which I assume was submitted each year to renew the study by the university, with the false information that Dr Armstrong is the sponsor/investigator. What went wrong? The University lied. They kept the study open without informing the FDA that the sponsor had left. They continued the study under false pretenses, under the hope that the new drug, if therapeutic, would bring in royalities or patent revenue.They failed in their rsponsibility to inform the FDA of changes (this responsibility did not shift to Dr Brown simply because Dr Armstrong gave him the files), and they failed to terminate the study, instead electing to "put it on hold" when they were caught with their pants down. During my many years in research, my colleagues have often asked me what exactly do administrators do to earn the overheads we generate with our research and grant proposals. I have not easily answered this question. I find more and more evidence that the role of administrators is to dupe funding and authorizing agencies as the University did in this case, and little more. Administrators stand in the way of proposals and lie after they are funded. Administrators leave at 4:30 PM and reap benefits of research done by faculty they disdain at early hours in the morning. Administrators have absolutely no role in research today, and should be eliminated. The funds freed as a result would be better used in helping young invesigators get started. Established investigators can sign the papers administrators sign as part of their established positions, and no one would know the difference.
written by Old Eli, May 03, 2010
With the massive coming and going of PIs and faculty in general, it requires almost superhuman knowledge to keep track of who was or wasn't in charge of each study. Please don't beat up on the adminsitrators; they turn over too. I commend these guys for finally getting caught up--and the graciousness of the FDA emplyee for the knowing comment of "Please don't tell me..." Would that there were more such govt staff!
written by Dr. Arbit, May 03, 2010
Thank you for your comments. Please refer to the following article: Arbit HM, Paller MS. A program to provide regulatory support for investigator-initiated clinical research. Acad Med. 81(2):146-153, 2006 Feb.
written by Robin, May 04, 2010
Directing blame seems pointless here. This could very easily have been a combination of innocent mistakes, so why assume the worst of those involved? We can and should learn from this though to avoid problems should a similar situation arise for any of us.
written by 3 boyz, May 12, 2010
I pose the following question on this topic to those of you who have experience in these matters: The PI of a study done in our institution which is a non-academic setting. He holds the IND. The study has been placed on a FDA hold until they investigated similar studies that had negative sequelae. Coincidentally, the PI left us at the same time. He has stated the research would not continue here but our institution implemented two of the 3 cohorts and has been following up the subjects. This was 18 months ago and the FDA has not released the hold. - Did we have an obligation to notify the FDA on any of this? - Does the PI hold all rights to the research conducted here? I would be interested in hearing your feedback since I cannot find any definitive CFR applying to the entire scenario.
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