Warning letters to sponsor- investigators at academic health centres - the regulatory "canaries in a coal mine"

Erin K. O'Reilly, M. E Blair Holbein, Jelena P. Berglund, Amanda B. Parrish, Mary Tara Roth, Bruce K. Burnett

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Abstract

Purpose: This study highlights Warning Letter (WL) findings issued to sponsorinvestigators (S-Is) by the Food and Drug Administration (FDA). Methods: The online index of WLs issued from October 1, 2007 through September 30, 2012 was reviewed [1]. Through a manual screening process, letters were evaluated if specifically issued to 'clinical investigators', 'sponsors' or 'sponsor-investigators'. A particular focus was given to S-Is at Academic Health Centres (AHCs). Each letter was scored for the presence of violations in 40 general regulatory categories. Results: A review of FDA WLs issued over afive-year period (FDA Fiscal Years 2008-2012) revealed that WLs to S-Is represent half of the WLs issued to all sponsors (16 of 32 letters). A review of these letters indicates that S-Is are not aware of, or simply do not meet, their regulatory responsibilities as either investigators or sponsors. In comparing total sponsor letters to those of S-Is, the most cited violation was the same: a lack of monitoring. A review of publicly available inspection data indicates that these 16 letters merely represent the tip of the iceberg. Conclusion: This review of the WL database reveals the potential for serious regulatory violations among S-Is at AHCs. Recent translational funding initiatives may serve to increase the number of S-Is, especially among Academic Health Centres (AHCs) [2]; thus, AHCs must become aware of this S-I role and work to support investigators who assume both roles in the course of their research.

Original languageEnglish (US)
JournalClinical and Investigative Medicine
Volume36
Issue number6
StatePublished - 2013

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Warning letters to sponsor- investigators at academic health centres - the regulatory "canaries in a coal mine". / O'Reilly, Erin K.; Holbein, M. E Blair; Berglund, Jelena P.; Parrish, Amanda B.; Roth, Mary Tara; Burnett, Bruce K.

In: Clinical and Investigative Medicine, Vol. 36, No. 6, 2013.

Research output: Contribution to journalArticle

O'Reilly, Erin K. ; Holbein, M. E Blair ; Berglund, Jelena P. ; Parrish, Amanda B. ; Roth, Mary Tara ; Burnett, Bruce K. / Warning letters to sponsor- investigators at academic health centres - the regulatory "canaries in a coal mine". In: Clinical and Investigative Medicine. 2013 ; Vol. 36, No. 6.
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