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

Journal Article (Journal Article)

PURPOSE: This study highlights Warning Letter (WL) findings issued to sponsor-investigators (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 a five-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.

Full Text

Duke Authors

Cited Authors

  • O'Reilly, EK; Blair Holbein, ME; Berglund, JP; Parrish, AB; Roth, M-T; Burnett, BK

Published Date

  • December 1, 2013

Published In

Volume / Issue

  • 36 / 6

Start / End Page

  • E290 - E296

PubMed ID

  • 24309225

Pubmed Central ID

  • PMC4476253

Electronic International Standard Serial Number (EISSN)

  • 1488-2353

Digital Object Identifier (DOI)

  • 10.25011/cim.v36i6.20626


  • eng

Conference Location

  • Canada