From the GAO Report
[Anybody have any idea what the Italian research institute is, and who the second scientist referenced is?]
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The two remaining scientists that FDA contacted in late February were not employees of FDA or FDA contractors. The agency characterized these scientists as volunteers and told us that they had been informally identified by CDER staff as experts in heparin analysis. FDA officials said that these two scientists provided services on an uncompensated basis in response to the oral requests ofCDER staff. With FDA’s knowledge, one of these two scientists obtained assistance in his work for FDA from external entities, including a drug development firm and an Italian research institute, also on an uncompensated basis.
The two scientists characterized by FDA as volunteers had professional and financial ties to heparin firms. Both served as paid consultants to two of the primary firms associated with contaminated heparin. In addition, one of the scientists was a cofounder and member of the board of directors, as well as an equity interest holder, in a third firm, which, at the time of the crisis, had a pending application for a heparin product before FDA.[so who was the other scientist, and which of the two consulted with the Italian Firm?] The agency allowed this scientist to obtain assistance in conducting analytical work to identify the contaminant in heparin from this firm despite its pending application for a heparin product.38 This drug manufacturer dedicated approximately 30 staff members from its analytical and biology groups for periods ranging from a few weeks to 3 months to assist in the effort to identify the contaminant in heparin.
AI
