Last March, the US General Accountability Office issued a report that found the FDA’s Office of Criminal Investigation suffers from lax oversight, despite increased in funding and staffing over the past decade. And the GAO also concluded the FDA “has relied largely on the OCI director to determine which aspects of OCI’s operations and investigations are made known to FDA’s top management.”

The effort was undertaken in response to a request by US Senator Chuck Grassley, who has now written a follow-up Sept. 16 letter to Gene Dodaro, the GAO’s acting comptroller general, over concerns that the findings in the GAO report “were less than stellar” after hearing from an unnamed whistleblower who charged the agency report was compromised by a mole.

“I am not sure what the GAO was doing while it was inspecting the FDA Office of Criminal Investigations, but I can tell you they weren’t awake while they were doing it,” Grassley quotes the whistleblower. Specifically, the complaints are levelled at Terry Vermillion, the OCI director who is a retired Secret Service agent. Grassley calls them “troubling allegations.”

Vermillion came under fire two years ago after House Republicans expressed concern that the OCI was overly emphasizing drug-abuse cases instead of pursuing researchers and drugmakers that commit crimes when seeking approval for meds (background here). Now, Grassley wants the GAO to explain charges levelled directly at Vermillion and why the GAO may report may have been shoddy.

According to the letter, Vermillion relocated his domicile to the Hampton, Virginia, area and directs OCI work predominantly over the phone; he allegedly used OCI technical support staff and his IT staff to do personal work for him; and he allegedly authorized payment for government contracting training at George Washington University for a fellow OCI employee characterized as his ‘office mistress.’

“The whistleblower then goes on to state that Vermillion also directed that she be promoted to the level of GS-14 against the advice of other senior OCI officials in charge of administration, who advised him that she did not have enough responsibilities at her current GS-13 level position,” according to the letter.

And there’s more: Vermillion allegedly directed reports prepared by OCI’s Office of Internal Affairs were sanitized of derogatory info about his fellow US Secret Service retirees now working at OCI, and regularly had OCI training session and conferences held in the Dallas, Texas area so that he could visit family - a son and grandchildren, the letter states.

Finally, the whisteblower told this to Grassley’s staff: “Oh, by the way, someone in GAO was telling someone in OCI things about the investigation. Apparently GAO sent a test case to OCI to see how OCI would handle it. Someone in GAO told OCI this and OCI knew it was coming and knew which was the test case. I don’t know who in GAO was the snitch and I don’t know who in OCI was receiving the information, it might have been to FDA’s office of legislative affairs and not OCI, but I do know it happened.”

We asked the GAO for comment and a spokesman wrote us to say: “We are in the process of carefully reviewing the assertions in the letter and we will be responding to the Senator when our review is complete. We want to be sure the review is thorough so at this point I do not yet know when it will be complete.” We also asked the FDA for comment, but have not received a reply. We will update when, and if, we do.