Under Fire, FDA’s Top Cop Steps Down

On November 23, 2010, Terry Vermillion, Director of FDA’s Office of Criminal Investigation announced his retirement next month.

The announcement came after several years of criticism by Republicans in Congress who raised concern about his misdirection of the Office’s resources: instead of pursuing drug companies and researchers who commit crimes when seeking FDA approval for drugs, OCI pursued drug-abuse cases–which are the purview of the Drug Enforcement Agency.  

On September 16, 2010, Senator Chuck Grassley sent a letter to the Acting Comptroller General of the U.S. Government Accountability Office (GAO) complaining about a "less than stellar" GAO investigative report that the Senator had requested.  The GAO was charged with investigating the activities of OCI.

Sen. Grassley’s letter was prompted by a whistleblower’s complaint who charged Vermillion of misconduct, and indicated that someone at the GAO had tipped off someone at OCI about the investigation–thereby compromising the investigation and the report.  

"The thought that someone at the GAO may have compromised the testing of a system unfortunately, brings the integrity of the entire report into question if it’s determined to be true."  

 Specifically, the whistleblower’s complaint charges that:

 * the GAO field inspection failed to include relevant information about professional misconduct by the director of OCI.

 * Vermillion "Directed that reports prepared by OCI’s Office of Internal Affairs be changed to sanitize them of derogatory information about his fellow US Secret Service retirees now working at FDA/OCI."

 * a mole in the General Accounting Office had tipped off someone in OCI about the GAO investigation–thereby compromising it.

 And there are charges of misuse of OCI technical staff for personal uses:

According to the complaint Vermillion moved to Virginia and "now directs the work of OCI predominantly over the phone," and authorized a promotion for his "Office Mistress" against the advice of other senior OCI officials.

 

See also, Pharmalot "What Mistress? The FDA’s Top Cop Is Retiring"


 

Vera Hassner Sharav

 

Associated Press
FDA prober, under fire, steps down
By MATTHEW PERRONE

WASHINGTON – The head of the Food and Drug Administration’s criminal-investigation unit is stepping down, months after the latest round of criticism directed at his department by congressional investigators.

An agency spokeswoman confirmed yesterday that Terry Vermillion was resigning. "We appreciate Terry’s years of public service and wish him well in retirement," said FDA Associate Commissioner Beth Martino. Vermillion, who spent 20 years in the Secret Service before joining the FDA in 1992, is among the highest-paid officials at the agency at about $200,000 per year.

 Earlier this year the Government Accountability Office said that the FDA must exercise more oversight over Vermillion’s unit, which has operated largely independent of agency leadership, despite growing into a $41 million operation with 230 staffers over the last decade. In 2008, House and Senate Republicans questioned the priorities of the unit, specifically its focus on drug-abuse cases instead of broader misconduct by large companies.

 On September, Sen. Charles Grassley, R-Iowa, brought to light additional complaints against Vermillion in a letter to the GAO. Grassley said that an anonymous FDA whistle-blower contacted his office complaining that the GAO’s most recent findings were "less than stellar" and did not include a number of questionable practices by Vermillion.

 The whistle-blower alleged that Vermillion directed that reports "be changed to sanitize them of derogatory information" about former Secret Service colleagues working at the FDA.

 Additionally, the whistle-blower said Vermillion used support staff to perform personal tasks for him and often directed department operations from his home in Hampton, Va.

 Calls to Vermillion’s office and e-mails seeking comment were not returned yesterday.

 Sen. Chuck Grassley’s letter to Acting Comptroller General , Government Accountability Office (GAO), outlining allegations of misconduct by both Terry Vermillion, Director of FDA’s Office of Criminal Investigations (OCI) and GAO field officers who were sent to investigate.  http://online.wsj.com/public/resources/documents/grassleyletter.pdf