A U.S. House committee launched a probe of the FDA’s criminal office, raising questions about the unit’s management and handling of cases involving devices, food and drugs.
The U.S. House Energy & Commerce Committee told FDA commissioner Dr. Robert Califf that it’s “examining management concerns” and “possible morale concerns with the field offices” of the federal safety watchdog’s Office of Criminal Investigations. The Sept. 20 letter, signed by committee chairman Rep. Fred Upton (R-Mich.) and Rep. Tim Murphy (R-Pa.), chairman of the subcommittee on Oversight & Investigations, seeks answers to a detailed list of questions by Oct. 12.
The letter asked why OCI director George Karavetsos is allowed to run the unit from an office near his home in southern Florida, less than 2 years after the FDA paid more than $25,000 to move him to Maryland; Karavetsos was named OIC director in January 2015. A previous OIC director, Terry Vermillion, resigned in November 2010 after being accused of several ethical violations, including running the OIC from his home in eastern Virginia.
Earlier this month, reports surfaced of a rift in the FDA’s criminal investigations office, with agents complaining that managers forced them to become “Botox police” by pursuing cases involving mislabeled foreign-imported injectable drugs at the expense of cases with more potential to protect the public health.
An FDA spokeswoman confirmed that the agency received the committee’s letter and said the FDA plans to respond to the committee directly.
The committee asked Califf to explain the process of opening criminal cases and for statistics on OCI’s arrests, convictions, case initiations and the amount of money recovered. From fiscal 2008 to 2015, 53% of OIC cases were closed without action. And federal prosecutors are declining to pursue many FDA cases, citing a lack of prosecutorial merit, criminal intent or strong evidence, according to the news service.
Karavetsos has defended the OIC, saying statistics are not a fair measure because public health and safety will “always trump the criminal investigation.”
Regulatory affairs associate commissioner Melinda Plaisier defended Karavetsos’ move to Miami, saying it was good both for the FDA and for his family.
(Material from Reuters was used in this report.)
