Karavetsos drew fire last year for allegedly forcing members of the criminal investigations office to pursue mislabeled foreign-imported injectable drug cases at the expense of issues more important for protecting public health. The debacle earned the department under Karavetsos lead the label of “Botox police.”
Karavetsos became director of the 280-person operation in Jan. 2015, and his last day is scheduled for Jan. 20.
His exit was announced Tuesday by regulatory affairs associate commissioner Melinda Plaisier and global regulatory operations and policy deputy commissioner Howard Sklamberg, who said Karavetsos “has delivered an exceptional body of work, leading noteworthy and important change in OCI.”
Karavetsos and the department he led have been under significant scrutiny over the past year. Last September 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 group asked why OCI director George Karavetsos was 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. 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 in September, 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 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.
The post FDA’s ‘Botox police’ Karavetsos chief to step down appeared first on MassDevice.
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