Less than two weeks after a report highlighted complaints from agents at the FDA’s criminal office, a U.S. congressional committee has decided to take a closer look at the unit and the way it handles cases.
As the House Energy and Commerce Committee told FDA Commissioner Robert Califf, it’s "examining management concerns" and "possible morale concerns with the field offices" of the Office of Criminal Investigations, Reuters reports.
In a Sept. 20 letter, committee chairman Fred Upton and Subcommittee on Oversight and Investigations chairman Tim Murphy posed a list of questions--including why the criminal office’s director, George Karavetsos, runs the unit from a South Florida office near his home--to be answered by Oct. 12, the news service notes.
The probe follows a Reuters report from earlier this month that featured gripes from some of the office’s workers, who say they’ve become the “Botox Police.” They’re instructed to go after every doctor who purchases authentic versions of the anti-wrinkle blockbuster that were labeled for use in other countries--sometimes at Allergan’s own request, they told the news service. And the practice has some agents believing their efforts do little else than protect Allergan’s ability to keep U.S. prices for the med high.
In one field office, a psychologist heard complaints about "micromanagement" in general--and about Botox cases, in particular, wasting “valuable agent time.”
The FDA takes issue with Reuters’ story, a spokesman told FiercePharma, and says the criminal division is focused far more broadly than on Botox.
It’s not the first time the OCI has come into the spotlight, the House committee letter points out. Prior reports--one from the Government Accountability Office and one from the Health and Human Services Office of the Inspector General (OIG)--have been critical of the unit.
The OIG report, released in 2012, cited a lack of independence within the office and recommended changes that would “ensure the independence of investigation.” But those suggestions were discarded by the FDA’s leadership at the time, Reuters notes.
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