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 "The FDA's long-overdue response leaves key questions unanswered
about the performance and effectiveness of the FDA's Office of
Criminal Investigations," House of Representatives Energy and
Commerce Committee Chairman Greg Walden told Reuters in a statement.
An FDA spokeswoman did not have an immediate comment.
Walden's comments come about four months after the congressional
panel launched an examination into the criminal office and how it
was managing cases involving food, drugs and devices.
The review came after Reuters reported that FDA agents were
concerned that managers, including former OCI Director George
Karavetsos, were forcing them to pursue often toothless cases
involving mislabeled foreign-imported injectable drugs, at the
expense of cases with more potential to protect the public health.
The agents said they had become the "Botox Police" and were spending
hours chasing down doctors who purchased authentic versions of
Allergan's popular anti-wrinkle drug that were labeled for use in
other countries.
Those concerns came at a time when the office was seeing more than
half its opened cases ultimately get closed without action, Reuters
found.
Reuters also reported on how the FDA permitted Karavetsos to
relocate back to Florida in mid-2016 and run the OCI from its Miami
office, even after the FDA had already paid more than $25,000 to
move him to Maryland in 2015.
The FDA did not meet the committee's October deadline to provide
written answers to questions until Jan. 19. The next day, Karavetsos
departed to work for DLA Piper where he will represent drug and
device industry clients.
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In its letter reviewed by Reuters, the FDA listed its investigative
priorities and said that traditional metrics used to gauge success,
such as arrests and convictions, cannot capture the impact of its
public health mission.
It also provided annual data on arrests, convictions, and the number
of opened cases. However, it omitted preliminary-stage investigative
numbers from the total number of cases opened each year, which makes
the conviction rate appear higher, according to a side-by-side
comparison.
Walden said the FDA did not provide a performance plan, among other
things.
He also complained of redactions on a separate record, which
according to a committee aide contained salary and compensation
information for Karavetsos.
(Reporting by Sarah N. Lynch; Editing by Tom Brown)
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