House lawmaker seeks more documents in FDA criminal office inquiry

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By Sarah N. Lynch | WASHINGTON

WASHINGTON A top U.S. lawmaker accused the Food
and Drug Administration on Friday of failing to hand over
documents that would show whether its criminal office is
fulfilling the critical mission of protecting public health.

“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.

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.



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