More Questions than Answers About FDA’s Office of Criminal Investigations

Walden: More Questions than Answers About FDA’s Office of Criminal Investigations

Following a request by committee leaders in September 2016, Energy and Commerce Committee Chairman Greg Walden (R-OR) says there continue to be more questions than answers regarding the U.S. Food and Drug Administration’s (FDA) Office of Criminal Investigations (OCI).

In pointing to FDA’s delayed response, Chairman Walden flagged the fact that the agency failed to include basic information like a copy of their performance plan or details on how strategic investigative priorities were chosen or ranked.

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January 26, 2017

House lawmaker seeks more documents in FDA criminal office inquiry

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.

Read the article online, click HERE.

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