FDA draws flack over transparency at criminal unit

The US FDA has found itself in the hot seat over claims it is failing to provide evidence that its Office of Criminal Investigations is protecting public health.

The accusation by energy and commerce committee chairman Greg Walden comes four months into an enquiry into the office and how it is managing criminal investigations related to FDA-regulated products.

The OCI, which has an annual budget of $77.3m, investigates criminal violations that pose a danger to public health including breaches in the legitimate medical supply chain and activities involving unapproved, counterfeit and substandard medical products and devices, as well as health fraud, product tampering, adulteration and mislabelling of food, and illegal importation of FDA-regulated products.

The FDA was due to meet a deadline of October last year to provide documents for the enquiry but it did not respond until 19 January.

Walden claimed that the FDA's delayed response in the enquiry instigated more questions than answers and he pointed to a lack of submitted documentation, including a copy of the OCI's performance plan and details on how strategic investigative priorities were chosen or ranked.

"The FDA's long-overdue response leaves key questions unanswered about the performance and effectiveness of the FDA's Office of Criminal Investigations," Walden told Reuters in a statement.

According to the news agency, the agency provided information on its investigative priorities, arrests, convictions and the number of opened cases but it omitted preliminary-stage investigative numbers, making interpretation of the provided data inconclusive. The FDA also said that a public health impact cannot be determined from traditional metrics based on arrests and convictions.

The enquiry into the OCI follows reports last year that FDA agents claimed that more trivial violations were being investigated, under the order of OCI managers, rather than bigger public health cases such as "probes involving steroids, the street-level sale of counterfeit painkillers and the importation of drugs like Kratom, a plant used as an alternative to opioids".

Meanwhile, it was also revealed that 53 per cent of cases were closed without action. Reuters compared this with the Environmental Protection Agency where 71 per cent of opened cases resulted in criminal charges.

Agents allegedly described themselves as the "Botox Police", where they were forced to pursue doctors who had purchased imports of the authentic injectable anti-wrinkle drug Botox that had been labelled for use only in foreign countries.

In the report, Senate Judiciary Chairman Charles Grassley said: "Wasting investigative resources on cases that go nowhere raises concerns about the responsible use of tax dollars."

At the time of the report, former OCI director George Karavetsos defended the OCI's actions but *Reuters *also reported concerns surrounding Karavetsos, which included an expensive relocation.

Karavetsos left the OCI a day after the FDA submitted the documents in January and has now taken a position at law firm DLA Piper.

This is not the first time the OCI has come under pressure for not meeting its public health protection objectives. In 2010 the then OCI head Terry Vermillion stepped down following criticism of his management and an investigation into the OCI.

Earlier that year, the federal Government Accountability Office said the FDA was not exercising enough oversight of the OCI and performance measures were needed to assess whether it was fulfilling its remit.

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