Changing faces at the FDA as Trump lines up his allies

There have been further staff changes at the FDA in the wake of the American presidential election result and another top position has become available, with the president-elect able to influence the replacement.

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The FDA’s internal police force – the Office of Criminal investigations (OCI), which has been operating for 25 years – will see its director leave at the end of January. This comes after controversy resulted in the resignation of its chief of department. George Karavetsos, the former federal prosecutor, will be leaving his OCI director post to take up a new role at a private law firm.

Karavetsos has come under criticism for various decisions during his time in the role. One of the primary criticisms was how he chose agents to work on caseloads relating to mislabelled foreign imports of drugs. Over 50 per cent of these cases did not reach prosecution stage, despite generous public funding being allocated to their progression.

A diminishing reputation?

The OCI has gained a new nickname in insider circles – the ‘Botox police’ – with attorneys around America typically agreeing that the majority of these cases lack true merit and are not worth prosecuting at great expense through the courts.

A tough job ahead

Whoever is chosen to fill the departing role will have a tough job to rebuild the department’s now-tainted reputation and instil public confidence in its purpose and operation. The Food and Drug Administration did not have its own internal policing function until 1992. It exists as a means of safeguarding the agency’s work and conducting investigations where it suspects violations have occurred under the federal acts to protect food, drugs and cosmetics.

The remaining agency team has 280 employees in role and is attached organisationally to the Office of Regulatory Affairs within the FDA. It has a yearly budget of just over $77m (£63m). While manufacturers work with the FDA to establish how long does it take to get a FDA 510k approved through a supporting body such as, the OCI is busy investigating and upholding standards and maintaining the agency’s reputation.

Its agents carry out investigations into food safety, with the FBI drafted in when cases are particularly complicated or prosecutions cover a range of federal criminal legislation, such as conspiracy and fraud.