House committee launches review of FDA criminal office

WASHINGTON A U.S. congressional committee has launched an examination of the Food and Drug Administration’s criminal office, raising questions about the unit’s management and handling of cases involving food, drugs and devices.

The House Energy and Commerce Committee told FDA Commissioner Robert Califf it is “examining management concerns” and “possible morale concerns with the field offices” of the Office of Criminal Investigations. The September 20 letter, signed by committee chairman Fred Upton and Tim Murphy, chairman of the Subcommittee on Oversight and Investigations, seeks answers to a detailed list of questions by October 12.

Among other issues, the House committee questions why George Karavetsos, director of the Rockville, Maryland-based FDA criminal office, is allowed to run the unit from an office in South Florida, near his home.

An FDA spokeswoman said the agency received the letter and will respond to the committee directly.

The House questions come two weeks after Reuters reported how some FDA agents complain criminal office managers have forced them to pursue cases involving mislabeled foreign-imported injectable drugs, at the expense of cases with more potential to protect the public health.

Current and former agents complain they have turned into the “Botox Police,” spending thousands of hours chasing doctors who purchased authentic versions of Allergan’s anti-wrinkle drug that were labeled for use in other countries.

Some agents say their efforts have done little more than protect the pharmaceutical industry’s high drug prices in the United States.

Those concerns come as the criminal office has had mixed success in bringing cases. From fiscal year 2008-2015, Reuters found, more than half of all opened OCI cases were closed without action.

The House committee asked Califf to explain the process for how criminal cases get opened, and to provide statistics on OCI’s arrests, convictions, case initiations and amount of money recovered.

Reuters also reported on Karavetsos’ relocation to Florida, a move that came less than two years after the FDA paid more than $25,000 to move him to Maryland.

Karavetsos, in a prior interview, defended the office’s efforts, saying statistics are not a fair measure of OCI’s success because public health and safety will “always trump the criminal investigation.”

FDA Regulatory Affairs Associate Commissioner Melinda Plaisier defended Karavetsos’ move to Miami, saying it was good for the FDA and his family.

The House committee letter also questions how the FDA responded to two prior reports, from the Government Accountability Office and the Health and Human Services Office of the Inspector General, that were critical of the criminal office.

The 2012 OIG report cited problems with how the Rockville-based office is run and concluded that field offices “lack the discretion” to open cases to address “food and drug concerns prevalent in their locales.”

The report cited a lack of independence within the FDA’s criminal office. OCI is housed within the Office of Regulatory Affairs, which is responsible for compliance inspections and helps determine the criminal office’s budget. The inspector general recommended structural changes to “ensure the independence of investigations.”

FDA leadership at that time rejected those suggestions.

The criminal office headquarters controls the opening of investigations. Some agents have questioned the office’s priorities and say they have, on occasion, been told not to open cases involving other federal agencies.

A September 2015 email from Robert West, the recently retired Special Agent in Charge of the Miami field office, is one example.

West, in the email, contended agencies including the FBI, the HHS OIG and Homeland Security investigators “were riding our coattails and were not bringing anything to the table.”

Involving those agencies in an investigation from day one, he wrote, “is unacceptable.”

West previously declined interview requests. Reuters could not immediately reach him Tuesday through an FDA spokeswoman.

(Editing by Ronnie Greene)

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