Trump Has Another Top FDA Post to Fill

January 11, 2017
By Alex Keown, BioSpace.com Breaking News Staff

WASHINGTON – In addition to the possibility of tapping a new head of the U.S. Food and Drug Administration, President-elect Donald Trump will certainly make recommendations for a new head of the agency’s Office of Criminal Investigations.

This morning George Karavetsos, the current director of the OCI, announced he will step down from his position to join a private law firm, Reuters reported. Karavetsos will leave the FDA on Jan. 20, the same day Trump is sworn in as president. The OCI is responsible for conducting criminal investigations into allegations surrounding food, drugs, medical devices, cosmetics and tobacco. Karavetsos has served as head of the OCI since January 2015.

The Office of Criminal Investigations has been under scrutiny for the past year. Mass Device reported that under the helm of Karavetsos, the OCI has pursued more “mislabeled foreign-imported injectable drug cases,” such as Botox, in favor of issues that were of greater importance to public health concerns.

The OCI has also been under scrutiny by a U.S. House of Representatives committee for its handling of those cases. In September, the U.S. House Energy & Commerce Committee told Robert Carliff, the FDA director, that it was looking into management and morale concerns, Mass Device reported at the time.

One of the concerns raised about Karavetsos by the committee was the FDA allowed him to operate from the Miami office even after the agency spent tens of thousands of dollars to move him to Maryland.

While on the campaign trail, Trump was critical of the FDA, calling it the “Food police,” regarding regulations placed on farmers and food inspections. Under Karavetsos, the OCI earned the nickname “Botox police.”

As president, Trump could disrupt some of the FDA practices with his choices to helm the agency. Trump has challenged some of the FDA’s oversight of regulating drug approval. In his 100 Day Plan, Trump said one FDA-specific reform he intends to undertake is to “cut the red tape at the FDA.” According to Trump’s plan, there are “over 4,000 drugs awaiting approval, and we especially want to speed the approval of life-saving medications.” Trump has also called for easing restrictions for drugs that have been approved by foreign regulatory agencies to be available in the United States, which would bypass the FDA’s regulatory authority over drugs available in the U.S.

Another move Trump could make is to expand “right to try” rules. Right to try rules would give terminally ill patients access unapproved therapies that have passed basic safety requirements.