FDA Policy/General

OCI Director Resigns to Join Law Firm

FDA Office of Criminal Investigations (OCI) director George Karavetsos has resigned and his last day is 1/20, the day president-elect Donald Trump is sworn into office. Karavetsos, who has a law degree, reportedly is joining a private law firm.

Karavetsos’ resignation comes amid Capitol Hill criticism and an investigation into OCI’s management and possible morale issues with field offices (see story). Last September, Reps. Fred Upton (R-MI), chairman of the House Energy and Commerce Committee, and Rep. Tim Murphy (R-PA), who heads the committee’s Oversight and Investigations Subcommittee, asked (includes link to committee letter) FDA for an OCI update in the wake of information from independent watchdogs that identified weaknesses in the organization. OCI also has been the subject of a Reuters investigation.

“Two independent reports, one from the Government Accountability Office (GAO) in 2010 and one from the Department of Health and Human Services Inspector General in 2012, have identified OCI management issues and made recommendations for improvements,” the two lawmakers wrote FDA commissioner Robert Califf. “The GAO report on FDA OCI found that FDA maintained limited oversight of the investigations conducted by OCI and lacked sufficient performance measures. The GAO report also raised concerns about the OIA (Office of Internal Affairs), a component of OCI comprised of OCI detailees, responsible for conducting (sic) internal allegations of misconduct by FDA employees.”

Karavetsos was appointed OCI director two years ago. Prior to that, he served as the executive assistant U.S. attorney for the Southern District of Florida. He had previously served as an assistant general counsel in the FDA’s Office of the Chief Counsel (OCC). While at OCC, he worked with OCI to prosecute criminal violators of the Food, Drug, and Cosmetic Act. Additionally, Karavetsos served as an assistant district attorney in Massachusetts and as an assistant U.S. attorney, as a deputy chief in the major crimes and narcotics sections, and as chief of the narcotics section in the U.S. Attorney’s Office in the Southern District of Florida.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome