On Sept. 20, the committee chairman Rep. Fred Upton (R-Mich.) and Rep. Tim Murphy (R-Pa.), chairman of the Subcommittee on Oversight and Investigations, sent a letter to FDA Commissioner Robert Califf, MD, informing him they were “examining management concerns” and “possible morale concerns with the field offices” of the OCI. The letter asks the FDA for answers to a dense list of questions by Oct. 12.
Here are four things to know.
- The House committee asked why George Karavetsos, director of the Rockville, Md.-based OCI, is running the division from an office in South Florida. Mr. Karavetsos moved to Florida less than two years after the FDA spent $25,000 to move him to Maryland.
- Both current and former field agents at the office claimed managers force them to pursue cases involving mislabeled foreign-imported injectable drugs instead of cases that could make stronger impacts on public health improvement, according to the report.
- From 2008 to 2015, Reuters found that more than half of all cases opened with the OCI were closed without action. The House committee seeks more information on the OCI’s criminal investigation process, along with statistics on arrests, convictions, case initiations and amount of recovered money, according to the report.
- The House committee also asked the FDA how it responded to two prior reports issued several years ago from the Government Accountability Office and HHS’ Office of Inspector General that recommended structural changes for the office. At the time of the reports, FDA leadership refused to make any changes.
More articles on supply chain:
Mylan CEO acknowledges company could have anticipated consumer concern over price hike
Active ingredient shortage puts Bristol-Myers Squibb cancer drug on backorder
Ohio police race through anti-overdose drug supply
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
