Office of Inspector General at Department of Health and Human Services Should Investigate Conflict of Interest Allegations Against Senior FDA Official

August 20, 2024

Office of Inspector General at Department of Health and Human Services Should Investigate Conflict of Interest Allegations Against Senior FDA Official

A disturbing article in the New York Times on Tuesday reveals that while a senior Food and Drug Administration (FDA) official, Jeff Shuren, M.D., J.D., was in charge of regulating medical devices, his wife's powerful Washington law firm was representing their manufacturers.

Despite ethics rules barring Shuren, the director of the FDA's Center for Devices and Radiological Health, from working on matters involving clients of his wife's law firm, he did not always fully recuse himself, according to the report. In July, Shuren announced that he was transferring to the FDA's Office of the Commissioner, and will leave the agency later this year.

Dr. Robert Steinbrook, director of Public Citizen's Health Research Group, calls on the Office of Inspector General at the Department of Health and Human Services (DHHS) to launch an investigation amid news of these allegations. He released the following statement:

"The revelations about Dr. Shuren, the former director of the FDA's Center for Devices and Radiological Health, are very troubling. There are long-standing concerns that the FDA's regulation of medical devices has been too friendly to industry under Shuren's leadership and has not prioritized patient safety and the effectiveness of novel medical devices. The Office of Inspector General at DHHS should formally investigate the allegations in the New York Times article. And the FDA must appoint a new director of the Center for Devices and Radiological Health who has no conflicts of interest and prioritizes patients' interests."