Jeffrey Shuren
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Jeffrey Shuren was the Director of the Center for Devices and Radiological Health (CDRH) at the United States Food and Drug Administration (FDA) from September 2009 to July 2024.[1][2]
Shuren was responsible for the development of Medicare national coverage determinations for drugs, biologics, and non-implantable devices, while director of the Division of Items and Devices, Coverage and Analysis Group at the Centers for Medicare and Medicaid Services.[1] His long-term position as director of CDRH was one of tremendous responsibility and importance; according to the New York Times, "Dr. Shuren led an office with about 2,500 staff members and a budget of about $790 million. He oversaw thousands of devices, ranging from tests to detect blood-lead levels to IV infusion pumps to ventilators."[2]
Jeffrey Shuren announced his plans to retire from the agency in July 2024.[2]
Education
[edit]- B.S. in Medical Education, Northwestern University
- M.D. in Medical Education, Northwestern University
- Residency: Neurology, Tufts University School of Medicine
- Fellowship: University of Florida College of Medicine, Behavioral Neurology and Clinical Neuropsychology
- J.D., University of Michigan[1]
Conflict of interest controversy
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On August 20, 2024, the New York Times published an article asserting that Shuren had repeatedly refrained from recusing himself from cases where his spouse, Allison W. Shuren, represented the medical technology firm. Ms. Shuren was serving as "the co-leader of a team of lawyers at Arnold & Porter, one of Washington's most powerful law firms." The cases included the well-known episode of fraud at Theranos, as well as cases involving cancer attributed to breast implants made by Allergan, and issues involving LASIK vision-correction surgery. The article quoted a source claiming that "Reports of device-related injuries soared to 900,000 in 2023, up from about 190,000 in 2012." The article also reported the sources of income in the Shuren family, based on a financial disclosure form filed by Jeffery Shuren in 2018: "Ms. Shuren earned from $1 million to $5 million ... Dr. Shuren’s F.D.A. salary is $400,000 a year."[2]
The Times also reported a response from the FDA, saying "Dr. Shuren has been advised of the need to exercise greater caution in matters concerning his recusal obligations and will be provided additional administrative support to better ensure future compliance."[2]
References
[edit]- ^ a b c "Meet Jeffrey E. Shuren, M.D., J.D., Director, Center for Devices and Radiological Health". Food and Drug Administration. Archived from the original on January 19, 2012. Retrieved May 6, 2024.
- ^ a b c d e Jewett, Christina (August 20, 2024). "He Regulated Medical Devices. His Wife Represented Their Makers". nytimes.com. The New York Times. Retrieved August 22, 2024.
External links
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Media related to Jeffrey Shuren at Wikimedia Commons
