Outrage of the Month: a Senior FDA Official Regulated Medical Devices While His Wife’s Law Firm Represented Their Manufacturers
Health Letter, September 2024
By Robert Steinbrook, M.D.
Director, Public Citizen's Health Research Group
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A disturbing August 2024 article in the New York Times revealed that while a senior Food and Drug Administration (FDA) official was in charge of regulating medical devices, his wife’s prominent Washington law firm was representing their manufacturers.
Despite ethics rules barring Jeff Shuren, M.D., J.D., the director of the FDA’s Center for Devices and Radiological Health, from working on matters involving clients of his wife’s, Allison Shuren’s, law firm, he did not always fully recuse himself, according to the report. In July 2024, Shuren announced that he was transferring to the FDA’s Office of the Commissioner and would later leave the agency. There are long-standing concerns that the FDA’s regulation of medical devices has been too friendly to industry under Dr. Shuren’s leadership and has not sufficiently prioritized patient safety and the effectiveness of novel medical devices.
The allegations in the New York Times article about Shurens’ intersecting roles involve high-profile medical-device companies, including Theranos, the discredited blood-testing company, and Alcon, an eye-care drug and device company that was a client of his wife and seeking approval of a lens implanted in the eye. The allegations also involve high-profile medical devices, such as breast implants. According to the report, Ms. Shuren’s firm “was working on a $63 billion acquisition of the company Allergan in 2019 when Dr. Shuren initially declined to urge a recall of the company’s breast implants tied to a rare cancer.” Months later, Dr. Shuren and another official reversed course and urged a recall, “citing additional reports of injuries and deaths related to the lymphoma.”
The revelations about Dr. Shuren are very troubling. Public Citizen’s Health Research Group has called on the Office of the Inspector General at the Department of Health and Human Services to formally investigate the allegations. Meanwhile, the FDA must appoint a new director of the Center for Devices and Radiological Health who has no conflicts of interest and who will prioritize consumers’ and patients’ interests. With about 2,500 staff members and an annual budget of about $790 million, the center and the public deserve no less.