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Dr. Jeffrey Shuren, the former head of the Food and Drug Administration’s (FDA) medical device division, presided over a period of both increased device approvals and public health concerns. While Dr. Shuren has retired, his tenure raises questions about potential conflicts of interest due to his wife’s work as a lawyer representing medical device companies.
A decade of overlap
For 15 years, Dr. Shuren oversaw the approval process for a vast array of medical devices. His wife, Allison Shuren, is a senior partner at Arnold & Porter, a powerful Washington law firm that represents medical device makers. Dr. Shuren signed ethics agreements meant to prevent him from involvement in matters connected to his wife’s clients. However, a review by The New York Times identified instances where their work intersected.
Cases in question
- Theranos: In 2015, Ms. Shuren’s firm challenged the FDA’s authority to inspect Theranos, a discredited blood testing company. Dr. Shuren claimed to be recused, but emails suggest he remained involved.
- Allergan: When Ms. Shuren’s firm represented Allergan in a lawsuit and during its acquisition by AbbVie, Dr. Shuren initially opposed a recall of the company’s breast implants linked to a rare cancer. The FDA later reversed course.
- LASIK: Ms. Shuren lobbied for a group representing ophthalmologists, some of whom are clients and who opposed the FDA’s proposed warnings about LASIK surgery risks.
A legacy of scrutiny
The FDA has acknowledged lapses in Dr. Shuren’s recusal practices. While Dr. Shuren maintains he acted ethically, consumer advocates criticize his leadership as too industry-friendly and point to a rise in device-related injuries during his tenure.
Looking forward
Dr. Shuren’s departure presents an opportunity for the FDA to prioritize patient safety and rebuild public trust. The agency must ensure strong ethical guidelines and transparency to avoid similar conflicts of interest in the future.
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