Dr. Jeffrey Shuren, former head of the Food and Drug Administration’s (FDA) medical devices division, presided over a period of increased device approvals and public health concerns. Although Dr. Shuren is retired, his tenure raises questions about potential conflicts of interest due to his wife’s work as an attorney representing medical device companies.
A decade of overlap
For 15 years, Dr. Shuren has overseen the approval process for a wide range of medical devices. His wife, Allison Shuren, is a senior partner at Arnold & Porter, a high-powered Washington law firm that represents medical device makers. Dr. Shuren has signed ethics agreements designed to keep him from becoming involved in matters involving his wife’s clients. However, a New York Times review identified instances where their work intersected.
Cases in question
- Teranos: In 2015, Ms. Shuren’s firm challenged the FDA’s authority to inspect Theranos, a discredited blood-testing company. Dr. Shuren said he was recused, but emails suggest he remained involved.
- Allergan: When Mrs. Shuren’s firm represented Allergan in a lawsuit, and during its acquisition by AbbVie, Dr. Shuren initially opposed the recall of the company’s breast implants linked to a rare cancer. The FDA later reversed itself.
- LASIK Surgery: Ms. Shuren lobbied for a group representing eye doctors, some of whom are clients, who have opposed the FDA’s proposed warnings about the risks of LASIK surgery.
A Legacy of Control
The FDA has acknowledged flaws 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 an increase in device-related injuries during his tenure.
Pending
Dr. Shuren’s departure represents 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.
