Jeffrey Shuren, MD, retired as director of the FDA's medical device division in July. Now, his ties to the industry are being questioned.
Dr. Shuren's wife, Allison Shuren, represented medical device manufacturers as a lawyer with the Arnold & Porter law firm in Washington, D.C., during Dr. Shuren's FDA tenure, according to The New York Times.
Here are six takeaways from the Times' investigation:
- Dr. Shuren was the FDA's director of the Center for Devices and Radiological Health for 15 years before retiring this year. He is assisting the agency in the search for his successor.
- Dr. Shuren signed ethics agreements to shield him from FDA matters involving the law firm Arnold & Porter's business and clients.
- Arnold & Porter represented Theranos in 2015 when the company demanded the FDA halt inspections of its California sites. The Times said court records show that despite being recused from the matter, Dr. Shuren remained involved.
- In 2019, at the same time Arnold & Porter was working on a $63 billion acquisition of Allergan, Dr. Shuren "initially declined" to recall the company's breast implants after reports the implants could be tied to a rare cancer.
- In 2014, eye care company Alcon was a client of Ms. Shuren's while simultaneously working with the FDA on a lens implant.
- Dr. Shuren and Ms. Shuren did not respond to the Times' interview requests.