Dr. Shuren’s wife, Allison Shuren, co-chairs law firm Arnold & Porter’s Life Sciences & Healthcare Regulatory practice. According to a signed ethics agreement obtained by The New York Times, Dr. Shuren was supposed to separate himself from matters involving Arnold & Porter.
However, the New York Times says it reviewed thousands of pages of court documents and FDA records and conducted dozens of interviews with present and former FDA staff members and advocates, finding several cases and instances where the Shurens’ jobs intersected.
An FDA spokesperson, Shannon Hatch, in a statement acknowledged instances from about 10 years ago in which Shuren should have either recused himself or sought ethics authorization, though the spokesperson said there was no indication that his wife’s job impacted FDA regulatory decisions. Here is the full New York Times article.
In a statement shared with MassDevice, Hatch also said there was no indication that Dr. Shuren made any decisions in the interest of parties other than the public served by the FDA — and there is no indication that he violated the criminal conflict of interest statute.
Dr. Shuren stepped down as director of the FDA Center for Devices and Radiological Health (CDRH) on July 28, ending 15 years as the FDA official in charge of medical device industry regulation. He’s presently serving as a director emeritus in the commissioner’s office for a smooth transition, with plans to leave the agency later this year.
“Jeff has been a catalyst for the modernization of medical device regulation and innovator in every sense of the word,” FDA Commissioner Dr. Robert Califf said in an internal email shared with MassDevice in July. “He has applied a holistic, patient-centric, customer service-focused, total product life cycle approach as director.”
The FDA spokesperson’s statement said of Shuren: “The FDA is proud of Dr. Shuren’s commitment and integrity in serving the American public throughout the course of his extensive government career. The agency stands by his science-based public health decisions and those made by others within the Center for Devices and Radiological Health, including those that were discussed in the recent New York Times article.”
The FDA has promoted Michelle Tarver to the role of acting CDRH director.
