Dive Brief:

• Two House Democrats have called for an investigation of former Food and Drug Administration device director Jeff Shuren after The New York Times reported on potential conflicts of interest.
• Reps. Anna Eshoo, D-Calif., and Rosa DeLauro, D-Conn., sent a letter to the Office of Inspector General of the Department of Health and Human Services on Tuesday citing the article. The New York Times story covered how Jeff Shuren led the FDA’s device center while his wife worked as legal counsel for medtech companies. 
• “At the very least, the article raises serious questions of appearance and serious conflict of interest,” the representatives wrote in the letter, which was provided to MedTech Dive. The New York Times was the first to report on the investigation request in a Wednesday article.

Dive Insight:

Jeff Shuren led the FDA’s Center for Devices and Radiological Health for 15 years before stepping down in July.  

A month later, the New York Times reported that the former director’s wife, Allison Shuren, represented medical device companies as co-chair of law firm Arnold & Porter’s life sciences and healthcare practice. 

Although Jeff Shuren signed ethics agreements, the article stated that their work sometimes intersected, such as when Arnold & Porter worked on an acquisition of Allergan as the FDA grappled with reports of a rare cancer associated with the company’s breast implants. 

An FDA spokesperson wrote on Thursday, in response to the letter, that “The FDA takes seriously its obligation to help ensure that decisions made, and actions taken, by the agency and its employees are consistent with ethics laws and regulations.” 

The spokesperson added that the FDA does not comment on whether matters involving specific employees are the subject of internal or external reviews. 

Last month, the agency told MedTech Dive that it had no indication that regulatory decisions were affected by Allison Shuren’s employment. However, an FDA spokesperson added that “it appears there were certain instances from about 10 years ago for which Dr. Shuren should have either recused himself or sought ethics authorization to participate to avoid any potential appearance of bias.” 

In their letter, Eshoo and DeLauro wrote that the “only way to get to the truth” is through an independent review to determine “whether this is simply an appearance of impropriety or actual inappropriate and unethical conduct.”

An OIG spokesperson said in an email to MedTech Dive, “We received the letter and are reviewing it for appropriate action.”

Consumer advocacy group Public Citizen called for the OIG to open an investigation when the news broke in August. Public Citizen said the FDA should appoint a new director who has no conflicts of interest and will prioritize patients’ interests.

Michelle Tarver was named acting director of the CDRH, and the FDA is searching for a permanent successor. Jeff Shuren is working with the agency as it transitions to a new leader. 

The FDA spokesperson told MedTech Dive last month that Jeff Shuren had been advised to exercise greater caution in matters concerning recusal, and is being provided “additional administrative support to ensure future compliance.”