Two House Democrats, Representatives Anna Eshoo of California and Rosa DeLauro of Connecticut, have called for an official investigation into Jeff Shuren, the former director of the FDA’s Center for Devices and Radiological Health. This request follows a report by The New York Times detailing potential conflicts of interest during Shuren’s tenure. The representatives expressed concerns about the ethical implications of Shuren’s actions while his wife, Allison Shuren, worked as legal counsel for medical technology companies. The report by The New York Times highlighted a particular instance when Allison Shuren’s law firm was involved in a corporate acquisition while the FDA, under Jeff Shuren’s leadership, was addressing safety concerns related to the involved company’s products.
Jeff Shuren directed the FDA’s device center for 15 years, ending his role in July, shortly before the concerns were publicized. His wife is a co-chair at the law firm Arnold & Porter, specifically in their life sciences and healthcare practice. Despite Jeff Shuren having signed ethics agreements meant to prevent conflicts of interest, The New York Times suggested that there were instances where the professional activities of Jeff and Allison Shuren may have overlapped in a way that could be perceived as a conflict of interest. This included times when Arnold & Porter dealt with issues directly affecting FDA decisions.
In defense of the agency’s integrity, an FDA spokesperson emphasized the organization’s commitment to adhering to ethics laws and regulations. However, they refrained from discussing specific cases or whether an internal or external review was underway concerning Jeff Shuren. They did acknowledge that there seemed to be historical instances, around a decade ago, where Jeff Shuren should have possibly recused himself or sought explicit ethical authorization to participate in certain dealings to avoid any appearance of bias.
Eshoo and DeLauro, in seeking clarity and resolution, have argued that the only resolution is through an unbiased and independent investigation to ascertain not just the appearances of impropriety but also any actual misconduct. Following the receipt of their letter, a spokesperson for the Office of Inspector General (OIG) confirmed that the complaint was being assessed for a suitable response.
The call for inquiry was also supported by Public Citizen, a consumer advocacy group, which stressed the importance of leadership free from conflicts of interest at the FDA. The organization underscored the need for a new director who prioritizes patient interests and is free from industry ties.
In the interim, Michelle Tarver has been appointed as the acting director of the CDRH, and a search for a permanent leader is ongoing. Jeff Shuren has been retained in an advisory role to assist with the transition to new leadership. Learning from past issues, the FDA noted that they had advised Jeff Shuren to be more vigilant regarding recusal and that additional administrative support was being provided to him to ensure future compliance with ethical standards. This move signifies the FDA’s efforts to enforce stricter compliance with ethical guidelines and restore confidence in the agency’s decision-making processes.
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