The Food and Drug Administration (FDA) has been defending Jeff Shuren, the former director of the agency’s medical device center, following a report by The New York Times. The report discussed potential conflicts of interest arising from Shuren’s professional role at the FDA and his wife Allison Shuren’s position as a legal counsel for medical technology companies at Arnold & Porter where she co-chairs the life sciences and healthcare regulatory practice. Jeff Shuren had a 15-year tenure at the FDA’s Centers for Devices and Radiological Health (CDRH) and announced his retirement in July. He remains with the FDA during the transition to a new leader.
The Times’ investigation brought attention to potential overlaps between Jeff Shuren’s regulatory responsibilities and cases his wife was involved in, including issues like Theranos’ faulty blood tests, Allergen’s breast implant recalls linked to cancer, and regulations surrounding LASIK eye surgery. Despite these concerns, the FDA claims there is no evidence that Shuren’s decisions were influenced by his wife’s role or that he ever acted against the public interest. However, FDA spokesperson Shannon Hatch admitted that there were instances approximately a decade ago when Shuren should have potentially recused himself to avoid the appearance of bias. As a result, Shuren has since been advised to adhere more closely to recusal rules, and additional administrative support has been provided to him to ensure he meets these obligations.
Arnold & Porter has expressed confidence in Allison Shuren’s compliance with FDA’s conflict of interest and impartiality rules. Yet, these reassurances have not entirely quelled concerns. Robert Steinbrook from Public Citizen’s health research arm has advocated for an investigation by the Health and Human Services’ Office of Inspector General into the allegations made by the Times, suggesting that the FDA under Shuren’s leadership may have been overly industry-friendly at the expense of patient safety and device effectiveness.
In response to broader concerns about medical device safety, the FDA has faced criticism for several safety incidents involving products like breast implants, birth control devices, heart pumps, and respiratory machines. The number of reported injuries related to medical devices spiked to 900,000 in 2023 from about 190,000 in 2012. This increase in reported injuries underlines persisting issues within the FDA’s system for monitoring device safety, prompting calls from lawmakers and patient advocacy groups for significant improvements. Accordingly, the Government Accountability Office is reviewing the FDA’s device recall processes following requests from Senators Dick Durbin and Richard Blumenthal.
Despite these controversies, the FDA maintains a strong defense of Shuren’s “commitment and integrity” during his government career. Shannon Hatch highlights the rigorous ethics reviews that Shuren’s financial and decision-making records underwent across multiple administrations. Furthermore, the FDA asserts confidence in the science-based decisions made by Shuren and the CDRH team, particularly those discussed in the Times article.
Overall, while the FDA stands firm in its support of Shuren, the allegations and concerns raise important questions about the integrity of medical device regulation and the balance between industry relationships and public health oversight. The ongoing scrutiny from watchdog groups and governmental bodies indicates a focused attention on these issues, aiming to enhance patient safety and ensure unbiased regulatory practices.
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