How Shuren’s Departure from the FDA May Impact the LDTs Rule
FDA seems determined to push ahead with final rule, regardless of CDRH director’s departure, hiring of replacement.
This summer, Jeffrey Shuren, MD, JD, director of the Center for Devices and Radiological Health (CDRH) at the U.S. Food and Drug Administration (FDA) for the last 15 years, announced his impending retirement. Since that time, information concerning gray ethical areas relating to FDA approvals for companies represented by his wife’s legal firm have arisen, most notably in an article from the New York Times.1
This has brought his impartiality into question, especially regarding the lab industry and the recently approved rule granting the FDA oversight of laboratory-developed tests (LDTs). The final rule, published in the Federal Register in May, aspires to ensure the safety and effectiveness of LDTs by implementing FDA regulation and oversight of these tests, outlining a phased-in approach to enforcement over the next four years.2 However, given the potential conflict of interest of some of Shuren’s activities while at the FDA and pushback from the laboratory industry and Congress, there are now questions about how Shuren’s departure may impact the implementation, roll-out, and enforcement of the rule.3,4
The FDA’s response to the New York Times article
Asked for comment on the New York Times article, an FDA spokesperson replied that, “The FDA takes seriously its obligation to help ensure that decisions made, and actions taken, by the agency and its employees are not, nor appear to be, tainted by any question of conflict of interest. The agency requires that senior leadership adhere to all applicable ethics requirements, including filing annual public financial disclosure reports (OGE 278). As part of the financial disclosure review, ethics guidance including recusal obligations or reminders of those obligations are provided to employees.”
Nevertheless, as the New York Times article pointed out, Shuren oftentimes continued to participate in matters between the FDA and clients of his wife’s law firm, even when recused. The FDA spokesperson noted that individual employees are “personally responsible for ensuring compliance with his or her recusal obligations” alongside consultation with the agency’s Office of Ethics and Integrity (OEI), but that there were circumstances in the last decade when Shuren should have recused himself or sought to obtain formal authorization to participate but did not. The spokesperson stated that “the FDA has no indication that any FDA regulatory decisions were impacted by Dr. Shuren’s wife’s employment nor that Dr. Shuren made any decisions in the interest of parties other than the public served by the FDA” or that he violated the criminal statute for conflict of interest.
The spokesperson went on to outline the regulatory agency’s “more enhanced ethics restrictions” as compared to other federal agencies and noted that it provides ongoing training and advice to employees on ethics-related matters, including compliance.
Alongside these assertions and the FDA’s seemingly unwavering support of Shuren and his actions during his tenure, the FDA spokesperson stated that Shuren was, however, encouraged to exercise “greater caution” in recusal obligation matters and—at the time of writing—was being offered additional administrative support to ensure compliance. The spokesperson asserted that, despite the admitted need for such supplemental measures, the FDA was “proud [of Shuren’s] integrity” and “stands by his science-based public health decisions,” noting that his ethics documents were vetted by the OEI over multiple administrations.
How might a new CDRH director affect the LDTs rule?
The lab industry may be wondering how Shuren’s departure and a replacement CDRH director may influence the final rule allowing FDA oversight and regulation of LDTs. However, the FDA isn’t offering answers to this question. When asked about the potential impact of a new CDRH director, the FDA spokesperson wouldn’t comment, instead restating the agency’s goal of ensuring the safety and effectiveness of LDTs.
The agency has been developing guidelines, hosting webinars, and responding to frequently asked questions on their website5 regarding the new rule and “will continue to take actions that are guided by science and consistent with federal law,” stated the spokesperson. Based on the FDA representative’s comments, it seems as if the agency is moving forward under the assumption that the rule and its roll-out will proceed as planned, without any major impact from Shuren’s departure or the arrival of his replacement. As a result, it appears in the best interest of labs that offer LDTs to continue preparing to comply with the rule.
When questioned about the yet-unnamed incoming director, the spokesperson relayed that the application period for the position was open from July 30 to August 27, 2024, and after all the proper administrative steps are followed, the FDA will announce when a selection has been made. Following the deadline for this article, the FDA announced on October 22 that it had chosen Michelle Tarver, MD, PhD, as the new CDRH director. Tarver, a board-certified ophthalmologist with a doctorate in epidemiology, had previously held a variety of leadership roles at the agency.6
“As someone who has served the FDA for more than 15 years, I am immensely proud of the work we have accomplished together, always keeping the people we serve at the core of our mission,” Tarver said in the FDA Roundup announcing her selection. “As we embark on CDRH’s next chapter, we remain committed in our service to public health and ensuring all patients in the US have access to high-quality, safe, and effective medical devices.”6
Final Thoughts
Notably, Shuren increased the FDA’s annual approval of medical devices by five times during his tenure.7 Yet, in doing so, there may have been ethical issues and conflicts of interest that were left unaddressed. As he departs the FDA and Tarver assumes the CDRH director role, it is still unclear how this change in leadership may impact the newly adopted LDT rule, its implementation, and enforcement phase-in, especially amidst complaints from legislators and lawsuits from laboratory advocates.
Regardless of the FDA’s denial of any tangible wrongdoing by Shuren and their continued support of his actions while employed, the FDA spokesperson wanted to reiterate that the agency takes its responsibility to prevent both conflicts of interest and the appearance of such ethical issues seriously. As such, the spokesperson said the FDA is continuously working to refine their processes to ensure staff, particularly those in executive positions, have the necessary support and counsel required to comply with their own ethics rules.
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