Dr. Michelle Tarver assumes the role of director of the Food and Drug Administration’s (FDA) device division, taking over from Dr. Jeffrey Shuren at a critical juncture. The division, responsible for regulating medical devices, has come under increasing scrutiny due to concerns over industry influence and ethical conflicts. Tarver’s tenure will be marked by the need to ensure device safety and establish rigorous standards for approvals, particularly in the rapidly advancing field of brain-computer interfaces.
One of the most remarkable technologies in development is brain-computer interfaces that can restore lost functions to individuals. Trials evaluating the safety and effectiveness of these devices fall under the purview of the FDA’s device division. Notably, Elon Musk’s Neuralink has gained significant attention for its brain-computer device, which enabled a paralyzed man to play video games using his mind. Musk’s vocal support for former President Donald Trump and criticism of the FDA have raised concerns about potential influence over federal agencies overseeing his businesses.
The FDA’s device division faces additional challenges related to funding and ethics. The division’s budget heavily relies on industry user fees, accounting for nearly half of its $790 million budget. Critics argue that this compromises the agency’s ability to protect public health, as it may prioritize the interests of for-profit industries. The negotiation process for these fees, which determines how the FDA allocates billions of dollars, will be a key responsibility for Tarver in the coming years.
Ethical concerns have also emerged surrounding Dr. Jeffrey Shuren, the outgoing director of the device division. An investigation revealed that Shuren failed to follow agency ethics rules in instances where his wife, Allison Shuren, represented medical device companies during negotiations. While the FDA stated that Shuren did not participate in matters specific to these companies, experts argue that the appearance of bias should have been considered.
The FDA’s device division has faced criticism for its approval process, particularly in relation to artificial intelligence (AI) programs used in medical care. Researchers have found that the agency’s review records for AI programs lack crucial information, raising concerns about algorithmic bias and health disparities. Despite these challenges, the potential of AI in healthcare has generated significant interest, with discussions about its use in drug development and internal applications within the FDA.