ARTICLE SUMMARY:
In this week’s Pathways Picks: President-elect Donald Trump says he will nominate RFK Jr. as HHS secretary and Mehmet Oz as CMS administrator; Breakthrough Device Medicare coverage is introduced in the Senate; the UK government seeks more input on its pending medical device regulatory framework; Europe rolls out its orphan device pilot; FDA’s new Digital Health Advisory Committee meets to discuss generative AI; and FDA updates on emergency use authorization and ethylene oxide.
Editors’ note: Pathways Picks will not publish next week, on November 27. It will be back on December 4.
Trump Picks
RFK Jr. and Dr. Oz tapped for HHS and CMS:
RFK Jr. as health chief. Robert F. Kennedy Jr. will be nominated by President-elect Donald Trump to run the Department of Health and Human Services, raising the specter of major policy and process shifts, and staffing changes, for US health agencies including FDA and CMS. Kennedy recently (prior to Trump’s November 14 announcing the planned nomination) warned FDA employees who are part of the agency’s “war on public health” to “1. Preserve your records, and 2. Pack your bags.” He has long pushed debunked theories on dangers from vaccines, and more generally he blames the pharmaceutical industry, fluoride in drinking water, and ultraprocessed food for a chronic disease epidemic.
Kennedy, who needs to be confirmed by the Senate, hasn’t discussed any medical device-specific issues in detail, and medtech industry advocates who spoke to Market Pathways suggest they are hopeful he won’t seek significant changes at FDA’s device center (CDRH). “I have no doubt Mr. Kennedy has encountered firsthand the power of medical technology in his own life and his family’s,” AdvaMed CEO Scott Whitaker noted in a prepared statement. “And I look forward to sharing our story with him, about the millions of lives our technologies transform in every care setting across the country.” Kennedy and his supporters have generally railed against perceived conflicts of interest at FDA, including the user fee programs, which are the basis for a significant chunk of FDA resources and linked to major improvements in predictability and transparency in medical device reviews at the agency. Trump has yet to announce who he wants to nominate to lead FDA. Currently, the name most frequently circulating as a candidate for FDA commissioner is Johns Hopkins University surgeon and author Marty Makary, MD, who had been critical of FDA’s COVID-19 response and the agencies postmarket surveillance systems for medical devices.
