FDA Docs Removed, Resignations Requested, Acting Commish, Global Picks, and More

Tracking the Trump transition: 

RFK Jr. commits to finalizing diversity guidance. Robert F. Kennedy Jr. committed to lawmakers during a January 29 hearing that FDA will finalize its guidance on “diversity action plans” under his leadership. The agency is required to issue teh guidance by Congress to implement a legal requirement that device and drug companies produce plans for ensuring equitable representation of patients in clinical studies. But a draft version of FDA’s diversity action plan guidance was removed from the agency’s website last week along with an array of other documents and webpages tied to diversity, equity, and inclusion efforts (see next brief). “Will you commit to finalizing the congressionally mandared FDA guidance to increasing clinicial trial diversity,” Sen. Ben Ray Lujan (D-NM) asked Kennedy during the hearing before the Senate Finance Committee to consider his nomination as secretary of Health and Human Services. “Yes,” RFK Jr. responded. The session was dominated primarily by questions targeting Kennedy’s position on vaccines and his positions on the Medicaid program. The Health, Education, Labor, and Pensions (HELP) Committee will get its turn to question the nominee tomorrow, on January 30. 

Documents removed. FDA last week took down an array of documents and pages from its website primarily connected to diversity, equity, and inclusion (DEI)-related efforts. The excisions are likely the result of President Trump’s January 20 Executive Order to end federal DEI programs. It also coincides with an announced “pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health.” Key device-related guidance and other documents that can no longer be viewed on FDA’s website include, with Internet Archive or other non-FDA links to the originally posted item:

• FDA’s June 2024 draft guidance on Diversity Action Plans: The draft laid out how FDA intends to implement a legislative mandate for device and drug firms to submit diversity action plans for clinical trials. Some companies have already voluntarily started submitting DAPs, and the requirement doesn’t take effect until six months after a guidance is finalized. Also, the Federal Register notice linked to this draft guidance remains online. 
• January 2025 draft guidance on evaluation of “sex-specific and gender-specific data” in device studies: This draft primarily sought to add a distinction between “gender” and “sex” and incorporate categories including nonbinary and transgender as considerations for designing studies. The original final guidance the draft was supposed to update, which just focuses on “sex-specific data” remains on FDA’s site. 
• January 2024 draft guidance on the collection of race and ethnicity data in clinical studies: This draft addresses studies for all varieties of medical products. The relevant Federal Register notice remains online.  
• An August 2024 discussion paper on Health Equity for Medical Devices: CDRH sought public comments last year on these proposals to improve equity by addressing the design and analysis of studies.
• CDRH’s 2022-2025 Strategic Priorities: The document, intended to guide the device center’s overarching priorities through the end of this year, emphasizes promoting a “modern and diverse workforce” and advancing health equity as two of its three focus areas.  
• CDRH’s Health of Women Program website: The program “has been working towards a better understanding of how medical devices perform in women and exploring unique issues in the regulation of medical devices related to the health of women.”
• CDRH’s 2024 Annual Report: Published on January 17, the report generally summarized the device’s accomplishments from last year.