Key Takeaways
- HHS Secretary nominee Robert F. Kennedy Jr. committed to finalizing FDA clinical trial diversity guidance in Senate testimony.
- Kennedy did not commit to a specific timeline or content of the guidance.
- Kennedy also would not commit to overturning all FDA actions taken in response to President Trump's anti-DEI executive order.
Robert F. Kennedy Jr. told US lawmakers he would finalize the US Food and Drug Administration’s guidance on increasing clinical trial diversity if the Senate confirmed him as Health and Human Services Secretary.
However, he would not commit to restoring all webpages or FDA staff that may have been impacted by the Trump Administration’s purge of diversity, equity and inclusion activities within the federal government.
“I cannot commit to that because I don’t even know who they are,” he told Sen. Ben Ray Luján, D-NM, during his 29 January Senate Finance Committee confirmation hearing. Kennedy said he would ensure “those positions are adequately staffed.”
The Senate Finance Committee will vote on Kennedy’s nomination on 4 February. Sen. Bill Cassidy’s noted struggles with the decision leave a committee endorsement somewhat in doubt, but a former GOP senator already has suggested to industry that the outcome is pre-determined.
Kennedy’s commitment to finalize the trial diversity guidance should be a positive development for public health. Trial diversity is essential to ensuring adequate data are available on a drug’s risks and benefits in all the patients that could use it, if approved.
The FDA’s 2024 draft guidance on diversity action plans (DAPs) was required by Congress. Drug and biologic sponsors must submit DAPs for Phase III or other pivotal trials where enrollment begins 180 days after publication of the final guidance.
The guidance disappeared from the FDA’s webpage soon after the Trump Administration arrived, along with other websites discussing diversity and health equity topics. The moves appeared to be in response to President Trump’s executive order “Ending Radical and Wasteful Government DEI Programs and Preferencing and Initial Recessions of Harmful Executive Orders and Actions,” which called for ending government programs focusing on diversity, equity and inclusion work.
Kennedy would not commit to a timeline to finalize the guidance or any specifics on its content.
The Trump anti-DEI EO seemed to be directed at federal agencies’ hiring practices, but other diversity work also seems to have fallen victim to the policy.
Webpages that have disappeared since Trump’s inauguration include the FDA’s Office of Minority Health page, as well as sites covering health equity and popular Oncology Center of Excellence programs.
Kennedy’s refusal to fully endorse rolling back recent changes to agency diversity staffing and work may raise questions about his commitment to ensuring the health of all Americans.
Kennedy was very deferential in his Senate testimony and written responses to lawmakers about abiding by Trump’s wishes and EOs. Whether he would be willing to push the president on the topic is unclear.
Kennedy also made some anti-pharma statements during his confirmation hearings, including that the US health agencies have too close a relationship with the drug industry.
