A string of executive actions issued by President Donald Trump during his first weeks in the White House triggered widespread uncertainty across government agencies.
Some orders have been particularly impactful in healthcare.
Last week, the White House issued a freeze on communications from health-related agencies, which rippled through a number of federal initiatives. The National Institutes of Health, for example, canceled a meeting on antibiotic resistance.
Meanwhile, in some ways, the FDA has been going about business as usual. The agency issued several drug approvals last week, for example, including the first nod for a new type of pain medication in decades.
Yet other aspects of the FDA’s work appear up in the air.
A Feb. 5 adcomm meeting to discuss new post-marketing rules for opioids is now missing from the agency’s calendar, and no public update has been offered about when it will be rescheduled.
The Trump administration’s anti-DEI sweep of the government could be impacting the agency as well.
After the White House issued an executive order to end “radical and wasteful government DEI programs,” the FDA’s draft guidance on ensuring diversity in clinical trials was removed from its website. Other FDA guidance documents, such as recently published draft guidance for the use of AI in drug development, remain in place.
No explanation has been given for why the DEI-related guidance has been stripped from the FDA’s site, and the agency did not return a request for comment.
“It’s incumbent on us [in] the industry to help educate the incoming administration around the importance of DEI."
Doug Peddicord
Executive director, Association of Clinical Research Organizations
A statement issued by the law firm Crowell & Moring called it “highly unusual” for the FDA to revoke guidance without a public explanation.
Given how entrenched DEI strategies have become in pharma, the agency’s sudden pullback is not likely to deter drugmakers’ ongoing efforts to increase diversity in clinical trials, according to Doug Peddicord, executive director of the Association of Clinical Research Organizations, a trade group that represents clinical research and technology organizations.
“The regulated industry including sponsors and research organizations remain committed to diversity and inclusion because there is strong evidence that having a more representative population in trials is good science, it’s good ethics and it’s good business,” he said. “It’s hard for me to suggest that there would be any movement from that position.”
Will clinical trial diversity remain safe?
While the Trump administration’s anti-DEI push largely aims at hiring practices, the term holds a different significance in the context of clinical trials, where efforts to broaden representation are thought to produce better health outcomes.
Educating incoming administrations about the nuanced impact of their policy initiatives is par for the course during a transition. As Peddicord monitors ongoing changes at the FDA, he said ACRO may ultimately have to work with legislators to illustrate the importance of clinical trial diversity in pharma.
“It’s incumbent on us [in] the industry to help educate the incoming administration around the importance of DEI and the widely recognized importance of better represented populations in clinical trials so that treatment populations are more reflective of the participants in clinical trials,” Peddicord said.
The final guidance on clinical trial diversity was slated to be issued by June. During his Senate confirmation hearings to be head of HHS last week, Robert F. Kennedy Jr. said he would commit to finalizing those rules.
Peddicord also pointed out that the core tenets of clinical trial diversity were codified into law by the Diverse and Equitable Participation in Clinical Trials Act.
Passed in 2022, the DEPICT Act stipulates that clinical trial sponsors establish enrollment goals based on age, sex, racial and ethical characteristics, explain the rationale for those goals and create a strategy for execution.
As the situation plays out, Peddicord said he’s also keeping an eye on whether other areas of the FDA’s work remain intact — in particular, its history of communicating directly with the industry through listening sessions.
“[The healthcare communication pause] causes some level of concern around continuing these conversations because they are important to both sides,” he said. “The ability to consult with the regulatory decision maker is a huge strength of the system.”
Despite the uncertainty, Peddicord said he believes clinical trial diversity initiatives will be safe — for now.
