When Donald Trump took office this week for his second presidential term, he issued an Executive Order to remove diversity, equity and inclusion (DEI) programs from federal offices. While the ultimate outcome of this EO remains unknown, some early hints may be seen on the US Food and Drug Administration’s website.
Links to some FDA pages specific to diversity and equity no longer work. For example, a page devoted to the Oncology Center for Excellence equity program, which seeks to advance equitable access to clinical trials for all patients with cancer, is down.
And notably, the link to the agency’s final guidance for evaluating sex- and gender-specific data in clinical trials of medical devices is down. However, the link to the draft document “Study of Sex Differences in the Clinical Evaluation of Medical Products” does work.
The guidances, published in the Federal Register 7 January — before the inauguration — provide recommendations for increasing female enrollment in clinical trials as well as analyzing sex- and gender-specific data and including that data in regulatory submissions.
The effort to boost female participation in clinical trials — as well as that of people of color — was a central theme under the Biden administration. In June, for instance, the FDA published recommendations for “diversity action plans” which stemmed from guidance the agency issued in 2022 on increasing trial diversity.
The page to that guidance is also down.
A recent FDA report to Congress showed that some companies are already filing diversity action plans with the Center for Devices and Radiological Health.
Part of the DEI Purge?
But what is unknown at this point is whether this is purposeful, or glitches due to the transition of massive bureaucracies as Biden officials leave and Trump officials settle in.
“HHS has issued a pause on mass communications and public appearances that are not directly related to emergencies or critical to preserving health.”
US FDA
Considering Trump’s recent executive order — which says DEI has “corrupted” government institutions “by replacing hard work, merit, and equality with a divisive and dangerous preferential hierarchy” — it’s plausible the removal of these pages is part of Trump’s campaign pledge to purge DEI from government ranks.
And while the link leading to the agency’s home as a health care hub — which reimagines the home as an integral part of the health care system — works, another link to the hub that describes it as seeking to “advance health equity” does not.
In an email to Medtech Insight, a spokesperson in the FDA’s office of media affairs said the Department of Health has issued a pause on mass communications and public appearances not directly related to emergencies critical to preserving health.
“This is a short pause to allow the new team to set up a process for review and prioritization,” the spokesperson said. “There are exceptions for announcements that HHS divisions believe are mission critical, but they will be made on a case-by-case basis.”
Yet, other DEI related sites that are currently unavailable include the National Institutes of Health Sexual and Gender Minority Research Office, Sexual and Gender Minority Health Scientific Research Group, and Office of Research on Women’s Health sex and gender page.
Additionally, as it did in 2017, the White House recently took down its Spanish-language page.
At the same time, the link to the CDRH 2024 annual report, which would seem to be unrelated to DEI, also leads to an error message.
It’s also worth pointing out the executive order targets DEI in hiring practices, which is a separate issue from promoting diversity in clinical trials and access to care.
In Trump’s view, as conveyed in the EO’s title — “Ending Illegal Discrimination and Restoring Merit-Based Opportunity” — getting rid of DEI is a matter of fairness.
And in his recent comments to the World Economic Forum in Davos, Switzerland, Trump said his administration has acted “to abolish all discriminatory diversity, equity and inclusion nonsense — and these are policies that were absolute nonsense — throughout the government and the private sector.”
Still, it’s a flashpoint for many.
Richard Besser, president and CEO of the Robert Wood Johnson Foundation, a philanthropic organization that advocates for health equity, said the EO signals a “reverse course” on the nation’s journey toward a more just and equitable future.
Greater diversity among doctors improves health outcomes for patients across the board, including minorities and those traditionally underrepresented in the health care field, according to Besser.
“Strategies aimed at reducing racial disparities in health care — such as maternal health and cancer care — lead to better outcomes for all patients,” Besser said. “The evidence is clear: A diverse health care workforce and inclusive policies serve us all. These executive orders serve no one.”
Targeting Health
Of the 78 Biden administration actions revoked under Trump’s EO, several pertain to public health and health coverage.
For instance, Trump’s order scraps a Biden measure to ensure the federal government’s response to the COVID-19 pandemic “was equitable, prioritizing the needs of historically underserved communities that were disproportionately affected” as well as those seeking to “improve access to affordable health care” and strengthen the Affordable Care Act — Obamacare — “to prioritize efforts in underserved communities and provide access to high-quality care at affordable prices.”
“Ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.”
Robert Califf
While attempts to end DEI hiring practices will play out in the political arena, efforts to exclude initiatives to promote diversity in clinical trials could prove not only scientifically unsound, but dangerous.
A broader spectrum of participants in studies goes well beyond trying to make up for past exclusionary practices — Congress only mandated the inclusion of women in clinical trials in 1993 — it’s a medical necessity.
It is well documented within the medical literature that some diseases target and affect men and women and minority groups differently. Failing to include all future patient groups in trials could mean ineffective treatment — or worse — for patients down the road.
As example, the ongoing all-female EMPOWER CAD plans to enroll 400 women with coronary artery disease to determine whether positive results in both men and women from earlier studies with Shockwave’s C2 coronary IVL catheter can be replicated in women.
This is crucial, because even though heart disease is the number one killer of women in the US, women have been historically underrepresented in cardiac trials or left out altogether. What’s more, surgical devices that scrape or remove plaque from the arteries — mostly designed by men, for men — often do not work as well in women because they do not account for women’s smaller and more fragile arteries and blood vessels.
Further, heart attack symptoms can present differently in women than in men, which can result in misdiagnosis.
According to former FDA commissioner Robert Califf, “Ensuring meaningful representation of racial and ethnic minorities in clinical trials for regulated medical products is fundamental to public health.”
Sara Brenner, chief medical officer for in vitro diagnostics and associate director for medical affairs at CDRH, has been named the agency’s acting commissioner.
Time will tell if Trump’s sweeping EO on DEI extends to clinical trials.
If it does, then Califf’s statement will serve as stark example of the divergent philosophies of the Trump and Biden administrations and how the health care landscape is likely to change — at least over the next four years.