FDA proposes adding 'race and ethnicity' category to expanded access requests
It’s well understood that racial and ethnic minorities often lack access to clinical trials in the US, either because of restricted inclusion/exclusion criteria or because they don’t have the time, insurance, interest or understanding of what clinical trials are available.
But what about ethnic and racial minorities accessing the FDA’s expanded access program?
That’s what the FDA wants to know, as the agency is now proposing to add an optional item regarding race and ethnicity under the “Clinical Information/Brief Clinical History” field in its form that physicians have to fill out for expanded access requests for individual patient INDs.
The FDA’s expanded access or “compassionate use” program, known as EAP, offers people with serious or immediately life-threatening illnesses or conditions access to potential new drugs, even if they don’t qualify for a clinical trial. The only catch is that the drugmaker developing the potential drug has to OK its use outside of a trial, which can be a limitation to access, although the FDA signs off on more than 99% of all EAP requests.
Alison Bateman-House, an assistant professor at the NYU Grossman School of Medicine who studies expanded access, told Endpoints News that she’s encouraged by this proposal from FDA to collect more race and ethnicity data around its EAPs as it will “goad sponsors into collecting this data” more frequently.
“The question we want answered is are some of these minorities who are shut out of trials able to be accommodated by expanded access, or is it the privileged few who are getting access to trials” and EAPs, she said. “My hunch is the latter.”
The push from FDA comes as it has released a new framework around how it plans to better address these racial and ethnic disparities. Part of that framework includes setting goals for enrollment and specifying retention strategies, such as providing language assistance and reducing the burdens of participation with tools like telehealth.
“Going forward, achieving greater diversity will be a key focus throughout the FDA to facilitate the development of better treatments and better ways to fight diseases that often disproportionately impact diverse communities,” FDA commissioner Rob Califf said in a statement.
More people are also interested in expanded access now because of the pandemic, Bateman-House said in explaining the recent rise in EAPs, particularly as former President Donald Trump used FDA programs to gain access to Regeneron’s monoclonal antibody combo treatment.
For instance, CBER reported more than 6,000 single patient emergency IND requests in FY 2020, compared with 216 in FY 2021. CDER also reported almost twice as many requests in 2020 when compared to other recent years.
“The thing we’re thinking about is how much the structural inequalities in clinical trials are replicated or enhanced in expanded access,” Bateman-House added.
And the FDA is expecting those higher numbers to continue, noting in the Federal Register on Wednesday that its information collection around EAP “reflects an increase in 254,750 burden hours and 11,568 responses annually since the last OMB review and approval of the information collection. We attribute this to an increase in the number of submissions.”
The estimate of 254,750 hours calculates out to about 122 new employees working 40 hours per week for one year.