Diversity plan draft guidance on track before year end, FDA official says

ANAHEIM, CA – The US Food and Drug Administration (FDA) is on track to publish a draft guidance on diversity plans before year’s end, which will take into consideration the unique challenges of conducting medical device clinical trials, according to a top agency official.

Under the 2023 Consolidated Appropriations Act, lawmakers have instructed FDA to require diversity plans for all Phase 3 clinical trials conducted for drugs and biologics, and the same for all devices and diagnostics that use the 510(k), premarket approval (PMA), de novo, and investigational device exemption (IDE) pathways, with some exceptions.

“When the legislation was passed at the end of last year, we started working immediately, figuring out what are we going to need in terms of expertise, what are we going to be reviewing, what's the process to even accept them,” Michelle Tarver, deputy center director and chief transformation officer at FDA’s Center for Devices and Radiological Health (CDRH), told attendees at the 2023 MedTech conference.

Congressional mandate

Heather Colvin, director for evidence and outcomes policy at Johnson & Johnson, moderated the panel on how digital health technologies can be used to improve clinical trial diversity. During the discussion, she reminded the room that Congress has mandated that FDA publish a draft guidance requiring sponsors to submit diversity plans in their premarket applications by the end of the year.

This, however, isn’t FDA’s first attempt at developing a guidance requiring sponsors to submit diversity plans in their premarket applications. The agency has held several public meetings on the topic over the years and published a draft guidance on the issue in April 2022 (RELATED: Clinical trial diversity: Sponsors seek clarity on data sources, timing, Regulatory Focus 15 June 2022).

Manufacturers are concerned that FDA may try to use the same approach for medical device applications as they would for drugs, even though medtech clinical trials are conducted very differently than those for drugs and biologics, Colvin said. She asked Tarver how the agency was addressing those concerns.

Tarver assured attendees that FDA is being very careful about how it writes the guidance to prevent any undue burdens. “We are actively writing a section in the guidance that will apply to devices,” she said. “So yes, we are being thoughtful and intentional in thinking about that.”

Tarver also noted that the agency wants to make sure it encourages more diversity in clinical trials, since they have found circumstances where products don’t work as intended after patients have been enrolled in trials. Additionally, as stated during the Patient Engagement Advisory Committee’s (PEAC) September meeting, the agency is trying to develop a framework for when it is necessary to include certain types of patients in clinical trials and why.

The 2023 Consolidated Appropriations Act includes provisions that waive the diversity plan requirements in very limited circumstances, and the agency has been working to figure out when those circumstances may be justified and how regulators would receive those waivers, she said.
“We also hope to help the industry by putting some things out in public that we're developing so that we all can learn together,” Tarver said. “This is a collaborative effort, it is not a one-sided push-it-over-the-fence type of thing.”

After the panel discussion, Tarver told Focus that the agency doesn’t want to rush the guidance and is being thoughtful about how it words the document in order to ensure it is effective in encouraging more clinical trial diversity. For instance, while Congress wants more patient demographic data for 510(k) applications, the reality is that they typically don’t have as much data as other applications and the agency is trying to figure out how to address that, she said.

“We don’t want this just to be an exercise,” Tarver said. “We want to make sure it actually helps people.”

Monetary consequences?

Other speakers on the panel had their own take on what they would like to see in the draft guidance. Yasmeen Long, director at FasterCures, recommended that trial diversity be tied to monetary consequences.

“This is going to sound very controversial, but I’d like to see something in it that says that if you don’t complete this, you don’t get funding,” she said.

Long noted her proposal may sound “a little harsh,” but the threat of having an application denied and losing funding may get reluctant sponsors to start taking the issue more seriously.

Kalvin Yu, vice president for medical affairs at Becton Dickinson, suggested a more carrot-based approach to encouraging sponsors to submit diversity plans. He proposed including a requirement that sponsors submit peer-reviewed information about the patient demographics that their product is intended to serve when submitting a clinical trial plan. He argued that companies want to sell as many products as possible and want to be seen as applicable to as many patients as possible.

“That's one of those areas where I think collaboration to be a win-win where everyone's getting what they want out of out of this, but most of all patients,” Yu said.

Diversity plan draft guidance on track before year end, FDA official says

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