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.

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