The FDA Proposal for Regulating Laboratory Diagnostics Could Improve Patient Care

By Rachel Sachs

[Note: I am very pleased to have had the opportunity to write a response to a recent commentary posted on the Hastings Center Bioethics Forum about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs), an issue I have previously written about for this blog. My response, which is posted here at the Bioethics Forum, is cross-posted below.]

Wendy Chung’s commentary last month about the FDA’s proposed draft guidance for the regulation of laboratory-developed tests (LDTs) is heavily critical of the agency’s plans. Professor Chung argues that the FDA’s involvement in this space will have two primary negative consequences: it will stifle innovation and it will harm patient care.

But the FDA’s proposal seems designed to address precisely these two consequences. The proposal could improve patient care by collecting, for the first time, clinical validity data on tens of thousands of LDTs in current use. And by using an extensive system of carve-outs, the FDA is seeking to minimize potential harms for diagnostic innovation. Understanding these key portions of the FDA’s disclosure to Congress is critical to a full policy discussion of the situation.  Continue reading