Following quickly on the heels of the AACR statement in support of FDA regulation of LDTs, the co-founder of The Coalition for 21st Century Medicine, Kathleen Wilsey, today presented to Congress testimony that includes significant concerns about the potential for negative impacts from FDA regulation.
The Coalition's general concerns are that FDA's proposed framework is "incomplete, creates substantial uncertainty, and does not reflect a careful and important balance that recognizes the value and benefits that advanced diagnostics offer to patients, providers, and payers."
Echoing my comments in the previous post, the Coalition points out that the lack of data supporting the claim that the public is at risk from the use of LDTs is a key missing part of striking the proper balance. The Coalition's testimony states: "The framework and the specific proposal to mandate adverse event reporting, for example, presupposes — without meaningful data or other analytical bases — that there are substantial safety risks affecting American patients from the use of LDTs. A reliable presentation and understanding of the potential risks is a key component of evaluating any regulatory action." Indeed.
Some of the Coalition's other concerns include:
- FDA underestimating the number of LDTs that will need to be reviewed by an already strained staff;
- FDA underestimating the challenges in reviewing/regulating diagnostic services versus products.
While both of these points are valid, I think they may actually work more in favor of LDT providers than against. I was emailing this week with Christopher Corless, Chief Medical Officer of the cancer diagnostic lab at Oregon Health Sciences University, and he summarized the likely turn of events succinctly: "The FDA will be flooded with paperwork from tens of thousands of tests across the country. They don't have the expertise, or even sufficient staffing, to handle this influx. I predict they will just sit on the paperwork and the approval process will drag on for years." Indeed.