Thursday, April 22, 2021

Huang et al. show, "What Would the VALID ACT (FDA) Really Cost Labs?"

Congress has the chance to consider the VALID ACT, which would extend FDA regulation to many lab-developed tests.   There hasn't been much known about how much this would cost on per-lab basis.

An international team - with experts from MGH to Melbourne and Antwerp, along with Friends of Cancer Research - tackles the problem.   Huang et al. report that VALID could cost an active molecular pathology lab from $638,000 to $1.2M (potentially raising US health costs by as much as $1B over a 3-year period).  This modeled the added expense for the U.S. count of 886 cancer treatment centers.

Here are some links:

  • See an MGH press release here.
  • See the original article released ahead-of-print at Journal of Clinical Oncology Practice.
    • Link here.
    • Subscription.
I had the chance to be author 4 of 8.  The article points out that VALID doesn't lead directly to cost projections; you have to interpose a series of assumptions, and the FDA could have wide latitude to produce a less expensive or more expensive regulatory program.