Sunday, February 4, 2024

Remarkable Pushback Against FDA LDT Regulation: The Hyman Phelps Law Firm Comment

HEADER.  I was very impressed by a 58-page FDA LDT comment, submitted by Hyman Phelps law firm and an LDT Coalition


The biggest splash I know of, among FDA LDT comments in December, was that of the ACLA, which was some 100 pages when including an extensive supplement in which an economist took apart the FDA's proposed financials.  ACLA entry point here.

Here's another grand example. it comes from  Hyman Phelps McNamara and the Coalition to Preserve LDT Access and Innovation. Find it here:

Topics include:

  • Prohibitive costs of the rule
  • Poor presentation of LDT risks and no presentation of LDT benefits
  • Deeply flawed economic analyses
    • Multiple categories of costs ignored and underestimated
  • Existing regulatory framworks are ample
  • FDA lacks statutory authority
    • Elaborate statutory discussion
The letter makes a point I have made, the FDA relies on risk categories by use case and indication, but CLIA tests don't have [in the same sense] statements of indicated use, which at FDA are often verbose, multiplex, and hammered out after months of negotiation (p. 33, 38).   


See also the firm's Feb 2 essay, on the holes in the FDA's Jan 31 press release about IVD reclassification.