Thursday, June 24, 2021

Very Brief Blog: VALID Act for Regulating LDTs Is Re-Introduced

In May, Rand Paul re-introduced his VITAL Act, which builds a wall around the FDA preventing it from regulating LDTs.  AMP, Association of Pathology Chairs, and others voiced support - here.

On June 24, 2021, Burr, Bennet, DeGette, and Bucshon, representing both House and Senate and Republicans and Democrats, re-introduced the VALID Act, which would reform FDA regulation of both IVD's and LDTs to a considerable extent, while introducing risk-based FDA oversight of LDTs.

  • Find the press release here.
  • Find the plain-English six-age summary here.
  • Find the legislative language here.
    • The full act weighs in at 245 pages, 46,000 words.
    • The 2020 version S3404 was only 38,000 words.
I had a chance to be a coauthor of a paper on budgetary impacts of the VALID act, under several different implementation assumptions - Huang et al., here.

Trade journal Healthcare Dive, here.


Redline?  How'd they get from 38,000 words to 46,000 words

I attempted to use MS Word to make a "redline" of the March 2020 version of VALID - as S.3404 - and the June 2021 release, provided in the Congressional weblink above.  The result is pretty clumsy, but if of interest, I've put in the cloud here.  I haven't made sense of it, but I did see the topline result that the S3404 March 2020 version was 38,000 words, and the new online version is 46,000 words, so something clearly was going on.