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.
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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.
