Update: March 25, 360DX runs an article on how laboratory and genetic experts are viewing the chance for a revived VALID bill: here.
March 20 Blog:
Usually I go further than just pointing to subscription articles, but here, there's one that is worth just pointing to.
On March 16, 2022, 360DX ran a detailed subscription article, by Adam Bonislawski, with the headline:
- FDA Control of LDTs Looms as Momentum Builds for VALID ACT
Recall that the VALID act has been kicking around for a number of years, and has been introduced in multiple versions - the "Verifying Accurate Leading-edge IVCT Development" Act. For the most current legalese, see the House HR4128 version for 2021-2022 here. The bill heavily edits existing FDA law, inserting or deleting clauses, which makes it particularly hard to read as a stand-alone document.
The new attention is that DC insiders seem to see momentum for attaching VALID Act to MDUFA, the five-year FDA funding authorization bill which must be past in 2022. Proponents are happy; opponents like AACC say this is a very bad idea; and ACLA is quoted as saying it is taking this very seriously and looking at it very closely, and if it passes, hopes to input some key edits and improvements. Most parties seem to agree that part of the political momentum is a January 2022 NYT lead article on NIPT testing, which is an LDT field, including parties that felt that article was an awful article.
See a 2021 paper on the cost of VALID Act for cancer labs (here; I'm a middle coauthor) and an article asking whether FDA lessons from the EUA rapid review experience might not benefit efforts like the VALID Act (here).
As noted in the "update" top section, see also a March 25, 2022, article in 360DX on how ACMG and other genomics experts are viewing a revived VALID.