- U.S. lawmakers again are trying to pass legislation to create a new regulatory framework for in vitro and laboratory-developed tests, this time by modifying the FDA user-fee bill that is now working its way through Congress.
- The revised bill from the Senate Committee on Health, Education, Labor and Pensions (HELP) features a modified version of the Verifying Accurate Leading-edge IVCT Development (VALID) Act. The act split the diagnostic industry when lawmakers previously tried to pass it in 2020.
- HELP’s push to pass VALID through the user-fee bill already has proven divisive. While the American Clinical Laboratory Association, which called the 2020 VALID Act “incompatible with a risk-based framework for regulation,” hailed the draft as a “pivotal moment in the multiyear effort on diagnostic regulatory reform,” the American Society for Microbiology (ASM) voiced concerns.
The VALID Act remains an attempt to create a tiered regulatory system for in vitro clinical tests. Lawmakers want to assign all tests, regardless of whether they are developed by a laboratory or commercial entity, to one of three risk categories.
Tests that likely would cause negative outcomes — such as serious or irreversible harm or death — if they give an undetected inaccurate result, will go in the high-risk category and be subject to premarket review. The proposal exempts low-risk tests from premarket review and proposes a middle ground for all other tests by creating a voluntary “technology certification” program that allows companies to bring products to market by showing they have suitable internal processes for validation. Once on the market, companies can tweak their moderate-risk tests without undergoing FDA review.
The Senate HELP Committee made the VALID Act the centerpiece of its user-fee bill. Analysts at Cowen said the user-fee bill proposed by the House includes 40 substantive provisions, many of which relate to drugs and biologics, but lacks a section on laboratory developed tests. Still, there are signs that the House is willing to consider the changes proposed by the Senate.
“The House leadership appears very open to including" laboratory developed tests (LDTs) provisions in the final bill – provided the Senate actually moves the legislation through to passage," the analysts wrote.
The House sponsors of the VALID Act – Diana DeGette (D-Colo.) and Larry Bucshon (R-Ind.) – both stressed their continued interest in including the issue in the user-fee package during last week's markup, according to the analysts. House Energy and Commerce Committee Chair Frank Pallone (D-N.J.) promised to consider anything that the Senate passes on the topic, adding how "rare" it is for the Senate to "pass anything,” the analysts said in a Thursday note to investors.
While the analysts see the Senate user-fee bill as the “best chance for LDT oversight,” history suggests it will be hard to enact the reforms. Lawmakers tried to reform oversight in 2017 through the Diagnostic Accuracy and Innovation Act and made three attempts to pass the VALID Act in 2018, 2020 and 2021.
Some of the earlier responses drew strong, opposing responses from different parts of the diagnostics industry. AdvaMed and the College of American Pathologists were broadly supportive of the 2020 and 2021 iterations of the VALID Act, while groups such as The American Clinical Laboratory Association (ACLA) and the American Association for Clinical Chemistry have raised concerns in the past.
The ACLA, which represents businesses including LabCorp and Quest Diagnostics, has yet to share a detailed analysis of the latest proposal, while it was upbeat in its initial statement. It called the release of the updated VALID Act “a pivotal moment in the multi-year effort on diagnostic regulatory reform.”
The trade group plans to review the draft and submit feedback to the HELP committee. The ASM was more circumspect, writing in a May 15 letter to the Senate committee that it is “unreasonable” to put clinical microbiology laboratories in the same category as commercial entities.