TWO DISTINCTLY DIFFERENT BILLS HAVE SURFACED IN CONGRESS, each with the potential to have substantial impact on how laboratory-developed tests (LDTs) are regulated by agencies of the federal government. One bill even creates a new acronym for the lab industry: IVCT for in vitro clinical tests.
One bill is called the Verifying Accurate Leading-Edge IVCT Development Act of 2020 (VALID). It is 245 pages long and has bipartisan sponsors in the House and Senate. The other bill is the Verified Innovative Testing in American Laboratories Act of 2021 (VITAL). It is just seven pages long and is sponsored by Sen. Rand Paul, MD, (R-KY).
As you will read in our intelligence briefing here, The VALID Act is written to give the federal Food and Drug Administration (FDA) oversight of the class of tests currently known as LDTs. By contrast, the VITAL Act retains the role of the federal Centers for Medicare and Medicaid Services in overseeing LDT regulation under CLIA (Clinical Laboratory Improvement Amendments).
Clinical lab administrators and pathologists who currently utilize LDTs in their daily lab operations are advised to read both bills and study the positions issued by their laboratory associations and societies. They may want to express their opinions about each bill to their members of Congress.
My observation is simple and has two elements. First, no bill gets written in Congress unless some private individual, company, organization, or non-government organization lobbies individual Senators and Representatives and persuades them of the need for a specific bill to be written and passed into law.
Second, the more pages in a bill, the more significant the consequences for the industry to be regulated by the language of that bill. Clinical labs and pathology groups that use LDTs today will want to understand what is inside those 245 pages of the VALID Act and compare them to the content of the seven-page VITAL Act. Plenty of mischief can be hidden in 245 pages of lawmakers’ prose.
As each of you develop your position on these two bills, remember that it was in 2014 when the FDA published draft rules that gave it the authority to regulate LDTs. That proposal was bitterly opposed by a large cross section of the clinical laboratory industry. Since then, opposing interests in the IVD industry and the clinical laboratory profession have been jockeying to advance their interests. That fact should motivate you to read the bills and speak to your elected officials.