Earlier today (Tuesday June 14 2022), the Senate Health, Education, Labor & Pensions (HELP) Committee held a hearing on S.4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act, and voted to move the bill to the full Senate for its consideration. This bill includes the current version of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act.

VALID recognizes the enormous capacity for innovation laboratory professionals are capable of generating with the tools and expertise they have at their disposal and also recognizes the profound impact that those laboratory developed tests have on patients.

For more than a decade, ASCLS has advocated for common sense federal regulation of laboratory developed tests. On May 22, 2022, ASCLS informed the Senate HELP committee that the Society supports passage of this version of VALID.

As precision medicine expands demands on the capabilities of a now broadly distributed base of molecular testing throughout the clinical laboratory system, along with the flood of associated data, patients are best served by a framework for regulation that is predictable, reasonable, and focused.

VALID does that.

Contrary to the overheated and unsubstantiated rhetoric heard over the last few months, the certainty of this regulatory framework is likely to spur innovation. Enforcement discretion that has changed with every new administration maintains an environment of unpredictability that discourages investment in diagnostic advancements.

ASCLS has worked directly with the bill’s sponsors during three different Congresses to educate and provide feedback on a variety of explored approaches. This version of VALID is the first the Society has endorsed because it meets a single test: it protects and promotes the health and well-being of patients.

VALID is both bipartisan and bicameral. ASCLS salutes Congresswoman Diana DeGette (D-CO) and Congressman Larry Bucshon (R-IN) in the House of Representatives who have devoted many years of effort towards crafting a focused and reasonable bill. ASCLS also thanks Senators Patty Murray (D-WA), Richard Burr (R-NC), and Michael Bennet (D-CO) for their tireless work in the Senate and their advocacy on this issue.

While ASCLS respects the concerns of other laboratory groups, the Society does not believe loosening any of the bill’s provisions is appropriate. Quite the contrary, from ASCLS’s perspective, based on previous discussions with the committee in reviewing drafts, we take the position that the law and regulations should be stronger. This is reflected in the comments we provided to the committee.

Bill (prior to any committee amendments): https://www.help.senate.gov/download/fdasla_–introduced-may-26-2022—-tam22997

ASCLS looks forward to VALID becoming law and engaging in a robust rule-making process to implement it. ASCLS urges laboratory professionals to contact their senators and representatives to encourage passage of VALID within S.4348.