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Senator Cassidy Issues RFI Asking for Input on Diagnostics Reform

NEW YORK – US Sen. Bill Cassidy, R-La., this week issued a Request for Information (RFI) asking stakeholders for input on diagnostics reform.

The RFI, which poses a series of questions regarding the US Food and Drug Administration's regulatory framework for diagnostics as well as the CLIA regulatory framework for laboratory-developed tests (LDTs), suggests Congress may be interested in taking up these issues once again following its failure in recent years to pass legislation covering in vitro diagnostics (IVDs) and LDTs.

"In the nearly 50 years since the Medical Device Amendments (MDA) of 1976 established the Food and Drug Administration’s (FDA) framework for medical devices, advancements in in vitro diagnostic (IVD) technologies have necessitated improvements to this framework to support timely patient access to safe and effective diagnostics, especially those intended for special or rare disease populations," Cassidy wrote.

"At the same time," he added, "clinical laboratory medicine has evolved in the 35 years since the Clinical Laboratory Improvement Amendments of 1988 (CLIA) were enacted, demanding standards that reflect advancements in molecular and genomic testing and ensure appropriate oversight over these tests."

The letter notes that legislative efforts to reform diagnostics regulation have been unsuccessful and asks that stakeholders offer insights "specifically addressing the actions Congress should pursue to meet the challenge of ensuring patient access to timely and advanced diagnostics."

The letter lists a series of specific questions for stakeholders to address, including how well the FDA's medical device framework is working for regulating diagnostics and what updates to CLIA could improve regulation of LDTs.

Notably, the RFI does not discuss the possibility of FDA oversight of LDTs but instead focuses on whether updates to CLIA regulation of LDTs might be needed. The Verifying Accurate Leading-edge IVCT Development (VALID) Act, which was perhaps the most serious legislative effort to date to address the question of LDT regulation, proposed giving the FDA oversight of these tests and, following the failure of VALID to pass in 2022, the FDA has sought to regulate LDTs through the rulemaking process. Some opponents of FDA oversight of LDTs have suggested that LDT regulation should instead be handled through updates to CLIA, though the US Centers for Medicare & Medicaid Services, which oversees CLIA regulation, has said it supports FDA oversight of LDTs.

In 2022, Cassidy expressed reservations about VALID during a Senate Committee on Health, Education, Labor, and Pensions (HELP) committee hearing discussing the bill and advocated for an amendment introduced by US Sen. Tommy Tuberville, R-Ala., that would have exempted LDTs developed at academic medical centers from FDA regulation under VALID.

While the clinical lab industry was not generally supportive of VALID and has largely opposed the FDA's efforts to regulate LDTs through rulemaking, IVD players saw VALID as a vehicle for a variety of diagnostic regulatory reforms that could benefit the industry. The Cassidy RFI separates the question of IVD regulation from LDT regulation.

Responses to the RFI must be submitted by April 3, 2024.