Abstract
The longstanding issue of how to regulate laboratory developed tests (LDTs), which last year sparked two competing bills in Congress, has returned to Capitol Hill with the reintroduction of one of the two measures.
Sen. Rand Paul, M.D. (R-KY) has brought to the U.S. Senate the Verified Innovative Testing in American Laboratories (VITAL) Act of 2021. The measure would keep LDT oversight outside of the FDA by directing that “no aspects of lab-developed testing procedures shall be regulated under the Federal Food, Drug, and Cosmetic Act, including during a public health emergency.”
Defending the VITAL Act's provision keeping LDTs from FDA oversight, Paul and supporters of the measure cite the agency's initially slow response to expanding access to SARS-CoV-2 tests beyond public health labs and Department of Defense labs.
“The requirement of qualified clinical laboratories to obtain an FDA EUA prior to performing COVID-19 diagnostic tests was a drastic and unnecessary addition to the substantial regulatory requirements that were already in place,” Mary Steele Williams, Executive Director of the Association of Molecular Pathology (AMP), told Clinical OMICs.
Williams cited an August 2020 AMP survey which found that almost a third of laboratories experienced similar hurdles while seeking an EUA. “The VITAL Act would ensure that even in a pandemic, laboratories… could continue to operate under the CLIA system, which will help ensure access to these potentially life-saving tests.”
