AACC joins more than 100 other medical and patient organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act, a bill that would limit patient access to vital laboratory developed tests and the lifesaving diagnoses these tests enable. Specifically, the medical and patient communities urge Congress to remove the VALID Act from the FDASLA Act, a piece of must-pass legislation that the Senate is on the cusp of ratifying.
AACC has sent comments to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee urging the committee not to include the VALID Act in its omnibus Food and Drug Administration (FDA) user fee legislation. VALID would limit the availability of vital laboratory-developed tests, decreasing patient access to life-saving diagnostic tools.
We share the FDA’s goal of alerting the public to the potential misuse of non-invasive prenatal screening (NIPS) tests. This is why we’ve been advocating for the modernization of how laboratory-developed tests (LDTs) are regulated by the Centers for Medicare and Medicaid Services (CMS).
Laboratory developed tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been clearer than during the current pandemic. In this briefing, AACC’s leading experts in laboratory medicine will discuss why laboratory developed tests are crucial to fighting the coronavirus, as well as the regulatory barriers that nearly prevented labs from developing and introducing these tests for the virus.
AACC welcomes a decision from the Department of Health and Human Services that the Food and Drug Administration does not have authority to regulate laboratory developed tests (LDTs) without formal notice-and-comment rulemaking.