On May 27, the Senate Committee on Health, Education, Labor and Pensions (HELP) introduced the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes the FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements and updates the Verifying Accurate Leading-edge In Vitro Clinical Tests (IVCTs) Development (VALID) Act. The HELP Committee is scheduled to hold a markup of several bills, including the FDASLA Act, on Tuesday.
The VALID Act would regulate laboratory developed tests (LDTs) by amending the Food, Drug, and Cosmetic Act to create a new regulatory framework under FDA authority and require premarket review for many tests. Currently, the Centers for Medicare & Medicaid Services (CMS) regulates laboratories performing LDTs, including many in academic medical centers, through the Clinical Laboratory Improvement Amendments. State laboratory certification programs, including New York State’s Wadsworth Center, and professional accrediting bodies provide additional regulation.
GNYHA submitted a comment letter (attached) to oppose placing regulations under FDA and urge the HELP Committee to allow the oversight of LDTs to remain in the experienced hands of CMS and state regulators. If it is determined that LDTs do require further oversight, we request that the HELP Committee at least preempt states like New York that already have a robust LDT review process in place.
GNYHA will continue to support innovation in the area of precision medicine and oppose unnecessary Federal regulation of LDTs. Our policy paper outlining our position on the regulation of LDTs is available here.