A top US Food and Drug Administration (FDA) official said that a pandemic funding reauthorization bill could act as a vehicle for in vitro diagnostics reform and discussed other legislative priorities for the agency, such as getting more data about the supply chain to prevent future shortages.
For several years, FDA has sought explicit authority from Congress to regulate laboratory-developed tests (LDTs). Despite bipartisan support last year for the Verifying Accurate Leading-edge IVCT Development (VALID) Act, the bill was stripped from the user fee reauthorization package that was passed in September and was not included alongside other FDA reforms in the omnibus spending bill that was passed late last month. (Related: US FDA sees boost in FY23 budget proposal but no diagnostics reform, Regulatory Focus 20 December 2022)
FDA Commissioner Robert Califf has stated that the agency may consider developing a rule to give it regulatory oversight of LDTs but would prefer getting the authority from Congress. (Related: Califf: FDA may use rulemaking for diagnostics reform if VALID isn’t passed, Regulatory Focus 25 October 2022)…
