The Senate Health, Education, Labor, and Pensions Committee (HELP) has approved legislation that includes the Verifying Accurate Leading-edge IVCT Development (VALID) Act. On July 14, the Senate HELP Committee adopted the
Food and Drug Administration (FDA) Safety and Landmark Advancements (FDASLA) Act. During Senate Consideration of the measure, several Senators raised concern about the impact the measure could have on the development and use of laboratory developed tests. The VALID Act would provide the FDA with authority over these tests and would significantly raise the regulatory requirements and approval fees associated with their review by the Agency. Due of a number of concerns about the VALID Act, ASCP has
opposed including the VALID Act in the FDASLA Act and has issued several action alerts about the bill.
Similar legislation was approved by the House Energy and Commerce Committee; however, that bill does not include the VALID Act. The House and Senate are believed to be working to craft a compromise to facilitate passage of the bill. FDASLA is considered “must pass” legislation, not just because it provides critical funding to the FDA, but also because the bill includes legislative provisions to address the severe shortage of infant formula. ASCP will be following the measure closely.
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