President Biden recently signed a temporary stop-gap funding bill to keep the federal government open through December 16. One provision of the bill will re-authorize the U.S. Food and Drug Administration’s (FDA) User Fee Program. Notably, the short-term measure did not include the controversial Verifying Accurate Leading-Edge In Vitro Clinical Tests Devices (VALID) Act.
Had the FDA User Fee Program not been re-authorized, the Agency would have been forced to lay off key staff and suspend the review of certain medical and diagnostic devices. Congress has spent significant time this year working to fully re-authorize the user fee program—considered “must-pass” legislation. Yet, when a Senate Committee included the VALID Act in the FDA re-authorization bill, significant opposition to the VALID Act emerged, preventing the Senate from approving the FDA user fee program. As a result, Congress was forced to exclude this contentious measure from the short-term funding bill.
ASCP is among numerous organizations opposed to the VALID Act and has released several action alerts to opposing the VALID Act in its current form. The Society opposes the measure for several reasons: its excessive regulatory burden, its negative impact on patient care and laboratory test innovation, and the massive fees that could prevent clinical laboratories and academic medical centers from providing these important diagnostics to their patients. Click
here to read more about ASCP’s concerns about the VALID Act.
The exclusion of the VALID Act from the funding bill is a significant victory. However, supporters of the Act are still trying to attach the measure to other must-pass legislation Congress is expected to enact this year. ASCP will continue working with many other organizations to prevent this from occurring.
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For more information regarding ASCP's advocacy initiatives and policy positions, please contact ASCP's Center for Public Policy at (202) 408-1110.
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