ASCP Continues Opposition to the VALID Act

Publication Date: Aug 5, 2022

In recent months, ASCP has issued several action alerts urging members to voice their concerns about the Verifying Accurate Leading-edge IVCT Development Act, also known as the VALID Act. ASCP’s primary concern with the legislation is it would give the U.S. Food and Drug Administration (FDA) too much authority over laboratory-developed tests (LDTs).

ASCP has been working with the Association for Molecular Pathology, the American Association for Clinical Chemistry, and others to educate Congress on concerns pertaining to the current draft of the VALID Act. (Click here.) The Society is gearing up to do even more advocacy on the VALID Act, and we will need your help.

When the Senate Health, Education, Labor, and Pensions (HELP) Committee approved its FDA user fee reauthorization bill (considered “must pass” legislation) in June, it attached the VALID Act to it.

It appears, however, that momentum for the FDA/VALID package is waning. The Senate has yet to approve the measure; Congress has begun its August recess and won’t resume session until September; and the bill has to be signed into law by late September. Otherwise, the Agency’s user fee program, along with thousands of FDA staff, will cease operations. Moreover, in apparent recognition that the VALID Act maybe hampering Senate approval of the FDA bill, Senate HELP Committee Ranking Republican Richard Burr (lead author of the Senate version of the VALID Act) recently introduced an FDA user fee bill, which strips away the VALID Act.

These events create a critical window of time in which to accelerate concern about the VALID Act and urge Congress to remove these provisions from the FDA reauthorization legislation. To ensure our members’ voices are heard, ASCP plans to releasing in the next few weeks a series of new Action Alerts to press Congress to remove the VALID Act from the FDA reauthorization bill. Stay tuned!

To read more articles from this issue of ePolicy, click here.To learn more about ePolicy News and access past newsletters and articles, click here.

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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