Colonial Laws Validity Act 1865

AACC Statement on Excluding VALID from End of Year Legislative Package

Retrieved on: 
Friday, December 23, 2022
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"AACC applauds the decision of the United States Congress to exclude the Verifying Accurate Leading-edge IVCT Development (VALID) Act from its end of year omnibus bill.

Key Points: 
  • "AACC applauds the decision of the United States Congress to exclude the Verifying Accurate Leading-edge IVCT Development (VALID) Act from its end of year omnibus bill.
  • We are grateful that Congress listened to the united voices of the more than 100 medical and patient groups that joined AACC in opposing the bill.
  • We urge the FDA and those who supported the VALID Act to join with us to make any necessary changes."
  • To speak to Dr. Haymond about this issue, please contact Molly Polen, AACC Senior Director of Communications & PR, at [email protected] or 202-420-7612.

Medical and Patient Communities Unite to Urge Congress to Stop Bill That Would Impede Patient Access to Essential Diagnostic Tests

Retrieved on: 
Monday, June 6, 2022
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Specifically, the medical and patient communities urge Congress to remove the VALID Act from the FDASLA Act, a piece of must-pass legislation that the Senate is on the cusp of ratifying.

Key Points: 
  • Specifically, the medical and patient communities urge Congress to remove the VALID Act from the FDASLA Act, a piece of must-pass legislation that the Senate is on the cusp of ratifying.
  • Laboratory developed tests are currently regulated by CMS under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
  • The VALID Act would add FDA oversight to the existing CMS oversight of laboratory developed tests.
  • "We are hopeful that Congress will listen to the united voices of more than 100 medical and patient groups that are joined in opposing the bill.

AACC Calls on Congress to Halt Legislation That Would Hinder Patient Access to Essential Medical Tests

Retrieved on: 
Monday, May 23, 2022
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VALID would limit the availability of vital laboratory-developed tests, decreasing patient access to life-saving diagnostic tools.

Key Points: 
  • VALID would limit the availability of vital laboratory-developed tests, decreasing patient access to life-saving diagnostic tools.
  • VALID would impose FDA oversight on laboratory-developed tests in addition to CMS oversight, creating a burdensome dual regulatory environment that would prevent many labs from performing these essential tests.
  • This bill would drastically alter the medical testing landscape, and it is being shoe-horned into must-pass legislation without going through appropriate review and debate.
  • As discussed in AACC's comments, the major problems with the VALID Actare as follows:
    VALID ignores the existing regulatory system for laboratory-developed tests.