Coalition for Innovative Lab Testing

Thanks for your interest and support. Please read and sign the following letter to Congress.

Hon. Patty Murray
Chairman, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Bldg.
Washington, D.C. 20510

Hon. Frank Pallone Jr.
Chairman, House Energy and Commerce Committee
2125 Rayburn House Office Bldg.
Washington, D.C. 20515

Hon. Richard Burr
Ranking Member, Senate Committee on Health, Education, Labor & Pensions
428 Senate Dirksen Bldg.
Washington, D.C. 20510

Hon. Cathy McMorris Rodgers
Ranking Member, House Energy and Commerce Committee
2125 Rayburn House Office Bldg.
Washington, D.C. 20515

Re:       VALID Act of 2021 (S. 2209; H.R. 4128)

Distinguished Members of Congress:

The undersigned are leaders of clinical laboratories and diagnostics companies from throughout the U.S. that develop innovative lab tests across the disease spectrum.

We write to express our deep concern that the regulations that would be implemented under the VALID Act would impose tremendous and wholly unnecessary burdens on labs. Smaller laboratories would be forced to abandon development and commercialization of tests that could otherwise improve patient outcomes and reduce healthcare costs. Many labs will be forced to downsize, and some will close leaving our nation unprepared for future Covid variants or new pandemics.

Under current CLIA rules the performance of lab developed tests (LDTs) are subject to extensive controls and ongoing inspection and accreditation requirements from the states and CMS, which maintain the quality of the laboratory’s testing products and processes. Congress should proceed slowly and with great caution before adding FDA approvals over LDTs, while soliciting significant input from smaller labs and companies that would be profoundly impacted by this legislation. In particular, the costs of any new regulations should to be quantified as should the consequences of these increased costs on the healthcare system due to the inevitable reduction in competition and innovation reaching the marketplace.

Before taking up the VALID Act it would be prudent first thoroughly assess the impacts of FDA test regulation during the pandemic. Many experts have harshly criticized the FDA’s role in slowing introduction of COVID-19 tests throughout the pandemic and the resulting deaths and disease spread stemming from these delays. An NIH funded report on this “testing debacle” published in the Yale Law Journal concluded that FDA imposed delays “potentially foreclosed opportunities to arrest widespread community transmission of the disease” and was “possibly the deadliest regulatory overreach in U.S. history.” This debacle could become a mere harbinger of things to come should S. 2209; H.R. 4128 become law.

Moreover, as the CDC’s Clinical Laboratory Improvement Advisory Committee (CLIAC) is now examining updates to the CLIA rules for LDTs, that effort should be giving time before FDA oversight of these tests is imposed.

For the forgoing reasons we urge that consideration of the VALID Act be suspended to provide time for both a full pandemic review and to examine whether updates to the CLIA rules might obviate the need for expanding FDA’s authority.

Thank you for considering our perspectives and recommendations.

Respectfully submitted,

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