In advance of committee activity to consider legislation to establish new regulations for laboratory-developed tests (LDTs), AAMC Chief Public Policy Officer Karen Fisher, JD, sent a June 2 letter to Senate Health, Education, Labor, and Pensions (HELP) Committee leadership reiterating concerns from the academic medicine community.
The letter specifically responded to incorporation of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2022 into the committee’s larger Food and Drug Administration (FDA) user fee reauthorization package, the FDA Safety and Landmark Advancements (FDASLA) Act of 2022 (H.R. 4348).
In the letter, Fisher noted that while the AAMC agrees that it is essential for LDTs to be accurate and clinically valid in their use as a diagnostic to inform treatment decisions for patients, the association remains concerned that the VALID Act as drafted would interfere with academic medical centers’ ability to deliver innovative medical care, negatively impact patients, and mire the development of critical new tests in a costly and laborious regulatory process. “Absent substantial fundamental revisions, we cannot support the FDASLA as currently drafted and join [many other] stakeholders in respectfully requesting additional time for both chambers to consider this broad swath legislation,” Fisher added.
The AAMC previously joined nearly 100 stakeholders in a May 31 letter raising concerns about the legislation and the accelerated process for consideration of the bill. The letter was originally delivered by the HELP Committee’s May 22 deadline to receive feedback on the draft bill following its release on May 17 [refer to Washington Highlights, May 20].
The HELP Committee introduced a revised version of the FDASLA Act on May 27, with a notable change in response to AAMC and stakeholder concerns regarding the types of LDTs that could be exempt from premarket review — if they are modified from tests that already went through the approval process and if they are modified by the original lab or another regulated, high-complexity lab.
The committee has noticed a June 8 executive session to consider the FDASLA.
The House Energy and Commerce Committee approved its FDA user fee reauthorization package, which did not include the VALID Act or provisions related to LDT regulation, on May 18 [refer to Washington Highlights, May 20]. The full House of Representatives may vote on the committee-approved package during the week of June 6.