The American Association for Clinical Chemistry (AACC) is urging the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee to not include legislation in the omnibus U.S. Food and Drug Administration user fee bill that would limit access to laboratory-developed tests.
In a May 22 letter, the AACC expressed its support for the FDA Safety and Landmark Advancements (FDASLA) Act, which reauthorizes user fee agreements between agency and industry. However, the association “strongly” urged the HELP Committee to remove the Verifying, Accurate, Leading-Edge IVCT Development (VALID) Act from the user fee package and instead “initiate a thorough, public examination of this measure and its potential impact on patient care,” the AACC wrote in the letter.
According to the AACC, the VALID Act would impose FDA oversight on laboratory-developed tests in addition to the oversight of the Centers for Medicare and Medicaid Services, “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,” the AACC wrote in a statement.
AACC is primarily concerned that the VALID Act ignores the existing regulatory system for laboratory-developed tests, the FDA does not have the capacity to regulate laboratory-developed tests, and the VALID Act would limit testing for rare diseases and for newborns because the bill does not exempt laboratory-developed tests of newborn screening from FDA oversight. The AACC notes that nearly all newborn screening tests used today are laboratory-developed tests.
“VALID’s removal would not impede passage or implementation of FDASLA. Most importantly, this move would give the HELP Committee time to thoroughly examine VALID’s potential impact on patient care and to correct the serious problems with this legislation,” the AACC wrote in its statement.
Source:
https://www.aacc.org/advocacy-and-outreach/comment-letters/2022/valid-comments
