The American Association for Clinical Chemistry (AACC) has sent comments to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee urging the committee not to include the VALID Act in its omnibus Food and Drug Administration (FDA) user fee legislation.
The association says the VALID would limit the availability of vital laboratory-developed tests, decreasing patient access to life-saving diagnostic tools.
Most laboratory-developed tests are created when there is no FDA-approved commercial test available, and they are often used to diagnose rare conditions—such as genetic abnormalities in children—or to respond to emerging health threats such as COVID-19. These tests are regulated by CMS via the Clinical Laboratory Improvement Amendments (CLIA).
The association says 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 included into must-pass legislation without going through appropriate review and debate.
As discussed in AACC’s comments, the major problems with the VALID Act are as follows:
- VALID ignores the existing regulatory system for laboratory-developed tests. AACC supports modernizing regulations for laboratory-developed tests under the current regulatory framework at CMS. Bringing laboratory-developed tests under FDA oversight would only saddle labs with duplicative administrative, regulatory, and financial requirements that would make developing these tests cost prohibitive for all but the wealthiest labs.
- FDA doesn’t have the bandwidth to regulate laboratory-developed tests. FDA has already admitted to having problems hiring the necessary staff to carry out its current responsibilities, and it should not be assigned additional duties. This was abundantly clear in the agency’s inability to review all but a handful of new COVID-19 tests, raising legitimate concerns about whether the agency has the bandwidth to handle oversight of all laboratory-developed tests on an ongoing basis.
- VALID would significantly limit testing for rare diseases. VALID claims to exempt laboratory-developed tests for rare diseases from FDA oversight—but it defines a rare disease test as a test used on “not more than 10,000” people per year. This number is exceedingly low, considering the fact that the 2002 Rare Disease Act defines a rare disease as one that affects up to 200,000 people in the U.S.
Just as concerning, VALID only exempts custom/low-volume laboratory-developed tests from FDA review if the tests are performed on no more than five patients per year. Again, this is an arbitrary and excessively low limit that will deter labs from developing custom/low-volume tests, and will inhibit patients with unidentified rare conditions from getting the diagnoses and care they need.
- VALID would also hinder care for newborns. The bill fails to exempt laboratory-developed tests used for newborn screening from FDA oversight. Nearly all newborn screening tests in use today are laboratory-developed tests.
The VALID Act was recently introduced in the HELP Committee as an add-on to the larger FDA Safety and Landmark Advancements (FDASLA) Act. While AACC supports the FDASLA Act, we strongly urge the committee to remove VALID from this bill. 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.
“AACC and many others have worked with the HELP Committee in good faith to correct the significant issues with the VALID Act,” says AACC President Stephen R. Master, MD, PhD. “However, this version of the bill does not address those concerns. We therefore advise the committee to remove VALID from the FDASLA Act and to diligently assess the consequences VALID would have for patient care. For the sake of our patients, we can’t afford to pass faulty legislation in the name of expediency.”