By Andy Lundin
The Association for Molecular Pathology (AMP) is urging medical organizations and other groups to contact their elected officials to remove the VALID Act from a large Fiscal Year 2023 “omnibus” appropriations bill.
Congress is seeking to pass the omnibus appropriations bill—which includes the Verifying Accurate Leading-edge IVCT Development (VALID) Act—by Dec. 16, 2022, and AMP is continuing to advocate for the removal of the new and controversial regulations. If the VALID passes through congress, LDPs will become regulated by the U.S. Food and Drug Administration (FDA), on top of preexisting CLIA regulations, and potentially delay or stunt the development of innovative diagnostic care.
“The VALID Act fails to differentiate medical procedures that are developed, validated, and performed within a laboratory from manufactured in vitro diagnostic test kits,” says Mary Steele Williams, executive director, AMP. “LDPs are essential medical services performed by board-certified specialist physicians, geneticists, and other highly qualified doctoral-level laboratory professionals who apply their professional, scientific, and medical knowledge to optimize patient care.”
Indeed, AMP has been critical of the VALID Act in myriad ways. According to the association:
- The development, validation, and interpretation of LDPs is a part of the practice of medicine, and as such, should not be regulated by the FDA. Laboratory professionals who develop LDPs are not manufacturers, but rather healthcare providers.
- A single pathway for both in vitro diagnostic (IVD) test kits and LDPs is not appropriate and fails to take into consideration the unique features of each.
- Under the VALID Act, clinical labs won’t be able to easily modify LDPs to best serve their patients and innovate so that tests reflect the latest advances in science and practice guidelines.
- Aspects of the VALID Act duplicate CLIA regulations, including those relating to quality control and adverse event reporting.
AMP says it would support certain aspects of the VALID Act to improve the regulation of commercially manufactured in vitro diagnostic (IVD) kits and platforms, but, as it currently stands, the new regulations propose dramatic modifications to current oversight mechanisms and is a reaction to perceived problems without real data to support the perceptions, the association says.
“The impact would be massive and enormously disruptive,” says Williams. “It will benefit some stakeholders’ business models but drastically hinder the ability of most to provide diagnostic care. Thus, it does not have consensus among all stakeholders, and many organizations representing various perspectives have expressed significant concerns with the version that was considered during Senate Committee activity last summer.”
AMP is advocating for a modernized approach to updating CLIA regulations—due to the rise of LDPs and their increasing complexity—that will improve oversight, enhances transparency, preserves innovation, avoids an escalation of healthcare costs, and ensures widespread patient access to essential medical services.
“AMP remains committed to working with Congress and other stakeholders to establish a more efficient regulatory framework that ensures high-quality patient care while continuing to foster the rapid innovation and promise of new diagnostic technologies,” Williams says. “We believe our CLIA-centric proposal is the most effective and streamlined approach to addressing clinical and analytical validity, transparency, and other concerns expressed by interested stakeholders.”
Williams added: “The fact that more than 125 medical organizations and other groups have signed letters to Congress opposing VALID should speak volumes to the problems with this legislation. We should all wonder who actually stands to benefit from VALID.”