After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
As part of the bipartisan FDA Safety and Landmark Advancements Act, introduced by Senators Patty Murray (D-WA) and Richard Burr (R-NC), the VALID Act would allow the FDA to regulate laboratory developed tests – an effort that has been underway for years.
If enacted into law, the VALID Act would take effect in October 2027, which would allow the FDA a few transition years to shift into the new diagnostic regulation process.
Like several other aspects of the healthcare system, the pandemic exposed gaps in the FDA’s testing system. Still, reaction to the proposed legislation has been split among healthcare stakeholders.
In a tweet, former FDA Commissioner Scott Gottlieb touted the proposal, noting “it’s time to modernize regulation of clinical tests,” adding that the VALID Act is a “historic opportunity to advance innovation.”
He also pointed to the COVID-19 pandemic as an example of the U.S. being “tragically behind” in its testing capabilities.
Gottlieb has been pushing for a modernization of testing for some time. In a post written on the FDA’s blog in 2018, he highlighted the advent of genetic and genomic tests as part of the reason why paradigm shifts in the medical world — like precision medicine and biomarker-led clinical trials — have occurred in recent years.
“Diagnostics are the technology enabling the development and delivery of the new and more targeted medicines that make the identification of the underlying targets possible,” Gottlieb wrote. “These diagnostics help identify the disease subsets and structure clinical trials based on these markets. They are also translating to changes in the clinic when it comes to how medicine is practiced.”
Innovation in diagnostics have helped move therapies in oncology, infectious diseases and rare diseases forward, Gottlieb argued.
“To fully realize these benefits, it’s critical that we continue to advance a modern framework for the development of advanced diagnostics — one that helps harness the full potential of new diagnostics to drive better treatment decisions with both current and future therapies, while also ensuring that such diagnostic tests are safe and effective,” he wrote.
This is where laboratory developed tests, or LDTs, come in. LDTs are in vitro diagnostic tests — meaning they use samples from the body like blood or tissues — that are manufactured and used in a lab. According to the FDA, LDTs are used to identify proteins, chemical compounds or DNA and historically haven’t been enforced as rigorously as FDA-approved in vitro diagnostic tests.
As LDTs have proliferated, the FDA has acknowledged that the lack of regulation could lead to some risks, including false results and data, which could lead to patients not receiving the correct treatment. The agency has listed heart disease, cancer, autism and conditions that require antibiotics as some of the areas that have a risk of being impacted by faulty LDTs.
The VALID Act would create a new category of medical products under the FDA’s oversight, including in vitro clinical tests made in medical device companies or private labs, as well as a process for the FDA to regulate these tests.
“The FDA must be able to take appropriate action against problematic tests,” Gottlieb argued.
However, not everyone is throwing their support behind the FDA’s initiative to overhaul the regulation of diagnostics. Laboratory groups like the American Society for Microbiology have expressed opposition to certain aspects of the bill, and some groups have been lobbying to halt the legislation.
“If enacted, this legislation could have significant impact on clinical microbiology laboratories,” the ASM said in a statement. “One size does not fit all when it comes to diagnostic testing, and it is crucial that the needs of infectious disease and academic, nonprofit and other non-commercial laboratories be taken into consideration.”
The ASM outlined several concerns — including the impact of fees linked to test reviews, which it claims “would be devastating financially” to laboratories. It also indicated that increased regulation would lead to “significant time and personnel burden on laboratories that are already stretched thin and short-staffed.”
Other industry groups support the general roadmap of the bill, but have offered recommendations for policymakers to tweak it.
“We believe the VALID Act is the only viable piece of legislation addressing the LDT issue,” Emily Volk, president of the College of American Pathologists, wrote in a statement. “In addition, we believe it is very likely the VALID Act will eventually be enacted into law… It’s a product of over four years of multi-stakeholder input.”
Volk added that CAP anticipates the VALID Act will be formally acted upon by the Senate HELP Committee soon and that the organization is committed to working with other laboratory groups to ensure the government “gets it right.”