This month, lawmakers introduced a bill that would vastly change the oversight system for diagnostics in this country and give the U.S. Food and Drug Administration explicit authority to regulate tests developed by labs.
The bipartisan sponsors of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act have claimed that their legislation will streamline regulations and speed access to tests in public health emergencies like the present COVID-19 pandemic.
However, it is an odd time to advance a bill that would place the FDA at the helm of an entirely new oversight framework for diagnostics, since some public health and lab industry experts are blaming the agency for over-regulating labs and hampering early efforts to track how the SARS-CoV-2 virus spread throughout communities.
Most industry observers are still considering VALID, but many remain concerned that in the hands of the FDA, the lab industry would be overburdened with regulation and no longer nimble in the face of advancing science or a sudden public health crisis. On the other hand, there are those like lab industry veteran Robert Boorstein, who pointed out that the supply chain issues hampering test roll out currently actually suggests the need for a centralized authority and more standardization. He believes that even if the FDA had allowed lab tests to enter the market earlier, it would not have helped with the present reagent shortages that labs around the country are facing.
The FDA and clinical labs have a contentious history. The FDA has always maintained it has authority to regulate all diagnostics, including lab-developed tests (LDTs). Meanwhile, the lab industry has argued that while the law allows the agency to regulate medical devices, the tests performed by labs are not devices but more akin to "the practice of medicine" outside of the agency's authority.
To further complicate matters, the FDA, while maintaining it has authority over LDTs, has exercised "enforcement discretion" over them, leaving oversight responsibilities to the CMS.
The CMS is responsible for ensuring labs meet federal laboratory standards outlined in the Clinical Laboratory Improvement Amendments (CLIA). That means that as long as LDTs are performed in CLIA-certified labs, labs can market them without first seeking premarket approval or clearance from the FDA. This has largely suited labs, since they believe that the FDA's device regulations do not address the work that they do and that the agency's policies would make it difficult to keep LDTs up to date with the latest science or emergent public health needs.
However, from time to time, when the agency felt that an LDT or a subset of LDTs puts the public health at risk, it required labs to either submit their tests for premarket review or to stop selling them. This piecemeal regulation has created an uncertain regulatory environment for labs for around three decades, say policy experts, and is at least part of the reason for the FDA's fumbles during the current pandemic.
"One of the problems of not having clarity upfront about whether an agency has authority to or will in fact regulate an industry is that it creates confusion, both within the government and by regulated entities, about who is or should be taking the lead, which prevents both industry and regulators from being nimble" said Gail Javitt, a director at Hyman, Phelps & McNamara specializing in FDA regulation for diagnostics, devices, and drugs. "Everyone is trying to figure out how to proceed while the clock is ticking."
Given the FDA's history of shutting down lab testing, when it became clear in January that COVID-19 had reached the U.S., lab professionals said they were hesitant to launch LDTs. They were unsure if the agency would practice "enforcement discretion." A few weeks later, the FDA made its position clear. After a faulty reagent hampered the rollout of the first test kits from the Centers for Disease Control and Prevention to public health labs around the country, the Association of Public Health Laboratories requested the FDA to practice "enforcement discretion" and allow its members to develop LDTs to meet testing needs. The agency declined, and subsequently highlighted the public health risk if results from tests deployed in an emergency are wrong.
In explaining how it regulates, the FDA often speaks of making a risk/benefit calculus. This involves weighing the public health gains from providing access to a healthcare product against the risks or potential harms if that product should malfunction. Its critics say the FDA failed to strike the right balance in the present public health crisis. The FDA, meanwhile, has repeatedly defended that it has been flexible with regulations and has worked closely with labs and commercial manufacturers to expedite test access and approve EUAs the same day or even faster.
In the past, the FDA has rationalized that it was restricting access to certain LDTs in order to prevent public harm, Javitt said, but "this episode shows, there can also be significant harm to public health from preventing access."
At a clinical lab industry meeting earlier this month, FDA Commissioner Stephen Hahn said that there are lessons in the present public health crisis about how the agency should balance patient access and safety in regulating tests going forward. The next day, Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) introduced the VALID Act.
When the bill was released on March 5, Bucshon argued that during a public health crisis the government must act quickly to ensure hospitals and labs can develop tests to identify those infected and stop the spread of the virus. He added that VALID "will overhaul the federal government's outdated system that is slowing down our ability to respond to these threats."
The framework described in the bill features new mechanisms such as technology precertifications and broad grandfathering and exemption criteria aimed at streamlining the regulatory process and making regulations less burdensome for labs. Importantly, the legislation, which was heavily influenced by the FDA, would end uncertainty around "enforcement discretion" by categorizing all diagnostics, including LDTs, as in vitro clinical tests (IVCTs) and bringing them under the agency's oversight.
Experts in the lab and pathology community, preoccupied with responding to the public health crisis, have not had much time to respond to the bill. Given how much criticism has been volleyed at the FDA for its handling of the coronavirus testing rollout, a bill that would give the agency explicit authority to oversee all tests in emergencies and non-emergencies may not have an easy path through Congress, particularly in an election year.
"There is a risk that this bill could be politicized. Right now, the clinical labs themselves are focused on developing and distributing coronavirus tests, and making sure tests are done correctly and the results are quickly reported," warned Amy Miller, a diagnostic policy expert and CEO Society for Women's Health Research.
"We're seeing the different parts of the lab industry in the public eye now. The CDC and public health labs are different from [large reference labs like] Quest and LabCorp, which are different from other academic and community labs. They operate differently and have different capacity," she said. "The [impact] of this bill on the broader industry truly needs to be thought through."