FDA Proposal Could Limit Custom Tests for Patients

There’s a battle brewing between hospital labs and the FDA, and caught in the crosshairs are patients—the one group both sides say they are trying to help. At issue is how these labs are regulated, which has major implications for how quickly they can respond to new health problems, such as viral outbreaks.
Currently, the FDA does not regulate diagnostic tests developed within clinical labs, like those based at hospitals. The rationale is that these labs aren’t usually building their own tests from scratch, the way a commercial diagnostic manufacturer would; instead, they take existing laboratory tools—many of which are regulated separately—and combine them in various ways to learn something about a patient. Think of this as a restaurant offering a new dish: the chef can combine ingredients in lots of ways, as long as each of those individual ingredients is legal and safe for consumption. As it stands now, clinical labs are overseen by the Centers for Medicare and Medicaid Services (CMS), which requires ongoing testing to ensure that labs meet high standards for the quality of their work and the services they offer—not unlike the health department periodically showing up at a restaurant to make sure the kitchen is spic and span.
Clinical labs do a lot of important things, from identifying bacteria in a patient sample so doctors can choose the right antibiotic to analyzing genetic variants in a tumor to figure out which treatment might work best. Back in the ’70s when the FDA first decided these labs did not need its oversight, the procedures used were fairly simple. Today, many lab procedures rely on advanced software to process data and interpret results. That may seem like standard technology evolution to you, but for folks at the FDA, it introduces an uncomfortable “black box” element because people running the lab may not be fully aware of how the computation is being performed—which information it’s considering, how it’s calculating risk, and how it gets to a certain result.
Add to that an existing problem in the regulatory landscape: some commercial diagnostics developers have evaded FDA oversight by claiming to be clinical labs. These organizations should be subject to FDA review and have to submit their tests for review before they can be used, but this loophole allows them to manufacture and sell their tests without official approval.
Over the years, the FDA has made a number of attempts to shut down this loophole, with little success. But their latest effort could seriously affect patient diagnosis and health. Last month, the agency published its proposal for new rules that would bring clinical labs squarely under its purview, requiring them to adhere to the same standards that commercial diagnostics companies do now. That means all tests would have to be reviewed and approved by the FDA—a process that could take months or even years—before they could be used on patients.
Today, if a patient walks into a hospital with symptoms of a disease that’s never been seen before, or for which no commercial diagnostic is readily available, the hospital’s lab staff can generate a bunch of information about that patient’s health, even coming up with new technology combinations to look at genetic data, molecular data, or anything else they think might help confirm a diagnosis or guide treatment. Under the proposed rule, the lab staff would be limited to running previously approved tests. Even if they had a good idea of what to look for and had the technology to do it, they would not be able to, because doing so would count as a new test and the FDA would have to review it. That would almost certainly mean that fewer such tests could be conducted.
Predictably, clinical lab professionals are in an uproar. Commercial diagnostic developers have entire departments of people who handle FDA submissions; clinical labs may not even have enough money to hire a clerk to handle billing. At a meeting earlier this month of the Association for Molecular Pathology (AMP), many of the clinical lab members expressed their concerns to a panel of FDA employees leading the charge for this new proposal. They argued that the burden of having to submit all of these tests for review—some labs have hundreds of these procedures in place right now, all of which would ultimately have to be submitted to the FDA—would be devastating. In the best circumstances, they contended, the new rules would slow down development of new tests or discourage these labs from designing tests at all. Worse, they predicted that compliance would be so expensive that hospitals may shut down their labs or restrict which patients get access to these tests. They also took issue with the basis of the FDA’s argument, noting that tests that appear simple can require advanced skill to interpret, while those that involve computer analysis are no more difficult for a lab professional to validate and run.
The FDA panelists, for their part, said that they aimed to keep the bar for approval reasonable. Alberto Gutierrez, director of the Office of In Vitro Diagnostics at the FDA, said that it simply doesn’t make sense to hold clinical labs to one standard while holding commercial diagnostic developers to another. “I think anybody who’s honest will tell you that this dual path isn’t working,” he said. Their plan is to phase in regulations over time, starting with the tests they deem most risky for patients.
Another spanner in the works is that the group that currently oversees clinical labs is not giving up its jurisdiction so easily. A number of medical professional associations have publicly urged the FDA to abandon the new proposal, and some have even lawyered up to argue that the FDA does not have the right to regulate clinical labs since they’re already covered by CMS oversight. AMP took its argument to Congress this month, hoping legislators can sort out the territory dispute and keep the FDA out of the clinical lab realm.
The FDA will be accepting public comments on this proposal until the end of January. If you have an opinion to share, now is the time to let the FDA know what you think about these rules and how they might affect your life.