The agency has issued a new guidance on laboratory developed tests (LDTs), even though a congressional committee challenged its legal authority to do. Action Alert!
Last month we told you how the powerful House Energy and Commerce Health Subcommittee took the FDA to task, saying that the agency’s proposal to put laboratory-developed tests in the same regulatory category as medical devices would put a stranglehold on innovation—and may not even be legal. LDTs are inexpensive diagnostic tests for patients that are developed and performed by local labs, and are the future of medicine, as the American Clinical Laboratory Association explains in great detail in its Citizen Petition to the FDA on LDTs.
On September 30, the FDA issued two draft guidance documents on LDTs. These documents confirm that the FDA does indeed plan to regulate LDTs as medical devices.
Even if it turns out that the FDA does have the requisite legal authority (and the subcommittee cast serious doubt on the matter), guidance is completely unnecessary anyway. LDTs are already regulated under the Clinical Laboratory Improvement Amendments (CLIA), which is overseen by Centers for Medicare and Medicaid, and does not require further FDA oversight. As the subcommittee stressed, the FDA’s proposal would virtually halt creativity and exploration in the rapidly growing field of individualized medical care.
The new guidance requires pre-market approval for many LDTs. This guidance has been stalled in the Office of Management and Budget (OMB) since 2010, but its publication comes after lobbying last May from the drug, device, and biologics industries, and more recently pressure from five senators.
Ask yourself: who benefits most from having the labs come begging the government to approve a new blood test before it’s placed on the market? Could it be the drug, device, and biologics industry—the heavy-hitters who are LDTs’ chief competition? Remember, there was no public health or safety incident that spurred the release of this guidance after so many years of sitting on the shelf—just good old fashioned cronyism, with industry making the government dance to its tune and help them secure the lion’s share of the market.
As we and other health advocates have stressed, such big regulatory changes require a formal rulemaking process. Of course, this is the very thing the FDA wants to avoid! Look at the benefits they get from not going through a rulemaking:
- They don’t have to solicit or listen to feedback and comments from citizens and stakeholders.
- They don’t have to perform an economic impact analysis.
- They get to skirt questions about the FDA’s statutory authority, their lack of informal outreach to lawmakers, and the lack of funding to pay for the agency’s increased regulation costs.
- They don’t have to explain their demonstrably incorrect belief that there are flawed LDTs on the market.
One of the immediate problems is that the FDA has significantly underestimated the number of labs negatively affected by the draft guidance. They estimated that 650 manufacturers would need to provide notifications for about seventeen LDTs each, but other estimates show that about 2,000 labs will feel the impact.
The first of the two guidance documents provides a framework for oversight of LDTs. It groups them into classes based on risk—the same framework used to classify medical devices. The classification guidelines are so broad that it will create tremendous uncertainty. Classes II and II (“moderate” and “high risk”) LDTs would require regulation, listing, and adverse event reporting, with a pre-market review to be phased in over several years.
There will be “enforcement discretion” for some LDTs—the FDA will determine on a case-by-case basis whether a pre-market review will be necessary for four groups:
- low-risk (Class I) LDTs,
- LDTs for rare diseases,
- “traditional” LDTs (older, grandfathered tests), and
- LDTs for unmet needs (when no FDA-approved or equivalent device is available).
But as we told you last month, “enforcement discretion” is an intentionally vague and dangerous term, since it offers no certainty that the manufacturer is fulfilling the guidance requirements or not—and that’s a recipe for FDA abuse, as we’ve seen from the agency time and time again.
Even worse, if a laboratory makes a “significant change” to the already-marketed, originally intended use of an LDT, the test will be considered a new LDT for the purposes of notification and pre-approval. This will absolutely throttle innovation: anything new or improved will automatically be placed in this expensive and burdensome new regulatory system.
The second guidance talks about the notification process that will allow the FDA to classify LDTs by risk-level. The FDA will require basic information about the laboratory, the volume of the test and intended use, any other clinical uses, any disease condition it might test for, the population that would need this test, etc. A full list of the data that will be required for each LDT from each laboratory can be found in Appendix A.
Action Alert! The comment period on these two guidance documents is now open, but with the elections coming up, it’s important that this not get lost in the shuffle—something the FDA is very much hoping will happen. Please tell the FDA how important LDTs are, and tell them to reject these guidances and instead go through a formal rulemaking process. Don’t let the FDA avoid its responsibilities to the American public. Don’t let them keep the voices of grassroots advocates like you from being heard. Send your message today!