After 30 years of wrangling with industry and Congress, the Food and Drug Administration (FDA) is in the formal process of trying to expand its authority to regulate lab developed tests (LDTs).
The agency is reviewing some 6,707 comments it received during the 60-day comment period, which ended on December 4. The FDA contends LDTs are medical devices subject to FDA authority under the Food, Drug, and Cosmetic Act (FDCA).
Two Regulatory Regimes
LDTs are tests used for collecting, preparing, and examining human specimens, like blood and tissue, to detect, treat, and prevent diseases and conditions. In vitro diagnostics (IVDs) are used for the same purpose.
LDTs and IVDs are both widely used in connection with a vast array of medical issues including, for example, cardiovascular disease, cancer, autism, and diabetes. The primary difference between LDTs and IVDs is that LDTs are “designed, manufactured and used within a single laboratory,” according to the FDA’s traditional definition, while IVDs, which are defined in FDA’s regulations, are manufactured by conventional manufacturers.
LDTs are largely regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). IVDs are regulated under the FDCA.
Many products manufactured by laboratories are “functionally the same” as IVDs. The FDA wants to “redress the [oversight] imbalance” between LDTs and IVDs to “protect the public health.”
Longstanding Issue
For years, the FDA has vigorously contended that LDTs are medical devices subject to the FDCA.
Facing fierce opposition, the agency has repeatedly capitulated. While arguing that LDTs are medical devices, it exercises “enforcement discretion” over them. Accordingly, except for certain high-risk products, LDTs have not been subject to FDA enforcement, including pre-market submissions, quality requirements, adverse event reports, and other medical device requirements.
The FDA’s proposal would amend agency regulations to make explicit that IVDs are medical devices, including when the manufacturer is a laboratory.
“The Proposed Rule, at least in part, is likely intended to prod Congress to enact legislation explicitly giving FDA authority to regulate LDTs as medical devices,” said Joel Zinberg, M.D., J.D., a senior fellow at the Competitive Enterprise Institute and director of the Public Health and American Well Being Initiative at the Paragon Health Institute, which published an analysis of the FDA’s proposal in a paper, “Unwise and Unauthorized: FDA Regulation of Laboratory Developed Tests.”
The preamble to the FDA’s Proposed Rule provides the FDA’s rationale for regulating LDTs.
“LDTs are generally, among other things, used more widely, by a more diverse population, with an increasing reliance on high-tech instrumentation and software, and more frequently for the purpose of guiding critical healthcare decisions,” the FDA stated.
Modern LDTs are increasingly complex, pose greater risks than older LDTs, cause harm, and there is no assurance they work. CLIA doesn’t substitute for FDA oversight, notes the proposed rule, and underlying these arguments, the FDA claims it has statutory authority to regulate LDTs.
Laboratories Are Different
The Center for Science in the Public Interest, AdvaMed, and others support the FDA’s effort.
Other players, including the American Hospital Association, National Independent Laboratory Association (NILA), and American Clinical Laboratory Association (ACLA), are opposed.
“FDA must overcome the fact that the FDCA doesn’t mention laboratories, laboratory services or LDTs and has many sections that appear contrary to FDA’s claim of regulatory authority,” Zinberg told Health Care News. Zinberg’s paper cites court decisions in Brown & Williamson Tobacco Corporation and West Virginia v. Environmental Protection Agency, for the premise that courts will not assume agency authority if the statute is silent.
Comments by the NILA and ACLA noted laboratories and commercial companies differ in function, and thus LDTs are not devices but “medical services” or “diagnostic tools developed and used in the context of patient care.”
FDA’s argument LDTs are unreliable, inaccurate, and harmful is based on weak evidence, says Roger Klein, M.D., J.D., chief medical officer of LabCorp and a policy advisor to The Heartland Institute, which co-publishes Health Care News.
“FDA has never shown systematic problems with laboratory developed tests or given reason to believe FDA intervention with LDTs would improve the quality of laboratory testing in the United States,” said Klein.
Regulation Stymies Innovation
Other commenters on the proposed rule contend current regulation is sufficient, that patient access to critical testing will be impeded, and laboratories will bear huge regulatory burdens.
Klein agrees with comments that more regulation will stifle innovation.
“Laboratories need to be able to develop, validate, and continually improve tests in response to advances in technology and medical knowledge. FDA regulation would end this typical practice, locking tests in place and preventing labs from meeting ever-increasing patient needs,” said Klein.
Comments expressed concern the FDA will be unable to hire qualified staff and does not have the capacity to review existing LDTs, let alone new LDTs.
“FDA lacks the resources to accomplish what it has proposed in a four-year timeline and perhaps ever. There are likely hundreds of thousands of LDTs in clinical use,” Klein said.
What’s Next?
FDA is “proceeding expeditiously.” A final rule could be published by April 2024. There is little question that any final rule will be litigated.
“Because FDA does not have sufficient enforcement capability, my guess is, many laboratories would not comply [if the rule is finalized],” said Klein. “This would undermine the regulatory framework and harm public perception of FDA’s effectiveness.”
Zinberg said “the current arrangement works reasonably well. Changes giving FDA authority over LDTs should come from Congress, which must ensure that proposals actually improve public health and preserve the development of life-saving innovation.”
Dvorah Richman, J.D. (dvorahrichman@gmail.com) writes from Fairfax, Virginia.
Internet info:
Food and Drug Administration, “Medical Devices; Laboratory Developed Tests,” Federal Register, October 3, 2023
Comments, “Medical Devices; Laboratory Developed Tests,”:
Joel M. Zinberg, M.D., J.D., “Unwise and Unauthorized: FDA Regulation of Laboratory Developed Tests,” Paragon Health Institute, November 2023