The U.S. Food and Drug Administration (FDA) proposed a rule that would bring laboratory-developed tests under its regulatory authority, a decision that the Trump administration opposed during the COVID-19 pandemic when the agency wanted to regulate COVID-19 tests.
Lab-developed tests (LDTs) are services developed by clinical labs and hospitals. Such testing services aren't commercially manufactured and marketed. Instead, they're designed, manufactured, and used within a single laboratory, intended for clinical use.
These tests are used to measure or detect substances or markers in the body such as glucose, proteins, cholesterol, or DNA, according to the FDA.
Safety ConcernsThe FDA’s rule “is aimed at helping to ensure the safety and effectiveness of these tests, which are used in a growing number of health care decisions and for which concerns have been raised for many years,” the agency said in a Sept. 29 announcement.
“The agency has become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests and others complying with FDA requirements,” the statement reads.
The agency is also worried that “patients could initiate unnecessary treatment, or delay or forego proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death.”
The Trump administration had strongly opposed FDA regulation of lab-developed tests. In 2020, when the COVID-19 pandemic broke out, labs had to secure emergency use authorization from the FDA to develop and use their own COVID-19 tests.
In August 2020, the Trump administration lifted this requirement.
Those in favor of the move pointed out that the FDA’s review process for COVID-19 tests slowed down testing in the initial period of the pandemic.
FDA’s New RulesIn its Sept. 29 statement, the FDA pointed out that many lab-developed tests in the 1970s and '80s were lower risk and conducted in small volumes. Historically, the FDA “generally has not enforced applicable requirements” on laboratory-developed tests. However, such tests are now used “more widely, for a larger and more diverse population.”
“A growing number of clinical diagnostic tests are being offered as laboratory developed tests without assurance that they work. The stakes are getting higher as these tests are increasingly being used to drive treatment decisions,” FDA Commissioner Dr. Robert M. Califf said in the announcement.
He noted that 70 percent of medical decisions in the current age depend on laboratory test results.
“Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health,” Dr. Califf said.
The agency stated that it's aware of lab-developed tests that could have led to cancer patients being exposed to “inappropriate therapies,” patients receiving improper treatment for heart diseases, and incorrect diagnoses of diseases such as Alzheimer’s and autism.
Lab-developed tests are classified as in vitro diagnostic products (IVDs). The proposed rule would amend FDA regulations to “make explicit” that IVD devices come under the Federal Food, Drug, and Cosmetic Act.
This amendment would apply even when the IVD manufacturer is a laboratory. The agency intends to boost its oversight of lab-developed tests.
The proposed rule would thus allow the FDA to treat tests made in labs like medical devices, ensuring that it has regulatory authority over them.
FDA Overstepping AuthorityThe advocacy group Center for Science in the Public Interest (CSPI) welcomed the FDA’s newly proposed rule, stating that oversight of lab-developed tests would “ensure reliable results.” The group applauded the agency for proposing registration and listing requirements for tests, which usually exist for all other medical devices.
It also praised the FDA for including tests for rare diseases in its proposed regulation, as this would ensure that patients with such illnesses are “equally protected from inaccurate tests.”
“This rule is a critical step forward for clinical medicine,” said Dr. Peter Lurie, CSPI president and a former FDA commissioner. “It will help ensure that when a patient receives a test, they can rely on the results to make essential decisions for their health. This rule will close a gaping hole in FDA’s current regulatory reach.”
“LDTs are not medical devices,” it stated.
The FDA’s authority should only exist within a regulatory framework that is in compliance with the regulation already in place, the ACLA insisted.
“Any expansion of FDA’s role in this framework should be tailored by Congress to fit LDTs, just as has been done for food, supplements, drugs, and cosmetics—each of which has a distinct framework suited to the unique characteristics of its category,” it stated.
“We also are concerned that FDA is already under-resourced and not prepared to complete all of the new work the Agency has now proposed to undertake. FDA seriously risks falling behind on its current public health priorities.”
In 2014, the FDA published draft guidance on regulating lab-developed tests, but the agency pulled back because of strong industry opposition.
Then in 2018, lawmakers began work on bipartisan legislation to establish a new regulatory framework for lab-developed tests under the FDA, but the bill hasn't progressed.