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When the deadline for appealing the court decision which blocked the regulatory laboratory for the final rule of the Food and Drug Administration has developed tests as medical devices slipped in May without a word From the agency, industrial groups were relieved that the plan they pursued to stop was dead.
The American District District Court of Texas found the FDA attempt to extend jurisdiction over the LDT has exceeded its statutory authority. However, regulatory experts believe that the agency can still see the place to assert the authority over the LDT by other means. A recent warning letter To a diagnostic company points to an avenue that the agency could take, lawyers said.
“There is a certain uncertainty about the direction of the administration and the FDA, in its independent capacity, would like to continue,” said Steven Gonzalez, lawyer at Hyman, Phelps & McNamara.
The Trump administration, choosing to leave the decision standing, did not publish a declaration clarifying its position. A spokesperson for health and social services, responding to a Medtech diving survey, said the agency does not comment on the dispute.
The extension of the FDA jurisdiction on the tests offered because the LDT would have been a new major regulatory effort at a time when the administration reduces the resources of the FDA.
“It is certainly not difficult to assume that part of the story here was that this current FDA, the current administration, just wanted to go in a different direction from the FDA final rule,” said Scott Danzis, partner of the Covington law firm. “I also believe that the decision that was made was clear and strong and would have been difficult to overcome in a call.”
Congress has intentionally created a separate regulatory framework for installations that carry out test services, under changes in the improvement of the 1988 clinical laboratories, the court said in its decision. Clia is administered mainly by the centers for Medicare and Medicaid Services.
Food, Drug and Cosmetic Act of 1938, or FDCA, authorizes the FDA to regulate manufactured products, wrote the judge of the American district court Sean Jordan in his opinion, adding that the “FDA does not have the power to modify or extend the definition of the FDCA device”.
An indirect approach
Gonzalez said there are alternative routes to regulate the LDT that the FDA could borrow, where the agency has either caused sporadically implementing measures in the past, or suggested that it could do so. Such avenue could be by regulating the components of the device.
The FDA warning letter to a German diagnostic company offers an example of how the agency could continue a less direct path to regulate the tests developed in the laboratory now that the Court has canceled its attempt to expand surveillance, lawyers said.
The letter to the instruments DRG has raised the eyebrows among legal observers, as it focused on evidence of violations of unprecedented devices for a test that has been labeled for the use of research only, or ruo, but seemed to be intended for clinical diagnostic use. The letter of March 31, which the FDA published on its website at the end of May, said that DRG had sent products to several companies that only carry out a clinical analysis.
In his opinion, Jordan noted that the definition of the FDCA device includes instruments, machines, in vitro reagents, parts, accessories and other elements used in the diagnosis, prevention or treatment of the disease.
“This is certainly not the end of our discussion on LDTs and how they will integrate in the regulatory framework of the FDA, and we have a lot of questions when we expect to see how dust settles.”
Steven Gonzalez
Lawyer Hyman, Phelps & McNamara
The DRG warning letter calendar and the FDA inspection which led there, took place before the LDT decision of the district court and therefore does not seem to be a direct response to the order, said Gonzalez.
A year earlier, the agency has published a warning letter To another company, Agena Bioscience, for a similar situation, he noted. The FDA issued few warning letters on the Diagnosis Ruo. Together, the two letters of warning “are remarkable due to the lack of previous ruo letters,” said Gonzalez.
Danzis said that although the FDA is not competent on test services, such as the District Court, the Agency could still use its authority on the instruments and other physical objects used by regulated laboratories as devices.
The DRG letter, he said, is “due to an example of that”.
While waiting for the dust to settle
The FDA is interested in the marketing of a product which is supposed to be for research only, said Allyson Mullen, director of Hyman, Phelps & McNamara. And even with the agency’s staff changes under the new administration, the management of the division which examines the in vitro diagnoses remained the same.
“People who work on this problem are specifically those who have been playing in this role for a very long time,” said Mullen.
Beyond the question of Ruo Diagnostics, the FDA could also seek to define more clearly what constitutes a test developed in the laboratory, said Gonzalez.
LDTs are defined as internal diagnostic tests developed, validated and carried out by professionals trained within a single clinical laboratory. “But there is a certain place in this definition of uncertainty and questions,” he said, as “what exactly means being a single clinical laboratory?”
Some large companies, for example, have several laboratory locations that could perform identical or similar test protocols developed by one or more laboratories as part of this corporate umbrella. “Another ambiguity is, what does it mean to develop a test in one place?” said Gonzalez.
How the FDA will address the regulation of additional diagnostic tests and software used with LDTs are other persistent questions.
“This is certainly not the end of our discussion on LDTs and how they will integrate in the regulatory framework of the FDA,” said Gonzalez, “and we have a lot of questions while waiting to see how dust settles.”
The association for Molecular Pathology, one of the industry groups that brought a lawsuit against the FDA on the LDT regulation department, said in an e-mail that it promotes a structure based on the risks which avoids the duplication of activities within federal agencies.
AMP proposes to update clia regulations by congress rather than increasing the authority of the FDA.
“AMP has long recommended that the best way to guarantee the accuracy, reliability and the appropriate use of LDTs is to clarify the longtime regulations of the CLIA,” a spokesperson wrote. “”Our proposal Offer another legislative path that will expand Clia to ensure that high quality tests are maintained. »»
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