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Oct 14, 2024

CAP, ADLM, NILA caution court in FDA LDT decisions | LabPulse.com

The College of American Pathologists (CAP), Association for Diagnostics and Laboratory Medicine (ADLM), and National Independent Laboratory Association (NILA) added to the medical laboratory

The College of American Pathologists (CAP), Association for Diagnostics and Laboratory Medicine (ADLM), and National Independent Laboratory Association (NILA) added to the medical laboratory industry's case against new laboratory developed test (LDT) regulations by filing amicus briefs October 7 in U.S. District Court.

In slightly different ways, the briefs support plaintiffs that have filed lawsuits -- the Association for Molecular Pathology (AMP) and the American Clinical Laboratory Association (ACLA) -- over sweeping regulations imposed by the U.S. Food and Drug Administration (FDA) that are seen as a huge setback for lab operations, patient care, and medical testing response.

The briefs assert the same point, however, CAP President Dr. Donald Karcher told LabPulse: that the FDA acted arbitrarily and capriciously, and the final rule should be vacated and implementation stopped. CAP has further taken the position that the court simply stop there.

"Our Number One motivation in all of our positions on LDTs is ultimately to protect patients," Karcher said. "The court does not have to make any ruling on whether or not the FDA has the authority to oversee laboratory developed tests; that's not necessary."

Dr. Donald Karcher.

At least four types of medical laboratory tests are in jeopardy with the FDA's new LDT regulations, according to the organizations:

In yet another issue, "sometimes a test becomes impossible to conduct as designed," ADLM's brief stated. "For example, shortages or supply chain problems may require sourcing a particular reagent or collection device from a different vendor or substituting a different chemical in its place. Similarly, the failure of older lab equipment for which replacement parts are no longer available may require the substitution of new equipment."

Even exemptions to the FDA's LDT final rule do not do much to ease the regulatory burdens.

"The FDA was moving in the right direction," Karcher told LabPulse, "but we don't feel that they went far enough." The provisions are too opaque as to what truly qualifies for continued enforcement discretion, he added.

In reality, many clinical laboratories will be unable to rely on FDA’s nonenforcement policies because the policies explicitly permit continued enforcement at FDA’s discretion and are so confusing and underinclusive that they make the risk of missteps (and prosecution) unacceptably high, CAP's brief said.

CAP also cautioned the court that suggesting that laboratory testing involves the practice of medicine would raise difficult questions regarding the necessary scope of practice under state law and reimbursement under the Medicare and Medicaid programs.

"It's not necessary [for the court] to raise the issues of whether or not laboratory tests themselves represent the practice of medicine," Karcher explained. "The tests themselves do not represent the practice of medicine. Developing the tests also does not represent the practice of medicine.

"What laboratory directors -- pathologists and non-(MD) pathologists as laboratory directors -- do is clinically very important; however, the test itself does not represent the practice of medicine.

"If the federal court declared that laboratory developed tests represent the practice of medicine, that could very significantly lead to unintended negative consequences in terms of scope of practice, even payment for medical services, and it would certainly mean that nonphysicians who are not licensed to practice medicine could not develop LDTs," Karcher explained for LabPulse. "We're arguing the court should avoid that."

The CAP further advised that the court should avoid implying that Clinical Laboratory Improvement Amendments (CLIA)’s existing regulatory framework renders additional FDA involvement in this area unnecessary or inappropriate.

"As noted already, the CAP believes that the optimal framework for LDT regulation would involve both FDA (with its expertise authorizing highly complex tests) and CMS (with its expertise overseeing laboratory operations more generally)," the brief stated.

Instead, CAP has advocated for the adoption of a new statutory framework for LDT regulation, Karcher added. Moreover, the CAP has supported the Verifying Accurate Leading-edge IVCT Development, known as the VALID Act (a new version is forthcoming, Karcher said), that would authorize the FDA to regulate only a small percentage of LDTs in "a very focused way."

Amicus curiae documents are written as advisements to the court. The briefs address two lawsuits that were filed -- by the ACLA and the AMP -- to vacate FDA's umbrella LDT oversight through a summary judgment.

ADLM's and NILA's brief, also filed October 7, in collaboration with the Association of Bioanalysts (AAB), American Society for Clinical Pathology (ASCP), American Society for Microbiology (ASM), and Infectious Diseases Society of America (IDSA), requested summary judgment and emphasized that regardless of the FDA's new policies, clinical laboratories are not operating outside of the law in relation to LDTs.

"The relevant federal law is the CLIA, administered by the Centers for Medicare and Medicaid Services, not the [Food, Drug, and Cosmetic Act] FDCA," the combined ADLM-based brief stated. "CLIA is tailored to the unique nature of LDTs," and "Congress has repeatedly declined to expand FDA jurisdiction to include LDTs, despite several opportunities to do so. Congress has consistently affirmed CLIA as the appropriate framework for regulating clinical laboratories and their practices."

The ADLM-based brief also noted the unmet need exception for testing services performed by integrated healthcare system laboratories.

"Laboratory Directors operated by integrated healthcare systems have been contacting legal counsel in an attempt to determine their liability if the FDA challenges their medical determinations of 'unmet needs,'" the filing stated. "Some directors have expressed concerns about certifying that an LDT would address an unmet need given the professional and personal risk that they would incur if the FDA disagrees."

ADLM's brief also raised concerns about the unmet needs exception and sustainability of specialty laboratories that offer large menus of niche LDTs.

The organizations' amicus briefs were filed in the Eastern District of Texas Sherman Division.

Read the CAP's full brief on its website here.

Find the brief filed by the ADLM and NILA, with the AAB, ASCP, ASM, ASCP, and ASM here.