ASCP Opposes Laboratory Developed Test Proposed Rule

On December 4, ASCP opposed the U.S. Food and Drug Administration’s (FDA) proposed rule claiming oversight over laboratory developed tests (LDTs), which include tests developed within medical laboratories as well as FDA-approved tests that have been modified and validated by the laboratory. In a letter to the FDA, ASCP urged the Agency not to finalize its proposed rule.

ASCP has secured unanimous support from the American Medical Association’s (AMA) House of Delegates for our resolution urging the FDA to extend the proposed rule’s comment period (click here for more). ASCP also released several action alerts resulting in more than 1,700 comments sent to the FDA and more than 6,000 letters sent to Congress. We also worked with our colleagues in other pathology and laboratory medicine associations, which were almost universally opposed to the proposed rule.

In our letter, ASCP addressed the critical importance LDTs have on patient care, noting that some patients’ lives depend on access to such tests. For example, acute leukemia typically presents in the later stages of the disease, usually when these patients, including children, are facing a medical emergency. This requires prompt diagnosis and treatment, and without LDTs this may not be possible. LDTs are also critical to diagnosing other cancers, like lymphoma, as well as many infectious diseases and other conditions that may not be diagnosable with commercial, FDA-approved tests.

The FDA is proposing it provide sweeping regulatory authority over LDTs, stating that it plans to subject approximately half of all LDTs to premarket review. That amounts to 20,000 to 50,000 tests needing premarket review. ASCP expressed skepticism that FDA has the capacity to handle such a massive undertaking, given that the Agency approves fewer than 100 medical devices a year. ASCP argued that the FDA’s proposal would adversely affect patient care and undermine the specialties of pathology and laboratory medicine.

Because of the significant financial and administrative burden associated with the FDA proposal, ASCP argued that most hospitals, academic medical centers, and local/regional “laboratories will cease to provide LDTs or will drastically reduce their LDT offerings, which will, in turn, greatly restrict patient access to treatment and care.” ASCP argued that if the Agency moves to adopt the rule, even if substantially pared back, certain tests, like immunohistochemistry, flow cytometry, human leukocyte antigen (HLA) typing, therapeutic drug monitoring, and others, must be exempt from the FDA’s premarket approval or premarket notification requirements or patient care would suffer.

It remains to be seen when FDA will announce whether it will finalize its proposed rule. If it does move forward, some believe the final rule will be the target of a lawsuit challenging whether the Agency has sufficient legal authority to provide oversight over LDTs. ASCP will continue to follow this issue very closely.

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