Devices

FDA LDT Enforcement Policy Update

David McFarland

— 1 min read
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Akin Gump attorneys say several recent FDA actions indicate a change in the agency’s enforcement discretion policy for laboratory-developed tests (LDTs). Writing in an online post, the attorneys say the agency recently issued a Warning Letter to a laboratory advising it to seek marketing authorization for its genetic tests that qualified as LDTs and until now were subject to agency enforcement discretion.

“FDA’s action evinces particular concern with the clinical validation of high-risk tests that purport to predict a drug response that may be inconsistent with FDA-approved drug labeling,” the post says. The attorneys say that the Warning Letter and recent agency attention to “cloud-based” labs demonstrate the limitations of the LDT designation for innovative test technologies.

The attorneys write that three aspects of activities conducted by the laboratory that received the Warning Letter likely contributed to FDA’s decision to issue it: 

  •          lack of clinical validity, including for treatment recommendations that contradicted approved drug labeling;
  •          provision of the test results directly to patients; and
  •          the laboratory’s refusal to implement changes in response to FDA’s initial communications.

Following issuance of the Warning Letter, the post says, the laboratory stopped offering the tests.

“Although the Warning Letter may signal a greater willingness to enforce in the LDT space generally,” the attorneys write, “the facts in this particular case made these tests especially ripe for agency attention. The Warning Letter and associated safety warning do not necessarily mean that all developers of laboratory tests face heightened enforcement risk, but laboratories and test developers may consider ways to limit their exposure to risk. The Letter indicates that FDA is concerned about two types of tests: (1) tests that have not been validated, but that recommend medications in a manner consistent with the drug’s FDA-approved labeling; and (2) tests that have not been validated and recommend medications in a manner that is inconsistent with the drug’s FDA-approved labeling. For both types of tests, conducting studies to establish the test’s clinical and analytical validity would limit risk exposure.”

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