ACLA: “Deeply Concerned” by FDA Actions

Pharmacogenetic testing has the Association’s attention

In response to the U.S. Food and Drug Administration (FDA)’s troubling actions against pharmacogenetic (PGx) testing, the American Clinical Laboratory Association (ACLA) urged the agency to immediately reconsider and reverse its recent decisions in light of the significant harm and consequences to patient care. Taken together, FDA’s actions appear to signal a move by the agency towards an outright ban of PGx testing developed and performed by laboratories, to the severe detriment of health care practitioners and patients.

Providers rely on PGx tests to identify genetic markers and clinically actionable information that can anticipate a patient’s response to drugs based on well-documented scientific evidence. By helping providers pinpoint likely adverse drug reactions, PGx testing helps limit the significant costs associated with trial and error and supports a more efficient, patient-centered approach to care.

In a letter to the agency, ACLA points out that the FDA’s approach to PGx enforcement will result in unprecedented upheaval in patient care. By advancing regulatory action without public justification, rulemaking or stakeholder feedback, the agency’s actions will lead to far greater complications and costs for patients and the health system at large.

“ACLA is deeply concerned about FDA’s actions, which will have the practical effect of taking away actionable information relied upon by health care professionals every day to make informed prescribing decisions. This will negatively impact patient care and increase medical costs, especially in situations where there is not an FDA-cleared or approved alternative to a PGx test.”


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