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ACLA Urges FDA to Reconsider Recent PGx Enforcement Moves

This article has been updated to clarify the FDA's request to labs.

NEW YORK – The American Clinical Laboratory Association (ACLA) yesterday issued a letter to the US Food and Drug Administration urging the agency to reconsider its recent actions against laboratories, asking them to change the way they matket pharmacogenetic (PGx) testing and report results.

The letter raised concerns that halting PGx testing "will negatively impact patient care and increase medical costs" by taking from doctors information that could help guide drug prescribing decisions.

ACLA also positioned the PGx issue as part of the larger dispute around FDA's authority to regulate laboratory-developed tests generally, writing that "LDTs are not medical devices," and that the PGx bans "amount to an inappropriate form of backdoor regulation of LDTs."

While the FDA has to date largely exercised enforcement discretion and not regulated most LDTs on the market, the agency has consistently maintained that such tests fall within its purview. As an agency spokesperson described its position in a recent statement to 360Dx, "The FDA remains committed to pursuing legislation relating to in vitro clinical tests. In vitro diagnostics, whether they are LDTs or not, are devices within the meaning of the Federal Food, Drug, and Cosmetic Act, and therefore, they are subject to applicable device requirements under the statute and regulations. … Although the FDA has generally exercised enforcement discretion for LDTs, the agency retains authority to take action when appropriate, such as to address significant public health concerns."

The spokesperson added that the agency took action against certain labs' PGx testing upon becoming aware that healthcare providers may have inappropriately changed patients' medications based on PGx tests that claim to inform dosing or regimens of some antidepressants.

The recent FDA actions on PGx testing began with a safety alert the agency issued last November cautioning patients and providers against changing drugs based on PGx tests not approved by the agency. In April it sent a warning letter to Inova Health Systems, which subsequently stopped providing PGx testing, and since then it has issued letters and initiated interactions with a number of labs about their PGx offerings.

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