Agency actions limit clinical information for physicians and patients, undermine Congress and ongoing diagnostic reform efforts
Washington, D.C. – In response to the U.S. Food and Drug Administration (FDA)’s troubling actions against pharmacogenetic (PGx) testing, 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.
Highlights from the letter are included below.
- “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.”
- “FDA’s actions are not based on any new statutory authority, regulation, or even a guidance document.”
- “Moreover, LDTs are not medical devices and in recent years ACLA has been engaged in ongoing discussions with FDA and Congress on enacting a new statutory framework for diagnostic regulation. Now, in the middle of those discussions, FDA has effectively banned a critical subset of LDTs. These actions not only undermine progress in developing a comprehensive legislative solution but also amount to an inappropriate form of backdoor regulation of LDTs.”
- “FDA’s actions have the practical effect of taking away valuable tools that physicians rely on for making informed prescribing decisions. Given that physicians will be forced to revert to older methodologies (such as try and fail, try and maybe succeed) in order to make prescribing decisions without actionable genomic information, it is likely that FDA’s new policy will result in more patients receiving less than optimal medications or doses, with consequent safety and cost ramifications. Moreover, the Agency’s actions threaten to bring the pace of innovation and investment in PGx testing to a halt.”
To read the full letter, click here.
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