Comment from Chris Pratt

Formal Submission to the FDA: Reclassification and Oversight of Proprietary Risk Algorithms (NarxCare) Attention: FDA Dockets Management Staff Subject: Formal Objection to the Unregulated Use of NarxCare in Clinical Settings. I. Violation of the 2026 FDA "Medical Device" Final Guidance Per the FDA’s January 6, 2026, Final Guidance on CDS software, a tool is a regulated medical device if it obscures its logic or issues "time-critical directives" that a clinician cannot independently verify. The "Black Box" Violation: NarxCare’s proprietary scoring system is inaccessible to both doctors and patients, violating Criterion 4 (Transparency) of the 2026 Guidance. De Facto Directive: While labeled "advisory," NarxCare functions as a command. In pharmacies, a "high score" triggers an immediate block on care, overriding the physician’s good faith medical judgment. II. Conflict with Supreme Court Precedent (Ruan v. United States) The unanimous ruling in Ruan v. United States (2022) protects a doctor's subjective intent to act in "good faith." Algorithmic Coercion: NarxCare creates an environment of fear where doctors must choose between a computer’s arbitrary "risk score" and their clinical training. This allows an unregulated algorithm to criminalize legitimate care through automation bias. III. Violation of the ADA and 2022 CDC Admission of Harm Civil Rights: By using "proxies" (e.g., number of pharmacies or distance traveled) that penalize complex, disabled patients, NarxCare violates Section 1557 of the ACA and the Americans with Disabilities Act. Misapplied Metrics: The CDC formally admitted in 2022 that its previous rigid metrics caused "serious harm." NarxCare continues to bake these same discarded metrics into its risk scores. Conclusion and Formal Demand: We demand the FDA: Enforce Reclassification: Classify NarxCare as a Software as a Medical Device (SaMD). Order Transparency: Require that all patients be given immediate access to their score and the specific data used to calculate it. Audit for Bias: Conduct a formal Section 1557 audit to ensure the algorithm is not discriminating against patients with intractable pain.