2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC12
Submitter : Mr. Stewart Ferry Date & Time: 05/11/2004 06:05:33
Organization : California Neuroalliance
Consumer Group
Category :
Issue Areas/Comments
Health outcomes research should consider the full range of health care interventions and evaluate total health care costs or savings over the length of a treatment horizon, not just the costs of specific treatments.

Patients have unique medical needs that are not reflected in population-level research. Government health outcomes research should be just one tool to inform doctor-patient decision-making. Clinical judgment and patient choice, within the bounds of acceptable medical practice, must always be the overriding force in decisions about individual care.