| 2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research|
|FDA Comment Number :||EC11|
|Submitter :||Dr. Rene Rodriguez||Date & Time:||05/11/2004 06:05:20|
|Organization :||Interamerican College of Physicians and Surgeons|
|Health Care Association|
| The Interamerican College of Physicians and Surgeons, the Nation's oldest and largest national Hispanic medical society submits the following comments in relation to the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research. We believe the guidelines will ensure government-sponsored health outcomes research meets patients? needs and supports continued improvement in overall medical care.
Research should have as a major goal the elimination of health disparities.
Government priorities for research should focus on diseases that impose high clinical and economic burdens on patients and society, rather than being limited to high cost medical interventions.
The Government should conduct research in the context of overall health care quality improvement. Research should occur as part of a broad agenda to improve health care quality and patient outcomes across the health care system.
Efforts focused on cost-containment for one service or product alone (e.g., medications) often shift costs from one medical service to another without improving patient outcomes.
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.
Research also should evaluate the needs of patient sub-populations, who often respond differently to medicines and need a variety of treatment options/combinations for the best outcome.
Government decisions about the focus and design of research programs should be made through open, transparent procedures with the involvement of stakeholders, including providers, patients, and medical researchers. Findings should be communicated in an understandable way to stakeholders, including the range of peer-reviewed results on all treatment options.
Research should evaluate both the direct benefits and the indirect benefits of health care interventions, including quality of life, patient functionality and economic productivity.
The Interamerican College of Physicians and Surgeons believes the Government is well positioned to help design and support research programs evaluating the benefits and risks of medical innovations, evaluating prospectively the value of different types of medical evidence in different
| clinical settings, and identifying the best methods to rapidly and broadly disseminate knowledge of medical advances. Standards for evidence should be consistent, transparent, and objective; additionally, standards should be established independently of potentially conflicted parties, including payers.