2004S-0170 - Medicare Prescription Drug, Improvement, and Modernization Act of 2003, Section 1013: Suggest Priority Topics for Research
FDA Comment Number : EC39
Submitter : Dr. ANN ROSE Date & Time: 06/07/2004 07:06:51
Organization : Dr. ANN ROSE
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Rx drugs are one of the most cost-effective means to reduce the cost of health care and to our GNP... keeping people productive, including the elderly. However the population selected for clinical trials do not include the elderly unless the drug is esxclusively marketed for this population. yet we know many of the diseases/conditions of the elderly are the same as for the general population. Similar to the case of drugs used in children, the physiology of the elderly may differ significantly from that of the general population on which these drugs were tested in clinical trials.The dosage, route of administration, etc. should be determined as well as a notation if the drug should be used at all in this population. Some very potent drugs, e.g. Cipro can kill the condition but also the patient when it is administered to a fragile elderly person.

I strongly believe a recommendation of this group should urge pharmaceutical, device and biotech firms to include testing of new compounds/devices in the elderly population if that drug or device might reasonably be expected to be used in the elderly population, e.g. cardiovascular, CNS, etc.