2005N-0354 Consumer-Directed Promotion of Regulated Medical Products; Part 15 Public Hearing
FDA Comment Number : EC352
Submitter : Ms. R. Moore Date & Time: 12/09/2005 11:12:10
Organization : Ms. R. Moore
Category : Individual Consumer
Issue Areas/Comments
Gentlemen, I vehemently oppose direct-to-consumer advertising of psychiatric drugs. Firstly, the pharmaceutical companies cite chemical imbalances in the brain; and these prescriptions are doled out WITHOUT comprehensive testing for these imbalances. Why? Because there ARE NO COMPREHENSIVE TESTS for chemical imbalances in the brain. In fact, there is no proof of chemical imbalances occurring in the brain. Secondly, consumers will go to their primary physicians (general practitioners) to get these prescriptions. This leads to prescribing without sufficient testing and diagnosis. Thirdly, the pharma companies say these drugs are safe. They are NOT safe. Even your agency admits their risks as you now have warning labels on the packaging. In addition,direct-to-consumer advertising and marketing leads to SELF-DIAGNOSIS. There are many conditions that mimic the so called symptoms of depression. Among them are: low blood sugar(hypoglycemia), hypothyroidism, chronic low blood pressure, lack of proper nutrition (virtually malnutrition), lack of energy due to no exercise (no oxygenation of the blood), insomnia leading to chronic tiredness, AND MANY OTHERS. Direct marketing to consumers to take a medication for a condition which has symptoms which are common to a host of possibly undiagnosed conditions, is IRRESPONSIBLE IN THE EXTREME. Although companies, like individuals have the right to free speech, pharmaceutical companies should NOT have the right to market a medication designed for a very narrow band of afflicted people to the mass, general public. Permitting them to advertise compounds that are seriously dangerous, leading to possible suicide according to your OWN mandated labeling, would be YOUR extreme irresponsibility. Truly, the buck stops with you. Make these companies sell their products through the proper channels - the doctors who may or may not prescribe them. These are not magic bullets for people to demand from their doctors. Thank you.