Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -162

Accepted - Volume 4

Comment Record
Commentor Miss Nichole Rice Date/Time 2002-07-25 11:17:21
Organization Miss Nichole Rice
Category Health Professional

Comments for FDA General
Questions
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? I see no positive effects on an industry's promotion of prescription drugs, biologics and/or devices. These things all have side effects that work against the human body, not with it. Patients then need to take others drugs to combat the effects of the drugs they are currently taking and therefore a doctor's visit it required. Doctors then treat the patient for a disease that is not usually there, they are not treated for the illness they possibly have, and when they are treated they are given drugs which damage and cause the body more harm than good. There is no adequate treatment for under-diagnosed diseases. Patients seldom know all the risks involved with taking drugs unless they read the PDR, the doctors do not inform the patient of all the risks.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? A claim that a food supplement can benefit the human body should only be made when there is scientific proof to back up the claim.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? Disclaimers should be the same size type as the rest.




EC -162