Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -171

Accepted - Volume 4

Comment Record
Commentor Mr. Wynn Fernandes Date/Time 2002-07-25 15:04:34
Organization Mr. Wynn Fernandes
Category Individual

Comments for FDA General
1. Are there arguments for regulating speech about drugs more comprehensively than, for example, about dietary supplements? What must an administrative record contain to sustain such a position? In particular, could FDA sustain a position that certain promotional speech about drugs is inherently misleading, unless it complies with FDA requirements? Does anything turn on whether the speech is made to learned intermediaries or to consumers? What is the evidentiary basis of such a distinction? I AM A MAN OF MODEST MEANS AND EDUCATION AND FIND SOME OF THE QUESTIONS DIFFICULT TO ANSWER PROPERLY. PLEASE ACCEPT THIS WRITING AS MY GENERAL COMMENTS ABOUT THE SERIOUS DILEMMA ALL CITIZENS FACE WITH HEALTH ISSUES. My family and I have had much success with dietary supplements that in effect have very positively influenced our health and well being. Please do not consider applying the same criteria for information to the dietary supplements industry as to the Drug industry. In speaking to relatives, neighbors and family, the opinions all seem to indicate the growing displeasure with our government that allows the drug companies' their continued financial and emotional rape of our ailing citizens. This applies to all our citizens and especially the aged who often have a limited fixed income and also have the greatest physical need for medications.
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? The same size
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? Doctors need to better inform the patients of the possible negative effects as well as the positive.

EC -171