Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -54

Accepted - Volume 1

Comment Record
Commentor Ms. brian thayer Date/Time 2002-05-29 10:49:46
Organization Ms. brian thayer
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? Only prescrption drugs should carry mandated speech from the FDA. The administrative record should simply state that there is an inherent trust factor in prescrpition drugs due to the physician/patient/drug company relationship that is not present in the buyer-beware that consumers understand to be present in the off-the-shelf market. The consumer products industry is full of claims that consumers evaluate at arms length each day - supplements are in the same category. All the warnings in the world will not protect certain people from themselves. Consumers should be learned intermediaries through self-education and cautious or not put a foreign substance in their body. No amount of goverment mandated intrusive labelling requirements will affect that. Thank You

EC -54