Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -67

Accepted - Volume 1

Comment Record
Commentor Mr. LEE PERRY Date/Time 2002-05-29 17:27:25
Organization Mr. LEE PERRY
Category Academic

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? INDIVIDUALS HAVE THE RIGHT TO ACCEPT OR REFUTE COMMENTS POSTED ON LABELS. THE FDA IS WELCOME TO INCLUDE THEIR OWN CODICLE THAT THE PROJECTIONS NOTED IN THE ABOVE STATEMENT (MENAING ANY MADE ON A BOTTLE OF SUPPLEKMENTS) IS NOT SUFFICIENT PROVED BY CONTROLED CLINICAL TRIALS OR SOMETHING TO THAT EFFECT, BUT TO DENY THE RIGHT TO CLAIM A POSSIBILITY IS AN INFRACITON OF OUR MOST VALUABLE AMENDMENT. BY DENYING THE RIGHT TO POST POTENTIAL BENEFITS OF A SUBSTANCE THE FDA CALLS THEIR MOTIVE TO QUESTION.

EC -67