Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -397

Accepted - Volume 6

Comment Record
Commentor Ms. Sue Reilly Date/Time 2002-09-11 09:11:01
Organization Ms. Sue Reilly
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? The FDA should have as it's primary concern the health and welfare of the American People. So called free speech for corporations, giving those coporations the right to advertise drugs that haven't been tested or approved, is not in the best interest of the people. It is very simple, people first, before corporate profits. That's your job. You don't need a long form to figure it out. The health and welfare of the people first. Test and approve drugs before they are advertised. There are enough problems with many of the tested drugs.

EC -397