Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -119

Accepted - Volume 2

Comment Record
Commentor Mr. Ian Rossman Date/Time 2002-06-05 21:53:03
Organization Mr. Ian Rossman
Category Individual

Comments for FDA General
Questions
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? Both the public and the health care professionals that serve the public have the right to know the benefits and risks associated with pharmaceuticals. The FDA is the governing body that safeguards this right, and altering FDA guidelines in any way, under the guise of First Amendment rights, would undermine this organization's authority. Statements about pharmeceuticals must be based on facts obtained by clinical trials published in peer-reviewed journals. Without these checks and balances there would be more flagrant, and dangerous, misuse of pharmaceuticals that could ultimately lead to unnecessary health risks monetary losses at the consumer level.




EC -119