Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -80

Accepted - Volume 1

Comment Record
Commentor Mr. William Drake Date/Time 2002-05-30 18:07:04
Organization N/A
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 questions that are being asked are more detailed, and require more knowledge than I have. Therefore, I am not comfortable trying to address those issues, individually. However, having said that, I do have a general comment. I am a consumer. I am not a scientifically oriented consumer. I am not a particularly specifically educated consumer, that is, I have no field of specific expertise. I rely on regulatory agencies to ensure that I am not misled, that I am not lied to on labels or through advertisements. That I am provided with the information that I need to make an informed judgment and/or decision, and only the information that I need (not puffery to imply that a product does something that it can not, nor was not intended to to do). I prefer to rely on Federal regulatory agencies, since I believe they are more likely to be independent that are State or local regulatory agencies. I recognize the importance of free speech, and of commercial speech. But I also recognize the general lack of ethics in the business community, the general lack of a conscience on the part of most corporations and businesses. One of the major roles of a Federal Regulatory agency (State and local, too, but I will defer) is to serve as the conscience for businesses, industries, etc., over which it has legal jurisdiction (and perhaps, even those where there is not specific jurisdiction). There is an adage to the effect that sometimes, you have to fight fire, with fire. If a company or industry oversteps common sense ethical bounds, in their advertising and/or labeling (and it is done daily, continually), the regulatory agency should, if nothing else, take to the Bully Pulpit, to inform the general public of the nature of the business, and the nature of the problem. Hopefully, the regultory agency can rely on established regulations to gain compliance (honesty, forthrightness, etc,), however, as I said, there is always public shame. I see nothing wrong with a regulatory agency being sued by a producer, etc., for taking action to inform and protect consumers.

EC -80