Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -121

Accepted - Volume 2

Comment Record
Commentor Dr. Marcia Smith Date/Time 2002-06-10 18:02:45
Organization Dr. Marcia Smith
Category Health Professional

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? Regulation of what is said about Drugs needs to be far more stringent than the regulation concerning Dietary Supplements. In general, there is a gigantic difference between the safety of dietary supplements and the safety of Pharmaceutical Drugs . It is imperative that there be ample educational information available on labels. It is very counter-productive to include the current phase This statement has not been evaluated by the Food and Drug Administration This statements misleads the public into thinking that the supplement may not be safe and implies that the FDA has the power to approve supplements which of course it does not under DSHEA. A supplement company should have the First Amendment Right to make any health claim that can be backed up by a balanced scientific study in accordance with DSHEA. The real issue with regard to supplements is the implementation of the Good Manufacturing Procedures which the FDA has been mandated to produce. The public can still be misled about the QUALITY of any given supplement because the required GMP guidelines have not been implemented.
7. Would permitting speech by manufacturer, distributor, and marketer about off-label uses undermine the act's requirement that new uses must be approved by the FDA? If so, how? If not, why not? What is the extent of FDA's ability to regulate speech concerning off-label uses? A manufacturer or distributor of dietary supplements should not be prohibited from off-label claims with regard to dietary supplements since the emergence of new information on the value of dietary supplements is occurring daily. Since the health of the citizens of the United States is in a tremendous state of decline, it is urgent that consumers have access to new information immediately. The current US consumer is quite sophisticated and generally has an ability to evaluate new information as it becomes available.
8. Do FDA's speech-related regulations advance the public health concerns they are designed to address? Are there other alternative approaches that FDA could pursue to accomplish those objectives with fewer restrictions on speech? The American People as a whole are more educated and discerning than they were 50 years ago. They should certainly have the First Amendment right to review information concerning dietary supplements.




EC -121