Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -40

Accepted - Volume 1

Comment Record
Commentor Ms. susan Vandegrift Date/Time 2002-05-29 00:41:40
Organization Ms. susan Vandegrift
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? The role of the FDA is to evaluate the safety and effectiveness of pharmaceuticals. If the FDA can prove that a product is unsafe or innefective, it should do so and the product taken off the shelf. The FDA should not add disclaimers which serve to frighten consumers.
3. May FDA distinguish claims concerning conventional foods from those relating to dietary supplements, taking into account limits on claims that can be made about foods in the Nutrition Labeling and Education Act, 21 U.S.C. 301, 321, 337, 343, 371? What must an administrative record contain to sustain or deny claims on food labels? How can information best be presented in a succinct but non-misleading fashion? To what extent do assertions in claims need qualifications or disclaimers added to the label to avoid any misconceptions that consumers may draw? Is there a basis to believe that consumers approach claims about conventional foods and dietary supplements differently? The role of the FDA is to evaluate the safety and effectiveness of pharmaceuticals. If the FDA can prove that a product is unsafe or innefective, it should do so and the product taken off the shelf. The FDA should not add disclaimers which serve to frighten consumers.
4. Should disclaimers be required to be in the same (or smaller or larger) size of type and given equal prominence with claims? Is there any relevant authority or social science research on this issue? It is up to the manufacturer to truthfully state what is in a product. A manufacturer should be able to add factual information of possible benefits. For the FDA to add disclaimers is overstepping FDA boundries.
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? The requirement for approval is for PRESCRIBED new uses of a DRUG. To prevent the producers of dietary supplement from adding information about a product is restriction of free speech.
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? FDA speech-related regulations are gag rules which favor pharmaceutical companys and should not be allowed at all.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA disclaimers should be eleminated.




EC -40