Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -201

Accepted - Volume 4

Comment Record
Commentor Mr. Andrew Klees Date/Time 2002-07-26 00:02:18
Organization Klees Remodeling and Restoration
Category Dietary Supplement Industry

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? Freedom of speech is inhibited by too many things when relating to the health and well being of society. We are becoming a nation that promotes lies and deceipt. Examples of this are in such rhetoric as the manner in which the questions of this comment form are written. Simple English is much better if you are not looking to confuse those of us with minimal educations. If the author of such material has the right to speak legaleese, one would believe that simple truth should be well accepted.
2. Is FDA's current position regarding direct-to-consumer and other advertisements consistent with empirical research on the effects of those advertisements, as well as with relevant legal authority? What are the positive and negative effects, if any, of industry's promotion of prescription drugs, biologics, and/or devices? Does the current regulatory approach and its implementation by industry lead to over-prescription of drugs? Do they increase physician visits or patient compliance with medication regimes? Do they cause patient visits that lead to treatment for under-diagnosed diseases? Does FDA's current approach and its implementation by industry lead to adequate treatment for under-diagnosed diseases? Do they lead to adequate patient understanding of the potential risks associated with use of drugs? Does FDA's current approach and its implementation by industry create any impediments to the ability of doctors to give optimal medical advice or prescribe optimal treatment? It is obvious that Drs. are not willing to prescribe proper medicine/supplements or talk against other medicine due to the fear of malpractice suits. This is not always the case, however it would behoove the FDA to look at the prescription related deaths in this country.
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? There is of course a basis to believe that consumers look at conventional food and dietary supplements differently. There is a strong trend moving toward the dietary supplement being health wise and food killing us. Where are the warning labels for the additives in food that are very harmful, ie: sugar substitue? I believe it turns to alcohol when it reaches a certain temperature. My soda (pop) has no label regarding this health issue.
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? I believe the tobacco warning on cigarette packs can answer this question. Do you smoke? Do you know anyone that does? Do you think they know what the lable says?
5. How can warnings be made most effective in preventing harm while minimizing the chances of consumer confusion or inattention? Is there any evidence as to which types of warnings consumers follow or disregard? I believe that there are few people, that I know, who actually take the time to read warning labels, unless they believe their headache, muscle cramps, upset stomach, etc. are due to the medication currently being used. The best way to make a warning helpful and understandable is to write it
6. What arguments or social science evidence, if any, can be used to support distinguishing between claims made in advertisements and those made on labels? Does the First Amendment and the relevant social science evidence afford the Government greater latitude over labels? If a lable or advertisement is true there is no reason to ask these questions. The First Amendment should be able to speak for itself.
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? Why is there a law that new uses must be approved by the FDA if the procuct in question is, for instance, a food supplement? I believe there is a lot of ego behind the FDA to assume such an omnipotent hold of non-side effect supplements.
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? If a product that has no known negative side effects is not able to be labeled to show it's potentially miriaculous effects public health concerns are not being properly or adequately addressed. If the FDA feels the need to determine the labeling of products it should study the empirical data for that product and accept the results.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? If there is empirical evidence to sustain a claim that any supplement promotes good health and helps to prevent disease as well as heal the body, that manufacturer or it's representatives should be allowed to state such fact.




EC -201