Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -298

Accepted - Volume 4

Comment Record
Commentor Mr. Grant Bennett Date/Time 2002-07-31 00:02:47
Organization individual
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? I think that companies that have natural health products that are proven effective and backed up with documented medical studies should be allowed to make medical statements within reason that the products can enhance or maintain good health ect.
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? I think there needs to be regulation to determine which medical suppliments are truly effective in helping with improving health or curing disease, and regulating drug companies so they don't continue to produce ineffective toxic drugs with unproven medical studies and effidence to attempt to validate the drug products. and quit harassing alternative companies that may produce effective alternative natural products.
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? I think labels on products should be more honest about actual ingredient content, and easier to comprehend or interpret by the general public. Labels should be simple and straightforward, period!
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 think they should be in larger type and understandible so comsumers would pay attention to them.
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? Again, as I stated earlier, labels need to be simple, honest, and understandable, it would prevent alot of confusion and inattention on the part of consumers.
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? Not sure, but it angers me that drug companies are trying to use first ammendment rights for their own advantage while at the same time trying to restrict alternative companies form exercising their rights. alternative companies are not allowed a voice.
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? Again, I think there needs to be more regulation to insure that product labels need to be honest and less confusing in their labeling!
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? No, currently, they are confusing at times and the FDA allows drug companies to have free reign on first ammendment rights where as alternative health companies are restricted!
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Yes, I am appalled that bigh drug companies are allowed to advertise their toxic medicines on TV with all the commercials with their disclaimers, yet natural health alternative companies are not allowed to advertise allowing the general public an alternative choice!

EC -298