Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -296

Accepted - Volume 4

Comment Record
Commentor Mr. Grant Bennett Date/Time 2002-07-30 23:29:15
Organization Mr. Grant Bennett
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 in by documented medical studies or evidence should be allowed to make statements within reason that the products can help 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 effect in helping with improving health or curing disease and regulating of pharmasuitical companies to ensure they do not allow harmful toxic medicines on the market. on the other hand I think that fda should be more open into looking into alternative suppliments and products that might actually be good for people. And stop putting so many restrictions on companies that try to produce alternative treatments or medicines.
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 that labels on products should be more honest about actual oriduct content and easier to interpret and comprehend or understand by the general public. They should be simple and straight forward, 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 understandable so 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, understandable it would prevent alot of confusion and inattention. I think there is a direct corraliation between the complication of lables and consumer inattention or misuse.
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? No, I don't think in does and I am angry that pharmicutal companies think they can hide by the first ammendment yet comsumer or independent health companys are not allowed to exercise this rite.
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 regulation to ensure that product lables from all companies need to be more 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 at times I think they can be confusing at times and I the the fda allows drug companies have free reign on speech where as small 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 drug companies are allowed to advertise medcicines with toxic side effects and truly effective companies or alternative treatments are not allowed to have a voice, or allowed to give the general public an alternative choice!

EC -296