Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -268

Accepted - Volume 4

Comment Record
Commentor Ms. Sarah Timme Date/Time 2002-07-29 16:29:20
Organization Ms. Sarah Timme
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? I am against any law that would regulate the public's right to purchase and consume any dietary supplement that is non-toxic regardless of the label printed on the bottle. I do not believe that the FDA could sustain a position that certain promotional speech about drugs, namely dietary supplements, is inherently misleading because the consumer who buys dietary supplements has most likely done the research behind the product anyway. The basis of most dietary supplemental labels state what the product COULD or MIGHT do, and leave the choice up to the consumer on whether or not to take it to help in an ailment. That choice is what I do not want to be taken away from the public or myself individually.
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 believe that the pharmaceudical industry stands to loose a lot of money if dietary supplements were introduced onto the open market and endorced by doctors. Consequently, neither the pharmaceudical or physician industry wants to endorce dietary supplements, if fact, even going so far as to try to discourage their use. I personally have gone in to the doctor once in the nine months since starting to take the supplements and my son has not gone even once as opposed to the every other month at least that I had to take him for ear infections, fevers, etc.!! Imagine if a doctor told all his patients about the supplements, pretty soon he'd have lost more than half of his business! The current drug industry promotes drugs like candy, and side effects have become the norm for society. Dietary supplements on the other hand have almost zero side effects, and they are more preventative, allowing the consumer to remain healthy for months and even years on end. Yes, I believe that the current drug industry over-promotes and pours drugs down inviduals that are scared into thinking that prescription drugs are the only means of curing their ailment. I do not endorse any law that would take away my choice to continue to take dietary supplements as an alternative source of health care.
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? Consumers have been led to believe that foods and drugs have two distict classes that cannot be merged. The dietary supplement strives to educate people on the necessity of eating and consuming the right foods to aid in the process of cell-to-cell communication. I think it would be a good idea to limit the speech that would guarantee the cure of a disease by a dietary supplement, yet still allow the wordage of the possibility of it helping the disease.
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 do not think that it matters what size type is used on a label. The point here is choice!!! The public should be allowed to choose what drugs, conventional or dietary, they would like to take. Personally, I don't care if the FDA has regulated the vitamins I take or not. I do my own research and find those supplements that I think would benifit me.
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? Warnings that I would pay attention to would be things that affect health, such as high dosages of iron, or over-dosing. In general, though, dietary supplements do not have these health risks in their products, being all-natural and non-toxic. The pharmaceudical drugs are the ones that have to be monitored so carefully and measured out. Dietary supplements are designed to work with our bodies, because they are made out of food. Most effective warnings?- the ones printed on the bottle.
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? I think that anything printed on a label or advertised should be backed by research and testing. Personal testimony should also be allowed a form of testing- you can't refute physical evidence.
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? What is the difference in the use of cornstarch on a bee sting and the use of dietary supplements to help aid in the healing of an ailment in a slightly different manner than printed on the label?? The FDA should regulate the actual drug- is it toxic?-is it poisonous?-it is proven to help ailments?-how much should you take? Dietary supplements really are in class of their own- they are non-toxic, all-natural, and have no set dosage, yet they have health benefits comparable to and beyond the pharmaceudical drugs. They should be regulated so as not to be a hazard to the public, but beyond that the choice should revert to the individual consumer as to how to take a dietary supplement.
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? I believe the only restriction on speech that should be made is that all statements should be true. If they are, then all the other issues will fall into place.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think that the American public should be allowed to purchase and consume dietary supplements without the restrictions of speech made on labels that would impede their search for an alternative medicine which could help to ease or elilmate an ailment. I believe in the freedom of choice!! If the FDA can regulate without infringing upon these freedoms, then it should continue without change. If not, then it should address those issues which are in conflict with the public's freedom of speech and choice.




EC -268