Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -213

Accepted - Volume 4

Comment Record
Commentor Mrs. vicki kacalek Date/Time 2002-07-26 11:01:30
Organization none
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 believe speech in regard to drugs should be regulated more than suppliments because of the toxicity of drugs as opposed to food supplements. Herbal remedies and such that could have a toxic effect should be regulated -not banned-but should have to state that it is possibly dangerous. Yes, the FDA could sustain a position that certain promotional speech about drugs is inherently misleading unless it complies with FDA requirements as long as those requirements aren't so stringent as to totally hamper any positive speech about a drug. While it's important to require absolute truth in a statement-making them declare many disclaimers or 'doublespeak'to get around regulations is very confusing for the consumer and may make consumers shy away from a very good product. Speech made to learned intermediaties should not be as stringently regulated as to unlearned consumers. Someone who has knowledge can be much more discerning than a consumer without. Speech to the consumer should also carry with it the knowledge needed to discern (as much as possible) that the learned intermediaries would already have. I've found that people have heard so many times about a drug or supplement that should help this condition or that and then later is proven to be harmful that they are very skeptical and afraid to try things. If labeling stated side effects or that there has been no testing for safety would be helpful. At least they'd know the risk they are taking.
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 the advertisements I've seen are confusing at best, and worthless for the most part. Many many times they don't even state what the medications are for-just use them! How is an untrained public to discern them? Then they are followed by all the risks associated with the drug. We often laugh after a commercial thinking why would anyone in their right mind change their symptoms for the side effects? I do not like the advertisement of drugs on TV or magazines. I think they could influence a person to insist on a certain advertised treatment rather than follow the recommendations of a doctor prescribing medication he or she is more familiar with.
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'm not very knowledgeable about this... But definately, consumers approach claims about conventional foods and dietary supplements differently. A quick look on a grocery store shelf is all most give to product labeling of foods...it is not a life or death situation after all. Supplements on the other hand, I find people to be much more discerning about. They will at least read the claims or the research and weigh whether they want to put the effort into taking them-weighed against the symptoms they're experiencing. I've found people to be very leary of suppliments..
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? Just from my experience, I would expect and want the disclaimer to be in smaller letters but right with the claim. Not too small to read for older people. I don't want to have to hunt for it, because they can be made very hard to find if allowed to ....
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 am more prone to believe a warning specific to that product than a general warning I see everywhere. Make it seem like some thought was put into it...like: Though many have seen improvement with arthritis, results are not always consistent between people. Or: Results may vary as each individual may need different dosages. Or: While many have had help with this supplement some individuals have had no significant results. If infact the research shows this, tell us so we know what we're working with and can make thoughtful choices rather than 'I hope it works so I'll try it' or 'I wonder what was wrong, I see no results'- leaving the consumer in limbo just trying things here and there and soon getting tired of the whole thing. Bottom line-just be truthful. I realize it is hard to put in writing regulations mandating truthfulness in a society where people believe it depends on what you mean by 'is'. Truthfulness by present knowledge should always be the litmus test.
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 don't have scientific evidence but I believe labels and advertisement should be equally informative. sometimes the label is the only advertisement/information a person gets.
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? If I'm understanding this issue correctly, I can't imagine why a drug could be advertised for uses other than what the FDA has approved it for. Isn't that the purpose of FDA approval? to check if it is valid to use for a certain condition?, not just if it's something that shouldn't kill you?
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'm most familiar and most interested in the supplement industry. I have been very pleased with the DSHEA law which allows education of people but regulates sales at the same time.. I have seen many times where this allows the evidence to be given to people but the hipe and hard sell kept out. Even tho the public is not used to researching and investigating and having to make their own decisions about health issues, and it is very hard to 'sell' them this way on a proven product, I see too many instances where unscrupulous people (whether they are aware of being unscrupulous or not) could take advantage of very sick people if allowed to use the education to sell. It allows information to be attained for those who want it yet is a safeguard for that information to be skewed or distorted to push a certain product.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I think the advances made by DSHEA should absolutely be safeguarded. I believe also if scientific evidence clearly shows a food supplement does indeed make significant positive changes in a particular health condition it should be allowed to state it as such. But there better be good research to back it up.




EC -213