Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -190

Accepted - Volume 4

Comment Record
Commentor Mrs. Stephanie Reed Date/Time 2002-07-25 19:18:33
Organization Mrs. Stephanie Reed
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? By definition, all drugs in this country are toxic, whereas dietary supplements are generally non-toxic and are more food-like. We know that drugs all have side-effects and can easily be misused. As we watch the frequent revelations of another drug that was deemed safe to use now being found to be dangerous, it seems clear that we cannot afford to loosen any regulations regarding the use of drugs. In fact, I believe there have been too many drugs that were rushed into use and we need to do better at protecting the public. It is generally believed that the FDA is supposed to protect our citizens, but many of us are very disturbed about how much harm is still occurring, even with properly prescribed drugs. It seems to me that by allowing drugs to be advertised to the general public that we are encouraging the use of drugs. We often also find people requesting these drugs from their doctors and the doctors are often pressured into giving out prescriptions they would not have otherwise provided. This is usually not beneficial and mainly serves the bottom line of pharmaceutical companies and puts doctors in a difficult position. I believe we are on the right track in how dietary supplements are being regulated. Probably the bigger problem with supplements is that so many are not what they claim to be and are not a good value to the consumer. It supplements have sound scientific evidence of what they can do, I think that is information that should be available and appropriate claims should be allowed. Supplements are simply not the same thing as drugs and should be regulated in a way that is appropriate for them - not in a way that is best for drugs. We need to enforce the regulations that are currently in effect.
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 am against drug advertising to the consumer, but find it acceptable to advertise to medical professionals. The advertising tends to make drugs look safer than they are. I have found that doctors are not very effective at reviewing the drug risks with their patients. All too often it is after someone is having problems that they may finally learn the drug is the problem. Increasingly consumers are learning to educate themselves about these things, but there are still too many who do not take responsibility for their health as they should. More information is beneficial, at least to those of us willing to take responsibility. Since health care in our country has become such a burden, it seems to me that we need to look at changing directions. We need to learn to be more responsible - individually - and our government is in the position to encourage moving in that direction. If we stay locked into the program of mainly expecting drugs to fix what ails us, we are not moving forward to an enlightened approach of prevention and healthier lifestyles. The FDA comes across as being most interested in promoting drugs and trying to discourage the use of supplements. I believe this to be the wrong direction and hope we can stay open to what truly supports optimal health.
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? If a manufacturer wants to make a claim on a food label, it should be subject to the same rules as supplements. We still do not have complete disclosure about our food and I would like to see improvements there as well. I would like to know more about the types of fats in foods, if genetically-engineered ingredients are included, specifics about natural flavors, about the presence of excitotoxins, etc. Until we see more responsibility in this area, I see no reason to grant any looser standard to making health claims on food labels than on supplements.
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? Most likely, if someone is taking the time to read a label, they would notice any disclaimers. Unless there is a disclaimer that is very critical to notice, I don't see why we need to make a disclaimer a major feature on the label...smaller print should be fine.
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? The more specific the warning, probably the more seriously it will be taken. The more critical the warning is, the more prominence it should receive on the label. There will always be some people who don't read, but that is their own fault.
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 see why advertising cannot include anything that is allowed on the label; however, I if there are any disclaimers, they need to be included. I am bothered by drug advertising that say all these wonderful things, and then the disclaimers are very quickly glossed over, making it difficult to anyone to really absorbed what was said. When there are specific warnings, they need to be a larger part of the information presented. What we see now is not a balanced presentation with drug advertising.
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 would we allow claims to be made that have not been properly proven?
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? We need better enforcement of current regulations. We need better access to information that helps us determine which supplements are a good value. We need labels to be accurate and claims to be true. The current FDA disclaimer on supplement labels tends to serve as a warning for those who are not very familiar with supplements and how the system works. It would be of value if there was a specific warning for the product or if it was stated in such a way that simply reflects that the product is not subject to FDA approval.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? Encourage people to eat healthier foods and choose healthier lifestyles. Give us good information and eliminate shoddy supplements. Allow us to make informed choices and be able to exchange proven information about supplements instead of making this area so restrictive. Be very cautious when approving drugs.

EC -190