Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -323

Accepted - Volume 4

Comment Record
Commentor Ms. Tara Fayter Date/Time 2002-09-05 09:44:51
Organization n/a
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 strongly believe that corporations (including both drug companies and dietary supplement companies) should not be given commercial speech rights as people are given free speech rights. There are certainly arguments for regulating speech about drugs, tobacco, and other risky advertising. First of all, the FDA's job is to protect public health, and this can only be done effectively by regulating the ways that drug and other companies advertise. The advertising of tobacco, alcohol, pharmaceutical drugs, etc. greatly affects the public health crisis in the United States, because these advertisements often target people (minors in particularly) in a psychological way. More important than this aspect, however, is the fact that when large corporations are given the same rights as individuals, the free speech rights of individuals are largely nullified because they often do not have the money or power to make their case(s) the same way. We must stop giving corporations more rights than the individual. Taking the position that certain promotional speech about drugs is inherently misleading unless it complies with FDA requirements is a start, but must go further than this. The FDA's position must hinge on the public health of our nation and how we are to protect that. We must target not only academics and people in the health professions, but also consumers. Everyone must be made aware that the information they are receiving is largely biased on prospective sales.
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 not a professional in either the health or advertising fields, so I cannot honestly state what the empirical research on the effects of drug and other advertisements is. However, I can certainly attest to the negative effects of the industry's promotion of prescription drugs and other products (tobacco, alcohol, etc.) which clearly affect public health. Daily, I see people diagnosing themselves with disorders, diseases, and infections that they regularly see advertised. When I go to see my family doctor or specialist, he waits for me to prescribe myself than writes the official prescription. I am not the only one with this situation, as most of the people I know can get just about any drug prescribed to them simply by asking their doctors. The advertising of these drugs makes all of the necessary information readily available to the patients, and makes it far easier for them to misdiagnose themselves or get prescriptions for drugs that might actually do more harm than good. Doctors no longer prescribe to heal, they prescribe for pharmaceutical company kickbacks that they receive regularly. And their patients (which are really more like customers) help them. I believe the current regulations surrounding these drug advertisements do indeed lead to over-prescription. The more a commercial or advertisement is viewed, the more aware of it a person becomes, therefore finding it easier for him/ her to diagnose him/ herself with a certain disorder. I do not honestly know whether or not this contributes to increased doctor's visits, but it seems like a non-spurious relationship between advertising and attendance at doctor's offices. However, rather than causing patient visits that lead to treatment for under-diagnosed diseases, I think they may do exactly the opposite. I believe that certain conditions, often diagnosed as disorders or other abnormal situations, are often over-diagnosed. Behaviors and conditions that may be overall normal in Americans are often labeled as being abnormal or amiss so that drugs may be distributed and sales made. I have no input on the effect of this advertising on under-treated diseases, however. I don't think that most people are at all aware of the potential risks of the drugs they are prescribed because I firmly believe that even doctors aren't aware of all the risks. Things come out far after the fact, as with Phen-Fen and other such drugs. I believe the scientists who test these drugs may have some hint as to what might happen with the distribution of certain drugs, but are more aware of profit margin than the potential risks associated. I think the current implementation of regulations by industry does not necessarily directly impeded the ability of doctors to give good medical advice and treatment; however, I think the incentives are too often available to have a doctor diagnose and prescribe for a certain disease or disorder. Often, medical professionals know the kickbacks they might receive for certain actions on the part of patients, and that pushes them to act in a certain way, not always in the best interest of the public or their patients. This needs to be better regulated by halting incentives for doctors to take these particular actions.
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? Claims made to the FDA regarding conventional food and/ or dietary supplements should certainly be distinguished from each other. An administrative record must contain adequate definitions of what is necessary to regulate claims on food labels. For example, what is the purpose of labeling food?, What is our primary goal in allowing/ disallowing this claim?, etc. Foods must be labeled in the interests of public health, of course, but they must also be primarily in those interests. In other words, even if a company or corporation stands to lose sales upon labeling food that has been genetically engineered, they must label it because public health is at stake. People must also be made publicly aware of what food labels mean; this should also be included in an administrative record. Labels mean nothing if the general population does not understand what precisely is meant by the label and why it is important to them and their families. A good example is of food that has been irradiated for bacteria, but has been labeled as pastuerized. This is entirely unacceptable, because pasteurization and irradiation are two completely different processes. The general public must be told the difference between these two processes; the package must honesly depict what, in fact, has been done to the food they are purchasing. A brochure distributed at public places, such as supermarkets and other stores, libraries, office buildings, etc., would be a rather succint way of bringing to the general public's attention the difference between certain processes and what it all means. The same can be said about the distinction between conventional foods and dietary supplements; there is certainly a basis to believe that consumers approach claims about conventional foods and dietary supplements differently. People will often approach dietary supplements in certain atmospheres, or under certain conditions, as opposed to conventional foods (which might be targeted more aptly in a grocery store or general goods store). Dietary supplements are often targeted towards people with certain conditions, and should be noted as such.
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? My strong belief is that disclaimers should always be in the same size of type as other wording on a package. Of course, they should be given equal prominence with claims. However, I am not so naive as to think that this will ever be the norm. It is natural for advertisers to seek ways of promoting certain products in specific lights. Profit is always at the forefront of advertising. I think one need look no farther than marketing/ advertising research to see that most people in focus groups or surveys will be less likely to notice something in smaller print on a package. It gives the impression of being less important, when in reality, these disclaimers are often one of the most important aspects of a particular product. These disclaimers have the ability to impact a person's overall experience of the product.
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? One of the most obvious ways to prevent harm to consumers by certain products is to make disclaimers and other notices as large as other type on a product's packaging. The best way to prevent harm is to make consumers aware of the potential harm that awaits them in use of a particular product. I do not know what the research shows as evidence as to which types of warnings are followed most by consumers, but this seems like a rather simple and effective act to follow.
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? Advertising is often the first taste of a product that consumers receive. Because Americans are so adept at watching TV, driving their vehicles down highways riddled with billboards and other advertisements, and reading magazines containing more ads than articles, these advertisements are readily available to prospective consumers. Because of this, I think it's very important to note any disclaimers or warnings in advertisements AS WELL AS on product packaging. There is a large section of the population known as impulse buyers, as well, so there is also the chance that a consumer will buy a product without ever having seen it before and because of this, the labels must also contain disclaimers and warnings. Many companies and large corporations are granted first amendment rights in the same way that individuals are. I have already gone over the reasons I believe this is unfair and unconstitutional. We must not allow large entities to become known as individuals, because it threatens the rights and privileges of actual people. Any social science evidence that proves the above point that I have strived to make would likely admit that the Government is afforded greater latitude over labels than they should be. The policies regarding safety of consumers as addressed in disclaimers or warnings should apply to ALL ENTITIES within the United States. No one should be exempt when we are dealing with the safety and health of individual people.
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 new uses must be approved by the FDA, then all products approved for these uses should also be labeled with their possibilities. Therefore, there would be no off-label uses in a best case scenario. However, seeing that we're living in the real world and the best case scenario rarely prevails, I would be likely to say that the speech by these bodies of production has the potential to undermine the act's requirement of new use approval by the FDA, simply because new uses that have not yet been approved may be subtly marketed or advertised to the public. This, of course, could impact public health in a very negative way. The FDA has the ability to regulate speech by not affording corporations the same rights as individuals. Corporations should not be able to deviate from law by misleading consumers under the guise of free speech. The FDA must always work in the best interests of public health.
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 that the FDA's speech-related regulations could be better utilized by using some of the examples I've given above. Addressing public health concerns could be better done through assurance that large companies do not have the rights of individuals. They should not be permitted to mislead consumers for profit margin. Therefore, this issue does not boil down to restrictions on speech but corporate responsibility and concern for the public over any other goal.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? I believe everything I've previously stated sums up this answer.

EC -323