Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -289

Accepted - Volume 4

Comment Record
Commentor Ms. Helen Rabourn Date/Time 2002-07-30 17:27:52
Organization Ms. Helen Rabourn
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? Absolutely, drugs should be more regulated in both speech and administration than dietary supplements because of the toxins in drugs. I believe that promotional speech regarding drugs is misleading in that generally speaking people don't have sufficient information to determine the value of one particular drug versus another when only receiving information on one drug at a time. I have even heard doctor's say that there are so many drugs and new ones becoming available all the time that they can't possibly know all they'd like to know about each one, so it often presents a problem for them in caring for a patient when the patient is adamant about taking a drug that they heard about on TV, when the doctor doesn't really know much about that particular drug. I also believe that another problem is that doctor's tend to get most of their ongoing information regarding the medical field from Drug companies once they complete school and begin practicing medicine. Don't get me wrong, I believe Drug Companies have the right to provide new information directly to professionals in the medical field who have the position of reference to assimilate the information and ask questions. And, I think there should be information assessible to the ultimate consumer regarding all drugs, especially their side effects. In fact, I think the information regarding side effects should be bolded and in larger NOT SMALLER print. On the other hand, I'm very concerned about the FDA becoming involved in placing anymore limitations on natural dietary supplements other than labeling and justified cautions. However, I am concerned that the money associated with drugs tends to cause the FDA to focus on drugs and either not seel to learn the value of natural supplements or to limit the presence of natural suppliements in the market because they may ultimately reduce the consumption amounts of drugs. If anything,I want more ability to receive and share better information about value, content, usage and results of using natural products. Just as with food, I want to see what's in the product but to be able to purchase what I choose to eat. And, I want to get to the point in time, where people once again don't see the doctor's and medical field as the only place to find good information about their health.
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 don't have all the answers in terms of research, but I truly believe and have experienced individual response which indicates that the many advertisements leads people to believe that there's a fix (drug) for everything and the one they just heard advertised is it. I believe it is highly possible that the advertisement of drugs causes people to go to the doctor seeking cures, but only getting treatments. I also think that people tend to do more self-diagnosing as a result of advertisements constantly being placed in front of them when otherwise, they wouldn't see their symptoms to be worthy of a doctor visit. NO, there is nothing that leads to adequate undertstanding of risks unless they receive detailed information regarding the risks directly from their doctor and have to sign something stating that they understand the risks and choose to take the drug anyway. Personally, I've never read those small print warnings that come with the drugs prescribed by my trusted doctor, who by-the-way is trusted because I know (s)he attended many years of school in order to be allowed to practice medicine, and because of my perception of the requirements to get into medical school being so stringent that only the really intelligent (and ethical) people make it.
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 don't believe that the FDA needs to be nearly as concerned with the labeling of either foods or dietary supplements as with drugs. However, when it comes to the labeling on foods and/or dietary supplements, I bleieve some of the current labeling is misleading and therefore, I have great reservations about future regulations without giving concern to what is currently misleading. Example: daily recommneded amount (based on what criteria -- since all people are not built the same, the criteria can't possibly be the same for all people). And, I don't want to see anything that makes it more difficult for me to make my personal choices. I am concerned, however, with the ability for products to be offered on the market which make claims of contents which are in a form which cannot be readily used by the body. Example, minerals in the form of rocks and dirt versus water solable or in a food form which the body can easily absorb and use. I personally want to be able to receive information about an individual's personal story (either directly from that person or from someone who has knowledge of that person) which supports the performance of a particular product. I prefer that the penalties be against people who fabricate or misuse information rather than there being an upfront penalty on everyone to limit and prevent them from sharing information that may be helpful to individuals trying to address health concerns, especially those which are life-threatening. I believe that people have a right to know that there are dietary supplements which people have taken when experiencing certain symptoms with positive results up to an including the disappearance of the symptoms. Yes, I beleive that consumers appraoch claims about conventiona foods and dietary supplements differently. They tend to accept what they know and rejct what they do not know. Therefore, if it still looks like the tomato they grew in their own garden (and picked at that just right ripened stage), why should they suspect that it does not contain the nutrients that they know a tomato to have. Therefore, they buy it in the supermarket and bleieve it is healthy food, when in actuality they are not receiving the nutrients they believe it to have. The same is true of other products which have been altered through the method of preparation and methods of perservation. A perserved apple is no comparison to a perserved apple. Yet, food is accepted more at face value than dietary supplements. Dietary supplements tend to be more in suspect because people don't have information about them. Then, when they do receive information, they either don't know how to differientiate between brands or they accept the first information and brand they gain awareness of as gospel. However, I would rather have this as the situation than to be limited in my ability to choose or to share information regarding a particular product with others.
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? Known risks should be in bold and larger print, disclaimers such as this product is not intended as a cure don't need extra emphasis. In fact, in my opinion since drugs only treat symptoms and don't cure, I believe they ought to be required to include this disclaimer unless the particular drug has been able to reduce and sustain a decreased occurrence of a particular disease. I am not aware of a rleevant authority or social science research. I just believe in consumer choice of natural products and right to make choices relative to toxic drugs based on known risks versus benefits information provided upfront before treatment to the extent known.
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? Good and open communication between all parties invovled: patients/consumers, doctors, drug companies, etc. I don't have evidence, but I'm sure that consumers have a tendancy to follow warnings about products not prescribed by their doctors more so than by the warnings on drugs prescribed by their doctors if those warnings are not verbally empasized by them by their doctors. However, until there can be assurance that all doctors have and are receiving quality, current and complete information about dietary supplements, I would be stronly opposed to requiring that these supplements be prescsribed only through doctors. However, I am a strong proponent of doctors being required to learn more about the dietary supplement field and its benefit in addressing symptoms experienced by patients. And, I also believe that people who are successfully using dietary supplements to reduce and avoid the need to seek medical treatment for symptoms or disease should be able to receive some form of credit through the medical insurance programs.
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? Advertisements on TV and radio provide the consumer with only what they are able to glean from the short exposure to the ad. Therefore, they will tend to only remember the benefit (positive) information and if they are looking for a cure to particular symptoms, they are going to have a greater tendancy to seek that drug than not. If I had my way, I'd eliminate the advertising of drugs in open media because I believe the senationalism of the media world is less than favorable to the end user.
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 think at times they are just as, if not more limiting than the intent, if the intent is to provide for the better and health of individuals.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? This is a difficult question for me because I want honesty of both the good and the bad information. And, I feel that currently economics drives more decisions than ethics. I want to see more ability for dietary supplements which have proven track records to be marketed in a broader manner to all people and if possible with the approval of the medical community because of people's tendancy to listen to the medical community. But, in the interim, I don't want to see us go backwards in terms of the progress made to date.




EC -289