Docket Management
Docket: 02N-0209 - Request for Comment on First Amendment Issues
Comment Number: EC -299

Accepted - Volume 4

Comment Record
Commentor Mrs. Tracy Perry Date/Time 2002-07-31 01:04:40
Organization Mrs. Tracy Perry
Category Health Professional

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? The consumer must become better educated about the differences between drugs and dietary supplements. The drug companies have the advantage because more doctors promote drugs compared to dietary supplements. Also, drug companies are using the media to promote the sale of their product. As a certified member of the American Nutraceutical Associatin, I understand the importance of not making claims about the supplements I represent. The drug companies are using all avenues to show people their drugs are needed, but in reality it is just marketing. The marketing of drugs has become a big business, it is time better regulate the promotion of drugs in advertisements. Doctors must also become better educated and more aware of the uses and benefits of dietary supplements in order to make an informed decision on what is best for their patient. Right now, the answer is in a prescription.
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? It is important for consumer be aware of the positive and negative aspects of the pills they put in their mouth. Again, the use of media gives drug companies a direct advantage over dietary supplements. People are more apt to go to their doctor and ask about a pill they saw advertised on television if the ad was related to a symptom they are experiencing. Our society is driven by syptoms, if something is wrong give me something to fix it. We need to be more responsible for preventive care so that fixing is not the norm. I believe drugs have an unfair advantage in the doctor's plan of care because it is what pays their bills. Drug companies are big business. But more importantly, becoming a life and death situation. Doctors MUST be educated on all types of alternative therapies and not be held without pay for having an open mind.
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? People do not see dietary supplements as food. In essence dietary supplements are foods since they are provide nutrients for our bodies to use and to function better. Since we live in prescription society, I believe people are using supplements to relieve symptoms rather than understanding what their benefits are. Consumers must me more responsible ineducating themselves with what is in a product, how much is the actual ingredient and how effective it is. It is essential that a consumer be aware if a product contains the stated quality and amount of ingredient on the label.
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 am not aware of the social science on this issue. As a consumer, when something is bigger the more aware I am of it.
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? Ensuring manufacturers post any warning on a label is imperative. If a representative (or even doctor) is sharing the product with another person, they must be held accountable in sharing the entire list of warnings on a given product in the conversation. Warnings should be clearly marked on the label. Consumber are becoming more watchful of warnings that pertain to quality of life. The more specific the warning, the more effective.
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 grab the attention of a viewer more quickly than a label on a bottle. Those who create the advertisements put a lot of thought in the use of color, graphics, action, music etc. anything to get us to listen or read about the product. Claims in advertisements are at the end and are usually spoken quickly. For a television commercial, it may be a consideration to post the warnings on the bottom of the screen, slowly, while the commericial is playing. Or in an advertisement, to print the warnings more prominently so consumers are better aware of the negative aspect is of the product.
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? A product's off-label uses does not undermine the act's requirement that new uses must be approved by the FDA. If I know the product is proven safe, then I have security in knowing that it will not cause harm to use it in other purposes. The FDA should be made aware of any new uses and inform the consumers of such changes.
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 FDA's speech-related regulations do advance the public health concerns they are designed to address because the tight reign on what can or cannot be said may not be known to the average listener. The facts must be provided in a comprehensible manner and may be supplied in a written document after the speech. The promotion of reading health related topics on the internet may be a way to address additional issues.
9. Are there any regulations, guidance, policies, and practices FDA should change, in light of governing First Amendment authority? FDA should be more awre of the advertisements made on television, in magazines, or billboards. Many in the public are naive about what they read and if it says it in print, it must be true. The public must be made aware of the FDA's regulations, guidances, policies and practices. By being informed, we have a better understanding of what the FDA is doingf or us. I believe the FDA are the good guys trying to weed out the bad guys. Well, a few have gotten away, and many in the public are listening to every word they say. It is time to evaluate the claims made by all types of food or dieteary suppliers and question their product. Does it say what it should? Do they have good manufacturing practices? Is the amount and quality of ingredients correct? What scientific research is done on this product? (Science has a lot to teach us, let us use it to make more informed decisions.) In closing, I believe it is important for the FDA to take a look at what food actually does for and our bodies and ask the same question of everything they must approve.

EC -299